Welcome to

JAPAN 2014

8 – 9 December 2014 Hotel Okura

Tokyo, Japan

What is CASSS?

Practical Applications of

Mass Spectrometry

EUROPE ▪ JAPAN ▪ NORTH AMERICA ▪ SOUTH AMERICA

CASSS is the leading non-profit professional scientific membership

society that provides networking and peer-to-peer learning

opportunities for professionals involved in the development and

regulation of biopharmaceutical products worldwide.

What makes CASSS different?

• CASSS utilizes our dedicated, volunteer network of

experienced scientists to bring together the right people

(experienced leaders in the field), the right way (a

culture of engagement), at the right time (scientifically

relevant content).

• Our promise to you: At every CASSS meeting, you will meet the right people

and gain tangible knowledge that will help you achieve

your deliverables of advancing analytical technologies and

bring safe and efficacious biopharmaceutical medicines to

patients worldwide.

What makes CASSS better? • You!

• Get Involved: Ask questions, Seek out other attendees,

Attend the receptions, Engage in discussions. Make the

most of your time here!

• Stay Involved: Participate in the CASSS on-line

discussion group, Follow up with meeting contacts,

Provide suggestions for upcoming meeting topics,

Volunteer your time and effort for future meetings.

• Get Others Involved: Share meeting outcomes with

colleagues; Spread the work to others about the value you

derived from the meeting.

"Every man owes part of his time and money to the business or industry to which he is

engaged." --- Theodore Roosevelt

Find out more at www.casss.org or speak with

a committee member or staff at registration.

Welcome to

JAPAN 2014

8 – 9 December 2014 Hotel Okura

Tokyo, Japan

Mission Statement

• Provide a venue biotechnology/biological product

discussion that focuses on relevant CMC issues

throughout the lifecycle of the product

• Foster collaborative technical and regulatory

interactions

• Share information with the regulatory agencies to

assist them in merging good scientific and

regulatory practices

CMC Strategy Forum History

• The CMC Strategy Forum was launched in 2002 from the well established WCBP Symposium.

• To date, 30 Forums have been held in the US (typically 3 per year) resulting in the publication of over 25 white papers on a wide variety of CMC topics.

• The CMC Forum Europe was launched in 2007 with support from the Biotech Working Party/EMA and quickly became a successful annual event.

CMC Strategy Forum History

• The CMC Forum Japan was launched in 2012 with support from the PMDA and JPMA and has been very successful for the first two years.

• The inaugural CMC Forum Latin America was launched in August 2014 with support from ANVISA (Brasil), local industry, as well as multiple LATAM regulatory agencies and was very successful. The 2nd CMC Forum Latin America will be held in August 2015.

CMC Strategy Forum Global

Steering Committee • Siddharth Advant, Kemwell Biopharma, USA

• John Dougherty, Eli Lilly and Company, USA

• Junichi Koga, Daiichi Sankyo Co., Ltd., Japan

• Steven Kozlowski, CDER, FDA, USA

• Rohin Mhatre, Biogen Idec, USA

• Anthony Mire-Sluis, Amgen Inc., USA

• Wassim Nashabeh, F. Hoffmann-La Roche Ltd., Switzerland (Chair)

• Ilona Reischl, BASG / AGES, Austria

• Anthony Ridgway, Health Canada, Canada

• Nadine Ritter, Global Biotech Experts, LLC, USA

• Mark Schenerman, MedImmune, USA

• Thomas Schreitmüller, F. Hoffmann-La Roche Ltd., Switzerland

• Karin Sewerin, BioTech Development AB, Sweden

Find out more about past

CMC Strategy Forums

Look under ARCHIVES

for past Forum

information and

publications.

www.casss.org

CMC Forum Format

• The Forum has two components:

- presentations (frame the discussion)

- Workshops where open dialogue and exchange of

ideas among participants is highly encouraged—

Typically each workshop will address about 3 specific

questions related to a given topic

• The workshop success is dependent on active

engagement of the participants

• Questions can be asked in either Japanese or

English—simultaneous translation

Japan Scientific Program

Organizing Committee • Ayako Enokida, Pharmaceuticals and Medical Devices Agency (PMDA)

• Kimio Esumi, Pharmaceuticals and Medical Devices Agency (PMDA)

• Futaba Honda, Pharmaceuticals and Medical Devices Agency (PMDA)

• Yasuhiro Kishioka, Pharmaceuticals and Medical Devices Agency (PMDA)

• Junichi Koga, Daiichi Sankyo Co., Ltd.

• In Eui Lee, Chugai Pharmaceutical Co., Ltd.

• Noriyuki Matsumoto, Japan Pharmaceutical Manufacturers Association (JPMA) (Secretariat)

• Hisako Ohnishi, Japan Pharmaceutical Manufacturers Association (JPMA) (Secretariat)

• Daisaku Sato, Pharmaceutical and Medical Devices Agency (PMDA)

• Yasushi Shikata, Eisai Co., Ltd.

• Kazuhisa Uchida, Kyowa Hakko Kirin Co., Ltd.

• Koji Usui, Pfizer Japan, Inc.

• Toyohiko Yamamoto, Asahi Kasei Pharma Corp.

• Reiko Yanagihara, Pharmaceutical and Medical Devices Agency (PMDA)

Forum Program Partners

•Astellas Pharma Inc.

•Baxter Limited

•Chugai Pharmaceutical Co., Ltd.

•Daiichi Sankyo Co., Ltd.

•Eisai Co., Ltd.

•Kissei Pharmaceutical Co., Ltd.

•Kyowa Hakko Kirin Co., Ltd.

•Nippon Kayaku Co., Ltd.

•Sanwa Kagaku Kenkyusho Co., Ltd.

•Sumitomo Dainippon Pharma Co., Ltd.

•Takeda Pharmaceutical Company Limited

Sustaining Diamond

Program Partner

• F. Hoffmann-La Roche Ltd

Sustaining Platinum

Program Partner

• Biogen Idec

Leading Media Partners

•BioProcess International

•International Pharmaceutical Quality

Media Partners •The Analytical Scientist

•BioProcessing Journal

•Genetic Engineering & Biotechnology News

•The Medicine Maker

•The Pathologist

•separationsNOW.com

•Technology Networks Limited

CMC Strategy Forum

Japan 2014

• Recent Trends in the Regulation of

Biopharmaceutical Products

• Aspects of Quality Evaluation and Control

of Cell-based Products for Regenerative

Medicine

• Antibody Engineering Technologies and

Products

• Accelerated Developing Programs

• Lifecycle Approach to Process Validation

CMC Strategy Forum Japan 2014

• Attendees pre-registered - 128

• Number of regulators pre-registered – 21

• Number of companies represented – 48

• Number of countries represented – 15

(Austria, Canada, China, Denmark, Finland,

Germany, Japan, Malaysia, Portugal,

Singapore, South Korea, Switzerland,

Taiwan, United Kingdom, USA)

Special Thanks to… CASSS Staff:

• Karen A. Bertani, CMP, Director of Meetings (CMC

Forum Manager)

• Stephanie L. Flores, CAE, Executive Director

• Anna Lingel, Project Coordinator

• Linda Mansouria, CMP, CMM, Manager of Meetings &

Events

• Renee Olson, Senior Program Manager

• Catherine Stewart, Director of Finance

Audio-Visual Support:

• Michael Johnstone

MJ Audio-Visual Productions

Reminders and Announcements

• Please remember to be courteous by turning all cell phones off and refraining from conversations in the meeting rooms

• 17:45 – 19:15 Networking Reception

• Evaluation form – we‘ve gone GREEN - online

link will be sent to your email on Wednesday,

10 December – don’t forget to complete and

hit SUBMIT