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Regulatory Science (RS) Community


The Regulatory Science Community includes individuals from industry, government, and academia who have an interest in the application of clinical pharmacology throughout all phases of the drug development process.  The goal of the Community is to promote interaction between development scientists, clinicians, and regulators as we integrate the broad expanse of skills required to develop a molecule into a clinically useful therapeutic entity.

Community Goals:
Focus on the communication and collaboration between academic, industrial and regulatory scientists to enhance patient care. This is accomplished through the following:

Education and Communication:
Education on hot topics in regulatory sciences in clinical pharmacology and drug development.

Discussion of Influence and Impact of Clinical Pharmacology 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 of the Regulatory Science Community

Collaboration:
  • Key external groups.
  • Key ASCPT groups.
Community News

ASCPT 2017 Annual Meeting Community Meeting
Pharmacometrics & Pharmacokinetics (PMK) & Regulatory Science (RS) Joint Community Meeting
Friday, March 17, 2017
5:00 pm - 6:30 pm Ballroom Foyer


  Recent Community Webinar
Regulatory Science Webinar
Title: PBPK Modeling and Clinical Evaluation of a Natural Product-Drug Interaction
Speaker: Mary Paine, RPh, PhD
Description: Natural products (NPs) such as botanical dietary supplements, fruit juices, and teas represent an ever-increasing share of the health care market. An estimated 20-30% of patients acknowledge taking NPs in conjunction with conventional medications, raising the risk of potential adverse NP-drug interactions. PBPK modeling and simulation of these complex interactions could be used to inform the necessity for clinical testing. Accurate models require a rigorous understanding of NP chemical make-up, knowledge of candidate precipitant NP constituents, robust parameters recovered from human-derived in vitro systems, and proof-of-concept clinical studies. This integrative approach was applied to an exemplar NP-drug combination. Further testing and refinement of this approach with additional NP-drug combinations will inform development of needed guidance for assessing the risk of NP-drug interactions.

Leadership


Chair
Megan Gibbs, PhD
Amgen

Megan Gibbs, BscPharm, Ph.D. FCP, is currently Executive Director, Global Head of Clinical Pharmacology, Modeling and Simulation in the Department of Medical Sciences at Amgen, where she leads a group of scientists focused on the application of quantitative pharmacology throughout the drug development continuum (discovery to post-marketing).  Full bio



Vice Chair
Robin O'Connor-Semmes, RPh, PhD
PAREXEL International


Robin O’Connor-Semmes, Ph.D., B.S.Pharm. is currently Director in Quantitative Clinical Development at PAREXEL International; with the majority of her career in Clinical Pharmacology Modeling and Simulation at GlaxoSmithKline.  She has in depth experience in pharmacokinetics, PK/PD, drug metabolism, pharmacometrics and systems pharmacology applications for small molecules and therapeutic proteins.  Full bio

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