CHIEF MEDICAL OFFICER SUMMIT - The Conference Forum · 2013-05-06 · CHIEF MEDICAL OFFICER SUMMIT...
Transcript of CHIEF MEDICAL OFFICER SUMMIT - The Conference Forum · 2013-05-06 · CHIEF MEDICAL OFFICER SUMMIT...
FOR INFORMATION, VISIT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580
CHIEF MEDICAL OFFICER SUMMITTHE FIRST EVENT ADDRESSING THE COMPLEX DUAL ROLE OF MANAGING R&D
WHILE RAISING CAPITAL FOR BIOTECHS
MAY 6 - 7, 2013 FAIRMONT BATTERY WHARF, BOSTON, MA
DESIGNED FOR:
✓ Chief Medical Officers, Heads of R&D/Clinical
Operations, Chief Scientific Officers
✓ Life Science Investors, Government Sources of
Capital & Passion/Patient Capital
NETWORKING ACCESS WITH:
✓ Life Science Investors
✓ Professionals who sit at the crux of drug
development, establishing proof of concept,
managing safety, planning phase 3, interacting
with regulatory bodies and driving corporate value
BEST PRACTICES ON DAY ONE:
Clinical Development/Outsourcing & Regulatory
Management in the Emerging Life Science Space
BEST PRACTICES ON DAY TWO:
Investment Strategies, Exit Planning & Trends that will
Change the Funding of Medical Research in the
Emerging Life Science Space
KEYNOTE ADDRESSKen Getz, MBADirector of Sponsored Research Tufts CSDD
CO-CHAIR:Sheila Gujrathi, MDCMOReceptos
CO-CHAIR:Steven Zelenkofske, DO, FACC, FACOI, FCCPSVP, Clinical and Medical Affairs & CMORegado Biosciences
CO-CHAIR:Greg Fiore, MDCMOThe Medicines Company
Participating Investors
Supporting Partners
Organized by
ExhibitorAssociate SponsorsExecutive Sponsors
Follow us on Twitter @ConferenceForum #CMOSummit
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The Conference Forum’s First Annual Chief Medical Officer Summit for Emerging Life Science Companies is delighted to present a truly distinctive and interactive event for CMOs. We are grateful to Dr. Elizabeth Stoner, Managing Director, MPM Capital, for suggesting the idea and to our CMO advisers for their insights on content and agenda development.
We are Dedicated to Accomplishing Two Goals
• To bring together CMO executives to address the unique challenges associated with directing and managing all R&D functions with limited resources, while raising capital, working and meeting with investors and strategizing for appropriate exits.
• To create a network of CMOs from small to mid-size life science companies to share ideas, solutions and support.
The World of a CMO in Emerging Life Science CompaniesThe role of a Chief Medical Officer is one that means many things to many people, and indeed is radically different depending on the type of organization in which a CMO works. For CMOs in early, emerging and even mid-size life science companies, the role can be an isolated one, but with all the responsibility for driving the clinical development and CRO management while meeting the needs of investors and positioning for an appropriate exit. CMOs are playing an increasingly larger role in raising funding for their life science companies.
Who Should AttendThe conference is designed specifically for CMOs, but certainly Heads of R&D, Clinical Operations/Development/Outsourcing, and Vice Presidents of Medical Affairs would also greatly benefit from attending the program. Clinical service providers and investors are encouraged to attend as conversations with CMOs are very much welcomed.
Zoran AntonijevicSenior Director, Strategic Consulting and Adaptive ImplementationCytel Inc.
Carl Berke, PhDPartner / Founding DirectorPartners Innovation Fund, Partners Healthcare / Mass Medical Angels
Kevin Bitterman, PhDPrincipalPolaris Partners
Jodi Black, PhDDeputy Director, Division of Extramural Research Activities, National Heart, Lung, and Blood InstituteNIH
Anthony Coyle, PhDVP & CSO, Centers for Therapeutic InnovationPfizer
Daniel J. Curran, MDVP, Therapeutic Area Lead, Value Creation AlternativesTakeda Pharmaceuticals International, Inc.
Greg DombalCOOHalloran Consulting Group
Paul EdgertonManaging PartnerGold Partners
Greg Fiore, MDCMOThe Medicines Company
Todd Foley, MBAManaging Director MPM Capital
Ken Getz, MBADirector of Sponsored ResearchTufts CSDD
Vikas Goyal, MBASenior AssociateSR One
CHIEF MEDICAL OFFICER SUMMIT OVERVIEW
OVERVIEW
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SPEAKING FACULTY
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David Grayzel, MDManaging DirectorAtlas Venture Development Corp.
Donna Grogan, MDCMOAnexon, Inc.
Sheila Gujrathi, MDCMOReceptos
M. Scott Harris, MDCMO, Avaxia Biologics, Inc., Principal, Middleburg Consultants and Clinical Professor of Medicine, Georgetown University School of Medicine
Eric Hedrick, MDCMOEpizyme
Steve HoffmannScientific Program Manager, The Biomarkers Consortium, Inflammation and Immunity Steering CommitteeFoundation for the National Institutes of Health
Randall E. Kaye, MDSVP, Medical Affairs & CMOAvanir Pharmaceuticals, Inc.
B. Christopher Kim, PhDPartnerOxford Bioscience Partners
Chris Kiritsy, MBAPresident & CEOArisaph
Nilesh Kumar, PhD, MBADirectorMerck Serono Ventures
Mark LevinPartner & Co-FounderThird Rock Ventures
Tyler Martin, MDCMO & DirectorDynavax Technologies
Jeffrey Moore, DPhil, MBAVPMP Healthcare Venture Management, Inc.
Tracey MumfordSenior Associate Director, Research PartnershipsThe Michael J. Fox Foundation for Parkinson's Research
Robert Pyke, MD, PhDCMOS1 Biopharma
Jim Roach, MDCMO & SVP, DevelopmentMomenta Pharmaceuticals
Oscar Segurado, MD, PhDCMOCrescendo Bioscience
Jeffrey Sherman, MD, FACPCMO & EVP, Development, Manufacturing and Regulatory AffairsHorizon Pharma
Lauren Silverman, PhDManaging DirectorNovartis Venture Funds
Greg SimonCEOPoliwogg
Jeffrey Spaeder, MDSVP & Chief Medical and Scientific OfficerQuintiles
Michael Sweeney, MDCMO & VP of R&DDepomed
Santosh Vetticaden, MD, PhDCMO, SVPMast Therapeutics, Inc.
Nancy Wetherbee, MBADirector, Office of Research Business Development in Industry TranslationTufts Medical Center
Samuel Wu, MD, PhDManaging DirectorMedImmune Ventures
Steven Zelenkofske, DO, FACC, FACOI, FCCPSVP, Clinical and Medical Affairs & CMORegado Biosciences
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SPEAKING FACULTY CHIEF MEDICAL OFFICER SUMMIT
The Conference Forum is grateful to its advisers and speaking faculty for their insights on the agenda development and overall support.
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8:00 amRegistration & Breakfast
8:45 amCo-Chairs’ Welcome
Greg Fiore, MDCMO, The Medicines Company
Sheila Gujrathi, MDCMO, Receptos
Steven Zelenkofske, DO, FACC, FACOI, FCCPSVP, Clinical and Medical Affairs & CMO, Regado Biosciences
9:00 amOpening Address: What is a CMO? Defining the Reality of the RoleHow does the decision making for a CMO play out in different organizations? What people typically envision when they think of a CMO and how that stacks up against the reality of the role will be addressed. Also covered in this session are the challenges (including how to function with restrictive capital) and what the trade-offs are. Other topics to address include:
• Supporting a CEO who does not have experience in the therapeutic area you are in charge of
• Functioning with restrictive capital
• What should a CMO be focused on?
• The great balancing act
Tyler Martin, MDPresident, CMO & Director, Dynavax Technologies
9:30 amKeynote: Strategic Initiatives Signaling Transformative Change in the Drug Development Landscape
• Overview of the current global operating environment for drug development
• Profiling strategic, transformative initiatives being implemented (including open innovation; integrated alliances with CROs and sites; risk-based monitoring; protocol design optimization)
• Forecasting the impact of these initiatives
Ken Getz, MBADirector of Sponsored Research, Tufts CSDD
10:20 amNetworking Break
10:50 amClinical Trial Design Part I: Considerations and Risk Management
• Balancing trial design cost and complexity with budget and timeline
• Reducing the cost and complexity with novel clinical trials
• How much science can you afford?
• Enrichment strategies
• Optimizing the pharmacovigilance program: finding early safety signals
Part II: Adaptive Trial Design: Benefits & Risks• How to implement Adaptive Trial Design
• Designing clinical trials to adapt parameters along with data
• Regulatory management
• Barriers to Adaptive Trial Design
Moderator:Santosh Vetticaden, MD, PhDCMO, SVP, Mast Therapeutics, Inc.
Panelists:Zoran AntonijevicSenior Director, Strategic Consulting and Adaptive Implementation, Cytel Inc.
Greg Fiore, MDCMO, The Medicines Company
M. Scott Harris, MDCMO, Avaxia Biologics, Inc., Principal, Middleburg Consultants and Clinical Professor of Medicine, Georgetown University School of Medicine
Robert Pyke, MD, PhDCMO, S1 Biopharma
11:55 amInnovative Outsourcing Strategies, Models & Options with CROsPart I
• How outsourcing is a decision to be made in the context of defining the way in which a company wants to programmatically differentiate itself
• How a CRO can be much more than an execution partner, also providing insights that augment your scientific expertise
• Assessing CRO capabilities to match your short-term and long-term needs using the metrics of: how much of a CRO’s revenue is generated by emerging biotechs, what therapeutic area expertise is of the CRO, and how biotechs fit into the growth of the CRO
CHIEF MEDICAL OFFICER SUMMIT AGENDA
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DAY ONE - MONDAY, MAY 6, 2013
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• How to maximize the potential successful collaboration with a CRO – lessons from the past
Part II• Assessing clinical outsourcing partnering models that
work best for biotech companies
• What CRO partnering models are available to biotechs and what makes the right fit?
• What can you afford to outsource?
• Managing quality expectations with vendors, maintaining accessibility to own data, avoiding fraud and misconduct, and keeping costs down
• How are CROs thinking about longer-term partnerships and biotechs as an investment?
• How do you negotiate unique deal structures where biotechs are entering into risk-sharing partnerships with CROs?
• How do you develop deals with multiple programs with CROs and hold on to leverage?
• CMO in virtual vs. non-virtual life science company
• Pros and cons of working with small vs. large CROs
• Finding a balance with your CRO with budget and cash flow challenges
Moderator:Greg Fiore, MDCMO, The Medicines Company
Panelists:Tyler Martin, MDPresident, CMO & Director, Dynavax Technologies
Jeffrey Spaeder, MDSVP & Chief Medical and Scientific Officer, Quintiles
Steven Zelenkofske, DO, FACC, FACOI, FCCPSVP, Clinical and Medical Affairs & CMO, Regado Biosciences
1:00 pmLuncheon
2:15 pmHow to Position Your Drug For Approval and Regulatory Management
• Positioning your drug to get through regulatory processes as quickly and efficiently as possible to balance European and U.S. authorities
• Writing thoughtful protocols, investigative brochures and clinical development plans; adopting standard procedure on monitoring; writing SOPs; and dealing with regulatory agencies
• How to meet with FDA pre-IND for higher likelihood for success
• How to prepare for end of phase I and end of phase II meetings
• Hurdles standing in way of going through product approval
• How to manage regulatory requirements for Patient Reported Outcomes
• Accelerated approval and innovative ways to get to the finish line: what are relevant endpoints?
• The utility of the orphan drug process
• How to correctly use consultants
• The overlap and potential disconnect occurring between the right medical practice and clinical study
• Post-approval: CMO responsibility for promotional/educational compliance; promotional oversight and management of the medical message
• Do’s and Don’t's
Moderator:Steven Zelenkofske, DO, FACC, FACOI, FCCPSVP, Clinical and Medical Affairs & CMO, Regado Biosciences
Panelists:Greg DombalCOO, Halloran Consulting Group
Jeffrey Sherman, MD, FACPCMO & EVP, Development, Manufacturing and Regulatory Affairs, Horizon Pharma
Michael Sweeney, MDCMO & VP of R&D, Depomed
3:00 pmHow to Enter Into an Effective Partnership with Large Pharma
• What are the five big trends big pharma companies want to see right now (novel targets vs. differentiated therapies) and in what stages of development?
• How to position yourself with a large pharma partner
• Large pharma expectations
• Presenting clinical data
• Communication between companies
• Assessment of roles and responsibilities in a partnering arrangement
• Opportunities to pool or share resources
• What makes an ideal IPO?
• Exit opportunities
Moderator:Jim Roach, MDCMO & SVP, Development, Momenta Pharmaceuticals
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AGENDA CHIEF MEDICAL OFFICER SUMMIT
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Panelists:Daniel J. Curran, MDVP, Therapeutic Area Lead, Value Creation Alternatives, Takeda Pharmaceuticals International, Inc.
David Grayzel, MDManaging Director, Atlas Venture Development Corp.
Donna Grogan, MDCMO, Anexon, Inc.
3:45 pmNetworking Break
4:00 pmGetting Your Drug Reimbursed
• Reimbursement strategy planning
• What type of data package to develop to be attractive to a large pharma from a payor perspective
Speaker TBA
4:30 pmRoundtable Session Choices1. Innovative Outsourcing StrategiesJeffrey Spaeder, MDSVP & Chief Medical and Scientific Officer, Quintiles
2. Physician RecruitmentPaul EdgertonManaging Partner, Gold Partners
3. Acquiring Orphan Designation/Benefits and the JourneyEric Hedrick, MDCMO, Epizyme
4. How to Effectively Partner with AcademiaAnthony Coyle, PhDVP & CSO, Centers for Therapeutic Innovation, Pfizer
Nancy Wetherbee, MBADirector, Office of Research Business Development in Industry Translation, Tufts Medical Center
5. Raising CapitalTodd Foley, MBAManaging Director, MPM Capital
Vikas Goyal, MBASenior Associate, SR One
B. Christopher Kim, PhDPartner, Oxford Bioscience Partners
Jeffrey Moore, DPhil, MBAVP, MP Healthcare Venture Management, Inc.
5:30 pmNetworking Reception
8:00 amBreakfast
8:30 amCo-Chairs’ Welcome
Greg Fiore, MDCMO, The Medicines Company
Sheila Gujrathi, MDCMO, Receptos
Steven Zelenkofske, DO, FACC, FACOI, FCCPSVP, Clinical and Medical Affairs & CMO, Regado Biosciences
8:45 amHow to Best Portray the Science in Raising Capital
• The role and expectation of the CMO in raising capital
• Knowing what investors are looking for: the technical likelihood of success, having a strong patent around the technology, the exit strategy, opportunity cost
• What's being done to mitigate risk and increase the probability of success; having a clearly differentiated product
• Communicating and portraying what is compelling about the science to non-scientists and the many types of investors and funding agencies
Moderator:Greg Fiore, MDCMO, The Medicines Company
Panelists:Randall E. Kaye, MDSVP, Medical Affairs & CMO, Avanir Pharmaceuticals, Inc.
Jeffrey Sherman, MD, FACPCMO & EVP, Development, Manufacturing and Regulatory Affairs, Horizon Pharma
9:30 amWhat a CMO Can Do to Secure Alternative Sources of Financing: Alternative Investorsʼ PerspectivesAlternative sources of capital, what alternative investors look for when funding emerging life science companies and what a CMO can do to contribute to the financing effort.
• Angel Investors: rushing in where venture capitalists fear to tread; using angels for funding de-risking round to make you more attractive to VCs
• Patient Advocacy and Passion Capital: foundation funding; other contributions: support and the patient perspective being brought to everything they do; how different foundations operate
CHIEF MEDICAL OFFICER SUMMIT AGENDA
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DAY TWO - TUESDAY, MAY 7, 2013
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• Crowd Funding: "the best is yet to fund": misconceptions in funding; alternative sources of funding; explaining the science and knowing the crowd
• Government Funding: FNIH's role in public-private partnerships; the role a CMO has in the project; direct and early access in development of drug development projects to catch attention of FDA; sharing costs across multiple identities; acting as a conduit to bring together interested parties and find a champion in industry or academia for funding
• Government Funding: NIH's SBIR/STTR program and true non-dilutive funding; pros and cons; practical mechanisms to secure non-dilutive funding; goals on the funding side on providing the capital; how to make non-dilutive funding successful; how to use SBIR funding to leverage other funding; when you have a government partner, what happens to the IP?; areas of disconnect as the money is being rewarded and being aware of who is doing the reviewing; "innovation conferences" and "investor forums" to decrease time between application to award
Moderator:Steven Zelenkofske, DO, FACC, FACOI, FCCPSVP, Clinical and Medical Affairs & CMO, Regado Biosciences
Panelists:Carl Berke, PhDPartner, Partners Innovation Fund and Founding Director, Mass Medical Angels
Jodi Black, PhDDeputy Director, Division of Extramural Research Activities, National Heart, Lung, and Blood Institute, NIH
Steve HoffmannScientific Program Manager, The Biomarkers Consortium, Inflammation and Immunity Steering CommitteeFoundation for the National Institutes of Health
Tracey MumfordSenior Associate Director, Research Partnerships, The Michael J. Fox Foundation for Parkinsonʼs Research
Greg SimonCEO, Poliwogg
10:15 amWhat a CMO Can Do to Secure Traditional Sources of Financing: VC and Corporate Venture Investors’ Perspectives
What venture and corporate venture investors look for when funding the emerging life sciences and what a CMO can do that will contribute to the financing effort when thinking about trial design, choice of indications, and even the supporting science.
• Understanding the business of raising capital, where the target profile needs to be in order to be attractive to pharma, what the product needs to look like and what makes it acquirable as a CMO
• Getting involved as early as possible and building a relationship with the board by being at board meetings, presenting the plan and updating them on what you're thinking about clinical development as a CMO
• How CMOs can be more involved and build relationships with VCs
• Being involved in presentations and making sure they include real plans for clinical development and budget
• How a CMO can contribute to the company and not just the financing process
Moderator:Greg Fiore, MDCMO, The Medicines Company
Panelists:David Grayzel, MDManaging Director, Atlas Venture Development Corp.
Nilesh Kumar, PhD, MBADirector, Merck Serono Ventures
Jeffrey Moore, DPhil, MBAVP, MP Healthcare Venture Management, Inc.
Lauren Silverman, PhDManaging Director, Novartis Venture Funds
Samuel Wu, MD, PhDManaging Director, MedImmune Ventures
10:50 amNetworking Break
11:15 amHow to Plan for an Exit & Sustainability Strategies
• How do you position for an appropriate exit?
• How do you develop a clinical plan to match your exit strategy?
• Creating fluid strategies and building a compelling database
• Building a data package for an acquirer
• How to position for exits in both public and private companies
• How the exit environment has changed
• What are the contingency plans in place?
• How to prepare from the beginning
• Planning for sustainability: looking at all the options
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AGENDA CHIEF MEDICAL OFFICER SUMMIT
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Moderator:Steven Zelenkofske, DO, FACC, FACOI, FCCPSVP, Clinical and Medical Affairs & CMO, Regado Biosciences
Panelists:Kevin Bitterman, PhDPrincipal, Polaris Partners
Chris Kiritsy, MBAPresident & CEO, Arisaph
Mark LevinPartner & Co-Founder, Third Rock Ventures
12:00 noonDriving Investor Interest with External Communications
• Managing external communications
• Balancing the business need of maintaining a funding stream and/or stock prices with maintaining scientific integrity and not over-reporting data
• When and how should you get data out there? Press releases to general public, academic meetings, industry sponsored meetings, peer reviewed publications
• Early vs. later disclosure and nature of disclosure
• How to handle when data is not worthy of a press release or the strength of statement does not support data to drive investor interest
• Managing investors
Greg Fiore, MDCMO, The Medicines Company
12:30 pmAdvising Your CEO on Advisory Board Development
• Finding experts for advisory boards who specifically can address clinical and sometimes regulatory issues
• How can you inter-face with advisors who know fields for science and medicine to design clinical trials?
• How can you minimize cost and maximize time to get go/no-go decision?
Carl Berke, PhDPartner, Partners Innovation Fund, Partners Healthcare and Founding Director, Mass Medical Angels
Oscar Segurado, MD, PhDCMO, Crescendo Bioscience
1:00 pmConference Concludes
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CHIEF MEDICAL OFFICER SUMMIT VENUE / REGISTRATION
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VENUE
REGISTRATION
SPONSORS CHIEF MEDICAL OFFICER SUMMIT
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Quintiles is the world’s largest provider of biopharmaceutical development and commercial
outsourcing services with a network of more than 27,000 employees conducting business in approximately 100 countries. We have helped develop or commercialize all of the top-50, best-selling drugs on the market. For more information, visit our website at www.Quintiles.com.
Our mission at Cytel is to improve success rates in the development of drugs, biologics and medical devices. We do this by improving clinical trials through innovative
application of statistical science, operations research, and new computational methods We are leaders in adaptive trial design and implementation. All 25 leading biopharma companies rely on our technology in their clinical studies. For more information, visit www.cytel.com.
Gold Partners has over 30 years experience successfully conducting retained searches assisting Biotech
and Pharmaceutical clients recruit outstanding Physician executives for Chief Medical Officer, SVP and VP as well as Executive Directors, Senior Directors and Directors of Clinical Development and/or Medical affairs across a wide range of therapeutic areas. We have been successful because of our dedicated focus in this area and our ability to develop long term relationships with thousands of physician executives over the years. Our database includes over 20,000 physicians so when we start a new project, we know who to contact and can respond very rapidly to client requirements. For more information, visit www.searchgold.com.
Mancino Burfield Edgerton has over 30 years of experience
successfully conducting retained searches for senior executives across a wide range of functions in biotech, pharmaceutical, medical device and diagnostics companies. We are results oriented and have a track record of providing quality and timely professional recruitment and business advisory services to our life science clients. We are routinely engaged by Fortune 500 companies, midsize firms as well as emerging, venture-backed start ups. For more information, visit www.mbel.com.
Halloran Consulting Group is a boutique management consulting firm that specializes
in navigating and accelerating life science product development. As an objective advisor and trusted partner to our clients, we work with industry organizations of all types and sizes in all stages of development, including pharma, biotech, medical devices and service providers. We identify developmental challenges and devise and implement the best-
fit, practical, long term solutions effectively and efficiently. For more information, please visit our website at www.hallorancg.com.
Alandra Medical is a full service Contract Research Organization at the forefront of the offshore clinical trials trend. We offer capital efficient clinical research services to the medical device and
pharmaceutical industries. Our clinical trial team has contributed to establishing the safety and efficacy of medical devices along with bioequivalence and bioavailability studies. For more information, visit www.alandramedical.com.
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ASSOCIATE SPONSORS
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PARTICIPATING INVESTORS
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