abbreviated history of innovation in regulatory science The mission of the

abbreviated history of innovation in regulatory science The mission of the US Food and Drug Administration (FDA) makes the FDA in many ways unique among federal agencies. and improved patient outcomes. These include such programmes as the Critical Path Safety First Safe Use and Sentinel Initiatives. In the early period after the completion of the Human Genome Project CDER embarked on one of its most forward-thinking infrastructure building projects to date. As pharmaceutical companies began to conduct exploratory genomics and pharmacogenetics studies in the context of their drug development programmes it became clear to leaders in CDER and the Office of Clinical Pharmacology (OCP) within CDER that the Center needed to: 1) encourage companies to continue to evolve the science with FMN2 the ultimate goal of Zibotentan enhancing drug product development; and 2) develop internal FDA expertise to deal with the myriad complexities of analysing and interpreting pharmacogenetic genomic proteomic and like data. To that end the Voluntary Genomic Data Submissions (VGDS) Zibotentan programme Zibotentan was developed in the early- to mid-2000s to allow drug companies consortia academic researchers and individuals to engage in scientific exchange with the FDA and to allow FDA regulatory scientists to gain experience with data in this then nascent field [1]. In its early days VGDS were largely focused on technical aspects of platforms used to generate genomic-era data. Since the first VGDS in 2004 however the FDA has received over 40 submissions which have become more Zibotentan applied in nature. That is more recent VGDS have been concerned with the practical application of genetic or biomarker information to drug development. Over the past five years there has been significant growth in the use of pharmacogenetic principles in drug development. This has established the need for regulatory scientists with a keen understanding of pharmacogenetics clinical pharmacology population science/epidemiology clinical trial design and pharmacotherapy (ie clinical practice). The Genomics Group within the OCP in CDER is a prototype regulatory review group within which such skill sets are being integrated and further developed. The OCP Genomics Group: The clinical pharmacogenetics prototype The stated mission of the OCP Genomics Group is: ‘to advance personalised health for the benefit of patients and society’. The group’s vision within the drug development and public health enterprises is the integration of pharmacogenetics and genomics in the discovery development regulation and safe and effective use of medications. To achieve this vision the group has as its objectives to: 1) develop an integrated translational regulatory review paradigm to enhance drug and biologic product development; 2) train regulatory scientists in pharmacogenetics and related disciplines; 3) conduct and disseminate the results of high-quality research to optimise clinical knowledge of the risk/benefit of products throughout their life cycles; and 4) develop regulatory policies and procedures to enhance the utilisation of genomics and related disciplines in drug discovery development regulation and utilisation. Zibotentan Currently the Genomics Group reviewers are integral members of the CDER cross-disciplinary review teams that regulate drug products in the neurology cardiovascular rheumatology gastrointestinal antiviral and oncology therapeutic areas. Opportunities for growth in the future are expected to include psychiatry metabolic and endocrine diseases pulmonology/allergy and biologics across all therapeutic areas. With respect to enhancing drug product development in the context of regulatory review work the Genomics Group is focused on two functions. First reviewers work with drug companies and researchers in the investigational new drug (IND) application stage to minimise the likelihood that experiments and research protocols will result in imperfect ambiguous and uninterpretable data related to pharmacogenetics and applied biomarkers. At this stage Genomics Group reviewers provide regulatory advice on everything from sample collection to the appropriateness of biomarker selection to study design methodology. Secondly the reviewers Zibotentan analyse and interpret data in regulatory submissions (eg new drug applications [NDAs] and therapeutic biologic applications [BLAs]).