Meeting Agenda

Monday, June 15

7:30 a.m. - 5:00 p.m.

Registration

8:30 - 10:00 a.m.

Workshops, Session 1

1A

Partnering with Emerging Economy Firms for Global Health

Moderator:

Meryle Melnicoff, Ph.D., The Wistar Institute

Speakers:

Beatriz Rodríguez, Procter & Gamble de Venezuela
Stephen M. Sammut, M.B.A., Wharton Entrepreneurial Programs

Emerging economies in Asia and Central and South America have made major progress toward establishing research and innovation-based life sciences sectors. Local health needs, including diseases that predominantly affect the poor, have driven much of this success. What are the opportunities and pitfalls awaiting institutions seeking partnerships with companies located in these regions? This session will bring together business experts and licensing professionals to share their experiences in establishing and maintaining relationships with life science companies in emerging economies.

1B    

You Can't Patent That! Can You?

Moderator:

Warren D. Woessner, Ph.D., J.D., Schwegman Lundberg Woessner & Kluth PA

Speakers:

Kathryn R. Doyle, Ph.D., J.D., Drinker Biddle & Reath LLP
Stephen J. Weed, J.D., RatnerPrestia

The patent statutes may be broadly drafted when it comes to "patentable subject matter" but both the Federal Circuit and the Patent Office have made it much more difficult to obtain patent protection for certain types of inventions, including business methods, methods of medical treatment, genes and diagnostic assays. It is likely the United States Supreme Court will weigh-in on a number of these areas in the near future. A panel of experts, including in-house pharma counsel and leading practitioners in the electronic/computer law and biotechnology IP arenas will summarize the trends and most recent landmarks - cases, regulations and proposed legislation - in this rapidly evolving area.

10:00 - 10:30 a.m.

Networking Break

10:30 a.m. - Noon

Workshops, Session 2

2A

Increasing Developing Countries' Local and International Investments in Innovative Technologies

Moderators:

Clare Fairfield, Concerto Ventures
Juan E. Figueroa, National Science Foundation

Speakers:

David C. Bonner, Ph.D., P.E., Stematix, Inc.
Jose Melendez, Ph.D., Spectral MD, Inc.
Maribelis Ruiz, Ph.D., Advent Morro Equity Partners
Elmer Roman, United States Embassy, Santiago, Chile
Chris Stahl, G4i Consulting
Tony Stanco, National Council of Entrepreneurial Tech Transfer

Income is not usually invested locally for most developing countries because the returns on such investments are significantly less and entail more risk than investing in more well-established, structured and regulated environments such as in the United States and Europe. The flight of capital from these countries does not help stimulate the creation of high paying jobs that could, in turn, generate a strong tax base to support infrastructure improvements to spur further innovations that could raise the local standard of living. What can these governments do to create an investment climate and culture that will be conducive to raising living standards in the developing world? What is the role of universities and university researchers in this process? What major paradigm shifts should occur or what new paradigms should be created?

2B

Global Patent Protection: Why You Need It and How to Get It

Moderator:

Kathryn R. Doyle, Ph.D., J.D., Drinker Biddle & Reath LLP

Speakers:

Kathleen D. Rigaut, Ph.D., J.D., Dann Dorfman Herrell & Skillman PC
Stephen M. Sammut, M.B.A., Wharton Entrepreneurial Programs

It has been 15 years since the adoption of the TRIPS Agreement. Global protection is not what it once was, particularly in certain innovative emerging market countries that are in the process of building the administrative structure for an effective patent system, such as China and India. True worldwide patent protection is even more important from a licensee’s perspective than ever before. This session will challenge the audience to think through the consequences of offering limited geographic rights and how these limited rights diminish the value of the license, how a corporation or venture capitalist reassesses value, how the development plan of the potential Licensee is affected and why and how a U.S.-only filing in the first instance might ultimately become a bar to follow-on patents in other jurisdictions. The session will also propose basic frameworks for foreign filing decisions, including whether or not there is a “later fix†for an initial U.S.-only strategy. In addition, learn more about approaches to funding initial foreign filing decisions, including valuation arguments to support higher fees and royalties, new avenues for expediting foreign prosecution, and creative approaches to cost sharing.

Noon - 1:30 p.m.

Lunch and Plenary Session
Ensuring Access to Innovative Products in the United States and Around the World
Speaker:                  Michael J. Werner, Holland & Knight
If you haven't heard what is making news inside the beltway these days on health care policy and global healthcare access, then you don't want to miss this plenary session. What policy and practical implications occur when a major pharmaceutical company  proposes that drug companies create a patent pool to support the development of therapeutics for neglected tropical diseases in least developed countries?* What about when a pharmaceutical company commits to cutting prices of patented drugs in developing nations to just 25% of prices charged in the developed world, while pledging to re-invest a portion of the profits from such sales to strengthen healthcare infrastructure in host countries?

How might these policy proposals influence health reform debates in Washington? Hear a truly enlightened view from one of Washington D.C.'s most informed sources, Michael Werner... because inquiring minds need to know!

Michael Werner has survived and flourished inside the beltway for almost 25 years. He specializes in issues affecting biotech and pharmaceutical companies, researchers and institutions, physicians, and patients. His expertise includes FDA drug/biologic regulations; FDA and NIH oversight of clinical trials; approval and marketing of orphan drugs; stem cell research and regulation of cell therapy and regenerative medicine products; as well as bioethics issues.
Before joining Holland & Knight, he was President of The Werner Group, which provided consulting services. Michael  was Chief of Policy for the Biotechnology Industry Organization (BIO). He is the author of more than 40 published articles and is a frequent media commentator appearing in The Wall Street Journal, The Washington Post, BIOWorld, Congressional Quarterly and The Baltimore Sun, as well as on many TV and radio news programs.

*As reported by BioCentury, Glaxo SmithKline CEO Andrew Witty in a speech given Feb. 13 at Harvard University

1:30 - 3:00 p.m.

Workshops, Session 3

3A

University Spin-outs and the Global Economic Crisis

Moderator:

Shalom Leaf, Law Offices of Shalom Leaf

Speaker:

Viviane Martin, Ph.D., Memorial Sloan-Kettering Cancer Center

Our panel of experts will examine emerging business and legal developments in the university spin-outs market in the wake of the global economic crisis. This diverse panel offers a rare opportunity to learn more about the crisis through the unique perspectives of the technology transfer office, the investor and the spin-out company, with an emphasis on trends in international practices and cross-border activity.

3B

The RCMI Translational Research Network as a Model for Global Health: Community at the Heart of Innovative Research and Technology Transfer

Moderators:

Tanaga Boozer, J.D., M.B.A., Florida A & M University

Speakers:

Donna Antoine-LaVigne, Jackson State University, Ph.D., M.P.H., M.S.Ed.
Zöe H. Hammatt, M.Phil., J.D.,John A. Burns School of Medicine, University of Hawaii
Stephen Olufemi Sodeke, Ph.D., M.A., Tuskegee University National Center for Bioethics in Research and Health Care
Daniel Sarpong, Ph.D., Jackson State University

The RCMI Translational Research Network (RTRN), funded by the National Institutes of Health, offers a community-based research model that could apply in the globalization of technology transfer. As a network dedicated to overcoming health disparities in minority populations across the country, RTRN faces challenges that also arise in the context of global health and technology transfer. These include conflicting legal and regulatory requirements, cultural, social and economic, institutional and geographic barriers, and the need for trust and equitable exchange in collaborative partnerships. RTRN engages the community at every phase of research, from design through implementation, ensuring community members are stakeholders in the process and derive tangible, meaningful benefit from their participation. This presentation will offer innovative approaches to enhancing global technology transfer by illustrating examples of community participation in research along with product development and commercialization. Members of the interdisciplinary RTRN Ethics and Regulatory Subcommittee will serve on the panel.

3:00 - 3:30 p.m.

Networking Break

3:30 - 5:00 p.m.

Workshops, Session 4

4A

Accelerating Transfer of Innovations to Big Pharma: How Best for Academia /Government/Biotech to Present Licensing Opportunities to Potential Industrial Partners

Moderator:

Alan Naidoff, J.D., Merck & Co., Inc.

Speakers:

Imma Barrera, Ph.D., Roche
Donnie W. Owens, Sr., Pfizer, Inc.
Christopher Yochim, AstraZeneca

During this interactive discussion, panelists will share processes for reviewing unsolicited technology disclosures and suggestions for how to improve the industrial and academic interface. Topics include the proper contents of a technology disclosure, how to identify potential partners, how to send the information, and what is required in a response, particularly a decline.

4B

Technology Serving Humanity

Moderator

Juan E. Figueroa, National Science Foundation

Speakers:

David C. Bonner, Ph.D., P.E., Stematix, Inc.
Joxel García, M.D., M.B.A., Ponce School of Medicine
Steven N. Treistman, Ph.D., University of Puerto Rico
Chris Velisaris, GloCal Network Corporation
M. Guven Yalcintas, Ph.D., M.B.A., The Research Foundation of SUNY

A technology and services gap exists between industrialized nations and developing countries. High and quick returns on investments drive the funding of technology companies. How the fact that these technology developments serve humanity is seldom taken into consideration when justifying such investments. It is rare to have this criteria invoked as part of the technology funding decision process. This is especially true when the technology investment belongs to the high-risk, high-reward category. This panel will discuss, among other things, humanitarianism, the idea of conscious capitalism and social entrepreneurship in investing decision making, the makeup of general partners and the formation of the fund in these cases and how perhaps to improve the returns on investment.

5:00 - 7:30 p.m.

Networking Reception

Tuesday, June 16

7:30 - 8:30 a.m.

Continental Breakfast

7:30 a.m. - 5:00 p.m.

Registration

8:30 - 10:00 a.m.

Workshops, Session 5

5A

Bridging the Gap Between Research and Commercialization: How the National Institutes of Health Can Help

Moderator:

Lili M. Portilla, National Institutes of Health

Speakers:

Anna Z. Amar, National Institutes of Allergy and Infectious Diseases
Claire T. Driscoll, National Human Genome Research Institute and National Institutes of Health
Michael Weingarten, National Cancer Institute, Small Business Innovative Research Development Center

The National Institutes of Health (NIH) develops, funds and manages a wide range of valuable biomedical research repositories including extensive reagents, animal model, natural product, small molecule and cDNA collections. NIH preclinical and clinical resources include testing services and access to established clinical trial networks. These resources are, in general, available to researchers worldwide including those who work in the academic, non-profit and private sectors. Often the NIH may be able to provide funding and expertise as well as contribute low cost critical materials and technologies that might otherwise be unavailable or too costly for some laboratories. A panel of NIH officials from four of the NIH's 27 Institutes will describe how to access to these valuable resources. Specific topics to be covered will include: small business research funding opportunities (SBIR/STTR), NIH-developed technologies available and research resources.

5B

Fostering an International Translational System for Health Innovation

Moderator:

Bin Yan, Ph.D., LL.B.,
Wallace H. Coulter Center for Translational Research, University of Miami

Speakers:

Mark E. Coticchia, Case Western Reserve University
Royal Hinther, National Research Council Canada
Jonathan Rosen, Ph.D., Institute for Technology
Entrepreneurship and Commercialization, Boston University

International technology transfer is especially relevant for health innovation because health innovation advances most efficiently when knowledge is shared. Although international scientific cooperation fosters progress, such cooperation has been limited due to patent rights and trade issues. This workshop will present different models and programs on international technology transfer with the aim to explore and identify cooperative strategies where collaborative approaches foster translation of health innovation, reduce duplication, and enhance economic returns and social benefits.

10:00 - 10:30 a.m.

Networking Break

10:30 a.m. - Noon

Workshops, Session 6

6A

The Role of Development Finance Institutions (DFIs) in Technology Transfer and Commercialization

Moderator:

Stephen M. Sammut, M.B.A., Wharton Entrepreneurial Programs

Speakers:

Jane Muir, University of Florida
Gordon Myers, International Finance Corporation
Patricia Weeks, Weeks Consulting LLC

The flow of academic technologies between the emerging markets and the developed world is inadequate but can be substantially improved. The International Finance Corporation (IFC), the private sector investment arm of the World Bank, conducted a study revealing several roles that the IFC can play in accelerating international technology transfer. The measures proposed include capacity building, marketing consortia, seed financing programs and other entrepreneurial approaches that allow emerging markets to integrate into the global technology economy. This session describes the IFC's pilot program, presents ways that technology transfer offices, companies and other service providers might benefit, and solicits participants for their ideas on how multilateral development organizations can work with research institutions and the private sector to further technology transfer and development in emerging markets.

6B

How to Present Your Requests for Compounds to Large Pharma

Speakers:

Kimberly A. Lamb, Ph.D., Merck & Co., Inc.
Donnie W. Owens, Sr., Pfizer, Inc.

There are specific routes to take when requesting material from large pharma. Learn more about the primary methods of requests and how to submit your study to different pharma organizations. Find out how the request process varies depending on the development stage of the compound being requested, the collaborative nature of the study, whether funding is also requested and intellectual property restrictions.

Noon - 1:30 p.m.

Lunch

1:30 - 3:00 p.m.

Plenary Session
Science and Technology Opportunities in Puerto Rico

Moderator:

Emma Fernández-Repollet, University of Puerto Rico

Panel:

Sigfrido García, Pfizer
Cyril Meduña, Avent-Morro Partners
Javier Vazquez Morales, Puerto Rico Industrial Development Company
Antonio García Padilla, University of Puerto Rico
Luis Enrique Rodriguez-Rivera, Puerto Rico Trust for Science, Technology and Research

At the crossroads of innovation and globalization, partnerships among academia, government and industry are essential in pursuing practical application of research emanating from university inventions and sustaining industry competitiveness. In this panel, representatives from the academic, private and government sectors will provide an overview of the process for stimulating life sciences, technology and economic growth being developed in Puerto Rico. The discussion will be geared to inventors, entrepreneurs, researchers as well as anyone interested in technology-commercialization. Learn about the how the University of Puerto Rico played a role in the development of Puerto Rico in the times of the knowledge economy by reinforcing and expanding translational research capacities, through the creation of economic incentives to stimulate innovation, through strategies to accelerate technology transfer, and by engaging the public and the private sector in collaborative research and development efforts.

Wednesday, June 17

7:30 - 8:30 a.m.

Continental Breakfast

7:30 a.m. - Noon

Registration

8:30 - 10:00 a.m.

Workshops, Session 7

7A

How to Negotiate Contracts Outside Your Border

Moderator:

Viviane Martin, Ph.D., Memorial Sloan-Kettering Cancer Center

Speakers:

Labeeb M. Abboud, Esq., International AIDS Vaccine Initiative
Carlos Pérez De La Sierra, Calderón y De La Sierra y Cia. SC
D. Calab Gabriel, K&S Partners
Deborah Somerville, Esq., Kenyon & Kenyon LLP
Charles Weiss , Esq., Kenyon & Kenyon LLP

In 2005, Thomas Freidman, author of The World is Flat presented how and why we should consider the world flat. This was already true for transactions and technology development. Today, this seems truer than ever in a world without borders, yet with different rules and regulations governing technology transfer. What do you need to know to negotiate contracts with foreign counterparts? What can we learn about transactions for medical devices and other healthcare related fields? This roundtable will address common pitfalls and lessons learned during negotiations between universities, companies and foreign counterparts.

7B

Considerations in Making the Go/No-go Decision on Patent Filings: What is Patentable Where?

Speakers:

Matthew Catlett, Clinical Data, Inc.
Kevin M. Farrell, J.D., Pierce Atwood
Michael R. Friscia, J.D., McCarter & English LLP
David E. Huizenga, Ph.D., J.D., Arnall Golden Gregory LLP

Much attention has been given to the potential impact of the recent in re Bilski decision on business method patents. The potential impact on biotechnology processes has received less attention, but is of considerable importance. The decision has implications with respect to fields such as medical diagnostics and pharmacogenomics, which have long been viewed as patent-eligible technologies. The follow-on one paragraph decisions inClassen Immunotherapies v. Biogen found that the claimed biotechnological method failed to satisfy the machine or transformation test enunciated in re Bilski, even though the method recited an immunization step.

10:00 - 10:30 a.m.

Networking Break

10:30 a.m. - Noon

Workshops, Session 8

8A

How Open is Open Innovation: Dealing Between Countries and Cultures

Moderator:

Eugene Buff, Ph.D., M.D., yet2.com, Inc.

Speaker:

Nathan A. Young, NEOS Servicios de Gestion Tecnologica Ltda.

The open innovation workshop is becoming a popular venue at AUTM meetings, highlighting the changed dynamic of industry/university relationships under an open innovation model. This workshop will focus on international technology transfer and discuss how business and cultural differences affect this relationship. Representatives from several distinct regions, including North America, Europe, South America and Asia will share their experiences, hurdles and successes in moving technologies across the ocean. The focus will be on university perspectives of building international connections and reputation as a continuous source of innovation. A representative from industry will discuss the corporate view on international partners, universities and research institutions in particular.

8B

Bilski and Beyond: Protecting Software Around the Globe

Speakers:

Ryan A. Schneider, Troutman Sanders LLP
James Schutz, Troutman Sanders LLP   

The Bilski decision dealt a blow to the protection of software and business inventions in the United States, and the Supreme Court will soon examine this important decision. In the mean time, recent Patent Appeal Board decisions give insight into how to overcome Bilski rejections and secure protection over these inventions. Additionally, challenges to obtaining patent protection over software inventions extend far beyond our borders. This session will examine the challenges and strategies for obtaining protection in key markets around the globe.

Noon

Meeting Adjourns