Pharmacogenomic Testing and Regulation: The Role of Pharmacogenomics in Pharmaceutical Development and the Regulation of
- PDF / 9,397,635 Bytes
- 7 Pages / 648 x 864 pts Page_size
- 47 Downloads / 258 Views
David Jeffrrys, MD, FFPM Senior Strategic Regulatory Advisor. Eisai Europe Ltd. Formerly Head ofthe Devices Sector, Medicines and Healthcare Products Regulatory Agency David Atkins, PhD Veridex, LLC, a Johnson and JohnsonCompany, Warren, New Jersey
Andy Brfton, BSc Director ofExternal and Regulatory Affairs. Abbott Diagnostics, United Kingdom Steven Gutman, MD Director ofthe Office ofJn Vitro Diagnostics. Centerfor Diseases and Radiological Health, Food and Drug Administration
Key Words Pharmacogenomics; In vitro diagnostics; Combination products; Pharmacogenetics; Conformity assessment; Traceability
Pharmacogenomic Testing and Regulation: The Role of Pharmacogenomics in Pharmaceutical Development and the Regulation of Pharmacogenetic Test as In Vitro Diagnostics*
INTRODUCTION
Pharmacogenomic and pharmacogenetic tests are increasingly used during drug development. Such tests are employed to improve or "personCorrespondence Address alize" drug dosage, to identify those at risk from David Jefierys, MD, FFPM. atypical adverse drug reactions, and to identify Eisai Europe, 3 Shortlands, Hammersmith, London, those in a population who will respond to the W 6 8 E E , UK drug. There is particular interest in the ability to (e-mail: [email protected]). select the optimal dose for each individual pa'This article is based on the tient (1). Pharmacogenomic/PharmaThe aim of this article is to review how pharcogenomic Track at the DIA Euro Meeting 10- 12 macogenetic tests are currently regulated in EuMarch 2004, rope and the United States. A personal view is Prague, Czech Republic. given regarding how these tests may be used in the future to assist pharmaceutical development and to enhance the safe and effective use of medicines. Suggestions are offered on how companies should integrate the development of the diagnostic test and its evaluation into their pharmaceutical development program. The review considers the implications of this for the regulatory system. Such an article cannot provide a comprehensive review of such a rapidly evolving field, but we provide a selective overview of key issues as a background to the main discussion. The terms pharmacogenetics and pharmacogenomics are often used interchangeably. Other
7
the current r d e and future
terms include theranostics and more recently onocogenomics. The European Committee on Proprietary Medicinal Products provided a definition in their 2001 position paper (2).This paper defined (p. 3) pharmacogenetics as "the study of interindividual variations in DNA sequencing relating to drug response." Pharmacogenomics is defined as the "study of the variability of the expression of individual genes relevant to disease susceptibilityas well as well as drug response at the cellular, tissue, individual or population level." For the purpose of this article, the term pharmacogenomics is employed. The Wellcome Trust has undertaken a thorough review of pharmacogenetics and pharmacogenomics. The report of this investigation was published in 2003 (3).This report not only reco
Data Loading...
