[November 26, 2014]

Research and Markets: Holistic Approach to Drug Development and Regulation for the Adaptive Licensing Markets

Research and Markets (http://www.researchandmarkets.com/research/6r8vnq/adaptive) has announced the addition of the "Holistic Approach to Drug Development and Regulation for the Adaptive Licensing Markets" report to their offering.

More robust data from post-license surveillance studies are used to determine full license permission. Improvements in the alignment of stakeholder needs in a fluid system, overall costs and patient access times can be reduced. However, uncertainty still exists around the approach, and it is clear that cultural and political changes will be necessary to realize the full potential of AL.

Adaptive Licensing (AL) is a flexible approach to drug development and regulation, with two live pilot schemes accepted by the European Medicines Agency (EMA (News - Alert)). The system acknowledges that levels of uncertainty will always surround innovative treatments. An initial license is granted a an earlier stage than possible under the traditional system, with less clinical information from Randomized Controlled Trials (RCTs). After the initial license is granted, the entry to market is heavily restricted, and the patient population is carefully monitored through observational studies, electronic devices and registries.

Scope:

• Adaptive Licensing: Overview
• Introduction
• A Declining Industry - How AL can tackle issues with the current system
• Strengths
• Challenges for AL
• Proponents
• Current Adaptive Licensing
• Precursors - Current systems within the traditional drug licensing framework that will act as facilitators to AL
• Legality - Feasibility of AL across different jurisdictions
• Employing Adaptive Licensing - EMA pilot scheme information, practical strategies
• Future Adaptive Licensing
• Transformative Strategies - Future utility of AL requiring legislative change
• Commercial Considerations
• Pricing and Reimbursement with AL
• Market Exclusivity
• Achieving Value through AL
• Value-at-risk

Key Topics Covered:

1. Methodology
2. Adaptive Licensing: Overview
3. Introduction
4. A Declining Industry
5. Strengths
6. Challenges
7. Proponents of Adaptive Licensing
8. Current Adaptive Licensing
9. Precursors
10. Legality
11. Employing Adaptive Licensing
12. Future Adaptive Licensing
13. Transformative Strategies
14. Commercial Considerations
15. Pricing and Reimbursement
16. Market Exclusivity
17. Achieving Value
18. Value-at-risk
19. Summary

For more information visit http://www.researchandmarkets.com/research/6r8vnq/adaptive

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