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Agenda-at-a-Glance

  • 8:00 am

  • Registration

  • 8:30 am

  • Co-Chairs’ Opening Remarks

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

    David Valacer, MD
    CMO, Molecular Templates

  • 8:45 am

  • Opening Panel: The Impact of Current Politics and Policy on Biotech R&D

    • Is the 21st Century Cures Act more hype than reality?
    • What does it mean for drug approval?
    • What does the change in administration mean for biotech?
    • What should CMOs be thinking about and acting on in 2017?

    Bob Coughlin
    President & CEO, MassBio

    Travis McCready
    CEO, Massachusetts Life Sciences Center

  • 9:30 am

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

    • Viewpoint and strategy
    • 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?
    • Understanding the ultimate value of pharmaceuticals in the healthcare ecosystem for managing illness and preventing progression of disease
    • 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
    • Insight into strategies and policies of operating a global company, putting a research program together, provide the right data for regulatory approval and market access
    • Price controls in the US? 
New ways of paying for medicines moving forward

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

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

  • 10:15 am

  • Case Study

  • 10:30 am

  • Networking Break

  • 11:00 am

  • Keynote Interview: Critical Stages in the Growth of a Biotech Start Up

    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

    Kelly Franchetti, RN, CCRN, CEN
    VP, Global Patient Insights and Engagement, Mapi Group
  • 12:00 pm

  • Luncheon

  • 1:15 pm

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

    Maximizing value from small clinical trials in rare populations.

    David Clark, MD
    CMO, Aldeyra Therapeutics

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

    Alvin Shih, MD, MBA
    CEO, Enzyvant

    Paresh Soni, MD, PhD
    CMO, Albireo Pharma

  • 1:45 pm

  • Maintaining Valuation Post Established Product

    • Growth challenges and impact on R&D decisions
    • How growing biotechs face the above with fewer drugs?

    Panelists To Be Announced

  • 2:15 pm

  • Navigating the Jungle at JP Morgan

    • 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

  • 2:45 pm

  • Networking Break

  • 3:15 pm

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

    Jim Roach, MD
    CMO, Veristat

  • 3:55 pm

  • Fireside Chat: Lessons Learned from the Journey of a Life Sciences Leader

    Michael Rosenblatt, MD
    CMO, Flagship Pioneering

    with

    Simba Gill, MBA, PhD
    CEO, Evelo Biosciences

  • 4:30 pm

  • Group Activity To Be Announced

  • 5:00 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.

  • 6:00 pm

  • Networking Reception

Agenda-at-a-Glance

  • 8:00 am

  • Registration

  • 8:30 am

  • Co-Chairs’ Opening

    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

  • Indication Assessment as a Powerful Tool in the Development Arsenal

    Iva Toudjarska, MBA, PhD
    Principal Consultant, Halloran Consulting Group, Inc
  • 9:30 am

  • Q&A with the FDA

    • How does the FDA view the role of a CMO
    • In depth guidance on PRO’s
    • 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?

    Adrian Senderowicz, MD
    CMO, Cerulean Pharma, Inc

    FDA Representative Invited

  • 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

    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?

    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 Drug Development in Different Parts of the World

    • 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

  • What Do the Board of Directors Expect from a CMO?

    • What do they want to hear from a CMO
    • How can a CMO best deliver bad news?

    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

  • 3:30 pm

  • Conference Concludes