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DAY 2 | Tuesday 11th March
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| 8.00 |
Registration & morning coffee in the exhibition area |
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Morning plenary session
How does each stakeholder group assess value, benefit and risk and decide what is acceptable? How should R&D respond?
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| 9.00 |
Chair’s introduction
David P. Recker, MD, FACR, FACP, Senior Vice President, Clinical Science, & Interim President, Takeda Global Research & Development Center, Inc
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| 9.10 |
Payers perspective: Balancing price, cost and value
- How will payers write policy for highly expensive drugs? How will they continue to afford to fund them?
- As more drugs become expensive combinations how will this burden be managed by payers?
- How to assure that they will be utilized appropriately
Dr Carole Longson, Director, Centre for Health Technology Evaluation, National Institute for Health & Clinical Excellence (NICE)
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| 9.35 |
Questions & discussion |
| 9.40 |
Roundtable discussion
How do different stakeholders assess value and what is required on the part of the industry to demonstrate it?
- Learning from the NICE model – is there any movement in US to more collective decisions on value for money?
- What constitutes value – from the perspective of patient / physician / payer / shareholder / industry
- What information does industry need to be able to communicate in order to demonstrate value to different stakeholders?
- What product value propositions/ evidence does industry need to develop in order to convince payers?
- What type of information is accepted? What is most convincing for stakeholders: The label, publications of randomized clinical studies in premier journals, CE models, budget impact models, registries? Is global data evidence good enough, how much are local HE data is needed...?
- At what point in time – pre-launch, at launch, post-launch - is this information most valuable?
- What impact is value having on the traditional R&D model?
- At what point in time should payers be consulted by industry and how much should they be involved in industry development decisions as compared to the early and frequent interactions with Regulatory Health Authorities?
- Building patient-centric networks and re-thinking the education of physicians about new drugs - what should be the role of R&D in this process?
- Full service approach: What evidence is there that patients / payers / physicians might value more complete solutions from biopharma?
- When will ‘right patient / right dose’ really take off and what impact will it have on perceived value?
Moderator:
Dr Ulrich Goldmann, Vice President & Global Head of Medical Affairs, Novartis Pharmaceuticals Corp
Panellists:
Leonard D. Reeves, MD FAAFP, Assistant Director, Floyd Family Medicine Residency
John Hardin, MD, Chief Scientific Officer, Arthritis Foundation
Stanley B. Watson, Vice President & Director, Kaiser Foundation Research
Institute
Bill Crown, President, i3 Innovus
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| 10.40 |
Morning coffee in the exhibition area |
| 11.20 |
Keynote address
How Avandia, COX-2 selective NSAIDs, and WHI changed our idea of what safety concerns are
Dr Robert J. Temple, Director, Office of Medical Policy, FDA
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| 11.45 |
Panel discussion
The regulatory view of acceptable benefit:risk appears to have changed in the post-Vioxx/Avandia world, which raises many questions:
- What methods will regulators use to assess the ratio?
- To what degree is/should unknown post-marketing risk be considered in the approval process?
- What methods are appropriate for quantifying risk?
- What’s the difference between relative and absolute risk?
- What’s the incentive for determining tiny values of risk?
- Can "acceptable risk" be defined? How should this be considered as part of portfolio management?
- What is the regulatory response to criticism of over conservatism?
- 50% of regulatory decisions are based on trust alone. Is trust more important than data?
Moderator:
Dr Wayne A. Rosenkrans, Director, External Relations, Evidence-based Medicine & Personalized Healthcare, AstraZeneca
Panellists:
Dr Robert J. Temple, Director, Office of Medical Policy, FDA
Dr Steven W. Ryder, Senior Vice President & Therapeutic Area Development Group Head, Pfizer Global R&D
Dr Alan Breier, Chief Medical Officer & Vice President, Medical, Eli Lilly and Company
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| 12.50 |
Buffet lunch in the exhibition area |
| OR |
Optional lunch briefing
Defining a drug development outsourcing strategy
Sponsored by 
(Highly interactive session for a maximum of 50 participants)
- Current state of the drug development outsourcing market
- Overview of outsourcing operating models and how companies are implementing these models to accomplish their drug development goals
- The impact of current drug development issues on the future of outsourcing
- How pharma/biotech should define an outsourcing strategy
Speakers:
Thomas Privette, Vice President, Strategic Partnering, Covance Inc
Charles Farkas, Partner, Bain & Company
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| OR |
Working Lunch
Filtering compounds for toxic liabilities early in the drug discovery & development process via Cellular Systems Biology
(very informal, discussion-based optional session for a maximum of 12 participants)
Moderator:
Dr D. Lans Taylor, President & CEO, Cellumen, Inc
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| OR |
Working Lunch
Attracting, securing and retaining R&D talent in a changing environment
(very informal, discussion-based optional session for a maximum of 12 participants)
- What are the key imperatives or trends that help or hinder innovation?
- How have these imperatives changed in the past 10 years?
- Will the evolution of the industry impact the talent base required for innovation? How?
- What do you need to do and what kind of people do you need to have to prepare for the next 10 years?
- What do you need to do to keep your talent in place?
Moderators:
Denise DeMan-Williams, Founder, Chairman & Chief Executive Officer, Bench International
Stephen J. Williams, PhD, President & Chief Business Officer, Bench International
Charlene Reed, PhD, Senior Vice President, Bench International
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Followed by your choice of 3 highly interactive parallel sessions:
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Focus session 1
Assessing recent progress in the early prediction of safety
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| 2.00 |
Chair’s introduction & opening presentation
How good are the preclinical tools that we now have for predicting safety in humans?
- What is the progress with early assessment tools for safety, prior to doing first GLP tox studies?
- Do we have enough confidence in modelling and simulation data to use it for decision-making?
- What are the data interpretation issues and what progress is being made with harmonization and consortia efforts?
Dr Paul Trennery, Senior Vice President of Safety Assessment, GlaxoSmithKline
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| 2.25 |
Questions & discussion |
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Case studies from the therapeutic areas making the greatest headway with the application of tools for the assessment of early safety: What are the results and the pay back to date? How can these examples be used to inform other areas?
- Are we focusing on deeper and broader understanding of the efficacy target, so we can predict potential 'on target' or 'near target' liabilities of the biochemical intervention earlier?
- Are there more innovative approaches or decision trees that help understand target organ toxicity and support decision-making, prior to conventional repeat dose GLP studies?
- Application and results from modelling and simulation tools
- Latest results from novel predictive safety markers and their early utility
- Use of stem cells for early toxicology testing
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| 2.30 |
Case study
Drug-induced phospholipidosis: Improving our understanding of structure/toxicity relationships and development of screening strategies for application in drug discovery
- What is phospholipidosis and is it really a clinical safety concern?
- Development of in silico and in vitro screening strategies
- Predictivity of in vivo toxicities and tissue effects
Dr Martin Dyroff, Senior Director, Safety Assessment US, Global Safety Assessment, AstraZeneca Pharmaceuticals
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| 2.55 |
Questions & discussion |
| 3.00 |
Case study
Early safety assessment: Application of structure/property based modelling & simulation in discovery and early preclinical development
- Importance of early safety considerations
- Fundamentals in predictive toxicology (in silico)
- Case examples: CV-toxicity prediction
- Today's challenges, tomorrow's solutions
Dr Manfred Kansy, Head, Molecular Properties & Structure Property Correlation, F. Hoffmann-La Roche Ltd
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| 3.25 |
Questions & discussion |
| 3.30 |
Panel discussion
What are the mechanisms to enable the data sharing that is critical to the future of in silico modelling?
- Is the industry ready to evolve more focused partnerships in understanding the significance of early non-clinical safety related screen based information, so models and SAR algorithms can be more effectively developed?
- What barriers remain and how can we move this forward?
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4.10
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End of focus session followed by afternoon tea in the exhibition area
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OR | Focus session 2
Transforming discovery research by stepping up collaboration within biopharma, and externally via academia and public/private partnerships
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| 2.00 |
Chair’s introduction & opening presentation
What are the successful models for bio/pharma collaboration and also pharma/pharma collaboration in research?
- Sharing risks, capabilities and resources – how does it work in practice?
- In a sellers’ market for new product ideas, how involved should the biotech be in decision-making and commercialization?
- Which models for collaboration have proved most successful?
Dr Sandy Macrae, Vice President of Scientific Licensing, GlaxoSmithKline
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| 2.20 |
Questions & discussion |
| 2.25 |
Case study
Efficiently and effectively collaborating with biotech and academia: Identifying and overcoming the major sticking points
- Tapping into emerging translational science – how are models evolving for engagement with academia?
- Establishing clear objectives and realistic value assessments in order to best structure the deal
- What is academia looking for from its pharma partner?
- What is biotech looking for from its pharma partner?
- How are the issues around IP and control being resolved? What is the role of IP pooling?
Frances Heller, Head, Strategic Alliances, Novartis Institutes for BioMedical Research
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| 2.45 |
Questions & discussion |
| 2.50 |
Speaker to be announced
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| 3.10 |
Questions & discussion |
| 3.15 |
The Marriage of the Mind - making biopharmaceutical collaboration work
- Collaboration is difficult as the failure of so many biopartnering arrangements demonstrates. But most senior executives now recognize the importance of collaborations in driving innovation and growth by generating new ideas and using different mechanisms to incubate and commercialize ideas; they understand that there is no such thing as a monopoly when it comes to innovation. This session will present a new R&D model that focuses heavily on innovation through external collaborations, embracing a different approach to the business of science. Learn how to unlock this intellectual capital by aligning your company strategy and structure with your scientific goals, manage internal and external boundaries, and remain committed to the shared enterprise. Enabling tools and technologies crucial for enabling all the participants to communicate and collaborate, unimpeded by distance will also be discussed
Salima Manji Lin, Associate Partner, IBM Global Business Services
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| 3.40 |
Panel discussion
What are the main differences when collaborating with these different partners and how can pharma deliver what’s required of it in order to be attractive to the other group?
Panellist:
David P. Recker, MD, FACR, FACP, Senior Vice President, Clinical Science, & Interim President, Takeda Global Research & Development Center, Inc
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4.10
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End of focus session followed by afternoon tea in the exhibition area
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OR | Workshop
Optimizing late stage clinical trials to capitalize on opportunities for product differentiation and value creation pre-licensure
Highly interactive session for a maximum of 30 participants
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| 2.00 |
Chair’s introduction & opening presentation
Building in differentiation and positioning a new compound pre-licensure –what’s the benefit:risk?
- What tools can you use to test for additional indications and build in greater differentiation pre-license?
- Leveraging biomarkers in late stage trials for differentiation in the marketplace – what examples are there? What value has been added?
- How much can you learn from small sample sizes or do you have to wait for large in-market trials?
Dr William Z. Potter, Vice President, Franchise Integrator Neuroscience, Merck Research Laboratories
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| 2.25 |
Questions & discussion |
| 2.30 |
Case study
Predicting likely health outcome by modeling treatment characteristics and patient behaviors: application to immunosuppressants in kidney transplantation.
- Linking pharmacokinetic properties of a compound to benefit/risk
- Understanding drug adherence and its impact on clinical outcome
- Simulating trials to enhance label claims
Ross Maclean, MD, Executive Director, Global Outcomes Research Strategy, Bristol-Myers Squibb
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| 2.55 |
Questions & discussion |
| 3.00 |
What are going to be the criteria for outcomes studies going forward?
- Patient reported outcomes as metrics of efficacy and as endpoints sufficient for approval
- Are outcomes studies going to be the cost of entry now – especially in some areas such as cardiovascular?
- What size of trial will constitute an adequate package for approval?
Dr Ari Gnanaskthy, Head, Research Operations, Health Economics & Outcomes Research, Novartis Pharmaceuticals Corp
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| 3.25 |
Questions & discussion |
| 3.30 |
Panel discussion
When is the optimum time to conduct rigorous, large, simple trials?
- Before or after market?
- How will they be funded?
- What does the regulator want to see?
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4.10
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End of focus session followed by afternoon tea in the exhibition area
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Then | Afternoon plenary session
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| 4.50 |
Identifying and developing qualified leaders to manage the transformation of R&D
- What are the current limitations of leaders that prevent companies from doing the unexpected? Or are we just a highly conservative industry?
- Do biotech leaders have a different style of leadership? What can pharma learn from their approach?
- Or is it just a question of scale – the larger you become the more pharma-like you become in leadership mindset?
- Will transformation only happen in pharma when there’s a serious crisis? What will it take?
- What steps are required to prepare 2nd and 3rd level potential leaders to enable transformation whenever it’s required?
- How much empowerment and flexibility do scientists really have? Is it always limited by restrictions from the top?
Dr Richard J. Heaslip, Vice President, Project & Portfolio Management, Wyeth Research
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| 5.15 |
Questions & panel discussion
Panellist:
Ellen Strahlman, MD, MHSc, Vice President, Worldwide Business Development, Pfizer Inc
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| 5.30 |
Close of day 2 followed by a themed cocktail reception in the exhibition area |
