Regulatory Science (RS) Community

The Regulatory Science Community represents a diverse community of scientists from biopharmaceutical industry, government, and academia who are interested in the science of clinical pharmacology and translational medicine and the application to the drug development process, with an ultimate aim to enhance patient care.

Community Goals

The goal of the Regulatory Science Community is to promote interaction between drug development scientists, clinicians, and regulators to facilitate integration of a broad expanse of skill sets required to develop a molecule into a clinically useful therapeutic entity. This is accomplished through the following:
Education and Communication:
Education on hot topics in regulatory sciences, both in clinical pharmacology and drug development. This includes discussion of influence and impact of clinical pharmacology, translational medicine, and regulatory science:
  • Present examples of clinical pharmacology that made a difference in drug development and usage.
  • High impact examples of modeling and simulation and impact on regulatory approvals and drug development decision making.
  • High impact examples of where systems pharmacology made a difference to the label.
  • How to translate information into a label (labeling associate director).
  • Outreach to global regulatory agencies to discuss key hot topic issues.
Advance the scientific expertise in regulatory science by promoting collaboration between academic, industrial, and regulatory scientists including:
  • Key external groups
  • Key ASCPT groups

Community Announcements:
The RS Community would like to encourage members to utilize the FDA Guidance Documents Repository as a useful resource to search all FDA guidance documents from a single source.

Past Webinars:
The webinars below can be accessed in the Members Only Webinar Library: Access Library
  • Failed Relative Bioavailability in Pediatrics: Modeling and Assessing Associated Putative Risk Factors
  • Biologics in Breastmilk: What Are the Risks?
  • A Pediatric Research Imperative: The Why and How of Addressing Diversity in Pediatric Research
  • Contemporary Topics in Drug Interactions Research
  • Improving the Efficiency of Drug Development Through Clinical Data Leveraging: A Clinical Pharmacology Success Story in Schizophrenia
  • Model-Informed Drug Development (MIDD): Collaboration to Streamline New Drug Development
  • Clinical Pharmacology Considerations for Antibody Drug Conjugates
  • Regulatory Challenges for the Complex Drug Class of Nanomedicines
  • Pediatric Master Protocols: Clinical Pharmacology Challenges and Opportunities (open access)
  • Intestinal OATP mediated Drug Interactions: Where are We
  • Using Concentration – QTc as the Primary Analysis in TQT & Phase 1 Studies: Considerations, Methods and Case Studies; and an Introduction to Comprehensive In Vitro Proarrhythmia Assessment (CiPA) Initiative
  • When are Transporters Important in Drug Disposition Including Tissue Distribution of Drugs?


E Mattson

Elin Matsson, PhD

Community Chair


Liang Zhao

Liang Zhao, PhD

Community Vice Chair


Z Zhou

Zhu Zhou, PhD

Community Past Chair


Regulatory Science Community Steering Committee:
Amal Ayyoub, PhD
Myong Jin Kim, PharmD
Liang Zhao, PhD
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