Day 1 | Day 2 | Day 3 | Short Courses
Day 3 - WEDNESDAY, MAY 7
7:45 am Morning Coffee
Strategic Partnerships: Reinventing the Drug Development Paradigm
Undoubtedly, there is an ongoing and widespread shift in the thinking of what is truly required for continued delivery of novel medicines for patients in need. Stakeholders are increasingly moving toward collaboration, particularly during early-stage research, as a primary means of realizing the remarkable potential of breakthrough medicines derived from advances in science and technology. As the interplay between early-stage stakeholders becomes more complex, the way forward requires not only managing the innate challenges of any partnership, but also the long term challenges of demonstrating and maintaining value of early-stage collaborative research as an integral business strategy. This session will focus on discussions providing a current and future look at the evolution of strategic partnerships, models for open innovation and academic-government-industry collaboration, as well as optimizing these partnerships for longer term business strategies.
8:25 Chairperson’s Opening Remarks
Teri Melese, Ph.D., Associate Adjunct Professor, Medicine & Rady School of Management; Assistant Vice Chancellor, Industry Research Alliances, University of California, San Diego
8:30 Drug Development Yesterday, Today and Tomorrow - Business Model Evolution
Magnus R. Björsne, Ph.D., MBA, Business Development Transaction Director, AstraZeneca
The pharma landscape has changed dramatically during the last decade and I will provide a perspective of the future interplay between academia, SMEs, venture capital and big pharma. In a sometimes divergent fashion, key players in the value chain have changed their strategies and what are the risks and opportunities emerging out of this?
9:00 Open Innovation-Based Drug Discovery: A Promising Precompetitive Paradigm
Rathnam Chaguturu, Ph.D., Founder & CEO, iDDPartners; Senior Director, Discovery Sciences, SRI International
Resurgence of the pharmaceutical industry to its preeminence can only be realized through collaborative innovation in biomedicine. These are challenging times, but they also offer unprecedented opportunities to form complementary and synergistic partnerships and collaborative research enterprises with an overarching goal of advancing drug discovery breakthroughs and bridge the translational gap. Stakeholders must engage in a partnership, where the core missions of each institution are recognized, respected and accommodated. The talk highlights innovative partnership models, and elucidates the changing landscape in drug discovery as ever more promising, and perhaps the colloquial herding the cats may be not that impossible.
9:30 CASE STUDY: How Public, Government and Private Investments Led to a Game-Changing Strategic Partnership that Leverages the Creative, Revolutionary Thinking of an Academic with the Delivery Power of an Innovative Pharma Company
Mark Coflin, Executive Director, Business Development and Licensing, Alliance Management, Novartis Pharmaceuticals Corporation
David Tollerud, Ph.D., COO, Regenerex
Novartis and Regenerex have recently formed a research alliance to advance novel cell therapy to treat conditions with high unmet need. This presentation will discuss a strategic state investment that brought a translational research institute including 23 families to form the foundation for rapid expansion of federally funded research at the University of Louisville. A Biotech start-up company, Regenerex LLC was formed to promote R&D activities and ultimately commercialization of the platform technology funded largely by federal (NIH) and state small business grants. Regenerex and the university formed a highly successful public/private partnership that supported several successful clinical trials and carried the flagship tolerance trial to FDA late Phase II. These clinical trial results formed the basis for a strategic global partnership between Regenerex and Novartis that includes basic and translational research initiatives as well as clinical trials to deliver an innovative portfolio of novel cell therapy therapeutics to treat patients in need.
10:15 Coffee Break in the Exhibit Hall
10:45 INTERACTIVE PANEL DISCUSSION: Optimizing the Impact of Academic-Industry Alliances on Innovation
Moderator: Teri Melese, Ph.D., Associate Adjunct Professor, Medicine & Rady School of Management; Assistant Vice Chancellor, Industry Research Alliances, University of California, San Diego
Over the past decade strategic alliances have become a critical business strategy for both public and private organizations. The panel will focus on innovation and the different strategies or thinking within companies about the role/value of company/university collaborations in fostering and supporting innovation. What lessons have been learned that allow us to maximize the value and mutual benefit of these partnerships? Apart from the short-term goals how have we structured partnerships to have a longer term fundamental change to our approaches to bringing products to market, especially with respect to developing disease interventions? What new thinking in the legal framework might be required to successfully catalyze the new open innovation models.
Anthony Marshall, Global CEO, Study Program Director; Leader, Strategy and Transformation Institute for Business Value, IBM
Sylvaine Cases, Director, External Innovation, Sanofi-Aventis
Noah Leibowitz, J.D., Partner, Intellectual Property Group and Litigation Department, Simpson Thacher & Bartlett LLP
Yvonne Tran, Vice President & General Counsel, Schrödinger, Inc.
11:45 Enjoy Lunch on Your Own
Refining Service-Based and Diagnostic Partnerships
CRO and diagnostic partnerships are becoming of critical importance for the driving of innovative science through clinical trials to reach and impact patients who may benefit from them. As these relationships increase, it is becoming clearer that typically the requirements of each partner do not mesh, causing dysfunction and perturbations throughout the agreement. This session will explore perspectives from those navigating these partnerships to shed light on things to consider while looking for a CRO or diagnostic partner, common issues to look out for, and newly-developed models for alliance management in this space.
12:55 pm Chairperson’s Opening Remarks
1:00 Alliance Management’s Role in Narrowing the Gap between Drug and Device
David Kern, Senior Director, Regulatory, Myraqa, Inc.
With the rise of personalized medicine comes an explosion in the number of biomarkers being developed as companion diagnostics. Aligning the goals and timelines of a drug and diagnostic has always been a challenge, but with some therapeutics now getting breakthrough status, the task is even more difficult. Alliance Management can play a key role in taking a test through clinical trials and FDA approval as swiftly and painlessly as possible by making sure that both sides stay in constant communications and that all the risks are being adequately addressed throughout the process.
1:30 What CROs Look for in Pharmaceutical, Medical Device and Diagnostics Partners
Adam Ruskin, Ph.D., Vice President, Clinical Development, LabCRO, Inc.
At some point most pharmaceutical, medical device and diagnostic companies look for a CRO partner. However, what the CRO is looking for in partner companies is not typically what the pharma/device company is looking for. As a pharma/device company there are certain items that potential CRO partners look for, and more importantly, certain items that they do not want in their partner companies.
2:00 Building and Maintaining Pharma-CRO Partnerships Focused on Early Discovery and Preclinical Drug Development
Rob Lobell, Director, Sourcing Operations, Merck
Over the past decade, Merck & Co. has shifted its early phase drug discovery model from a position where most of the work was done with in-house resources to its current state, where a significant percentage of the work is executed using external resources. A key component of this strategy has been the building of a focused set of collaborations with Contract Research Organizations that can supply research activities across a range of functional areas critical to early drug discovery and development. This operational model has been enabled by a Sourcing Operations group that serves in a coordinating capacity to link research teams and other research support functions at Merck with their counterparts at the CRO partners. Members of the Sourcing Operations group serve as relationship managers with the CRO partners, and employ a governance framework and set of processes for managing and building the partnership, resolving issues, evaluating partner performance, and building research capabilities. The application of this working model of Alliance Management to one of Merck’s key CRO partnerships will be discussed.
2:30 Close of Conference
250 First Avenue, Suite 300
Needham, MA 02494
Biological Therapeutic Products
Biomarkers & Diagnostics
Bioprocess & Manufacturing
Clinical Trials & Translational Medicine
Drug & Device Safety
Drug Discovery & Development
IT & Informatics
Technology & Tools For Life Science
Cambridge Healthtech Institute