Jan 11 – 12, 2012
Marines' Memorial Club and Hotel, San Francisco
New Paradigms is guided by key individuals from biotech, pharma and the investment community to advance R&D through alternative sources of funding, non-traditional partnering strategies and innovative approaches to drug approval for the successful commercialization of new therapies. The conference is backed by an exceptionally distinguished speaking faculty with diverse experience and expertise. Co-located at the same time as the JP Morgan Healthcare event, on-site networking partnering services available to registered attendees. Details at http://www.theconferenceforum.org/NewParadigms-Agenda-DayOne.html
Agenda
Day One - Wednesday, January 11, 2012
7:30 am
Registration & Morning Coffee/Tea
8:00 am
Co-Chairs Opening Remarks
Sandra Garrett, PhD, Executive Chair, GRS
Peter Milner, MD, Co-founder, CVT, ARYx and Optivia
8:15 am
Opening Presentation: Market Disruptions and How to Prepare for Them
George Bickerstaff, Managing Director, MM Dillion & Co and Executive Chairman and Co-Founder, The Global Leaders
8:45 am
R&D Partnerships-Alternative Financial Sources, Non-Profit and Government
Funding
•New financial sources/models
•Finding partners to bring products to market
•New paradigms in non-profit investment and partnering
•How to navigate non-profits as potential partners
•How to raise non-dilutive funds
•What are we to do as a community to ensure that biotech remains healthy and vibrant with the challenges of raising funds?
Moderated by:
Stephen Conafay, Principal, Fabiani & Company
Panelists:
Ali Andalibi, PhD, Program Director, SBIR/STTR, National Cancer Institute, NIH
Margaret Anderson, Executive Director, FasterCures
Barbara Fox, PhD, CEO, Avaxia Biologics, Inc.
Chris Kiritsy, CEO, Arisaph
Magdalena Leszczyniecka, PhD MBA, President and CEO, STC Biologics, Inc.
Dennis Purcell, Sr., Managing Partner, Aisling Capital
Harri Taranto, Partner, Symphony Capital
9:45 am
FDA's View on How Biotechs Can Better Navigate the Regulatory System
Vicki L. Seyfert-Margolis, PhD, Senior Advisor for Science Innovation and Policy, FDA Commissioner’s Office
10:15 am
Keynote Interview on the Essential Ingredients to Regulatory Success
•What are the key factors for success in securing a high proportion of regulatory agency approvals - on time and without delay?
•Are there words of advice regarding how to avoid major regulatory failures?
•How would you differentiate your regulatory strategy with the FDA versus that in Europe or Asia or elsewhere?
David Pyott, CBE, Chairman of the Board, President & CEO, Allergan
10:45 am
Networking Break & Partnering Meetings
11:15 am
Investor Perspectives on Biotech Investments: Evolving Strategies
•How do investors view biotechs right now?
•How do smaller companies with transformative technologies get funding?
•Timelines for exits
•Managing capital efficiencies
•How to bring in other sources of revenue
•Investment structure and milestones
•Milestone liquidity
•Why biotechs are having a hard time getting funding
•Forming relationships with your CEOs
Moderated by:
Peter Milner, MD, Co-founder, CVT, ARYx and Optivia
Panelists:
Leon Chen, Partner, Skyline Ventures
William Greene, MD, Venture Partner, MPM Capital
James Li, Partner, Kleiner Perkins
Stephen Parker, DPhil, Partner, Celtic Pharma Holdings
Ivor Royston, MD Managing Member, Forward Ventures
12:00 noon
CEO Biotech Panel on Partnering Expectations: Sharing the Journey of Growth and Lessons Learned
•Partnering lessons for small biotech companies
•Attracting and retaining top talent
•Health care reform and the impact on mid-cap companies - now and over the next 5 years
•Financing trends over the next 2-3 years.
Safi Bahcall, PhD, CEO, Synta Pharmaceuticals
Mike Bonney, President and CEO, Cubist Pharmaceuticals
Martin Cleary, Executive Chairman, Amarantus BioSciences, Inc.
Robert Gould, PhD, President and CEO, Epizyme
Thomas Hughes, PhD, President and CEO, Zafgen
Chris Kiritsy, CEO, Arisaph
Rick Winningham, Chairman and CEO, Theravance
12:50 pm
BioCentury Luncheon Keynote
Each September since 1993, BioCentury has published a "Back to School" commentary on issues that are fundamental to the industry's development. The Founders of BioCentury provide insights into the findings of their research on current thinking around innovation and collaboration and share data on who is getting funded and who is not.
Karen Bernstein, PhD, Chairman and Editor in Chief, BioCentury
David Flores, President & CEO, BioCentury
2:00 pm
New Paradigms in Deal Structures: What BioPharma Investors are Looking for in Biotech Partners
Moderated by:
Howard Palefsky, Partner, Montreux
Panelists:
Srini Akkaraju, MD, PhD, Managing Director, New Leaf Venture Partners
Laurence Blumberg, MD, Senior Vice President, Business Development, Kadmon
Rajeev Dadoo, PhD, Partner, SR One Ltd.
Christopher Gallen, MD, PhD, Executive Vice President, R&D and CMO, Zalicus Inc
Jake Handy, Partner, Fenwick & West LLP
Roger J Hill, PhD, MBA, Head, Global Licensing - Commercial Opportunities, Business Development & Licensing, Boehringer Ingelheim
Lauren Silverman, PhD, Managing Director, Novartis Option Fund, Novartis Venture Fund
Thomas Zioncheck, PhD, Senior Director, Business Development, Genentech
3:15 pm
Networking Break
3:45 pm
Opportunities in China
•Review of the financial deals with non Chinese products and the reverse
•Data on tracking IPOs and cross-border deals
Moderated by:
Greg Scott, Founder and CEO, ChinaBio, LLC
Panelists:
George Bickerstaff, Managing Director, MM Dillion & Co and Executive Chairman and Co-Founder, The Global Leaders
4:15 pm
How to Conduct Commercial Assessment on a Drug with a Tight Budget
•Which aspects of a commercial assessment most impact investment decisions?
•Where should companies focus their market research efforts?
•The Non-Scientific Side of Drug Development
•Essentials
•A look at virtual business models
•The tradeoffs
Moderated by:
John Orloff, MD, Senior Vice President, Global Development & Chief Medical Officer, Novartis
Panelists:
Christopher Gallen, MD, PhD, Executive Vice President, R&D and CMO, Zalicus Inc
Vikas Goyal, Associate, SR One Ltd.
M. Ken Kengatharan, PhD, MBA, President and Chief Scientific Officer, Altheos
5:00 - 6:00 pm
Networking Reception hosted by:
Day 2
7:30 am
Registration & Morning Coffee/Tea
8:00 am
Co-Chairs Opening Remarks: New Paradigms to Get Your Drug Approved
Sandra Garrett, PhD, Executive Chair, GRS
Peter Milner, MD, Co-founder, CVT, ARYx and Optivia
8:15 am
Navigating Regulatory Hurdles: A Comparison of US vs EU Regulatory Environment and Suggestions for FDA Reform
•What’s different today and what you must do to prepare to move your development forward
•Assessing and addressing the regulatory uncertainty in the US
•What could the FDA learn from the approach to regulation in Europe? Is there anything the FDA should be doing differently?
•Managing the increasing demands for higher and higher safety hurdles
•How can a smaller, US based company approach gaining approval in Europe? What are the challenges?
•What are the main outlines of the drug and medical device user fee negotiations?
•What is Congress doing – with respect to oversight and legislation – to improve FDA performance?
•What’s happening with regulatory oversight of non therapeutics: the difficulty of obtaining of diagnostic approval
•Proposed antibiotic reform, The GAIN ACT
•What you need to know about the impact of the critical path in drug development
•How the healthcare bill will impact innovation in the US
Moderated by:
Peter Milner, MD, Co-founder, CVT, ARYx and Optivia
Panelists:
David Gollaher, PhD, President and CEO, California Healthcare Institute
Simon Goodall, Vice President, The Boston Consulting Group
Coleen Klasmeier, Partner, Sidley Austin LLP
Rick Winningham, Chairman and CEO, Theravance
9:30 am
Executing Innovative Clinical Trials that Save Time, Money and Improve Outcomes
Greg Simon, Senior Vice President, Patient Engagement, Pfizer
10:15 am
Networking Break
10:45 am
An Investor’s Perspective on the Importance & Future of Virtual Trials
Virtual trials are the future and how we are going to be able to afford to move drug development forward. In this discussion, you will gain insight into an investor’s vision on the future and impact of virtual trials in the preclinical, clinical and post clinical space.
Elizabeth Stoner, MD, Managing Director, MPM Capital
11:15 am
Plasma and Imaging Biomarkers that Drive Value and Improve Success Rates
•Plasma and imaging biomarkers
•Improved imaging biomarkers
•Who got a deal because of a biomarker?
•Utilizing biomarkers to attract partners
•FDA changes
•The direction of biomarkers in cancer evaluations
Moderated by:
Peter Milner, MD, Co-founder, CVT, ARYx and Optivia
Panelists:
Michael R. Bristow, MD, PhD, President and Chief Executive Officer, ARCA BioPharma
John Orloff, MD, Senior Vice President, Global Development & Chief Medical Officer, Novartis
12:00 noon
Getting your Drug in Development Talked About with New Media Tools
Sandra Garrett, PhD, Executive Chair, GRS
Carin Canale-Theakston, President, Canale Communications
Rich Westelman, Chief Operating Officer, Sermo
12:45 pm
Best Practices in Reimbursement
Some argue that approval and commercialization of new therapies is part I of the arduous journey and part II is reimbursement. This session will go through how to be proactive in managing reimbursement pricing, formulary inclusion and market perception.
Kent Rogers, VP, Managed Markets, Acorda Therapeutics
1:15 pm
Conference concludes
