Abstract
The recent launch of a pilot scheme for ‘adaptive licensing’ by the European Medicines Agency could spell a new era in drug development. Rather than focusing on the purely regulatory aspect of the system, the proposals challenge several aspects of existing development processes, including the conventional roles of sponsor, regulatory and reimbursement agencies, payers and patients. They also exploit a number of scientific advances not available when the existing development path was laid out. Like all other innovations the new model of adaptive development also carries significant challenges, in areas as diverse as clinical management, economics, intellectual property, ethics and public communications. This paper outlines these changes to thinking, summarizes the benefits the model offers and proposes how some of the challenges should be met. The perspectives in the paper are drawn from the authors’ own involvement with this European project and are informed by discussions at several workshops and conferences held over recent months.
Keywords: Adaptive licensing, drug development, MAPPs.
Reviews on Recent Clinical Trials
Title:Realising the Potential of Adaptive Development of Medicines
Volume: 10 Issue: 1
Author(s): Richard W. Barker and Sarah Garner
Affiliation:
Keywords: Adaptive licensing, drug development, MAPPs.
Abstract: The recent launch of a pilot scheme for ‘adaptive licensing’ by the European Medicines Agency could spell a new era in drug development. Rather than focusing on the purely regulatory aspect of the system, the proposals challenge several aspects of existing development processes, including the conventional roles of sponsor, regulatory and reimbursement agencies, payers and patients. They also exploit a number of scientific advances not available when the existing development path was laid out. Like all other innovations the new model of adaptive development also carries significant challenges, in areas as diverse as clinical management, economics, intellectual property, ethics and public communications. This paper outlines these changes to thinking, summarizes the benefits the model offers and proposes how some of the challenges should be met. The perspectives in the paper are drawn from the authors’ own involvement with this European project and are informed by discussions at several workshops and conferences held over recent months.
Export Options
About this article
Cite this article as:
W. Barker Richard and Garner Sarah, Realising the Potential of Adaptive Development of Medicines, Reviews on Recent Clinical Trials 2015; 10 (1) . https://dx.doi.org/10.2174/1574887110666150430150201
DOI https://dx.doi.org/10.2174/1574887110666150430150201 |
Print ISSN 1574-8871 |
Publisher Name Bentham Science Publisher |
Online ISSN 1876-1038 |
![](/images/wayfinder.jpg)
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
Related Articles
-
MiRNA153 Reduces Effects of Chemotherapeutic Agents or Small Molecular Kinase Inhibitor in HCC Cells
Current Cancer Drug Targets Potentiating Effect of Ethnomedicinal Plants Against Proliferation on Different Cancer Cell Lines
Current Drug Metabolism Identification of Disease-Relevant Genes for Molecularly-Targeted Drug Discovery
Current Cancer Drug Targets Anticancer Metallotherapeutics in Preclinical Development
Current Medicinal Chemistry Regulatory T Cells as Targets for Immunotherapy of Autoimmunity and Inflammation
Inflammation & Allergy - Drug Targets (Discontinued) Drug Targets to Pro-Angiogenetic Factors with Special Reference to Primary Peritoneal Mesothelioma
Endocrine, Metabolic & Immune Disorders - Drug Targets A Systematic Review of Genes Involved in the Inverse Resistance Relationship Between Cisplatin and Paclitaxel Chemotherapy: Role of BRCA1
Current Cancer Drug Targets Analysis of Comparative Proteomic and Potent Targets of Peniciketal A in Human Acute Monocytic Leukemia
Anti-Cancer Agents in Medicinal Chemistry COPD Management: Look Beyond the Airway Obstruction, Chronic Bronchitis and Emphysema
Current Respiratory Medicine Reviews Characteristic Alterations of Nuclear Structure and Chromatin Organisation of Cancer Cells Addressed by Proteome Analysis**
Current Proteomics Aptamers as Innovative Diagnostic and Therapeutic Agents in the Central Nervous System
CNS & Neurological Disorders - Drug Targets Urokinase-a Very Popular Cardiovascular Agent
Recent Patents on Cardiovascular Drug Discovery Combination of DC Vaccine and Conventional Chemotherapeutics
Anti-Cancer Agents in Medicinal Chemistry Cardiac-Specific Expression of the Hepatocyte Growth Factor (HGF) Under the Control of a TnIc Promoter Confers a Heart Protective Effect After Myocardial Infarction (MI)
Current Gene Therapy Synthetic Lethality to Overcome Cancer Drug Resistance
Current Medicinal Chemistry PET in Anti-Cancer Drug Development and Therapy
Recent Patents on Anti-Cancer Drug Discovery Proteomics Using Mammospheres as a Model System to Identify Proteins Deregulated in Breast Cancer Stem Cells
Current Molecular Medicine Mechanisms of Resistance to Photodynamic Therapy
Current Medicinal Chemistry The Role of STAT3 Signaling in Mediating Tumor Resistance to Cancer Therapy
Current Drug Targets Neuroprotection by Natural Polyphenols: Molecular Mechanisms
Central Nervous System Agents in Medicinal Chemistry