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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 Pharmacometrics & Pharmacokinetics (PMK) and Regulatory Science (RS) Communities
Title: Clinical Pharmacology Considerations for Antibody Drug Conjugates
Date and Time: Friday, January 29, 2021, 1:00 pm ET
Speaker: Krithika Arun Shetty, PhD
Moderators: Bilal AbuAsal, PhD, and Chunze Li, PhD
Description: Since 2000, ten Antibody Drug Conjugates (ADCs) have been approved by the US Food & Drug Administration all for oncology indications. Several other ADC products are in various stages of development. This presentation will provide an overview of the clinical pharmacology considerations in ADC development with a focus on the utility of PK-PD modeling and simulation in the ADC drug development process and in regulatory decision making. Summaries/case examples of population PK and E-R models that have been utilized in the regulatory review, approval and labeling of current ADCs will be discussed.
Registration Link: 
https://us02web.zoom.us/webinar/register/1616076355147/WN_beLmdFaISS-gsi4Be0UuTQ

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
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