8TH ANNUAL

Chief Medical Officer SummiT

The Annual Gathering for Biotech CMOs to Exchange Best Practices, Benchmark Ideas and Work Through R&D Challenges

EXECUTIVE SPONSORS

Organized by the Conference Forum | www.theconferenceforum.org | #CMOBoston

APRIL 6-7, 2020 BOSTON MARRIOTT, CAMBRIDGE, MA

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CHIEF MEDICAL OFFICER SUMMIT AGENDA

DAY ONE - MONDAY, APRIL 6, 2020

8:00 am Registration and Morning Coffee/Tea

8:30 am Co-Chairs’ Opening Remarks Zain Kassam, MD, MPH Co-Founder, CMO, Finch Therapeutics

Julie Krop, MD CMO, EVP, Clinical Development & Regulatory Affairs, AMAG Pharmaceuticals, Inc

Steven Zelenkofske, DO EVP, CMO, Achillion Pharmaceuticals

OPENING KEYNOTE 8:45 am A Physician Leader’s Journey to CEO of Both Large and Emerging Pharma Dr Levin shares his journey as a physician leader in both large pharma and small biotech. He will also address what he looks for in a CMO and tips for CMOs in how they can best support their CEOs.Jeremy Levin, DPhil, MB BChir CEO and Chairman of the Board of Directors, Ovid Therapeutics/ Chairman of the Board, Biotechnology Innovation Organization (BIO)

KEYNOTE 9:25 am R&D Leadership Talk from a Physician CEO In this session, Dr Keith Gottesdiener, CEO of Rhythm Pharmaceuticals shares some best practices with creative FDA interactions and thoughts on leadership, culture and innovation in the changing biotech environment. Dr Gottesdiener will also provide advice to CMOs in how they can best support their CEOs.Keith M Gottesdiener, MD CEO, Rhythm Pharmaceuticals with Zain Kassam, MD, MPH Co-Founder, CMO, Finch Therapeutics

9:55 am TrialSpark Case Study Ken Somberg CMO, TrialSpark

10:10 am Breakfast & Grand Opening of the Exhibits & Networking Café

10:50 am CMO Leadership Talk In this session, hear from Dr Jakob Dupont, CMO, Gossamer Bio, who was the CMO during the IPO of Gossamer Bio in 2019 and OncoMed Pharmaceuticals, Inc in 2013. As CMO and SVP of OncoMed, he oversaw the successful submissions of eight INDs. Most recently, he announced a collaboration and clinical supply agreement with Merck to combine GB1275 and Keytruda in an ongoing clinical trial.Jakob Dupont, MDCMO, Gossamer Bio

11:15 am Navigating the Pricing and Reimbursement Environment with Memorial Sloan, CEVR and PAVE • Best practices in navigating the payer system• Negotiating after an ICER assessment• Next steps after the FDA approval• Commercializing new therapiesModerated by:Steven Zelenkofske, DO EVP, CMO, Achillion Pharmaceuticals

Panelists:Anna Kaltenboeck, MASenior Health Economist & Program Director, Memorial Sloan Kettering Drug Pricing Lab

Dan Ollendorf, PhDDirector of Value Measurement and Global Health Initiatives,  Center for the Evaluation of Value and Risk in Health (CEVR)

Joey Mattingly, PhD, PharmD, MBA Associate Professor of Pharmaceutical Health Services Research, Director of Operations, Patient-Driven Values in Healthcare Evaluation (PAVE)

11:55 am Prioritizing Effectively: How to Serve What Seems Like Everyone in the CMO Role • Ensure the safety and efficacy monitoring of the company’s trials

are well-conducted.  Data quality is the currency of biotech/pharma and is the responsibility of the CMO.

• Ensure you are in alignment with the other members of the C-suite when speaking both internally and externally.  Discordance among the C-suite can be discouraging for investors and demoralizing for employees.

• Keep an open mind to new ideas or new suggestions from anyone in the company, at any level.  Good ideas can bubble up from anywhere.

Moderated by: Roger Waltzman, MD, MBA CMO, Molecular TemplatesPanelists:Thomas Davis, MDCMO, Genocea Biosciences Christopher Heery CMO, Precision BioSciences, IncAlison Schecter, MDCMO, Selecta Biosciences

12:25 pm Adaptive Designs - Planning for Flexibility In this talk, Natasa Rajicic will introduce the non-statistical stakeholders to the knowledge they need to make more informed decisions about applying adaptive trials in their organizations.  She will walk through the adaptive concept, the potential beneficial outcomes, and few types of adaptive trials and the scenarios in which they can be applied. She will also share examples of case studies that illustrate these key points.Natasa Rajicic Principal, Strategic Consulting, Cytel

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AGENDA CHIEF MEDICAL OFFICER SUMMIT

12:40 pm - Lunch & Networking

1:40 - 2:45 pm Two Track Session Choices: Track 1: Dealing with Multiple Indications and Leading through Pre- and Post-Merger Track 2: IPO and Merger Pre and Post Management and Leadership

2:45 pm - Afternoon Networking Break

KEYNOTE 3:25 pm The Alnylam Story: Lessons Learned During 14 Years of Helping Grow a Platform CompanyAkshay Vaishnaw, MD, PhD President, R&D, Alnylam Pharmaceuticals

3:50 pm Transitioning from Big Pharma to Small Pharma: Peer-to-Peer Learning • What to expect and managing expectations• Big differences, pros and cons• How do you know what you don’t know?Moderated by:Joseph Palumbo, MD, FAPA, MACPsych CMO, Zynerba Pharmaceuticals

Panelists:Debora Barton, MD CMO, Carisma Therapeutics, Inc

Andrew Satlin, MDCMO, Intra-Cellular Therapies, Inc

Liz O’Brien Bergin, MB, MRCGPGlobal CMO, Besins Healthcare Ireland Ltd

Eric Mortensen, MD, PhD CMO, CytoSorbents Corporation

4:30 pm Insourcing and Outsourcing as Your Company Evolves • The role of the CMO• How do you decide whether or when to build internally or

outsource?• Managing capital and resources• How exit strategies impact insourcing and outsourcingModerated by:Steven Zelenkofske, DO EVP, CMO, Achillion Pharmaceuticals

Panelists:PROMETRIKAPPD BiotechVeristatIQVIA

5:10 pm AI, Machine Learning & Statistical Company Presentations The future of AI and machine learning has arrived, but what are the options for biotech, especially on a smaller budget? Statistical companies can help biotech reduce risk and develop more accurate assessments of drug performance. In this section of the Summit, we will feature three to four companies to demonstrate what’s possible and for whom. Moderated by:Zain Kassam, MD, MPHCo-Founder, CMO, Finch Therapeutics

AI and Statistical companies TBA

5:30 pm - Networking Reception 6:30 pm - Day One Concludes

Track 1 - Dealing with Multiple Indications and Leading through Pre- and Post-Merger

1:45 - 2:15 pmMaster Protocols and Platform Trials Brian Alexander, MDCMO, Foundation MedicineMarianne Chase, Director of Research Operations, Neurological Clinical Research Institute (NCRI), Massachussetts General Hospital

2:15 - 2:45 pmTracking Personalized Medications in Gene and Cell Therapy • Gene and Cell therapies require special planning for clinical drug

supply• Patient entry criteria for cell and gene therapies allow for selection

of better responders but limit pool of subjects • Regulatory agencies have a favorable view of precision medicine

and personalized approachesModerated by:Barry Ticho, MD, PhD, CMO, Stoke Therapeutics Panelists:Oscar Segurado, MD, PhD, CMO, ASC Therapeutics

Douglas Losordo, MD, FACC, FAHA, EVP, Global Head of R&D, CMO, Caladrius Biosciences

Track 2 - IPO and Merger Pre and Post Management and Leadership

1:45 - 2:15 pmThe Evolving Role of a CMO from Pre- to Post-IPO • How the role changes and what to expect• Lessons learned• How to prepare your company and unexpected changes to know

aboutRamon Mohanlal, MD, PhD, MBA, EVP, R&D and CMO, BeyondSpring Pharmaceuticals

Beth Tréhu, MD, FACP, CMO, Jounce Therapeutics

Nerissa Kreher, MD, CMO, Tiburio Therapeutics

2:15 - 2:45 pmLeading through Pre-and Post-Merger • The dynamics around a merger• How the CMO role changes• What to do before and after a mergerModerated by:Zain Kassam, MD, MPH Co-Founder, CMO, Finch Therapeutics

Panelists: Jim Roach, MD, SVP and Global Head, Rare Diseases Therapeutic Area, Clementia, an Ipsen Company

Steven Zelenkofske, DO, EVP, CMO, Achillion Pharmaceuticals

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CHIEF MEDICAL OFFICER SUMMIT AGENDA

DAY TWO - TUESDAY, APRIL 7, 2020

8:00 am Morning Coffee/Tea

8:20 am Co-Chairs’ Opening Remarks Zain Kassam, MD, MPH Co-Founder, CMO, Finch Therapeutics

Julie Krop, MD CMO, EVP, Clinical Development & Regulatory Affairs, AMAG Pharmaceuticals, Inc

Steven Zelenkofske, DO EVP, CMO, Achillion Pharmaceuticals

ZEITGEIST PRESENTATION 8:30 amThe Collective Struggle to Evolve a Drug Development Organization’s Data and Analytics Culture and Capabilities Perhaps one of the most inquisitive CDOs in R&D, Milind Kamkolkar joins CMO Summit for the first time to address:• The theory of going digital in drug development• Identifying hype from reality• What is the big problem we are trying to solve?• Taking a complex organization and evolving it to be digitally

modern• What is the intended use of the data?• Priorities, structure, culture, and next stepsMilind Kamkolkar Chief Data Officer, Cellarity

ANNUAL KEYNOTE ADDRESS 8:55 am The Changing R&D Landscape in the  Biopharma Industry Ken Getz, MBA Director of Sponsored Research, Tufts CSDD / Founder, CISCRP

9:20 am Fireside Chat: Key Trends in the Present and Future of Life Sciences Venture Kiran ReddyVenture Partner, Blackstone Life Sciences with Julie Krop, MD CMO, EVP, Clinical Development & Regulatory Affairs, AMAG Pharmaceuticals, Inc

9:45 am Parexel Case Study

10:05 am Breakfast & Networking Break

10:45 am Finding, Retaining, and Motivating Your Top-Level Talent • What do you look for in candidates’ CVs?• How to tell if your candidate it trying to escape big pharma or

joint small biotech

• Dealing with difficult employees• How to retain and motivate besides offering more money• Corporate culture — drivers, killers, concepts, ideas, and

actions that impact workplace behaviorModerated by: Elliot Ehrich, MD CMO, Expansion Therapeutics / Venture Partner, 5AM

Panelists:Kara Coluccio Bern Partner, Perspective Group

James Lewis Global Contract Director, Barrington James

11:30 am Building Teams and Expanding Your Reach with Virtualization • How to think about who a CMO needs on his/her team for a

compliant clinical and regulatory organization optimized to meet and exceed corporate objectives.

• Factors to consider when deciding what roles to fill with FTEs and which to outsource depending on the stage of your programs and the long term strategic plan for the company.

• Tips and tools for managing remote employees.Moderated by: Beth Tréhu, MD, FACPCMO, Jounce Therapeutics

Panelists:Anna Frostegård, MD, PhDCo-Founder, Chief Scientific and Medical Officer, Annexin Pharmaceuticals

Dana Hilt, MD CMO, Frequency Therapeutics

Chris Poshka VP, Govig

12:10 pm Harmonizing Drug Development and Clinical Operations Across Different Continents and Countries • How do you organize trials to comply with endpoints and

regulations from different countries (FDA, EMA, China, and Japan)?

• How to choose where to focus?Moderated by:Laurie Smaldone, MDCMO, CSO, NDA GroupPanelist:Adrian Senderowicz, MD SVP, CMO, Constellation Pharmaceuticals

12:45 pm TD2 Case study

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AGENDA CHIEF MEDICAL OFFICER SUMMIT

1:00 pm Luncheon Breakout Round Tables After attendees get their lunch, they are free to choose one of the optional 40-minute interactive break out-sessions on one of the following topics: 

1. Determining Whether and When to Acquire Assets for DevelopmentChampioned by:Julie Krop, MD CMO, EVP, Clinical Development & Regulatory Affairs, AMAG Pharmaceuticals, Inc

2. Working with Not-for-Profits and Academic PartnershipsChampioned by:Zain Kassam, MD, MPH Co-Founder, CMO, Finch Therapeutics

3. Putting Together and Managing an Advisory Board

4. Best Practices in Pitching to Investors and Preparing for the RoadshowChampioned by: Donna SchwarzFounder and Owner, Schwarz Consultants

5. A CNS Round Table To Share Common Challenges and Solutions

6. An Oncology Round Table To Share Common Challenges and Solutions

Each topic has a session leader who will moderate the discussion. The discussions will begin at 1:20 pm.

2:00 pm Exploristics Case Study

2:15 pmNew Skills Required for CMOs • A panel discussion of CMOs with different backgrounds about

what skills they needed to learn for the role and how they learned them

• Support systems and networks for CMOsModerated by:Martin Childers, DO, PhD CMO, Asklepios BIopharmaceuticals, Inc

Panelists:Shefali Agarwal, MBBS CMO, Epizyme

Anna Frostegård, MD, PhDCo-Founder, Chief Scientific and Medical Officer, Annexin Pharmaceuticals

Cadmus Rich, MD, MBA CMO and Head of R&D, Aura Biosciences

2:55 pm Best Practices in Communicating Effectively to CEOs and Boards • Managing CEOs and Boards who may not have a scientific

background and may be ambitious or aggressive in their vision

• Understanding what CEOs and Board members are looking for in a CMO; what are their perspectives?

• Communicating and dealing with setbacks: change in leadership, lack of consistent strategy, and encouraging transparency from board meetings

Moderated by:Julie Krop, MDCMO, EVP, Clinical Development & Regulatory Affairs, AMAG Pharmaceuticals, Inc

Panelists:Nerissa Kreher, MDCMO, Tiburio Therapeutics

RJ Tesi, MDCEO and CMO, INmuneBio

3:30 pm Town Hall: Balancing Values Back by popular demand, this concluding session is highly interactive as it involves the entire audience where ideas are exchanged among peers. Topics include, but are not limited to:• How safety changes over time from Phase I to Phase III• Balancing subject safety and efficacy with the speed of the

clinical path• Balancing the ethical role of the CMO with the needs of the

diverse stakeholdersLed by:Zain Kassam, MD, MPHCo-Founder, CMO, Finch Therapeutics

Julie Krop, MDCMO, EVP, Clinical Development & Regulatory Affairs, AMAG Pharmaceuticals, Inc

4:00 pm Conference Concludes