The full agenda for the R&D Leaders' Forum Spring 2008 is now available on this site and will be updated weekly. If you have any queries about the programme or would like to suggest any additional topics you would like to see added, please contact David McCall at Phacilitate on +44 (0)20 7839 6151 (david@phacilitate.co.uk)
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DAY 1 | Monday 10th March
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| 7.30 |
Registration & buffet breakfast in the exhibition area |
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Morning plenary session
Addressing the productivity crunch and fostering sustained product innovation: How is scale impacting performance?
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| 9.00 |
Chair’s introduction
Stuart T. Henderson, Americas Life Sciences Pharma R&D Leader, IBM Global Business Services
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| 9.10 |
From the financial markets' perspective: What are the metrics by which productivity is judged, what have been the historical trends and what is the outlook for the future?
- Trends in R&D spend versus productivity
- Filling the pipeline gap
- M&A as a means to improve productivity
- Evolving pharma/biotech business models
Annette Grimaldi, Managing Director, Head of Life Sciences Investment Banking, Jefferies & Company, Inc
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| 9.35 |
Questions & discussion |
| 9.40 |
KEYNOTE ADDRESS
Big pharma perspective: Tackling the productivity crunch
- If you can’t break through the traditional R&D model then how can you work around it to improve productivity?
- What are the different business models and metrics to address productivity and generate value, particularly in the target discovery through to early PoC space?
- How are big pharma venture arms exploiting these opportunities and with what impact on productivity?
- What’s going to come out of clinic to replenish primary care franchises?
- Will the full service, highly diversified model once again be attractive?
Speaker to be announced
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| 10.05 |
Questions & discussion |
| 10.10 |
Big pharma, mid pharma productivity challenges: Interface to external innovation (biotech, VC, etc) to enhance the internal pipeline
Professor Mikael Dolsten, Private Equity Partner, OrbiMed
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| 10.35 |
Questions & discussion |
| 10.40 |
Panel discussion
Is big pharma just too large to generate the growth necessary for market expectations because of bureaucracy?
- Growing and retaining the tacit knowledge that scale gives you whilst enabling innovation – is it possible to achieve both?
- When might be the right time for big pharma to think about splitting up / divesting again?
- To what extent can a large, centralised organization emulate and enable the creativity of the small team environment?
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| 11.00 |
Morning coffee in the exhibition area |
| 11.50 |
Study results: How do biopharma operating structures and strategies correlate to corporate growth and innovation?
This session will examine the findings from the new ground-breaking study on operational strategies conducted by PRTM and the Tufts Center for the Study of Drug Development. The discussion will explore how operational strategies drive growth and innovation to help boost performance and enhance the probability of commercial success. Specifically, this session will:
- Examine large and mid-size pharmaceutical companies’ existing operating models and their correlation with key performance measures
- Review common operational elements with large and mid-size pharmaceutical segments
- Discuss emerging operational strategies in response to the changing pharmaceutical landscape
- Evaluate what operating models – or combination of models – are associated with optimal growth and efficiency
Scott Mahoney, Director, PRTM Management Consultants
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| 12.15 |
Questions & discussion |
| 12.20 |
Pharmaceutical innovation in the current environment: How can research leaders respond?
- Why does the pharma industry under-perform when benchmarked for innovation against other industries?
- Responding to intense cost pressure – as the ROI on discovery is getting closer and closer to cost of capital - how to beat the odds?
- Balancing long and short-term solutions - how to marry the time taken to develop a drug with short term financial performance targets
- How are new organizational models influencing the delivery of more innovative Proofs of Concepts?
- Will big pharma become hugely leveraged, highly outsourced organizations - with virtual discovery businesses – is that the forecast?
- At what point does accessing external innovation stop being cost-effective?
J. Carmel Egan, PhD, Vice President, Project Management, Lilly Research Labs, Eli Lilly and Company
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| 12.45 |
Questions & discussion |
| 12.50 |
Panel discussion
Is biopharma really innovative or are we just copying each other?
- What aspects of biopharma are innovative and what aspects are commodities?
- How can diversity be maintained and the stifling of innovation be prevented moving forward?
Moderator:
Mike Pegler, Director, PRTM Management Consultants
Panellist:
Dr Michael Hanley, Vice President, Discovery Research, Amylin Pharmaceuticals, Inc
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| 1.20 |
Buffet lunch in the exhibition area |
| OR |
Optional lunch briefing
Leveraging payer insight and healthcare data in the clinical development planning process
Sponsored by 
(Highly interactive session for a maximum of 50 participants)
- Critical clinical design requirements
- Pricing and formulary placement
- Comparative standards and analysis
- Payer market conditions for evaluation
Until very recently, pharmaceutical products were developed primarily on the basis of their potential clinical benefits and largely without regard to their commercialization. Over the next several years nearly $100 billion in revenue from branded drugs will evaporate as these products go generic. Clinical development programs have not been sufficiently productive to fill the void. This session will address how healthcare data, health economics and outcomes research, stakeholder input, and risk management can accelerate and improve the productivity of clinical development programs. We will also describe the evidence that is required by payers to make coverage and reimbursement decisions, as well as how this may evolve in the future
Speakers:
Bill Crown, President, i3 Innovus
Bill Broderick MS, MBA, Practice Leader, Payer & Reimbursement Strategies, i3 Innovus
» Click here for more information
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| OR |
Working Lunch
Study results in-depth: How do biopharma operating structures and strategies correlate to corporate growth and innovation?
(very informal, discussion-based optional session for a maximum of 12 participants)
Moderator:
Scott Mahoney, Director, PRTM Management Consultants |
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Working Lunch
Clinical development in China and Asia: Current success and future challenges
(very informal, discussion-based optional session for a maximum of 12 participants)
Moderator:
Dr Dan Zhang, CEO, Fountain Medical Development |
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Followed by your choice of 3 highly interactive parallel sessions:
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Focus session 1
Making decisions on strategic directions for new modalities and new therapeutic areas: Finding value in primary care, speciality care and biologics
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| 2.30 |
Chair’s introduction & opening presentation
Continued investment in primary care: What is the decision-making process and which therapeutic areas continue to hold promise?
- Which types of human disease lend themselves to primary versus speciality care? What should the discovery portfolio targets look like?
- Fast followers and generic competitors versus innovative targets
- Addressing the regulatory hurdles for efficacy and particularly safety as they become increasingly burdensome in primary care – how is it influencing directional decisions?
- How can primary care portfolio management keep pace with a non-static population?
- How will big pharma balance primary and speciality care?
- Will primary care provide a new realm for smaller players? What partnerships might evolve?
Dr Joseph Hulihan, Vice President, Medical Affairs – CNS, Ortho-McNeil Janssen Scientific Affairs, LLC
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| 2.55 |
Questions & discussion |
| 3.00 |
Deciding where to specialize: How is big pharma making decisions on strategic direction for speciality care markets?
- How attractive are the margins from speciality care products?
- What role will diagnostics and integrated solutions play in speciality care?
- How will big pharma balance primary and speciality care?
- What should the discovery portfolio targets look like?
- Fast followers / generic competitors versus innovative targets
Richard Gaynor, MD, Vice President, Cancer Research & Global Oncology Platform, Eli Lilly and Company
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| 3.25 |
Questions & discussion |
| 3.30 |
How is Merck embracing and extracting value from biologics such as RNA therapeutics?
- Integrating the development of novel biomedical products
- How are decisions made about investment in skills / scale-up / building internally versus externally?
- Optimizing the development of large molecules - what are the judgement processes all along the route to development?
Dr Alan Sachs, Vice President, RNA Therapeutics, Merck Research Laboratories
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| 3.55 |
Questions & discussion |
| 4.00 |
Panel discussion
Biologics and beyond: How do biotech, pharma and the VC community now view the market opportunities?
- What role will biologics play in primary versus speciality care?
- mAbs / RNAi / stem cells / gene therapy / DAb technology
- What will the market look like by 2015? What’s the VC view?
- What will be the role of biosimilars?
Panellist:
Fred Aslan, MD, Vice President, Venrock
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| 4.30 |
End of focus session followed by afternoon tea in the exhibition area
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OR | Focus session 2
Translational medicine: What is the progress with implementation and what are the first signs of ROI?
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| 2.30 |
Chair’s introduction & opening presentation
What have been the first signs of ROI from the implementation of translational medicine?
- What evidence is there of a ROI in terms of
- Better decisions
- Better dose selection
- Better efficacy signals earlier
- Better patient selections
- Product differentiation
- What metrics are being used to determine the ROI of translational medicine?
- How and when can do you determine whether the mechanism works and whether it is paying off?
- Do we have the right information to know?
Dr Nicholas Dracopoli, Vice President of Biomarkers & Translational Research, Johnson & Johnson
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| 2.55 |
Questions & discussion |
| 3.00 |
Progress report on overcoming the strategic and organizational issues encountered when migrating to the translational medicine paradigm
- The challenge of bringing more research into development and more development into research, without diluting the main objectives
- Addressing the organizational barriers – bringing discovery and clinical expertise together to maximize its utility and value
- Different organizational models for translational medicine – pros and cons, what seems to work and what has not yet delivered
- From a strategic and operational perspective how is translational medicine breaking down silos?
- The impact of translational medicine data in decision-making.
- How and when can ROI be calculated?
- Has ROI occurred or is translational medicine still an unproved approach that has emerged out of desperation with the high failure rate?
Dr Johan Luthman, Global Head, Therapy Area Neurology, Autoimmune & Inflammatory Diseases, Merck Serono International SA
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| 3.25 |
Questions & discussion |
| 3.30 |
Case study
Demonstrating the utility of biomarkers to support translational medicine and early decision making
Dr Eiry W. Roberts, Vice President, Research Technology & Exploratory Medicine, Eli
Lilly and Company
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| 3.55 |
Questions & discussion |
| 4.00 |
Panel discussion
Panellist:
Dr Lorin Roskos, Senior Director, Pharmacokinetics & Toxicology, MedImmune, Inc
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| 4.30 |
End of focus session followed by afternoon tea in the exhibition area
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OR | Workshop
Biotech business models: Is the model for engagement with pharma still dominated by M&A or are new opportunities for collaboration emerging?
Highly interactive session for a maximum of 30 participants
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| 2.30 |
Chair’s introduction & opening presentation
How is pharma now approaching deal timing, sourcing and management in order to create the optimum internal market economy?
- Early versus late stage licensing – how is deal timing impacting pharma R&D as well as biotech?
- What models for engagement are being sought at both research and clinical stages?
- What innovative approaches to licensing, partnering and collaboration are emerging?
- What are the implications of the trends towards the virtual model for pharma?
Ellen Strahlman, MD, MHSc, Vice President, Worldwide Business Development, Pfizer Inc
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| 2.55 |
Questions & discussion |
| 3.00 |
How is the VC role evolving in terms of structuring biotech business models and deals with pharma?
- With deal making happening earlier and earlier, how is this impacting the VC’s role and relationship with all parties?
- How does the VC community see deal making evolving in the short and long term?
- Which biotech business models with prove most attractive – both at research and clinical stages?
- Beyond M&A – what are the alternatives?
Vaughn Kailian, General Partner, MPM Capital
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| 3.25 |
Questions & discussion |
| 3.30 |
What is the new wave of biotech looking for from big pharma in terms of collaboration?
- How is this generation of biotech retaining independence – or are they fated to be acquired?
- How can biotech business plans deliver what investors want fast enough to fend off acquisition?
- Aligning the divisions between biotech board and management teams for the benefit of all
- Will there be a resurgence of ph II/III compounds for out-licensing?
Dr Steven R. Deitcher, President & CEO, HANA Biosciences
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| 3.55 |
Questions & discussion |
| 4.00 |
Panel discussion
What impact is the virtual model now having on both biotech and pharma?
Panellist:
Robert Baltera Jr, CEO, Amira Pharmaceuticals
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| 4.30 |
End of focus session followed by afternoon tea in the exhibition area
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Then | Afternoon plenary session
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| 5.10 |
Turning innovation into impact: New R&D business models
- The business models used in Biopharmaceutical Research and Development have seen numerous changes over the years. Yet more significant and transformational set of changes are emerging as a result of the challenges that the leadership teams of R&D are tackling. This session will present these emerging business model changes, review the root causes driving the direction of these changes, and share our point of view on the R&D business model of the future and discuss how to cross the chasm between business and science, innovation and impact. Mr. Henderson will draw from his extensive experience in the Biopharmaceutical industry as well as leverage key learnings from the R&D models in other industries including IBM's own R&D transformation from a company that focused solely on enterprise innovation to one that Innovates through collaboration
Stuart T. Henderson, Americas Life Sciences Pharma R&D Leader, IBM Global Business Services
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| 5.30 |
Panel discussion
Crossing the chasm between science and business: Progress with end-to-end initiatives that deliver seamless integration
- When and how to integrate science and business? Tactics for transitioning
- How does the separation or integration of early and late development incentivize different behaviours?
- Improving communication at the interface between R&D and commercial
- Minimizing the disconnect between the science psyche, the clinical development psyche and the marketing psyche
Moderator:
Dr Wayne A. Rosenkrans, Director, External Relations, Evidence-based Medicine & Personalized Healthcare, AstraZeneca
Panellists:
Stuart T. Henderson, Americas Life Sciences Pharma R&D Leader, IBM Global Business Services
Dr Eiry W. Roberts, Vice President, Transitional Phase Development, Eli Lilly and Company
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| 6.00 |
Close of day 1 followed by a themed cocktail reception in the exhibition area |
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