8.55

Presentation reserved

Judgement of value and the reward for innovation: How are the perspectives and practices of payers/healthtech evaluators in the US and Europe evolving with regard to pricing and reimbursement of novel therapeutics, and in terms of improving healthcare standards in general?

• How do we define 'value' in oncology, CNS and other therapeutic areas? Will there be a long-term trend towards value-based reimbursement on a global basis?
• How are we viewing methods/considerations for reducing the cost of delivered care (eg. comparative effectiveness research)?
• How can payers make best use of their data streams externally? How can biopharma benefit?
• What role will real life studies play in reimbursement?
• We have seen in the small molecule space that fundamentally inferior (in terms of benefit) generic versions of Lipitor gained immediate traction in the marketplace purely on the basis of cost savings. How will this 'lack of superiority' play out against potential cost savings for healthcare providers in the oncology and CNS spaces as biogenerics emerge?

9.15

US perspective

Speaker to be announced

9.35

Questions & discussion

9.40

European perspective
Healthtech evaluator's perspective

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

10.00

Questions & discussion

10.05

Industry keynote address
How can the industry make the case in R&D for the reimbursement of premium-priced medications in an increasingly cost-averse environment?

Joanne Waldstreicher, MD, Chief Medical Officer, Johnson & Johnson, Pharmaceuticals

10.25

Questions & discussion

10.30

Roundtable discussion
Comparative effectiveness: How might it be employed and what will be the implications for, and the impact on, drug development models?

• What will be the key differences between US and European payers’ incorporation of comparative effectiveness research?
  • What impact will it have on reimbursement?
  • What impact will it have on milestones in deal making / licensing?
    • How will it be applied?
• How does clinical development play in to healthcare authorities, and how can the industry provide the sorts of outcomes-related data that will satisfy them?
• What comparative trials does it make sense for pharma and biotech companies to run?
  • How to evaluate health economic outcomes earlier in development?
• How to approach the future with regard to fast-followers in oncology?

Panellists:
Roy Baynes, MD, PhD, Vice President, Global Development & Therapeutic Area Head Hematology/Oncology, Amgen, Inc
David Weiner MD, Senior Medical Director, Head of Early Clinical Development, Neurology Global Clinical Development Unit, EMD Serono, Inc
Dr Michael Krams, Vice President - Head of Neurology Franchise, Johnson & Johnson

11.10

Morning coffee in the exhibition area

Comparing big pharma strategies: Case studies reflecting different objectives for entering these markets, which will also discuss

11.55

How to move aggressively into these markets and make yourself relevant

• How to unfold and capitalize on talent in emerging regions
• Integrating global drug development strategies
• Fixed vs flexible cost models: If you set up in emerging markets how does that impact investment and facilities in the west?
• What disease areas to treat – local / western?
• How to approach global simultaneous registration

Michelle Dipp, MD, PhD, Senior Vice President, Head of CEEDD, GlaxoSmithKline

12.15

Questions & discussion

12.20

Local outsourcing to expand R&D footprint

• The importance of creating win-win local R&D partnerships
• Looking beyond the obvious for near- and long-term impact
• An emerging market case study demonstrating the use of local capabilities and talent development

Sam Azoulay MD, Senior Vice President of Medical & Development, Emerging Markets, Pfizer, Inc

12.40

Questions & discussion

12.45

Case study

Speaker to be announced

1.05

Questions & discussion

1.10

Buffet lunch in the exhibition area

OR

Lunch workshop
(Highly interactive optional session for a maximum of 50 participants)
Sponsored by

Comparative effectiveness: Strategies, trends, the impact on healthcare reform and the tools to empower key stakeholders in informed decision-making

Speakers:
Wendy Hamilton, Senior Vice President, Product Strategy & Operations, Healthcare & Science, Thomson Reuters
Tami L. Mark, PhD, MBA, Director Analytic Strategies, Healthcare & Science, Thomson Reuters

» Click here for more information

Emerging market R&D leaders discuss common and particular issues and opportunities in their country / region

• IP, quality, skills – strengths and weaknesses
• Investment climate and risk
• Existing and emerging areas of unmet need
• Progress with regulatory harmonisation
• Approaches to integrated global drug development
  
• Collaboration and integration models

2.20

Case study – China

China Novartis Institutes for BioMedical Research – name of speaker to be announced

2.40

Questions & discussion

2.45

Case study – India

Rashmi H. Barbhaiya, PhD, CEO & Managing Director, Advinus Therapeutics Pvt Ltd

3.05

Panel discussion
To what extent can you have a single emerging market strategy?

• What are the major points of difference between each of the major emerging countries / regions?

3.50

Afternoon tea in the exhibition area

4.40

Questions & discussion

4.45

Diversification towards biologics: What new capabilities and competencies will be needed for.

• innovation in target discovery;
• innovation in development;
• innovation in therapeutic moieties?

Terry Hermiston, PhD, Site Head, US Innovation Center & Vice President, Biologics Research, Bayer Healthcare Pharmaceuticals

5.10

Panel discussion
Capitalizing on the next wave of opportunities: How will pharma access the competencies required, and what’s the value proposition in diversification?

• Biologics beyond oncology / inflammation and monoclonals
  • 1st oral biologic – impact of the paradigm shift
• Generics and biosimilars: Opportunity or threat?
• Diagnostics, disease management
• Regenerative medicine – how to enter – what’s the opportunity?

Panellists:
Dr Alan B. Ezekowitz, Senior Vice President, Franchise Head, Bone, Respiratory, Immunology & Dermatology, Merck Research Laboratories
Roy Baynes, MD, PhD, Vice President, Global Development & Therapeutic Area Head Hematology/Oncology, Amgen, Inc
David Donabedian, Vice President of Strategic Alliances, US CEEDD, GlaxoSmithKline
Detlev Biniszkiewicz, PhD, Global Head of Portfolio Management and Analysis, Novartis Institutes for BioMedical Research,

6.00

Close of day 2, followed by a themed cocktail reception, sponsored by The Institute for Neurosciences at Brigham and Women's Hospital, in the exhibition area

9.05

Financial market view of 2009–2010: Was big pharma’s commitment to externalization as big as was promised?

• How to value an external versus an internal portfolio
• Are there enough external opportunities to sustain growth and pipelines?
• Analyzing the variations in licensing strategies between big pharma
• How have recent M&As – including mid-sized company acquisitions – impacted externalization?

Dr Andrew Baum, Managing Director, Equity Research, Morgan Stanley

9.30

Questions & discussion

Keynote addresses
Smarter research and innovation models in pharma: Is Seek and Develop the answer? How will the trend evolve?

• How big should internal research be?
• In-house versus outsourcing / out-licensing in discovery – when to do it yourself?
• Better strategies to bring in / share assets and be more efficient: Using relationships to enhance pipeline development
• Managing relationships when a considerable % of the portfolio is outsourced
• Maintaining output and quality despite cost containment
• How is the ‘virtual’ pharma model working?
  

9.35

Dr David Nicholson, Senior Vice President, Worldwide Licensing & Knowledge Management, Merck & Co, Inc

10.00

Questions & discussion

10.05

Speaket to be announced

10.25

Questions & discussion

10.30

Smarter research models outside pharma: Managing innovation globally

• How GM has transformed its R&D organization from one laboratory site with 5% of resources spent externally to eight global lab sites with 30% external spending
• Best practices for making it simple for researchers to collaborate externally
• Increased global opportunities, in recent times, for greater government funding
• The streamlining of GM's internal gate processes for getting advanced technical work into GM products and processes

Alan I. Taub, PhD, Vice President, Global Research & Development, General Motors Company

10.50

Panel discussion
What do we mean by innovation, how do we value it, and to what extent is it the role of pharma?

• What is the value of innovation to payors and patients: Driving for ‘applied’ science
• Balancing innovation & risk in the portfolio
• Open innovation – how to get it into the business?
  • Capitalizing on the digital interface
• Innovation opportunities arising from the merger of engineering and pharma
  
• How to measure and reward innovation: What are the business models to enable it?

Panellist:
Dr Michael M. Morrissey, President of Research & Development, Exelixis, Inc

11.10

Morning coffee in the exhibition area

11.55

Academia: Earlier collaboration and synergy with academia to achieve better bartered deals

• How can academia position / prepare itself to adapt and respond to externalization in pharma?o
• Has academic medicine become translational enough?
• What new models are need for academia to play a more constructive role in
  • Target selection / molecular target validation
  • Lead discovery and optimisation
  • New technologies for toxicology and PK beyond standard approaches
  • clinical trials
  • Orphan drug development
• Where and how do you draw the line for IP?
• Ensuring equivalent returns so that value is created jointly
• Comparing the situation in US and EU

Dr Alan B. Ezekowitz, Senior Vice President & Franchise Head, Immunology, Respiratory & Endocrine, Merck Research Laboratories

12.15

Questions & discussion

12.20

Biotech: Improved dialogue, collaboration and healthier risk-sharing models with pharma

• How well does big pharma really speak to biotech? Ensuring more productive dialogue upfront regarding deliverables and timeframes
• Can you achieve closer interaction without biotech feeling they are in the pocket of one company?
• Who should be involved in deal structuring?
• Deal comparables for licensing early stage assets eg mid lead optimization

Zafrira Avnur, PhD, Head, Global Academic Innovation Partnering, F. Hoffmann-La Roche Ltd

12.40

Questions & discussion

12.45

VCs: How is their appetite for early and late stage deals evolving?

• VC views on pharma’s model of getting out of research altogether

Sandra Panem, PhD, Partner, Cross Atlantic Partners

1.05

Panel discussion

• There are multiple externalization models: Which work in which situations?
• Analyzing funding mechanisms: Are they driving productivity or demise?
• How are CRO models evolving? How much control do you lose – with what results?

Panellist:
Dr Michael M. Morrissey, President of Research & Development, Exelixis, Inc
Terry Hermiston, PhD, Site Head, US Innovation Center & Vice President, Biologics Research, Bayer Healthcare Pharmaceuticals

1.30

Lunch

12.10

Questions & discussion

12.15

Managing a mixed portfolio of small vs large molecules: Getting the portfolio that you want

• Managing the bolus of biologics moving through the pipeline of so many companies – balancing a small molecule pipeline with a growing biologics portfolio
• Ensuring the sustainable production of clinical candidates for all therapeutic areas

Dr John G. Houston, Senior Vice President, Applied Biotechnology & Discovery Biology, Bristol-Myers Squibb

12.35

Questions & discussion

12.40

How might the ‘science’ of portfolio management in the finance sector be applied to pharma to help reduce attrition?

• What constitutes a quality candidate coming out of research?
• Does the process know the right questions to ask?
• Balancing risk in the portfolio

Dr Richard Evans, Managing Partner, Sector & Sovereign, LLC

1.00

Panel discussion
Running an attrition-based portfolio versus investment in feedback, deeper project understanding and predictive science

• Building in feedback loops from clinical to discovery to inform decision-making, predict efficacy and reduce attrition
• How to build in time for this? What does it mean for value?
• Addressing the absolute conflict within pharma R&D between process / efficiency versus science / building knowledge base
• How will this help to build the compound rate of success and improve survival of phase I and address the gap between PoC, phase II and phase III?
  

1.30

Lunch

3.30

Afternoon tea & close of the R&D Leaders’ Forum 2010