Biotech Showcase 2011 Program

The Alliance for Regenerative Medicine will convene 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 the major regenerative medicine companies and the primary patient groups supporting regenerative medicine.

Moderators:
Mark Monane – Managing Director, Equity Research, Biotechnology and Life Sciences, Needham & Company
Gil Van Bokkelen – Chairman and CEO, Athersys

Panelists:

• Chris Calhoun – CEO, Cytori Therapeutics
• Richard A. Insel – CSO, Juvenile Diabetes Research Foundation (JDRF)
• Tom Okarma – President and CEO, Geron
• Dean Tozer – Senior VP, Advanced BioHealing (ABH)
• Alan Trounson – President, California Institute for Regenerative Medicine (CIRM)

The future of dealmaking lies in the ability of both pharma and biotech companies to move beyond a focus on achievement of Proof of Concept to one of Proof of Relevance—that is, the ability to recognize and communicate the indisputable clinical and commercial value of compounds at early stages of development. This presentation will focus on the importance of seeking Proof of Relevance for early stage programs and provide recent examples of strategies for achieving value inflection from demonstration of Proof of Relevance in early stage development.

Speaker:
Ed Saltzman – President, Defined Health

At a recent symposium, Francis Collins, NIH director suggested that personalized medicine may play a key role in not only reducing the cost of healthcare but also in improving patient outcomes. So, what is the reality today? Where do we stand in terms of seeing molecular diagnostics taking a key role in determining therapeutic treatment for a patient? What will the regulatory scene look like? And, finally, how about reimbursement—who will pay?

Moderator:
Susan Reardon – Director, Medical Devices and Diagnostics, Government Affairs and Policy, Johnson & Johnson Services

Panelists:

• Mara Aspinall – CEO, On-Q-Ity
• Bruce Booth – Partner, Atlas Ventures
• Bryan Dechairo – Senior Director, Head of Extramural R&D, Medco Research Institute
• Stephen M. Dunn – President and Senior Managing Director of Research, LifeTech Capital
• David Levinson – President and CEO, CardioDx
• Eric W. Linsley – Managing Partner, Pappas Ventures

Hear reports from the front lines on how to navigate the FDA approval process in today's environment. What are successful strategies for reaching agreement with Agency reviewers on clinical trial design? Are there ways to shorten development timelines? Will the FDA require comparative effectiveness testing? Should you consider biomarkers? What changes are coming in PDUFA 5? Answers to these key issues and more from a panel of industry leaders.

Moderator:
Michael S. Labson – Partner, Covington & Burling

Panelists:

• Nancy Bradish Myers – President and Founder, Catalyst Healthcare Consulting
• Klara A. Dickinson – Senior VP, Regulatory Affairs and Compliance, Hyperion Therapeutics
• Michele Yelmene – Consultant, Product Development and Registration Consulting, Hamilton BioVentures

An in depth look at the life science industry from leading journalists, Gene Marcial, a financial reporter, and Kimberly Ha whose concentration is on science. Both are known for their skillful analysis and intelligent reporting on the hottest biotech news, or potential investment. Learn how to communicate your story for an optimal response from the experts. Each will describe their distinct needs and impart advice on how to communicate your story to your best advantage. This discussion will focus on the latest trends in the ever changing biotech landscape for the industry expert or novice, industry insider or investor.

Moderator:
Melody Carey – Founder and Co-president, Rx Communications Group

Panelists:

• Kimberly Ha – Global Editor, Pharmawire
• Gene Marcial – Senior Writer, DailyFinance, where he writes the "Inside Wall Street" column

Small-cap and private biotech companies are quite dependent upon news flow and events external to their companies for fundraising. Positive news in the form of approvals, an active M&A market, corporate venture, solid IPO performance and clarity on the regulatory front buoy both specialist and generalist investor interest in the whole sector. This panel will take a look at 2010, and the all important Q4, and discuss what they expect in 2011 and how it will impact private and small-cap life science companies.

What will it take to entice generalist investors back to the biotech sector?

Moderators:
Ellen B. Corenswet – Partner, Covington & Burling
Glen Giovanetti – Partner, Ernst & Young

Panelists:

• Karen Bernstein – Chairman and Editor-in-chief, BioCentury Publications
• Barbara Dalton – VP, Pfizer Ventures
• Kurt von Emster – Partner, venBio
• Dennis Purcell – Managing Partner, Aisling Capital
• Evonne Sepsis – Managing Director, ESC Advisors

Securing appropriate insurance coverage and reimbursement for your product can make the difference between a product doctors and hospitals will use and one that gets left behind. A thoughtful coverage and reimbursement strategy will also give investors confidence to support your company. This interactive workshop addresses the healthcare payment environment over the long term, how to position your product for insurance coverage and reimbursement, plus practical tips on how to work with Medicare and other health payors.

Moderator:
Demetrios L. Kouzoukas – Of Counsel, Covington & Burling

Panelists:

• George Kenny – Senior Corporate Counsel, Health Law Group
• James O’Neill – Managing Director, Clarium Capital
• Rob Stager – VP, The Marwood Group

On one front, viral infections have proven to be one of man’s toughest foes. While H1N1, H5N1 and SARS grab world headlines, the biotech industry is in an ongoing battle with HIV, hepatitis and the more exotic Ebola and dengue fever. On another front, bacterial infections are becoming more and more difficult to treat because of antibiotic resistance. While MRSA is best known, bacterial resistance is developing against every antibiotic in use today and solutions are still on the horizon. This panel of companies developing our arsenal of next generation antiviral and antimicrobial weapons will discuss the infectious disease landscape and their technologies and targets.

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

• Brian Dixon – CEO and President, BioRelix
• Rom Eliaz – CEO, Nasvax (NSVX:IT)
• J. Joseph Kim – CEO, Inovio Pharmaceuticals (Amex:INO)
• Steven King – CEO, Peregrine Pharmaceuticals (Nasdaq:PPHM)
• Ron Najafi – CEO, NovaBay Pharmaceuticals (Amex:NBY)

Following nearly two years of financial uncertainly in the marketplace, many large pharmaceutical and biotech companies remain cautious. As always, but now more than ever, companies must balance a desire to bring innovative products to market with the risk associated with placing expensive “bets.” While large companies express an interest in new and innovative targets, in many cases their publicly-available areas of interest remain focused on proven targets. What is big pharma’s plan for bringing innovation to market in the current environment and how will that plan affect small and emerging companies hoping to get to the next level?

Join this interactive discussion as we dig deeper into what the industry’s key players view as the best approaches to making sound decisions on where to focus their development, licensing and financing efforts.

Moderator:
Ben Bonifant – Senior VP and Practice Area Leader, Campbell Alliance

Panelists:

• David Low – Managing Director, Lazard
• Gerald McMahon – Head, Global Biologics Oncology, MedImmune
• Polly Murphy – VP, R&D Business Development, Pfizer
• Janis C. Naeve – Director, Amgen Ventures
• Garry A. Neil – VP, Corporate Office for Science and Technology, Johnson & Johnson
• James H. Sabry – VP, Genentech Partnering, Genentech