R&D Leaders' Forum Spring 2006
Presentations
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DAY 1 | Monday March 20th 2006
Morning plenary session
Responding to external influences on R&D: Stakeholder engagement, data sharing and optimizing links with academia
Dr Wayne A. Rosenkrans, Jr
Industry Keynote Address
How is industry engaging with customers / stakeholders and responding to external influences earlier in the R&D process?
Dr Amber Salzman
Government Keynote Address
Centers for Medicare and Medicaid Services Quality Improvement Roadmap: The emerging importance of CMS as a US public health agency and its impact on pharma R&D
Dr Barry M. Straube
Pharma 2010: What's next?
Guy Lefever
Case study
Advancing scientific discovery through Public-Private Partnerships: A view from the NIH
Dr Barbara B. Mittleman
Case study
Why do we need a coalition to support personalized medicine?
Edward Abrahams, PhD
Elevating the importance of information in drug development
Linda S. Bowers
Cross industry case study
The Clorox model of technology partnering in the consumer products industry: What lessons can R&D leaders in the biopharmaceutical industry learn?
David Lowrance
Focus session 1
Organizing for success: Comparing approaches to systems redesign for R&D optimization and productivity enhancement
Chair’s introduction
Dr Abbie Celniker
Case study
Organizing global R&D to drive high performance
Dr Keith James
Case study
Accelerating drug R&D by taking advantage of China resources
Dr Samantha Du
Case study
Johnson & Johnson: Shared excellence in a decentralized research company
Scott A. Reines, MD, PhD
Why our intuition fails us in early development
Jerry Cacciotti
Focus session 2
Oncology focus: Regulation, routes to market and economics of targeted medicine
Chair’s introduction
Case study
The economics of targeted medicine. The promise. The reality
Frank Pasqualone
Development of Personalized Medecine and Targeted Therapies- A Platform Technology’s Perspective
Martin LeBlanc
Case study
BiovaxID anti-cancer vaccine: lessons and paradigms for the cost-effective and scalable production of personalized therapeutics
Carl M. Cohen, PhD
Panel discussion
Assessing risk:benefit in oncology
Dr Bob Milsted
Workshop
Integrating risk management and portfolio management: Right-sizing your portfolio for both risk and value
Moderator’s introduction
Michael G. Parker
Factors which influence risk policy in R&D: Technical and operational risk versus trust
and long-term market risk
Dr David Slavin
Case study
Risk and value in the R&D portfolio
Dr Christine J. Cioffe
Case study
Portfolio risk management in a biopharmaceutical company
Dr William D. Matthews
Panel discussion
Jeff Hewitt
Afternoon plenary session
Redefining, driving and funding innovation
Chair’s introduction
Stuart Henderson
Keynote Address
How are traditional roles evolving and merging in pharma R&D: Academics / pharma / biotech / Consortia. With what impact on innovation? Learning from the Open Innovation business model
Dr Alpheus Bingham
Panel discussion
Addressing the shortfall in VC funding for early stage innovation
Stuart Henderson – NO SLIDES PRESENTED
Dave Bowser, MBA – NO SLIDES PRESENTED
Kent Gossett – NO SLIDES PRESENTED
DAY 2 | Tuesday 21st March 2006
Morning plenary session
Engaging with the regulator to rebalance the risk:benefit equation in favour of benefit to all parties without compromising safety
Chair’s introduction
Roger J. Garceau, MD – NO SLIDES PRESENTED
FDA Keynote Address
Critical Pathway Initiative: What are the outcomes to date?
Dr Lawrence Lesko
Industry Keynote Address
Benefit:risk optimization in the post-Vioxx world
Dr Catherine Bonuccelli
Update on the objectives and establishment of the IOM Drug Safety Committee
Kathleen Stratton, PhD
Drug safety: Redefining risk:benefit in the post-launch clinical environment
Alan Breier, MD – NOT AVAILABLE
Drug safety: Update on the FDA's Safety Oversight Board
Susan K. Cummins, MD, MPH
Working Lunch
Compliance in clinical: Systems & processes for trial management
Chris Moore – NO SLIDES PRESENTED
Focus session 1
Right-sizing: How should decisions on core competencies and scale drive your internal and outsourced structures and processes?
Chair’s introduction
Dr Nahed Ahmed
Strategic focus, core competencies and diversification: Identifying and achieving the right balance
Dr Anthony Artuso
Case study
Ensuring that outsourcing / offshoring solve rather than add to the efficiency conundrum
Ira C. Spector
Case study
Outsourcing discovery chemistry to China / India
Dr James Audia
Case study
Risk management in an alliance based portfolio
Christine Carberry
Case study
Arbitrage between in-licensing and home-grown projects at Pfizer
Margi McLoughlin, PhD
Panel discussion
Smoothly handling the internal management of external functions
NO SLIDES PRESENTED
Focus session 2
Prioritizing, leveraging & integrating new target validation technologies for the benefit of early stage development
Chair’s introduction
Maximizing the impact of target validation technologies on R&D productivity
Dr Hans-Joachim Boehm
Safety evaluation strategies in discovery and early development
Dr Michael W. Leach
Beyond traditional animal models of safety and efficacy: Distinguishing present capabilities from future aspirations
Dr William M. Kluwe
Panel debate
New technologies aren’t making a big enough difference to R&D cycle times and productivity – or, is the implementation of the technologies in the R&D process flawed?
Dr Robert Booth
Panellists:
Dr Lawrence Lesko – NO SLIDES PRESENTED
Mark Boguski, MD, PhD – NO SLIDES PRESENTED
Workshop
Designing and managing clinical trials to ensure the best chance of success for transition from Phase IIa to IIb/III
Moderator’s introduction
Ensuring that Phase IIb and III are demonstrational rather than experimental in order to maximize their chance of success
Chris Moore
Moving away from standardized protocols: Weighing up the risks:benefits of Adaptive
Trial Design
Dr Roy Bullingham
Dr Mohan Beltangady
Case study
Using Phase II data to guide successful Phase III designs
Dr Bob Milsted – NO SLIDES PRESENTED
Kevin J. Carroll
Case study
Phase II: The Big Challenge and what to do about it
Gary L. Stiles, MD
Panel discussion
How will clinical trial protocols evolve to accommodate the migration towards a more targeted approach?
NO SLIDES PRESENTED
Afternoon plenary session
Panel discussion
Will systems biology result in the death of the target approach?
Mark Boguski, MD, PhD
Panellists:
Dr Robert Booth – NO SLIDES PRESENTED
Dr Michael W. Leach – NO SLIDES PRESENTED
DAY 3 Wednesday 22nd March 2006
Morning plenary session
Anticipating future market needs and leveraging your assets for short and long-term growth
Chair’s introduction
Projecting project value in an uncertain future: Lessons from the past, directions for the future
Dr Richard J. Heaslip
Keynote Address
Understanding what constitutes good R&D leadership and how it has to evolve with changing market drivers and demands
Frank Douglas, PhD, MD
Leaders are made not born: Preparing the next generation of R&D leaders
James A. Cutler, PhD
Keynote Address
Making the transition from blockbuster to targeted and personalized medicine: How will the gap be filled?
Dr Abbie Celniker
Panel discussion
What will new products look like? Investing in R&D for both short and long term growth
Dr Catherine Bonuccelli – NO SLIDES PRESENTED
Panellists:
Dr John Curnutte, MD, PhD – NO SLIDES PRESENTED
Dr Neil Weir, PhD – NO SLIDES PRESENTED
Dr Abbie Celniker – NO SLIDES PRESENTED
Main session
Developing the products of the future
Chair’s introduction
Mark Levick, MD, PhD – NO SLIDES PRESENTED
Case study
Impact of biomarkers on cancer drug development: The role of Her2 diagnostics in driving the success of Herceptin
Dr David C. Heimbrook
Case study
Healthcare as individual risk management: the role of diagnostics
Dr Ellen Beasley
Case study
Developing biologics within big pharma: The Schering-Plough Model
Dr John Curnutte, MD, PhD
Case study
New developments in biologics: Structures, mechanisms & effect
Dr Neil Weir, PhD
Workshop
Join us for learnings from China
Moderators’ introduction
Opportunities and challenges
Frank Douglas, PhD, MD – NO SLIDES PRESENTED
Dr Nahed Ahmed
Case study
Novo Nordisk experience in operating a R&D unit in Beijing
Dr Baoping Wang
The increasing globalization of the life sciences industry
Dr Mario Gobbo
