Key questions to be debated

Oncology Leaders’ Forum

1. The oncology clinical development model cannot operate efficiently in the current regulatory environment: Where do we go next?
2. Comparative effectiveness: How might it be employed, and what will be the implications for, and the impact on, drug development models?
3. How are regulators and industry adapting to increasingly stratified markets in oncology, and addressing the key remaining obstacles to the commercially feasible co-development of targeted therapeutics with companion diagnostics?
4. Examining big pharma and big biotech's short-, mid- and long-term strategies for replenishing their oncology pipelines: How are they addressing the challenges in balancing internal and external innovation?
5. How to rationally combine two or more experimental oncology therapeutics?
6. Comparing and contrasting the various screening and sequencing tools and technologies now available: Which ones have real practical utility relating to patient stratification?
7. Analyzing practical examples of novel adaptive clinical trial designs in oncology: To what degree can you remain nimble during clinical trials in order to alter design, patient population, and even endpoint, in a way that is acceptable to the regulator?
8. How do you translate data from late-stage/marketed drugs that work in a given pathway back to early R&D to look for synergies with other products and/or to inform development of early-stage products targeting the same (or a similar) pathway?
9. What is the current practical utility and future potential of key emerging technology/science areas including Circulating Tumour Cells, cancer stem cells and epigenetics?
10. Phase 0 trials in oncology: How useful are they in practice?

CNS Leaders’ Forum

1. Investing and divesting in the field: What does it mean to be in CNS, and how is pharma re-organizing around it?
2. What are the relevant target product profiles and positioning strategies to be able to survive regulation, to be attractive to patients, and to be reimbursed?
3. How close are we to a significant breakthrough? What are the implications of recent successes; what are we learning from the failures, particularly in AD and stroke?
4. Why is CNS drug discovery more risky, and why does it take longer for compounds to get to market, than non-CNS disorders? Lessons from both neurology and psychiatry
5. What’s next for discovery research in CNS? Where will pharma’s dollars be risked in order to get to phase II?
6. What has investment in translational / exploratory development models, imaging and validated biomarkers delivered to CNS?
7. Searching for novel meaningful endpoints and finding the most appropriate outcome to measure: What kind of supportive strategies are required? How can placebo response be controlled?
8. High risk early stage projects in CNS: What are the ideal roles for start-up companies / pharma / academia / advocacy groups?
9. Extending drug development in AD to earlier in the disease cycle: Where and when and how to do early intervention?
10. Combination and orphan indications: How to take, model and assess risk and value in CNS

R&D Leaders' Forum

1. What are the core competencies of a pharmaceutical company now? What does it now mean to head up a research or clinical development group?
2. With multiple externalization models to choose from, which work in which situations? How can companies maintain output and quality despite cost containment
3. What do we mean by innovation, how do we value it, and to what extent is it the role of pharma? Are there enough external opportunities to sustain growth and pipelines?
4. What is the role of emerging markets for pharma R&D? How to move aggressively into these markets to capitalize on the talent and make yourself relevant
5. Addressing the absolute conflict within pharma R&D between process / efficiency versus good science and building the knowledge base: What’s the future of attrition based portfolio management?
6. How well does big pharma really speak to biotech? Ensuring more productive dialogue upfront regarding deliverables and timeframes
7. What’s the value proposition for diversification – into healthcare, biologics, generics, regenerative medicine?
8. How can academia position / prepare itself to adapt and respond to externalization in pharma? What new models are needed for academia to play a more constructive role?
9. What breakthroughs are being achieved in building the compound rate of success, improving survival in phase I, and addressing the gap between PoC, phase II and phase III?
10. What have different organizational models in pharma R&D really achieved? Is it time for the architects to change?
    
    

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