R&D Leaders' Forum

1. 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, productivity, revenues and efficiency been improved?
   
   
2. How is the economic environment impacting partners for big pharma and biotech, and how will the value chain be protected?
   
   
3. What approaches are companies taking to get buy-in from payers and other stakeholders much earlier in the development cycle?
   
   
4. What is the structure of R&D to be right-sized, but to retain expertise and critical mass? Can focused mid-sized companies now match the performance of the larger scale multi-disease companies of the past?
   
   
5. How should R&D be responding to help shift the B:R balance in favour of benefit? At each touch point, how much benefit versus risk do you talk about?
   
   
6. How do you determine what is strategic or core to the business? How do you take a holistic look at the value chain to determine where externalization would provide greatest benefit in terms of risk, costs and value?
   
   
7. How should the pipeline be valued now if we are approaching it so differently? What new analytical processes might be required both from the outside looking in and also internally?
   
   
8. Balancing small molecules and biologics in a fully integrated drug development company: What are the governance decisions? What therapeutic areas have the best risk/reward proposition for biologics?
   
   
9. What are the latest approaches to portfolio management to support the business objectives of: Moving toward areas of highest unmet medical need; moving away from areas that will require large outcome studies; deciding which assets to out-license as they are no longer a strategic fit?
   
   
10. By moving away from R&D silos are we fundamentally redefining what we mean by disease area and, therefore, how we manage the business? At an operational level, how are these changes improving the viability of the business?
    
    
11. Is it possible to achieve PoC faster without increasing risk to patients? What do we take out of the development process? Is value being lost by killing too early and how cost effective is it proving to be?
    
    
12. How does disease burden and unmet need influence safety requirements? Are there any particular therapeutic areas where the REMS requirements are likely to be more extensive or inclusive?
    
    
13. How have adaptive trials fared in practice? What results have been achieved to date and what are the implications of the new regulatory guidelines?
    
    
14. How do you build a sustainable business round chronic diseases, orphan diseases and biosimilars? How will diversification be approached in the context of cost:benefit in the current economic climate?
    
    
15. New business models, new organizational structures, new cultures, new leadership... what do we really need in an era of financial structure and healthcare reform?