X

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.
Collaboration:
Advance the scientific expertise in regulatory science by promoting collaboration between academic, industrial, and regulatory scientists including:
  • Key external groups
  • Key ASCPT groups

Upcoming Webinar
ASCPT Pharmacometrics & Pharmacokinetcs (PMK) and Regulatory Science (RS) Communities Members-Only Webinar
Title: Pharmacokinetic Characterization of Antibody-Drug Conjugates in Clinical Development: An IQ Consortium Perspective
Date and Time: 1:00 PM ET, Friday, September 11, 2020
Speaker: Rajeev Menon, PhD
Moderators: Chunze Li, PhD, and Lakshmi Vasist, PharmD
Description: This webinar will update attendees on the common pharmacokinetic strategies for Antibody-Drug Conjugates (ADCs) and will discuss analytes used for exposure-response analyses for safety and efficacy as well as which analytes correlate best to safety and efficacy. Attendees will learn how to use this information to determine pharmacokinetic strategies across various stages of drug development. For additional information, please click the registration link below.
Registration Link: 
https://us02web.zoom.us/webinar/register/WN_LJcYvu8pQGeO7rAAqI6onQ

Past Webinars
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.

Upcoming Meetings and Workshops of Potential Interest to RS Community Members: The 2017 NME report has been published. Click here to access the report.

Lakshmi Vasist, PharmD

Community Chair

 

E Fletcher

Elimika Fletcher, PharmD, PhD

Community Vice Chair

 

Puneet Gaitonde, PhD

Community Past Chair

 

Regulatory Science Community Steering Committee:
Elimika Fletcher, PharmD, PhD
Jeff Wald, PhD
Zhu Zhou, PhD
Photo Gallery
Recent News
Contact Us