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Key questions to be debated
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R&D Leaders' Forum
- How will new reimbursement models evolve as we move towards cost-effectiveness criteria? What will be the role of evidence-based medicine?
- How do you assess the true risk profile for a drug in the face of increasing regulatory and commercial uncertainties?
- How can a product's '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 to post-marketing surveillance work - being affected?
- What exactly are today's core competencies for pharma and biotech, and will they remain so? How much money can really be saved through outsourcing/offshoring R&D operations in future?
- 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?
- When and how to engage with payers in the drug development process? How can the industry partner better with payers, moving forwards?
- How can big biotech maintain the culture of innovation, flexibility and efficiency that brought initial success as both scale and external cost/price pressures increase
- In reality, just how big a threat - or opportunity - are biosimilars to pharma and biotech R&D?
- How does the VC community see the future evolution of the drug discovery model given the expected economic pressures?
- What are the keys to successfully balancing resource allocation in a biologics – or mixed modalities - R&D portfolio?
- What sort of data can demonstrate the productivity of a biologics R&D group? How do you convince management and analysts alike that this data represents evidence of ongoing productivity and performance?
- 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?
- 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?
- M&A: How to define the integration model up front, and how to then keep that dynamic post-deal?
- What innovative management techniques may be employed to bridge the culture gap between pharma and biotech?
- Note to NM – add more here to even up with Oncology – esp re China/India etc
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Oncology Leaders' Forum
- Which endpoints are most appropriate for consideration of commercial value? Overall survival? Progression of disease/metastasis?
- How are Patient Reported Outcomes being applied to pricing and reimbursement decisions globally? What would it take to design a clinical trial based on PROs that would meet with regulatory approval?
- Is the financial risk of diagnostic development lower than the risk of moving towards pay-for-performance reimbursement? What data do you need to justify the investment?
- What is the advice for companies wanting to make compatible efforts to satisfy EU and US regulatory agencies?
- Should we conduct clinical trials guided by biomarkers? Do we know enough to take the risk? What are the pros and cons economically?
- When should you do randomized studies in oncology? If you are adding your new drug to a regimen how can you prove effectiveness without randomization? What impact have randomized phase II trials had on attrition rates?
- How does patient stratification impact the cost of patient and physician recruitment in clinical development?
- What dosing margins are necessary for oncology – wide or narrow? Debating dose selection for combination products and targeted therapies
- What lessons have been learned regarding progression-free survival versus overall survival, particularly in open label studies? When is time-to-progression useful – always, sometimes, never?
- What role will partnerships and risk-sharing deals play, especially for non-targeted agents like cytotoxics or supportive care?
- What will it take to achieve a significant impact on survival? What progress is being made in terms of improved characterization of cancer type and stage?
- What do inferiority / superiority really mean in an era of population subsets? How will the identification of new population subsets impact on the label?
- What are the options for financing a comparator drug that may not be reimbursed as standard of care for that indication?
- What does it take to reintroduce an old drug for oncology? How would you manage your way through the IP system and the development process?
- At what point should the development of diagnostic tools and therapeutic tools be integrated? Is Proof of Concept too late?
- How can industry ensure that diagnostic tests will be used and interpreted properly by patient/clinician?
- What are responsible and practical approaches to cancer drug development for rare pediatric indications?
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