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Keynote Presentations
Dr. Corey Goodman
Academia, Biotech, and Pharma:
Navigating the Interface to Build a New Model for Drug Discovery and Development
 Discoveries from biomedical research have reached heights that we only dreamed about a decade ago. The potential for making breakthrough medicines to help solve major unmet medical needs has never been so high.
If the tools and technologies and targets for drug discovery are greater than ever, then why are there so few new drugs? Why have the costs for developing new medicines gone up so dramatically? Why are so many drug candidates failing in the clinic? What if anything can be done about it? One answer is that we need new models for drug discovery and development that build bridges from academia to biotech to pharma, harnessing the best from all three worlds. In this talk, we will consider what is broken, and how to fix it. How do we translate discoveries from biomedical research into drug candidates and into the clinic? How do we transform R&D in pharma from large monolithic sites to smaller, nimble units that drive innovation? Can biotech units exist in pharma? And with the capital markets broken, what is the future model and role for the biotech industry going forward? We need all three legs of the stool – academia, biotech, and pharma – working together in new collaborative models if we are going to deliver on the promise of bringing important new medicines forward for human health.
Dr. Michael Hayden
From Genetic Disorders in a Few to Drugs for Many
 Despite increases in investment, there has been no parallel greater success in bringing new drugs into clinical practice. In fact there have been many failures late in drug development due to less efficacy than needed. In part, this is influenced by inadequate validation of targets selected for drug development.
A required feature of validation is the demonstration in humans that the activity against a certain target is likely to have the desired effects. Mutation is human genes with a phenotype of interest often can provide in vivo validation it insure that interrogation of a particular target will lead to the desired effects. Even though these mutations might be rare, the findings are relevant for drug development for common conditions. These include current approaches to drug discovery for treatment of lipid disorders, cancer, osteoporosis, anemia, obesity, diabetes and pain. The careful phenotyping of the exceptional patient together with identification of the gene involved represents crucial first steps to validation of targets for drug development for many common disorders.
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Panel Presentations:
 Dr. Alan Bernstein - HIV / AIDS: The Global Challenge of Our Time
More than 33 million women, men and children around the world have been infected with HIV, with approximately 7,000 people newly infected every day. Multiple treatment options have helped slow the progression of the disease, however treatments have not yet resulted in a cure. Ultimately, a comprehensive prevention program, including a safe and effective HIV vaccine is the best way to stop the HIV virus. A coordinated global effort is urgently needed to: (1) address the unmet scientific needs in HIV vaccine research and development (R&D); (2) mobilize new investments and facilitate the prioritization of funding and resource commitments to HIV vaccine R&D; and (3) stimulate and incentivize public-private partnerships to discover, develop, and manufacture an AIDS vaccine. The Global HIV Vaccine Enterprise (Enterprise) is a unique, collaborative, and independent global alliance that convenes key stakeholders, catalyzes fresh thinking, supports new approaches and promotes collaboration in the quest to develop a safe and effective HIV vaccine. Enterprise stakeholders agree on shared research priorities through a scientific strategic plan and promote coordination, collaboration, and transparency between researchers, funders, industry, advocates, governments and non-governmental organizations worldwide. Innovation and early stage product development often takes place in academic labs and biotechnology companies while larger biopharmaceutical companies participate in translational R&D via academic/government-industry partnerships. New incentives, financing, and public policy mechanisms are vital to expanding the AIDS vaccine pipeline and to facilitating the translation of innovative ideas into AIDS vaccines. Dr. Bernstein will discuss the Enterprise model and its approach to harnessing science to drive vaccine development.
 Susan M. Smith - The Courage to Win
Canada has made strong progress in positioning itself as a potential leader in biotech and medical research and in its commercialization efforts. In the last fifteen years we have transformed our landscape. The culture in academe has shifted so that commercialization is seen as one of the desirable outcomes of our investment in research: in the world of finance the potential of biomedical innovation has been recognized and there are some domestic and international sources of expert financing; governments have introduced a number of supportive policy initiatives to help move us to a more knowledge based economy. We are still struggling to develop the processes and dynamics needed to be one of the leading nations, and our position vis a vis competitor nations is tenuous. Nevertheless we were in the running. Were. At this critical juncture we face two clear threats. The global financial calamity together with the lack of clear federal government support is placing our collective efforts at risk .We will lose our best researchers and funding will dry up. Do we have the energy, drive and courage to see our struggle to a successful endpoint? Do we have a new generation of leaders who will work to ensure public policy represents and supports informed public opinion?
 Professor E. Richard Gold - Vaccines: Intellectual Property
Developing new vaccines, particularly those aimed at meeting health needs in developing countries, will require new attitudes and deployment of patent and data protection rights. This presentation will discuss challenges to current models of using patents and promising ways to overcome them.
 Moderated Discussion
Panel Moderator: Mark Lievonen
Participants: Dr. Corey Goodman, Dr. Michael Hayden, Dr. Alan Bernstein, Susan M. Smith, and Professor E. Richard Gold.
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