Adaptive Licensing - A Holistic Approach to Drug Development and Regulation

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Adaptive Licensing - A Holistic Approach to Drug
Development and Regulation
(Type, Mode of action, Crop Type and Geography) -
Size, Share, Global Trends, Company Profiles,
Demand, Insights, Analysis, Research, Report,
Opportunities, Segmentation and Forecast, 2013 -
2020
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Published on Oct 2014
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Report Overview

• 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.
• Read More At http//www.researchbeam.com/adaptiv
  e-licensing-a-holistic-approach-to-drug-developmen
  t-and-regulation-market

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Report Overview

• 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

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Report Overview

• - 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

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