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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 Webinar presented by the Special Populations (SPO) Community and Regulatory Science (RS) Community
Title:  Pediatric Master Protocols: Clinical Pharmacology Challenges and Opportunities
Date and Time: Monday, October 7, 2019, 1:00 pm ET
Speakers and Panelists: Luna Musib, PhD, Elimika Pfuma Fletcher, PharmD, PhD, and Nita Seibel, MD
Moderators: Anuradha Ramamoorthy, PhD
Description: This special session will focus on opportunities, considerations and challenges related to pediatric master protocols. The speakers will discuss pharmacogenomic and other clinical pharmacology considerations for master protocols. Examples of pediatric master protocols will be highlighted. The pharmacogenomic discussion will highlight considerations for patient selection and treatment allocation based on molecular subsets of disease. The session will also include a moderated panel discussion, including a clinician involved in the NCI Pediatric MATCH trial.
Registration Link: 
https://register.gotowebinar.com/#register/4299107357330724867

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
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