1. Market Research
  2. > Pharmaceutical
  3. > Drug Discovery and Development Market Trends
  4. > Adaptive Licensing - A Holistic Approach to Drug Development and Regulation

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

ScopeKey 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.

Table Of Contents

Adaptive Licensing - A Holistic Approach to Drug Development and Regulation
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

View This Report »

Get Industry Insights. Simply.

  • Latest reports & slideshows with insights from top research analysts
  • 24 Million searchable statistics with tables, figures & datasets
  • More than 10,000 trusted sources
24/7 Customer Support

Talk to Veronica

+1 718 514 2762

Purchase Reports From Reputable Market Research Publishers
Bioinformatics Market by Sector (Molecular Medicine, Agriculture, Forensic, Animal, Research & Gene Therapy), Product (Sequencing Platforms, Knowledge Management & Data Analysis) & Application (Genomics, Proteomics & Metabolomics) - Global Forecast to 202

Bioinformatics Market by Sector (Molecular Medicine, Agriculture, Forensic, Animal, Research & Gene Therapy), Product (Sequencing Platforms, Knowledge Management & Data Analysis) & Application (Genomics, Proteomics & Metabolomics) - Global Forecast to 202

  • $ 5650
  • Industry report
  • October 2016
  • by MarketsandMarkets

The global bioinformatics market is projected to reach USD 16.18 billion by 2021 from USD 6.21 billion in 2016, growing at a CAGR of 21.1% during the forecast period. In this report, the bioinformatics ...

Clinical Trial Management System Market by End-user, Delivery Mode, Type, Component - Global Forecast to 2021

Clinical Trial Management System Market by End-user, Delivery Mode, Type, Component - Global Forecast to 2021

  • $ 5650
  • Industry report
  • August 2016
  • by MarketsandMarkets

The global clinical trial management system (CTMS) market is estimated to grow at a CAGR of 11.5% from 2016 to 2021, to reach USD 920.0 billion by 2021. The adoption of CTMS software is on the rise across ...

Contract Research Organizations Services Market by Type, Therapeutic Area, End User - Global Forecast to 2021

Contract Research Organizations Services Market by Type, Therapeutic Area, End User - Global Forecast to 2021

  • $ 5650
  • Industry report
  • October 2016
  • by MarketsandMarkets

The global CRO services market is estimated to grow at a CAGR of 7.4% from 2016 to 2021, to reach USD 41.86 billion by 2021 from USD 29.29 billion in 2016. Growth in this market is primarily attributed ...


ref:plp2014

Reportlinker.com © Copyright 2016. All rights reserved.

ReportLinker simplifies how Analysts and Decision Makers get industry data for their business.