New Pharmaceuticals market report from CBR Pharma Insights: "Adaptive Licensing - A Holistic Approach to Drug Development and Regulation"
Boston, MA -- (SBWIRE) -- 10/01/2014 -- 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.
View Full Report Details and Table of Contents
- Adaptive Licensing: Overview
- A Declining Industry - How AL can tackle issues with the current system
- Challenges for AL
- 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
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.
About Fast Market Research
Fast Market Research is a leading distributor of market research and business information. Representing the world's top research publishers and analysts, we provide quick and easy access to the best competitive intelligence available. Our unbiased, expert staff is always available to help you find the right research to fit your requirements and your budget. For more information about these or related research reports, please visit our website at http://www.fastmr.com or call us at 1.800.844.8156.
Browse all Pharmaceuticals research reports at Fast Market Research
You may also be interested in these related reports:
- Kyowa Hakko Kirin Co., Ltd. (4151) - Pharmaceuticals & Healthcare - Deals and Alliances Profile
- Genentech, Inc. - Pharmaceuticals & Healthcare - Deals and Alliances Profile
- Janssen Biotech, Inc. - Pharmaceuticals & Healthcare - Deals and Alliances Profile
- 3M Drug Delivery Systems - Pharmaceuticals & Healthcare - Deals and Alliances Profile
- Cancer Research UK - Pharmaceuticals & Healthcare - Deals and Alliances Profile
- Cancer Research Technology Limited - Pharmaceuticals & Healthcare - Deals and Alliances Profile
- Eli Lilly and Company (LLY) - Pharmaceuticals & Healthcare - Deals and Alliances Profile
- Drug Delivery Partnering Terms and Agreements
- Drug Addiction - Pipeline Review, H2 2014
- Wounds - Pipeline Review, H1 2014