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Adaptive Licensing - A Holistic Approach to Drug Development and Regulation

Published: Jun 2015 | No Of Pages: 79 | Published By: CBR Pharma Insights

Adaptive Licensing (AL) is a flexible approach to drug development and regulation, with two live pilot schemes accepted by the European Medicines Agency (EMA). The system acknowledges that levels of uncertainty will always surround innovative treatments. An initial license is granted at 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. Data from ongoing RCTs, and the more robust data from post-license surveillance studies are used to determine full license permission. By improving 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. 
 
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 Reasons to Purchase
 
Adaptive Licensing is a highly current topic. In March 2014, the EMA (European Medicines Agency) began to invite drug developers to apply for involvement in the pilot projects.
Currently, two drug development programs have been accepted by the EMA as pilots. Three were rejected, four are in reserve and 11 are still under consideration.
AL is part of a suite of global initiatives with shared features. These include: Staggered Approval, Progressive Authorisation, Conditional Licensing and, more recently, Medicines Adaptive Pathways (MAPs) or Medicines Adaptive Pathways to Patients (MAPPs).
The high level of variance in AL approaches and scarcity of practical information justifies the need for an unbiased report of the strengths, weaknesses and opportunities for this system.

If pilots are successful, AL may become more widely used across all regions, and also play an important role in shaping future regulatory policy, with the potential to affect all healthcare stakeholders.

This new CBR report examines all existing information, and builds on that with conference attendance and new primary research with KOLs and figures central to the movement. It creates a balanced view, and provides an understanding of the current status and potential implications.
 

Methodology
Adaptive Licensing: Overview
Introduction
A Declining Industry
Strengths
Challenges
Proponents of Adaptive Licensing
Current Adaptive Licensing
Precursors
Legality
Employing Adaptive Licensing
Future Adaptive Licensing
Transformative Strategies
Commercial Considerations
Pricing and Reimbursement
Market Exclusivity
Achieving Value
Value-at-risk

Summary
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