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Executive Sponsors

Cytel
NDA

Associate Sponsors

Halloran Consulting
PRA
Veristat
Vince & Associates

Supporting Sponsor

ClinEdge

Supporting Partner

BioTechnology Industry Organization

Media Partners

CenterWatch
Clinical Leader
Life Science Leader
MassBio
PharmaVoice

Agenda

  • 8:00 am

  • Registration & Coffee

  • 8:45 am

  • Chair’s Opening Remarks

    Lee Allen, MD, PhD
    CMO, Spectrum Pharmaceuticals

  • 9:00 am

  • Keynote: Characterizing the High Capitalized Cost of Drug Development and the Critical Drivers of R&D Inefficiency

    In this annual keynote address Ken Getz, Director of Sponsored Programs at Tufts CSDD addresses:

    • A review of the Tufts CSDD’s new R&D cost study results
    • Root causes of inefficiencies, low success rates and high costs
    • Major strategies and operating models transforming the R&D paradigm
    • The value proposition, impact and challenges of these strategies and operating models

    Kenneth Getz, MBA
    Director of Sponsored Programs, Tufts CSDD

  • 9:45 am

  • How the Availability of Capital Impacts the Role of the CMO

    In this session, the panelists cover:

    • Optimal use of the proceeds
    • Determining a development path, new molecules vs. new studies on the same molecules
    • Appropriate stewardship of the capital
    • Balancing short-term and long-term objectives; particularly when they may conflict
    • Concerns and/or benefits of early financing without having reached clinical goals
    • Examining the new threshold in moving development forward
    • How is the progress in the industry translating into new drug discovery?
    • Maintaining the same rigor for investment

    Moderated by:
    Lou Brenner, MD
    SVP & CMO, Idera Pharmaceuticals

    Panelists:
    Raj Malik, MD
    CMO, G1 Therapeutics

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

    Oliver Rosen, MD
    CMO, Deciphera Pharmaceuticals

  • 10:30 am

  • Networking Break

  • 11:00 am

  • Building Successful Trials in a Small Company

    In this session, the panelists examine the positives and negatives of implementing design strategies and best practices in deploying them. More specifically:

    • Adaptive design (Not just dose change)
    • Regulatory POV on changes to trial design
    • Navigating regulatory landmines
    • Trial design strategies
    • Determining endpoints

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

    Panelists:
    John Balser, PhD
    President, Founder and Chief Biostatistician, Veristat

    John Friend, MD
    SVP, R&D, Helsinn Therapeutics

    Mike Royal, MD, JD, MBA
    EVP, Clinical & Regulatory Affairs, Sorrento Therapeutics

    Lorraine Rusch, PhD
    VP, Business Development, Vince & Associates

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

  • 11:45pm

  • Optimizing Clinical Outsourcing for Small Pharma

    In this session, the panelists cover:

    • Current thinking on what is the best R&D operating model
    • Current thinking on risk sharing models
    • How to engage in a deep dialogue to create strategy with partners and make sure goals are aligned to deliver for patients
    • How to build a truly collaborative partnership in the confines of today’s market place that allows for execution of strategic plans beyond the bottom line
    • What is important to the stakeholders (CEO, Wall Street, Customers, etc)
    • Working collaboratively to constant regulatory changes

    Moderated by,
    Lee Allen, MD, PhD

    CMO, Spectrum Pharmaceuticals

  • 12:15 pm

  • Capturing the Value of Innovation

    Jane Quigley, RN, BSN, OCN

    VP, Medical Informatics, PRA Health Sciences

  • 12:45 pm

  • Luncheon

  • 2:00 pm

  • Keynote: The Journey of a Physician CEO

    In this session, gain an insight into Dr. David Schenkein’s journey from physician to CEO of a biopharmaceutical company leading the way in the field of cancer metabolism. More specifically:

    • The journey
    • Prioritizing resources
    • Successes and failures
    • Overcoming hurdles
    • Strategic partnerships
    • Business plan

    David Schenkein, MD
    CEO, Agios

  • 2:45 pm

  • The Cultural Shifts During the Growth of a Biotech: CMO as a Change Agent

    In this session the panelists review the lifecycle of a biotech, from start-up through to commercialization and what these transitions mean for a CMO. More specifically:

    • Navigating the growing pains:
    • The “new departments on the block”
    • New processes when going public
    • Document management
    • Increase in external communications
    • The good, the bad and the ugly of social media
    • Maintaining communications and that “small group” feel internally
    • Strategies to alleviate growing pains

    Moderator:
    Seth Hetherington, MD
    CMO, Genocea Biosciences

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

    Lou Brenner, MD
    SVP and CMO, Idera Pharmaceuticals

    M. Scott Harris, MD
    CMO, Avaxia Biologics, Inc.

    Steven Zelenkofske, DO, FACC, FACOI, FCCP
    VP, Cardiovascular Medical Affairs Therapeutic Area Head, AstraZeneca

  • 3:15 pm

  • Exploring Alternate Regulatory Pathways: an FDA & EMA Update

    This session provides the latest trends and case examples on:

    • Breakthrough designation
    • Fast Track
    • Priority Review
    • Orphan Designations
    • Accelerated Approval
    • EMA’s pilot project on adaptive pathways
    • Other initiatives to eary access to medicines

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

    Richard Moscicki, MD
    Deputy Center Director for Science Operations, FDA (invited)

  • 3:45 pm

  • Networking Break

  • 4:00 pm

  • Why CMOs Have to be Prepared for Regulatory Inspections

    There are never clinical development programs without issues, which must either be prevented or fixed before regulatory inspections occur at the time of marketing submission. Preventing them ultimately will save both time and money, but in the incredibly busy time of late stage clinical trials, there is often little attention paid to what might not happen for a year or more. This session will address options to build in the problem solving and remediation through prospective activities.

    • Infrastructure and resources to manage and prepare for regulatory inspections
    • Offensive vs defensive program management and documentation
    • What should you do if you’re already there to close the gaps

    Laurie Halloran, BSN, MS
    President and CEO, Halloran Consulting Group

  • 4:30 pm

  • Biosimilars 101 for CMOs: Brief Overview, Hot Topics, and Implications for Your Business

    Since the Biologics Price Competition and Innovation Act (BPCIA) and the 351(k) biosimilar pathway was signed into law in 2010, the field of biosimilars has been exploding. In this session which can have broad implications for many companies, Dr. Jim Roach, SVP, Development and CMO, Momenta addresses the following:

    • What is a biosimilar and what does the 351(k) pathway allow for?
    • What is the commercial opportunity?
    • What are the unique regulatory and development opportunities and challenges?
    • Should “innovator” companies be supportive or afraid of biosimilar competition?
    • Who are the stakeholders and what are they advocating for?

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

  • 5:00 pm

  • The Shift in Focus of Orphan Drugs

    Orphan drugs have similar considerations which also apply to other therapeutic areas. Approvals for orphan drugs went up last year and there is no slow down in drug designation requests, which are on pace to break last year’s record This session addresses:

    • Commercial and humanitarian
    • Sustainability
    • What are the internal pressures
    • Value proposition
    • Out-of-the-box thinking for approval process
    • Challenges to get ODD
    • Unmet medical need
    • More favorable regulatory climate
    • Pricing flexibility
    • External pressures; patient advocacy groups & clinical KOL networks

    Moderated by:
    Lee Allen, MD, PhD
    CMO, Spectrum Pharmaceuticals

    Panelists:
    David Clark, MD
    CMO, Wilson Therapeutics

    Horacio Plotkin, MD
    CMO, Retrophin

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

  • 5:30 pm

  • Networking Reception

    Sponsored by Cytel & Halloran

    cytel Logo

    New-Halloran Consulting Group Logo

Agenda

  • 8:15 am

  • Coffee

  • 8:45 am

  • Chair’s Opening Remarks

    Lee Allen, MD, PhD
    CMO, Spectrum Pharmaceuticals

  • 9:00 am

  • CEO Panel: Striking a Balance with your CEO

    This panel explores the balanced working relationship necessary for product and company success. More specifically:

    • How to engage with your CEO
    • What does a CEO look for in a CMO?
    • Managing the board
    • Boundaries and scope in decision-making
    • How best to utilize consultants and manage them

    Moderated by:
    Lee Allen, MD, PhD
    CMO, Spectrum Pharmaceuticals

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

    Panelists:
    Lew Bender
    Founder and CEO, Intensity Therapeutics

    Mark Corrigan, MD
    Chairman of the Board, Epirus Biopharmaceuticals

    Barbara Fox, PhD
    CEO, Avaxia

    Mary Szela, MBA
    CEO, Melinta Therapeutics

    Leslie Williams, MBA
    CEO, ImmusanT

  • 9:45 am

  • How Investors Assess Management

    In this session, we begin with a presentation on a perspective on the method of evaluating a disease space, which includes a comprehensive understanding of 1) the science, 2) the competitive landscape and 3) the management teams for each company. How does this get mapped out? Following will be more discussion on:

    • Understanding the context of value proposition
    • Strategic fit
    • Processes used to evaluate management and an understanding of competitive strategy
    • How best to convey your plans
    • How best to communicate with investors (before investment) and boards (afterwards) – via the CEO or directly?
    • Importance of clinical development plan expectations

    Moderated by:
    Peter Kolchinsky, PhD
    Managing Director, RA Capital Management, LLC

    Panelists:
    Jonathan Behr, PhD
    EIR and Market Sector Leader, Innovation, Partners Healthcare (invited)

    David Berry, MD, PhD
    Partner, Flagship Ventures

    Jeffrey Moore, DPhil, MBA
    President, MPH Venture Management(invited)

  • 10:30 am

  • Networking Break

  • 11:00 am

  • Large Pharma Business Development POV on Partnering with Biotechs

    In this session we address:

    • Early engagement with large pharma
    • Identify the key value drivers
    • What do large pharma look for from the CMO
    • What makes it worthwhile for large pharma
    • Best practices and changes during a transition period

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

    Daniel Curran, MD, MBA
    VP, Value Creation Therapeutic Areas, Takeda Pharmaceutical Company (invited)

    John Knapp
    Managing Director, FTI Consulting

    Laurie Olson, MBA
    EVP, Strategy, Portfolio and Commercial Operations, Pfizer (invited)

    Scott Orchard, JD
    Senior Counsel, Johnson & Johnson Innovation

  • 12:30 pm

  • Executing a Reimbursement Strategy

    In this session, we address:

    • Leveraging a payor advisory board
    • Conducting health economic studies in parallel with regulatory clinical trials
    • Planning a reimbursement strategy in early stages of clinical development

    Oscar Segurado, MD
    Director, MedicAffairs


  • Luncheon Sessions

  • 1:00 pm

  • Q&A with BIO

    Cartier Esham, EVP, Emerging Companies at BIO speaks with our Chair, Lee Allen on what the organization are doing to represent the industry in Washington. We explore how BIO are tackling tax reform and 21st century cures in support of emerging biotechs.

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

    with

    Lee Allen, MD, PhD
    CMO, Spectrum Pharmaceuticals

  • 1:30 pm

  • What Does a Responsible Exit Look Like?

    Companies with ‘hot’ assets may be courted by multiple potential acquirers during the process of exit. With well-placed effort, company leaders can ensure best likelihood of benefit for their patients by following a few simple steps. This session will touch on the following, using case study methodology:

    • Selecting the best partners during development
    • Performing appropriate diligence on potential acquirers
    • Ensuring that pre-acquisition commitments are fulfilled post-acquisition to investigators, health authorities, patient advocacy groups and patients
    • Positioning the acquiring entity for success

    Greg Fiore, MD
    CMO, SSI Strategy

  • 2:30 pm

  • Conference Concludes