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Agenda-at-a-Glance

  • 8:00 am

  • Registration and Breakfast

  • 8:30 am

  • Chair's Opening Remarks

    How does a CMO walk the line between medical and corporate objectivity?

    David Valacer, MD
    CMO, Molecular Templates

  • 8:45 am

  • Federal and State Leadership on Supporting Research and Development - A Path Forward

    • How to take advantage of the 21st Century Cures Act
    • What does it mean for drug approval?
    • Update on federal and state support for biotech R&D
    • What should CMOs be thinking about and acting on in 2017?

    Bob Coughlin
    President & CEO, MassBio

    Travis McCready, JD
    CEO, Massachusetts Life Sciences Center

  • 9:30 am

  • Assessing and Creating Value and the Impact of Pricing Trends on R&D Strategies

    • What types of data do we need to generate?
    • What health economic research data is necessary?
    • What is expected of real world data and who is making use of it?
    • What are we doing to make drugs more affordable?
    • How are we able to create affordable care in emerging markets?
    • How R&D is interacting within the company as it relates to drug pricing?
    • Will it be necessary to give into the pressure of pricing especially in the era of large scale partnering?
    • Are we over pricing at the detriment of the patient to our own P&L?
    • Approaching pricing in the US vs Europe
    • Price controls in the US? 
New ways of paying for medicines moving forward

    Moderator:
    Jeffrey Sherman, MD, FACP
    CMO & EVP, R&D, Horizon Pharma

    Panelists:
    Luba Greenwood
    VP, Global Business Development and M&A, Roche

    Ramon Mohanlal, MD, PhD, MBA
    CMO, BeyondSpring Pharmaceuticals

  • 10:15 am

  • Case Study

  • 10:30 am

  • Networking Break

  • 11:00 am

  • Keynote Interview: Kees Been, CEO, Lysosomal Therapeutics Outlines his Personal Journey on Critical Growth Stages of an Emerging Biotech

    In this session, Kees Been sits down with Dr Valacer to share insights on what it takes to progress from a start up to a successful biotech. What were the factors that influenced the go and no-go decisions? How did he and his CMO balance and tackle their responsibilities?

    Kees Been, MBA
    Founder, President and CEO, Lysosomal Therapeutics
    with
    David Valacer, MD
    CMO, Molecular Templates
  • 11:45 am

  • Leading the Charge: A Case Study of How Medical Affairs Engaged Patients to Create Patient-Centric Clinical Trials

    Valerie Powell
    Director, Patient Insights and Engagement, Patient Centered Sciences, Mapi Group

  • 12:00 pm

  • Luncheon

  • 1:00 pm

  • Achieving Operational Excellence in a Small Biotech Company

    • How to build a successful development team?
    • Who do you hire early to achieve your goals?
    • How do your hires impact culture and revenue?
    • What role is your first hire?
    • What is the most important hire?
    • How to streamline your activities?
    • When is outsourcing the answer?
    • What resources do you really need in-house?

    Moderator:
    Joe Stauffer, DO, MBA
    CMO, CARA Therapeutics

    Panelist:
    Lynn Sutton
    VP, Clinical Operations, InSeption Group, LLC

  • 1:30 pm

  • How Do We Collaborate on Exquisite Project Delivery with Internal and External Partners

    • Choosing your outsourcing partner
    • How do biotechs manage the relationship with their outsourcing partner?
    • How do you collaborate for exquisite project delivery?

    Moderator:
    David Valacer, MD
    CMO, Molecular Templates

    Panelist:
    Jim Roach, MD
    CMO, Veristat

    Additional panelists to be announced

  • 2:00 pm

  • How to Best Navigate and Prepare for the JP Morgan Healthcare Conference

    • How to best prepare?
    • Presenting a united front with your CEO
    • Time management: how to use time to your best advantage
    • Mastering salesmanship and marketing
    • How to get an investor to believe in you
    • Lessons from the trenches

    Joe Stauffer, DO, MBA
    CMO, CARA Therapeutics

  • 2:30 pm

  • Networking Break

  • 3:00 pm

  • How to Define and Validate Endpoints in Rare Disease Trials for Approval

    Maximizing value from small clinical trials in rare populations.

    Moderator:
    David Clark, MD
    CMO, Aldeyra Therapeutics

    Panelists:
    Jeffrey Sherman, MD, FACP
    CMO & EVP, R&D, Horizon Pharma

    Alvin Shih, MD, MBA
    CEO, Enzyvant

    Paresh Soni, MD, PhD
    CMO, Albireo Pharma

  • 3:40 pm

  • Keynote Fireside Chat with Michael Rosenblatt, MD on Lessons Learned from the Journey of a CMO Leader

    In this session Dr Rosenblatt, former Merck CMO, will share his insights on career path decision-making and will compare the experiences and lessons learned from being the CMO on the drug development side versus the biotech investor side of the industry.

    Michael Rosenblatt, MD
    CMO, Flagship Pioneering

    with

    Simba Gill, MBA, PhD
    CEO, Evelo Biosciences

  • 4:10 pm

  • Group Activity Led By MIT's Zen Chu

    Zen Chu, MBA
    Faculty Director and Entrepreneur-in-Residence, MIT

  • 5:10 pm

  • Quickfire Technology Solutions

    This is an opportunity for innovative technology companies to address the challenges faced by drug development teams of small & emerging biotech. This session will showcase how each company is making a difference in biotech.

    Presenters:
    Adam Hanina, MBA
    CEO, AiCure

    Certara
    Speaker TBD

    Additional companies to be announced.

  • 6:00 pm

  • Networking Reception

Agenda-at-a-Glance

  • 8:00 am

  • Registration and Breakfast

  • 8:30 am

  • Chair's Opening Remarks

    David Valacer, MD
    CMO, Molecular Templates

  • 8:45 am

  • Annual Keynote Address: The Impact of M&A on Drug Development Performance and Collaborations

    Ken Getz, MBA
    Director of Sponsored Research Programs, Tufts CSDD

  • 9:15 am

  • Q&A with the FDA

    • How does the FDA view the role of a CMO
    • What are the opportunities with accelerated programs? – Value creation for each program from both the biotech & regulatory perspective
    • What is the impact of 505b2 on patient centricity?
    • How has the Sarepta approval impacted how the FDA will behave going forward?

    Richard Moscicki, MD
    Deputy Center Director for Science Operations, Center for Drug Evaluation and Research (CDER), FDA

    Adrian Senderowicz, MD
    CMO, Cerulean Pharma, Inc

  • 9:45 am

  • Indication Assessment as a Powerful Tool in the Development Arsenal

    Iva Toudjarska, MBA, PhD
    Principal Consultant, Halloran Consulting Group, Inc
  • 10:00 am

  • R&D Efforts that Translate to Approvals

    This session will examine what is important in the R&D process and advise what companies should do early in the drug development cycle to best position for regulatory approval in the US and Europe.

    Laurie Burke, RPh, MPH
    Former Director, Study Endpoints and Labeling Development (SEALD), ONDIO, CDER/ Founder, FDA/ LORA Group

    Craig Rayner, PharmD
    President d3 Medicine, A Certara Company

    Paresh Soni, MD, PhD
    CMO, Albireo Pharma

  • 10:30 am

  • Networking Break

  • 11:00 am

  • How Can R&D Leadership Work More Collaboratively with Investors?

    • How investors gauge how R&D leadership is doing?
    • Thoughts on structural gaps in R&D?
    • How R&D can be providers to investors?

    Moderator:
    Joe Stauffer, DO, MBA
    CMO, Cara Therapeutics

    Panelists:
    David Berry, MD, PhD
    General Partner, Flagship Pioneering

    Vikas Goyal, MBA
    Senior Associate, SR One

    Alex Zisson
    Managing Director, H.I.G. Capital

  • 11:45 am

  • Case Study

  • 12:00 pm

  • Luncheon

  • 1:00 pm

  • Developing a Pathway for Compassionate Use Cases

    • What should the CMO do when they receive a request?
    • What’s the role of the CMO, the FDA and the IRB?
    • Lessons learned from Janssen Case Study
    • How do you scale down for a biotech?
    • Potential models
    • Can the process be accelerated?

    Alison Bateman-House, PhD, MPH
    Assistant Professor, Division of Medical Ethics, NYU

    Arthur Caplan, PhD
    Drs. William F. and Virginia Connolly Mitty Professor of Bioethics; Director- Division of Medical Ethics, NYU

  • 1:40 pm

  • Strategies for Harmonizing Global Drug Development with Laurie Burke, Former Director, FDA

    • At what stage should a CMO develop a global strategy?
    • Pros and cons of USA versus Rest of the World
    • How do you best implement the strategy?
    • Which is most cost efficient?

    Laurie Burke, RPh, MPH
    Former Director, Study Endpoints and Labeling Development (SEALD), ONDIO, CEDER/ Founder, FDA/ LORA Group

  • 2:10 pm

  • Board of Directors Provide CMOs with Information and Guidance on How to Maximize the Value of Their Role and Communication Strategies

    • The boards vision of the role of the CMO
    • What information does the board look for from a CMO
    • How can a CMO best deliver bad news?
    • How does the CMO best articulate the value proposition and risk appropriation of the business’s programs to the Board?
    • Should there ever be a direct line of communication between the CMO and the BOD?

    Moderated by:
    Monica Luchi, MD, FACR, MBA
    CMO, EVP Global Clinical Development, IMMUNE Pharmaceuticals

    Panelists:
    Mark Corrigan, MD
    Executive Chairman of the Board, BlackThorn Therapeutics, Inc

    Steven Rauscher, MBA
    Board Member, Acorda Therapeutics

  • 2:50 pm

  • Keynote Address: The Political Environment’s Impact on Drug Development in 2017

    Mark McClellan, MD, PhD
    Robert J. Margolis Professor of Business, Medicine and Health Policy, and Director Margolis Center for Health Policy, Duke University

  • 3:30 pm

  • Conference Concludes