Day 1: 9 a.m.-4:30 p.m.
Welcome & Introduction
Welcome and Overview Tamara Johnson, FDA
Introductory Remarks Robert Califf, Commissioner, FDA
FDA Evaluation of In Utero Exposure to Drug and Biologic Products: Regulatory Considerations Katie Kratz, FDA
Background Session: Background and Current Landscape
Mechanisms of Placental Transfer for Small Molecules and Biologics Leslie Myatt, Oregon Health & Science University
Placental Transfer of Immunosuppressive Small Molecules: Current Clinical Pharmacology Landscape Raman Venkataramanan, University of Pittsburgh
Placental Transfer of Immunosuppressive Biologics: Current Clinical Pharmacology Landscape Edwin Lam, Johnson & Johnson
Current Clinical Landscape Uma Mahadevan, University of California San Francisco
Benefit-Risk Conceptual Framework for In Utero Exposure of Biologics Laura Bozzi, Johnson & Johnson
Session 1:
Panel Discussion Leyla Sahin, FDAPanelists:
Relevant In Vitro and Ex Vivo Assessments for Small Molecules and Biologics Nick Illsley, Placental Research Group LLC, Rutgers University
In Silico Assessments for Small Molecules and Biologics Rohan Lewis, University of Southampton
InVivo Animal Assessments John DeSesso, Exponent
Nonclinical Guidances Pertinent to Developmental Immunotoxicity David McMillan, FDA
Session 2: Nonclinical Evaluation of Placental Transfer and Immunotoxic Potential
Panel Discussion Jashvant Unadkat, University of Washington
Session 3: Framing Concerns for In Utero Exposed Infants Based on Available Data
Panel Discussion Kelly Stone, FDA
Day 1 Closing Remarks Tamara Johnson, FDA
Day 2: 9 a.m.-1:00 p.m.
Welcome & Introduction
Welcome& Introductory Remarks Tamara Johnson, FDA
Session 4:
Ethical Considerations for Clinical Investigations in Children to Assess the Impact of Placental Transfer of Drugs and Biologics with Immunosuppressive Properties Melanie Bhatnagar, FDA
How Can We Predict Fetal Drug Exposure Throughout Pregnancy To Inform Potential Fetal Toxicity? Jashvant Unadkat, University of Washington
Clinical Pharmacology and Modeling of Drug Transfer Across the Placenta: Biologics Ruth Oliver, Takeda
Panel Discussion Lily Mulugeta, FDA & Sonaly McClymont, FDA Panelists: Joseph Cafone, Johnson & Johnson
Session 5: Synthesis, Future Directions, and Next Steps
Panel Discussion Lynne Yao, FDAPanelists: - Kevin Ault, Western Michigan University
Closing Remarks Tamara Johnson, FDA
Speaker Bios Kevin Ault, MD, FACOG, FIDSA Professor & Chair, Department of Obstetrics and Gynecology, Western Michigan University Homer Stryker M.D. School of Medicine
Dr. Kevin Ault is Professor and Chair of the Department of Obstetrics and Gynecology at Western Michigan University Homer Stryker MD School of Medicine. He is an author of current maternal vaccine recommendations. He is a former member of the Center for Disease Control Advisory Committee on Immunization Practices, and a consultant to the American College of Obstetricians and Gynecologists. He is also the Vice President of the National Foundation for Infectious Diseases. His research and academic interests include infection diseases and women’s health.
Giorgia Berardi, MD Clinical Trial Assessor, Clinical Trial Office, Italian Medicine Agency – AIFA
Dr. Giorgia Berardi is an MD, specialized in Rheumatology at the Catholic University of the Sacred Heart (Rome) and has been working as a clinical trial assessor for the Italian Medicine agency for the past 5 years. She is also involved in the safety assessment of drugs underdevelopment. She has over ten years of hospital experience working with young patients affected by various immunological and musculoskeletal disorders, including systemic vasculitis, systemic sclerosis, SLE, myositis and polyarthritis. She is now involved as EC member in the ICH working group for the “Inclusion of pregnant and breastfeeding individuals in clinical trials”. Her principal area of interest is improving care of subjects with autoimmune diseases.
Melanie E. Bhatnagar, MD Associate Director for Pediatric Education and Outreach
Dr. Melanie E. Bhatnagar is the Associate Director for Pediatric Education and Outreach within the Office of Pediatric Therapeutics (OPT) at the U.S. Food and Drug Administration (FDA). In her role overseeing OPT’s Pediatric Education and Outreach Program, Dr. Bhatnagar works to promote, enhance, and drive cross-cutting educational activities and initiatives to further knowledge on important issues pertaining to children’s health and well-being. She also works to build and strengthen strategic partnerships to drive and inform scientific and policy priorities to advance children’s health.
Laura Bozzi, M.S., Ph.D. Associate Director, Global Epidemiology, Johnson & Johnson
L. Latéy Bradford, MD, Ph.D. Family Physician, Core Faculty attending in Family Medicine Residency Program, University of Maryland Capital Region Health (UMCRH)
Dr. L. Latéy Bradford is a Family Physician and Core Faculty attending in the Family Medicine Residency Program at the University of Maryland Capital Region Health (UMCRH). Though a native of Dayton, Ohio she is a product of the University of Maryland System, with a B.S. in Biology from UMBC and a dual doctorate (MD/Ph.D.) from the University of Maryland School of Medicine. As part of the physician scientist training program, she earned a Ph.D. in Microbiology & Immunology, using genomics and molecular epidemiology to study the vaginal microbiome and changes associated with vulvovaginal candidiasis. Following Family Medicine residency training at the University of Maryland Medical Center, where she served as Chief Resident, she joined the Family Medicine faculty at UMCRH in October 2022. Dr. Bradford provides comprehensive primary care for all members of the family, with a specialty in obstetrics and newborn care. She has a wealth of experience working with underserved communities and addressing complex healthcare needs through a social justice lens.
Joseph Cafone, MD Director, Dermatology Late Clinical Development, Johnson & Johnson Innovative Medicine
Dr. Joseph Cafone received his undergraduate degree in BioMedical Engineering from the George Washington University and medical degree from St. George’s University. He completed a combined Internal Medicine / Pediatrics residency at Stony Brook University in New York and an allergy and immunology fellowship at the Children’s Hospital of Philadelphia. While in training, he was a sub-investigator on multiple clinical trials, including the Phase 2/3 trials for Dupilumab in adolescents with atopic dermatitis. In 2021, he joined the Janssen Immunology Pediatric Development Team and in 2023 transitioned to the role of Director within Dermatology Late Clinical Development. When he isn’t working, he enjoys tracking down the best slice of pizza in South Philly with his wife and two children.
Robert M. Califf, MD 25th Commissioner, FDA
Dr. Robert M. Califf was confirmed as the 25th Commissioner of Food and Drugs. As Commissioner, Dr. Califf oversees the full breadth of the FDA portfolio and execution of the Federal Food, Drug, and Cosmetic Act and other applicable laws. This includes assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices; the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation; and the regulation of tobacco products. nd Commissioner. Before assuming the position at that time, he served as the FDA’s Deputy Commissioner for Medical Products and Tobacco.
John M. DeSesso, Ph.D., Fellow ATS Former Professor, Biochemistry and Molecular& Cellular Biology, Georgetown University School of Medicine, Washington, D.C.
Dr. John DeSesso is a Principal Scientist at Exponent, a scientific and engineering consulting company. He has more than four decades of post-doctoral experience specializing in developmental and reproductive toxicology, general toxicology, anatomy, and risk assessment. He has authored more than 120 papers and chapters, two of which were selected as Outstanding Published Papers Demonstrating an Application of Risk Assessment. He earned his A.B. in chemistry from Hamilton College and his doctorate in Anatomy and Teratology from the Medical College of Virginia (now VCU School of Medicine). He serves on the editorial board for Reproductive Toxicology and the editorial advisory board of Birth Defects Research. At Georgetown University School of Medicine, he taught embryology, teratology and gross anatomy for 39 years. He has received numerous teaching awards, including 6 teacher of the year awards from two institutions (Georgetown University and the School of Pharmacy, Medical College of Virginia); as well as Distinguished Service Awards from the Teratology Society and FASEB. As a consultant, he interacts regularly with both EPA and FDA. He is a Past-President of the Teratology Society (now Society for Birth Defects Research and Prevention), MARTA, and the Risk Assessment Specialty Section of the Society of Toxicology.
Maria Fernanda Scantamburlo Fernandes, MD Associate VP- Global Patient Safety/Oncology, Eli Lilly and Company
Dr. Maria Fernanda Fernandes is an obstetrician and gynecologist, with over 15 years of experience in her field. Over the past seven years, she has transitioned into the pharmaceutical industry, where her focus lies primarily on patient safety. Currently, she holds the position of industry expert/deputy topic leader on the ICH21 working group, a role that focuses on the inclusion of pregnant and breastfeeding individuals in clinical trials. In addition, Dr. Fernandes is a contributing member of TransCelerate, an industry consortium, where she contributes to the Pregnancy and Breastfeeding topic under the Interpretations of Pharmacovigilance Guidances & Regulations Workstream. She is a valuable resource for safety or development questions and serves as the Co-chair of the Reproductive, Pregnancy & Pediatric Safety Advisory Committee at Eli Lilly.
Natalie (Sparacio) Hayden, B.A. Founder, Lights, Camera, Crohn’s
Ms. Natalie (Sparacio) Hayden is a former TV news anchor and reporter whose mission in life is to advocate for those battling inflammatory bowel disease. She was diagnosed with Crohn’s disease in July 2005, two months after graduating from Marquette University. Her award-winning blog, Lights, Camera, Crohn’s, which launched in July 2016, covers everything from overcoming struggles to celebrating small victories throughout all parts of the patient journey from diagnosis and beyond.
Nick Illsley, DPhil Principal and Senior Scientist, Placental Research Group, LLC
Dr. Nick Illsley is a Principal and Senior Scientist with the Placental Research Group LLC. He is also Emeritus Professor of Pharmacology, Physiology and Neuroscience at Rutgers-New Jersey Medical School and Adjunct Professor of Pharmacology and Toxicology at the Ernest Mario School of Pharmacy at Rutgers University. He earned his B.Sc. at the University of Bristol, U.K. and his D.Phil. at the University of Oxford. He founded the Placental Research Group after staff/faculty positions at the UKMRC Clinical Research Centre, University of California San Francisco, Hackensack University Medical Center and Rutgers University. He is recognized internationally for his work in the fields of placental biology and perinatology. He held the Presidency of the International Federation of Placenta Associations from 2007-2012. He has received multi-year funding from NIH and served on review panels for both NIH and CIHR. He currently serves as editor for the journal PLACENTA. His research is focused on human placental transport and metabolism, hypoxia, trophoblast differentiation and invasion and aspects of these fields in pregnancy pathologies such as fetal growth restriction, preeclampsia and placenta accreta. He is currently involved in the NIH Integrated Transporter Elucidation Center (InTEC) at Rutgers University.
Tamara Johnson, MD, M.S. Lead Physician, Maternal Health Team
Dr. Tamara Johnson is a Lead Physician of the Maternal Health Team within the Division of Pediatrics and Maternal Health (DPMH), Office of New Drugs (OND), Center for Drug Evaluation and Research, US Food& Drug Administration. Dr. Johnson has been with the FDA for over 16 years. Initially, as a Medical Officer in the OND Division of Gastroenterology and Inborn Errors Products, she has led the DPMH Maternal Health Team for 9 years. The Maternal Health Team is responsible for evaluating the safe use of drug and biologics products in pregnant and lactating individuals, and is involved in review of prescription drug labeling (including implementation of the Pregnancy and Lactation Labeling Rule (PLLR), clinical lactation studies, and post-approval pregnancy safety studies. Dr. Johnson participates in policy and guidance development, as well as several CDER and FDA working groups. Dr.Johnson earned her Doctorate in Medicine from the Rutgers Robert Wood Johnson Medical School in New Jersey. She completed internship at the Georgetown/Providence Hospital Family Medicine program and completed residency training in General Preventive Medicine/PublicHealth at the University of Maryland Baltimore.
Michael Keller, MD Pediatric Immunologist, Associate Professor, Director, Jeffrey Modell Research and Diagnostic Center for Primary Immunodeficiency Disorders, Children's National Hospital
Dr. Michael Keller is a pediatric immunologist and Associate Professor at Children's National Hospital and director of the Jeffrey Modell Research and Diagnostic Center for Primary Immunodeficiency Disorders at Children’s National. His research focuses on the use of adoptive T-cell therapies for the treatment of infections inimmunocompromised patients, and he is the director of the Translational Research Laboratory in the Program for Cell Enhancement and Technologies for Immunotherapy at Children’s National.
Mona Khurana, MD Pediatric Team Leader
Dr. Mona Khurana is board-certified in general pediatrics and in pediatric nephrology. She obtained her undergraduate Bachelor of Science and Doctor of Medicine degrees from the George Washington University in Washington, DC. Following her internship at Nicklaus Children's Hospital and residency at Yale New-Haven Children's Hospital, she completed a fellowship in Pediatric Nephrology at Children's Hospital Boston. In 2004, she joined the faculty at Children’s National Hospital in Washington DC after her fellowship where she was an Assistant Professor of Pediatrics before joining FDA in 2009. Dr. Khurana initially worked as a Medical Reviewer in the FDA’s Division of Nonprescription Drug Products in the Center for Drug Evaluation and Research (CDER). She moved to the Division of Pediatrics and Maternal Health (DPMH) as a Medical Reviewer in 2015 and has been a Pediatric Team Leader in DPMH since 2016, where her efforts have primarily focused on working collaboratively with review divisions in the Office of New Drugs to assist with pediatric drug development in all therapeutic areas.
Katherine (Katie) Kratz, MD Medical Officer
Dr. Katherine (Katie) Kratz is a Medical Officer in the Division ofPediatrics and Maternal Health (DPMH) on the Maternal Health Team in the Office of Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORDPURM)at the FDA’s Center for Drug Evaluation and Research (CDER). Dr. Kratz is an obstetrician/gynecologist (ob/gyn) and received her medical degree from The University of Chicago Pritzker School of Medicine in 2004. She completed her internship and residency in ob/gyn at The Johns Hopkins Hospital and a fellowship in minimally invasive gynecologic surgery at Florida Hospital. Prior to starting as a Medical Officer at FDA in 2020, Dr. Kratz practiced clinical medicine as gynecologic specialist and assistant professor at The Johns Hopkins Hospital, a generalist with the Mid-Atlantic Permanente Medical Group, and an ob/gyn hospitalist at Anne Arundel Medical Center.
Edwin Lam, PharmD Senior Scientist, Clinical Pharmacology & Pharmacometrics, Maternal Fetal Immunology, Johnson& Johnson Innovative Medicine R&D
Dr. Edwin Lam is a Clinical Pharmacologist at Johnson & Johnson Innovative Medicine R&D supporting Maternal Fetal Immunology drug development. He is also adjunct faculty in the Department of Pharmacology and Physiology at Thomas Jefferson University, Philadelphia and is a Ready Reservist in the US Public Health Service Commissioned Corps. He received his Bachelor of Science in Pharmaceutical Sciences from the University at Buffalo, PharmD from Long Island University and completed a NICHD-NIGMS T32 post-doctoral fellowship in adult and pediatric Clinical Pharmacology at NIH & Thomas Jefferson University. Prior to joining Johnson & Johnson in 2022, Dr. Lam was a Pharmacokineticist at the Clinical Pharmacokinetics Research Unit at the NIH supporting Phase I & II clinical pharmacology research in anti-infective, immunology, and maternal-fetal therapeutic areas.
Ofer Levy, MD, Ph.D. Staff Physician & Principal Investigator, Director, Precision Vaccines Program, Division of Infectious Diseases, Boston Children's Hospital
Dr. Ofer Levy was born to and raised by the artist Benjamin Levy and music composer Hannah Levy in New York City, where he graduated from the Bronx High School of Science. After graduating from Yale College (B.S., Molecular Biophysics and Biochemistry ), Dr. Levy entered the Medical Scientist (MD/PhD) Training Program at New York University School of Medicine. There, he earned his PhD under the mentorship of Drs. Peter Elsbach and Jerrold Weiss, characterizing neutrophil-derived antimicrobial proteins and peptides. Inspired by his wife Sharon’s example, he chose Pediatrics and completed both residency and fellowship at Boston Children’s Hospital. He is currently Professor at Harvard Medical School as well as principal investigator, staff physician in Infectious Diseases and the Director of the Precisions Vaccine Program in the Department of Pediatrics, Boston Children’s Hospital. The Precision Vaccines Program is an academic program that fosters international collaboration between academia, government, and industry for development of vaccine formulations optimized to protect vulnerable populations. Dr. Levy’s laboratory is focused on modeling vaccine-induced human immune responses in vitro using a variety of platforms including three-dimensional microphysiologic systems as well as global molecular (“OMIC”) approaches to accelerate and de-risk development of vaccines optimized for populations with distinct immune responses, including those at the extremes of age who suffer the most infections. He currently leads or co-leads multiple NIH/NIAID-supported studies, including (a) Adjuvant Discovery and Development Program contracts, leveraging high throughput screening to discover, characterize, and formulate novel small molecule adjuvants to enhance vaccine responses of vulnerable populations such as infants and older adults and (b) systems biology projects via the Human Immunology Project Consortium and the Immune Development inEarly Life (IDEAL) program to define biomarkers of vaccine responsiveness, respiratory infection and asthma. Funded by the Coalition for Epidemic Preparedness Innovations (CEPI), the PVP is also leveraging systems biology to study vaccine safety. Dr. Levy pursues discovery and development of vaccines against SARS-CoV-2, influenza, HIV, RSV and pertussis as well as an opioid vaccine against fentanyl overdose. Dr. Levy serves on the U.S. Food & Drug Administration (FDA) Vaccines and Related Biologic Products Advisory Committee (VRBPAC) and participated in the Emergency Use Authorization and approval of COVID vaccines. He has given two TEDx talks and has regularly appeared in major media including BBC , CNN , FoxNews , NBC Nightly News , National Geographic , The New York Times , Scientific American , USA Today and The Wall Street Journal . He lives in Cambridge, Massachusetts with his wife Dr. Sharon Levy and their three children.
Rohan Lewis, Ph.D. Professor of Placental and Integrative Physiology, Faculty of Medicine, University of Southampton
Dr. Rohan Lewis is Professor of Placental and Integrative Physiology at the Faculty of Medicine, University of Southampton. He completed his PhD at the University of Auckland in New Zealand, followed by postdoctoral fellowships at the Universities of Cambridge and Southampton. In 2005, he secured a faculty position at the University of Southampton, where he currently serves as Deputy Head of School Research for the School of Human Development and Health within the Faculty of Medicine.
Uma Mahadevan, MD Lynne and Marc Benioff Professor of Gastroenterology, University of California, San Francisco
Dr. Uma Mahadevan is the Lynne and Marc Benioff Professor of Gastroenterology, Director of the Colitis and Crohn's Disease Center and Director of the Advanced IBD Fellowship at the University of California, San Francisco. She specializes in inflammatory bowel disease (IBD), particularly pregnancy and drug safety. She completed a medical degree at the State University of New York in Brooklyn, residency in internal medicine at Mount Sinai Medical Center in New York, Fellowship in gastroenterology at UCSF, and Advanced fellowship in IBD at the Mayo Clinic, Rochester, Minnesota. For her exceptional work in pregnancy and drug safety and her mentoring of GI fellows and junior faculty she received the AGA 2022 Immunology, Microbiology &Inflammatory Bowel Diseases (IMIBD) Section Research Mentor Award and the 2022 Sherman Prize.
Sonaly R. McClymont, MD Medical Officer, Pediatric Team
Dr. McClymont joined the FDA in 2021 as a Medical Officer on the Pediatric Team in the Division of Pediatric and Maternal Health (DPMH), Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER). Prior to joining the FDA, she practiced Pediatric Hospital Medicine at Children’s National Hospital for 11 years. Sonaly’s clinical practice and academic work focused on the care of children with medical complexity as well as newborn care and resuscitation. Sonaly has a medical degree from Thomas Jefferson University and completed pediatric residency at the University of California San Diego/Rady Children’s Hospital. She received a bachelor’s degree in religion from the University of Rochester with a minor degree in biology.
David McMillan, Ph.D., DABT Toxicologist
Dr. David McMillan is a Toxicologist in the Division of Pharmacology/Toxicology for Infectious Diseases at the FDA and is assigned to the Division of Antivirals. Prior to FDA, Dr. McMillan received his Ph.D. in Toxicology from the University of Rochester in 2013 and completed a postdoctoral fellowship at the University of Vermont in 2015. His expertise lies primarily in immunology and immunotoxicology. Dr.McMillan is the former co-chair of the FDA CDER Immunotoxicology Subcommittee, the current Treasurer of the Society of Toxicology (SOT) Immunotoxicology Specialty Section, and is the invited speaker for the “Hematopoietic and ImmuneSystems Toxicology” presentation within the American College of Toxicology (ACT) Advanced Comprehensive Toxicology course. He is also a regular presenter at ACT and SOT meetings and is a member of the HESI Immuno-Safety Technical Committee.
Lily Mulugeta, PharmD Acting Associate Director, Policy and Research
Dr. Lily Mulugeta is the Acting Associate Director for Policy and Research in the Division of Pediatrics and Maternal Health at the FDA. She engages in scientific and regulatory review and research related to pediatric drug development. Dr. Mulugeta serves as a representative for the Division on the FDA Pediatric Review Committee (PeRC). Prior to joining the Division in 2017, Lily was the Scientific Lead for Pediatrics in the Division of Pharmacometrics at the FDA. Prior to joining the FDA, Dr. Mulugeta practiced as a Critical Care Specialist at Children’s National Medical Center in Washington D.C. She also served as a faculty member in the Department of Pediatrics at the George Washington School of Medicine and in the Department of Pharmacy at the University of Maryland College. Dr. Mulugeta received her Pharm.D. degree from the University of Kentucky College of Pharmacy and completed a pediatric residency at Inova Fairfax Hospital in Falls Church, Virginia.
Leslie Myatt, Ph.D., FRCOG Professor, Obstetrics and Gynecology, Director of Perinatal Research, Director of the Center for Development Health, Director and Endowed Professor in Bob and Charlee Moore Institute of Nutrition and Wellness, Oregon Health & Science University, Portland
Dr. Leslie Myatt is Professor of Obstetrics and Gynecology, Director of Perinatal Research, Director of the Center for Developmental Health and Director and Endowed Professor in the Bob and Charlee Moore Institute of Nutrition and Wellness at the Oregon Health & Science University, Portland. Dr. Myatt has served as North American Editor of the journal Placenta, President of the Perinatal Research Society, President of the International Federation of Placenta Associations and President of the Society for Gynecologic Investigation. His primary research interests are 1. The effects of maternal obesity, gestational diabetes and sexual dimorphism on mitochondrial respiration in the placenta and their relationship to epigenetic regulation of placental function and fetal programming and 2. Autocrine/paracrine mechanisms in fetal membranes involved in parturition. He has published over 300 papers and 375 abstracts and has served on many review panels and study sections for NIH, CIHR and other international grant giving bodies. He was presented with the Naftolin Award for Mentorship in 2014 and the Distinguished Scientist Award in 2017 by the Society for Reproductive Investigation.
Robert "Skip" Nelson, MD, Ph.D. Executive Director, Pediatric Drug Development, Child Health Innovation Leadership Department, Johnson & Johnson
Previously (2006-2017), Dr. Robert Nelson was the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics at the U.S. Food and DrugAdministration. Prior to joining FDA, Dr. Nelson spent 20 years in the academic practice of pediatric critical care medicine, most recently as Professor of Anesthesiology, Critical Care and Pediatrics at The Children’s Hospital of Philadelphia (CHOP), and University of Pennsylvania School of Medicine. Dr. Nelson is a member of the International Council for Harmonisation (ICH) E11A Working Group developing a guideline on the use of extrapolation in pediatric drug development plans. He recently completed a four-year term as a member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) and serves as the Industry Representative to the FDA Pediatric Advisory Committee. After receiving his MD degree from Yale University, Dr. Nelson trained in pediatrics (Massachusetts General Hospital), neonatology and pediatric critical care (University of California, San Francisco). He has a Master of Divinity degree from Yale Divinity School and a Ph.D. in The Study of Religion from Harvard University, specializing in ethics.
Elisa Ochfeld, MD Allergy/Immunology Attending Physician, Children’s Hospital of Philadelphia (CHOP)
Dr. Elisa Ochfeld is an attending physician at the Children’s Hospital of Philadelphia. She completed her Allergy/ Immunology fellowship at Northwestern University / Lurie Children’s Hospital in Chicago in 2021.She completed an advanced research fellowship (T32 NUAIR grant), pursuing research on Kappa-deleting recombination excision circles (KRECs) in primary immunodeficiency patients as a potential indicator of Bcell bone marrow output. She clinically practices in both allergy and immunology at CHOP, and specializes in areas including food challenges and oral immunotherapy, as well as the Program for IntegratedImmunodeficiency and Cellular Therapy (PIICT ) clinic. She has pursued research in areas including: in-utero exposure to immunosuppressive medications resulting in abnormal newborn screening for severe combined immunodeficiency, hematopoietic stem cell transplantation for primary immunodeficiency, and additionally is a research collaborator with the Primary Immune Deficiency Transplant Consortium (PIDTC) investigating long-term outcomes in transplanted and non-transplanted patients with primary immune dysregulatory diseases (PIRDs) and CGD.
Ruth Oliver, Ph.D. Global Quantitative Clinical Pharmacology, Data Sciences Institute, Takeda
Dr. Ruth Oliver leads the Global Quantitative Clinical Pharmacology function as part of the Data Sciences Institute at Takeda.
Aaron C. Pawlyk, Ph.D. Chief,Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB), NIH Contact for Pediatric Medical Device Development, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Dr. Aaron Pawlyk is the Chief of the Obstetric and Pediatric Pharmacology and Therapeutics Branch at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Dr. Pawlyk is a pharmacologist with decades of leadership experience in drug discovery and pre-clinical development, pharmacogenomics, and mathematical modeling across multiple therapeutic areas. Under his leadership, the OPPT Branch aims to assure that there are safe and effective therapeutics for children and pregnant and lactating women and that these medications are used optimally according to individual needs. To accomplish these goals, his Branch is responsible for developing and supporting a comprehensive national effort to increase the knowledge base for understanding how to appropriately treat disease during pregnancy, lactation, infancy, childhood, and adolescence using evidence-based therapeutic approaches. Dr. Pawlyk received his bachelor’s degree from the University of Pennsylvania, where he studied biology and biochemistry. He completed his PhD training in biochemistry at Texas A&M University, followed by postdoctoral studies at the University of Pennsylvania. Before joining the NIH, he held multiple positions in the pharmaceutical sector.
Jeff Roberts, MD Associate Vice President, Vaccine Clinical Development, Merck Research Laboratories (MRL)
Dr. Jeff Roberts joined Merck Research Laboratories (MRL) inNovember 2021 as Associate Vice President, Vaccine Clinical Development. In this role, he is responsible for clinical development of candidate and licensed vaccines for a variety of disease targets.
Leyla Sahin, MD Deputy Director for Safety
Dr. Leyla Sahin is an obstetrician-gynecologist who serves as the Deputy Director for Safety in the Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research at FDA. She oversees pregnancy and lactation safety activities and leads various maternal health-related scientific and regulatory/policy initiatives. She joined FDA in 2008 as a medical officer after practicing obstetrics and gynecology for twelve years.
Dinesh Stanislaus, Ph.D. Head of Reproductive Toxicology, GSK
Dr. Dinesh Stanislaus is the head of reproductive toxicology at GSK,with over two decades of experience in the field. His work focuses on assessingrisks associated with fertility and pregnancy. He played a key role inproposing a new guideline for pregnant and lactating women (ICHE21) and is anonclinical Topic Leader in the expert working group since 2023. He holds a PhDfrom Oregon Health Sciences University and actively involved in the scientific debate on strategies for data collection during pregnancy and lactation.
Kelly Stone, MD, Ph.D. Associate Director for Therapeutic Review
Dr. Kelly Stone is a pediatrician and allergist/immunologist who serves as a Supervisory Physician and Associate Director for Therapeutic Review in the CDER Division of Pulmonology, Allergy, and Critical Care. In this role, he supervises regulatory review of INDs and NDAs/BLAs for products related to allergic/immunologic diseases and asthma. He serves on the FDA Pediatric Review Committee and was the recipient of a CDER Excellence in Mentoring Award and two group recognition awards for his efforts in guidance development and review of products to treat COVID-19.
Marie Teil, M.S. Global Head, Women of Childbearing Age Program, UCB Biopharma SRL
Ms. Marie holds a medical degree from Lyon, a Master's degree in Statistics from Paris, and a Regulatory Affairs Certification in the U.S.
Jashvant (Jash) Unadkat, Ph.D. Professor, Deptartment of Pharmaceutics, School of Pharmacy, University of Washington, Seattle
Dr. Jashvant (Jash) Unadkat is a Professor in the Dept. of Pharmaceutics at the School of Pharmacy, University of Washington, Seattle. He received his Bachelor’s degree in Pharmacy (B.Pharm.) from the University of London (1977), his Ph.D. from the University of Manchester and his postdoctoral training at the University of California at San Francisco. He held the Milo Gibaldi Endowed Professorship in the Department from 2016-21. Dr. Unadkat’s research interests are on mechanisms of transport and metabolism of drugs during pregnancy, and transport of drugs across the placental, hepatic, intestinal and blood-brain barrier. Dr. Unadkat has published more than 250 peer-reviewed research papers. He is a fellow of AAAS, AAPS, JSSX, and the founding co-chair (1999-2001) of the focus group of AAPS on Drug Transport and Uptake. Dr. Unadkat received the AAPS Research Achievement Award in 2012 and the ISSX Scientific Achievement Award in 2023. Dr. Unadkat created and led the UW Research Affiliates Program on Transporters (UWRAPT), a cooperative effort between the UW School of Pharmacy and pharmaceutical companies, for 10 years. He also leads UWPKDAP, a NIDA funded Program Project grant (P01) on drug disposition during pregnancy.Dr. Unadkat has been an Associate Editor for the Journal of Pharmaceutical Sciences, an Editor of AAPS Journal , and a member of the NIH Pharmacology study section (2000-3). Dr.Unadkat has organized or co-organized numerous national and international conferences on the role of transporters and pregnancy in the disposition of drugs.
Vani Vannappagari, MPH, Ph.D. Vice President & Global Head of Epidemiology and Real World Evidence, ViiV Healthcare
Dr. Vani Vannappagari is VP & Global Head of Epidemiology and Real World Evidence at ViiV Healthcare. In this role, she sets the strategy for conducting studies to collect real-world evidence on treatment effectiveness, adherence and safety of the antiretroviral drugs. She also leads studies in pregnancy and registries that evaluate drug safety during pregnancy; and non-interventional studies in pediatric and adolescent populations. She is the industry co-chair of the Antiretroviral Pregnancy Registry steering committee.
Raman Venkataramanan, Ph.D., FCP, FAAPS Distinguished Service Professor of Pharmaceutical Sciences and Pathology, University of Pittsburgh
Dr. Raman Venkataramanan is a Distinguished Service Professor of Pharmaceutical Sciences and Pathology at the University of Pittsburgh. He is also Director of the clinical pharmacokinetics laboratory and Director of Therapeutic Drug Monitoring and Toxicology at UPMC. Therapeutic Drug Monitoring , and four online journals. He is also editor for the American Journal of Analytical Chemistry, and a reviewer for 10 additional journals. Venkataramanan has received many awards, including: Distinguished Investigator Award – ACCP-2024; Distinguished Investigator Award – ACCP -2024; Distinguished Service Award, AAPS, 2021; Distinguished Scientists Award from AAiPS, Nov. 2016; Tyler Prize for Stimulation of Research (American Pharmacists Association [APhA], 2011); Bristol-Meyers Squibb Mentorship in Clinical Pharmacology (American College of Clinical Pharmacy [ACCP], 2009); and more.
Lynne Yao, MD Director
Dr. Lynne Yao is the Director, Division of Pediatric and Maternal Health (DPMH) in the Office of New Drugs, Center for Drug Evaluation and Research. Dr. Yao received a B.S. degree in Biology from Yale University, and an M.D. degree from the George Washington University School of Medicine. She is board-certified in both Pediatrics and Pediatric Nephrology. Prior to joining FDA, Dr. Yao was the Director of Dialysis and Associate Pediatric Residency Program Director at the Inova Fairfax Hospital for Children in Fairfax, VA. She has been with the FDA since 2008 and has been DPMH Director since 2012. As DPMH Director, Dr. Yao oversees quality initiatives, which promote and necessitate the study of drug and biological products in the pediatric population; and improve collection of data to support the safe use of drugs and biological products in pregnant and lactating individuals. She collaborates with numerous stakeholders both inside and outside of FDA to advance development of safe and effective therapies for children, and pregnant and lactating women.
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