2017 Agenda

  • 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
    Ramon Mohanlal, MD, PhD, MBA

    CMO, BeyondSpring Pharmaceuticals

  • 10:15 am

  • Asking the Right Questions of Your Data: Experiences with Model-informed Development Approaches


    Chuck Gelb, MBA

    Senior Director of Business Development, Cytel

    and


    Cecilia Fosser

    Director, Quantitative Pharmacology and Pharmacometrics, Cytel

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

    Moderator:
    Lynn Sutton
    Lynn Sutton

    VP, Clinical Operations, InSeption Group, LLC

    Panelists:

    Jim Roach, MD, FACP, FCCP

    CMO, Veristat


    Joe Stauffer, DO, MBA

    CMO, CARA Therapeutics


    David Valacer, MD
    CMO, Molecular Templates

  • 1:45 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

  • 2:15 pm

  • Networking Break

  • 2:45 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

  • 3:25 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

  • 4:00 pm

  • What Technology is Needed to Solve CMOs Operational Challenges?

    In this session, Hacking Medicine Institute’s, Qi Li, MD, MBA, will lead the group in a think tank on identifying a technological solution for operational issues experienced by biotech CMOs.


    Qi Li, MD, MBA

    Board Member, Hacking Medicine Institute and Director, Product Innovation, InterSystems

  • 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.

    Presenters:

    Adam Hanina, MBA

    CEO, AiCure


    Gary Kusha

    VP, Business Development, Certara

  • 5:45 pm

  • Networking Reception

2017 Agenda

  • 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

    • What are the opportunities with accelerated programs? – Value creation for each program from both the biotech & regulatory perspective
    • An update on the expanded access program
    • Lessons learned in the aftermath of the Sarepta drug approval
    • How does the FDA view the emerging role of the patient in drug development?


    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
    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.

    Moderator:

    Laurie Burke, RPh, MPH

    Former Director, Study Endpoints and Labeling Development (SEALD), ONDIO, CDER, FDA
    Founder, LORA Group

    Panelists:
    Craig Rayner
    Craig Rayner, PharmD
    President d3 Medicine, A Certara Company


    Paresh Soni, MD, PhD

    CMO, Albireo Pharma

  • 10:40 am

  • Networking Break

  • 11:15 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:

    David Valacer, MD

    CMO, Molecular Templates

    Panelists:

    David Berry, MD, PhD

    General Partner, Flagship Pioneering


    Vikas Goyal, MBA

    Senior Associate, SR One


    Alex Zisson

    Managing Director, H.I.G. Capital

  • 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

  • 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, FDA
    Founder, LORA Group


    Edwin Rock, MD, PhD

    Executive Director, Clinical Research, Astex Pharmaceuticals

  • 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
    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