2012 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

  1. New financial sources/models

  2. Finding partners to bring products to market

  3. New paradigms in non-profit investment and partnering

  4. How to navigate non-profits as potential partners

  5. How to raise non-dilutive funds

  6. 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

  1. What are the key factors for success in securing a high proportion of regulatory agency approvals - on time and without delay?

  2. Are there words of advice regarding how to avoid major regulatory failures?

  3. 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

  1. How do investors view biotechs right now?

  2. How do smaller companies with transformative technologies get funding?

  3. Timelines for exits

  4. Managing capital efficiencies

  5. How to bring in other sources of capital

  6. Investment structure and milestones

  7. Milestone liquidity

  8. Why biotechs are having a hard time getting funding

  9. 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

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

  1. Partnering lessons for small biotech companies

  2. Attracting and retaining top talent

  3. Health care reform and the impact on mid-cap companies - now and over the next 5 years

  4. 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:

  1. Innovation and collaboration

  2. The differences between today and the past five years

  3. Funding trends

  4. PDUFA

  5. INDs

  6. Biosimilars

Karen Bernstein, PhD, Chairman and Editor in Chief, BioCentury

David Flores, President & CEO, BioCentury

Peter Milner, MD, Chair, New Paradigms

2:00 pm

New Paradigms in Deal Structures: What Investors are Looking for in Corporate 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

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

While investment in life science continues to shrink in the U.S., China is setting new records. VC investment, IPOs and M&A activity all saw new highs in 2010, with VC investments in life science companies averaging $21M and many VC and partnering deals netting $20M to $100M and more. This session will provide information on the sources of funding in China and how western companies can access government, institutional and commercial funding.

  1. Review of the financial deals with non Chinese products and the reverse

  2. Data on tracking IPOs and cross-border deals

Greg Scott, Founder and CEO, ChinaBio, LLC

4:15 pm

How to Conduct Commercial Assessment on a Drug with a Tight Budget

  1. Which aspects of a commercial assessment most impact investment decisions?

  2. Where should companies focus their market research efforts?

  3. The Non-Scientific Side of Drug Development

  4. Essentials

  5. A look at virtual business models

  6. 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 pm

Essential Elements to Any Non-Traditional, Risk-Share Partnership Between Pharma Sponsors, Investors and Execution Partners

This innovative transformative case study will center around:

  1. Alignment of Incentives

  2. Empowerment

  3. Requirement to Cede Accountability

Brian Huber, PhD, Vice President and Managing Director, Customer Solutions Business, Quintiles

5:30 - 6:30 pm

Networking Reception hosted by:




Day Two - Thursday, January 12, 2012

 

Agenda

Day One

2012

Executive Sponsors

Co-Sponsors

Exhibitor

Supporting Partners

Media Partners

3rd Annual New Paradigms to Fund & Move Drug Development
Finding the Fastest Path to Funding & Regulatory Approval
January 8 - 10, 2013     Marines’ Memorial Club & Hotel, San Francisco, CANewParadigms-Overview.html