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Executive Sponsors

Theorem Clinical Research
Cytel

Associate Sponsors

Aptiv Solutions
Comprehend Systems
Covance
Halloran
InSeption Group
Medidata

Exhibitor

Vince & Associates

Media Partners

BioCentury
BioPharm Insight
BioPortfolio
Can Biotech
CenterWatch
Larta
Life Science Leader
Massachusetts LSC
MassBio
Pharmaphorum
PharmaVoice
Technology Networks
Trials

Agenda

  • 8:00 am

  • Registration & Breakfast

  • 8:30 am

  • Co-Chairs’ Opening Remarks: Defining the Role of the CMO

    • Differences in a CMO in large pharma, pre-IPO pharma, post IPO pharma
    • Individual roles in pharma that make up a biotech
    • The reality of the CMO role in an emerging biotech
    • Functioning with a lot of hats
    • What’s on the minds of the CMOs?

    Lee Allen, MD, PhD
    CMO, Spectrum Pharmaceuticals

    Steven Zelenkofske, DO, FACC, FACOI, FCCP
    CMO & SVP, Clinical and Medical Affairs, Regado Biosciences

  • 8:45 am

  • Keynote Case Study on the Life of a CMO Pre and Post IPO

    • Insights into the experience
    • Expanding the role of the CMO to meet the requirements of commercialization
    • Post market expectations
    • The role of the CMO
    • The CMO’s contributions
    • Managing growth
    • What role does the CMO have in articulating the data of the clinical trials in the timing of exercising more shares or deal making?
    • Lessons learned

    Jakob Dupont, MD
    CMO & SVP, OncoMed

  • 9:30 am

  • Best Practices to Position your Drug for Regulatory Approval

    • What is the FDA looking for?
    • De-risking programs
    • How to ensure a clinical program has the broadest geographic applicability
    • What are all the different regulatory options for registration
    • Breakthrough designation experience, what worked and what did not work
    • Best practices on how to work with the FDA

    Edward Kaye, MD
    CMO & SVP, Sarepta Therapeutics

    Jesse McGreivy, MD
    CMO, Pharmacyclics

    Lee Simon, MD
    Former Division Director, FDA and Principal Consultant, SDG, LLC

  • 10:15 am

  • Clinical Development Planning Based on Business Objectives

    Emerging biotechs have a unique opportunity to set the “right” framework for the company. Careful thought should be given when determining what areas are unique and there is no “one size fits all”.

    Key areas to consider:

    • Strategic development planning (When?)
    • Resourcing and Functional Area Expertise (Who?)
    • Operational and Systems Infrastructure (What?)
    • Program Leadership (How?)

    Moderator:
    Laurie Halloran, BSN, MS
    President & CEO, Halloran Consulting Group, Inc.

    Panelists:
    Louis O’Dea, MB BCh BAO FRCP(C)
    SVP, CMO & Head of Regulatory Affairs, Moderna Therapeutics

    Robert Shalwitz, MD
    CMO, Akebia Therapeutics

    Catherine Wheeler, MD
    VP, Clinical Development, Acetylon Pharmaceuticals

  • 11:00 am

  • Networking Break

  • 11:30 am

  • Re-Shaping Clinical Trials to be More Cost Effective

    • Prominent reasons for failure of drug development
    • Early phase development signals that predict later phase success
    • Leveraging knowledge on cost and PoS as the biggest driver for investment
    • What strategies are companies implementing to most improve clinical trial efficiency?
    • What approaches are organizations taking to reinvent study design (e.g., feasibility assessment, adaptive designs, single arm trials)?
    • How should we be thinking about leveraging big data to optimize study designs?
    • Exploring new approaches (e.g. point-of-care and payer practices) to gather strategic information informing study design
    • The costly price of not having a plan to oversee patient safety

    Moderator:
    Kenneth Getz, MBA
    Director, Sponsored Research, Tufts CSDD

    Panelists:
    Shi Yin Foo, MD, PhD
    CMO, Cardioxyl Pharmaceuticals

    Eric Lang, MD
    VP, Molecule Development Group, Covance, Inc.

    Jim Roach, MD, FACP, FCCP
    CMO & SVP, Development, Momenta Pharmaceuticals

    Noah Rosenberg, MD
    Senior Advisor to CEO, Esperion Therapeutics and
 President & CMO, ARC Clinical Consulting

  • 12:15 pm

  • Optimizing Trial Protocols: Addressing Design and Execution Challenges Upfront

    • Ensuring the right inputs are considered during the protocol design phase
    • Using simulation tools to improve trial design
    • Using adaptive design to drive effective development decision-making
    • Deploying a risk-based monitoring to reduce cost and enhance data quality
    • Building in flexibility

    Parvin Fardipour, PhD
    VP, Adaptive Clinical Trials, Aptiv Solutions

  • 12:45 pm

  • Luncheon

  • 2:00 pm

  • Determining the Optimal Development Path: Early Phase Tools and Techniques

    • Modern techniques/tools to help determine best development path
    • Mitigating development risk using adaptive approaches, model-building, biomarker incorporation
    • Determining program/portfolio valuation for more quantitative decision-making.

    Jim Bolognese
    Senior Director, Strategic Consulting, Cytel, Inc.

    Kenneth Getz, MBA
    Director, Sponsored Research, Tufts CSDD

  • 2:30 pm

  • Working through Complex Contracts

    Contracting is evolving to be even more complex and can seriously delay clinical trials. To understand what is causing this and how to deal up front will reduce some of the complexity and help with the structure and approach to DSMBs, sites, hospitals and CROs.

    More specifically:

    • How new regulations are impacting contracting
    • How risk levels are impacting efficient contracting

    Moderator:
    Steven Zelenkofske, DO, FACC, FACOI, FCCP
    CMO & SVP, Clinical and Medical Affairs, Regado Biosciences

  • 3:00 pm

  • Optimizing Clinical Outsourcing with Fixed Funds

    • Model options and pros and cons that go with them, (i.e, hybrid mix)
    • What is really meant by risk sharing? How can it be achieved and what is in it for the CRO?
    • Best practices in choosing a CRO
    • Best practices in managing a CRO
    • How to establish service levels with CROs
    • KPIs
    • Key concerns and solutions

    Moderator:
    Pamela Palmer, MD, PhD
    CMO & Co-Founder, AcelRx Pharmaceuticals, Inc.

    Panelists:
    Marc Hoffman, MD
    SVP & General Manager, Biopharmaceutical Development, Theorem Clinical Research

    Pablo Lapuerta, MD
    EVP, Clinical Development & CMO, Lexicon Pharmaceuticals

    Tyler Martin, MD
    CMO, Director, Dynavax Technologies

    Mark Versavel, MD, PhD, MBA
    CMO, Alzheon Therapeutics

  • 3:30 pm

  • Networking Break

  • 4:05 pm

  • Publication Strategy/Data Communications: Objectives, Organization and Process

    • Key strategic components: planning and execution, quality data and biostatistics, manuscript development, interactions with authors and journals
    • Many variables to think about: How to choose from different types of papers, what journals to work with, etc
    • Generating proof sources in support of regulatory, health economics, reimbursement, guidelines and commercialization efforts
    • What is the most efficient organizational approach: internal, outsourcing or mixed model?
    • Considerations for data release and the role of the CMO interacting with Wall Street, scientists, investigators, and payors

    Lou Brenner, MD
    CMO & SVP, Idera Pharmaceuticals

    Ronald Burch, MD, PhD
    CMO, Naurex

    Vujo Vukovic, PhD
    SVP & CMO, Synta Pharmaceuticals Corp.

  • 4:30 pm

  • How to Get your Product Positioned for Reimbursement

    • Strategies in trial design
    • Strategies around applications
    • Pharmacoeconomics
    • Value based pricing
    • How to ensure a clinical program has the broadest geographic applicability

    Pablo Lapuerta, MD
    EVP, Clinical Development & CMO, Lexicon Pharmaceuticals

    Oscar Segurado, MD, PhD
    CMO, Crescendo / Myriad Genetics

  • 5:00 pm

  • Career Development Opportunities for CMOs

    • View on the life cycle of a CMO
    • What opportunities are there for CMOs?
    • Founder CMOs: how does that get translated into advancement
    • Venture POV

    Lee Brettman, MD, FACP
    President, Greystone BioConsulting, Inc.

  • 5:30 pm

  • Best Practice Exchange Session

    In this session, attendees can pick a topic to gain best practices and share helpful ideas on the following:

    1. Setting up and Managing a Virtual Company

    • Challenges and Opportunities
    • Infrastructure needs/Creating virtual platforms
    • Publication management
    • Setting up SOPs, templates
    • What do you really need close to you and what can you manage virtually?
    • Managing without a bench
    • Safety issues
    • HR issues
    • Ethical issues

    Greg Fiore, MD
    CMO, SSI Strategy

     

    2. How to Create an Effective Sourcing Talent Model to Yield the Highest Level Professional to Ensure Safe and Efficient Drug Development

    • Outside the box strategic sourcing
    • Strategic relationship building and networking
    • In the market or on the market?

    Joseph Arcangelo Sr.
    Managing Partner, InSeption Group

     

    3. Making Medical Review Faster and Easier

    • Analytical needs of small companies: Identifying the challenges
    • How to analyze clinical, operational and safety data from clinical trials visually
    • Live demonstration

    Ben McGraw
    VP of Marketing, Comprehend Systems

     

    4. Best Practices for Interacting with the Board

    Oscar Segurado, MD, PhD
    CMO, Crescendo / Myriad Genetics

     

    5. Biosimilars 101 for CMOs: Threat or Opportunity?

    Jim Roach, MD, FACP, FCCP
    CMO and SVP, Development, Momenta Pharmaceuticals

  • 6:00 pm

  • Networking Reception

    Hosted by:

    inSeption Logo

  • 7:00 pm

  • Mentoring Session on What it’s Like to be a CMO

    This panel designed for MDs entertaining the idea of becoming a CMO features experienced CMOs who give an overview on the reality of their role in leading drug development, supporting the CEO and how they add value to their companies. They will lead a Q&A for those considering this career path. More specifically:

    • Do you have the right experience in clinical development and medical affairs? (technical know-how)
    • Do you have the right skills to lead, setting objectives and executing them effectively? (character)
    • Are you able to communicate and interact clearly and effectively, both internally and externally? (style)
    • As a senior executive, are you ready to contribute to other business and corporate needs of your company?(business acumen)

    This session is only open to MDs and includes the reception and this panel. For information, contactService@theconferenceforum.org.

    Greg Fiore, MD
    CMO, SSI Strategy

    Oscar Seguardo, MD, PhD
    CMO, Crescendo Bioscience and Myriad Genetics

    Steven Zelenkofske, DO, FACC, FACOI, FCCP
    CMO & SVP, Clinical & Medical Affairs, Regado Biosciences

Agenda

  • 8:00 am

  • Breakfast

  • 8:30 am

  • Co-Chairs’ Welcome

    Lee Allen, MD, PhD
    CMO, Spectrum Pharmaceuticals

    Steven Zelenkofske, DO, FACC, FACOI, FCCP
    CMO & SVP, Clinical and Medical Affairs, Regado Biosciences

  • 8:45 am

  • Featured Presentation: Strategies to Position your Drug for Regulatory Approval and Market Access in Europe

    • The EU Landscape
    • What are the regulators looking for?
    • What are the payers looking for?
    • Strategies to successfully navigate your product into the European market

    Thomas Lonngren, PhD (hc), MRPharmS, FRCP
    Former Head, EMA

  • 9:30 am

  • CEO Panel: What do CEOs look for in a CMO?

    • Hiring: Identifying the appropriate CMO
    • Board interaction
    • Development path
    • What makes a CEO cringe?
    • How the CMO can help position the company

    Moderator:
    Pam Palmer, MD, PhD
    CMO & Co-Founder, AcelRx Pharmaceuticals, Inc.

    Panelists:
    Keith Dionne, PhD
    President & CEO, Constellation Pharmaceuticals

    Gaytri Kachroo
    CEO & Chairman, Rapid Pharmaceucticals

    Chris Kiritsy, MBA
    President & CEO, Arisaph

    Anthony McKinney
    President & CEO, Neurovance, Inc.

    Martin Tolar, MD, PhD
    Founder, President & CEO, Alzheon

  • 10:15 am

  • Networking Break

  • 10:45 am

  • How Investors Determine Valuation of Biotechs

    • Evolution on what investors are looking for from an end game
    • Good ideas funded and great ideas not funded
    • How venture looks at management
    • POV on exits

    Moderator:
    Steven Zelenkofske, DO, FACC, FACOI, FCCP
    CMO & SVP, Clinical and Medical Affairs, Regado Biosciences

    Panelists:
    Todd Foley, MBA
    Managing Director, MPM Capital

    Vikas Goyal, MBA
    Senior Associate, SR One

    David Grayzel, MD
    Managing Director, Atlas Venture Development Corp.

    Roger Hill, PhD, MBA
    Managing Partner, Willow Tree Capital

    Jeffrey Moore
    VP, MP Healthcare Venture Management

    Robert Weisskoff, PhD
    Partner, Fidelity Biosciences

  • 11:30 am

  • Pharma Business Development POV on Partnering

    • Structuring deals
    • Early phase investment vs late phase investment
    • Strategy
    • Selecting the right partner

    Moderator:
    Lee Allen, MD, PhD
    CMO, Spectrum Pharmaceuticals

    Panelists:
    Richard Brudnick
    VP, Co-Head Business Development/ M&A, Biogen Idec

    Ivana Magovcevic-Liebisch, PhD, JD
    SVP, Head of Corporate Business Development, Teva Pharmaceuticals

    Sue Yao
    Licensing and Business Development, Purdue Pharma

  • 12:15 pm

  • How BIO is Representing Emerging Biotechs

    • What is BIO doing to support emerging biotechs?
    • An overview on policy changes and market trends
    • The relationship between BIO and the FDA
    • BIO’s list of priorities for emerging biotechs

    Cartier Esham, PhD
    EVP, Emerging Companies, Biotechnology Industry Organization (BIO)

  • 12:45 pm

  • Conference Concludes