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R&D Leaders' Leaders' Forum
Agenda | Day 1

We are now bringing together the programme for the R&D Leaders' Forum 2009 and the latest information is posted below. Please pop back to this page again soon for news on newly confirmed speakers and presentations.

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DAY 1 \| Monday, November 9th, 2009
7.15	Registration & buffet breakfast in the exhibition area
Morning plenary session Proving the value of R&D innovation in an era of healthcare reform and financial stricture

9.00	Chair’s introduction Wayne A. Rosenkrans, Jr, PhD, Distinguished Fellow, MIT Center for Biomedical Innovation; Program in Ethics & Systems Medicine, Georgetown University; Chairman & President, Personalized Medicine Coalition; Vice President, Strategic Consulting, Fuld and Co; Chief Applications Officer, SciTech Strategies
9.15	The Hidden Blockbuster - generating income from intellectual property in R&D Stuart T. Henderson, Americas Life Sciences Pharma R&D Leader, IBM Global Business Services
9.35	Questions & discussion
9.40	Analyst's perspective Future of pharmaceutical pricing power Overview of current system - patent protection offers temporary monopoly to incentivize innovation Government intervention will be large determinant of pricing going forward Potential HC reform outcomes include - monopsony buyer, direct government price negotiation Data show reduction in pharmaceutical price growth with increase in the growth of government's share of total spending on pharmaceuticals Unlikely US will implement QUALY spend cap (i.e. UK NICE-like structure) Biosimilar payment mechanism will have meaningful impact on future of biologics pricing (single- vs multi-source) Continue to expect value for innovative therapies targeting high-severity diseases and 'personalized medicine', but slower price growth Recent NCI report on high cost of cancer drugs - cost of therapy grew exponentially with advent of a few biologics Pricing to be driven more by meaningful (vs incremental) benefit, and increasingly difficult to show clinical benefit over available therapies Steven D. Harr, MD, Managing Director & Analyst, Morgan Stanley
10.05	Questions & discussion
10.10	Morning coffee in the exhibition area
10.00	Private insurer's perspective Healthcare reform is inexorably linked to payment reform making value based purchasing a reality Healthcare reform must include payment reform Payment reform will certainly create a transparency of both cost and quality Payment reform will require healthcare providers and suppliers to be engaged with, have responsibility for, costs in the new "value-based" healthcare system Financial responsibility by providers (bundled or global payments) and patients (value based benefit designs) will add new dimensions to the "informed decision" process Healthcare reform in Massachusetts is already addressing public reporting of healthcare complications, cost drivers, and recommending a new risk adjusted global payment methodology (to replace fee-for-service) Dr John Fallon, Senior Vice President, Chief Physician Executive, Blue Cross Blue Shield of Massachusetts
11.15	Questions & discussion
11.20	Multiple stakeholders' panel discussion & extended Q&A with the audience What is the best way to conduct healthcare reform in order to preserve R&D innovation? What are the various potential scenarios for the US healthcare environment in the mid- to long-term What will each mean for industry R&D strategists Which model is most likely to prevail? What have been the pros and cons of NICE in terms of its impact on industry R&D innovation in the UK, particularly in the oncology field? What are the implications of a universal healthcare model on clinical trial costs and timelines? Is the industry's traditional value-generating model broken? What do we mean by value? What experimental models are being tested to better understand and defend the value of your drug? Getting buy-in from payers much earlier in development Generating evidence at the R&D stage that will justify the economic value of the drug Using public data to focus on the differentiating features of a product Comparative effectiveness in oncology: What benefit is worth reimbursement moving forwards, particularly in the context of adding to/replacing the Standard of Care? Is survival going to be enough (and if so, how long?) or will curative treatments be the only reimbursable option? What would the ideal model for oncology pricing and reimbursement look like? Panellists: Lee M. Nadler, MD, Dean of Clinical & Translational Research; Director, Harvard Catalyst; Virginia & D.K. Ludwig Professor of Medicine, Harvard Medical School, Senior Vice President, Experimental Medicine; Director, Center for Clinical & Translational Research; Pan Mass Challenge Senior Investigator, Dana-Farber Cancer Institute Dr Blaine McKee, Senior Vice President of Business Development, Oncology, Genzyme CorporationLouise M. Perkins, PhD, Chief Scientific Officer, Multiple Myeloma Research Foundation
12.30	Buffet lunch in the exhibition area OR \| Working lunches Alliance and business models to enable pharma and biotech to develop innovative medicines together Moderator: Dr Eric de La Fortelle, Global Head, External Research & Technologies, Roche OR \| How should we drive the development and commercialization of oncology therapeutics in the adjuvant setting moving forwards? Moderator: Dr Jean-Pierre Bizzari, Senior Vice President, Clinical Oncology/Hematology, Celgene Corporation (Very interactive, informal discussion-based sessions for a maximum of 12 participants each)
FOLLOWED BY YOUR CHOICE OF 2 PARALLEL SESSIONS:

Focus session 1 Externalization and networked R&D: Building sustainable, flexible business models by scaling through partnerships and alliances

1.40	Moderator's introduction Deciding exactly what is strategic or core to the company and, therefore, what can be more flexibly and cost effectively resourced through externalization How do you determine what is strategic or core to the business? Taking a holistic look at the value chain and where externalization would provide greatest benefit What is the role for in-house R&D? What impact does externalization have on risk and cost – particularly at the discovery research end? As we move into increasingly niche areas, how much reliance should there be on external companies and organizations to give flexibility? How much of the know-how should you own yourself? John V. W. Reynders, PhD, Head of Integrative Neurosciences & Biomarkers & Head of the Informatics Center of Excellence, Johnson & Johnson
Case studies of externalization in action How have partnerships and networked R&D delivered better business outcomes and consistent delivery metrics for biopharma? What was externalized and why? What form did the deal take? How were operational models restructured to facilitate the externalization process?
2.00	Case study Externalizing non-clinical development infrastructure: How are innovation partnerships being structured and managed and with what results? What was the impetus for setting up this model? How does it work in practice? What are the value propositions for the (i) partner, (ii) suppliers and (iii) GSK? Dr Paul Trennery, Senior Vice President & Head of Externalisation, Preclinical Development, GlaxoSmithKline
2.20	Case study Streamlining drug development through strategic partnerships Perhaps out of necessity small companies have been early adopters of strategic partnering for drug development. More recently mid sized and large companies are also engaging in strategic partnering to streamline drug development. This presentation will examine a variety partnership models across the drug development continuum via case studies that highlight the challenges, metrics, and ingredients for success from the sponsor perspective and the CRO perspective. John Watson, President, Strategic Partnering & Integrated Drug Development, Covance Inc
2.40	How are mid-sized companies approaching externalization and scaling through partnerships to weather the economic climate, maintain differentiation and sustain innovation? What are the key elements and trends that are important to your partnership? What are the underlying drivers of these trends and how they impact small and mid-sized biotech companies in particular? Discussing Exelixis’ partnership models as means of weathering the current economic climate Rekha Hemrajani, Vice President, Business Development, Exelixis, Inc
3.00	Case study Analyzing the virtual company model: Moving beyond alliances as individual relationships and building alliance networks for strategic sourcing and open innovation How does this business model work in practice? How are decisions made? What are considered to be core functions? What is the impact of having such limited resources? Dr Eric de La Fortelle, Global Head, External Research & Technologies, Roche
3.20	Panel discussion Is there value to full integration anymore? Have we finally arrived at a point where there is sufficient expertise, scale and economics associated with networked models that these will dominate even the most efficient integrated entities? What is the model once the dust settles?
3.55	Moderator's closing summary
4.00	Close of session followed by afternoon tea in the exhibition area

Portfolio management workshop Optimizing and right-sizing the portfolio to maximize ROI from small molecules and biologics - How to achieve a healthier spend:outcome ratio

1.40	Moderator's introduction Managing uncertainty by adopting an options based portfolio management model Breaking the process down into a series of investment opportunities How do you assess uncertainty and risk at each stage? What criteria would buy you the option to continue at each stage? How does this model allow senior management to attain a more complete understanding of tradeoffs? Making portfolio decisions for diseases that have a molecular basis versus broadly defined diseases – to what extent is a new approach required? Gary M. Phillips, MD, MBA, Global Head of Portfolio Management, Merck Serono International SA
2.00	Questions & discussion
2.05	Right-sizing the portfolio: Balancing risk and value in challenging times 40 years of corporate portfolio strategy – what’s new? The limitations of popular decision frameworks for portfolio management How to best balance risk and value across projects, therapy and business areas? How to align portfolio size, available resources and capabilities Shaping the pharmaceutical portfolio – a few hypotheses for the next ten years Dr Markus Thunecke, Senior Partner, Catenion GmbH
2.25	Questions & discussion
2.30	Managing a mixed portfolio: Making key decisions at the science, resource and governance level Ensuring you interrogate the target with best option: When do you have enough information to make the choice? Do you do it explicitly or do you allow the science to ‘muddle along’? Resourcing correctly and efficiently throughout discovery and development Having the right tools in place to move biologics and small molecules through each stage Accelerating the validation of the most valuable scientific tools for supporting development decisions How is product development of biologics different from product development of small molecules? Balancing small molecules and biologics in a fully integrated drug development company: What are the governance decisions? Dr J. Carmel Egan, Vice President, Project Management, Lilly Research Labs, Eli Lilly and Company
2.50	Questions & discussion
2.55	Presentation followed by panel discussion Do you need to be strong in biologics to have a long-term sustainable business as a pharma company these days? Is it necessarily the right strategy for the future? How can portfolio management ensure you make the right decisions? What’s the risk and investment profile for developing biologics? Are there any low-hanging fruit left in biologics? What therapeutic areas have the best risk/reward proposition for biologics? What does big pharma need to learn from biotech in terms of optimizing the discovery and development of biologics? Expanding the portfolio through organic change and/or acquisition Moderator: Dr Peter Halle, Vice President, Early Stage Licensing, Merck Serono Presenter: Greg Wiederrecht, PhD, Vice President & Head, External Scientific Affairs, Worldwide Licensing & External Research, Merck & Co, Inc
3.55	Moderator's closing summary
4.00	Close of session followed by afternoon tea in the exhibition area

Afternoon plenary session Optimizing the communication of benefit versus risk, and managing the economics of risk management

	Chair: George M. Botsakos, Associate Partner - Strategy & Change, IBM Global Business Services
4.40	The Future of Pharmacovigilance - results from a study conducted with Pfizer and 20 other companies in Q2'09 Tom Swanekamp, Executive Director, Saftey & Risk Management, Pfizer Inc George M. Botsakos, Associate Partner - Strategy & Change, IBM Global Business Services
5.05	Panel discussion Balancing the identification, assessment and communication of benefit:risk while maintaining the economic incentive to develop drugs Ensuring that industry and regulators are seen to be collaborating on the early communication of potential safety signals and transparency of safety information How should R&D be responding to help shift the balance in favour of benefit? At each touch point, how much benefit versus risk do you talk about? Capitalizing on all new data gathered that demonstrate benefit by communicating it for biggest impact Anchoring benefit:risk in the minds of the regulator, the reimbursement authorities and physicians What impact will the advent of tailored therapies have on the cost of safety studies? Will the economics of risk management prevent companies from going into certain areas? REMS - what are the experiences to date with their development, practical application and cost? Panellists: Dr Eve E. Slater, former US Assistant Secretary for Health; Associate Clinical Professor, Columbia College of Physicians & Surgeons Frank Misselwitz, MD, PhD, Vice President & Head, Therapeutic Area Cardiovascular & Coagulation, Bayer HealthCare AG Dr Richard Peck, Global Head of Clinical Pharmacology, Roche Products
5.35	End of day 1 followed by a cocktail reception in the exhibition area

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