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Collaborative Innovation in Biomedicine - Day 1


 

Main Conference Program

Monday, June 22, 2009 - Day One

7:30 am Registration and Morning Coffee


Morning Session

8:30 Conference Introduction

8:45 The Power of Collaborative Innovation and the Architecture of Trust

Robert Porter Lynch

The most impactful future breakthroughs in science and technology will be NOT WITHIN a single field of science, but BETWEEN fields. Innovation comes from differentials in thinking, at the edges of eco-spheres, making it essential to engage with thought-centers outside the normal internal team. Sharing intellectual property can become a massive impediment to joint development as legal strategies emphasize “Defend and Protect”, rather than “Proliferate and Regenerate”. Distrust can often be the highest barrier, especially in the absence of a clear methodology for creating and sustaining trust. A defined “Architecture for Collaborative Innovation”, a highly integrated and systematic approach using best practices, principles, and processes that emanate from best practices in strategic alliances, joint innovation, and trust building will be presented. This coverage will include ideas for measuring and rewarding performance and diagnosing problems to help insure ongoing success.

9:15 Defining Characteristics of Successful Models of Collaborative Innovation

William Mattes, Ph.D., Director, Toxicology, The Critical Path Institute

There is no “I” in team. Yet both in sports and in science the competitive individual is rewarded with money and prestige. Scientists are trained in competitive institutions, and are rarely exposed there to truly open collaboration. So a truly collaborative model requires addressing the competitive nature of both the individuals and the organizations. The scientific studies of collaboration and cooperation show that familiarity and trust are major factors that can underpin collaboration. We examine how incentives such as clearly shared “wins” and directly applicable know-how, reinforce collaboration. Legal agreements can play a vital role in addressing organizational concerns about knowledge sharing. However, collaborations are ultimately social endeavors where careful management of interests, resources, skills, personality, and leadership play a key role in stability and success. Criteria for evaluating the success of consortia will also be discussed.

9:45 Revising the Role of Intellectual Property - From Exclusivity to Partnership

Richard Gold, Ph.D., Professor and Director, Center for Intellectual Property Policy, McGill University

The financial crisis may represent the last nail in the coffin not the failed business models surrounding the use of intellectual property in the life sciences. These models, in which small biotech and universities obtained patent rights to attract financing, have not only never generated a profit for this 30 year old industry but will not bring in investment from dried up venture capital. While the passing of these Old IP business models will be mourned by a few, they will usher in a New IP era in which knowledge assets will be used not to exclude but to create partnerships and collaborations. This presentation will describe the change from Old IP to New IP, focusing in on the need to create platforms through which to facilitate knowledge exchange through either the market (knowledge markets), regional hubs or public-private partnerships.

10:15 Information Flows and IP Control in Pre-Competitive Collaborations

Mark Anthony Mersereau, Esq., PTC Intellectual Property Law, LLC

In this presentation, we will examine Innovation Partnerships as “an IP attorney’s nightmare”. We examine historical, “one way out mentality” models and attitudes based on “the need to protect our information and need for open access to your information” and contrast those to newer IP Management models focused on “the need to exploit mutual benefit to support a common good for parties in the collaboration”. We examine these models within the constraints of limited resources and unlimited needs and suggest ways of staying focused on critical objectives. We also look at how an organization shifts from a “Fort Knox” type model of control of early stage IP models to a “gated community” approach and how to create an understanding of where and when you need to protect vs. where and when you want to protect. Topics covered include:

  • Contract Negotiations Tactics to Avoid: “What’s mine is mine – What’s yours is mine too”, Breakdowns.
  • Creating a “Spoke and Hub” System for Information Dissemination and control.
  • Ownership, licensing, and Policing Rights of the Collaborative Results.
  • Understanding the End-Game and Knowing when to say “Stop”.

10:45 Networking Coffee Break

11:10 “Radical Collaboration” – How IBM Transformed the Semiconductor Industry through Pre-Competitive Collaborative Innovation – A Hi-Tech Industry Case Study

Bernard Meyerson, Ph.D., IBM Fellow and Vice President, Strategic Alliances and Chief Technology Officer, Systems and Technology Group, IBM

Semiconductor technology is no longer proceeding down the path of the past 40 years with the ability to benefit from further scaling alone having been lost. This discontinuity led segments of the industry over a “power cliff” many did not see coming, driving the need for dramatic strategic and organizational shifts. Forced to move to a strategy demanding continuous innovation as the alternative to ongoing scaling, the Semiconductor industry R&D expenditures grew at rates rendering prior business models and alignments financially unsustainable, similar in ways to the escalating costs and falling productivity pattern within pharmaceuticals. This chain of events led to a consolidation of competitors around global innovation networks engaged in pre-competitive alliances, and the emergence of a model based upon co-opetition. This talk explores the implications that these changes have for today’s pharmaceutical industry and on the increased use of alliances, consortia and open systems innovation as a means to deal with todays challenges.

11:45 How Collaborative Innovation Aids the Regulatory Process and Vice-Versa

Bruno Flamion, MD, Ph.D., Professor of Physiology and Pharmacology, University Of Namur, Belgium,and Chairman, Scientific Advice Working Party, The European Medicines Agency (EMEA)

Entrusting innovation in drug development to single companies has partly failed. Among possible remedies to this situation, several would benefit from sharing or comparing data collected by different stakeholders, for example appropriate preclinical models, translational medicine, new efficacy and safety biomarkers, innovative endpoints, modeling and simulation, or disease-drug models. Regulatory authorities have put up systems to discuss and assess collaborative data, such as the recent EMEA procedure on Qualification of Novel Methodologies that runs in parallel with the FDA. In addition, both the FDA and EMEA have been called to take part in larger public-private partnerships such as the Critical Path Initiative and Innovative Medicine Initiative (IMI). The current status of the IMI will be presented with a focus on regulators involvement and the possibility to include other stakeholders such as patients. Thoughts on how the regulatory authorities could feed back information to reduce attrition and improve selection of unmet medical needs for drug development, will also be discussed.

12:15 pm Lunch on Your Own


Afternoon Session

FACILITATING DATA SHARING

1:45 Chairperson’s Remarks

1:50 Keynote Address
Speeding Research and Development through a Collaborative Ecosystem

Ken Buetow, Ph.D., Associate Director for Bioinformatics and Information Technology and Director of Center for Biomedical Informatics and Information Technology, National Cancer Institute (NCI); Co-founder, caBIG™ and The BIG Health Consortium™

Today all research organizations – pharma/biotech or academic -- need to improve the speed, efficiency, and efficacy of their research efforts to increase their ROI. Traditional disconnected approaches are neither adequate nor feasible, and the next generation of therapeutics will come from implementing data-driven, collaborative, translational research programs that will lead to effective personalized medicine. Comprehensive, interoperable, scalable IT infrastructures that can address extensive data management issues are required for this type of translational research. This presentation examines the NCI’s prototype new biomedical “ecosystem”, called The BIG Health Consortium, that joins integrated healthcare providers, academic medical centers, medical schools, diagnostic laboratories, pharmaceutical product developers, personal genomics firms and biopharmaceutical companies and government programs. The “electronic glue” that holds this consortia together is the NCI’s caBIG® technology—a national scalable infrastructure that enables and integrates all personalized medicine functions from biobanking to molecular-based discovery to clinical research.

2:25 Taking a Pre-Competitive Approach to Defining Standards and Leveraging Best Practices to Enable Basic Research Collaboration

Martin Leach, Ph.D., Executive Director, Basic Research & Biomarker IT, Merck & Co., Inc.

Internal development and customization of research software applications and systems is not a sustainable business model for pharmaceutical companies. With the exception of key algorithms and heuristics, there is limited differentiation between the needs of systems to enable research. With this in mind, Merck has taken a step towards risk- and cost-sharing by participating in joint-pharma and software vendor applications, systems, and standards design and development. In this presentation, we will share lessons learned and discuss future avenues where we hope to explore pre-competitive collaboration in pharma systems and data standards.

2:55 Gaining Efficiencies through Open Innovation

Susie Stephens, Ph.D., Principal Research Scientist, Lilly Research Labs, Eli Lilly and Company

The effective use of information technology is imperative for the continued success of the pharmaceutical industry. Successful solutions must be developed and implemented for gaining scientific insight, capturing and sharing that knowledge, and enabling optimal decision making. However, this is challenging to achieve due to the large size and complexity of the domain, rapid advances in knowledge, an increasing need to share data with collaborators, and pressure to reduce cost. Individual companies need to be selective as to the projects that they embark on and the new technologies that they embrace, as it is not possible to do it all. Can the pharmaceutical industry achieve more by working together, through sensible collaborations, than we could each achieve on our own? This presentation contends that the pharmaceutical industry needs to embrace pre-competitive collaborations as a mechanism to achieve more by working together, and concludes with a call to action for all participants.

3:25 Networking Refreshment Break

4:00 Developing Industrial Best Practices: Lessons Learned from the Biological Registration Consortium

Todd Pihl, Ph.D., Chief Technology Officer, Vice President for R&D, Human Workflows

4:30 The Value of and Standards for Facilitated Data Sharing- Collaborative Activities in Research and Healthcare

Rebecca Kush, Ph.D., Founder, President and CEO, Clinical Data Interchange Standards Consortium (CDISC)

Jessica Nadler, Ph.D., AAAS Fellow for Policy and Technology Policy, Department of Health and Human Services

Opportunities for clinical research information to be leveraged to improve clinical care and for healthcare to provide valuable clinical research information are vast. However, the discontinuities present today in accessing such information and completing this circle in a reasonable timeframe present major barriers. The realization of the potential value hinges upon data sharing between the two worlds and an enabling infrastructure built upon a foundation of data interchange standards, integration profiles and interoperability specifications. Efforts to develop such an infrastructure are progressing through the collaboration of numerous organizations globally. This presentation will provide an overview of prior and current activities to harmonize standards and create interoperability opportunities between electronic health records and clinical research systems and the value and benefits of this collaborative initiative.

5:00 Breakout Round-Table Discussions

Issues of Shared IP from Consortia Research

Moderators: Richard Gold, Ph.D., and Mark A. Mersereau, Esq.

Solutions for Facilitating Data Sharing in Collaborative Research

Moderator: Martin Leach, Ph.D.

Overcoming Resistance to Sharing Drug Safety Results

Moderator: Arthur Holden

Governance, Organizational Management and Trust Building Issues for Consortia

Moderator: Robert Porter Lynch

Shared Development of Tools and Technology

Moderator: Erik Kuja and Catherine Oyler

Working to Enable Regulatory Changes

Moderator: Bruno Flamion, Ph.D.

Information Infrastructure for Collaborative Therapy Development

Jay “Marty” Tenenbaum, Ph.D.

6:00 Networking Reception

7:00 End of Day One



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