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ShashiAmurDianeMouldBrianMoyerArnabMukherjee

Diane Mould is currently president of Projections Research Inc., a pharmacometrics consulting company.
Brian Moyer is president and principal of BRMoyer & Associates and a full-time senior science advisor for the Biomedical Advanced Research and Development Authority (BARDA), of the Assistant Secretary for Preparedness and Response (ASPR).
Shashi Amur is currently the Scientific Coordinator of the Biomarker Qualification Program at the Office of Translational Sciences, CDER, FDA.
Arnab Mukherjee is currently director, clinical pharmacology, at Pfizer Inc.

Advances in molecular medicine, genomics, imaging, pharmacometrics, and clinical research have generated a wealth of new methodologies expected to improve the safety and efficacy of pharmaceutical therapeutics by explaining variability in patient response to therapy. The ultimate goal is to utilize new information to optimize therapy for individual patients—that is, treating patients with the right dose of the right drug at the right time—to maximize benefit and minimize risk. Terms such as personalized, individualized, or stratified medicine are used interchangeably to describe this concept. Identification, qualification, and approval of patient factors predictive of efficacy or safety are typically performed by academic researchers, drug developers, and regulators during drug development or post-approval. Using the information for individual patient care is the prerogative of the clinical care provider, who must be equipped to collect, organize, and interpret the large volume of patient-centric information. Ensuring consistent and efficient utilization of data remains a challenge, requiring multidisciplinary collaboration and communication between scientists and clinicians working in academia, drug development, regulatory organizations, and clinical care settings.

The recent increase in utilization of genomic markers in drug development, labeling, and targeted therapy points to a continuing uptrend and rapid expansion of availability and utilization of new genomic methodologies in the future. The advent of novel and emerging technologies, such as next-generation sequencing, is making the transition from research tool to clinical tool possible and holds great potential to identify the basis of Mendelian diseases, a previously unattainable goal using traditional methodologies. Imaging technologies have advanced enormously, driven by advances in molecular biology, tracer chemistry, computational physics, and material sciences, and likely represent the next technological frontier in personalized medicine. Imaging technologies such as magnetic resonance and optical imaging (i.e., MRI/MRS and functional MR, bioluminescence, fluorescence, self-illuminating quantum dots) and other non-visible light and non-ionizing radiation platforms have made imaging a practical and safe clinical tool. Advances in pharmacometric methodologies and computational power have enabled development of decision-support tools for the clinical care provider to utilize the new technologies. Examples of such tools include “dashboards”, which are web-based interfaces that allow the care provider to input patient-centric information to easily and rapidly generate a treatment recommendation for the individual patient. The algorithms that drive dashboard systems are often based on pharmacokinetic-pharmacodynamic models, and dashboards may potentially be utilized and co-developed during the drug development process, especially for drugs requiring therapeutic drug monitoring.

In the December issue of the AAPS Newsmagazine, we provide a multidisciplinary perspective on the current state of a number of new technologies and opportunities for greater utilization of targeted, individualized drug therapy. Read the article The Impact of New Technologies on the Science of Clinical Care and Drug Development, from the Pharmacoimaging, Pharmacogenomics, and Pharmacometrics focus groups, affiliated with the Clinical Pharmacology and Translational Research section, and then participate in the discussion question below.

What are your thoughts on the impact of these innovations on health care?

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More about the Authors

Mould is the chair-elect of the pharmacometrics focus group within AAPS.

Moyer is the recent past chair for the Pharmacoimaging Focus Group and is the program chair elect for the 2016 National Biotechnology Conference.

Amur is also the chair of the Pharmacogenomics Focus Group at AAPS.

Mukherjee is vice-chair of the CPTR section and also the current past chair of the Pharmacometrics Focus Group.