The U.S. Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) hosted a two-day virtual public workshop entitled “Fetal Pharmacology and Therapeutics” on October 21-22, 2021 to discuss the current state of fetal pharmacology and therapeutics and how it pertains to pediatric drug development.

Day 1 Recording (password: w?pY3ZQt)

Day 2 Recording (password: RZ.^a1@b)

Fetal pharmacology has made significant advances in recent years and has moved into the  “clinical science” space with considerations for both fetal therapeutics allowing in-utero treatment of the fetus to avert postnatal disease as well as aversion of fetal toxicity from in-utero exposure to drugs following medications administered to the pregnant woman. This advance in knowledge requires addressing both the regulatory and scientific aspects of fetal pharmacology.

  1. Review general regulatory and ethical considerations for fetal pharmacology and therapeutics

  2. Describe methods to assess clinical and nonclinical safety and efficacy assessments to support clinical trials of drugs in pregnancy and the fetus 

  3. Highlight advances and existing knowledge in fetal therapeutics

  4. Discuss key aspects of maternal-fetal modeling and simulation 

Thursday, October 21, 2021
10:00 a.m. – 3:15 p.m. ET


Welcome & Introduction

Gilbert J. Burckart, Pharm.D. (Moderator)
Associate Director for Pediatrics, Office of Clinical Pharmacology 
Center for Drug Evaluation and Research (CDER) 
U.S. Food and Drug Administration (FDA) 


General regulatory considerations

Dionna Green, M.D., FCP 
Acting Director, Office of Pediatric Therapeutics (OPT) 
Office of the Commissioner (OC), FDA 


Antenatal steroids to prevent respiratory distress syndrome in  the preterm newborn – considerations for fetal safety and efficacy Alan Jobe, M.D., Ph.D. 
Cincinnati Children’s Hospital 
Emeritus Professor of Pediatrics 


Ethical and regulatory considerations  Kevin Prohaska, D.O., MPH 
Associate Director/Senior Medical Policy Advisor,  
Office of Good Clinical Practice 


Fetal Safety Studies
Moderator: William Slikker, Ph.D., (Center Director, National  Center for Toxicological Research (NCTR), FDA) 

Nonclinical assessment to inform maternal and fetal safety in  clinical trials enrolling pregnant women Kim Hatfield, Ph.D. 
Lead Toxicologist  
Division of Pharmacology Toxicology for Rare Diseases, Pediatric  
Urology and Reproductive Medicine 


Clinical assessment of fetal well-being and fetal safety  indicators

Anna David, Ph.D. 
Professor of Obstetrics and Maternal Fetal Medicine 
Maternal & Fetal Medicine 
UCL EGA Institute for Women’s Health 
Faculty of Population Health Sciences 
University College, London, UK 


Model development and effects of opioids on neural tube defects 

Amy Inselman, Ph.D. 
Research Biologist, Division of Systems Biology 

Grace Lee, Ph.D. 
Pharmacologist, Division of Pharmacology Toxicology for  


Fetal Therapeutics
Moderator: Gerri Baer, M.D. (Team Leader,  Pharmacovigilance & Neonatology Team, OPT, OC, FDA) 

Fetal gene therapy

Simon Waddington, Ph.D. 
Professor of Gene Therapy 
University College, London 
EGA Institute for Women’s Health, London, UK 


Fetal arrhythmias

Janette Strasburger, M.D. 
Pediatric Cardiology, Pediatrics 
Children’s Wisconsin  
Researcher, Herma Heart Institute 
Professor, the Medical College of Wisconsin 


Fetal therapies to target inflammation  

Sarah Stock M.D., Ph.D. 
Reader and Honorary Consultant Maternal and Fetal Medicine 
Usher Institute, University of Edinburgh 


In utero stem cell transplantation for the treatment of prenatally  diagnosed diseases 

Tippi Mackenzie, M.D. 
Professor, Surgery 
UCSF Division of Pediatric Surgery and Fetal Treatment Center
Pediatric Surgeon, UCSF Benioff Children's Hospital, San 


Panel Discussion & Questions 

Dionna Green, M.D., FCP 
Jill Morgan, Pharm.D. 

Chair, Department of Practice and Science 
University of Maryland 

Johannes N. van den Anker, M.D., Ph.D. 
Division Chief of Clinical Pharmacology 
Children's National Hospital 

William Slikker, Ph.D. 
Alison Harrill, Ph.D. 
Program Officer 

Larissa Lapteva, M.D. 
Associate Director 
Robert Ward, M.D. 
Professor Emeritus, Pediatrics 
University of Utah 

Edress Darsey, Pharm.D. 
Global Pediatric Medical Director 

Homa K. Ahmadzia, M.D, MPH 
Assistant Professor, Division of Maternal-Fetal Medicine 
Department of Obstetrics and Gynecology 
George Washington University

Wrap up & Adjourn Day 1

Gilbert J. Burckart, Pharm. D. 


Friday, October 22, 2021
10:00 a.m. – 2:00 p.m. ET

Welcome & Introduction

André Dallmann, Ph.D. 
Scientist Systems Pharmacology 
Research & Development, Pharmaceuticals, 
Bayer AG, Germany 


General aspects of maternal-fetal modeling & simulation
Moderator: André Dallmann (Bayer AG) 

Pregnancy-induced anatomical and physiological changes  relevant to physiologically-based pharmacokinetic (PBPK) modeling Anne Zajicek, M.D., Pharm.D., FAAP 
Deputy Director, Office of Clinical Research 
National Institutes of Health 


Quantifying placental drug transfer with ex vivo cotyledon  perfusion assays as PBPK input 

Rick Greupink, Pharm.D., Ph.D. 
Assistant professor of Pharmacology, member of staff at  
Department of Pharmacology & Toxicology 
Radboud University Medical Center, Nijmegen, The Netherlands 



Selecting the right dose for pregnant women using PBPK  Ping Zhao, Ph.D. 
Senior Program Officer  
Bill & Melinda Gates Foundation 
Seattle, Washington, United States 


Modeling & simulation case studies
Moderator: Johannes N. van den Anker,  M.D., Ph.D., Division Chief of Clinical Pharmacology Children's National Hospital

Successful prediction of fetal exposure to transported and non transported drugs using in vitro studies and PBPK M&S  Jashvant D. Unadkat, Ph.D. 
Milo Gibaldi Endowed Professor, Department of Pharmaceutics 
School of Pharmacy, University of Washington


Mechanistic modeling of placental drug transfer and fetal neonatal drug exposure  André Dallmann, Ph.D. 
Scientist Systems Pharmacology 
Research & Development, Pharmaceuticals, 
Bayer AG, Germany 


Maternal-fetal PBPK modeling of antipsychotic drugs as case  study  Miao Li, Ph.D. 
Visiting Scientist 
Division of Biochemical Toxicology 


Predicting drug exposure in fetus and genital tract during pregnancy 

Adeniyi Olagunju, Ph.D. 
Tenure Track Fellow 
Centre of Excellence for Long-acting Therapeutics 
Department of Pharmacology & Therapeutics 
University of Liverpool, Liverpool, UK 


Regulatory perspective
Moderator: Dionna Green, M.D., FCP (Acting Director,  OPT, OC, FDA) 

MHRA perspective on pregnancy PBPK models Paola Coppola, M.Sc. 
Pharmacokinetics Assessor 
Medicines and Healthcare Products, Regulatory Agency 
London, UK


FDA perspective on pregnancy-fetal PBPK models Leyla Sahin, M.D. 
Deputy Director for Safety, Division of Pediatric and Maternal  
Health, Office of New Drugs, CDER, FDA 


Panel Discussion & Questions 

André Dallmann, Ph.D. 
Ping Zhao, Ph.D. 


Khaled Abduljalil, Ph.D 
Simcyp Division
Certara, UK 

Gilbert J. Burckart, Pharm.D. 
Associate Director for Pediatrics, Office of Clinical Pharmacology CDER, FDA 

Jeremiah Momper, Pharm.D., Ph.D. 

Associate Professor of Clinical Pharmacy 
University of California, San Diego 

Zhaoxia Ren, M.D., Ph.D 
Program Officer at the Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB), NICHD 

Stephan Schaller, Ph.D 
Principal Consultant, Founder & CEO 
esqLABS, Germany 

Sander Vinks, Pharm.D, Ph.D, FCP 
Director, Division of Clinical Pharmacology 
Cincinnati Children's Hospital Medical Center 

Xinyuan Zhang, Ph.D 
PBPK Co-lead 

Wrap up & Adjourn Day 2

André Dallmann, Ph.D. 



This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD005946  with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.