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R&D Leaders' Forum 2009 | Tuesday, November 10th
Agenda | Day 2

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DAY 2 \| Tuesday, November 10th, 2009
7.15	Registration & buffet breakfast in the exhibition area
Morning plenary session Are you adequately prepared and equipped to face the current policy, legal and economic environment? • Analyzing the macro external factors impacting R&D leadership and decision making

8.45	Chair’s introduction
8.50	Analysis of the Obama administration’s Stimulus Package and its implications for drug discovery and for development: Where do the main areas of opportunity lie? Which areas of discovery research have most to gain? Changes to stem cell policy in US: What are the implications for drug discovery? What is the potential impact of the political climate on geographic movement of the industry? Are we likely to see major movement of R&D away from the US? Dr Eve E. Slater, former US Assistant Secretary for Health; Associate Clinical Professor, Columbia College of Physicians & Surgeons
9.15	Questions & discussion
9.20	What do recent legal developments portend for R&D investment? Everchanging regulatory and legislative landscape Wyeth vs Levine: What are the implications for drug development and safety strategy? Compliance Impact and overlay Update on patents and the battle around protection of information Generics and biosimilars: Could pharma be held responsible for drugs they didn’t make? With the drive to expedite biosimilars what is the latest status on duration of patent exclusivity for first to file? Corporate global social responsibility vs. international patent protection – where is the balance? William C. Bertrand, Executive Vice President, General Counsel & Corporate Compliance Officer, MedImmune, Inc
9.40	Questions & discussion
9.45	Panel discussion Consolidation in the industry: What is the long term, sustainable value in recent M&A activity? To what extent is history repeating itself? What is Wall Street’s and industry’s opinion of the value delivered by the latest round of M&As? To what extent have pipelines, revenues and efficiency be improved? Or are they primarily a short term cost saving measure? Historically, what value has pharma derived as it has grown from one merger to another? Will the latest deals be any different? What new portfolio opportunities have been enabled? How will the new entities be structured and absorbed? Integration and collaboration models to extract maximum value and minimize margin of error from the deal How are new spin-off entities emerging to absorb the surplus R&D talent? Panellist: Dr Jennifer Cermak, Director, Portfolio Management, Sirtris, a GSK Company
10.35	Panel discussion Cash shortage for biotech: What opportunities does it create for pharma and other investors? How will the economic environment impact partners for big pharma and biotech, and how will the value chain be protected? What will happen to the myriad of private companies that service big pharma? What are viable strategies they could consider? If they have to reduce the scope of their activities how will they go about it? How will the value chain evolve? Will there be more or less externalization and what form will it take? Do we see large pharma changing their role from collaborator to acquirer and earlier stage funding source? How will competition for mid-sized / small companies pan out? How will big pharma position itself? At what point is pharma ready to buy? What are the implications of disease foundations and large pharma funding an increasing amount of early stage innovations? Is there a larger role for expert angel investors? How are capital requirements changing? What are the relative roles in the funding ecosystem as VC funding is under increasing pressure? Where are private and public investors looking to deploy their capital, and what is their timeframe and vision for industry? VCs / commercial banks / corporate VCs / foundations / NGOs / syndicates / CROs Creatively funding innovation: Satisfying short term cash needs without trading off long-term potential Filling the gap before pharma is interested: What new business models are emerging to broker assets at this point? Moderator: Dr Jeffrey Elton, Biotech Investor and Advisor & formerly Senior Vice President of Strategy & Chief Operating Officer, Novartis Institutes for BioMedical Research Panellists: Dr Eric de La Fortelle, Global Head, External Research & Technologies, Roche Greg Wiederrecht, PhD, Vice President & Head, External Scientific Affairs, Merck & Co, Inc Dr Peter Halle, Vice President, Early Stage Licensing, Merck Serono
11.25	Morning coffee in the exhibition area
FOLLOWED BY YOUR CHOICE OF 2 PARALLEL SESSIONS:

Focus session Size is everything: Optimizing internal organizational and operational models to foster agility, innovation and value driven R&D

12.05	Moderator's introduction What is the right size and structure for a pharma company? How to innovate given the failure of our historic paradigm? How can pharma make informed decisions about new organizational models – and approach them as scientifically as we do R&D? What is the structure of R&D to be right-sized, but to retain expertise and critical mass? What are the ideal organizational models in a knowledge-based environment? How does size and structure influence agility and ability to be innovative? Traditionally big pharma organizes round functional capabilities: Is this still the prevailing organizational principle or has it evolved well beyond that? Professor Jackie Hunter, Senior Vice President, Science Environment Development, GlaxoSmithKline
12.25	Questions & discussion
12.30	Case study Different operational models in action: Organizational structures addressing productivity, innovation and business transformation Centralized versus decentralized approaches Working smaller: How are groups scaled and organized? Approaches to effectively integrating R&D organization Impact and consideration on governance, internal collaboration, and effective culture How have models addressed key industry challenges Speaker to be announced
12.50	Questions & discussion
12.55	Case study Organizational optimization to foster innovation and delivery Research area autonomy Cross discovery networking Driving performance through Continuous Improvement Is it working? Dr Jeffrey Hanke, Vice President, Cancer Research, R&D Boston, AstraZeneca
1.15	Questions & discussion
1.20	Buffet lunch in the exhibition area OR \| Lunch briefing sponsored by Drug development for cancers arising out of increased genetic risk Topics to include: Informed consent and legal issues for clinical sites that see patients who carry increased genetic risk for cancer Implications for pharmaceutical industry in designing clinical trials for these patient populations Optimal use of specialized diagnostic procedures such as radiology and laboratory evaluation Current guidelines for the management of patients who carry increased genetic risk for cancer Moderators: Dr Gary Fishbein, Senior Medical Director, PharmaNet Development Group Kristen Shannon, MS, Program Manager for Cancer Genetics, Massachusetts General Hospital (For a maximum of 50 participants) » Click here for more information OR \| Working lunch What are the keys to accessing traditional and non-traditional early-stage R&D funding for biotech? From start-up to Proof of Concept Moderator: Aaron Schacht, Executive Director, Global External R&D, Eli Lilly and Company (Very interactive, informal discussion-based session for a maximum of 12 participants each)
2.30	Getting the interface right between R and D: Implications of new business models for biopharmaceutical R&D on traditional organizational models What is the best way to organize to be most effective in a virtual, networked, global R&D environment? How is the relationship between R&D changing in light of new strategies for sharing the risk of R&D? How will the relationships between venture-backed biotech and large pharma R&D evolve? Which capabilities should the innovative biopharmaceutical company emphasize to prosper in the future? Aaron Schacht, Executive Director, Global External R&D, Eli Lilly and Company
2.50	Questions & discussion
2.55	Changing from a linear to a circular link between R&D and commercial: Breaking down silos to drive a real understanding of medical need and business focus Optimizing teamwork and collaboration throughout the drug discovery and commercialization process Using talent acquisition and placement strategies to broaden and strengthen holistic pipeline performance. Linking the knowledge at each step – how to achieve in practice? Dr Ginger L. Gregory, Global Head of Human Resources, Novartis Institutes for BioMedical Research
3.15	Questions & discussion
3.20	Panel discussion Managing R&D in an increasingly heterogenous environment: How will all the different ‘flavours’ of the business be integrated and organized? Biosimilars / generics / diagnostics / pure play How to mix high / medium / low risk business models under one corporate umbrella Moving away from R&D silos Are we fundamentally redefining what we mean by disease area and, therefore, how we manage the business? Is the pathway approach making a difference at last? Panellists: Dr Markus Thunecke, Senior Partner, Catenion GmbH Dr Theodore Reiss, Corporate Vice President, Global Clinical Integrated Drug Development, Covance, Inc
4.00	Moderator's closing summary
4.05	Close of session, followed by afternoon tea in the exhibition area

Workshop Managing attrition and achieving faster and cheaper proof of concept through optimal design: Utilizing clinical data to be more predictive in terms of its value Workshop (Highly interactive session for a maximum of 30 participants)

12.05	Chair’s introduction Case study Getting more for less: The value of data integration and modelling in drug discovery and development Bridging the gap between pre-clinical and human Optimizing study design to build a better understanding of compound behaviour Reducing R&D costs by improving the quality of decisions across the drug development process. Gaining a better understanding of the Exposure Response relationship - key to successful approval. Valerie S. Kitchen, MD, FRCP, Vice President, Clinical Pharmacology Modelling & Simulation, Bristol-Myers Squibb
12.25	Questions & discussion
12.30	Case study Optimizing the design of 1st in man studies: How to achieve PoC faster and with greater confidence, but with limited resources and investment What is the latest thinking around guidelines for phase I study design Optimal sample size, sample time and measurement Optimizing the use of pre-clinical modelling and data to better inform dosage in phase I trials and control risk taking Is it possible to achieve PoC faster without increasing risk to patients? What do we take out of the development process? Achieving more predictive analytical modelling based on statistical methods rather than logistical constraints Regulatory interaction regarding choice and measurement of end points Dr Richard Peck, Global Head of Clinical Pharmacology, Roche Products
12.50	Questions & discussion
12.55	Adaptive and seamless designs for late stage oncology studies: Making the right decision Adaptive approaches are increasingly common in earlier studies, but only beginning to be utilized at the all important confirmatory stage. Join noted adaptive trial expert Yannis Jemiai, PhD, to examine actual adaptive trial case studies and their impact on our industry and your own development efforts Designing and implementing seamless phase 2 / 3 trials - defining the opportunities and challenges Re-estimating sample size and events for survival endpoints Determining efficacy and futility stopping rules in cancer trials What to expect from regulators – best practices from experience Yannis Jemiai, PhD, Associate Director of Biostatistics, Cytel Inc
1.15	Questions & discussion
1.20	Buffet lunch in the exhibition area OR \| Lunch briefing sponsored by Drug development for cancers arising out of increased genetic risk Topics to include: Informed consent and legal issues for clinical sites that see patients who carry increased genetic risk for cancer Implications for pharmaceutical industry in designing clinical trials for these patient populations Optimal use of specialized diagnostic procedures such as radiology and laboratory evaluation Current guidelines for the management of patients who carry increased genetic risk for cancer Moderators: Dr Gary Fishbein, Senior Medical Director, PharmaNet Development Group Kristen Shannon, MS, Program Manager for Cancer Genetics, Massachusetts General Hospital (For a maximum of 50 participants) » Click here for more information OR \| Working lunch What are the keys to accessing traditional and non-traditional early-stage R&D funding for biotech? From start-up to Proof of Concept Moderator: Aaron Schacht, Executive Director, Global External R&D, Eli Lilly and Company (Very interactive, informal discussion-based session for a maximum of 12 participants each)
2.30	Some practical drivers and considerations for adaptive clinical trials Why adapt? Adaptive concepts Adaptation in early clinical development Benefits and issues Status and considerations Dr Michael Hale, Head of Global Medical Sciences Biostatistics Group, Amgen, Inc
Optimizing trial design for registration versus reimbursement: How are phases being combined, shortened or extended to achieve different ends? Case studies demonstrating innovation, flexibility, results and cost:benefit How is adaptive design being used to enable combined or reduced trials - how might this change with the new FDA guidelines? Set up costs versus clinical development costs Regulatory interaction at each stage to ensure buy in Comparing and contrasting different strategies to reduce development cycles without compromising on quality
2.50	Case study Predicting clinical trial outcomes while the trial is in progress: How are adaptive trials being used to combine, shorten or extend the drug development process to achieve efficiency and cost savings? How are prediction, adaptive trials and simulation used to increase the value of the portfolio? Set up costs versus clinical development costs Regulatory interaction at each stage to ensure buy in Comparing and contrasting different strategies to reduce development cycles without compromising on quality Jerald S. Schindler, DrPH, Vice President, Biostatistics & Research Decision Sciences - Late Development Statistics, Merck Research Laboratories
3.10	Case study Full and detailed phase II: Xarelto prevention of Venous Thromboembolism Phase IIa with surrogate endpoints Scientific advice with major HA Phase IIb with surrogate endpoints and NCB – BID dosing Phase IIb once daily dosing End of phase II meetings with HA SPA for phase III protocols Frank Misselwitz, MD, PhD, Vice President & Head, Therapeutic Area Cardiovascular & Coagulation, Bayer HealthCare AG
3.30	Panel discussion Is killing early the right approach? What evidence is there that it is resulting in less late stage development failures and increased productivity? How cost effective is it proving to be? Is value being lost by killing too early? Panellist: Dr Jeffrey Chodakewitz, Vice-President, Early Development Group Leader, Merck & Co
4.00	Moderator's closing summary
4.05	Close of session, followed by afternoon tea in the exhibition area

Afternoon plenary session Diversification or focused strategies for growth - or both? Where is value to be created next and how will risk of entry be managed? • Biosimilars, chronic conditions, orphan drugs

4.35	Chair’s introduction Aaron Schacht, Executive Director, Global External R&D, Eli Lilly and Company
4.40	Keynote address What is our business? Is it medicines or broader healthcare and, if the latter, what does that mean? Putting R&D into a broader context How will diversification be approached in the context of cost:benefit in the current economic climate? How to direct R&D focus to areas of unmet need What are the appropriate benchmarks? Do pharmacogenomics and patient segmentation mean that we are moving beyond the blockbuster model with less ambivalence than ever before? Can we afford personalized medicine? How can we "future proof" scientific investment and what is the evidence for ROI with different approaches? Dr Jean-Pierre Lehner, Senior Vice President, Chief Medical Officer, Sanofi-Aventis
5.00	Panel discussion How is biopharma evaluating new opportunities in The prevention and management of chronic diseases? How do you build a business round diseases where changes in organ function may be only 1-2% per year? How do you justify the cost of development? How are industry and regulators collaborating to make this economically viable? Orphan / ultra-orphan diseases? How can industry afford to develop drugs for such rare conditions? Should there be a separate regulatory pathway? What role might academia play – and how would the drugs reach commercialization? Biosimilars? Threat or opportunity? How do you build a sustainable business model round them? How do you launch a biosimilar in a very crowded area? Panellists: Professor Jackie Hunter, Senior Vice President, Science Environment Development, GlaxoSmithKline Dr Duncan McHale, Vice President of Translational Science, AstraZeneca
5.30	Close of day 2 followed by a cocktail reception in the exhibition area

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