Tuesday, June 23, 2009 - Day Two
8:00 am Chairperson’s Remarks
8:05 Round-Table Reports
8:45 The Innovative Medicines Initiative: Driving a New Paradigm in Pre-Competitive Research
Jackie Hunter, Ph.D., Senior Vice President, Science Environment Development, GlaxoSmithKline
The Innovative Medicines Initiative (IMI) represents a radical, new way of addressing the challenges of drug discovery and development within a European context and is partnership between the European Commission and the pharmaceutical companies that are members of EFPIA. The IMI is funded under the Framework 7 programme and is currently the largest public private-partnership (PPP) in life sciences in the world. It is unique in many aspects including the breadth of scientific areas covered, the degree of industry participation (26 EFPIA companies) and its management and finance structure. IMI represents the first PPP where industry has the ability to prioritize the projects that will be supported, ensuring that the research conducted remains focused on the delivery of quality medicines to patients. Some of the challenges and successes in the implementation of IMI and GSK’s participation will be outlined.
9:15 Successes and Renewal of the Dundee Signaling Consortium
Malcolm M. Skingle, Ph.D., Director, European Academic Liaison, Genetic & Discovery Alliances, GlaxoSmithKline
Consortium projects are particularly appropriate when they involve big scientific challenges or specialist facilities but also when there is a large amount of basic biology to be undertaken in a new or emerging field. Professor Sir Philip Cohen has assembled a team of world experts in kinase signaling at the University of Dundee Division of Signal Transduction Therapy who are both leading edge and industry friendly. More than a decade ago he set up a pioneering model for collaboration involving the Medical Research Council (the funder of the initial research and facilities) and six major global pharmaceutical companies. The model has been so successful that the consortium agreement, which has been extended twice, is currently due to run until 2012 and is considered by most to be a model of best practice. The talk will outline the value this unique collaboration brings to industry.
9:45 Where No One Has Gone Before – A Collaborative Model to De-risk Discovery and Development of First-in-Class Therapies (How Non-Profits can use their Mission to be a Unique Convener of Pre-Competitive Collaborations)
Russell “Rusty” Bromley, Chief Operating Officer, Myelin Repair Foundation
The Myelin Repair Foundation has gained extensive experience in the development and proof-of-concept of their pioneering Accelerated Research CollaborationTM model. A variety of best practices will be presented, including: using a start-up business model to manage academic resources for proof-of-concept in a new therapeutic area; aligning incentives and rewards with an organizational mission and desired results to gain and sustain commitment; managing consortia-generated IP; and engaging industry to facilitate commercialization.
10:15 Enlight Biosciences and Related Examples: Pre-competitive Collaboration to Ensure Development and Acceptance of Critical New Technology
Erik Kuja, Strategic Alliances, Pfizer Worldwide Business Development
Catherine Oyler, Senior Director, Emerging Technologies, Corporate Office of Science and Technology, Johnson & Johnson
The development of new technology platforms represents an ongoing need for advancing biomedical research despite the difficulty technology companies have in obtaining financial support from the venture community. In an effort to address this issue, several large pharmas are now collaborating with Enlight Biosciences to evaluate, provide end-user feedback and beta-test new technology. Representatives from two pharma partners will discuss how the Enlight Biosciences program works, key issues associated with this approach, and how this partnership differs from other platform technology investments.
10:55 Networking Coffee Break
11:30 The Serious Adverse Event Consortium, Ltd.
[SAEC] — Formation and Current Status of an International Effort to Understand the Genetic Basis of Drug Related Serious Adverse Events
Arthur Holden, Chairman and Chief Executive Officer, Serious Adverse Events Consortium; Former Chairman and Chief Executive Officer, Pharmaceutical Biomedical Research Consortium Ltd.; Former Chairman, The SNP Consortium
The SAEC, a nonprofit comprised of leading international pharmaceutical companies and academic institutions, with scientific and strategic input from the U.S. FDA, has been formed to identify and validate DNA-variants useful in predicting the risk of drug induced serious adverse events [SAEs]. The origins and current status of this novel research initiative, its current research methods, results to date and potential new solutions for more efficient and effective SAE research will be provided. The SAEC’s initial studies will focus on identifying genetic markers associated with drug-related liver toxicity [DILI] and serious skin rash [SSR]. The SAEC will collect SAE samples and data from the participating pharmaceutical companies and academic institutions. These well-characterized cases will be compared with control cases to identify genetic variants that may be associated with these SAEs. The identification of these genetic variations is believed to be essential to develop safer drugs while also identifying patient populations at risk. The SAEC is also exploring partnerships with international private and government institutions to better conduct their research.
12:00 pm The Drug Safety Executive Council (DSEC) Efforts in Collaborative Drug Safety Evaluation
Ernie Bush, Ph.D., Vice President and Scientific Director, Preclinical Safety, Cambridge Healthtech Associates
In order to improve R&D effectiveness in the pharma industry, perhaps one of the most powerful tools available today is collaboration. CHA has been conducting collaborative technology evaluations since 2004, particularly focusing on the preclinical safety space. In total, 7 full projects and many smaller projects have been conducted, bringing together experts from 4 to 10 pharma companies per project to explore in-depth the quality, effectiveness and practicality of new technologies/paradigms for doing safety evaluation. This 5 year experience has resulted in a significant body of knowledge regarding how the pharma industry views these efforts and what are their major motivations/inhibitions. In addition, there have been surprises along the way, including unexpected benefits and opposition from unforeseen parties. The highlights of what has worked, what has not worked and ways to help convince individuals that, in fact, this is an advantage to themselves and their employers, will be presented.
12:30pm Luncheon Presentation
Health Commons: An e-Business Approach to Collaborative Therapy Development
Jay “Marty” Tenenbaum, Ph.D., Chairman and Chief Scientist, CollabRx, Inc.
Competitive models of drug discovery and development are broken -- not just failing to discover new blockbuster drugs, but failing to contribute meaningful research that can be leveraged to develop more personalized, molecularly targeted therapies. Conventional consortia, while useful, are themselves silos, limited in their ability to broadly share findings and infrastructure, and thus to impact commercial drug development. What’s needed is nothing less than reworking the entire business model for therapy development – processes, economics and culture -- into a thoroughly collaborative model that exploits the spectacular breakthroughs in genomics and information technology to slash the time, costs and risks of therapy development. Health Commons is doing just that, through an ecosystem of knowledge and research services that can be rapidly assembled to develop therapies for patients with serious unmet medical needs. Health Commons aims to create the same radical increase in efficiency for therapy development that commerce saw in the 1990s.
2:10 Chairperson’s Remarks
2:15 HESI’s Experience in Collaborative Approaches to Science
Syril D. Pettit, M.E.M., Associate Director, Scientific Outreach, ILSI Health and Environmental Sciences Institute (HESI)
Since 1989, the ILSI Health and Environmental Sciences Institute (HESI) has provided a forum for industry, academic, non-profit, and government scientists to collaborate on toxicological and safety evaluation issues relating to chemical and pharmaceutical safety. This presentation will highlight the benefits and challenges of this collaborative approach, as well as present some case examples of the scientific outcomes this paradigm has generated.
2:45 The Biomarkers Consortium
David Wholley, Director, The Biomarkers Consortium, Foundation for the National Institutes of Health
Data contribution and sharing, intellectual property, dissemination of results, and associated governance issues are the key drivers in building and managing any effective biomedical research collaboration, but present particular challenges in the context of public-private partnerships. This presentation will explore some of the innovative ways these challenges have been addressed in the context of The Biomarkers Consortium: a unique, first-of-its-kind public-private partnership involving the NIH, the FDA, the biopharmaceutical industry, and a wide assortment of patient advocacy and research organizations, managed by the Foundation for the National Insitutes of Health (FNIH), that is dedicated to developing and qualifying biological markers (biomarkers) to speed the development of medicines and therapies for detection, prevention, diagnosis, and treatment of disease and to improve patient care. With 60 members, the involvement of hundreds of scientists from all sectors of biomedicine, and active development and management of projects underway in multiple disease areas, the Consortium is constantly faced with the issue of how to use the resources of its many stakeholders in ways that balance its core mission of providing public health benefit ensuring both adequate incentives to commercialize biomarker technologies and compliance with relevant requirements of federal law. Specific case examples that illustrate both the successes and the lessons learned from managing these challenges over the last two years of the Consortium’s operation will be discussed.
3:15 The Predictive Safety Testing Consortium: Advancing Translational Toxicology through Inter-disciplinary and Inter-organizational Collaboration
Elizabeth Walker, Ph.D., Assistant Director, Toxicology, Predictive Safety Testing Consortium, The Critical Path Institute
Existing safety biomarkers typically used in a regulated drug development setting have amassed a useful, but arguably unscrutinized and ponderous body of evidence that has allowed the delay of putting more sensitive and specific biomarkers into routine application. The Predictive Safety Testing Consortium (PSTC), a public-private partnership led by The Critical Path Institute, was formed in 2006 with the dedicated mission of identifying and cross-qualifying new safety testing methods under advisement from the FDA and EMEA. PSTC’s efforts thus also facilitate the development of new regulatory processes for approving and applying such methods. In three years, the PSTC has grown from 80 to over 220 industry scientists representing 16 global pharmaceutical companies; scientists from the FDA, EMEA and academia also participate as crucial advisors. A critical and candid analysis of the consortium’s successes and challenges will be presented.
3:45 The Future of Pre-Competitive Consortia – A Best Practices Panel Discussion
Discussion Leader:
William Mattes, Ph.D., Director, Toxicology, The Critical Path Institute
Panelists:
Jay “Marty” Tenenbaum, Ph.D., Chairman and Chief Scientist, CollabRx, Inc.
Arthur Holden, Chairman and Chief Executive Officer, Serious Adverse Events Consortium
Martin Leach, Ph.D., Executive Director, Basic Research & Biomarker IT, Merck & Co., Inc.
Jackie Hunter, Ph.D., Senior Vice President, Science Environment Development, GlaxoSmithKline
This wrap-up panel discussion will examine key issues and future directions for pre-competitive consortia in drug discovery and development, including:
Where the greatest opportunities for high-impact collaborations lie
Future drivers and trends in pre-competitive collaborative consortia
Greatest obstacles to the development and impact of pre-competitive collaborative consortia and how to overcome them
The role of the Critical Path Institute and other government bodies
5:00 Close of Conference