R&D Leaders' Forum Spring 2007
Presentations
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Monday March 5th 2007
Day 1
Morning plenary session in the Main Conference Room
Evaluating alternative approaches to the traditional R&D phases: When and how will they positively impact productivity?
Chair’s introduction
Dr Wayne A. Rosenkrans, AstraZeneca
Market analyst’s perspective
How are the financial markets evaluating R&D strategies?
Jim Kelly, Goldman Sachs – NOT AVAILABLE
FDA viewpoint
Update on the Critical Path and Personalized Medicine Initiative implementation
Felix W. Frueh, PhD, FDA
Evaluating alternative approaches to the traditional R&D phases - a European viewpoint
Dr C. Ian Ragan, Eli Lilly
Keynote address
Inside out: Can externalization of drug discovery impact productivity?
Dr Maxine Gowen, GlaxoSmithKline – NOT AVAILABLE
Project and program leadership in a newly emerging pharmaceutical R&D model:
(Re)defining the project leader role
Dr Richard J. Heaslip, Wyeth Research
A zero-based look at the pharma business model: How would someone from outside our industry discover, develop and market drugs?
Jerry Cacciotti, SDG Life Sciences, a Unit of IMS
Focus session 1
Early-stage clinical trials: What progress is being made with phase zero trials and demonstrating early Proof of Concept in man?
Chair’s introduction
Criteria for entry of novel mechanism compounds into human PoC studies
Dr William Z. Potter, Merck Research Laboratories
Chorus, Lilly's experiment in early clinical development
Neil Bodick, MD, PhD, Chorus, Lilly Research Laboratories, Eli Lilly and Company
Case studies: What is the value of phase zero?
Dr Bruce H. Littman, Pfizer Global R&D
Case study
Accelerating drug development through enhanced preclinical and early clinical discovery efforts
Edwin A. Clark, PhD, Bristol-Myers Squibb
Case study
Demonstrating early proof of principal to reduce attrition in later development
William D. Matthews, PhD, Johnson & Johnson – AWAITING PERMISSION TO PUBLISH SLIDES
Panel discussion
Managing the transition from preclinical to man: People, process, systems, pre-defined partner agreements – what are the key factors to consider?
NO SLIDES PRESENTED
Focus session 2
How is drug discovery research now being equipped and organized to rigorously qualify and deliver high quality clinical candidates?
Chair’s introduction
How do we use all the information available in the post-genomic era?
Dr Mark Boguski, Novartis Institutes for BioMedical Research – NOT AVAILABLE
Report card on ‘old’ and "new' HTS/ HCA technologies: What has been their real impact on efficiency and cost?
Dr Ralph J. Garippa, Roche, Inc
Equipping and organizing research and development for a franchise environment
Dr Anthony Ford-Hutchinson, Merck Research Laboratories – NOT AVAILABLE
Panel discussion
How are organizations being energized to be increasingly exploratory and experimental in the early stages?
Panellists:
Richard Pither, PhD, UCB-Celltech
Dr Ralph J. Garippa, Roche, Inc
Workshop
Developing robust decision criteria for the development and use of biomarkers: Learning from regulatory and industry experiences to date
Moderator’s introduction
Clarifying the current regulatory position on the validation and standardization of biomarkers for approval and ongoing patient care
Felix W. Frueh, PhD, FDA
Delivering Big Science: The importance of public/private partnerships
- what progress is being made with pre-competitive data sharing of genomic biomarkers?
Patrice M. Milos, PhD, Pfizer Global R&D
Case study
Using biomarkers for key decision-making in oncology development: Are we there yet?
Dr Charles Morris, AstraZeneca R&D – NOT AVAILABLE
Panel discussion
Establishing ground rules for developing and using biomarkers: Developing decision criteria to support various milestones, and to balance risk with investment
Panellist:
Daniel K. Burns, PhD, GlaxoSmithKline
Afternoon plenary session
Panel discussion
Linking commercialization with R&D: How have different organizational models for R&D impacted productivity, innovation and the development of real talent?
Moderator:
Mark Mynhier, PRTM
Panellists:
Whaijen Soo, MD, PhD, Biogen Idec – NO SLIDES PRESENTED
Dr Wayne A. Rosenkrans, AstraZeneca – NO SLIDES PRESENTED
DAY 2
Tuesday March 6th 2007
Morning plenary session
Health economics and patient outcomes: What is R&D’s current and future role in the demonstration of value and choice for patients, prescribers and payers?
Chairs’ introduction
Daniel K. Burns, PhD, GlaxoSmithKline
Financial analyst perspective
Healthcare and pharma economics are under assault
Barbara Ryan, Deutsche Bank Securities, Inc
Payer's perspective
What demonstrates value with new medications?
Helen Sherman, RPh, PharmD, The Regence Group
Healthcare and pharmaceutical industry convergence: What are the benefits for pharma and the patient?
Stuart T. Henderson, IBM Global Business Services
Physician’s perspective
Understanding changing prescribing habits and how they might impact R&D
David A. Mrazek, MD, FRC, Psych, Mayo Clinic
Keynote address
Responding to the changing economics of the healthcare environment: Thinking creatively about R&D productivity, patient outcomes, and the drive towards personalized medicine
Dr Alan Breier, Eli Lilly and Company – AWAITING PERMISSION TO PUBLISH SLIDES
Panel discussion
R&D in the information age: Will the explosion of information capture and analysis be our demise or our nirvana?
Panellist:
Dr Mark Boguski, Novartis Institutes for BioMedical Research – NOT AVAILABLE
Optional Lunch Workshop
Enabling collaboration in R&D in China
Moderator:
Dr Nahed Ahmed, Amgen, Inc – NO SLIDES PRESENTED
Speakers:
Dr Frank Douglas, MIT Center For Biomedical Innovation
Dr Ting Lei, Beijing Pharma & Biotech Center (BPBC)
Dr Conglin Zuo, Beijing Joinn Pharmaceutical Center, ABO (Alliance of Biotech Outsourcing)
Dr Le Sun, Abmax Biotechnology Co., Ltd.
Focus session 1
Assessing progress with innovation in late stage clinical trials and managing the evolution to phase IV ‘lifecycle trials’
Chair’s introduction
Dr Michael Hehenberger, IBM Global Business Services
Case study
Adaptive designs in phase III clinical trials
Dr Kiang-Kuo Gordon Lan, Johnson & Johnson Pharmaceutical R&D
Adaptive designs as an enabler for teamwork: Two case studies on dose-response finding
Michael Krams, MD, Wyeth Research - AWAITING PERMISSION TO PUBLISH SLIDES
How can adaptive designs and randomized discontinuation designs improve clinical development and lifecycle management trials?
Dr Gervais Tougas, Novartis
Case study
Making the decision to proceed into phase IV: What are the timing and operational considerations?
Dr Alan Breier, Eli Lilly and Company - AWAITING PERMISSION TO PUBLISH SLIDES
Panel discussion
Managing the transition from phase III to IV and post-marketing commitments: What impact will they have on R&D and lifecycle management?
NO SLIDES PRESENTED
Focus session 2
Justifying investment in modeling and simulation: How and where are they adding significant value to the R&D process?
Chair’s introduction
Measuring the value added by simulation and modeling, especially in the early stages of R&D
Marc Pfister, MD FCP, Bristol-Myers Squibb
What is the progress with the FDA’s application of drug/disease modeling and simulation?
Dr Robert Powell, US Food & Drug Administration
PK/PD model based drug development, a defined role and responsibility in R&D
Andrew T. Chow, PhD, Amgen Inc – NOT AVAILABLE
Examining the impact of in silico techniques on the R&D process: Current status and possible future perspectives
Manfred Kansy, PhD, F. Hoffmann-La Roche Ltd
Panel discussion
Deeper human disease modeling versus better animal models: Where should you invest to improve confidence in novel drug targets?
NOT AVAILABLE
Workshop
Valuing and managing assets and factoring in risk throughout their lifecycle to optimize portfolio management
Moderator’s introduction
How do you determine the value of an asset?
Dr Anthony Artuso, Bristol-Myers Squibb
Defining benefit/risk assessments along the product lifecycle chain: Qualitative or quantitative?
Dr Diana Lanchoney, Merck & Co, Inc
Delivering predictable results in an unpredictable business environment: A petroleum industry benchmarking example of balancing risk and reward
John I. Howell III, Portfolio Decisions, Inc
Overcoming barriers to effective portfolio management
Dr Jan-Remt Mellema, NV Organon
Panel discussion
Will portfolio management techniques preserve the standard R&D business model?
NO SLIDES PRESENTED
Afternoon plenary session
Panel discussion
Examining clinical development trends and challenges on a global basis
Moderator:
Mary Jo Lamberti, PhD, Thomson CenterWatch
Panellists:
Dr Alan Breier, Eli Lilly and Company – NO SLIDES PRESENTED
Stuart T. Henderson, IBM Global Business Services – NO SLIDES PRESENTED
David A. Mrazek, MD, FRC, Psych, Mayo Clinic – NO SLIDES PRESENTED
DAY 3
Wednesday March 7th 2007
Morning plenary session
Sourcing new opportunities for pharma R&D: Developing the portfolio via investment in biotech, networking externally, and focusing innovation on areas of unmet need
Chair’s introduction
What do you do to meet your growth objectives when there is a paucity of product opportunity?
Christian Gabel, PhD, PRTM
Keynote address
Pharmaceutical innovation: Balancing price, cost and need
Professor Sir Michael Rawlins, National Institute for Clinical Excellence
Financial viewpoint
Examining the state of the biotech industry
Dr Jeffrey Leiden, Clarus Ventures, LLC – NOT AVAILABLE
Mergers & acquisitions debate
What role does / should M&A play in promoting innovation, and what are the IP implications?
Moderator:
Christian Gabel, PhD, PRTM- NO SLIDES PRESENTED
Panellists:
Dr David Rosen, Pfizer Global R&D - NO SLIDES PRESENTED
Kerry K. Reinertsen, PhD, Vertex Pharmaceuticals Incorporated - NO SLIDES PRESENTED
Panel discussion
How will the pharma portfolio develop to capitalize on remaining areas of unmet need?
Moderator:
Christian Gabel, PhD, PRTM - NO SLIDES PRESENTED
Panellists:
Professor Mikael Dolsten, Boehringer Ingelheim
Dr Joseph B. Bolen, Millennium Pharmaceuticals, Inc - NO SLIDES PRESENTED
Dr Jean-Francois Formela, Atlas Venture - NO SLIDES PRESENTED
Afternoon plenary session
Strategically planning the R&D capabilities of biotech and determining the criteria for success
Chair’s introduction
Richard P. Polisson MD, MHSc, Genzyme Corporation - NO SLIDES PRESENTED
Case study
Biotech R&D across borders: The Ascenta experience
Dr Mel Sorensen, Ascenta Therapuetics, Inc
Getting your development program started in a timely fashion
Whaijen Soo, MD, PhD, Biogen Idec
Case study from a biotech offshoring late stage clinical trials
Graeme Currie, PhD, PDL BioPharma
