Biotech Showcase™ 2013 Program Overview

According to the World Health Organization, almost one quarter of deaths globally are due to infectious diseases, almost double the deaths due to cancer and behind only cardiovascular disease as the world's biggest killer. With more bacterial strains becoming drug-resistant, mutating viral pathogens spreading to the developed world, and increasing links between viral infection and cancer, biotechnology companies talk about their promising new approaches in the global war against infectious diseases.

Moderator:
Stephen M. Dunn – President, Senior Managing Director of Research, LifeTech Capital

• J. Joseph Kim – President and CEO, Inovio Pharmaceuticals
• Raphael Gernot Klingmann – CEO, Omnia Molecular
• David W. Martin – CEO, AvidBiotics
• Frank Oakes – CEO, Stellar Biotechnologies
• John Trizzino – CEO, Immunovaccine

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The ability of a life science company to obtain favorable third-party reimbursement for its therapeutic or device affects valuation. This panel will discuss high level strategies for obtaining coverage and maximizing payment amount in today's environment and under evolving CMS standards.

Moderator:
Demetrios L. Kouzoukas – Of Counsel, Covington & Burling LLP; former Deputy General Counsel and Principal Associate Deputy Secretary, US Department of Health & Human Services

• Lauren Barnes – Senior VP, Reimbursement Practice, Avalere Health
• Bryan Dechairo – Senior Director, Head of Extramural R&D, Medco Research Institute
• Herb K. Schultz – Regional Director, US Department of Health and Human Services Region IX
• Lambert van der Walde – Founder, van der Walde & Co.

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Given the limited number of biotech IPOs in 2011, industry experts say we will continue to see M&A dominate as the principal exit pathway, although pharma says they can't absorb all companies. In this panel, VCs will discuss the liquidity options for their portfolio companies, representatives of potential acquirers will review the type of risk reduction deal structures they are proposing, and corporate advisors will discuss other funding options being adopted by management.

Moderator:
Michael J. O'Donnell – Partner, Morrison & Foerster

• Mark Barrett – Senior Director, Business Development, Johnson & Johnson
• Stephen M. Dunn – President, Senior Managing Director of Research, LifeTech Capital
• Jonathan J. MacQuitty – Partner, Abingworth Management
• Benjamin Perkins – Senior Managing Director, Group Head, US Life Sciences M&A and Capital & Debt Advisory, Ernst & Young Capital Advisors

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While the rest of the world struggles, China is setting new records in venture capital investment, IPO and M&A activity, and partnering deals. More money was pumped into Chinese life science companies by the Chinese government, VCs and private equity funds in 2010 than ever before. In 2011, several early stage companies have attracted more than USD 100 million in equity funding. Will this trend continue in 2012? This special session will focus on the funding climate in China and the potential opportunities for investors and entrepreneurs alike.

Moderator:
Greg B. Scott – President and Founder, ChinaBio^® LLC

• Leon Chen – Partner, Fidelity Growth Partners Asia
• Darren Ji – Acting CEO, NP Biosciences
• Victor Shi – President, Asia Pacific, QIAGEN
• Tony Zhang – VP, Global External R&D, Asia, Eli Lilly

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The Alliance for Regenerative Medicine is convening a briefing on the state of the cell therapy and regenerative medicine industries. The briefing will cover the performance of currently marketed products, major clinical developments, key technology advancements, use of stem cells in drug discovery, regulatory issues and the current financial outlook for the sector. Speakers will include CEOs from several of the major regenerative medicine companies with products in advanced clinical development along with senior executives from three pharmaceutical companies with key programs in the sector.

Moderator:
Gil Van Bokkelen – Chairman and CEO, Athersys

• Silviu Itescu – CEO, Mesoblast
• Tim M. Mayleben – President and CEO, Aastrom Biosciences
• Gary Rabin – Chairman and CEO, Advanced Cell Technology
• Robin Smith – Chairman and CEO, NeoStem

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This workshop will focus on what tools an emerging company can use to finance their development programs and include a discussion on debt, royalty and other government backed options.

Moderator:
Luke C. Duster – Principal, Capital Royalty

• Michael Hanewich – Head, Life Sciences/Life Science Venture Capital East/Europe, Silicon Valley Bank
• Sachin R. Kelkar – Managing Director, Investment Banking, LifeTech Capital
• Kristen C. Kosofsky – Managing Director, Horizon Technology Finance
• Ram May-Ron – Managing Partner, FreeMind Group
• Michael J. Nowak, PhD – Managing Director, Head of Healthcare, Yorkville Advisors

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At last year's Biotech Showcase, we posed the question: "Does Big Pharma Want What You Have?" Since that time we've seen the interests of large pharma companies dramatically shift from filling late stage pipeline gaps to an interest in early stage assets. The results of Campbell Alliance's Dealmakers' Intentions Survey also showed that pharma is compelled to move deeper into specialty therapeutic areas, including those that were traditionally considered primary care. How will these strategic decisions made by large pharma affect the partnering strategies and business models employed by emerging biotechs? And where will the next phase of value come from for the pharma and biotech industries?

Moderator:
Ben Bonifant – Practice Area Leader, Campbell Alliance

• David Flores – Co-Founder, President and CEO, BioCentury Publications
• Shaun Grady – VP, Strategic Partnering and Business Development, AstraZeneca
• Dennis J. Purcell – Senior Managing Director, Aisling Capital
• Gunnar Weikert – Founder, Chairman and CEO, Inventages
• Greg Wiederrecht – VP, Worldwide Licensing and External Research, Merck

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In this session, experienced MDx developers, investors, dealmakers and policy advocates will explore the challenges and opportunities within the MDx sector including:

• Managing the pace of changing technology
• Developing MDx in an increasingly regulated environment
• Educating payors on the value of novel MDx and the increasing importance of health economic studies
• Positioning your product for partnering with commercial partners
• Understanding the appetite in MDx of venture investors

Moderator:
John Freshley – CBO, Compendia Bioscience

• Andrew Fish – Executive Director, AdvaMedDx
• Pia Gargiulo – Senior Director, Companion Diagnostic Partnerships, QIAGEN
• Joseph Monforte – Executive VP and CSO, AltheaDx
• Thomas H. Tulip – VP, Business Development, Neoprobe
• Mickey Urdea – Founder, Chairman and CSO, Tethys Bioscience

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The FDA recently kicked off an organization-wide Innovation Initiative, which promises to redouble the agency's efforts to encourage innovations that will promote public health as well as strengthen the American economy. While the FDA has many critics calling for change and there is hope that this initiative will benefit not only patients but innovators and their investors as well, this does not obviate the need for companies with drugs in advanced stages of development to have a strategy to get their drugs approved. This panel will share their thoughts on what to do and how do it even as this all important agency is going through change.

Moderator:
Jules T. Mitchel – President, Target Health

• Afia K. Asamoah – Senior Associate, Covington & Burling LLP; former Special Assistant to the Principal Deputy Commissioner, FDA
• Nancy Bradish Myers, JD – President and Founder, Catalyst Healthcare Consulting
• Michele Yelmene – President, QCRC Services

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A recent study by the NVCA reported that many venture capitalists are eliminating their investments in US life science companies altogether while others are shifting their focus to ex-US investments principally because of perceived regulatory obstacles. Furthermore, with few exceptions, companies with early stage pipelines are not likely IPO candidates nor are they compelling targets for M&A transactions with big pharma. These trends paint a daunting picture for any life science company trying to advance their programs. This panel will discuss potential ways to address these obstacles on multiple levels for innovator companies as well as their investors.

Moderator:
Ellen B. Corenswet – Partner and Chair, Venture Capital and Emerging Companies practice, Covington & Burling LLP

• Roger Longman – CEO, Real Endpoints
• Polly Murphy – VP, R&D Business Development, Pfizer
• Arthur Pappas – Managing Partner, Pappas Ventures
• Evonne Sepsis – Managing Director, ESC Advisors
• Todd Sherer, PhD – CEO, Michael J. Fox Foundation for Parkinson's Research

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