| Page 3 | Center of Excellence in Regulatory Science and Innovation

CERSI P.I.s and Collaborators: Wendy Camelo Castillo, M.D., M.Sc., Ph.D., UMB School of Pharmacy; Susan dosReis, Ph.D., UMB School of Pharmacy; Gloria Reeves, M.D., UMB School of Medicine

FDA SME and Collaborator: Leonard Sacks, M.D., CDER

Project Description and Goals

CERSI P.I. and Collaborator: Leonardo Tonelli, Ph.D.,UMB School of Medicine

FDA SME and Collaborator: Daniela Verthelyi, M.D., Ph.D., CDER, FDA

Project Overview

CERSI P.I.s and Collaborators:Ashlee Mattingly, Ph.D., Steven Hoag, Ph.D., James Polli, Ph.D.

FDA SMEs and Collaborators: Charles Ganley, M.D., Gabrielle Cosell, MSc, Sara Rothmen, MPH, Rosilend Lawson, Elizabeth Hanklen

www.pharmacy.umaryland.edu/compounding

https://archive.hshsl.umaryland.edu/handle/10713/11647

CERSI P.I.s and Collaborators: Daniel Mullins, Ph.D., Susan dosReis, Ph.D., Ester Villalonga Olives, Ph.D., Moaz Abdelwadoud, MD, DrPH, MPH, Michelle Medeiros, MS, MA, CCRP, Rodney Elliott

FDA SMEs and Collaborators: Marc Kusinitz, MS, Ph.D., Jing (Julia) Ju, PharmD, Ph.D., Michelle Campbell, Ph.D., Heather Ovelmen, MA, Kathleen Yu, MPH, Taiye Oladipo, MPH, Ayma Rouhani, MPH, Felisha Wu, MPH, Linda Verrill, Ph.D., CDRH

Project Overview

CERSI P.I.s and Collaborators: Matthew Trudeau, Ph.D., Ashley Johnson, Ph.D.

FDA SMEs and Collaborators: Wendy Wu, Ph.D., David Strauss, Ph.D., CDER

Project Overview

CERSI P.I.s and Collaborators: Sarah Michel, Ph.D.; Maureen Kane, Ph.D.; Abraham Schneider, DDS, Ph.D.; Richard Dalby, Ph.D.

FDA SME and Collaborators: Vyomesh Patel, Ph.D., CTP

Project Overview

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CERSI P.I. and Collaborator: James Polli, Ph.D.

FDA SMEs and Collaborators: Robert Heflich, Ph.D. and Lea McDaniel, MS (NCTR)

Project Overview

A workgroup of the International Life Sciences Institute (ILSI) Health and Environmental Sciences Institute (HESI) is developing an Organisation for Economic Co-operation and Development (OECD) Test Guideline (TG) for the in vivo Pig-a gene mutation assay. The TG will foster regulatory acceptance of the assay for conducting safety assessments.

CERSI P.I. and Collaborator: Audra Stinchconb, Ph.D., UMB

FDA SME and Collaborator: Caroline Strasinger, CDER FDA

Project Overview

CERSI P.I.s and Collaborators: Lex Schultheis, MD, Ph.D., William Bentley, Ph.D., UMCP

FDA SMEs and Collaborators: Jorge Hernandez, M.S., James Coburn, M.S., CMDR USPHS, Matthew Diprima, Ph.D., Samanthi Wickamasekara, Ph.D., Berk Oktem, Ph.D., CDRH, Rahki, Ph.D., CDRH

Project Overview

Using mHealth to measure Impact in Functionality Behavior, Activity and Sleep Patterns in Children and Adolescents Treated with Psychotropics

Development and characterization of an animal model of perinatal infection with Zika virus: assessment of long-term neurological deficits

Clinical Use of Bulk Drug Substances Nominated for Use in Compounding by Outsourcing Facilities

Improving FDA Health Communications with Older Women Regarding FDA-Regulated Products

hERG Channel Pharmacology for CiPA

Evaluation of Metal Ions in Electronic Cigarette Aersol Condensates and Determination of their Effects on Oral Keratinocytes

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In vivo Pig-a gene mutation assay

Transdermal Drug Delivery Systems-Fentanyl: In Vitro Studies

Biocompatibility in Additive Manufacturing

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