• Section Affiliations
  • Clinical Pharmacology & Translational Research (CPTR) Section
  • Biotechnology (BIOTEC) Section
  • Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) Section

Purpose and Description

The most challenging task identified by the U.S. Food and Drug Administration and pharmaceutical companies is how to translate in vitro and laboratory findings into clinical applications and to facilitate drug development (qualifying and fitness of use). There is a need for such a focus group to facilitate education as well as knowledge exchange, and optimally to accelerate scientific advancement in this area. Throughout the future programming activities, this focus group will provide to its members educational opportunities, stimulation of the research to clinical application, and opportunities for dialogue among its members from academic institutions, pharmaceutical companies and regulatory agencies regarding biomarker qualifications and application of biomarkers for dose regimen identification and for clinical development. Through the outreach programs with other professional organizations, the members will be able to update their knowledge with cutting-edge research findings and regulatory guidance.

Goals and Objectives

With the mission of providing educational programs to its members in the scientific areas of qualifying biomarkers for clinical applications, including clinical efficacy, safety, adverse effects, and disease modeling, the goals of the focus group are to:

1. Develop joint programs for the AAPS annual meetings with other focus groups including Pharmacogenomics and Population Pharmacokinetics and Pharmacodynamics focus groups.
2. Reach out to other professional societies and organizations, including the American Association of Cancer Research (AACR) and the American College of Clinical Pharmacology (ACCP), for successful joint symposia and workshops in the area of translating biomarkers into clinical application.
3. Develop symposia and workshops at the AAPS Annual Meetings and National Biotechnology Conferences.
4. Provide opportunities for knowledge exchange and networking between its members and members of other professional organizations, and to facilitate the advancement of science in translating genomic, proteomic, and metabolomic biomarkers into clinical application

Upcoming Events

To be announced.

JOIN THE BIOMARKERS IN TRANSLATIONAL MEDICINE FOCUS GROUP

To join the Biomarkers in Translational Medicine Focus Group, click here.

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