Adaptive Licensing - a Holistic Approach to Drug Development and Regulation

Hexa Reports

Market Research Reports and Insightful Company Profiles

Adaptive Licensing A Holistic Market Share, Size,

Trends, Growth, Analysis and Outlook Research

Report by Hexa Reports

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.

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Scope

- Adaptive Licensing: Overview

- Introduction

- A Declining Industry - How AL can tackle issues with the current system

- Strengths

- Challenges for AL

- Proponents

Hexa Reports

Market Research Reports and Insightful Company Profiles

- 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 -...