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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 Members-Only Webinar presented by the Regulatory Science (RS) Community and Membrane Transporter (MT) Community
Title: Intestinal OATP-Mediated Drug Interactions: Where Are We?
Date and Time: Monday, July 29, 2019, 1:00 pm ET
Speaker: Zhu Zhou, PhD, Maciej Zamek-Gliszczynski, PhD, and Xinning Yang, PhD
Moderator: Elimika Pfuma Fletcher, PharmD, PhD
Description: Considerable progress has been made in understanding the role of intestinal efflux transporters in drug absorption, and some of them (P-gp and BCRP) have been routinely studied to assess drug-drug interaction (DDI) liability. However, much less attention has been paid to intestinal uptake transporters, although an increasing number of drug interactions have been attributed to the inhibition of uptake transporters, particularly OATP2B1. Specific recommendations on how these transporters should be evaluated are currently lacking. The aim of this webinar is to present the current state of the art in intestinal OATP DDIs and foster discussion on the need and timing to evaluate these DDIs during drug development.
Registration Link: https://attendee.gotowebinar.com/register/127924179471419395

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.

Puneet Gaitonde, PhD

Community Chair

 

Lakshmi Vasist, PharmD

Community Vice Chair

 

Anuradha Ramamoorthy, PhD

Community Past Chair

 

Regulatory Science Community Steering Committee:
Elimika Fletcher, PharmD, PhD
Jeff Wald, PhD
Zhu Zhou, PhD
Photo Gallery
Recent News
  • ASCPT 2019 Annual Meeting Pre-conferences
    June 25, 2019
  • Upcoming Journal Review Club
    June 25, 2019
  • ASCPT Members-Only Webinar presented by the Regulatory Science (RS) Community and Membrane Transporter (MT) Community
    June 20, 2019
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