The Business Workshops are designed to provide professional guidance to emerging companies and faculty entrepreneurs looking to launch, build and fund a life sciences company.

These sessions will identify and explore the critical issues and challenges unique to this industry and vital to value creation for an emerging company whose objective is to develop and extend new therapies for the treatment of human disease.

Wednesday, Nov 16 – 11:15-12:10 pm:

Workshop 1: Beyond VCs and Wall Street: The role of government agencies and foundation as fuel to the Life Science R&D engine

Today the financial world supporting life science research and development efforts is at a standstill. On the one hand the VC model has proven incapable of supporting the needs of the market and industry alone and on the other big pharma's and the public market as well as angel investor have not proven themselves capable of stepping in and covering the gap. To many this is spelled "Valley of Death". Non-diluting funding represent a possible alternative and a definite complementary source of funding aimed at supporting R&D and possibly could assist the industry to lay a bridge over the valley.

Moderator:

• Ram May-Ron, Managing Partner, FreeMind Group

Panelists:

• Jonathan J. Fleming, Managing General Partner, Oxford Bioscience Partners
• Sharon E. Semones, Portfolio Consultant, Global External Research and Development, Eli Lilly
• Lance Stewart PhD, Chief Executive Officer, Emerald BioStructures
• Michael G Kurilla, MD-PhD, Director, Office of BioDefense Research Affairs
  Associate Director for BioDefense Product Development, DMID, NIAID, NIH, DHHS
• Barry Wolitzky, PhD, Executive Director of Strategic Partnering, Immune Tolerance Network

Wednesday, Nov 16 – 1:15-2:10 pm:

Workshop 2: Reimbursement: Why Is It Important To Think About Getting Paid Early?

This workshop will address the health care payment environment and why management of emerging companies should think about reimbursement even at the earliest stages of development. A thoughtful plan to address this critical issue will position an emerging company attract investors as well as partners.

Moderator:

• Anna D. Kraus, Of Counsel, Covington & Burling LLP

Panelists:

• Les Funtleyder, Health Care Strategist & Portfolio Manager, Miller Tabak Health Care Transformation Fund, Miller Tabak + Co., LLC
• Kent Rogers, MBA, Vice President, Managed Markets, Acorda Therapeutics
• Lambert van der Walde, Founder, van der Walde & Co.

Wednesday, Nov 16 –2:15-3:10 pm:

Workshop 3: Financing Mechanisms for Emerging Companies: Venture Capital, Debt Financing, Angel Investments, Royalty Monetizations, and Other Alternative Financing Structures.

This panel will discuss practical tools and mechanisms for financing an academic start-up company. While the environment is difficult, there are many financing alternatives to support emerging companies. Emerging companies should assess a number of options to raise capital to best match their financing needs.

Moderator:

• Luke C. Düster, Principal, Capital Royalty L.P.

Panelists:

• Louis Berneman , Founding Partner, Osage University Partners
• Michael J. Hanewich, Head of Life Sciences East, Life Science Venture Capital, Silicon Valley Bank
• Kristen C. Kosofsky, Managing Director, Horizon Technology Finance
• Barry Myers, MD,PhD,MBA, Executive-in-Residence, Pappas Ventures
• Evonne Sepsis, Managing Director, ECS Advisors

Wednesday, Nov 16 - 3:15-4:10 pm:

Workshop 4: Seeking Early Proof of Relevance for Partnering or Funding

In order to attract partners and investors, management of emerging biotech companies have 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. Ed Saltzman 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.

Presenter:

• Ed Saltzman, President, Defined Health

Thursday, Nov 17 – 11:15-12:10 pm:

Workshop 5: Technology Transfer: Evolving to meet the needs of multiple stakeholders

The practice of technology transfer, in particular with regard to drug development, is evolving to meet the needs of numerous stakeholders. Academic institutions that rely on the income stream to replace declining grant revenue; patients waiting for therapies; biopharmaceutical companies seeking to enhance pipelines; investors looking for new opportunities; and, researchers with discoveries that have the potential to help patients. By necessity, the practice of technology transfer has to evolve to meet the needs of all stakeholders. This panel will discuss the future of moving academic discoveries into the hands of drug developers and considerations for all stakeholders.

Moderator:

• Barbara Sawitsky, Barbara A. Sawitsky, MBA CLP, , Director of Patents & Licensing & Business Development for The New York Blood Center and the Lindsley F. Kimball Research Institute (LFKRI)

Panelists:

• Kathleen A. Denis, PhD CLP, Associate Vice President, Office of Technology Transfer, The Rockefeller University
• E. Jonathan Soderstrom, PhD, Managing Director, Office of Cooperative Research, Yale University
• Gunther Winkler, PhD, Board of Trustees, Beth Israel Deaconess Medical Center and member of the Research Oversight Committee

Thursday, Nov 17 – 1:15-2:10 pm:

Workshop 6: Drug Development Basics: It is a very multidisciplinary effort

Taking an asset from early discovery through to commercial development is a very complicated process, requiring many steps that satisfy not only regulatory requirements but commercial reality. A thorough understanding of this process will help entrepreneurial investigators and emerging management teams attract development partners and funding. This panel will provide top-line guidance on the issues and considerations.

Moderator:

• Jules T. Mitchel, President, Target Health Inc.

Panelists:

• Afia K. Asamoah, Senior Associate, former Special Assistant to the Principal Deputy Commissioner, FDA, Covington & Burling LLP
• Braham Shroot, PhD, Chief Executive Officer, Argyle Therapeutics Inc.
• Barbara S. Slusher, PhD, MBA, Chief Scientific Officer, Brain Science Institute, NeuroTranslational Program, Johns Hopkins School of Medicine
• Donny Strosberg, PhD, Professor, The Scripps Research Institute-Florida
• Charles P. Theuer, MD, PhD, President & CEO, Tracon Pharma

Thursday, Nov 17 – 2:15-3:10 pm:

Workshop 7: Intellectual Property: Rethinking value, rethinking the way it’s been done, changing the paradigm

There is pressure on established and emerging industry and academia to find new and more efficient ways to collaborate to benefit from the advancement and commercialization therapeutics. It is understood that solid IP protection is a must to attract any investor or collaborator while valuation is often an issue that interferes with efficient translation. This panel will discuss the issues of IP as they relate to academic-industry collaboration and the transitions in thinking about it and its value that are emerging on both sides of the deal.

Moderator:

• Anthony Giaccio, Partner, Kenyon & Kenyon LLP

Panelists:

• Richard A. Basile, Chief Executive Officer and Principal, BioPontis Alliance LLC
• Eric Cottington, PhD, Vice President for Research and Technology Management, Memorial Sloan-Kettering Cancer Center
• Thomas Gallagher, Chief Patent Counsel, Kadmon Corporation, LLC
• Charles Ryan, PhD, JD, Sr. Vice President & Chief Intellectual Property Counsel, Forest Laboratories, Inc.

Thursday, Nov 17 – 3:15-4:10 pm:

Workshop 8: Working with the Biopharmaceutical Industry: They want to work with you

Arguably, the best organizations to collaborate with to advance the development of a novel therapeutic are those organizations that have done it many times before - the pharmaceutical companies. However, approaching a pharma can appear daunting to a CEO of an emerging company. This panel will elucidate the ins and outs of approaching a pharma including understanding their strategy and how you can demonstrate that you fit that strategy and expectations on both sides.

Moderator:

• James Foley, PhD, Managing Director, Aqua Partners LLC

Panelists:

• Katherine E. Breedis, CFA, CMT, Senior Director, Global External Research & Development, Eli Lilly & Company
• Susan Rohrer, PhD, Senior Director, External Scientific Affairs, Merck & Co., Inc.
• Christopher Yochim, Director, Strategic Planning & Business Development, AstraZeneca
• Robert A. Zivin, PhD, Senior Director, Corporate Office of Science & Technology, Johnson & Johnson