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Adaptive Licensing Market - Approach to Drug Development and Regulation: Radiant Insights

( New Market Research Reports Title “Adaptive Licensing Market Research Report: Radiant Insights, Inc" Has Been Added to Report Database.
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.

Access Full Report With TOC at:


• 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

See More Reports of This Category by Radiant Insights:

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.

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About Radiant Insights

Radiant Insights is a platform for companies looking to meet their market research and business intelligence requirements. We assist and facilitate organizations and individuals procure market research reports, helping them in the decision making process. We have a comprehensive collection of reports, covering over 40 key industries and a host of micro markets. In addition to over extensive database of reports, our experienced research coordinators also offer a host of ancillary services such as, research partnerships/ tie-ups and customized research solutions.

For more information, visit:


Company Name: Radiant Insights, Inc. Contact Person: Michelle Thoras, Corporate Sales Specialist - USA Email: Phone: (415) 349-0054, Toll Free: 1-888-202-9519 Address:28 2nd Street, Suite 3036 City: San Francisco State: Califonia Country: United States Website:

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