Professionals Association 2018 SAPA Annual Conference ... · Sino ⬧ 2018 SAPA Annual Conference...

www.sapaweb.org ⬧ 2018 SAPA Annual Conference ⬧ October 5 and 6, 2018

October 5 – 6, 2018

DoubleTree by Hilton

Somerset Hotel and Conference Center

200 Atrium Drive

Somerset, NJ 08873, USA

Sino-American Pharmaceutical Professionals Association

2018 SAPA

Annual Conference

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Bridging US & China’s Pharmaceutical Industries Expediting Treatments for Patients

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Dear SAPA members and friends,

On behalf of Sino-American Pharmaceutical Professionals Association, I would like to give you all warm welcome to SAPA 2018 Annual Conference, on the occasion of SAPA’s 25th Anniversary. This Annual Conference will focus on the theme “Bridging US and China’s Pharmaceutical Industries – Expediting Treatments for Patients”, and it is the biggest event in SAPA history in terms of the duration, the participants and level of distinguished speakers.

During the past year, it has been my great honor and pleasure to lead this amazing organization. To achieve the four missions of SAPA – to promote the advancement of pharmaceutical science and biotechnology; to make contributions benefiting public health education; to promote scientific exchange and business cooperation between US and China; to foster the career growth of pharmaceutical professionals – SAPA headquarters and our chapters have carried out many

activities. We summarize these four missions as “Science, Education, Collaboration, Career” in the promotion flyer of 2018 SAPA Annual Conference. This year, in addition to SAPA traditional flagship events: Scientific Symposium, Career Development Workshop and Annual Conference in the US, we started a new series, called the Pharma and Biotech Investment Forum and Project Road Show. The investment forum was held at Columbia University which has close proximity to the capital and investors of Wall Street. We achieved remarkable success exceeding our expectation. Our goal is to make this investment forum an annual meeting in New York City. To promote scientific exchange and business collaboration between the US and China, SAPA continued its tradition in organizing the two major events in Beijing and Shanghai – the 21st Beijing International Healthcare Industry Forum in November 2017 with Beijing Municipal Science and Technology Commission, and the 20th Shanghai BioForum in May 2018 with Modern Biotechnology & Pharmaceutical Industry Office of Shanghai Municipal. During the past year, SAPA also initiated collaboration with many secondary major cities in China with the corporative supports from SAPA headquarters and chapters. SAPA organized the first Sino-American (Taizhou) International Biomedicine Development Forum in Taizhou Zhejiang, which attracted more than 300 participants. Because this is SAPA’s 25th Anniversary, this year’s annual conference is extended to a two-day event, with many distinguished speakers including 2017 Nobel Laureate in chemistry Professor Joachim Frank from Columbia University. The conference will have two morning plenary sessions plus ten parallel sessions in the afternoon:

• Cutting-edge Technology to Expedite Breakthrough Therapies

• SAPA Healthcare Investment Forum

• Clinical Drug Development: Update on Recent Advancements and Challenges

• Regulatory Considerations for Generic Drug Bioequivalence Studies

• Evolving Landscape for Cell and Gene Therapies

• CEO Forum – Beyond Pharma Horizon

• Business Development and Corporate Development Forum

• Career Development: Develop Your Entrepreneurship

• Market Access and Commercialization

• Breakthrough Technology: AI and Medicine During this conference, SAPA will also arrange investors and business development managers to have one-on-

one meeting with entrepreneurs for investment and collaboration opportunities. At the same time, there will be a huge job fair with more than 40 companies and hundreds of job openings to recruit talents.

Please take advantage of this conference to learn the new trends in pharmaceutical industry, network with industry experts from across the globe, search for collaboration opportunities and explore next step in your career development.

I would like to acknowledge the continuous support of SAPA Board of Directors, the great contribution of SAPA Executive Council and hundreds of volunteers to SAPA activities, the tremendous participation and support of SAPA members and friends to SAPA events, and the generous sponsorship by SAPA corporate members. We look forward to the continuous development of SAPA in the next 25 years and beyond.

Sincerely,

Jian Liu, PhD SAPA President and 2018 SAPA Annual Conference Chair

2018 SAPA

Annual Conference

Greeting Message from the SAPA President


2018 SAPA Annual Conference Program at a Glance

Friday, October 5, 2018

7:30 am – 5:00 pm Registration Lobby

8:50 am – 12:30 pm Plenary Session 1: Cutting-edge Technology to Expedite Breakthrough Therapies

Ballrooms

12:30 – 1:30 pm Lunch Mirabelle

1:30 – 5:00 pm Parallel Session A: SAPA Healthcare Investment Forum Ballroom Center

1:30 – 5:00 pm Parallel Session B: Clinical Drug Development: Update on Recent Advancements and Challenges

Ballroom West

1:30 – 5:00 pm Parallel Session C: Regulatory Considerations for Generic Drug Bioequivalence Studies

Ballroom East

1:30 – 5:00 pm Parallel Session D: Private! One-to-One! Pre-scheduled! Direct communication

Hillsborough, Princeton, Westfield

1:30 – 5:00 pm Parallel Session E: SAPA Job Fairs Vendor booths

5:30 – 6:30 pm SAPA Reception Mirabelle

7:00 – 9:00 pm SAPA Annual Gala Dinner Ballrooms

Saturday, October 6, 2018

7:30 am – 5:00 pm Registration Lobby

8:50 am – 12:30 pm Plenary Session 2: Advancing Pharmaceutical and Biotechnology Development

Ballrooms

12:30 – 1:30 pm Lunch Mirabelle

1:30 – 5:00 pm Parallel Session F: CEO Forum – Beyond Pharma Horizon Ballroom Center

1:30 – 5:00 pm Parallel Session G: Business Development and Corporate Development Forum

Ballroom West

1:30 – 5:00 pm Parallel Session H: Career Workshop: Develop Your Entrepreneurship

Ballroom East

1:30 – 3:40 pm Parallel Session I: Market Access and Commercialization Executive Parlor 158

1:30 – 5:00 pm Parallel Session J: Breakthrough Technology: AI and Medicine Executive Parlor 164

1:30 – 5:00 pm Parallel Session D: Private! One-to-One! Pre-scheduled! Direct communication!

Hillsborough, Princeton, Westfield


2 Greeting Message from the SAPA President

3 Annual Conference Program at a Glance

5 About SAPA

9 SAPA Events – A Year in Review 2017-2018

12 Conference Program

29 Biographies of Speakers and Panelists

40 SAPA Annual Conference Session Moderators

42 SAPA Service Excellence Award

43 2018 SAPA Scholarship & Excellence in Education for Life Sciences

44 2018 SAPA-ForDoz Graduate Travel Grant

45 SAPA Corporate Sponsors

2018 SAPA

Annual Conference

Table of Contents


SAPA Mission

• To promote the advancement of pharmaceutical science and biotechnology

• To make contributions benefiting public health education

• To promote scientific exchange and business cooperation between US and China

• To foster the career growth of pharmaceutical and biomedical professionals

Introduction to SAPA

SAPA was founded in 1993 in the US as a non-profit organization and since then has grown rapidly and become one of the most active and well-recognized professional organizations in the US with a membership base of over 6,000. SAPA is headquartered in the Greater New York area (NJ/NY/CT) with six US regional chapters (SAPA-NE in New England, SAPA-GP in Greater Philadelphia, SAPA-CT in Connecticut, SAPA-DC in Greater Washington DC area, SAPA-MW in Midwest area, and SAPA-West in West Coast), and one chapter in China. SAPA members are engaged in drug discovery, pre-clinical & clinical development, manufacturing, regulation, marketing, and distribution of pharmaceuticals and biotech therapeutic products. To fulfill its missions, each year SAPA and its regional chapters organize and sponsor many events including annual conference, scientific symposia, seminars, workshops, and social activities both in the US and China. These events have been supported and sponsored by many organizations, including major pharmaceutical, biotech and CRO companies as well as many Bio-Parks and Development Zones in China.

SAPA Organization Structure

• SAPA Executive Council (EC): President, President-Elect, Immediate-Past-President, Executive Vice President, Vice Presidents, General Secretary, EC Members, and Standing Department Heads. Conducting SAPA daily operations, organizing SAPA events and activities.

• SAPA Board of Directors (BD): BD Chair and BD Members including SAPA President and Immediate-Past-President. Setting up policies and regulations, nominating and approving SAPA officers, and guiding SAPA direction.

• SAPA Advisory Committee (AC): Chaired by SAPA Immediate-Past-President and over 20 AC Members. Advising, guiding and supporting.

SAPA Locations

• SAPA Headquarters: New Jersey, USA

• SAPA-CT (Connecticut Chapter): Connecticut, USA

• SAPA-DC (Greater Washington DC Chapter): Greater Washington DC areas, USA

• SAPA-GP (Greater Philadelphia Chapter): Philadelphia and other Pennsylvania areas, USA

• SAPA-MW (Mid-West Chapter): Illinois and Indiana areas, USA

• SAPA-NE (New England Chapter): Boston and New England areas, USA

• SAPA-WEST (West Chapter): California, USA

• SAPA-China: China

2018 SAPA Annual Conference

2018 SAPA

Annual Conference

About SAPA

美中醫藥開發協會

Sino-American Pharmaceutical Professionals Association


President Jian Liu, PhD

President-Elect Xiaole Shen, PhD

Immediate-Past President Lei Tang, PhD

Vice Presidents and Jasmine Cui, PhD, Han Dai, PhD, Alicia Liu, PhD, Fred Yang, PhD, Chapter Presidents Jun Johnny Yang, PhD, and Jin Zhou, PhD

Executive Council (EC) Members

Larry Cai, MBA

Xiaodong Chen*, PhD

Mangeng Cheng, PhD

Haifeng Cui, PhD

Han Dai, PhD

Xing Dai, PhD

Vince Deng, PhD

Wei Ding*, PhD

Xin Du*, PhD

Helena Feng*

Amanda Fu, MD

Frank Gan*, PharmD

Chenchao Gao, PhD

Jiachang Gong, PhD

Hong-Ping Guan*, PhD

Yong Guo*, PhD

Mike Hu, PhD

Qiying Hu, PhD

Jasmine Huang

Lisa Huang, PhD

Yanming Jiang

Jerry Li, PhD

Junfang Li, PhD

Kejie Li, PhD

Yufeng Li

James Liu*, PhD

Jian Liu, PhD

W. Jerry Liu*, PhD, JD

Xiuling Lu, PhD

Fang Shen, PhD

Xiaole Shen, PhD

John Tan, PhD

Lei Tang, PhD

Li Wan, PhD

Hui Wang, PhD

Jack Wu, PhD

Zhenhua Wu, PhD

Aiguo Xu*, PhD

Lin Yan, PhD

Fred Yang, PhD

Guangyao Yang*

Jun Johnny Yang, PhD

Yong Yue, PhD

Aming Zhang, PhD

Zhao Zhang, PhD

Yiming Zhao, PhD

Jin Zhou, PhD

Wenping Zhou, PhD

*Department Directors

Board of Directors (2017-2019)

Jiwen Chen, PhD

Jisong (Jasmine) Cui, PhD

Weiguo Dai, PhD

Handan He, PhD

Jun-Yan Hong, PhD

Jiangbin (John) Hu, PhD

Baoguo Huang, PhD

Huo Li, PhD

Mark Lin, PhD

Min Li, PhD

Yongmei Li, PhD

Jian Liu, PhD

Lei Tang, PhD

Huayi Tong, PhD

Charles Wang*, PhD

Jianji Wang, PhD

Yusheng Wu, PhD

Mingde Xia, PhD

Zhi-Xin (Rick) Xu, PhD

Steven Yu, PhD

Hancheng Zhang, PhD

Xiangyang (Sean) Zhang, MD

Zhongda Zhang, PhD

*Chair of the Board of Directors

Sino-American Pharmaceutical

Professionals Association

www.sapaweb.org


Advisory Committee Members

Bao-lu Chen, PhD

Harry Chen, PhD

Jiwen Chen, PhD*

Keting Chu, PhD

Weiguo Dai, PhD

Jian Zhong Guo, PhD

Kewen Jin, PhD

Junning Lee, PhD

Jenny Li, PhD

Jian Li, PhD

Kechun Li, PhD

Xiaoling Li, PhD

Mark Lin, PhD

Shiwen Lin, PhD

Cheng Liu, PhD

Puchun Liu, PhD

Yongchun Shen, PhD

Li Shi, PhD

DQ Wang, PhD

Jin Wang, PhD

Jingsong Wang, PhD

Shifeng Wei, PhD

Jun Xiang, PhD

Li Yan, PhD

Dan Zhang, PhD

Hancheng Zhang, PhD

Yong Tony Zhang, PhD

Qunyi Zheng, PhD

Jian Zhu, PhD

*Chair of the Advisory Committee

Former SAPA Presidents

Xiucai Liu, PhD 1993-94

Guohua Zhang, PhD 1994-95

Jun-Yan Hong, PhD 1995-96

Bill S. Wei, PhD 1996-97

Puchun Liu, PhD 1997-98

Junning Lee, PhD 1998-99

Lihu Yang, PhD 1999-00

Rick Z-X Xu, PhD 2000-01

Li Chen, PhD 2001-02

Jianzhong Guo, PhD 2002-03

Min Li, PhD 2003-04

John J. Hu, PhD 2004-05

Yusheng Wu, PhD 2005-06

Charles Ying Wang, PhD 2006-07

Hancheng Zhang, PhD 2007-08

Mingde Xia, PhD 2008-09

Jisong Cui, PhD 2009-10

Jianji Wang, PhD 2010-11

Baoguo Huang, PhD 2011-12

Handan He, PhD 2012-13

Jiwen Chen, PhD 2013-14

Ning Yan, PhD 2014-15

Weiguo Dai, PhD 2015-16

Lei Tang, PhD 2016-17


Veronica Chen, PhD

Xiaodong Chen, PhD

David Cragin, PhD

Weiguo Dai, PhD

Xing Dai, PhD

Xin Du, PhD

Helena Feng

Frank Gan, PharmD

Chenchao Gao, PhD

Hong-Ping Guan, PhD

Yong Guo, PhD

Lisa Huang, PhD

Yanming Jiang

Cai Li, PhD

James Li, PhD

Junfang Li, PhD

Jerry Li, PhD

Zili Li, MD

James Liu, PhD

Jian Liu, PhD

Ling Liu, PhD

Wansheng Jerry Liu, PhD, JD

Su-Fen Pu, MD, PhD

Xiaole Shen, PhD

John Sun, PhD

John Tan, PhD

Lei Tang, PhD

Norman Tang

Li Wan, PhD

Charles Wang, PhD

Jian Wang, PhD

Jin Wang, PhD

John Wang, PhD

Wenyan Wang, PhD

Jack Wu, PhD

Aiguo Xu, PhD

Stephen Xue

Lin Yan, PhD

Guangyao Yang

Jianda Yuan, MD

Le Zhan, PhD

Xiaowei Zang

Aming Zhang, PhD

Yiming Zhao, PhD


Organizing Committee

Conference Chair: Jian Liu, PhD

Conference Co-Chair: Xiaole Shen, PhD


Date Chapter Event Location

Sep 20 & 22, 2017

SAPA-China Co-organized 2017 the 5th Pharmaceutical R&D Symposium - “Development and Application of Emerging Technology in Biologic Drug R&D”

Shanghai & Chengdu, China

Sep 23, 2017 SAPA-DC Successfully held the 2nd Annual Conference - “Drug Launch Make It Happen Global Development and Commercialization”

Washington DC

Sep 29-30, 2017 SAPA-HQ Successfully held the 25th Annual Conference - “Advancing Pharmaceutical and Biotechnology Development through Global Collaboration: Challenges and Opportunities” with more than a thousand attendees

NJ

Oct 1, 2017 SAPA-GP Hosted Pharmaceutical Career Development Workshop Columbia University

Oct 7, 2017 SAPA-CT Successfully held the 4th Annual Conference - “Adapting to the Changes in Biotech/Pharmaceutical Industry”

Yale University

Oct 19-20, 2017 SAPA-China Supported the 3rd PharmaCon2017 Shanghai, China

Oct 20, 2017 SAPA-HQ Held dinner meeting with Kelun Pharmaceutical Research Institute delegation

NJ

Oct 21-22, 2017 SAPA-GP Launched the 1st end to end Advanced Course on Pharmaceutical R&D

PA

Oct 28, 2017 SAPA Held 2017-2018 Executive Council Meeting NJ and Online

Nov 2-3, 2017 SAPA-China Co-organized Scientific Symposium - “Research on Drug Impurities - Methodologies, Strategies, Regulatory Filing, and Case Studies”

Suzhou, China

Nov 16, 2017 SAPA-HQ Hosted 1st Regulatory Affairs Webinar - “Overview of FDA Orphan Drug Designation and Its Application”

Online

Nov 29, 2017 SAPA-HQ SAPA-HQ representatives hosted visit by CFDA leaders Beijing, China

Nov 29-Dec 1, 2017

SAPA-EC Co-organized the 21st Beijing International Healthcare Industry Forum

Beijing, China

Dec 1-3,2017 SAPA-China Co-organized the China-US International Pharmaceutical Development Forum with the government of Taizhou

Taizhou, Zhejiang Province, China

Dec 2, 2017 SAPA-GP Organized Cell and Gene Therapy Forum - “Breakthrough Science and Technology in CGT”

Philadelphia, PA

Dec 3, 2017 SAPA-HQ Held meeting with officials from Modern Biotechnology & Pharmaceutical Industry Office of Shanghai Municipal

Shanghai, China

Dec 14, 2017 SAPA-HQ Hosted the visit of ShenZhen Neptune’s Group NJ

Dec 18, 2017 SAPA-HQ Hosted the visit of delegation from Jiangshu Nanjing Gaochun District

NJ

Dec 19, 2017 SAPA-HQ Held 2nd Regulatory Affairs Webinar - “Overview of Chinese CRO Regulation, Current Status and Potentials”

Online

Dec 22, 2017 SAPA-HQ Held SAPA Senior Leadership Strategy Meeting NJ

Jan 14, 2018 SAPA-HQ Co-organized the visit of BGI delegation with BioKatalyst NJ

Jan 30, 2018 SAPA-HQ Hosted the 3rd Regulatory Affairs Webinar - “Regulatory Guidelines Governing Non-Clinical Safety Evaluation in Drug Development”

Online

Feb 10, 2018 SAPA-HQ Chinese New Year Celebration NJ

Feb 28, 2018 SAPA-HQ Hosted the 4th Regulatory Affairs Webinar - “Overview and Insights on U.S. Medical Device Regulations”

Online

Mar 3, 2018 SAPA-DC Co-organized the Career Workshop with Hopkins Biotech Network Washington DC

Mar 3, 2018 SAPA-GP Held the 2017-2018 Annual Committee Meeting PA

Mar 5, 2018 SAPA-HQ Held strategic partnership discussion with Medicilon NJ

Mar 23, 2018 SAPA-China Organized the Forum of Immuno-oncology in Precision Medicine Shanghai, China

Mar 24, 2018 SAPA-HQ Held the Career Development Workshop NJIT

Mar 29, 2018 SAPA-HQ Hosted the 5th Regulatory Affairs Webinar - “Key Consideration in the Successful Global Regulatory Strategy Development for Anti-Cancer Targeted Therapy”

Online

Apr 2, 2018 SAPA-HQ Hosted visit by delegation from Jiangsu Changzhou CND NJ


2018 SAPA

Annual Conference

SAPA Events – A Year in Review 2017-2018


April 7, 2018 SAPA-HQ Organized the Scientific Symposium - “Current Trends in Drug Development: From Discovery to Clinical Application”

Princeton University

April 19, 2018 SAPA-HQ Hosted the 6th Regulatory Affairs Webinar - “Regulatory Pathways for Cell and Gene Therapy Products”

Online

April 20-22, 2018 SAPA-China Cooperated the Taihu Healthcare Forum - “2018 Biotech Pharmaceutical and Financial Innovation”

Wuxi, China

May 13, 2018 SAPA-CT Held the Career Development Workshop - “Making the Leap - prepare for a career in life sciences”

University of Connecticut

May 19, 2018 SAPA-HQ Organized 2018 Career Development Workshop - “The Missing Piece”

Rutgers University

May 23-25, 2018 SAPA-HQ Organized “Small Molecule Target Therapies” in Shanghai Bio-Forum 2018

Shanghai, China

May 20, 2018 SAPA Co-organized the event - “How to start a Tech Company: IP, Ownership/Equity, Funding, Marketing and other Aspects”

Columbia University

May 24, 2018 SAPA-HQ Hosted the 7th Regulatory Affairs Webinar - “Regulatory Consideration for Clinical Development in Product Life Cycle Management”

Online

May 28, 2018 SAPA-HQ SAPA-HQ representatives visited China National Genebank and discussed collaboration with Huada Gene Research Institute

Shenzhen, China

Jun 2-3, 2018 SAPA-NE Successfully held the 20th Annual Conference – “Helping Patients with Unmet Needs Through Innovation and Collaboration”

Cambridge, MA

Jun 4, 2018 SAPA-HQ Hosted the visit by delegation from Zhejiang Hangzhou NJ

Jun 4-5, 2018 SAPA-China Co-organized the Jiaxing Forum titled “Formulation Process Development and the Key of Clinical Evaluation”

Jiaxing, Zhejiang Province, China

Jun 8-9, 2018 SAPA-GP Successfully held the 16th Annual Conference – “Reshaping Global Pharma Ecosystem”

King of Prussia, PA

Jun 9, 2018 SAPA-GP Successfully held Pharma R&D Executive Forum and Pharma R&D 360° Training Course

King of Prussia, PA

Jun 16, 2018 SAPA-HQ Successfully organized 2018 Pharma and Biotech Investment Summit and Roadshow for investors and companies

Columbia University

Jun 17, 2018 SAPA-HQ Hosted the visit by delegation from Jiangsu HoDo group and established partnership

Edison, NJ

Jun 27, 2018 SAPA-HQ Hosted the 8th Regulatory Affairs Webinar – “Basics of U.S. Patent Law for Pharmaceutical Professionals”

Online

Jun 30, 2018 SAPA-HQ Granted scholarship for selected high school graduates

Jun 30, 2018 SAPA-DC Hosted Scientific Symposium and 3rd NIH-CSSA Annual Research Symposium - “From Discovery to Translation: Immuno-oncology, Cell and Gene Therapies and Novel Methods of Drug Delivery”

Rockville, MD

Jul 3, 2018 SAPA-HQ Announced the 2018 SAPA-ForDoz Graduate Travel Grant for Graduates and Post-Doctors

Jul 7-8, 2018 SAPA-China Supported 2018 Healthcare Investment Future Pioneers Forum Shanghai, China

Jul 14, 2018 SAPA-CT Co-organized the 2018 SAPA-CT Summer Picnic Indian Wells State Park, CT

Jul 21, 2018 SAPA-HQ SAPA friends and families get together at the 2018 SAPA-HQ Summer Picnic

Johnson Park, Piscataway, NJ

Jul 27, 2018 SAPA-HQ Hosted the visit by delegation from Jiangsu Changzhou to NJCCIT NJ

Sep3, 2018 SAPA-HQ Hosted the visit by delegation from Henan Food and Drug Administration

NJ

Sep 8, 2018 SAPA-DC Organized the 2018 SAPA-DC Summer Picnic Black Hill Regional Park, MD

Sep 10, 2018 SAPA-HQ SAPA-DC

SAPA-HQ and DC leadership team held meeting with delegation from NMPA and PhRMA for collaboration

DC


Friday, October 5, 2018

7:00 am – 5:00 pm

Registration

Friday, October 5, 2018, 8:50 am – 12:30 pm Ballrooms

Plenary Session 1: Cutting-edge Technology to Expedite Breakthrough Therapies Session sponsor:

Session Moderators: Jian Liu, PhD, Xiaole Shen, PhD, and Lei Tang, PhD

More and more cutting-edge and disruptive technologies have been developed in recent decades. They enable the expansion of a large number of new targets, realize the application of new modalities, and allow the mass production of complicated biologics, cell and gene therapies. The plenary session brings together great presentations on diverse topics ranging from development strategies on vaccine discovery, development and commercialization, Nobel-winning cryo-electronic microscopy technology, new digital capabilities and computer capacities to leverage artificial intelligence and digital health, pediatric clinical trial, to the bioprocess for production of biologics drugs for various diseases.

8:50 – 9:20 am

Opening Remarks Jian Liu, PhD, SAPA President, Principal Scientist, External Discovery Chemistry, Merck Jijun Xing, PhD, Counselor Consul for Science and Technology, Chinese Consulate General in New York

Gordon M. Johnson, Deputy Assembly Speaker of New Jersey Assembly

9:20 – 9:50 am Global Vaccines, Merck: Legacy of Partnership and Public Health Impact in China Michael Nally, MBA, President Global Vaccine, GHH, Merck & Co.

China has become a top player in the global economy. With its population of 1.4B people,

large birth cohort, impressive growth rates, and government focus on improving healthcare, it

represents a tremendous opportunity for healthcare companies both in terms of public health

and business impact. Merck is one of the few companies that remain dedicated to the complex

business of researching and producing vaccines. From Hepatitis B to Rotavirus and HPV-

related Cancers and Diseases, Merck Vaccines has been working with local partners for many

years to expand access to vaccines in China. This session will highlight this history and

examine the opportunities and challenges that the company faces in pursuit of its goal to help

protect current and future generations from vaccine preventable diseases in China.

2018 SAPA

Annual Conference

Conference Program


9:50 – 10:35 am Cryo-Electron Microscopy of Biological Molecules, and the Future of Structural Biology Joachim Frank, PhD, Professor, Biochemistry and Molecular Biophysics, Columbia University; 2017 Nobel Laureate in Chemistry

With the advent of direct electron detection cameras, the single-particle approach in electron microscopy to determination of structure has come to full fruition. Crystallization is no longer needed for structure research, and the full range of functionally meaningful conformations can be recovered. This gives single-particle cryo-EM a prominent position in structural biology, promising a large expansion in the number of drug targets suitable for molecular medicine.

10:35 – 11:00 am Coffee Break

11:00 – 11:30 am Digital Innovation Matters: How Advanced Analytics and Technology are Accelerating the Fight Against Unmet Medical Needs Paul von Autenried, MS, PMD, Sr. Vice President, Chief Information Officer, BMS

Professionals advancing the biopharma space are using analytics at an unprecedented level and raising the bar on what could be promising scientific advances. Data scientists and IT leaders are enabling capabilities that accelerate efforts to discover, develop and deliver innovative medicines that help patients prevail. Paul von Autenried, Bristol-Myers Squibb's CIO, is leading the company's efforts to position the company for success in the digital era. His team is planning and building new digital capabilities, increasing computing capacity, leveraging artificial intelligence and co-sponsoring the company’s digital health initiatives. He'll give you his vision of digital health and share real world examples of the impact it is making on patients.

11:30 am – 12:00 pm

Developing World-class Innovative Technologies to Enable Affordability of Biologics Chris Chen, PhD, CEO, WuXi Biologics

Biologics are difficult to manufacture which limits market uptake of biotherapeutics. Through developing high-yield cell line, innovative processing technologies and disposable manufacturing technologies, WuXi Biologics can potentially manufacture traditional monoclonal antibody and novel bispecific antibody developed using WuXiBody platform at a cost of $15-50 per gram, enabling these novel medicines to be accessible in emerging markets.

12:00 – 12:30 pm Engineering Antibodies for Cancer Cure – A Pediatric Perspective Nai-Kong Cheung, MD, PhD, Head, Neuroblastoma Program, Enid A Haupt Chair in Pediatric Oncology, Memorial Sloan Kettering Cancer Center

Conventional IgG monoclonal antibodies (mAbs) rely on Fc-dependent mechanisms with insufficient potency because of poor therapeutic index and limited effector cell traffic/function. Novel antibody platforms can overcome these limitations. Bispecific antibodies (BsAb) have the potential to turn circulating polyclonal T cells into tumor-infiltrating cytotoxic T cells without MHC-restriction to overcome the immunosuppressive tumor microenvironment. BsAb can also be exploited to deliver massive doses of beta or alpha radiation in multistep targeting with vastly improved therapeutic indices. Antibody based therapeutics should provide curative options with minimal toxicity for cancers in children and young adults.

Friday, October 5, 2018, 12:30 – 1:30 pm Mirabelle

Lunch and Networking


Friday, October 5, 2018, 1:30 – 5:00 pm Ballroom Center

Parallel Session A: SAPA Healthcare Investment Forum

Session Moderators: Xiaodong Chen, PhD, Jin Wang, PhD, and Bob Ai, PhD

Building on the success of the past year’s Venture Forum as well as SAPA Pharma/Biotech Investment Forum and Roadshow events, SAPA is again to host a healthcare investment forum highlighting our ongoing commitment to promote business cooperation between US and China. We are bringing together key influencers in venture capital at different stages, corporate business development professionals, technology transfer professionals in top US universities, entrepreneurs and legal counsels. This session will feature presentations on life science investment trend both in US and China as well as cross border investment. Entrepreneurs will share their journey and experience. In the panel discussions that follows, you will hear key issues facing investors and startups, successful cases and tips of fundraising.

1:30 – 2:00 pm Current Trends in Healthcare Investment

Dennis J Purcell, MBA, Founder and Senior Advisor, Aisling Capital LLC

2:00 – 2:30 pm Capital Markets Performance In US & HK and Trends In Cross Border Investing Debra Yu, MD, Managing Director, Cross Border Healthcare & Life Sciences, China Renaissance

• Overview of the HK market performance

• HK biotech: lessons learned and forward view

• Overview of the US market performance

• US interest in Chinese stories

• Cross-border opportunities

2:30 – 3:00 pm The Evolution of Life Sciences Venture Capital and the Company Creation Model Chris Garabedian, CEO, Xontogeny

Over the last 10 years, the role of Venture Capital has evolved toward taking a more active role in company creation. Specifically, the structure and financing of life science companies has moved toward more platform discovery research that hold the promise of transforming medicine, but require larger pools of capital and many years before derisking and validating a new technology. This trend has also generated alternative structure models and an interest in alternative sources of capital for technologies that don’t require the same level of investment or timeframe to enter into clinical trials in a given patient population. Chris Garabedian founded Xontogeny and partnered with Perceptive Advisors, a life science investor, to address gaps in this evolved model of venture capital / company formation to offer ‘middle market’ investing to allow entrepreneurs/founders to retain more equity in earlier rounds. These trends will be highlighted and contextualized in this session.

3:00 – 3:30 pm Coffee Break

3:30 – 4:00 pm China Biopharma R&D Ecosystem: Opportunities and Challenges Hongjian Zhang, PhD, Managing Director, Morningside Ventures

Recent industry-friendly policy changes, ICH membership and the opening of the Hong Kong Exchange Biotech Chapter have created much excitement in China and surrounding regions. As China’s Biopharma R&D Ecosystem is maturing, entrepreneurs, executives and investors may face challenges in talent shortage, capacity limitation and pricing competition. Topics to be discussed include but not limited to team building, fund raising, and the interplay between


unmet medical needs, technical innovation, clinical and regulatory paths and commercial viability, etc.

4:00 – 5:00 pm Panel Discussion Cynthia Cai, PhD, MBA, Senior Advisor, US Lead in Healthcare, Northern Light Venture Capital

Seamus Jiang, MBA, CFA, CPA Managing Director Co-leader for China/US Cross-Border Deals PwC

Tingting Qi, Executive Director, Investment Banking Department, CICC US Securities, Inc.

Linda Zhao, MS, Senior Director, SDIC Innovative New Drug Fund (国投创新药基金)

Friday, October 5, 2018, 1:30 – 5:00 pm Ballroom West

Parallel Session B: Clinical Drug Development: Update on Recent Advancements and Challenges

Session Moderators: Frank Gan, PharmD, Su-Fen Pu, MD, PhD, Junfang Li, PhD, Jianda Yuan, MD, PhD, Wenyan Wang, PhD, Veronica Chen, PhD, and Chenchao Gao, PhD

Over the past decade, both scientific and technological advances have paved the way for the development of revolutionary new treatments for some of the devastating diseases such as cancer. However, there are also challenges in developing new drugs for other unmet medical needs in spite of large efforts made, such as neuro-degenerative diseases. In this featured clinical development session, we will bring experts from pharmaceutical and biotech companies to present the latest advances and innovations in clinical development, especially in the immune-oncology field. We will also discuss the challenges, lessons learned and latest trends in drug development for the most common and devastating neurodegenerative disorder, Alzheimer’s disease.

1:30 – 2:00 pm Current Advances in the Clinical Development of Immuno-Oncology Drugs

Michelle Rashford, MD, SVP, Adlai Nortye Biopharma Co., Ltd.

Since the beginning of 2018 the FDA has approved the use of combinations of check point inhibitors as well as many new uses of check point inhibitors as monotherapy or combined with standard chemotherapy whereas in 2017 saw the approval and introduction of CAR T-cell therapy. This presentation will cover what is new and what stays the same from a clinical development perspective in this field.

2:00 – 2:30 pm Discovery and Development of ICP-022, a 3rd Generation of BTK Inhibitor Jasmine Cui, PhD, CEO, Beijing InnoCare Pharma

The B-cell receptor pathway plays an important role in a variety of B-cell malignancies. Bruton’s tyrosine kinase (BTK) inhibition has been shown to be effective in the treatment of several B-cell lymphoid malignancies. The 3rd generation of BTK inhibitor, ICP-022 has been discovered and developed for the treatment of chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). ICP-022 has demonstrated outstanding potency, target selectivity and PK/PD profiles. Consistently, ICP-022 exhibited excellent efficacy, safety/tolerability in patients of MCL and CLL/SLL in phase I/II clinical studies.


2:30 – 3:00 pm Alzheimer’s Disease – Time for a Paradigm Shift: The Latest Trends and Lessons Learned in AD Drug Development Haichen Yang, MD, MA, Vice President, Drug Development Services, ICON Plc.

Alzheimer’s Disease is the most common cause of dementia. As the world aging population rapidly expanding in coming decades, it remains an enormous and growing global health challenge. Alzheimer’s Disease is a fatal neurodegenerative disorder with no cure or substantially effective treatment available. Recognizing its treatment as a public health priority, academia, governments, and industry have been collectively throwing tremendous efforts into disease research and new drug development. Although many progresses have been made in understanding the Alzheimer’s disease, so far there have been string of failures with few successes in the race to develop effective treatment. This talk will trace the latest developments in disease diagnosis, regulatory guidance, and assessment tools. We will further discuss many lessons learned from those successes and failures of drug development.


3:30 – 4:00 pm 1021-Gene Panel, a Comprehensive Panel for Prediction of Diverse Therapeutic Response and Prognosis Sha Wang, PhD, Director, Department of International Affairs, Geneplus

As an important part of clinical trial for antitumor drugs, study of accompanying biomarker will provide reliable evidence for sensitive cohort. Pan-cancer panel from Geneplus Corporation provide precise detection for biomarkers of targeted therapy and immunotherapy. Pan-cancer panel covers multiple regions in 1021 genes that are related to tumorigenesis. Both tissue and plasma samples can be used to detect the actionable mutations for targeted sequencing, TMB, MSI and potential progress-related genes for immunotherapy. We also validate the feasibility of TMB calculation using plasma samples. Above all, pan-cancer capture sequencing can contribute to the development of biomarkers for both targeted therapy and immunotherapy, and further provide useful diagnosis and prognosis information for patients.

4:00 – 4:30 pm A Perspective on Companion Diagnostics: Effective Strategies to Ensure Successful Drug/Diagnostic Co-Development William Pignato, MS, Founder and Principal, W.J. Pignato & Associates, LLC

The successful development and integration of a companion diagnostic strategy into a therapeutics’ clinical development plan are dependent on a number of key factors to ensure concurrent review and approval of the drug and diagnostic. While some issues may be viewed as self-evident, this talk will discuss the necessary considerations and effective strategies that companies must understand and adopt in order to lead to a successful co-development outcome. The importance of the right technology and partner selection, relationship management and the incorporation of global regulatory affairs considerations will be reviewed.

4:30 – 4:45 pm Accelerate Development and Maximize Values of Innovative Drugs – Leverage CFDA's Adoption of ICH Standards Haishan Xiong, PhD, MBA, SVP Business Development, Fountain Medical Development

In a dazzling speed the global clinical development space is morphing into new dynamics, driven by China’ adoption of ICH standards. Instead of being an afterthought, China is becoming the new frontier for global innovative research. About 1 year ago, we accepted and were content that China was 5-8 years behind global launches. Today, that timeline is simply not acceptable. From patent linkage, to mutual data acceptance, to pricing and reimbursement, China’s regulatory overhaul is reverberating across the globe. Taking full advantage of this new dynamic requires careful planning and decisive actions. Of course, there are many issues to be solved. But inaction would lead to competitive disadvantage for the long term.


4:45 – 5:00 pm Single Molecule Localization Microscopy and Its Potential Applications in Drug Development Daiying Xu, PhD, Senior Scientist, NanoBioImaging Ltd. (Hong Kong)

Over the past ten years, super resolution microscopes featuring up to ten times the resolution of conventional light microscopy have been widely used, allowing the investigation of biological systems at nanometer scale. Here, the principle of single molecule localization microscopy and its applications in various biological fields will be introduced, including neuroscience, cell biology and microbiology.

Super resolution microscopy also finds its utility in therapeutic drug development, as the visualization of nanometer scale structure or protein-protein interaction yields direct evidence of a drug’s mode of action and interaction with the designated target. Multiple potential application scenarios of super resolution microscopy will also be discussed, including immune therapy, neuro-degenerative disease model and nanoparticle-based drug delivery approaches.

Friday, October 5, 2018, 1:30 – 5:00 pm Ballroom East

Parallel Session C: Regulatory Considerations for Generic Drug Bioequivalence Studies

Session Moderators: Xin Du, PhD, Li Wan, PhD, and Cai Li, PhD

Generic pharmaceutical products play an important role in global healthcare systems. Generic drugs significantly reduce government and patient spending. Generic drugs should demonstrate the same standards of quality, efficacy and safety as required of the originator’s (innovator) products. Bioequivalence studies are performed to establish the therapeutically equivalent relationship between the generic drug and the approved reference drug, thus allowing the approval and commercialization of the generic drug. The SAPA annual conference regulatory session for generic drug bioequivalence will bring FDA and industry leaders and experts together to share their insights and experiences on this interesting and important topic.

1:30 – 2:00 pm

Innovation in Developing Generic Products for both USA and China Markets Guohua Zhang, PhD, CEO and President, Novast Holdings

The objective of the presentation will focus on:

• Policies and requirements for ANDA filings to USFDA and China National Medical Product Administration (NMPA),

• Patent strategy and innovation in ANDA product development,

• Quality by Design in ANDA process development, and

• Sharing Novast’s practice for ANDA filings to both USFDA and China NMPA.

2:00 – 2:30 pm

Regulatory Considerations for Generic Drug Bioequivalence Studies in USA Bing V. Li, PhD, Director in the Division of Bioequivalence I, Office of Bioequivalence, Office of Generic Drugs, Center of Drug Evaluation and Research, FDA

A generic drug product is approved based on its pharmaceutical equivalence (PE) and bioequivalence (BE), and therefore therapeutic equivalence to the reference listed drug (RLD). BE study serves as a major component for approval of a generic drug product submitted as Abbreviated New Drug applications (ANDAs). The U.S. Food and Drug Administration (FDA) has recommended various approaches, based on scientific rationale and regulatory considerations, for the evaluation of BE for a broad range of drug products.


This presentation will: 1) explain the scientific rationale for FDA’s recommendations to establish BE of various products; 2) discuss the approval process of the ANDAs submitted to US FDA; 3) present recent updates on the regulatory sciences relating to BE study evaluations and approval process of ANDAs.

2:30 – 3:00 pm

Formulation and Manufacturing Considerations for Ensuring Successful Bioequivalence Studies Wei-Qin (Tony) Tong, PhD, President, Austarpharma

Developing a bioequivalent generic product requires a rational formulation strategy and robust process development. This presentation will:

• Review various factors that affect drug bioavailability including API and excipient critical material attribute (CMA), formulation design, critical process parameters (CPP), and equipment;

• Analyze the differences between the US and Chinese regulations and their impact on formulation and process development;

• Discuss some common misconceptions and mistakes in formulation and process development especially when applying Quality by Design (QbD) principle in the process and

• Emphasize some key formulation and process considerations in ensuring successful bioequivalence studies and ultimately supplying quality products to meet the patients’ need.


3:30 – 4:00 pm New Trend in US FDA Regulation Robert Ashworth, PhD, SVP, Advaxis Inc.

In the past one year or so, FDA has issued a few guidance and initiatives that could significantly impact the drug development in the pharmaceutical industry. This presentation will discuss these FDA guidance and initiatives and how should we fully utilize them to expedite their drug development programs and drug approvals.

4:00 – 4:30 pm

New Trends of China's Generic Drug Consistency Evaluation and Drug Review and Approval System Reform Zengjiang Cheng, PhD, Chairman of the board, PharmaSea (Beijing) Biomedical Technology Co., Ltd.

This report will introduce the evolution of China's generic drug consistency assessment policy and the new trends in the reform of the new drug approval system.

4:30 – 5:00 pm

The Story of the First Anti-PD(L)-1 (Opdivo) Approval in China Hwei-Gene Wang, PhD, Vice President and Head of Global Regulatory Science-China and Hong Kong, Bristol-Myers Squibb Company

Opdivo (nivolumab) was the first PD(L)-1 inhibitor approved in China. This ranked as one of the fastest BLA approvals by the agency. With this approval, it heralded a new era of Immuno-oncology treatment in China. Through the journey of Opdivo development and regulatory approval in 2L non-small cell lung cancer, the rapidly evolving regulatory reform and the exciting new dynamics in China will be shared.


Friday, October 5, 2018, 1:30 – 5:00 pm Hillsborough, Princeton, Westfield

Parallel Session D: Private! One-to-One! Pre-scheduled! Direct communication!

Session Moderators: Stephen Xue, MS and Le Zhan, PhD

Entrepreneurs, are you passionate about starting your own business? Are you in need of a platform of high visibility so you may deliver your creative ideas effectively? Investors, do you have sufficient information on potential startup companies? Are you in need of a pool of ingenious bio-medical talents so you may access their innovative projects? To better serve our members, not only entrepreneurs and investors or corporate business development professionals, but also other potential partners, this coming 2018 SAPA annual conference offers special 1:1 sessions, designed to bridge the gap between the investors, corporate BDs, and entrepreneurs, so that more potential business partnerships in biotech and pharma may be initiated. In each 25-minutes session of meeting, partners of interests may be arranged based on the requests to have an up-close dialogues. This brand new 1:1 direct communication opportunity will surely increase your networking and expand the dimensions of your business!

Friday, October 5, 2018, 1:30 – 5:00 pm Vendor Booths

Parallel Session E: Job Fairs

Session Moderators: Xing Dai, PhD

This Job Fair session is specially designed to facilitate the connections between job seekers and employers at SAPA Annual Conference. For job seekers, this is a perfect opportunity to scope out potential employers, and get face-to-face access to HR, Hiring Managers, and Senior Managements who are the key contacts to the next career opportunity. The job fair session brings together over thirty hiring companies and the best talents in the biotechnology and pharmaceutical industries. You can expect the connections made here have great potentials to turn into real meaningful opportunities. We will also have designated conference rooms to provide the most efficient way for recruiting companies to communicate with prospective candidates and conduct “instant on-site interviews”.

Friday, October 5, 2018, 5:30 – 6:30 pm Mirabelle

SAPA VIP Reception (By invitation only; tickets are required attending the VIP Reception) Session sponsor:

Friday, October 5, 2018, 7:00 – 9:00 pm Ballrooms

SAPA Annual Gala Dinner Tickets are required attending the Annual Gala Dinner

7:00 – 9:00 pm SAPA Annual Gala Dinner

Masters of Ceremony: Helena Feng, MS and David Cragin, PhD


7:00 – 7:15 pm SAPA Year in Review Jian Liu, PhD, SAPA President

7:15 – 7:30 pm Award Ceremony Jian Liu, PhD, SAPA President Xiaole Shen, PhD, SAPA President-Elect

7:30 – 9:00 pm Dinner and Networking

Saturday, October 6, 2018

7:00 am – 5:00 pm

Registration

Saturday, October 6, 2018, 8:50 – 12:30 PM Ballrooms

Plenary Session 2: Evolving Landscape for Cell and Gene Therapies Session sponsor:

Session Moderators: Jian Liu, PhD, Xiaole Shen, PhD, Lei Tang, PhD, and Xin Du, PhD

With the FDA approval of two CAR-T cell therapy products, Kymriah and Yescarta, and a gene therapy product, Luxturna, cell and gene therapies have progressed from an infant stage to a reality. With so many new targets and novel products getting into clinical trials, regulatory landscape will continue to evolve and new regulations are needed to guide these products through the development process. This SAPA annual conference cell and gene therapy program will bring regulators, industry leaders and experts together to share their insights and experience and to deliberate over the future of cell and gene therapies.

8:50 – 9:00 am Opening Remarks and 2018 SAPA Election Results

Jian Liu, PhD, SAPA President, Principal Scientist, External Discovery Chemistry, Merck Xiaole Shen, PhD, SAPA President-Elect, Senior Scientist, Celgene

9:00 – 9:30 am Facilitating the Development of Advanced Therapies Peter Marks, MD, PhD, Director, Center of Biologics Evaluation and Research, FDA

Cell and gene therapies offer tremendous promise for the treatment of many different serious conditions. These products can pose challenges from the standpoint of manufacturing and clinical development. The use of scalable manufacturing processes and novel clinical trial designs should be considered very early on in development. To help facilitate development, the U.S. FDA has several pathways, including the expedited programs, which have been expanded to include Regenerative Medicine Advance Therapy Designation. In addition, a program for early non-binding regulatory advice, the INTERACT program, is available to assist sponsors engaged in product development.

9:30 – 10:00 am Development of Kymriah, a CAR-T Cell Therapy Samit Hirawat, MD, Executive Vice President, Head of Oncology Global Development, Novartis


Kymriah (tisagenlecleucel) is part of a new class of immunocellular therapies. Adoptive T cell therapy involves the reprogramming of T cells with a transgene encoding a specific cell surface receptor and thus enabling the modified T cells to bind to the target antigen present on tumor cells. The expression of modified receptors known as chimeric antigen receptors (CARs) allows these T cells to specifically target and destroy CD19 positive B-cells in an antigen dependent but MHC-independent manner. The CAR receptor in Kymriah contains a murine single chain antibody fragment (scFv) specific for CD19 linked to a transmembrane region derived from the CD8 receptor, which is linked to an intracellular bipartite signaling chain of TCR-ζ (or CD3-ζ) and 4-1BB intracellular signaling domains.

Kymriah was shown in pivotal trials to achieve high rates of complete remission in several hematologic malignancies. Based on this data, Kymriah was the first CAR-T to gain a BLA approval, for children and young adults with relapsed or refractory acute lymphoblastic leukemia. More recently, the drug was approved in both the U.S. and Europe for diffuse large B-cell lymphoma. My talk will discuss the Novartis development program for Kymriah, as well as future directions in CAR-T cell therapy.

10:00 – 10:30 am Strategies and Methodologies for Selecting and Implementing New Technologies for Cell Therapy Processes Greg Russotti, PhD, Vice President, Cell Therapy Process and Analytical Development at Celgene

Presentation Objectives

• to describe the risk-based approach we followed in selecting new technologies for a cell therapy process

• to give examples of technologies that we implemented as well as some that we chose not to implement

• to demonstrate a data-driven methodology to assess whether the implementation of a new technology was worth the risk

10:30 – 10:45 am Coffee Break

10:45 – 11:15 am Precision Immunotherapy: CAR T-Cell Therapy for Multiple Myeloma Yuan Xu, PhD, CEO at Legend Biotech Co.

Legend Biotech is a clinical stage biopharmaceutical company focused on the discovery and development of novel cell therapies for various oncology and immunology indications. Legend is founded on the vision that the previous incurable cancer will be safely and effectively treated with fine-tuning products from our innovative technology platforms.

LCAR-B38M chimeric antigen receptor T-cells (CAR-T) are an autologous CAR-T cell therapy that targets B cell maturation antigen (BCMA), a molecule expressed on the surface of malignant plasma cells. It is a bi-specific CAR-T product developed using Legend Biotech’s own proprietary CAR-T technologies. Preliminary results from an ongoing first-in-human clinical study (Legend-2) indicate that LCAR-B38M CAR-T cells have significant anti-myeloma activity and a safety profile consistent with the known mechanism of action of the product (ASCO Annual Meeting, June 2017, Chicago (J Clin Oncol 35 (suppl; abstr LBA3001)).

In December 2017, Legend Biotech and Janssen Biotech, Inc. (a Janssen Pharmaceutical Company of Johnson & Johnson) entered into a worldwide collaboration and license agreement to jointly develop, manufacture and commercialize LCAR-B38M.

By targeting BCMA via a CAR-T approach, CAR-T therapies may have the potential to redefine the treatment paradigm for multiple myeloma and potentially advance towards cures for patients with the disease.


11:15 – 11:45 am CAR-T Product Development and Regulation in China Alex Zengjun Xu, MD, PhD, Chief Scientist (Pharmacology and Toxicology), CDE, NMPA (formerly CFDA)

With the approval of Kymriah and Yescarta by US FDA, more and more Chinese pharmaceutical companies initiated their CAR-T development. This presentation will briefly introduce and discuss the status and challenges of CAR-T product development in industry and regulation by China FDA (CFDA).

11:45 am – 12:30 pm

2018 SAPA Distinguished Achievement Award

The SAPA Distinguished Achievement Award is established to recognize and promote outstanding leaders with great impact on biomedical and pharmaceutical industry in both US and China. This Award exemplifies the SAPA vision of promoting the advancement of pharmaceutical sciences and biotechnology, scientific exchange and business cooperation between US and China, and career growth of pharmaceutical professionals. The Award is also in recognition of continuous support provided by selected individuals to the SAPA organization.

11:45 am – 12:00 pm

Video Presentation David D. Ho, MD, Scientific Director and CEO of the Aaron Diamond AIDS Research Center; Irene Diamond Professor at the Rockefeller University

12:00 – 12:30 pm The Power of One Ge Li, PhD, Chairman, WuXi AppTec Group

Over the past 18 years, every decision made and every step taken at WuXi has been driven by one commitment - to build the most comprehensive capability and technology enabling platform. One that can be open-accessed by anyone and any company to lower the barrier of R&D and expedite the development of new medicines. We take deep pride in serving thousands of collaborative partners whose fearless mission is to bring better medicines to patients – they are the true heroes. Together, we are pushing the boundaries of what’s possible to realize the dream that “every drug can be made and every disease can be treated”.

Yet we also believe that the industry’s most exciting accomplishments are the ones still to come. The future is where data meets knowledge, where technology meets healthcare, and where any scientist and any entrepreneur has the power to innovate. The power of one - one individual, one organization, one idea, or just one dream - is what the future can, and will be built upon.

Saturday, October 6, 2018, 12:30 – 1:30 pm Mirabelle

Lunch and Networking


Saturday, October 6, 2018, 1:30 – 5:00 pm Ballroom Center

Parallel Session F: CEO Forum – Beyond Pharma Horizon Session sponsor:

Session Moderators: Xiaole Shen, PhD, Weiguo Dai, PhD, Lin Yan, PhD, and W. Jerry Liu, PhD, JD

The SAPA CEO Forum is a unique platform for education, discussion and debate around current and future challenges and opportunities in the pharmaceutical industry. This panel discussion will depict industry trends and provide insights into future growth and development. It will also provide strategy as portfolios continue to advance and evolve. Topics will include entrepreneurship, innovation, healthcare policy and regulatory reform, production and quality, financing in US and China, current challenges in recruitment and talent development, and opportunities in unique and beneficial partnership structures. You will hear live stories, opinions, and solutions from successful CEOs from both US and China, and find answers and career advices from industry leaders.

1:30 – 5:00 pm (Coffee break from 3:00 to 3:30 pm)

Featured discussion with the distinguished panelists:

Lars E. Birgerson, MD, PhD, CEO & President, Adlai Nortye USA Inc.

Chunlin Chen, PhD, CEO, Shanghai Medicilon Inc.

Jasmine Cui, PhD, CEO, Beijing InnoCare Pharma

Dahai Guo, MBA, MS, Founder & CEO of PuraCap Pharmaceutical LLC; Chairman & CEO of Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.

Jim Huang, PhD, Founder and CEO, Ascendia Pharmaceuticals

Hongliang Jiang, PhD, CEO, Wuhan Hongren Biopharmaceutical Inc.

Yongkui Sun, PhD, CEO, IONOVA

Yusheng Wu, PhD, Chairman of Board and CEO, Tetranov Pharmaceutical, Inc. and its subsidiary Deuracor Therapeutics

Yuan Xu, PhD, CEO, Legend Biotech Corporation

Li Yan, MD, PhD, CMO, Brii Biosciences, Inc. 腾盛博药

Saturday, October 6, 2018, 1:30 – 5:00 pm Ballroom West

Parallel Session G: Business Development and Corporate Development Forum

Session Moderators: Jack Wu, PhD, John Wang, PhD, Aming Zhang, PhD, and Guangyao Yang, MS

Many pharmaceutical companies are facing pipeline gaps because of the complexity of disease biology and clinical studies, increasing economic burden and insufficient internal research and development programs. Nowadays,


pharmaceutical companies are increasingly relying on in-licensing and partnering to build, complement, and de-risk their development pipelines. The Business Development and Licensing (BD&L) team identifies such partnering opportunities, leads technical and financial due diligence, negotiates and executes partnering agreements, and manages the alliances to ensure that novel medicines are discovered and developed more rapidly to satisfy the unmet medical needs. The BD&L session at SAPA Annual Conference offers a unique opportunity to learn from BD&L experts their valuable partnering experience and their opinions about the best practice in pharma partnering. Don’t miss your chance to engage in discussions with speakers, hone your professional knowledge, and network with industry peers.

1:30 – 2:00 pm Business Development at Merck

Michelle Li, PhD, MBA, Associate Vice President, Corporate Development, Merck & Co., Inc.

Merck is a global healthcare company with over 125-year history of working to make a difference. Its business focuses on innovation and scientific excellence to deliver vaccines, medicines, and animal health products that can help millions around the world. Business development has become a main lever for supplementing growth within the biopharmaceutical sector, and the pace of transactions in the market over the past 2-3 years has been rapid. Merck has participated in this wave with several key transactions. Today I will discuss the critical role of business development played in augmenting Merck’s pipeline and product.

2:00 – 2:30 pm Harnessing the Power of the Technical Expert with Alliance Partners Qun Lu, PhD, Executive Director, Pharmaceutical Sciences and Technology, Celgene Corporation

The last several years has seen a flurry of deals across the biopharmaceutical space. Celgene alone launched over fifty collaborations in the past five years. With the focus of providing the next breakthrough therapy for the patient, the requirement for new and innovative approaches and technology platforms in these deals is a must. With an eye towards the future, the complexity of the molecules mirrors the innovation. Early deals are particularly prone to the necessity of understanding the more the scientific complexity and translating what this means to the long-term success of the partnership and delivery to the market. With changes in approaches to the biopharmaceutical portfolios and the rise of advanced manufacturing technologies, a new way in which we partner with our scientific experts is needed. Celgene’s alliance technical lead model to expedite the technical collaborative relationships will be discussed.

2:30 – 3:00 pm Biotech Market Dynamics in the U.S. and China Brad Loncar, CEO, Loncar Investments

Mr. Loncar will discuss how recent changes in China might impact market dynamics for the healthcare sector and what it could mean for partnering between Chinese and U.S. biopharma companies. These changes include Hong Kong Stock Exchange’s new biotech listing rule, regulatory reform in China, and the invitation China recently extended to certain multinational firms to submit for marketing approval innovative medicines not yet available in China. He will highlight some past partnerships and discuss his thoughts on what the structure of future deals might look like. Best practices will also be discussed for U.S. companies who are looking to land a regional partner in China and how Chinese companies can search for compelling assets in the United States and Europe. He will also discuss recent volatility of the biotech public markets and how it might impact partnering activities and the sector generally.


3:30 – 4:00 pm Legal Pitfalls in Life Science Transactions Lihua Zheng, PhD, JD, Partner, Zheng & Karg LLP

The presentation will focus on common legal pitfalls in life science transactions. The first part will discuss various deal structures such as equity and debt financing, licensing, joint venture, sponsored research, and combinations thereof. The second part will discuss what legal due diligence (“LDD”) is usually performed before definitive agreements are signed, what pitfalls


to avoid, and how to address issues uncovered in LDD. The third part will discuss the recent U.S. legislation Foreign Investment Risk Review Modernization Act (FIRRMA) which was enacted on August 13, 2018 and its potential impact on cross-border transactions.

4:00 – 5:00 pm Panel Discussion

Additional panelists: Kevin Huang, PhD, Chief of Staff, Head of Corporate Strategy and Investment JoLee Li, PhD, Executive Vice President, Global Business Development, Tayu Biotech Weimin Tang, PhD, Global BD head and EVP, I-MAB Biopharma

Saturday, October 6, 2018, 1:30 – 5:00 pm Ballroom East

Parallel Session H: Career Workshop: Develop Your Entrepreneurship

Session Moderators: John Sun, PhD, MBA, PMP and Xiaodong Chen, PhD

An uncommon career path for many, entrepreneurship is less understood and to some degree remains to be a mystery and even daunting. Jumping from an academic or a scientific career track to embark on a new journey and become an entrepreneur requires not only the courage, passion, and enthusiasm, it often asks for more skillsets and supporting network to be ultimately successful. By definition, entrepreneurship is the process of designing, launching and running a new business. At this year’s Career Development session at the Annual Conference, together we will explore the key success factors, learn from the experts and scholars on the major concepts in preparing to start a new venture, tap into the best practices and lessons learned. We will do this in an engaging, intensive, fun and interactive environment. Many of these learnings will be applicable and adaptable to various situations. Whether you are ready to take the new challenge or still contemplate whether to take the plunge, this is a session not to be missed.

1:30 – 5:00 pm An interactive workshop with experienced workshop faculty:

Daniel Chai, MD, Managing Partner at Turret Capital

Amanda Fu, MD, MBA, MSc, VP of Clinical Operation, 3DMed

Lenzie Harcum, Manager of the NJEDA’s Biotechnology Development Center (BDC) and the Commercialization Center for Innovative Technologies (CCIT)

Andrew Jiang, CEO, Aleon Pharma International

Seamus Jiang, MBA, CFA, CPA, Managing Director, Co-leader for China/US Cross-Border Deals, PwC

Jianming Jimmy Hao, JD, PhD, MBA, Partner, Fox Rothschild LLP

Jin Wang, PhD, Managing Partner/Founding Partner, Jianxin Capital/Manhattan Capital Group


Saturday, October 6, 2018, 1:30 – 3:40 pm Executive Parlor 158

Parallel Session I: Market Access and Commercialization

Session Moderators: Jerry J. Li, PhD and Norman Tang

Many of us have been involved in R&D activities at different capacities including discovery, clinical development and even business development. The impact of commercialization strategy and market access are closer to each and every one of us in pharmaceutical industries than what we actually realize or admit. Commercialization is involved from the very beginning of the clinical drug development including identifying target patient population, market/product assessment and even the trial design. Successful companies assemble great commercial team way before the product reach the market. Such efforts will be critical to maximize companies’ assets in the long run. In this session, we will demystify major commercial functions and use real-world cases to demonstrate the cross interactions in decision-making process. The potential career opportunities in commercial sector will be also discussed. As healthcare costs continue to skyrocket, healthcare systems in many countries are transforming to a value-based system in order to drive toward value and contain costs. Mere regulatory approval is no longer sufficient for a product to be commercially successful. We will discuss the critical roles payers and healthcare systems play in market access and formulary decisions. As the investment and entrepreneurship are coming in full force especially in China we will also discuss in this session from investor’s perspective how commercialization and market access of a company might affect investors’ decisions regarding when and how to invest in a company.

1:30 – 2:00 pm How to Make a Product Successful in a Value-based Healthcare System?

Donald Yin, PhD, Vice President and Head of Economic and Data Sciences at Merck

Healthcare cost continues to grow at a faster rate than GDP growth in US and global markets due to aging population, growing demand and new technologies. Healthcare systems in these countries are transforming to a value-based system in order to drive toward value and contain cost. At the same time the pharmaceutical industry’s cost structure has become unsustainable. It takes over $2.5 billion to bring a new product to market. The demand from customers for additional evidence, combined with the attendant costs and delays to best access are only worsening the economics of the existing model. In this new valued-based system, it is no longer sufficient to obtain regulatory approval for a product to be commercially successful. During this session, we will discuss the critical roles payers and healthcare systems play in market access and formulary decisions. We will look at successful and unsuccessful cases to understand the reasons why some products are commercially successful while others are not. In addition, we will discuss how to incorporate payer needs and health economic considerations in product development and commercialization decisions.

2:00 – 2:30 pm The Myth of Commercialization: When, Where and What Emmie Fan, MBA, MS, Head of Commercialization, Avotres Inc.

Commercialization of assets in the pharmaceutical industry is a long and challenging journey along the spectrum of product life cycle. It involves a network of multiple functions and is critical to maximize the value of an asset. This presentation will provide a simple explanation of major commercial functions in terms of their roles and responsibilities, and use real-world cases to demonstrate their interactions for decision-making.

2:30 – 3:00 pm Commercialization and Marketing Strategy from Investors Perspectives Bob Ai, PhD, MBA, SVP, Solebury Trout

Abstract not available for printing.



Saturday, October 6, 2018, 1:30 – 5:00 pm Executive Parlor 164

Parallel Session J: Breakthrough Technology: AI and Medicine

Session Moderators: Hong-Ping Guan, PhD, James Li, PhD, and Wei Ding, PhD

In a fast evolving world, technologies are advancing at an unprecedented speed. In the past several years, artificial intelligence (AI) has significantly changed our world and is playing more and more important roles in many hi-tech industries such as self-driving cars and personal assistants. Biopharmaceutical industry has never lagged behind in utilizing cutting-edge technologies. As a matter of fact, development of pharmacological therapeutics heavily depends on breakthrough technologies. We foresee that these technologies will help shorten the time of drug discovery, cut R&D costs, increase success rates in clinical trials, and eventually create better and safer medicines for different diseases. In this session, we will bring experts in AI and machine learning to introduce a few hot topics in pharmaceutical fields. Our speakers will show how AI and machine learning can expedite drug development and discovery; accelerate pathology data analysis, mine heterogeneous drug development and real world data, predict drug delivery effectiveness, identify potential therapeutic targets and diagnostic biomarkers, and model mechanisms of tumor immune evasion.

1:30 – 1:55 pm Prediction of Drug Delivery Effectiveness Using Machine Learning Techniques

Yaoping Ruan, PhD, Chief Data Scientist, LinkDoc

Combination therapy has been an effective approach for cancer treatment. However, it remains challenging to determine the optimal combination, and to adjust for a particular patient’s dosage. With the large quantity of available drugs, and the emergence of new drugs, it is unlikely to examine all the possible combinations. This talk presents new approaches using machine learning to predict synergy of novel drug combinations.

1:55 – 2:20 pm Intelligent Drug Development and Discovery Driving by a Hybrid Knowledge and Data Mining Engine Fei Wang, PhD, Assistant Professor, Weill Cornell Medicine

Drug development and discovery (DDD) has been a time consuming and expensive process, during which large amounts of drug related data, from chemical structures to clinical trials, are collected. Recently lots of machine learning/artificial intelligence techniques have been developed for analyzing these data and the insights have been shown to have the big potential to accelerate the DDD process. Although these data-driven approaches have attracted lots of attentions recently, DDD is a highly specialized field and the domain knowledge is the key to its success. Therefore, we believe combining knowledge and data driven insights is the right way to revolutionize the DDD process. In this talk, I will present a series of research in my lab along this line, including the construction of drug knowledgebase, as well as mining heterogeneous drug development and real world data.

2:20 – 2:45 pm Deep Learning in Digital Pathology Lin Yang, PhD, Director of the Board, Deep Informatics LLC

Digital pathology image analysis can provide crucial quantitative support for improving characterizations of various diseases such as lung cancer, breast cancer, brain tumor, etc. However, due to the ever-increasing amount of image data, it is inefficient or even impossible to manually process the image data. Recently deep learning has attracted a large amount of attention in digital pathology. In this presentation, we will provide a snapshot of multiple applications in digital pathology based on deep learning, specifically for the general cell detection task on various types of pathology images. Deep learning methods typically take in raw input data and gradually learn hierarchical feature representations via a stack of non-linear transformations. Both theory and practice have proven that deep architecture is capable of learning highly complex functions and uncovering the intrinsic structure in the data. Convolutional neural network (CNN)


is one of the most successful and widely used architectures. We present several CNN based learning frameworks including fully residual convolutional neural network (FCN), deep voting, and structured regression for efficient and robust digital pathology. We will also present our commercialization efforts in digital pathology and deep learning.

2:45 – 3:10 pm Machine Learning and Its Wide Use in Pharma Robert Sheridan, Senior Principal Scientist (Retired), Modeling and Informatics, Merck

Machine learning is a set of techniques to summarize “rules” from a number of examples and use the rules to predict new examples. There is much recent excitement about “machine learning in chemistry” but in fact that field has been around for decades under the name “QSAR”. In fourteen years Merck has gone from a place where QSAR was hardly ever used to one where it plays a very central role at most stages of drug development. Development of QSAR at Merck has three aspects:

1. Science: Finding the combination of descriptors and statistical methods that gives the best predictions for the least computational cost.

2. Infrastructure: Having the hardware and software to efficiently build and update models and have users be able to easily get and interpret predictions.

3. Applications: Finding new places where QSAR could be applied, from discovery chemistry to analytical chemistry.


3:30 – 3:55 pm Advancing Precision Medicine through Data Science Rong Chen, PhD, VP, R&D Bioinformatics, Sema4 Genomics

Large scale implementation of next generation sequencing based clinical genetic testing and electronic medical records in the health care system provides an unprecedented opportunity for precision medicine. We have been developing clinical software to automate literature evidence collection, automate genetic variant pathogenicity assessment according to clinical guidelines, and integrate various types of molecular measurements for comprehensive clinical reports. We have further used natural language processing (NLP) and expert curation to develop tools to abstract comprehensive clinical data from physician notes, from diagnosis, pathology, clinical outcome, to co-morbidity automatically. Integrating both genetic and longitudinal clinical data into a structured database, we are now able to use real-world patient data to match patients to the right treatment towards precision medicine.

3:55 – 4:15 pm

Big-data Approaches to Model Cancer Therapy Response and Resistance Peng Jiang, PhD, Dana Farber Cancer Institute & Harvard School of Public Health

The rapid growth of big-data resources, catalyzed by breakthroughs in genomics technologies, has resulted in a paradigm shift in cancer research. I will introduce my recent works that integrated the vast amount of public data to model the cancer therapy efficacy. To predict immunotherapy response, we developed TIDE, a computational method to model two primary mechanisms of tumor immune evasion: the induction of T cell dysfunction in immune-hot tumors and the prevention of T cell infiltration in immune-cold tumors. TIDE repurposed many clinical data cohorts without immunotherapy to identify immune evasion signatures as surrogate immunotherapy biomarkers. Using pre-treatment RNA-Seq or NanoString tumor expression profiles, TIDE predicted the outcome of melanoma patients treated with first-line anti-PD1 or anti-CTLA4 more accurately than other biomarkers. TIDE also revealed new immunotherapy resistance regulators, such as SERPINB9, which hijacked the self-protection strategy of T cells for tumor immune evasion. Besides the immunotherapy focus, we also developed CARE, a computational method focused on targeted therapies, to identify synergistic drug combinations to overcome the resistance to primary treatments, using cell line compound screens. In summary, my recent works demonstrated that the integration of big public data is a cost-effective approach to rediscover new therapeutic knowledge.



Bob Ai, PhD, MBA SVP, Solebury Trout

Bob is a Senior Vice President of Solebury Trout, focusing on Sino-U.S. cross-border banking, strategic consulting services and investor relations. Prior to

joining the company in 2016, he was managing director, senior biotech analyst at WallachBeth Capital. Before that, he was the Chief Financial Offer of Aoxing Pharmaceuticals, a NYSE MKT listed Chinese specialty pharmaceutical company. He has also served as Principal in crossover life science private equity firm Merlin Nexus and senior equity analysts at assets management firms Bennett Lawrence and Merlin Biomed Group. Bob received his PhD and MBA from Penn State University and did postdoctoral training at University of Pennsylvania. He has published eight articles in peer-reviewed scientific journals. He also won the prestigious Ray Wu scholarship for outstanding Chinese Student to study abroad. Bob holds Series 7, 63, 79, 86, and 87 securities licenses.

Robert Ashworth, PhD SVP, Advaxis Inc.

Dr. Robert Ashworth has over 30 years of pharmaceutical industry experience spanning chemistry research and regulatory affairs. During the

course of his career, he has made significant contributions to the FDA approvals of 12 new drugs. His drug development and regulatory experience includes small molecules, therapeutic proteins and antibodies. He joined Advaxis from NPS Pharmaceuticals Inc., where he served as Vice President, Global Regulatory Affairs and spearheaded the global approval of drugs for rare diseases. Prior to that, he had similar roles at Otsuka Pharmaceutical Development and Commercialization, Inc. and Biovail Corporation. Earlier in his career, he held positions of increasing responsibility at Forest Laboratories Inc., BASF Pharma (Knoll) and Ciba-Geigy Corporation. Dr. Ashworth holds a doctorate in organic chemistry from the Massachusetts Institute of Technology and a Bachelor of Science in chemistry from St. John’s University.

Paul von Autenried, MS, PMD Sr. Vice President, Chief Information Officer, BMS Paul von Autenried heads Bristol-Myers Squibb’s Information Technology organization, positioning the

company for success in the rapidly evolving digital age. He is focused on ensuring the company’s information assets and operations are reliable, accessible and secure, driving the digitization of the company, adopting new approaches to digital health, and continuing an innovative approach to long-term partnerships with key IT service delivery companies. “It’s an exciting time to lead an IT team as advances in technology are providing new opportunities to streamline our lives in unprecedented ways, including managing our health,” Paul said. “Delivering digital capabilities that accelerate the company's work of bringing innovative medicines to patients

is both a challenge and an honor.” Throughout his experiences in domestic and international high-tech, consumer packaged goods, and biopharmaceuticals companies, Paul's career has been focused on strategically leveraging information technology to drive superior performance. Before joining Bristol-Myers Squibb, Paul held positions with Kraft General Foods, Hewlett-Packard and IBM. He is a member of the Research Board, and serves on the Board of Trustees of the Princeton Healthcare System. Paul has a bachelor’s degree in electrical engineering and a master’s degree in computer science from Stevens Institute of Technology, and has completed the Program for Management Development at Harvard Business School and the Program for Leadership Development at IMD in Switzerland.

Lars E. Birgerson, MD, PhD CEO & President, Adlai Nortye USA Inc. Dr. Lars Birgerson is a physician with more than 25 years of biopharmaceutical industry experience in senior positions. He started in Drug Development where he

filed several NDAs. After senior global positions in Business where he was responsible for global launches and in Business Development and Licensing he moved on to Medical. In this field he is a well recognized global authority and expert. He has built and led Global and US functions integrating Medical and Health Economics Outcomes Research for several leading companies Bristol-Myers Squibb, Genentech, Roche, and Pharmacia. Since 2018 he is Chief Development Officer for Adlai Nortye Ltd. and President & CEO for Adlai Nortye USA Inc.

Cynthia Cai, PhD, MBA Senior Advisor, US Lead in Healthcare, Northern Light Venture Capital

Dr. Cai is a senior advisor for Northern Light Venture Capital, a leading venture capital firm for Healthcare,

TMT, and Advanced Technologies. She is focused on early-stage investments in the US healthcare segment. Dr. Cai had over 20 years of experience in leadership positions with one of the world’s most respected biotech companies. As senior director of marketing in the Mass Spec. Division for Agilent Technologies, she was responsible for global thought leader collaboration and solution development for its billion-dollar MS business. Before that, as business development manager and product marketing manager, Dr. Cai involved in multiple acquisitions and divestitures, also led a $500+ million-dollar flagship product development and global commercialization. Dr. Cai earned a B.A. and Master of Engineering from Tsinghua University, received her Ph.D. in Chemistry from the University of Massachusetts and her MBA from The Wharton Business School of the University of Pennsylvania. Dr. Cai served as Delaware governor economic advisor, a member of the Board of the Forum for Executive Women (FEW-DE). Dr. Cai has also been a mentor for Wharton EMBA, Tsinghua University Global MBA and Drexel LeBow School of Business for many years. She is a regular speaker at conferences such as Wharton China Business Forum, for topics related to cross-border commercialization and cross-culture career development.

2018 SAPA

Annual Conference

Biographies of Speakers and Panelists


Daniel Chai, MD Managing Partner, Turret Capital

Dr. Chai has close to 20 years of both private and public investment experience in the global healthcare sector. He founded Turret Capital Management in

2016 and previously served as Portfolio Manager at several leading investment firms including Citadel Investment Group, UBS, and Neuberger Berman. Dr. Chai is an investor and co-founder of Serenikey Therapeutics Inc., a private biotechnology company focused on the treatment of neurological diseases. He was an investor and board member of Nexgen Spine Inc., a private medical devices company focused on the treatment of spinal related disorders, which was acquired by K2M Group Holdings (KTWO). Dr. Chai has a B.S. from the University of Michigan and an M.D. from Columbia University, College of Physicians & Surgeons.

Chris Chen, PhD CEO, WuXi Biologics Dr. Chris Chen is currently Chief Executive Officer at WuXi Biologics, a Hong Kong listed public company with market cap of approx $10+ billion USD. At WuXi he has

built a world-class open-access integrated biologics discovery, development and manufacturing platform enabling full spectrum of companies ranging from 2-employee virtual companies to Top 20 global large pharma. WuXi has transformed the global biotech industry by enabling entrepreneurs to build successful biotech companies with no need for investing in infrastructure for people, labs or manufacturing. Under his leadership, WuXi has assembled one of the largest biologics teams with over 2700 scientists enabling 60+ biologics entering into clinical trials per year. WuXi has also pioneered disposable-bioreactor based state-of-the-art commercial manufacturing facility and built the first 30,000L bioreactor capacity in the world using disposables. The globally leading platform developed by WuXi Biologics is now serving more than 200 companies worldwide. Dr. Chen obtained his dual bachelor degrees of chemical engineering and automation at Tsinghua University, Beijing China and his Ph.D. in chemical engineering at the University of Delaware, US. He then gained valuable experience in biologics development, manufacturing and quality in the US, where his previous assignments include director and manager positions at Lilly and Merck. Dr. Chen later joined Shanghai Celgen Biopharmaceuticals as Chief Operating Officer, successfully developed a high-titer high-quality commercial process for biosimilar etanercept, and obtained regulatory approval for the program in China in 2011. He chaired multiple conferences in biochemical engineering and mab development in US and China and is frequently invited to speak at multiple conferences. He is also adjunct professor at Shanghai Jiaotong University. Dr Chen is co-author and co-inventor of 60+ publications and patents.

Chunlin Chen, PhD CEO, Shanghai Medicilon Inc.

Chen Chunlin PhD, co-founder of Medicilon in 2004, has been the CEO of Medicilon for more than 14 years. Dr. Chen is one of the leaders in the pharmaceutical

industry with extensive experience in academia, pharmaceutical and regulatory. Dr. Chen received his PhD from Oklahoma State University and completed postdoctoral training at the St. Jude Children’s Research Hospital. Prior to the founding of Medicilon, Dr. Chen worked in Vertex Pharmaceuticals as Senior Investigator Scientist for 2 years. Dr. Chen has been awarded as special expert under national "Thousand Plan" program in 2009. Dr. Chen is currently the deputy director committee member in Shanghai Pharmacokinetics Society and Vice President at Shanghai Pudong Biomedical Society. Dr. Chen is also a visiting professor at the China Pharmaceutical University.

Rong Chen, PhD VP, R&D Bioinformatics, Sema4 Genomics

Rong Chen is VP of R&D Bioinformatics at Sema4 Genomics, a next generation health information company,

and Assistant Professor at Icahn School of Medicine at Mount Sinai. Dr. Chen is an expert on translational bioinformatics and has published 100 papers in journals such as Nature Biotechnology, Lancet, and Science Translational Medicine. He has developed numerous databases and software to integrate genetic and clinical data to drive clinical diagnosis, precision medicine, and drug discovery, including knowledge bases for cancer and inherited diseases, VIAS for genetic variant annotation, VISta for clinical variant pathogenicity assessment, ClinLabGeneticist for clinical exome sequencing, and ZDOCK for protein-protein docking. Dr. Chen has led the resilience project to identify genetic ‘superheroes’ in more than 589,000 individuals, a personalized cancer therapy project, and real-world cancer patient clinical data for precision medicine. He has illustrated the genetic landscapes of parathyroid carcinoma and Cushing’s disease, identified potential therapeutic targets for cardiovascular diseases, and diagnostic biomarkers for organ transplant rejection. He published the first Clinical Assessment of Human Genome and is a leader in the development of the personal genome report. Dr. Chen has built a startup company called Personalis and served in the advisor boards for several genome informatics companies, including Bina Technologies (bought by Roche) and Tute Genomics.

Zengjiang Cheng, PhD

Chairman of the board, PharmaSea (Beijing) Biomedical Technology Co., Ltd.

Dr Cheng is the Founder of Tonxieye Forum, Secretary General of Tonxieye New Drug Elite Club. He is the editor of the first session of the series book of The Pharmaceutical Index, the editor of the magazine for Pharmaceutical Progress, one of the senior advisers of first session in China Medical Development Research Center.

Dr. Cheng founded PharmaSea (Beijing) Biomedical Technology Co., Ltd. in 2007, which is an R&D institution with certain dimension and multiple service lines. It focuses on the technology development for generic and new drug development, and has completed many new drug and generic drug projects declaration.

Nai-Kong Cheung, MD, PhD Head, Neuroblastoma Program, Enid A Haupt Chair in Pediatric Oncology, Memorial Sloan Kettering Cancer Center

Nai-Kong V. Cheung, Enid A. Haupt Endowed Chair in Pediatric Oncology at Memorial Sloan Kettering Cancer Center, New York, NY, received his B.Sc. degree from the University of Chicago, as well as MD and PhD in Immunology from Harvard Medical School. He studied suppressor T cells and B cell tolerance under the mentorship of Dr. Baruj Benacerraf, the 1980 Nobel laureate in Medicine. Upon completing his specialty training in Pediatrics and Pediatric Hematology/Oncology at Stanford University Medical Center, Dr. Cheung has devoted his career to translational science with a clinical focus on neuroblastoma, and a research focus on antibody-based therapies. His work has changed the outlook of children with high risk metastatic neuroblastoma, including those with central nervous system metastases; two of the drugs he invented received FDA breakthrough designation in 2017 and 2018, respectively. His current research is directed at plug-and-play antibody platforms, as well as tumor target discovery, with specific focus on bispecific antibodies tailored for clinical translation in Pediatric Oncology.


Jasmine Cui, PhD CEO, Beijing InnoCare Pharma

Dr. Jasmine Cui is the co-founder, President & CEO of Beijing InnoCare Pharma, a biopharmaceutical company rooted in China with the global vision to

discover and develop novel treatments for cancer and autoimmune diseases. Prior to founding InnoCare, Dr. Cui was the General Manager of BioDuro. Her area of responsibility included BioDuro’s overall scientific and operational management, as well as business & resource management. Before BioDuro, Dr. Cui worked at Merck Research Laboratories in New Jersey for 14 years as Director of Cardiovascular Diseases and also served as the Chair of Early Development Team for development of drug candidate from preclinical to clinical phase 2a for POC in humans. Dr. Cui received her Ph.D. in biology from Purdue University and completed her postdoctoral fellowship at Howard Hughes Medical Institute affiliated with the University of Michigan. Dr. Cui was the 17th SAPA President and the current President of SAPA China.

Emmie Fan, MBA, MS

Head of Commercialization, Avotres Inc.

Emmie is an accomplished pharmaceutical marketing executive with over 20 years of combined commercial and R&D experience in multiple therapeutic areas. She

has led business initiatives at all stages of a product life cycle with increased responsibilities while working for Novartis, Roche, Merck and Allergen. Emmie has led and participated in multiple product launches in both global and US markets, worked extensively with Business Development team and led numerous new product assessments covering US, Europe and Asia markets. Prior to her consulting career in 2014, Emmie was the US marketing director managing both a growth brand and an established product with significant P&L responsibilities. Emmie foundered a boutique management consulting firm, Launch Machine Consulting, in 2014 with focus on marketing/commercialization. The firm has advised clients on new product strategy, life cycle management, and inline brand management. Emmie has recently joined a biotech start up, Avotres Inc. as Head of Commercialization to move forward the Avotres portfolio in autoimmune diseases and immune-oncology therapies. Emmie holds an MBA in finance and marketing from New York University, a Master of Science in Molecular Biology from York University, Canada, and a Bachelor in Biochem from Fudan University, China.

Joachim Frank, PhD Professor, Biochemistry and Molecular Biophysics, Columbia University; 2017 Nobel Laureate in Chemistry

Joachim Frank is a Professor of the Department of Biochemistry and Molecular Biophysics, and a Professor of the Department of Biological Sciences at Columbia University. He received his Ph.D. from the Technical University in Munich and, in 1975, joined the Wadsworth Center in Albany as a Senior Research Scientist and, in 1985, joined the faculty of the Department of Biomedical Sciences in the newly founded School of Public Health of SUNY Albany. In 2008 he moved to New York to assume his current positions. Dr. Frank’s lab has developed techniques of electron microscopy and single-particle reconstruction of biological macromolecules. He has applied this technique of visualization to explore the structure and dynamics of the ribosome during the process of protein synthesis. Dr. Frank is a member of the National Academy of Sciences and of the American Academy of Microbiology. He is also a fellow of the American Academy of Arts and Sciences and of the American Association for the Advancement of Science. He was recently honored for his contributions to the development of cryogenic electron microscopy of biological molecules and the study of protein synthesis with the 2014 Franklin Medal for Life Science. In 2017 he shared the Wiley Prize in Biomedical

Sciences with Richard Henderson and Marin van Heel, and the Nobel Prize in Chemistry with Richard Henderson and Jacques Dubochet.

Amanda Fu, MD, MBA, MSc VP of Clinical Operation, 3DMed

Dr Fu currently serves as the VP of Clinical Operation at 3D-Med. Amanda has over 15 years’ industry experience in clinical operation across AsiaPac, North

America, South America, Europe and Australia. She has served as General Manager of Gleneagles CRC (China) Pte. Ltd in China, Global Clinical Operation Team Lead at GE HealthCare, Global Project Lead at Syneos Health, Clinical Operation and Development Director at Pharmacyclics, and Senior Global Program Lead at MedImmune. Amanda got her MD from Jilin University, Norman Bethune Medical School, MBA from Ohio University, MSc from the University of Sheffield.

Chris Garabedian CEO, Xontogeny

Chris Garabedian founded Xontogeny in June of 2016 to support multiple promising technologies from early development through clinical proof of concept, and

formed a partnership with Perceptive in 2017 to establish the firm’s venture fund strategy. As a member of the Perceptive Investment Team, Chris will help source and identify venture opportunities for investment as part of the Xontogeny portfolio and beyond. Chris has a broad base of experience and a track record of success across his 25 years in the pharma and biotech industries, including at two of the most successful biopharma companies over the last 20 years, Gilead and Celgene. Most recently, Chris served as the President and CEO of Sarepta Therapeutics from 2011 to 2015, overseeing the turnaround of a company that is now a commercial stage leader in the genetic technology space after leading the development of the company’s Duchenne Muscular Dystrophy program. Prior to Sarepta, Chris served as VP of Corporate Strategy for Celgene from 2007 to 2010. Prior to Celgene, Chris served in a number of global leadership roles at Gilead from 1997 to 2005, including as VP of Corporate Development, VP of Medical Affairs and VP of Marketing. Chris is currently on the Board of Directors of MassBio, on the Board of Advisors for the Keck Graduate Institute and serves as a Senior Advisor for the Boston Consulting Group.

Dahai Guo, MBA, MS Founder & CEO of PuraCap Pharmaceutical LLC; Chairman & CEO of Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.

Mr. Dahai Guo is the Founder & CEO of PuraCap Pharmaceutical LLC., Chairman & CEO of Humanwell PuraCap Pharmaceutical (Wuhan) Ltd., etc. He has managed and served as CEO of 6 companies in US & China, including CEO of Epic Pharma, & CEO of Humanwell USA LLC. in his career.

Under Mr. Guo’s leadership, PuraCap Pharmaceutical & its affiliated companies are one of the leaders in specialty pharma & healthcare industry, who is developing, manufacturing and marketing broad range of Branded Rx, Generic Rx and OTC pharmaceutical products in US & the global markets. Currently, PuraCap & affiliates have over 80 different drugs and over 400 products selling in US, China, Canada and other countries. It has four US FDA inspected manufacturing and packaging facilities in US & China. Under Mr. Guo’s leadership, PuraCap has been recognized and awarded as “Top Ten leading Chinese pharmaceutical company in global market” & “China’s Top 100 Gazelle Companies” award.


Mr. Guo has MBA from Cornell University and M.S. of Biology from Rutgers University. He also completed distinguish Six-Sigma Black Belt training, awarded by America Society for Quality. Mr. Guo is current Chairman of BioKatalyst Corp, a non-profit organization whose invited-only members are the top management elites of Chinese Americans crossing healthcare industry.

Jianming Jimmy Hao, JD, PhD, MBA Partner, Fox Rothschild LLP

Mr. Hao is a partner and U.S. patent attorney at Fox Rothschild LLP. With more than a decade of legal

experience, Mr. Hao serves clients including Fortune 500 companies, startups, entrepreneurs, investors, and academic institutions on a broad range of legal issues, including patent, trademark, licensing, IP litigations, FDA, international, corporate, VC financing, and nonprofit. While focusing on preparation/prosecution of U.S. and foreign patents. He provides a full range of patent law services, including developing and managing worldwide patent portfolios, assisting in patent matters in connection with startups, strategic alliance, technology transfer, corporate transactions, freedom-to-operate, invalidity and non-infringement opinion analysis. Mr. Hao has provided representation to several notable business transactions, including Alexion Pharmaceuticals Inc.’s acquisition of Synageva BioPharma (valued at $8.4 billion), Humanwell Pharmaceutical Group Corporation’s acquisition of Epic Pharma ($550 million), BMS’s acquisition of Amira Pharmaceuticals ($475 million), licensing and collaboration deals involving major universities and companies.

Mr. Hao received a JD from Boston College Law School, a PhD from Columbia University, an MBA from Cornell University, and a BS from Nankai University. He is a Board Member and Founder of BioKatalyst, a non-profit organization of Chinese business leaders in commercial areas of biopharmaceutical industry.

Lenzie Harcum Manager of the NJEDA’s Biotechnology Development Center (BDC) and the Commercialization Center for Innovative Technologies (CCIT)

Lenzie Harcum is the manager of the NJEDA’s Biotechnology Development Center (BDC) and the Commercialization Center for Innovative Technologies (CCIT), where he is responsible for all aspects of developing and administering CCIT & BDC leasing and programming. Lenzie’s activities support the growth of the life sciences businesses at CCIT, managing tenant relationships while providing guidance to foster successful expansion or graduation of tenant companies. BDC & CCIT are located in the NJEDA’s Technology Centre of New Jersey, a 50-acre, 5 building research park in North Brunswick. Consisting of 300,000 S.F. of lab and office space, with over $70 million invested in facilities and improvements, the Technology Centre of New Jersey was developed to meet the lab and office needs of entrepreneurial startups, to emerging R&D companies, to large established corporations in the biosciences.

Lenzie joins the EDA after a decade at the New York City Economic Development Corporation, where he ultimately served as vice president of the agency’s Life Sciences & Healthcare Teams launching such programs as Harlem Biospace and the $150M NYC Early Stage Life Sciences Funding Initiative with Celgene and Eli Lilly serving as strategic investment partners. He also led a technology and life sciences program for the University of North Carolina system.

Samit Hirawat, MD

Executive Vice President, Head of Oncology Global Development, Novartis

Samit Hirawat, M.D., joined Novartis Oncology in 2007 and is the Executive Vice President and Head of Oncology Global Development.

In his role as head of Oncology Development, Samit leads the development, registration and approval of all molecules in the solid tumor and hematology franchises including CAR-T cell therapies. Under Samit’s leadership, several therapies have achieved regulatory approvals including CTL019 for relapsed/refractory Pediatric and young adult ALL and relapsed/refractory DLBCL; TAF/MEK for adjuvant treatment of BRAF mutant melanoma; LEE011 for HR+/HER2- advanced breast cancer among and others. Samit has been a key leader in Novartis oncology business for more than 10 years. Previously, as a Global Program Head in Oncology, he led the successful development, regulatory submission and approval for LEE011 – a breakthrough therapy for hormone receptor positive, HER2-negative advanced breast cancer. Samit has been in pivotal leadership roles in the Oncology Development Organization advancing several cancer medicines including panobinostat, buparlisib, alpelisib and ribociclib. Prior to Novartis, Samit led clinical development programs in multiple indications at PTC Therapeutics and Pfizer/Pharmacia Corporation.

Samit received his Bachelor of Medicine and Bachelor of Surgery (M.B; B.S.) from the Sawai Man Singh Medical College in India, and completed his Internal Medicine Residency and Medical Oncology Training at North Shore University Hospital, New York. He is an author of several manuscripts and abstracts published in peer reviewed journals and presented at major conferences. Samit is a recipient of several government grants, academic and corporate awards.

David D. Ho, MD Scientific Director and CEO of the Aaron Diamond AIDS Research Center; Irene Diamond Professor at the Rockefeller University

David D. Ho, M.D. is the founding Scientific Director and CEO of the Aaron Diamond AIDS Research Center and the Irene Diamond Professor at The Rockefeller University. He received his degrees from the California Institute of Technology and Harvard Medical School. Dr. Ho has been at the forefront of AIDS research for 36 years, publishing over 400 papers. His elegant studies unveiled the dynamic nature of HIV replication and revolutionized our basic understanding of AIDS pathogenesis. This knowledge led Dr. Ho to champion combination antiretroviral therapy that has transformed an automatic death sentence into a manageable condition. He now devotes his time to novel approaches to block HIV transmission, including the engineering of potent antiHIV antibodies. His scientific leadership in the HIV/AIDS area has also led to successful development of a new antibody-based drug, Trogarzo, which was recently approved by FDA for the treatment of HIV infection. Dr. Ho has received fourteen honorary doctorates and has served on the governing boards of Harvard, MIT and Caltech. Moreover, he has been elected a member of the National Academy of Medicine (US) as well as the Chinese Academy of Engineering (PRC) and Academia Sinica (Taiwan). He was also named Time Magazine’s Man of the Year in 1996 and awarded a Presidential Medal by Bill Clinton in 2001.

http://www.njeda.com/incubation

http://www.njeda.com/incubation


Jim Huang, PhD

Founder and CEO, Ascendia Pharmaceuticals

Dr. Huang is Founder/CEO of Ascendia. He has 18 years of pharmaceutical R&D and management experience at Pfizer, Baxter, AstraZeneca, and most recently Roche. He has led the formulation development efforts for the successful transition of several oral and parenteral dosage forms from discovery through formulation, manufacturing, technical transfer and ultimately commercialization. Dr. Huang holds a Ph.D. in Pharma-ceutics from the University of the Sciences in Philadelphia (formerly Philadelphia College of Pharmacy and Sciences) where he worked with Joseph B. Schwartz. Dr. Huang’s research interests are centered on improvement of solubility and dissolution, and controlled delivery of, poorly water soluble drugs through nano technologies. He has published numerous patents and papers and serves as reviewer for leading pharmaceutical journals; Currently, he is a member of American Association of Pharmaceutical Scientists (AAPS) and American Chemical Society (ACS).

Kevin Huang, PhD Chief of Staff, Head of Corporate Strategy and Investment, WuXi Biologics

Dr. Kevin Huang is Chief of Staff, Head of Corporate Strategy and Investment at WuXi Biologics. He leads the company’s global expansion efforts through acquisitions and external collaborations, and coordinate new technology evaluation and corporate venture investment. His team also manages corporate communication and provides operation support to senior management. Before WuXi Biologics, Dr. Huang worked on late stage process life cycle management of Nivolumab (anti-PD1 antibody) at Bristol-Myers Squibb, including technology transfer, process validation, and commercial manufacturing. He also has analytical R&D and process development experience at Amgen and AbbVie, and received business training at Morgan Stanley Hong Kong and Roland Berger Shanghai. Dr. Huang holds Ph.D. degree in Pharmaceutical Chemistry from University of Illinois and B.S. degree from Peking University.

Andrew Jiang

CEO, Aleon Pharma International

Andrew Jiang is the founder and president of Aleon Pharma International, Inc. (Aleon), a company which has extensive experience in pharmaceutical and

biologics global development strategy consulting, regulatory submissions (IND & NDA) and clinical trial management. Since its establishment in 2010, Aleon has collaborated with a significant number of global pharmaceutical/biotech companies and has played critical roles in the development of multiple innovative drug candidates. Prior to founding Aleon, Andrew held director positions in global regulatory affairs at Bayer HealthCare, Novartis, Astellas, Pfizer, and other companies. He has 20 years of direct experience liaising with major health authorities including FDA, CFDA, EMA, Health Canada and has held many formal meetings with the FDA as multiple company’s lead representative. Andrew has led global regulatory teams in the regulatory submissions of pharmaceutical and biological products in various therapeutic areas including oncology, cardiovascular & metabolic diseases, neurology, etc. He has received several corporate awards for outstanding professional performance.

Hongliang Jiang, PhD CEO, Wuhan Hongren Biopharmaceutical Inc.

Hongliang Jiang is the founder and CEO of Wuhan Hongren Biopharmaceutical Inc. Dr. Jiang received his PhD degree in Pharmaceutical Science from University of Arizona in 2005. Then, he conducted his Postdoc. Training in LC-MS/MS based omics study at Pacific Northwest National Lab. Subsequently, he joined the Department of Bioanalysis at Covance Inc. in 2006. He was recruited as a full Professor by Huazhong University of Science & Technology in 2011 and he established Wuhan Hongren in the same year. Dr. Jiang has published over 50 scientific articles and serves as an editorial board member for three scientific Journals. He also received funding support from National Natural Science Foundation of China for three projects.

Peng Jiang, PhD

Dana Farber Cancer Institute & Harvard School of Public Health

Dr. Peng Jiang is a postdoc fellow at Xiaole Liu Lab at the Dana Farber Cancer Institute and Harvard T.H.

Chan School of Public Health. His research focused on developing computational models to identify biomarkers and regulators of anticancer drug resistance, with an application focus on cancer immunotherapies. Peng has many first and co-first authored papers in high profile journals, such as Nature Medicine, Science, and PNAS. Peng finished his Ph.D. at the department of computer science and Lewis Sigler genomics institute at Princeton University, and his undergraduate study with the highest honor at the department of computer science at Tsinghua University. He is a recipient of the Pathway to Independence Award (K99/R00) of National Cancer Institute.

Seamus Jiang, MBA, CFA, CPA Managing Director Co-leader for China/US Cross-Border Deals PwC

Seamus is a Managing Director in the PwC US Deals practice with over 18 years of M&A and finance

experience in North America and Asia. He has spent the last 13 years assisting strategic and financial buyers/sellers in evaluating over 140 M&A and investment transactions with an aggregate deal value of over $180 billion in a variety of industries including Pharmaceutical and Life Science.

Seamus co-leads PwC US’s China/U.S. cross-border deals team and is a key member of China Business Network, a dedicated team of bilingual and bicultural professionals experienced in addressing the opportunities and challenges of US-China business and investment. In the past 4 years alone, Seamus has led over 50 China/U.S. cross-border M&A and investment projects.

Prior to joining PwC US, Seamus worked at GE Capital and PwC China, whereby he provided financial audit and business advisory services for over 40 publicly traded companies and Fortune 500 subsidiaries, including several cross-border IPOs on NYSE and HKEx.

Seamus earned a B.A. in International Economics from Fudan University and an M.B.A. from Goizueta Business School of Emory University. He is a CFA charterholder and holds CPA licenses in both U.S. and China. Seamus is a regular speaker at Wharton China Business Forum, UCLA Wilbur K. Woo Greater China Business Conference and PwC Silicon Valley Deals Summit.

He is also an author of PwC’s quarterly Deals Insights and PwC’s Deals Blog.

Winston Jiang, PhD

General Manager, Hong Dou Shan Pharmaceutical Research INC (NY)

Graduated from Nanjing Tech University with a bachelor’s degree in pharmaceutical engineering in


2010. After graduated, joined Jiangsu Yew Pharmaceutical Co., Ltd. as a researcher, and then studied at Nihon University (a Japanese University School of Pharmacy) and got Ph.D. in Pharmacy in 2017. In the same year, returned to the Jiangsu Yew Pharmaceutical Co., Ltd. working as a senior researcher, project manager, marketing manager (also BD manager), and now is the CEO of the New York branch.

Gordon M. Johnson Deputy Assembly Speaker of New Jersey Assembly

Gordon M. Johnson (D-Bergen) was elected to the New Jersey State General Assembly in 2001, by the people

of the 37th Legislative District. As part of the General Assembly Leadership, Assemblyman Johnson serves in the position of Speaker Pro Tempore. He serves as Chairman of the Assembly Commerce and Economic Development Committee. He is a member of the Assembly Judiciary Committee and a member of the Assembly Budget Committee. Previously, he served as the Majority Conference Leader, a leadership post in the New Jersey State Assembly during the 2012-2013 legislative session. From 2006-2011 Assemblyman Johnson served as Chair of the Assembly Law and Public Safety Committee.

Bing V. Li, PhD

Director in the Division of Bioequivalence I, Office of Bioequivalence, Office of Generic Drugs, Center of Drug Evaluation and Research, FDA

Dr. Bing V. Li’s responsibility is to direct and oversee the work of highly skilled staff of professionals in reviewing drug product bioequivalence studies submitted in Abbreviated New Drug Applications (ANDAs), develop guidelines applicable to the completion of reviews, plan and manage the regulatory review operations. Prior to joining FDA in 2004, she was a Research Investigator at Bristol-Myer-Squibb where her responsibilities included formulation identification, development and optimization for oral solid dosage form formulations. Dr. Li is an expert pharmacologist at FDA in the area of bioequivalence of aerosolized drug products. She is the editor and author for the book “FDA Bioequivalence Standards”. She has published numerous papers, book chapters and patents, and has been invited to give a number of presentations at national and international conferences. Dr. Li is the winner of many awards including Thomas Edison Invention Award, AAPS Outstanding Contributed Paper for Regulatory Sciences Awards, National Institute of Health Biotechnology Award, Bristol-Myers Squibb Triumph Award, FDA Center Director’s Special Citation Award and FDA Regulatory Science Excellence Award. Dr. Bing V. Li received her Ph.D. in Pharmaceutical Sciences from University of Wisconsin at Madison, and a bachelor degree in Medical Chemistry in Beijing University, China.

Ge Li, PhD Chairman, WuXi AppTec Group

Dr. Ge Li is the founder and Chairman of WuXi AppTec Group. Dr. Li is one of the most influential leaders in the global biopharma R&D industry. He pioneered an

integrated R&D service model and the open access R&D enabling platform model, with the conviction that more efficient and cost effective R&D should be at the core of better medicines for patients, and that “every drug can be made and every disease can be treated.” As the company’s Chairman, Dr. Li has led WuXi’s rapid growth from four employees and a single chemistry laboratory of 7,000 square feet in December 2000 to a transformative global R&D power house enabling over 3,000 collaborative partners worldwide. Dr.

Li earned his Bachelor’s degree in chemistry from Peking University and his Ph.D. in organic chemistry from Columbia University.

JoLee Li, PhD Executive Vice President, Global Business Development, Tayu Biotech

Dr. JoLee Li joined Tayu Biotech in Aug. 2018 as Executive Vice President of Global Business Development. Prior to Tayu, she was SVP of Business

Development and Global Client Service at Crown Bioscience Inc. She participated in several M&A/partnership/licensing-in and licensing-out negotiations. The most recent one was the cash acquisition of Crown Bioscience by JSR for $400M. During the more than 8 years of tenure at Crown, she worked directly with a couple hundred clients with deep connections of the market place and extensive networks to the biotech and pharma companies. Prior to Crown Bioscience, Dr. Li was with Exelixis Inc. as a structural biologist worked on multiple drug development programs from target validation to drug candidate selection. Prior to Exelixis, she was working at Zyomyx Inc in combinatorial biology and assay development. Jia (JoLee) Li graduated from Nanjing University with a bachelor degree in Chemistry. She went on to UCSF for further training as the recipient of the esteemed Cheng’s Scholarship founded by the Hong Kong billionaire Dr. Cheng Yu-Tung. She did her master training program in Biochemistry from University of Alberta Canada and obtained her Ph.D. in Molecular Physiology and Biological Physics from University of Virginia.

Michelle Li, PhD, MBA Associate Vice President, Corporate Development, Merck & Co., Inc.

Michelle has almost 20 years of business development and finance experience with Merck. She is currently Associate Vice President of Corporate Development, where she is responsible for the company’s strategic business development initiatives with a focus on M&A, joint venture and divestitures. Michelle also leads all commercial business development activities for Merck’s Global Pharma and Vaccine businesses as well as for the Americas (US, Canada and Latin America).

Michelle received her B.S. in Biochemistry from Nankai University, Ph.D. in Physiology from Penn State University College of Medicine, and MBA from the Johnson Graduate School of Management at Cornell University.

Jian Liu, PhD

Principal Scientist and External Lead, External Discovery Chemistry, Merck; SAPA 2017-2018 President

Jian Liu, PhD is currently a Principal Scientist and External Lead in the External Discovery Chemistry Department at Merck. Dr. Liu has managed many projects on target validation, lead identification, and lead optimization in the discovery chemistry department, and has generated multiple clinical candidates which went into first-in-man, phase I, and phase II clinical trials. Dr. Liu is an expert in drug discovery for many therapeutic areas such as osteoporosis, obesity, diabetes, cardiovascular disease, rheumatoid arthritis, oncology, infectious disease, pain and neuro-degenerative diseases. Dr. Liu has also been in charge of outsourcing and collaborating with several external CRO companies. Based on his research work, Dr. Liu has published 31 peer reviewed papers, and obtained 48 US and international patents. Dr. Liu obtained a Ph.D. degree in organic chemistry from UCLA in 1998 and joined Merck in 2001. He is the 2017-2018 President of Sino-American Pharmaceutical Professionals Association (SAPA).


Brad Loncar

CEO, Loncar Investments

Brad Loncar is an independent biotechnology industry investor. Through Loncar Investments LLC, he uses his research of biotech companies and technologies to

develop thematic biotech investment indexes. His first two products are the Cancer Immunotherapy Index and the China BioPharma Index. He previously worked in the financial services industry at Franklin Templeton Investments where he was a member of the Management Training Program, and was appointed to serve in a Senior Advisor role at the U.S. Department of the Treasury. Mr. Loncar currently writes biotechnology commentary at www.LoncarBlog.com and has contributed opinion pieces to Endpoints News and Xconomy. He holds a BA in Finance from the University of Miami.

Qun Lu, PhD Executive Director, Pharmaceutical Sciences and Technology, Celgene Corporation

Dr. Lu is an Executive Director in Pharmaceutical Sciences and Technology of Celgene Corporation, where she focuses on defining and delivering integrated CMC (chemistry, manufacturing, and control) development strategies and outcomes for small molecules in Celgene pipeline. Her group is also responsible for developing and managing the technical relationship between Pharmaceutical Sciences and Technology and Celgene alliance partners in joint development activities to create high value solutions and assets. Dr. Lu has more than 20 years of industry experience in CMC development from discovery through commercialization at various companies including Elan, Pfizer, Merck and Celgene. Dr. Lu received her B.S. in Chemistry from Peking University, completed her Ph.D. in Physical Chemistry at Arizona State University, and carried out post-doctoral studies in Pharmaceutics at the University of Wisconsin – Madison. Dr. Lu is currently serving as the chair of Drug Product Leadership Group and a member of the Board of Directors of International Consortium for Innovation and Quality (IQ).

Peter Marks, MD, PhD Director, Center of Biologics Evaluation and Research, FDA

Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.

Michael Nally, MBA President Global Vaccine, GHH, Merck & Co.

Mike Nally is President of Global Vaccines at MSD. MSD, with a strong vaccines business, is a global leader

providing a broad portfolio of pediatric, adolescent, and adult vaccines to the world. In his role, Mike aims to drive a dramatic increase in the reach and public health impact of vaccines, while delivering business growth. Prior to this appointment, Mike led the company's business in Sweden and the UK, focusing on the development and implementation of innovative, customer-centered approaches that delivered improved business results and accelerated patient access to our medicines. Previously, Mike was Executive Director of Strategic Initiatives and Operations and has also held positions in

Finance, Business Development and in Investor Relations. Mike holds a MBA from Harvard Business School, a degree in Accounting and Finance from the London School of Economics and a BA in Economics from Middlebury College.

William Pignato, MS Founder and Principal, W.J. Pignato & Associates, LLC

Bill Pignato is the Founder and Principal of W.J. Pignato & Associates, LLC a Boston based consulting

firm specializing in global regulatory affairs strategy, which is focused on in vitro diagnostics, medical devices, companion diagnostics and precision medicine, drug/diagnostics co-development and the regulatory deployment of new technologies. Previously Bill was the Vice President, Global Head of Regulatory Affairs for Companion Diagnostics at Novartis where he led the companion diagnostic regulatory program in support of the company’s novel therapeutics in oncology and general medicine. He previously worked at Genentech, Inc leading the diagnostic regulatory initiatives specific to the company’s companion diagnostic initiatives. Bill brings over 30 years of strategic global diagnostic regulatory affairs experience in support of bringing products to market, including working on more than 50 drug/diagnostic co-development programs. Prior positions include Vice President of Regulatory Affairs for EXACT Sciences Corp., an applied genomics company focused on the early detection of colorectal cancer and Vice President of Regulatory Affairs for Valeo Medical. He has also previously held senior regulatory positions at Bayer Diagnostics, Chiron Diagnostics and Ciba-Corning Diagnostics. He recently served as an independent Board Director on Chinese Diagnostic company on behalf of one its investors. He has spoken widely on a number of regulatory issues and challenges associated with commercialization of in vitro diagnostic technologies including personalized medicine, companion diagnostics and drug/diagnostic co-development.

Dennis J Purcell, MBA Founder and Senior Advisor, Aisling Capital LLC

Mr. Purcell is Founder and Senior Advisor to Aisling Capital LLC. Previously, he served as the Senior

Managing Partner. Aisling Capital is a leading investment firm that invests in products, technologies, and global businesses across the Life Sciences industry. Aisling Capital has raised over $1.8 billion since inception. Prior to founding Aisling Capital, Mr. Purcell served as Managing Director of the Life Sciences Investment Banking Group at Chase H&Q (formerly Hambrecht & Quist, “H&Q”). While at H&Q, he was directly involved with over two hundred completed transactions and supervised over $10 billion of financing and advisory assignments in the pharmaceutical, biotechnology and medical products industries. Prior to joining H&Q, Mr. Purcell was a Managing Director in the Healthcare Group at PaineWebber, Inc. Mr. Purcell is a frequent commentator on the industry and is actively involved with many of the industry's professional organizations. He has been a member of the Board of numerous private and public healthcare companies and currently serves as Executive Chairman of Poliwogg Holdings, a company devising new financial products for the healthcare industry. He also currently sits on the board of Real Endpoints, Summus Global, Inc., Life Science Leader Magazine –Editorial Advisory Board, NY BIO Association and the New York Investment Fund as well as a Senior Industry Advisor for Bioscience Managers Pty Ltd an Australian based specialist healthcare fund manager. Mr. Purcell is a member of The University of Delaware Investment Committee, Harvard Kennedy School - M-R CBG Advisory Council, and the New York Leadership Council. He received his M.B.A. from Harvard University and his B.S. in Accounting from the University of Delaware.

http://www.loncarblog.com/


Yaoping Ruan, PhD

Chief Data Scientist, LinkDoc

Dr. Ruan is a computer scientist with expertise in interdisciplinary research areas, in particular medical and bioinformatics utilizing big data and high-

performance computing platforms. He was a Senior Technical Staff Member and Sr. Manager at IBM Watson Health, responsible for the design and development for Watson Platform for Health HIPAA and GxP version, and a Research Staff Member at IBM TJ Watson Research Center. He holds a Ph.D. degree in Computer science from Princeton University, a Master’s degree from USTC, and a Bachelor’s degree from Tsinghua University.

Michelle Rashford, MD SVP, Adlai Nortye Biopharma Co., Ltd.

Michelle is a Pharmaceutical Physician with over 20 years’ experience in both clinical development and medical affairs at a senior level. She began her career

in Australia before moving to a global medical role in Switzerland launching rituximab. Moving to clinical development to work on late stage development, Michelle joined Bristol-Myers Squibb in 2014 in oncology clinical development before joining Adlai Nortye as SVP Clinical Science.

Greg Russotti, PhD Vice President, Cell Therapy Process and Analytical Development at Celgene

Gregory Russotti is currently Vice President of Cell Therapy Technical Development at Celgene

Corporation, responsible for process development, analytical method development, product sciences and process/assay support for, and tech transfer into, clinical and commercial manufacturing for cell therapy products. Prior to joining Celgene in 2006, Greg spent 15 years at Merck Research Laboratories developing products that included live virus vaccines, monoclonal antibodies, recombinant vaccines, and microbially-produced natural products. He worked on development, scale-up, and tech transfer of cell culture, microbial fermentation, and downstream isolation processes to clinical and commercial manufacturing facilities. Greg received his B.S. and M.S. degrees in Chemical Engineering from Rensselaer Polytechnic Institute and his Ph.D. in Chemical and Biochemical Engineering from Rutgers University.

Tingting Qi, MBA Executive Director, China International Capital Corporation

Ms. Qi is currently the Executive Director in the Investment Banking Department of China International

Capital Corporation. Ms. Qi joined CICC in 2005. Based in New York, she works with multinationals and private equity firms and manages relationships with financial intermediaries on US-China cross border deals. Prior to taking on this role in 2010, Ms. Qi was based in China where she specialized in providing investment banking services for financial institutions. Ms. Qi graduated from NYU Stern with a master degree in Business Administration and Fudan University with a B.A. degree in Economics.

Robert Sheridan Senior Principal Scientist (Retired), Modeling and Informatics, Merck

Robert Sheridan is a computational chemist and cheminformatics expert. He earned his PhD in

Biochemistry from Princeton University. He did postdoctoral work at Fox

Chase Cancer Center and Rutgers University before joining Lederle Laboratories in 1983. He joined Merck in 1991 and concentrated on developing new methods in molecular modeling, first in the field of virtual screening, and currently in QSAR. While formally retired from Merck, he continues to develop QSAR methods and apply QSAR to new types of problems.

Yongkui Sun, PhD

CEO, IONOVA

Dr. Sun graduated from Caltech with a Ph.D. in chemistry and began his professional career at Merck Research Laboratories as a Senior Research Chemist

in 1993. He gained rich experiences in drug development and business management at Merck by taking on responsibilities across six departments, from R&D, to China R&D strategy and operation, and to Business Development and Licensing. During his tenure at Merck, Dr. Sun delivered significant value of science to the Company. He also led the effort to license in, for the first time from Greater China, an innovative therapeutic candidate. In recognition of his contributions and leadership, internally he was named a Presidential Fellow in 2006; externally he received several notable accolades, including the Thomas Alva Edison Patent Award (2009), the Presidential Green Chemistry Challenge Award in 2005 and in 2006, UK’s Institute of Chemical Engineers' AstraZeneca Award for Excellence in Green Chemistry and Engineering in 2005. He was elected a member of the US National Academy of Engineering in 2016. He is currently CEO of IONOVA, a biotech focusing on translation of biomedical research discoveries into novel medicines for cancer therapy.

Weimin Tang, PhD Global BD head and EVP, I-MAB Biopharma

Dr. Tang obtained PhD degree from Rutgers University, majoring in Cancer Biology. He started his industry

career with American Cyanamid, now part of Pfizer, as Research Scientist. He has since worked with BMS, Sanofi and Johnson and Johnson in different Research and Development function with growing roles. He first authored multiple papers and patents. Previously he was VP of Global business development for Crown Bioscience and has grown business 5-fold during his 5 years tenure. He established Hengrui Medicine’s US Clinical operation and served as US Business Head and interim CEO before joining I-Mab. Dr. Tang maintains his can-do attitude toward business operation. He is well connected and result driven. He has proven track record of success business in both global biotech and Chinese Pharmaceutical environment.

Wei-Qin (Tony) Tong, PhD President, Austarpharma

Wei-Qin (Tony) Tong, Ph.D. is President of Austarpharma and CSO of Guangzhou Bostal Drug Delivery Co.. Prior to joining Austarpharma, Tony was

head of R&D for G&W labs for a year, responsible for company’s R&D and RA organizations; Vice President and Head of Development for Teva’s US R&D center located in Pomona, NY for 8 years responsible for the development of high-barriers-to-entry generic and 505b(2) new drugs; Executive Director, Pharmaceutical Development at Novartis for 6 years, responsible for all the formulation development activities of the US R&D center. Before Novartis, he spent 11 years with GlaxoSmithKline, progressing through positions of increasing scientific and managerial responsibilities. He has successfully contributed to the development of more than 30 marketed products including over 10 brand products with annual sales over $1b and over 10 first-to-file generic products. He has published over 70 research papers, book chapters and presentations, contributed to over 15 patents. His research publication on in situ salt screening received


the AAPS Outstanding Manuscript Award. He is a frequent invited speaker at national and international meetings. Tony got his BS degree in Pharmaceutics from Shanghai Second Military University in 1982 and his Ph.D. in Pharmaceutics from University of Iowa in 1991.

Fei Wang, PhD Assistant Professor, Weill Cornell Medicine

Fei Wang is an Assistant Professor in Division of Health Informatics, Department of Healthcare Policy and

Research, Weill Cornell Medicine, Cornell University. He is also a consultant for IBM Research and Air Liquide Research, as well as a medical advisor on Fidelity Investments. His major research interest is data mining, machine learning methodologies, as well as their applications in health data science. His papers have received over 6,500 citations so far with an H-index 43. His (or his students’) papers have won 6 best papers in international conferences. His team also won the Parkinson's Progression Markers' Initiative data challenge organized by Michael J. Fox Foundation in 2016, and NIPS 2017 challenge on Classification of Clinically Actionable Genetic Mutations. Dr. Wang is the chair-elect of the KDD working group in AMIA. Dr. Wang is the editor of several prestigious academic journals, including the journal Data Mining and Knowledge Discovery and IEEE Transactions on Neural Networks and Learning Systems. Dr. Wang has filed more than 40 US patents, among which 15 are granted.

Hwei-Gene Wang, PhD Vice President and Head of Global Regulatory Science-China and Hong Kong, Bristol-Myers Squibb Company

Dr. Heidi Hwei-Gene Wang is the Vice President and Head of Global Regulatory Science-China and Hong Kong, Bristol-Myers Squibb Company (BMS). She has led the team to obtain the first HCV direct acting agents (Daklinza and Sunvepra) approvals in China in April 2017. She also led the team to obtain the first Immuno-Oncology PD(L)-1 inhibitor (Opdivo) approval in China in June 2018. Prior to China, Dr. Wang had 22 years of experience working in BMS US headquarter, including conducting research in HIV and hepatitis B and C viruses and working on multiple regulatory submissions and approvals in the US and 30+ international markets, including China. With innovative thinking to overcome challenges, she led cross-functional teams to complete Daklinza and Sunvepra initial filings and approvals in 30+ international markets in a short timeframe. She had contributed to obtaining Sprycel initial US/EU approvals and Erbitux submissions and labelling approvals in the US.

Jin Wang, PhD Managing Partner/Founding Partner, Jianxin Capital and Manhattan Capital Group

In late 90s, Dr. Jin Wang joined Paramount Capital, serviced as an Asia/Great China Regional Director, he also provided value-added service as a venture partner & executive for a portfolio company, PolaRx Biopharma. After that, he became a China Head for business & clinical development of a public company, Cell Therapeutic, Inc. In 2002, he returned to China, started his own VC firm, MCG Group and invested more than 20 biotech or healthcare related companies in China and US. He is a co-founder of SAPA. In his early research career, he worked for Worcester foundation and Roche Pharmaceutical. He obtained his BS from Zhejiang University and PhD in Biomedicine from WPI in the US.

Sha Wang, PhD

Director, Department of International Affairs, Geneplus

I obtained my PhD from Institute of Microbiology, Chinese Academy of Science, Beijing, in 2010, majored

in Molecular Biology and Biochemistry. From 2010/03 to 2014/03, I worked as a post-doctoral fellow in State Key Laboratory of Biomembrane and Membrane Biotechnology, School of Life Sciences, Tsinghua University, focusing on the mechanism of cataract. From 2014/04 to 2015/04, I worked in Dr. Timothy Springer’s lab in Program in Cellular and Molecular Medicine, Boston Children’s Hospital, focusing mainly on the binding mode of a small molecule and a blood factor, VWF. In 2015, I transferred my direction to cancer genomics and joined Dr. Kang Zhang’s lab in Institute for Genomic Medicine, University of California, and San Diego. In 2018/01, I joined Beijing Geneplus Institute, and worked as the Director of the Department of International Affairs, and take charge of the cancer early detection projects.

Yusheng Wu, PhD Chairman of Board and CEO, Tetranov Pharmaceutical, Inc. and its subsidiary Deuracor Therapeutics

Yusheng Wu, Ph.D., Chairman of Board/CEO, Tetranov Pharmaceutical, Inc. and its subsidiary: Deuracor Therapeutics, a pharmaceutical company focusing on novel drug discovery targets to drug development.

Dr. Wu has more than 20 years experience in drug discovery. He worked at Schering-Plough Research Institute from1996-2009 and involved/lead in many drug discovery projects for Thrombosis, Obesity, Alzheimer, etc. and made key contributions to each of these projects in Schering. Thrombosis project was launched in market. Obesity and Alzheimer projects were recommended for the development. Alzheimer project was the first in class in clinic trial and currently in Phase III.

Dr. Wu’s extensive resume also includes more than 70 scientific publications in the leading chemistry and medicinal chemistry journals and more than 40 patents. He is the recipient of 2004 New Jersey Minority Achievement Award, Schering-Plough President Award in 2006 (Alzheimer project).

Since 2009, Dr. Wu lead his own drug discovery team in Tetranov and developed more than 10 novel therapeutic drug candidates in which 5 projects are under IND application currently. Dr. Wu is currently a concurrent professor of Zhengzhou University and Wei Fang Medical School where he supervises Ph.D. and M.S. students. He is also associate director of Henan Joint Innovation Center of drug discovery and drug safety evaluation. Dr. Wu is a Board member of Sino-American Pharmaceutical Professionals Association (SAPA) and Chair of Board of its China Chapter.

Jijun Xing, PhD Science and Technology Counselor in Chinese Consulate-General in New York

Dr. Jijun Xing, Science and Technology Counselor in Chinese Consulate-General in New York. He received a

bachelor degree of engineering, Tianjing University, a master degree in economics, People’s University of China and a PhD in administrative management, Huazhong S&T University. Dr. Xing has years of experience since 1990 in managing and facilitating international scientific and technological cooperation. He served in Chinese Embassies in Norway and the Netherlands, Director of Asia and Africa and Director of Europe in the Chinese Ministry of Science and Technology (MOST). Before taking the current position, Dr. Xing served China Science and Technology Exchange


Center as Deputy Director General covering governmental and non-governmental cooperation in science and technology, technology transfer and academic exchanges. His personal academic interest includes low carbon development technologies and low cost health technologies etc. Dr. Xing is now still a strategic evaluation expert for international cooperation under European Horizon 2020 program.

Haishan Xiong, PhD, MBA SVP Business Development, Fountain Medical Development

Haishan is responsible for commercial operations at FMD, a full service clinical CRO with operations in Asia,

Europe, and North America. Before joining FMD, Haishan was EVP and Chief Business Officer of KBP BioSciences, a clinical stage biotech company. Haishan was responsible for the overall operations of the company. Before joining KBP, Haishan was head of Commercial Strategy at WuXi AppTec. He was responsible for strategic planning and new business. Haishan started his pharma career in commercial operations. He worked at Roche Labs for 10 years in marketing and sales. He later joined Spectrum Pharma, an oncology-focused biotech, managing all Government business. Haishan is an entrepreneur as well. He co-founded Vitalico LLC, a California-based consumer health company. Over the 3 years, Haishan and his team successfully launched 2 products and developed strategic alliances with major consumer health companies. Haishan received his PhD in physiology from Penn State University and MBA from the Wharton School.

Alex Zengjun Xu, MD, PhD Chief Scientist (Pharmacology and Toxicology), CDE, NMPA (formerly CFDA)

Dr. Xu is currently working in the Center of Drug Evaluation (CDE), Chinese Food and Drug Administration (CFDA), as the chief scientist in pharmacology and toxicology. Prior to this appointment, he worked as a senior Pharmacologist/Toxicologist in the Office of New Drugs (OND) at US Food and Drug Administration, Center for Drug Evaluation and Research (US FDA/CDER). Before joining FDA, he worked as a senior scientist in pharmacogenomics and toxicogenomics in Gene Logic Ltd. Dr. Xu received a Master degree in pathology and PhD degree in pharmacology and toxicology from the University of Arkansas for Medical Sciences. He completed his PhD research project in Duke University and had his postdoctoral training in the National Center for Toxicological Research (NCTR). Dr. Xu has over 20-year experience in Toxicology and over 12-year in drug regulation. He is a Diplomate of American Board of Toxicology (DABT) since 2005. He is a full member of Society of Toxicology (SOT) and the immediate past president of the American Association of Chinese in Toxicology (AACT).

Daiying Xu, PhD Senior Scientist, NanoBioImaging Ltd. (Hong Kong)

Education:

• 08/2005-02/2011 Ph.D. in Biology, Department of Biological Sciences, SUNY, University at Albany

• 09/2003-07/2005 M.S. in Biochemistry and Molecular Biology, Sun Yat-sen University, P.R. China

• 09/1999-07/2003 B.S. in Biotechnology, Sun Yat-sen University, P.R. China

Working experiences:

• 2014 to present Senior Scientist, Nanobioimaging Ltd. Development and application of super resolution microscopy

• 2011 to 2012 Postdoc, Selection and characterization of RNA aptamers to inhibit essential RNA-binding proteins in Plasmodium falciparum, Massachusetts Institute of Technology.

Yuan Xu, PhD CEO, Legend Biotech Corporation Yuan Xu joined Legend Biotech in 2018 and serves as CEO. Formerly, Yuan was Senior Vice President at Merck leading Biologics and Vaccines Discovery,

Development and commercialization activities. Prior to Merck, Yuan held executive positions and gained global operations experience with Gilead, Novartis, Amgen, Chiron, GSK and Genentech. Yuan has over 25 years of Biologics, Biosimilar, Vaccine and Cell Therapy discovery, development, commercialization and life-cycle-management experience with contributions to 23 marketed products. Yuan performed Postdoc training in Virology and Gene Therapy at University of California, San Diego. She received her Ph.D. in Biochemistry from University of Maryland at College Park and her B.S. in Biochemistry from Nanjing University in China.

Li Yan, MD, PhD

CMO, Brii Biosciences, Inc. 腾盛博药

Li Yan, MD/PhD, Chief Medical Officer of Brii Biosciences, is a seasoned medicine developer. He held executive positions at GSK, Merck, and Johnson &

Johnson, most recently, VP and Oncology Head Unit Physician of GSK. He contributed to the development and approval of numerous medicines including Keytruda™ in China. His passion is to bring innovative medicines to transform patients’ lives, especially those in underprivileged communities. He firmly believes in the power of global collaboration. Li is a graduate of Peking University Medical College where he is an adjunct professor. He is an alumnus of Harvard Business School Enterprise Leadership program.

Haichen Yang, MD, MA Vice President, Drug Development Services, ICON Plc.

Dr. Haichen Yang is a physician scientist and seasoned executive with more than 20 years of pharmaceutical

drug development experience. She has successful track records designing and leading global clinical development programs in Neuroscience (Neurology, Psychiatry, and Pain), leading to multiple NDA/MAA submissions and worldwide drug approvals. She has extensive expertise on all phases (1-4) of clinical development and product support. Dr. Yang has authored more than 35 peer-reviewed publications and 2 book chapters, and more than 120 international meeting posters. She is frequently invited to speak at high-profile professional conferences. She also serves in multiple drug development societies and external task forces. Dr. Yang is currently a VP at ICON plc provide drug development expertise and scientific leadership to pharmaceutical and biotech clients. She also conducts due diligence work in Neuroscience for venture capital clients.

Lin Yang, PhD Director of the Board, Deep Informatics LLC

Dr. YANG is a computer scientist with expertise in interdisciplinary research areas, in particular biomedical

image computing and deep learning. He is an associate professor in the


department of biomedical engineering, computer science and electrical and computer engineering. He is also the co-founder and board of director of DeepInformatics, LLC. He holds a Ph.D. degree in Electrical and Computer Engineering from Rutgers University, a Master’s degree from and a Bachelor’s degree from Xian Jiaotong University. He has published over 100 peer-reviewed journal and conference papers with over 6000 citations, including two papers in Nature Medicine. He is the co-author of the award winning papers for 2008 ISBI NIH Young Investigator Best Paper and Travel Award, 2014 NANETS Young Investigator Paper and Travel Award, 2015 Young Scientist Best Paper Award Runner-up, and 2015 MICCAI Young Scientist Best Paper Award.

Donald Yin, PhD Vice President and Head of Economic and Data Sciences at Merck

Dr. Yin is Vice President and head of Economic and Data Sciences at Merck. His previous positions at

Merck included the head of CORE Hospital and Specialty Care Product Line, the head of Global Health Outcomes, head of Market Access and Public Policy at Merck in China and Executive Director and head of Global Market Access Strategy. He has more than 20 years of academic and industry experience in health economics and outcomes research, health technology assessment, comparative effectiveness research and health services research. He has authored or co-authored more than 80 peer reviewed scientific articles and published more than 150 abstracts at national and international scientific meetings. Before joining the pharmaceutical industry in 1996, Dr. Yin was an Assistant Professor of Health Economics at the University of Pennsylvania and a Senior Fellow at the Leonard Davis Institute of Health Economics. He received his Ph.D. from the Wharton School of the University of Pennsylvania and a Master of Science degree from the California Institute of Technology. He received his B.S. degree in Applied Mathematics and a M.S. degree in Econometrics from the Huazhong University of Science and Technology in Wuhan, China.

Debra Yu, MD Managing Director, Cross Border Healthcare & Life Sciences, China Renaissance

• 30 year history in life sciences industry including roles in VC, business development, strategic advisory, an in-house company management.

• Previously served as founder and Managing Director of Labrador Advisor, a cross-border advisory firm and VP Strategic Planning at WuxiApptec

• Architected and co-led Pfizer’s Venture Capital group, served as General Partner at Bay City Capital and Delphi Ventures, outside Director for Permanente Company

• Roles at McKinsey and Morgan Stanley

• M.D. from Harvard Medical School, BA in Molecular Biology from Princeton University

Guohua Zhang, PhD

CEO and President, Novast Holdings

Dr. Guohua Zhang has been a CEO and President of Novast Holdings since 2006. He started pursuing his career in pharmaceutical industry after received his

Ph.D. degree of Pharmaceutics from Philadelphia College of Pharmacy in early 1989. He served as Post-doctorate Fellow, Sr. Scientist, Vice President

and Senior Vice President with increasing responsibilities in Schering-Plough, Hoffman-Roche, Duramed and Andrx Pharmaceuticals from 1989 to 2006, respectively. Under his leadership, more than 150 products (ANDA/NDA) were successfully developed and commercialized or pending FDA approvals in USA. These products encompass a wide range of oral dosage forms, including extended release, delayed release, immediate release capsules and tablets. Dr. Zhang holds more than 10 issued or pending patents and has authored more than 50 publications, book chapters and presentations. Guohua is one of founders of SAPA and served as SAPA Vice President and President in the first two years, respectively.

Hongjian Zhang, PhD

Managing Director, Morningside Ventures

Dr. Hongjian Zhang is a managing director of

Morningside Ventures (晨兴创投) with 20+ years of

academic research, pharma R&D, management and investment experiences. Previously, Dr. Zhang was a board member of Sirius Investment Co, Ltd and served as CEO for its portfolio companies engaged in transpacific R&D and business operation. Prior to that, Dr. Zhang was a co-founder and COO of PharmaResources (Shanghai) Co, Ltd., a NEEQ listed company, and a senior project leader at Bristol-Myers Squibb Pharmaceutical R&D. Over the years, Dr. Zhang directed and delivered more than 16 drug candidates to various stages of clinical trials spanning several therapeutic areas. Aside from his industrial commitment, Dr. Zhang enjoys translational research and is an adjunct professor at College of Pharmaceutical Sciences, Suzhou University, with 70+ publications in peer-reviewed journals. Dr. Zhang obtained his PhD degree from University of California-Davis and completed his postdoctoral training at National Institutes of Health (NIH).

Linda Zhao, MS Senior Director, SDIC Innovative New

Drug Fund (国投创新药基金)

Ms. Linda Zhao is a Senior Director of Business

Development at SDIC Innovative New Drug Fund (国投创新药基金).

Linda has extensive experience in both global pharma R&D (Roche) and pharma BD (WuXi AppTec). Linda holds Master Degrees in Org Chem & Med Chem, and will finish her EMBA program soon.

Lihua Zheng, PhD, JD Partner, Zheng & Karg LLP

Dr. Lihua Zheng, is a founding partner and owner of Zheng & Karg LLP. His practice focuses on corporate

formation, venture financing, cross-border licensing, joint-ventures, legal due diligence, patent portfolio management and procurement. With deep understandings of both technical and legal nature, he is particularly experienced in transactions for life sciences companies and has assisted investors as well as companies to complete transactions valued in total more than a few hundred million dollars in the past three years. Previously he was with another boutique New York law firm for two years where he was a co-founder and prior to that he was with an international law firm for more than seven years. He graduated from Fordham University School of Law with Juris Doctor and from Baylor College of Medicine with PhD in Molecular and Human Genetics. He obtained Master of Science and Bachelor of Science both from Fudan University. He is licensed in the State of New York and the United States District Court for the Eastern District of New York. He is also a registered patent attorney at the United States Patent and Trademark Office.


Veronica Chen, PhD Associate Director, Global Regulatory Strategist, Bayer

Xiaodong Chen, PhD Senior Research Investigator, Bristol-Myers Squibb

David Cragin, PhD Associate Director Chemical Notification and Registration at Merck

Xing Dai, PhD Co-Founder and Head of Chemistry at InventisBio

Weiguo Dai, PhD Scientific Director/Janssen Fellow, Johnson and Johnson

Wei Ding, PhD Chief Scientific Officer, Admera Health China

Xin Du, PhD SVP, Head of Global Regulatory Affairs at Adlai Nortye Biopharma Co., Ltd

Helena Feng CFO, SAPA

Frank Gan, PharmD Director, Oncology Clinical Research, Janssen Pharmaceuticals

Chenchao Gao, PhD Clinical Regulatory Affairs Specialist II, Seattle Genetics

Hong-Ping Guan, PhD Chief Scientific Officer, Quixgen Inc.

Cai Li, PhD Principal Scientist, Merck

James Li, PhD Assistant Professor, Rutgers University

Jerry J. Li, PhD Associate Principal Scientist (Principal Clinical Statistician) at Merck

June (Junfang) Li, PhD Vice President, Biometrics, Kyowa Kirin Pharmaceutical Development, Inc.

Wansheng Jerry Liu, PhD, JD Partner & Chair of China Practice, Fox Rothschild LLP

2018 SAPA

Annual Conference

SAPA Annual Conference Session Moderators


Su-Fen Pu, MD, PhD Director, Global Clinical Safety & Pharmacovigilance, Merck & Co., Inc.

Xiaole Shen, PhD Senior Scientist Celgene Corporation

John Sun, PhD, MBA, PMP Program Lead for TransCelerate, Novartis

Le Tang, PhD Director of Scientific Affairs, Drug Disposition, Global Projects, Standards and innovation at Sanofi

Norman Tang Regional Commercial Leader, Vaccine at Merck

John Wang, PhD

Director Strategic Planning at Merck

Li Wan, PhD, RAC Director, Head of Global Regulatory Affairs, Luye Pharma Group, Ltd

Wenyan Wang, PhD Clinical Development Director, Novartis Pharmaceuticals

Jack Wu, PhD Head of Business Development (USA) at Adlai Nortye Biopharma Co., Ltd

Jun (Stephen) Xue, MS President, ASNS NJ Consulting, LL

Lin Yan, PhD Principal Scientist Merck & Co., Inc.

Guangyao Yang, MS Manger, Business Development/Client Service, CMC Services, Frontage Laboratories, Inc.

Jianda Yuan, MD, PhD Senior Director, Translational Oncology, Early Clinical Oncology Development, Merck & Co., Inc.

Le Zhan, PhD Research Associate III Rutgers Cancer Institute of New Jersey

Aming Zhang, PhD Staff Scientist at Regeneron Pharmaceuticals, Inc


The names will be provided by the SAPA President Office and announced at the SAPA Annual Gala Dinner on October 5.

2018 SAPA

Annual Conference

SAPA Service Excellence Awards


The SAPA Scholarship and Excellence in Education Program was established in 1999. The Scholarship is dedicated to recognize and support excellence on the part of outstanding high school students, and to encourage the finest high school graduates in the US to develop career in Life Sciences. Each scholarship awards a one-time fund of $1,000 towards tuition payment.

Daniel Zhang

Daniel Zhang graduated from Westview High School in San Diego, California in 2018. Throughout his life, he has moved several times, spending half of his time on the east coast, in Boston, and the other half on the

west coast, in San Diego. As an ardent scientific enthusiast, he has conducted genomic research at UCSD since his freshman year of high school and neurobiology research at the Weizmann Institute of Science during the summer of 2018. After countless hours of computational and wet lab work, he has successfully completed three complex research projects and became the youngest coauthor in the lab to publish peer-reviewed papers in PNAS, Cell Research, etc. His discovery of novel cancer biomarkers won him Best in Category at the 2017 Intel International Science and Engineering Fair in addition to the Philip V. Streich Memorial Award, with an all-expense paid trip to the London International Youth Science Forum. He recently published a first author chapter in a prestigious book series by Springer. Additionally, he was also invited to present his research at the 69th American Association for Clinical Chemistry Conference, and honored as the informatics division abstract winner for his work.

Beyond scientific research, he also strives academically as a National AP Scholar and a USA Biology Olympiad Semifinalist. In high school, he served as President of his school’s National Honor Society as well as chair of the Greater San Diego Science and Engineering Fair Student Advisory Board. As a four-year varsity tennis athlete, he led his team to Palomar League Champions and was recognized with the Most Valuable Player award for his efforts. Driven to make the world a better place, he established an eyeglass drive project in collaboration with ALAFFIA, a global organization striving to alleviate poverty and encourage gender equality. In doing so, he collected more than 500 pairs of eyeglasses to provide the visually impaired in Togo, Africa with the gift of vision.

With a major in Biology, Daniel joined the class of 2022 at the Massachusetts Institute of Technology and continues his cancer research under the guidance of world-renowned faculty members. He hopes to obtain an M.D. PhD., and ultimately lead his own lab at the intersection between CRISPR-Cas9 and cancer biology.

Nathan Mudrak

Nathan Mudrak graduated from Theodore Roosevelt High School in Kent, Ohio in 2018. A full-time dual-enrollment student for his entire secondary education, Nathan graduated this year with a 5.0 GPA and 109

college credits to his name.

As a Davidson Young Scholar, and two-time first-place winner in Northwestern University’s Midwest Academic Talent Search, Nathan has always excelled academically. Receiving the highest possible scores on both the SAT Molecular Biology Subject Test and the AP Biology exam before leaving middle school, Nathan fell in love with the life sciences from an early age. An accomplished student researcher, Nathan has accrued multiple first- and second-author publications in peer-reviewed journals and has worked at both Kent State University and the Cleveland Clinic as a research student. Presenting these works at local, national, and international conferences and symposia (including TEDx Kent State and the International Congress on Cell Volume Regulation), Nathan has won multiple awards for his research. Additionally, Nathan was named the President of the College Credit Plus Student Organization at Kent State University, as well as a Research Ambassador for the school.

Not only academically accomplished, Nathan is also the recipient of a first-place award from the World Ballet Art Competition for an ensemble piece performed by him and other members of the Stabrova Youth Ballet Company. Additionally, Nathan and his company have received multiple Top 12 awards from the Youth American Grand Prix, and Nathan has been honored to attend Pittsburgh Ballet Theatre’s Summer Intensive Program on a full-ride merit scholarship for three years. A compassionate and caring soul, Nathan has also given thousands of hours back to his community through volunteerism, including through his development and implementation of a lunchtime mathematics-enrichment program for 4th and 5th grade students at a local elementary school.

Nathan is currently a freshman at Johns Hopkins University in Baltimore, MD, pursuing a double major in both Biophysics and Molecular and Cellular Biology.

2018 SAPA

Annual Conference

2018 SAPA Scholarship & Excellence in Education for Life Sciences


The SAPA Graduate Travel Grant was established in 2014 to promote and encourage innovative research in the fields related to pharmaceutical and biotechnological sciences and to provide selected graduate students or postdocs a networking and learning opportunity to get to know the industry. The grant is given annually to two or more graduate students or postdocs who have conducted outstanding research in the field of life sciences and decides to pursue a career in pharmaceutical or biotech industry. Each Grant includes a one-time fund of $500 to be awarded to each of the selected Grant recipients for attending the SAPA annual conference in New Jersey, while waiving registration fees for attendance of the Conference. The Grant is open to any qualified graduate students and postdocs throughout the United States.

The 2018-2020 Grant is supported by the SAPA Scholarship and Excellence in Education for Life Sciences Foundation and co-sponsored by ForDoz Pharma Corp., a specialty pharmaceutical company established in 2014 focusing on developing and manufacturing complex injectable products, such as liposome, microsphere, and nano suspension based on its proprietary drug delivery technology (http://www.fordozpharma.com/). The company’s pipeline includes a series of complex generic drug products of liposome and microsphere, as wells as several improved existing 505(b)(2) products using liposome and microsphere delivery system. ForDoz Pharma has its headquarter, R&D labs, and cGMP manufacturing facility on its own 27-acre property located at 69 Princeton Hightstown Road, East Windsor, New Jersey 08520.

The “2018 SAPA-ForDoz Graduate Travel Grant” has been awarded to:

Xu Liu Graduate student in the College of Pharmacy University of Texas Austin, Texas

Yingfu Lin Graduate student in the Department of Chemistry University of Florida Gainesville, Florida

2018 SAPA

Annual Conference

2018 SAPA- ForDoz Graduate Travel Grant

http://www.fordozpharma.com/


2018 SAPA

Annual Conference

2017-2018 SAPA Corporate Sponsors


ACS Scientific Inc, established in 2008, located at Berkeley Heights, NJ, focus on Organic Synthesis to offer FTE service, Custom Synthesis and Catalog Products.

Driven by research innovation, with a team of high-level Ph. D chemists, our integrated services include custom synthesis and manufacturing, route scouting and process research, designing and synthesizing novel and unique building blocks, synthesis of advanced intermediate and non-GMP API products. Our featured products cover tri-substituted Pyridine, Pyrimidine and Pyrazine, Boronic Acid and ester, chiral Pyrrolidine (substituted at 3,4 and 2,3-position), various F- and CF3- containing products.

Our expertise spans medicinal chemistry and process research from small scale to kilo-gram quantities tailored to meet your specific needs.

ACS Scientific has been striving to be the most trusted partner to your success.


Aleon Pharma International, Inc. (Aleon) offers expert regulatory consulting and high quality clinical development solutions specifically tailored to each client’s individual requirements in pharmaceutical and biotech product development.

Our primary focus is to assist pharmaceutical and biotechnology companies in their new product development and post-marketing compliance in the United States and other countries. Aleon’s goal is to make the path to new drug approval more effective for its clients. Our company is driven by our commitment to quality solutions, scientific innovation, and continuous improvement.

Headquartered in Parsippany, New Jersey, the heartland of the pharma industry, and staffed by seasoned professionals, Aleon has provided effective strategies and product development solutions for our clients. Aleon’s team members are seasoned industry executives, with decades of experience in creating strategic solutions for clients in pharmaceutical and biotechnology industries. Because of this, we bring a tremendous amount of skill and value to our clients.

Ascendia Pharmaceuticals, founded in 2012, is a privately-owned, specialty pharmaceutical company dedicated to developing enhanced formulations of existing drug products, and enabling formulations for pre-clinical and clinical stage drug candidates. We specialize in creating formulation solutions for poorly-water soluble molecules and other challenging pharmaceutical development projects. Using our suite of nano-particle technologies, we can assess the feasibility of a broad array of formulation options in order to improve a drug’s bioavailability. We execute rapid,

comprehensive, and cost-effective programs for our clients. Our technologies include nano-emulsions, amorphous solid dispersions, and production of nano-crystals. Ascendia provides development and testing services - from discovery-stage molecules to life-cycle-management projects - creating formulation solutions with enhanced biopharmaceutical properties suitable for clinical scale-up. Ascendia formulates products for injectable, transdermal, ophthalmic delivery, and both immediate-release and controlled-release products for oral administration. Ascendia provides these services to emerging, discovery-based, specialty and generic pharmaceutical and biotechnology companies. Ascendia offers drug development services that encompass preclinical development, pre-formulation development, clinical formulation development, analytical/bio-analytical development, and modeling & simulation of small and biological molecules.

Ascendia has a proprietary pipeline of pharmaceutical product candidates, led by ASC-002, a novel, injectable form of the anti-thrombotic drug Clopidogrel and ASD-004, a novel clear eye drop nano-emulsion of cyclosporine for dry eyes.

Ascendia Pharma is headquartered in North Brunswick, NJ, with a state-of-the-art pharmaceutical research located at the Commercialization Center of Innovative Technology (CCIT), and is also building a 9,000-square foot formulation research and development facility in Xiamen, China.

For more information visit us at www.ascendiapharma.com or contact:

Jim Huang, CEO/CSO, [email protected]


Celgene

Celgene is building a preeminent global biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for patients with cancer, immune-inflammatory, and other unmet medical needs. From 1999 to today…

• Since the 1998 launch of Thalomid, Celgene has brought 7 new products to market including IDHIFA in 2017

• Annual revenues have grown from $14M to >$11B, making Celgene the 20th largest biopharma globally

• In 1999 Celgene had 115 employees. Today Celgene has more than 7000.

• Today Celgene’s market cap is ~440x greater than the $255M market cap it had in 1999

Our Strategic Imperatives Include…

• Execute Operational Excellence - Sustain a lean entrepreneurial culture focused on continuing to deliver industry-leading operating performance in order to maintain our commitment to R&D reinvestment and future innovation.

• Capitalize on Strength in Hematology & Oncology - Leverage our world-leading knowledge of Hematology & Oncology to bring novel therapies to market in an effort to address unmet patient needs. We except more than 10 new disease indications by 2021.

• Build a Leading Inflammation & Immunology Franchise - Continue strong growth within our Inflammation & Immunology Franchise, and explore and deliver opportunities in Neuroscience and Inflammatory Bowl Disease.

• Drive Innovation and Sustain Long-term Growth - We commit to relentlessly pursuing the discovery and development of novel and transformative therapies to deliver more medicines and better medicine to more people.


New Jersey's First Pharmacy School Associated with a Private University

The rapid evolution of the health care industry is having a critical impact on the pharmacy profession. Pharmacists are not simply dispensing medicine – they are leaders in areas such as health care management, long-term care, public health and pharmaceutical industry. FDU’s School of Pharmacy and Health Sciences is founded on a future-oriented approach to pharmacy education and offers a four-year professional program in a student-centered learning environment. FDU’s state-of-the-art facilities include non-conventional classrooms for active learning, research laboratories, a patient simulation lab, a simulation sterile compounding lab and contemporary study lounges. In addition to Pharm.D degrees, FDU’s School of Pharmacy and Health Sciences also offers dual degree programs that enable students to earn both a Pharm.D and master’s degrees at the same time.

Fairleigh Dickinson University School of Pharmacy & Health Sciences' Doctor of Pharmacy program is accredited by the Accreditation Council for Pharmacy Education, 135 South LaSalle Street, Suite 4100, Chicago, IL 60503, 312-664-3575; Fax 312-664-4652, web site www.acpe-accredit.org.

http://www.acpe-accredit.org/


Add: Hongdou industrial zone City Wuxi, Province Jiangsu, China post code:24199

Contract approver: Mr Yu Qionglin;

Position:General manager

Tel: +86 510-66868838, Mobil phone: +86 133822225178

Email：[email protected]

Jiangsu Yew Pharmaceutical Co., Ltd is one part of the HODO group. The factory was built about 42000 square meters, according with the china GMP standard. To total investment is above USD 30 million. Currently we has a paclitaxel-based anti-tumor series product line, including paclitaxel, docetaxel, cabazitaxel, 10-DAB, oxaliplatin, romasetron hydrochloric acid, etc. we become china’s leading high-tech enterprise in the field of taxus, from cultivation of yew, paclitaxel extracting, paclitaxel purification process and paclitaxel injection. The production capacity of paclitaxel API is 500kg annually. We built the R&D department, and inviting overseas doctors to develop new products, to ensure product innovation. Now we have more than 20 senior specialists, every year there are new product listed. Our paclitaxel API was listed on USFDA, the DMF registration No is 25759, and also registered and export to South Korea, India, Belarus, Brazil, Taiwan, etc. The Jiangsu yew Chinese herbal medicine Co., Ltd which is the wholly owned subsidiary of Jiangsu Yew Pharmaceutical Co., Ltd was built in 2014. It is mainly developing, production and selling of the yew Chinese herbal medicine, ordinary Chinese herbal medicine and ginseng and pilose antler health care. We focus on the developing, production and promotion of the small package Chinese herbal medicine.

江苏红豆杉药业有限公司是下属于红豆集团的生物制药企业。公司按 GMP标准建成 42000平方米标准厂房，总投资 1.8

亿元人民币。

公司已形成紫杉醇为主的抗肿瘤系列产品线，每年可提炼 300 公斤紫杉醇成品；产品有紫杉醇、多西他赛、卡巴他赛、

10-DAB、盐酸伊立替康、去甲斑蝥素、奥沙利铂等系列原料药及中间体。建成了从红豆杉资源培育到红豆杉枝叶加工、

紫杉醇初提物、紫杉醇原料药及其制剂的产业链，成为中国紫杉醇提取加工的高科技企业。

公司设立研究院，聘请海归博士主导新品研发，保证了产品的推陈出新；现有博士 4名，中高级人才 20多名，每年有不

同新品推出：其中 16年推出 L-5甲基四氢叶酸钙系列产品以质优价美获得客户好评。

公司紫杉醇产品 DMF 获得美国 FDA 的登记号（25759），并且已在韩国、印度伊朗、白俄罗斯、台湾等国家和地区注

册，产品远销海内外，主要出口韩国，印度，白俄罗斯，巴西，台湾等国家和地区，深受用户好评。

2014 年成立全资子公司江苏红豆杉中药饮片有限公司，主要从事以红豆杉中药饮片为主的精制饮片、普通装中药饮片、

参茸保健三大系列的研发、生产和销售。专注于小包装中药饮片的研发生产与推广，品质精良，众口皆碑。

Logan Instruments is a leading lab instrument manufacturer with a focus on dissolution, physical, and now more than ever, topical/transdermal testing systems for pharmaceuticals and cosmetics. It prides itself on three core concepts that have been the pillars of the organization: INNOVATION, QUALITY, SERVICE. Logan Instruments consistently looks to the future in terms of product development while never ceasing to maintain and nourish its existing relationships with their current customers. This type of forward thinking and customer care has helped them flourish in the industry for twenty-eight years. When searching for lab testing instrumentation, look no further than Logan Instruments.


绿叶制药是致力于创新药物的研发、生产和销售的国际化制药公司。绿

叶制药在中国、美国和欧洲设有研发中心，拥有 30 个中国在研药物和

超过 10 个海外在研药物，在中枢神经和肿瘤领域已有多个创新制剂和

创新药在欧美市场开展注册及临床研究。绿叶制药在微球、脂质体、透

皮释药等先进药物递送技术领域达到国际先进水平，并在创新化合物和

抗体、细胞、基因治疗以及智能制剂等领域进行了积极布局和开发。

绿叶制药在全球建有 7 大生产基地，超过 30 条生产线，建立了与国际接轨的 GMP 质量管理和控制体系。绿

叶制药现有 30 余个上市产品，产品覆盖抗肿瘤、中枢神经系统、心血管、消化及代谢等规模最大及增长速度

最快的治疗领域；业务遍及全球 80 多个国家和地区，其中包括中国、美国、欧洲、日本等全球主要医药市

场，以及高速增长的各地新兴市场。

About Luye Pharma Group

Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has established R&D centers in China, the U.S. and the EU, with a robust pipeline of 30 drug candidates in China and more than 10 drug candidates overseas. The company currently has a number of new drugs and new formulations in the central nervous system and oncology therapeutic areas under study in the U.S. and the EU. Luye Pharma is a global cutting edge company in terms of research into new drug delivery technologies, such as microspheres, liposomes and transdermal drug delivery systems. The company is forward looking, with strategic development of innovative new compounds and antibodies, gene & cell therapies and smart formulations.

Luye Pharma has set up 7 manufacturing sites with over 30 production lines in total, establishing GMP quality management and international standard control systems. The company offers more than 30 products covering the 4 largest and fastest growing therapeutic areas — oncology, cardiovascular, metabolism and central nervous system, with business conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets - China, the U.S., the EU and Japan, as well as fast growing emerging markets.

Medicilon offers fully integrated pharmaceutical services for the global scientific community. We focus on providing an exceptional client-centered experience and advancing the drug discovery process.

Since the founding of our company in 2004, our integrated services across biology, chemistry and preclinical services are uniquely designed to help clients developing their research and discovery programs from the initial idea stage to the IND filing phase.

Our headquarters is located in Zhangjiang High-Tech Park in Shanghai, China, with an additional facility in Chuansha Economic Park, Shanghai, China. We occupy over 300,000 sq. ft. in lab space and have over 800 employees cross biology, chemistry and preclinical research. Over 50% of our employees have M.S. and Ph. D., over 10% of them have foreign education and/or working experiences.

Medicilon has been recognized as one of the top drug discovery contract research organizations (CRO) in China and is managed by a team of scientists with a wealth of experience in US-based pharmaceutical and biotechnology companies. As our areas of expertise and service capabilities continue to expand, more and more pharmaceutical and biotechnology companies have taken advantage of our integrated drug discovery and development services.


Phililab, Inc. is a U.S.-based pharmaceutical company with worldwide connections, which specializes in formulation and analytical development services for an eclectic group of clients. In particular, Phililab focuses on the production, development, and testing of high quality, niche drugs for public health that are difficult to formulate, with the ultimate goal of bringing the highest quality generic drug products to both the American and Chinese markets. With a strong pipeline of products--including controlled release oral solids, suspensions, ionic exchange resins, inhalers, and injections--Phililab has grown rapidly over the past four years.


Raybow Pharmaceutical provides state-of-the-art technologies and scientific expertise to support API & intermediate development and manufacturing (cGMP and non-GMP) from preclinical to clinical and commercial. Our world-class facilities offer production at a cost-effective price. Our services include process research and production for advanced intermediates, RSM and API, API CMC study, manufacturing of clinical APIs, and commercial API production.


SunGen Pharma aims to create a

healthier future for patients

while increasing shareholder

value through the development and introduction of quality,

affordable generic products by experienced, passionate and

talented pharmaceutical professionals.

SunGen Pharma is a specialty pharmaceutical company focused on

development, manufacturing and marketing of high quality

generic prescription pharmaceuticals that improve patient's health

while creating stakeholder value. We specialize in difficult-to-

manufacture and high barrier to entry complex dosage forms,

including ophthalmic, injectables, topicals and oral solids. SunGen

has Research and Development facilities in Monmouth Junction

and Princeton, NJ, and several manufacturing facilities across

North America and Asia through partnership and contract

manufacturing.

SunGen has over 40 products under development at various stages

that have been and will be filed with the FDA and Chinese FDA

through different partnerships. These products cover multiple

dosage forms including oral solids, topicals, and injectables.

SunGen Pharma is seeking pharmaceutical licensing, acquisition,

and partnership opportunities for ANDA products that are already

marketed or currently approved. We also are seeking for joint

product development (ANDA, NDA, 505(b)(2)) for US and

international markets.

Email: [email protected]

Contact: (609) 606-1060

Details please visit our website: www.sungenpharm.co

5 Penn Plaza, 23rd floor, New York, NY 10001 http://www.zhengkarg.com

http://www.zhengkarg.com/


Sino-American Pharmaceutical Professionals Association PO Box 282 Nanuet, NY 10954, USA

http://www.sapaweb.org http://weibo.com/sapaweb

WeChat:

http://www.sapaweb.org/

http://weibo.com/sapaweb

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