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10:45 a.m. - 11:40 a.m.
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Concurrent Panel Sessions
Going Global: Cross-Border Issues Facing Life Sciences Companies
Imperial IV
As the life sciences industry continues to expand, becoming a more global arena every day, several unique issues have emerged that impact all industry sectors including biotechnology, pharmaceuticals, medical devices and agricultural biotechnology. Our panel of experts has a diverse background, in all of the above sectors, and years of experience in manufacturing, sales and marketing and consulting. Several important issues will be discussed including the importance of identifying and accessing global markets; how to best operate in foreign countries; how best to position products and/or services for global manufacturing and delivery; and what pitfalls are to be avoided. A candid assessment of what works and what does not work will be explored by the panelists, including an opportunity for direct interaction with the audience.
Moderator:
- Michael Constantino, Audit Partner, Ernst & Young LLP
Panelists:
- Randall Marcuson, President and Chief Executive Officer, Embrex, Inc.
- Amit Munshi, President, Adrista Inc.
- Nader Naeymi-Rad, Senior Vice President, Brand Management Practice, Campbell Alliance
North Carolina: Partnering with the US Department of Defense
Imperial V
This panel describes North Carolina’s strategic initiative to provide the Department of Defense with cradle-to-grave support for bio-supported products and systems, including basic and applied research, advanced technology demonstrations, prototypes and products. This support includes integrating biological and electronic technologies for “e-bio” products and systems. The strategic initiative will also help build strategic and working relationships that enable the Department of Defense to leverage our capabilities and national and international networks in biotechnology research and bio-supported products/systems for national defense. NC’s initiative also includes creating effective partnerships to use best practices, remove acquisition and technology transfer barriers and provide incentives for research and bio-supported products and systems for national defense.
Moderator:
- Kenneth Tindall, Ph.D., Senior VP for Science and Business Development, North Carolina Biotechnology Center
Panelists:
- Robert Helms, Ph.D., Director, Strategic Initiatives Engineering Group, RTI International
- Russ Lea, Ph.D., VP for Research and Sponsored Programs, University of North Carolina
- Michael Walter, Ph.D., Senior Staff Scientist, Joint Program Executive Office for Chemical/Biological Defense
- Terry Williams, Chief Development Officer, Hemoscience Inc.
Building the Bridge to a First Round: The Ins and Outs of Early Stage Financing
Imperial VI-VII
Bootstrapping, loans, angel funds and early seed venture funds can collectively and individually carry a start-up biotech company just so far. On the other side of the equation, larger funding sources are becoming reluctant to step up to the plate early in the life of a company, creating a funding chasm that needs to be bridged. Several unique mechanisms do exist that may help a company bridge the troubled funding waters while also driving the company forward onto new benchmarks and achievements.
Moderator:
- John Richert, Vice President, Business and Technology Development, North Carolina Biotechnology Center
Panelists:
- Jeff Clark, Managing Partner, The Aurora Funds, Inc.
- Lou Anne Flanders-Stec, Fund Executive, Piedmont Angel Network (PAN)
- Hans Houser, Vice President of Portfolio and Credit, Oxford Finance Corporation
- Sheila Mikhail, Chief Executive Officer, Asklepios Biopharmaceutical, Inc.
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Noon - 12:55 p.m.
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Concurrent Panel Sessions
Developing Personalized Medicines: The Impact of Genomic Data on Regulatory Submissions
Imperial IV
The issuance of the FDAs final guidance on Pharmacogenomic Data Submissions is a landmark event for both the pharmaceutical and pharmacogenomics industries. For the first time, the FDA has clearly stated that pharmacogenomic traits with proven scientific evidence, “valid biomarkers,” should be included in regulatory drug submissions.
Pharmaceutical companies have been exploring the use of genetics to look at known mutations that predict a patient’s response to drug treatment for more than 12 years now. Now the FDA has codified this approach by stating in writing that “…some pharmacogenetic tests — primarily those related to drug metabolism — have well-accepted mechanistic and clinical significance and are currently being integrated into drug development decision making and clinical practice.”
The next set of questions that comes from the FDA’s guidance are “what affect will this have on pharmaceutical companies currently using pharmacogenomics in drug development?” Further, “how will pharmaceutical companies now approach the implementation of pharmacogenomics in clinical trials knowing that certain data will be expected to be a part of Investigational New Drug (IND) or New Drug Application (NDA) submissions?”
Moderator:
- Paul W. Allen, VP, Managing Partner Life Sciences, Clarkston Consulting
Panelists:
- Federico Goodsaid, Ph.D., Senior Staff Scientist, Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, Food and Drug Administration (FDA)
- Michael P. Murphy, M.Sc., President & CEO, Gentris Corporation
- Laura Reid, Ph.D., Director, Research and Development, Expression Analysis
Where Technologies Converge: Examples from the Life Sciences Industry
Imperial V
This panel will present and discuss life science-based ideas in which the tools of biotechnology are being integrated with such areas as materials science, information technology, optics, nanotechnology and robotics to generate new and better products for healthcare. Examples include products for diagnostics, drug delivery, biodefense, medical devices, tissue engineering and drug development. The next big breakthrough ideas in healthcare will come from opportunities at these boundaries and these areas of convergence represent fertile opportunities for life science investors.
The panel will address three main components: optical coherence tomography and the convergence of photonics and biology for biomedical imaging, bioassays on nanodroplet-based platforms and stem cells, gene transfer and tissue engineering and why they are applications to novel therapeutics.
Moderator:
- Richard Kouri, Ph.D., President, CEO and Co-Founder, Nanolytics, Inc.
Panelists:
- George Christ, Ph.D., Professor of Regenerative Medicine, Urology and Physiology & Pharmacology; Head of the Cell, Tissue & Organ Physiology Program, Wake Forest University Baptist Medical Center
- Joseph Izatt, Ph.D., Associate Professor, Biomedical Engineering Department, Duke University
The Challenges of Later Stage Financing in 2005
Imperial VI-VII
To go or not to go; that is the question. The biotech IPO market remains a challenging scenario, with many IPOs representing a down round from the last private financing. Companies must weigh the benefits of gaining access to the public markets and increased capital options against the appetite for a down round, reduced IPO proceeds and the substantial burdens of public reporting and compliance.
CEO’s of two North Carolina companies that took different paths—one to IPO and one to wait and withdraw registration—will speak about their company’s choices. Leading life science investment bankers will present the broader picture with overviews on the state of the public and private capital markets for late stage life science companies.
Moderator:
- Deborah Hylton, Partner, Womble Carlyle Sandridge & Rice PLLC
Panelists:
- Charles Baltic, Managing Director, Healthcare Investment Banking, Wachovia Securities
- Donald deBethizy, Ph.D., President and CEO, Targacept, Inc.
- Lee Stettner, Managing Director, Head of Healthcare Investment Banking, Deutsche Bank
- Kay Wagoner Ph.D., Co-Founder and Chief Executive Officer, Icagen, Inc.
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