DAY 1 - Tuesday 28th October

7.30 Registration & buffet breakfast in the exhibition area

Morning plenary session
(to be shared with the Oncology Leaders' Forum 2008)
Proving cost effectiveness and communicating value
- Reimbursement and risk sharing for premium-priced therapeutics

9.00 Co-chairs' introduction
How does drug pricing drive therapeutic choice?
Dr Charles T. Gombar, Vice President, R&D Strategy & Business Improvement, Wyeth Research
Dr Wolfgang Wein, Senior Executive Vice President, Global Business Unit Oncology, Merck Serono

9.10 European perspective
Update from NICE on risk sharing initiatives and value for money in oncology

• Update on the Velcade risk sharing initiative
• Update on the new program of early engagement with Novartis and others at clinical trial stage: How might NICE be consulted prospectively and with what impact on risk sharing?
• Implications of changes to the Pharmaceutical Price Regulation Scheme (PPRS)
• How is the switch to reviewing ALL new anti-cancer drugs progressing?
  • What examples are there of drugs that have conditional authorization for EU?
• Update on the Health Select Committee Review into whether NICE’s economic view is too narrow

Professor Sir Michael Rawlins, Chairman, National Institute for Clinical Excellence

9.30 Questions & discussion

9.35 Evidence-based assessment and decision-making based on comparative clinical effectiveness of different interventions: How it is used to communicate value
Jean R. Slutsky, PA, MSPH, Director, Center for Outcomes & Evidence, Agency for Healthcare Research & Quality (AHRQ)

9.55 Questions & discussion

10.00 Insurer’s perspective
How do payers assess value for money from premium-priced products and what are the most important indicators?

• If the drug doesn’t extend survival is it commercially useless?
  • What are the right endpoints for consideration of commercial value? Overall survival? Progression of disease/metastasis?
• How are high priced combination biological agents valued?
  • Will they continue to be reimbursed in a sequential way?
    o Do the outcomes justify the costs?
  • How might companion diagnostics change the equation and eliminate some of the reimbursement issues?
• How do payers view the service versus kit diagnostics reimbursement picture developing in the future?
• What are the implications of a movement towards a compendia approach as a basis for approv
  • What are the implications of this system for physicians, hospitals and companies?

Dr Naomi Aronson, Executive Director, Technology Evaluation Center (TEC), BlueCross & BlueShield Association

10.20 Questions & discussion

10.25 IBM Global CEO study: The enterprise of the future

• What will the enterprise of the future look like?
• Eight out of ten CEOs see significant change ahead, and yet the gap between expected change and the ability to manage it has almost tripled since our last Global CEO Study in 2006
• CEOs view more demanding customers not as a threat, but as an opportunity to differentiate
• Nearly all CEOs are adapting their business models — two-thirds are implementing extensive innovations
• CEOs are moving aggressively toward global business designs, deeply changing capabilities and partnering more
  

Stuart T. Henderson, Americas Life Sciences Pharma R&D Leader, IBM Global Business Services

10.50 Questions & discussion

10.55 Keynote industry perspective
Responding to the challenges of global drug development in the current reimbursement market

• What are the challenges that health technology assessments present to the drug development process?
• Cost/QALY fit for purpose or a barrier to innovation?
• Velcade risk sharing - a special case or a model for the future?
• Does the drug development process naturally lend itself to the creation of a "value proposition"?

David Brickwood, PhD, Vice President, International Government Affairs – Europe, Johnson & Johnson

11.15 Questions & discussion

11.20 Morning coffee in the exhibition area

Followed by your choice of 3 interactive breakout sessions:

Focus session 1
Predicting trends in Asian R&D, regulatory and market evolution
• How will you position your organization to capitalize on the opportunities, and meet the challenges, from China, India and the Pacific Rim?

12.00 Chair’s introduction
Analyst's introductory overview: How will the healthcare environment evolve in Asia-Pacific and India?

• What are the individual markets going to be worth and when will they reach fruition?

Dr Guy Fish, Vice President, Health Care Practice, Fletcher Spaght, Inc

12.20 Western industry perspective
Defining our overall vision for our future presence and role in Asia

• How do we assess and integrate the strategic dynamics across Asia (market and infrastructure growth, innovation and talent, regulatory harmonization)?
  • Where are the opportunities? What are the key challenges?
• How are we positioning ourselves to maximize value along the entire value chain, from discovery to marketing?
• How do we see the future evolution of our position in Asia? (Outsourcing/offshoring or true globalization?)
  

Karl E. Burgin, PhD, Project Leader, CODESTA Project (Coordinated Development Strategy for Asia), F. Hoffmann-La Roche AG

12.45 Questions & discussion

12.50 Maximizing value from both global and local drug development perspectives in north Asia

Dr David Boyko, Senior Vice President, Global Medical Affairs & Pharmacovigilance, Bristol-Myers Squibb

1.15 Questions & discussion

1.20 Buffet lunch in the exhibition area

OR | Lunch workshop | Sponsored by
Adaptive oncology trials: Design considerations and practical implementation
A multi-faceted examination of the rise of adaptive trials in oncology. Using actual
adaptive study experiences, we’ll look at the statistical innovations behind these new
trials and their impact on clinicians and patients

• What design adaptations are best suited for oncology studies?
• Designing adaptive trials to leverage the most important aspect of the study - the data
• Logistical and operational considerations for implementing an adaptive trial
• How the challenges of drug supply and "on-the-fly" randomization are being met
• Actual case studies from both early phase and late phase oncology trials

Moderator:
Jeff Palmer, Senior Statistician, Cytel Inc
(Highly interactive session for a maximum of 50 participants)

OR | Working lunch
(Very informal, interactive, discussion-based optional session for a maximum of 12 participants)
Discussing evolving regulatory pathways for drug-device and biologic-device
combinations

• What specific factors determine which division of the FDA is responsible for these
  products?
• In cases where you actually have a choice of either submitting your product as a
  therapeutic, or as a device, which do you choose? What are the strategic implications
  of either pathway?
• Comparing and contrasting US and European approaches in this regard

Moderator:
Dr L. Christian Clauss, Director of New Product Development, RA Global Biologics, Baxter International

2.30 Asian regulatory perspective
How will the regulatory environment at large, and pathways to market for first-in-class therapeutics in particular, develop in China and India moving forwards?
Nadine Cohen, Senior Vice President, Global Regulatory Affairs, Biogen Idec

2.55 Questions & discussion

At what rate can innovative drug discovery develop within the regions' pharma and biotech community?

• How do we see our futures and how will we reach these goals? What will be the next stage of our value creation?
• How and when are we planning on moving towards becoming fully integrated drug discovery and development companies?
• What are our strategies for gaining the knowledge, expertise and mindset that innovative drug discovery requires?

3.00 Indian company perspective
Innovative biologics research in India: Actis Biologics as a case study of offshoring vs. outsourcing

• Actis Biologics is one of the few companies currently conducting innovative biotechnology research (as opposed to biosimilars/biogenerics) in India. We in-license novel technologies from the West and develop them further in India for commercialization worldwide. We were faced with the issue of offshoring vs. outsourcing to India, both of which have their pros and cons. How do you weigh one against the other and determine what makes sense? This presentation will present a case study of why we chose to offshore as opposed to outsource

Sanjeev Saxena, Chairman & CEO, Actis Biologics, India

3.25 Questions & discussions

3.25 Chinese company perspective
Michael Hui, CEO, ShangPharma

3.45 Questions & discussion

3.50 Close of session followed by afternoon tea in the exhibition area

Or | Focus session 2
De-risking the clinical development pipeline in an uncertain regulatory and reimbursement climate

12.00 Chair’s introduction
When and how to engage with payers in the drug development process?

• How must pharma and biotech adapt their overall drug development strategies so that the elements that are important to payers are factored in?
• How can the industry partner better with payers, moving forwards?

Dr Hartmut Ehrlich, Vice President, Global R&D, Baxter BioScience

12.20 How can a product's chance of commercial success including 'reimbursability' be accurately assessed at each stage of R&D?

• How is decision-making at each step of the R&D cycle - from target selection through post-marketing surveillance- being effected by the new environment?
• What are the new risks in drug development and the post-approval life cycle?
• Do post-approval clinical studies need to be re-assessed for unintended consequences?

Robert J. Spiegel, MD, FACP, Senior Vice President & Chief Medical Officer, Schering-Plough Research Institute

12.45 Questions & discussion

12.50 Case study
How do you assess the true risk profile for a drug in the face of increasing regulatory and commercial uncertainties?

• What tools and techniques are available to enable sufficiently accurate valuation of your portfolio to enable tough go-no go decisions to be made?

Speaker to be announced

1.15 Questions & discussion

1.20 Buffet lunch in the exhibition area

OR | Working lunch
(Very informal, interactive, discussion-based optional session for a maximum of 12 participants)
Discussing evolving regulatory pathways for drug-device and biologic-device
combinations

• What specific factors determine which division of the FDA is responsible for these
  products?
• In cases where you actually have a choice of either submitting your product as a
  therapeutic, or as a device, which do you choose? What are the strategic implications
  of either pathway?
• Comparing and contrasting US and European approaches in this regard

Moderator:
Dr L. Christian Clauss, Director of New Product Development, RA Global Biologics, Baxter International

2.30 Case study
Which innovative clinical development strategies and designs can be considered for de-risking compounds during clinical development?

• Review attrition and determinants of pharmaceutical predictivity
• Provide frameworks for scientific risk assessment
• Outline different early clinical development strategic designs
• Identify factors to consider when selecting amongst different clinical development options
• Address organizational implications
  

Dr Thorir Bjornsson, Vice President, Early Development & Clinical Pharmacology, Wyeth Research

2.50 Questions & discussion

2.55 Case study
What is the evidence to date for adaptive trial designs successfully improving clinical development?

• The potential benefits of adaptive trials
• Defining the adaptive design scope including references to regulatory publications/guidelines
• Survey of adaptive design case studies across the industry (by phase of development)
• Learning to date: Reported benefits and barriers encountered
• Approaches undertaken to address barriers

Dr Brenda L. Gaydos, Research Advisor, Eli Lilly and Company

3.15 Questions & discussion

3.20 Panel discussion
As regulatory conservatism increases, will outcomes studies be required for approval, and how might this be factored in to a viable drug development model?

Panelist:
Christopher Bowden, MD, Senior Group Medical Director, BioOncology Development- Avastin, Genentech Inc

3.50 Close of session followed by afternoon tea in the exhibition area

Or | Workshop
In reality, just how big a threat - or opportunity - are biosimilars to pharma and biotech R&D?
• Forming an overall picture of the impact that biosimilars will have on the industry over the next decade and beyond
(Highly interactive session for a maximum of 30 participants)

12.00 Chair’s introduction
Dr Conor O'Dea, General Manager, Genemedix

12.05 Regulatory perspective
How has the regulatory pathway for biosimilars developed in Europe?

• What key concerns remain for the regulatory community?

Professor Pekka Kurki, Head of Licensing Department, National Agency for Medicines, Finland & Former Chair of the CHMP Biosimilar Working Party

12.25 Questions & discussion

12.30 10-year market overview
Which are the biologics that will, or might, come off patent over the next decade?
Ian Sanderson, Managing Director & Senior Research Analyst, Cowen & Company, LLC

12.50 Questions & discussion

12.55 Technical perspective
Of the biologics that will potentially be open to generic competition within the next 10 years, which ones are currently feasible targets for the generics industry?

• Comparing the technical complexity of different classes of biologic

Dr L. Christian Clauss, Director of New Product Development, RA Global Biologics, Baxter International

1.15 Questions & discussion

1.20 Buffet lunch in the exhibition area

OR | Working lunch
(Very informal, interactive, discussion-based optional session for a maximum of 12 participants)
Discussing evolving regulatory pathways for drug-device and biologic-device
combinations

• What specific factors determine which division of the FDA is responsible for these
  products?
• In cases where you actually have a choice of either submitting your product as a
  therapeutic, or as a device, which do you choose? What are the strategic implications
  of either pathway?
• Comparing and contrasting US and European approaches in this regard

Moderator:
Dr L. Christian Clauss, Director of New Product Development, RA Global Biologics, Baxter International

2.30 Manufacturer's perspective
Could you conceivably make enough money from producing a biosimilar?

• What would be the cost of setting up and maintaining plant for the production of a biosimilar?
• Would situating the facility or facilities in the developing world be a must in cost terms?
  • What impact might this have on the already daunting challenge of demonstrating quality?

William F. Haddad, Chairman & CEO, BioGenerics, Inc

2.50 Questions & discussion

2.55 Marketing perspective
How quickly could generics companies gain sufficient traction in the speciality care market on a global basis?
Speaker to be announced

3.15 Questions & discussion

3.20 Panel discussion
With biosimilars being potentially one of the lowest risk product development pathways moving forwards, how might pharma and biotech turn threat into opportunity?

3.50 Close of session followed by afternoon tea in the exhibition area

Then | Afternoon plenary session
How are regulators re-thinking drug safety evaluation?
• Will US, European and Japanese agencies align on drug safety and other key regulatory aspects?

4.30 Chair's introduction

4.35 US FDA keynote perspective
Discussing new initiatives and approaches to drug safety regulation

• Information management and sharing: Essential components to success in managing postmarketing safety
• Validating progress: Biomarker qualification for organ-specific toxicity to improve decision-making

Dr Douglas Throckmorton, Deputy Director, CDER, The Food and Drug Administration

5.00 Questions & discussion

5.05 Panel discussion
A panel including regulatory experts from the US FDA, Europe and Japan to discuss:

• How accepting of inherent risk are the major regulators at the current time?
  • Is there a point of tolerable balance between efficacy and safety in large populations?
• Key areas of focus in the ongoing ICH process moving forwards
• How is Japan becoming more aligned to ICH guidelines, and will recent changes with regard to the acceptability of clinical data derived outside Japan streamline the pathway to licensure?
  • Are further changes planned, particularly with regard to pan-Asian collaboration?

Panellists:
Dr Douglas Throckmorton, Deputy Director, CDER, The Food and Drug Administration
Professor Pekka Kurki, Head of Licensing Department, National Agency for Medicines, Finland & Former Chair of the CHMP Biosimilar Working Party
Leyna Mulholland, PhD, Director, Global Regulatory Affairs, Pharma Development Regulatory (PDRA) - Japan Liaison, F. Hoffmann-La Roche Ltd

6.00 End of day 1 followed by a themed cocktail reception in the exhibition area

DAY 2 - Wednesday, October 29th 2008

7.30 Registration & buffet breakfast in the exhibition area

Morning plenary session
Delivering cost-cutting, streamlining and outsourcing strategies to drive R&D towards an innovative and productive future model

9.00 Chair's introduction
Dr Neil Weir, Senior Vice President, Research, UCB Celltech

9.05 Analyst's perspective
Examining ongoing trends in R&D costs and productivity: How much more cost efficient must pharma and biotech become to survive in the marketplace of the future?

• Cost efficiency: Yes it is necessary, but it won't be enough
• Fundamental restructuring of the process is required: Project selection, scrutiny, development strategies, risk sharing all must be addressed
• Systems and strategies to harness the best opportunities internally, and externally from basic research will be required
• Expect a larger divergence between the winners and the losers

Barbara Ryan, Managing Director, Deutsche Bank Securities, Inc

9.25 Questions & discussion

9.30 Big pharma keynote address
What strategies, including globalization & externalization of R&D, will transform the big pharma business model and deliver the necessary changes in cost base and productivity?

• How can the cost-efficiency of centralized functions co-exist with the entrepreneurial culture and productivity of independent business units?
• Does a broad or a focused R&D portfolio represent the right strategy for success in today’s risk averse regulatory climate?
• What new partnering models will enable pharmaceutical companies to spread the cost and risk of their future development portfolios?
• How is the industry positioning itself to grow its presence, healthcare impact and sales in developing nations such as China?
  

Dr Keith James, Vice President, La Jolla Research Site Head, Pfizer Global R&D

9.55 Questions & discussion

10.00 Big biotech keynote address
How can we maintain the culture of innovation, flexibility and efficiency that brought our initial success as both our scale and external cost/price pressures increase?

• What is the optimal size of a pre-clinical research organization?
• Motivation in a static growth research environment
• Not Invented Here - the other meaning of 'NIH'
• Using outside collaborations, both academic and commercial, to enlarge the reach of research
• Exploring the role of NIH funded drug discovery programs
• Utilizing translational medicine approaches to enhance the probability of clinical success
• Using commercial-academic consortia to address fundamental questions related to disease mechanisms and drug targets
  

Dr David R. Webb, Vice President, Research, Celgene Corporation

10.25 Questions & discussion

10.30 Venture capitalist's perspective
How do we see the future evolution of the drug discovery model given the expected economic pressures?

• The venture capital model
• The future needs of pharma and biotech
• The evolution of the "Virtual R&D Model"
• The advantages and disadvantages of the "Virtual Model"

Dr Robert Booth, Operating Partner, TPG Ventures & Executive Chairman, ViroBay, Inc

10.55 Questions & discussion

11.00 Panel discussion
Cutting costs in R&D through outsourcing: What exactly are today's core competencies for pharma and biotech, and will they remain so?

• Which specific factor should pharma and biotech primarily focus on to achieve optimal cost savings and productivity improvements in R&D over the long term
  • Speed?
  • Scale?
  • Integration?
  • Flexibility?

Panelists:
Kerry L. Blanchard, MD, PhD, Chief Operating Officer - Discovery Research, Eli Lilly and Company
John Larus, Chief Operating Officer, Fulcrum Pharma Developments, Inc

11.30 Morning coffee in the exhibition area

Followed by your choice of 3 interactive breakout sessions:

Focus session 1
How are varying offshoring and outsourcing R&D strategies performing in real terms in India and the Far East?
• Which approach will secure your organization short-term cost savings and long-term competitive advantage?

12.10 Chair's introductory overview
Outsource

Working in a lab with "long corridors" - what must change in our approach to work successfully with CROs?

• Identifying the value proposition in an outsourcing relationship and communicating to internal "customers"
• Identifying the internal needs from potential collaborators. When is good, "good enough"?
• The challenge of developing and maintaining competencies, both externally and internally
• Identifying and applying the relationship model that works for both internal customers and vendors
  

Dr Diana Galer, Vice President, Strategic Management Group, Pfizer Global R&D

12.35 Questions & discussion

12.40 Build
Building R&D capabilities in Singapore and China: the GSK experience

• GSK is exploring two models of building R&D capabilities in Asia-Pacific
• In 2004 GSK created an extension of the Neurology and GI CEDD in Biopolis in Singapore. Although initially comprised of biology and DMPK expertise, it was further expanded to include medicinal chemistry and also acted as a hub to build links into the clinical community in Singapore
• More recently in 2007, GSK has made a commitment to create an end-to-end R&D organisation in China
• The opportunities and challenges created in these models will be discussed.
  

Professor Jackie Hunter, Senior Vice President, Science Environment Development, GlaxoSmithKline

1.05 Questions & discussion

1.10 Buffet lunch in the exhibition area

OR | Working lunch
(Very informal, interactive, discussion-based optional session for a maximum of 12 participants)
Where should you make the division between drug discovery and development with a biologic candidate?

• How do you decide when a given project should be handed over to the clinical group
  • When you get to First in Man, or after Proof of Concept?
• Who should take stewardship and when to optimize innovation and productivity across the R&D value chain, particularly in examples where pharma and biotech are in collaboration

2.20 Case study
What are the key considerations in selecting a CRO partner in China?

• Weighing up the pros and cons of working with a global 'one-stop-shop' CRO versus local options
• Proactively addressing potential issues with the quality and 'integratability' of clinical data and its acceptability to Western regulators
• How should varying standards of care be factored in to your clinical trial strategy and patient selection?
  • What ethical issues can this present?

Dr Peter L. Myers, Chief Executive Officer & Chairman of the Board, Lead Therapeutics

2.45 Questions & discussion

2.50 Case study
What are the key considerations in entering India and establishing a company presence in the clinical development area?

• Factors to consider in establishing a clinical research presence in India
• Logistical reality of setting up a multinational pharmaceutical company clinical research center in India
• Strategic implementation: challenges and opportunities
• Going live: Integration into the global organization

Dr Dianne C. Kikta, Vice President, Global Clinical Strategic Resourcing, Wyeth Research

3.15 Questions & discussion

3.20 Panel discussion

3.50 Close of session followed by afternoon tea in the exhibition area

OR | Focus session 2
What are the keys to successfully balancing resource allocation in a biologics – or mixed modalities - R&D portfolio?

12.10 Chair's introduction
Is there a good model for defining productivity for a biologics portfolio?
Christine Carberry, Vice President, Program & Alliance Management, Biogen Idec

12.20 Case study
What sort of data can demonstrate the productivity of a preclinical development group evaluating small molecules, biologics and vaccines?

• What are some key strategies contributing to the success of our new productivity model?
• How have we enhanced productivity while embracing attrition?
• How has stage appropriate development been utilized to manage risk?
• How has the integration of activities between discovery and development aided in early identification and mitigation of potential risk?

Mahdi B. Fawzi, PhD, Executive Vice President, Preclinical Development, Wyeth Research

12.40 Questions & discussion

12.45 Case study
How to allocate resources between biologics and small molecules in a portfolio that contains both types of projects?

• What are the strategic choices required?
• How do you determine the resource demand?
• What is the process to balance risk, time, cost and value across an integrated portfolio of biologic and small molecule projects?

Dr William D. Matthews, Vice President, R&D Management Operations, Centocor R&D, Inc

1.05 Questions & discussion

1.10 Buffet lunch in the exhibition area

OR | Working lunch
(Very informal, interactive, discussion-based optional session for a maximum of 12 participants)
Where should you make the division between drug discovery and development
with a biologic candidate?

• How do you decide when a given project should be handed over to the clinical group
  • When you get to First in Man, or after Proof of Concept?
• Who should take stewardship and when to optimize innovation and productivity across the R&D value chain, particularly in examples where pharma and biotech are in collaboration

Case studies
What are the strategic considerations before, during and after investing in a biologic modality?

• How do you organize to pursue them? Weighing up the pros and cons of collaborative versus internal approaches
• What are the potential repercussions of each on the go-no go decision-making process?

2.20 In the context of operating with mixed modalities

• What are the overall implications of managing a mixed modality portfolio?
• Key strategic and operational implications
• Resource, timeline and POS considerations across small molecules, vaccines and biologics
• Considerations around scale and internal/external sourcing of activities

Dr Christine J. Cioffe, Vice President, Strategic & Enterprise-wide Portfolio Management, Merck & Co, Inc

2.45 Questions & discussion

2.50 In the context of a specific modality
Case study: Strategic considerations for the development of new BiTE antibodies

• What are BiTE antibodies?
• Internal, collaborative or outsourced development?
• How to select new targets and indications?
• How to place key risk reduction steps early in the development process?
• What kind of an organization is needed?

Patrick A. Baeuerle, PhD, Professor for Immunology, Senior Vice President, Chief Scientific Officer, Micromet, Inc

3.15 Questions & discussion

3.20 Panel discussion
Maximizing the value of biologics products through lifecycle management - approaches to exploring portfolio options

• Expanding the value of biologics through new indications

3.50 Close of session followed by afternoon tea in the exhibition area

OR | Workshop
Biotech business models: Collaborative strategies to maximize product value while controlling costs
(Highly interactive session for a maximum of 30 participants)

12.10 Chair's introduction
Neil M. Kurtz, MD, President & CEO, TorreyPines Therapeutics, Inc

12.20 Case study
What cost control measures can small biotechs adopt to counter increasing economic pressures?

• How are we streamlining and creating efficiencies in R&D?

Stephen Worland, PhD, President & Chief Executive Officer, Anadys Pharmaceuticals, Inc

12.40 Questions & discussion

12.45 Case study
How are we aligning our R&D business model to meet the evolving demands of pharma and healthtech assessment agencies alike for potentially premium-priced therapies?

• How to build a product portfolio using a variety of collaborative tools
• Cell Genesys’ business model
  • Creation of research efficiency
  • Achievement of long term vision
• How to establish a pricing strategy for premium priced products
  

Robert H. Tidwell, Senior Vice President, Corporate Development, Cell Genesys

1.05 Questions & discussion

1.10 Buffet lunch in the exhibition area

OR | Working lunch
(Very informal, interactive, discussion-based optional session for a maximum of 12 participants)
Where should you make the division between drug discovery and development
with a biologic candidate?

• How do you decide when a given project should be handed over to the clinical group
  • When you get to First in Man, or after Proof of Concept?
• Who should take stewardship and when to optimize innovation and productivity across the R&D value chain, particularly in examples where pharma and biotech are in collaboration

2.20 Case study
What are the keys to demonstrating product value to a potential pharma partner in the current environment?

• Picking projects and determining a plan
• Proof of concept approach to clinical candidates vs. registration studies
• Integration of scientific, medical, commercial and regulatory concerns
• The selling process

Robert Baltera Jr, CEO, Amira Pharmaceuticals

2.40 Questions & discussion

2.45 Case study
R&D outsourcing strategy: Managing multiple service providers and building a strong pipeline

• Strategize outsourcing globally and maximize value
• Engage in effective CRO/CMO management
• Create and sustain long term relationships
• Encourage face-to-face interactions and synergize productivity

Dr Lijun Sun, Vice President, Chemistry, Synta Pharmaceuticals

3.05 Questions & discussion

3.10 Case study
How does biotech go global maintaining aggressive timelines using CRO
partners?

• What are the pieces necessary to move into the global arena?
• How much control are you willing to concede? As a consequence of this concession what are your internal resource needs? Do you have core competencies that need to be considered?
• How does one integrate the communication among all of the groups involved?

Ann L. Wang, Vice President, Clinical Operations/Data Management, Human Genome Sciences, Inc

3.30 Questions & discussion

3.35 Panel discussion
What is the optimal timing for licensing and partnering deals from both pharma and biotech perspectives in the current environment, and is this set to change?

3.50 Close of session followed by afternoon tea in the exhibition area

Then | Afternoon plenary
Defining and tackling the key leadership conundrums for the future of pharma and biotech

4.30 Presentations & panel discussion

• Optimizing innovation in the age of pharma-biotech R&D collaboration: What innovative management techniques may be employed on either side to bridge the culture gap between pharma and biotech?
  • Which differences in the way that biotech and pharma do things are perceived (and can therefore be addressed by a change in attitude) and which ones are real and fundamental?
• How will the sector evolve as a whole, and how must R&D leaders of the future adapt?
  • If the current price squeeze continues in the wake of the next US Presidential election, with the expected move towards a 'universal healthcare' model, how will the R&D model need to change and what particular management challenges will this evolution present?

Panelists:
Dr Keith James, Vice President, La Jolla Research Site Head, Pfizer Global R&D
M. J. Finley Austin, PhD, US Head, External Research & Innovation Environment, Hoffmann-La Roche Inc.
Robert Baltera Jr, CEO, Amira Pharmaceuticals
Dr Roy Baynes, Vice President, Clinical Development, Therapeutic Area Head, Oncology Supportive Care, Amgen, Inc
Dr Neil Weir, Senior Vice President, Research, UCB Celltech
Dr Peter L. Myers, Chief Executive Officer & Chairman of the Board, Lead Therapeutics

5.45 End of day 2 followed by a themed cocktail reception in the exhibition area

DAY 3 - Thursday, October 30th 2008

8.00 Registration & buffet breakfast in the exhibition area

Morning plenary session
The best of both worlds: Capitalizing on the ongoing convergence of pharma and biotech

9.00 Chair's introduction
Jens Oliver Funk, MD, Global Head of TA Oncology, Merck Serono Research, Merck KGaA

M&A: How to define the integration model up front, and how to then keep that dynamic post-deal?

9.05 From the pharma perspective...

• What was our thought process as we planned the acquisition in terms of how we would accommodate the biotech into our own operations?
  • How did we balance the benefits of autonomy versus integration and their respective effects on biotech innovation and flexibility?
• What have been our experiences so far in reality? What would we have replicated and what would we have done differently with the benefit of hindsight?

Frances Heller, Executive Vice President, Business Development, Exelixis, Inc (formerly Head, Strategic Alliances, Novartis Institutes for BioMedical Research)

9.30 ...And from the biotech perspective
How have we have capitalized on the benefits of being part of a larger organization while maintaining our own biotech culture and level of productivity?

• What have been the key specific integration opportunities and challenges, and to what extent do they need to be addressed in advance?
  • Context of the company being acquired defines future integration path (brief background of Adnexus going into the merger with BMS)
  • Establishing, fine tuning, and clearly communicating operating philosophy throughout organization crucial to post-merger success
  • Specific considerations by organizational area – opportunities & challenges
  • Where we are today & lessons learned

John B. Edwards, President, Adnexus Therapeutics, IncJohn B. Edwards, President, Adnexus Therapeutics, Inc

9.55 Questions & discussion

10.05 Keynote address
Genentech-Roche: What were/are the decisive factors in making the relationship work?

• Collaboration at the core of the Roche Group
• Factors which lead to a successful long-term partnership
  

Warwick S. Bedwell, Vice President & Global Head of Business Development, US, Hoffmann-La Roche Inc.

10.30 Questions & discussion

10.35 Analyst's perspective
Defining ongoing trends in partnerships and deal structuring between pharma and biotech

• As investors struggle to find liquidity, biotechs are struggling to stay alive. The financing environment is looking bleak, however alternative financing has been on the rise and new risk sharing alliance structures are allowing biotech to retain considerable upside with their partnered programs
• What types of partnerships structures are available today and what are the trade-offs of risk-sharing models?
• How are dealmakers successfully navigating the current environment, and what do you need to know?
  

Mike McCully, Director & Senior Analyst, Recombinant Capital, Inc

10.55 Questions & discussion

11.00 Morning coffee in the exhibition area

11.40 Case study
Taking a new approach to assessing collaborative R&D opportunities: How is Merck's R&D franchise-based model impacting the success rate of partnerships?

• Merck has been working with a franchise-based model for over two years now
• The result has been a significant and coordinated focus on licensing in a partnership between R&D and marketing, especially with regards to clinical stage assets
• This enhanced approach has been very valuable for Merck, and ensures that all parts of the company are in alignment with decisions regarding licensing candidates
• Four out of seven of Merck's late stage candidates have been licensed in, and three of those were brought into Merck in 2007
• How was this success achieved? How does Merck continually improve its alliance capabilities?

Dr Mervyn J. Turner, Senior Vice President, Worldwide Licensing & External Research, Merck Research Laboratories, Merck & Co, Inc

12.05 Questions & discussion

12.10 Reviewing an initiative designed to merge the best elements of big pharma and biotech R&D organizations - did the CEDD concept deliver for GSK?

• The CEDDs were formed at the merger of GlaxoWellcome and SmithklineBeecham to harness the nimbleness of biotech whilst retaining the economies of scale for large platform organizations
• The timelines of drug discovery and development mean that it is only now that an evaluation of the contribution of the CEDDs to the GSK pipeline can start to be meaningful
• Further evolution of the CEDD concept within GSK will be discussed

Professor Jackie Hunter, Senior Vice President, Science Environment Development, GlaxoSmithKline

12.35 Questions & discussion

12.40 Panel discussion

• The overall rate of failure for partnerships between pharma and biotech is still well over 50%. With the sector expected to rely increasingly on such partnerships moving forwards, what will be the key elements for either side to consider in seeking to improve this statistic?
• What is different about 'typical' licensing and partnering contracts written in 2008 compared to 10 years ago, and how the changing external environment might drive further changes
  • Will gaining reimbursement become a key milestone in early stage licensing and partnering deals moving forwards?
    • How else might R&D collaborations be affected by evolving payer requirements?
    • How will increasing post-marketing surveillance requirements be factored in to deals?

1.20 End of session followed by lunch & close of the R&D Leaders’ Forum 2008

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