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Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop (2023)

Chapter: Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff

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Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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C

Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff

PLANNING COMMITTEE BIOSKETCHES

Ruth Faden, Ph.D., M.P.H. (cochair), is the founder of the Johns Hopkins Berman Institute of Bioethics, and its director from 1995 until 2016. She is also the Philip Franklin Wagley Professor of Biomedical Ethics. Her research focuses on structural injustice theory and public policy including national and global challenges in public health, food, agriculture and climate, women’s health, health systems design and priority setting, and advances in science and technology. Currently Dr. Faden is working at the intersection of structural justice and the COVID-19 response, primarily in vaccine allocation and prioritization, pregnancy, and K-12 education. Her latest book, with Madison Powers, is Structural Injustice: Power, Advantage, and Human Rights (September, 2019; Oxford University Press).

Shirley Sylvester, M.D., M.P.H. (cochair), is a Senior Medical Director for Women’s Health with the Office of the Chief Medical Officer at Johnson & Johnson (J&J). She works with a team to drive change toward reducing maternal mortality in the United States and globally. As a leader of the Women’s Health team, she is responsible for providing strategic and scientific expertise in the development and implementation of programs that support the overall aims of Women’s Health at J&J and partnering with external stakeholders to develop a policy agenda that supports women’s health. Dr. Sylvester also works across the J&J Enterprise and externally to identify and act on opportunities that use J&J’s collective assets to positively affect women’s health through ethically based, science- and data--

Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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driven approaches, and acts as a subject matter expert in health matters related to women, providing guidance to stakeholders on topics related to women’s health.

Dr. Sylvester joined J&J in 2013 where she most recently led the creation of the global medical affairs strategy behind the development of hepatitis B compounds for the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). She established external collaborations with key stakeholders, including scientific societies, patient advocacy groups, and academic institutions to advance the scientific agenda and to deepen Janssen’s commitment to “Make Hepatitis History.” She also co-led the clinical development of investigational compounds in partnership with Janssen Research & Development.

In previous roles at J&J, Dr. Sylvester served as Medical Director for compounds in hepatitis C and multidrug-resistant tuberculosis (TB) in the United States. In these roles, Dr. Sylvester provided brand oversight on all medically related aspects of the compounds, including the design and execution of phase IIIb and IV studies in support of the medical affairs strategy.

Prior to joining J&J, Dr. Sylvester had a long history of working in the public sector, having partnered with NGOs, USAID, Bill & Melinda Gates Foundation, WHO, PAHO, ministries of health, and other global constituents. Through these collaborations, she helped to design and implement several public health programs around the world focused on postpartum hemorrhage prevention and other maternal health issues, immunizations, HIV/TB control, Chagas disease, and management of complications from obstetric fistula, among others.

Dr. Sylvester holds an M.D. degree from Universidad de Cartagena with a focus on family medicine and a Master of Public Health with a specialty in global health and infectious diseases from the Harvard T. H. Chan School of Public Health.

Ebony Boyce Carter, M.D., M.P.H., is a tenured associate professor and chief of the Division of Clinical Research in the Department of Obstetrics and Gynecology at Washington University School of Medicine. She practices maternal fetal medicine and serves as associate editor for Equity at Obstetrics & Gynecology (The Green Journal). Her research focuses on group prenatal care as a tool to promote health equity and is funded by the Robert Wood Johnson Foundation, National Institutes of Health, and the American Diabetes Association.

Dr. Carter earned her undergraduate degree in human biology with honors from Stanford University, Master of Public Health in health policy from the University of Michigan, and medical degree from Duke University. She completed residency in obstetrics and gynecology at the

Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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Harvard integrated program at Brigham and Women’s/Massachusetts General Hospitals and fellowship training in Maternal Fetal Medicine at Washington University School of Medicine.

Nahida Chakhtoura, M.D., is an obstetrician/gynecologist who joined the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in October of 2014 as a medical officer in the Maternal and Pediatric Infectious Disease Branch. As a medical officer, she overseas various mother-to-child transmission (PMTCT) research including congenital CMV, Zika, and HIV/AIDS-related clinical trials involving women, adolescents, and infants within the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) network. She also overseas grants and clinical trials related to prevention of HIV transmission and Multipurpose Prevention Technologies (MPTs). Her grant portfolio includes PMTCT of HIV, tuberculosis, cytomegalovirus, Hepatitis, as well HIV and contraception.

William O. Cooper, M.D., M.P.H., is a practicing physician, researcher, teacher, and administrator. He has led School of Medicine programs, including the Center for Patient and Professional Advocacy, the Master of Public Health Program, and the Pediatrics Office for Faculty Development. He is an internationally recognized expert in medication safety in children and has published more than 140 scholarly articles to date. In his role as associate dean for faculty affairs for Vanderbilt University School of Medicine and vice president for patient and professional advocacy, Vanderbilt University Medical Center, Dr. Cooper oversees the Medical Center’s professional programs and provides leadership and direction for the Center for Patient and Professional Advocacy.

Brownsyne Tucker Edmonds, M.D., M.P.H., M.S., is the inaugural vice president and chief health equity officer for Indiana University Health and the associate dean for health equity research for Indiana University School of Medicine, where she holds an endowed chair for Health Equity Research. She is an associate professor of obstetrics/gynecology (OBGYN) at Indiana University School of Medicine (IUSM) with training in general OBGYN, health services research, public health, and clinical ethics. Her research interests are in patient–provider communication and shared decision-making in reproductive health care. She is interested in understanding the impact of race, class, and culture on patient preferences and risk perceptions; physician decision-making and counseling; and ultimately, variations in treatment provision and service delivery. Dr. Tucker Edmonds’ work currently focuses on communication and decision-making in the management of periviable deliveries. She utilizes qualita-

Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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tive and quantitative methodologies to develop decision support interventions for parents facing this, and other, preference-sensitive decisions in high-risk obstetrical settings. Dr. Tucker Edmonds previously served as her department’s vice chair for faculty development and diversity and also served as an assistant dean for Diversity Affairs for the IU School of Medicine. Dr. Tucker Edmonds previously served on the Ethics Committee for the American College of Obstetrics and Gynecology (ACOG) and was the Legislative Affairs Chair for Indiana ACOG. She now serves on ACOG’s Committee on Government Affairs and is the chair of the Indiana Section. Dr. Tucker Edmonds was an Anniversary Fellow for the National Academy of Medicine (NAM) from 2015 to 2017, during which time she served on the committee that authored, The Health Effects of Cannabis and Cannabinoids: The Current State of the Evidence and Recommendations for Research. Most recently, she served on the committee that authored the report, Birth Settings in America: Outcomes, Quality, Access, and Choice.

Darcie Everett, M.D., M.P.H., is a medical officer for the FDA’s Division of Vaccines and Related Product Applications (DVRPA) in the Office of Vaccine Research and Review, Center for Biologics Evaluation and Research. As a clinical reviewer for DVRPA since 2014, she evaluates a variety of investigational vaccines and other biologics in all phases of clinical development. Her professional interests include maternal immunization. Dr. Everett is board certified in Internal Medicine, Pediatrics, and Preventive Medicine. She received her medical degree and a Master of Public Health in International Health and Development from Tulane University in New Orleans. She completed residencies at the Mount Sinai School of Medicine in New York (combined internal medicine and pediatrics), where she also worked as a hospitalist, and at Emory University in Atlanta (preventive medicine), where she focused on maternal and infant health.

Leslie Meltzer Henry, Ph.D., J.D., M.Sc., is a lawyer and bioethicist with expertise in assessing, navigating, and advising on a range of ethical and legal issues that arise at the intersection of medicine, public health, and public policy. She is a professor of law at the University of Maryland Carey School of Law, and a faculty member at the Johns Hopkins Berman Institute of Bioethics. Her scholarly work primarily focuses on aspects of biomedical research regulation and practice that have implications for, and are implicated by, social justice and public health. Her recent scholarship has addressed barriers as well as potential facilitators to including pregnant people in research, compensation schemes for research-related injuries, challenges associated with including adolescents in research, and the complexities of conducting research during pandemics. She has been an investigator on both NIH and internationally funded grants aimed

Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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at developing ethically and legally acceptable strategies for conducting research during pregnancy. Dr. Henry’s research has been published in the nation’s leading law reviews and medical journals. She has served in an advisory capacity to a variety of federal and local agencies and commissions—including the U.S. Department of Defense, Trans-NIH Bioethics Advisory Committee, NIAID, NICHD, NIMH, NIH Office of Research on Women’s Health, and FDA—to identify limits, as well as areas of flexibility, in regulations related to the inclusion of special populations in research. Dr. Henry received her J.D. from Yale Law School, Ph.D. from the University of Virginia, and M.Sc. from the University of Oxford, where she was a Wellcome Trust Fellow in the History of Medicine. She completed postdoctoral work at Johns Hopkins University as a Greenwall Fellow in Bioethics and Health Policy.

Steven E. Kern, Ph.D., is deputy director of quantitative sciences at the Bill & Melinda Gates Foundation. The Quantitative Sciences group is focused on quantitative analysis to support program strategies for therapeutic projects that the foundation funds across multiple disease domains. Prior to this, he was Global Head of Pharmacology Modeling at Novartis Pharma AG based in Basel, Switzerland, where he led a team focused on providing model-based drug development support to therapeutics in many disease conditions across all stages of drug development. He joined Novartis in 2010 from the University of Utah in Salt Lake City, where he was Associate Professor of Pharmaceutics, Anesthesiology, and Bioengineering, and served as coinvestigator for their NIH-funded Pediatric Pharmacology Research Unit. He has designed, conducted, and served as a principal investigator for clinical pharmacology studies in adults and children that spanned the population from preterm infants to elderly adults. He has a bachelor’s degree in mechanical engineering from Cornell University, a master’s degree in bioengineering from Pennsylvania State University, and a doctoral degree in bioengineering from the University of Utah. Dr. Kern has published more than 70 papers in areas of pharmacokinetic and pharmacodynamic modeling, applying principles of control systems engineering to drug delivery, and clinical pharmacology.

Leyla Sahin, M.D., is an obstetrician/gynecologist who is 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. She has led various maternal health-related scientific and regulatory/policy initiatives, including publication of FDA guidances. She was a working group member on the HHS Task Force for Research Specific to Pregnant Women and Lactating Women (PRGLAC Task Force). The focus of her

Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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work involves advancing FDA’s scientific and regulatory policies related to pregnancy and lactation, through all phases of drug development. Her principal area of interest is promoting the public health of pregnant and breastfeeding individuals through improved data collection.

Kavita Shah Arora, M.D., M.B.E., M.S., is the division director for general obstetrics and gynecology and an associate professor at the University of North Carolina-Chapel Hill. She is the current Greenwall Fellow in Bioethics at the National Academy of Medicine. She serves as the chair of the national ethics committee of the American College of Obstetricians and Gynecologists and serves on the Governing Council for the Young Physicians Section of the American Medical Association. She has served on the national ethics committee of the American Medical Association and on the Board of Directors of the American Society for Bioethics and the Humanities. Her clinical, research, and education interests center around reproductive justice and ensuring evidence-based and equitable reproductive health policy, with a focus on sterilization disparities. She completed her B.S. from the Pennsylvania State University, medical school at Jefferson Medical College, a master’s in bioethics at the University of Pennsylvania, a master’s of science in clinical research at Case Western Reserve University, and her obstetrics and gynecology residency at Northwestern Memorial Hospital.

Diane Spatz, Ph.D., R.N., is a professor of perinatal nursing and the Helen M. Shearer Professor of Nutrition at the University of Pennsylvania School of Nursing sharing a joint appointment as a nurse scientist in lactation for the Children’s Hospital of Philadelphia (CHOP) in the Center for Pediatric Nursing Research and Evidence-Based Practice. Dr. Spatz is the founder of the CHOP Lactation Program and Mothers’ Milk Bank.

Dr. Spatz is an active researcher, clinician, and educator who is internationally recognized for her work surrounding the use of human milk and breastfeeding, particularly in vulnerable populations. Dr. Spatz has been principal investigator or coinvestigator on more than 60 research grants, included several from the NIH. She has authored and coauthored more than 210 peer-reviewed publications and written numerous book chapters related to human milk and breastfeeding. Dr. Spatz has authored or coauthored position statements for the International Lactation Consultant Association, the Association of Women’s Health Obstetric and Neonatal Nursing (AWHONN), the Society of Pediatric Nurses (SPN), and the National Association of Neonatal Nurses. She has also written the clinical practice guidelines on human milk and breastfeeding for AWHONN and SPN as well as a technical brief for the USAID on human milk and breastfeeding in developing countries.

Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
×

In 2004, Dr. Spatz developed her 10-step model for human milk and breastfeeding in vulnerable infants. This model has been implemented in neonatal intensive care units throughout the United States and other countries worldwide (Thailand, India, China, Mexico, Japan, Chile). Dr. Spatz has been named a prestigious “Edge Runner” for the American Academy of Nursing related to the outcomes of her model. Her nurse driven models of care are critical in improving human milk and breastfeeding outcomes and thus the health of women and children globally. Dr. Spatz is the only Ph.D.-prepared nurse appointed to the Congressional Task Force on Research Specific to Pregnant Women and Lactating Women. Dr. Spatz has also been appointed to a World Health Organization task force on human milk and milk banking globally. Dr. Spatz was elected to the Executive Committee of International Society of Research in Human Milk and Lactation in April 2020.

Dr. Spatz is also the recipient of numerous awards, including the Lifetime Achievement Award from the National Association of Neonatal Nurses, the Research Utilization Award from Sigma Theta Tau International, and from the University of Pennsylvania: the Dean’s Award for Exemplary Professional Practice, the Expert Alumni Award, and the Family and Community Department’s Academic Practice Award. She is also the recipient of the Lindback Award for Distinguished Teaching. Dr. Spatz received the Distinguished Lang Award for her impact on scholarship, policy, and practice. In 2019, Dr. Spatz received AWHONN’s Distinguished Researcher Award and was named Nurse of the Year by the Philadelphia Inquirer.

In the university portion of her job, she teaches a course on breastfeeding and human lactation to undergraduate nursing students and in the hospital portion of her job, she developed the Breastfeeding Resource Nurse program. Dr. Spatz is past chair of the American Academy of Nursing’s Expert Panel on Breastfeeding and their representative to the United States Breastfeeding Committee.

Raman Venkataramanan, Ph.D., is currently a professor of pharmaceutical sciences and pathology in the University of Pittsburgh. He is the director of the university’s Clinical Pharmacokinetics Laboratory and the Therapeutic Drug Monitoring program. Venkataramanan received his Bachelor of Pharmacy degree from the University of Madras, India; Master of Pharmacy degree from the Birla Institute of Technology and Science, India; and doctorate in Pharmaceutical Sciences from the University of British Columbia, Canada. After a postdoctoral fellowship at the University of Washington, he joined the University of Pittsburgh in July 1980. He has been appointed as a Food and Drug Administration special government employee by the Center for Drug Evaluation and Research.

Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
×

Venkataramanan serves as a scientific reviewer for several journals. He is an editorial board member for Therapeutic Drug Monitoring, and four online journals. He is the editor for the American Journal of Analytical Chemistry. He is the recipient of the Distinguished Service Award from AAPS (2021), HiREC Endowed visiting chair at the University of Puerto Rico (October 2021), Distinguished Scientists Award from the American Association of Indian Pharmaceutical Scientists (AAiPS) in 2016, graduate faculty of the year award from the School of Pharmacy in 2015 and 2021, Tyler Prize for Stimulation of Research from the American Pharmacists Association (APhA) in 2011, the Bristol-Meyers Squibb Mentorship in Clinical Pharmacology from the American College of Clinical Pharmacy in 2009, the Provost’s Award for Excellence in Graduate Education from the University of Pittsburgh in 2009, the Innovations in Teaching award from the Rho Chi Society at the University of Pittsburgh in 2009, the Scholarly Contributions award from the Rho Chi Society at the University of Pittsburgh in 2007, the Ranbaxy Research Award in Pharmaceutical Sciences in 1998, and the Distinguished Research Scientists Award from KDRI in Ahmadabad, India, in 1996. The research in his laboratory revolves around “LIFE.” One half addresses the first chance in life—optimizing the use of medications in pregnant women based on pharmacokinetics and pharmacodynamics data; the second half addresses optimization of the use of medications in organ transplant patients—a second chance in life. His current research is funded by NICHD (OPRC-Co-PI), NCI, and United Therapeutics. He has presented more than 200 lectures or seminars at national and international meetings and published more than 450 scientific articles. He has been an active member in various professional organizations such as American Association of Pharmaceutical Scientists, American Association of Indian Pharmaceutical Scientists, American College of Clinical Pharmacology, American Association of Colleges of Pharmacy, and the American Society of Transplantation.

Michelle Vichnin, M.D., is the Executive Director and Global Lead, Patient Advocacy and Strategic Alliances at Merck, where she and her team are strengthening the company’s patient engagement and advocacy presence around the world. She works on several initiatives to address health care disparities, increase health literacy, and explore innovative ways to meet the needs of patients during and beyond the COVID-19 pandemic.

Dr. Vichnin joined as a U.S. Medical Director for adolescent vaccines in 2007, and became a Global Medical Director in 2009. With her experience in cervical cancer prevention, she served as the medical lead for Merck’s public health initiatives to bring vaccines to low-income countries. She then served as the executive director for oncology in the Office of the Chief Medical Officer and worked to bring patient perspectives

Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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into the company. She is an expert advisor for Merck for Mothers, the company’s global initiative to help create a world where no woman has to die while giving life. She also is a member of the Diversity and Inclusion in Clinical Trials team, and recently published a paper in JCO Oncology Practice on strategies for increased inclusion of racial and ethnic minorities in clinical trials.

A board-certified obstetrician/gynecologist, she is a graduate of the Pennsylvania State University/Jefferson Medical College accelerated 6-year medical program and performed her residency in Obstetrics and Gynecology at the New York-Presbyterian Weill Cornell Medical Center. Prior to joining Merck, Dr. Vichnin was an Assistant Clinical Professor in the Department of Obstetrics and Gynecology at the University of Pennsylvania School of Medicine. She practiced at Penn Health for Women, a nationally recognized program for excellence in women’s health, and was the Director of the Colposcopy Clinic at the Hospital of the University of Pennsylvania, where she received awards for her research. For several years she served on ACOG’s Committee on Adolescent Health. She supports numerous nonprofit organizations, has volunteered as an attending physician at a clinic in the Andes Mountains in Peru, and most recently volunteered at a COVID-19 vaccine clinic.

Carmen Zorrilla, M.D., is a professor of obstetrics/gynecology (OBGYN) at the University of Puerto Rico (UPR) School of Medicine, certified by the American Board of Obstetrics and Gynecology and the American Academy of HIV Medicine. Dr. Zorrilla has experience in OBGYN and HIV-related research that includes behavioral interventions and clinical trials with HIV-infected and at-risk populations, as well as with pregnant and nonpregnant women. She was part of the group of examiners for the American Board of Obstetrics & Gynecology (ABOG) for 22 years and Past Residency Program Director for the UPR OBGYN program. She established an infrastructure for the care of pregnant and nonpregnant women living with HIV. The transmission rate of HIV infection among the more than 500 infants born to pregnant women living with HIV during the past 20 years at her clinic has been zero. Dr. Zorrilla worked with the PR Health Department in the elimination of HIV transmission for which she published the experience, stating that PR was in fact the first country to eliminate transmission. For almost 2 decades, she has been the PI of the Integrated UPR Clinical Trials Unit (IUPR-CTU), including the Pediatric AIDS Clinical Trials Unit (IMPAACT), the Adult Clinical Trials Unit (ACTG) until last year when funding was modified to protocol specific. She has been a consultant for diverse national and international organizations including the National Institutes of Health (NIH), the Maternal and Child Health Bureau (MCHB), the Centers for Disease Control and

Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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Prevention (CDC), the Agency for Health Research Quality, and others, and she was a former member of the Office of Women’s Health Advisory Committee and the CDC/HRSA AIDS and STD Advisory Committee (CHAC). Dr. Zorrilla is a member of the National Institute of Health Disparities and Minority Health Advisory Council (NACMHD).

Dr. Zorrilla established the first group prenatal care program in PR (Centering Pregnancy) with funds from the Innovation Center of the Centers for Medicare & Medicaid Services (CMS). This is the first Spanish Centering Program outside of the mainland United States. One of the outcomes of the program has been the reduction in preterm births and low birth weight among infants born of women enrolled in group prenatal care at the University Hospital. Expanding the program to impact and improve the health of mothers and infants is also one of her professional goals. She is part of the group of leaders who spearheaded the research response to the emerging Zika epidemic among pregnant women in PR. She also established a multidisciplinary clinic for pregnant women with Zika. Dr. Zorrilla is the site PI for the Zika in Infants and Pregnancy (ZIP Study) in San Juan. She is a member of the Scientific Coalition named by PR Governor Hon. Pedro Pierluisi to advise on issues related to the COVID pandemic response and to further incorporate the input of science into public policy. During the COVID-19 pandemic she spearheaded the development of a molecular testing program at the RCM, a COVID vaccine center, and a phase III vaccine trial at the UPR-MSC. Her team was responsible for the immunization of 97 percent of the faculty, students, and staff at the UPR Medical Sciences Campus early in 2021.

SPEAKER BIOSKETCHES

Tolúwalàṣé (Laṣé) Ajayi, M.D., is a board-certified pediatrician and fellowship-trained palliative care physician. She serves as the director of clinical research and diversity initiatives at Scripps Research Translational Institute as well as an assistant professor of pediatrics at UC San Diego and Rady Children’s Hospital San Diego where she works as a hospitalist and pediatric palliative medicine physician. She is also the medical director of adult palliative medicine at Scripps Mercy Hospital San Diego.

Dr. Ajayi’s research focuses on health disparities and opportunities at the intersection of novel digital medicine technologies and unmet needs in maternal fetal health as well as pain and palliative medicine. She hopes to increase participation of pregnant people and their newborns in clinical research and further investigate how mobile health can provide real-time, patient-reported outcomes that can be rapidly integrated into individualized clinical plans to reduce health disparity gaps and improve

Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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health-related quality of life. With these efforts, she hopes to diversify the standard of care provided to pregnant people and augment how we manage the symptoms prevalent in serious illness, with the goal of decreasing distress and associated hospital and emergency room utilization.

Brittany Bettendorf, M.D., is a clinical assistant professor at the University of Iowa where she started a pregnancy and rheumatology clinic in 2017. In this clinic, she sees patients with rheumatologic disease who are pregnant or are hoping to conceive and seeking preconception counseling. She received her M.D. from Medical College of Wisconsin where she also completed her residency in internal medicine and pediatrics as well as her fellowship in rheumatology. She holds an M.F.A. degree in nonfiction writing from University of Iowa. Dr. Bettendorf served as a member of the literature review committee and coauthor for the 2020 American College of Rheumatology (ACR) Reproductive Health Guideline. She was also part of the ACR working group to develop educational training content for clinical providers on Systemic Lupus Erythematosus and Reproductive Health (SLE-RESPECT). She enjoys the opportunity to network with others who are passionate about taking care of pregnant patients with rheumatic and musculoskeletal disease. Dr. Bettendorf teaches a class to first-year medical and physician assistant students on social justice, and she also teaches an advanced elective to medical students on Opinion Editorial Writing to help students improve the public’s understanding of health and health care. She is a faculty member in the Program in Bioethics and Humanities at Carver College of Medicine.

Diana Bianchi, M.D., is the director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and a Senior Investigator in the Center for Precision Health Research at the National Human Genome Research Institute (NHGRI); both are at the National Institutes of Health (NIH). She is responsible for leading a $1.6 billion research portfolio that focuses on children, reproductive biology and pregnancy, and physical and intellectual disabilities. She received her M.D. from Stanford University and her postgraduate training in pediatrics, medical genetics and neonatal-perinatal medicine at Harvard. Dr. Bianchi’s research focuses on noninvasive prenatal screening and development of novel fetal therapies for genetic disorders. She has published more than 350 peer-reviewed articles and is one of four authors of Fetology: Diagnosis and Management of the Fetal Patient, which won the Association of American Publishers award for best textbook in clinical medicine in 2000. She has held multiple leadership positions, including presidencies of the International Society for Prenatal Diagnosis (ISPD) and the Perinatal Research Society, council memberships in the Society for Pediatric Research (SPR)

Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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and the American Pediatric Society, as a member of the board of directors in the American Society for Human Genetics. She served as the editor-in-chief of the journal Prenatal Diagnosis from 2007 to 2020. Dr. Bianchi has received the Neonatal Landmark Award from the American Academy of Pediatrics, the Maureen Andrew Award for Mentorship from the Society for Pediatric Research, the Colonel Harland Sanders Award for lifetime achievement in medical genetics from the American College of Medical Genetics, the Pioneer Award from ISPD, and the Health Public Service Visionary Award from the Society for Women’s Health Research. In 2013 she was elected to the National Academy of Medicine. She received a Ph.D. honoris causa from the University of Amsterdam in 2020.

Christina Chambers, Ph.D., M.P.H., is a professor in the School of Medicine at UC San Diego. She is codirector of the Center for Better Beginnings; program director of MotherToBaby, a service providing evidence-based information on exposures during pregnancy and lactation; and is program director of Mommy’s Milk, a human milk biorepository for research.

Dr. Chambers leads a number of national and international complex longitudinal cohort studies and clinical trials of prenatal exposures and child health and development. Her research has been instrumental in identifying previously unrecognized human teratogens, as well as ruling out substantial risk for medications and vaccines.

Jessica Cohen, M.H.S., is the director of PATH’s Office of Research Affairs. In this capacity, she manages systems and policies to ensure PATH research is scientifically and ethically sound, directs research training, and provides guidance on best practices for research at PATH. Ms. Cohen serves as the senior cochair of PATH’s research ethics committee, a role she has held since 2006.

Ms. Cohen has worked as a researcher and project manager at PATH, conducting research to develop, adapt, and improve reproductive health and HIV prevention technologies for use in low-resource settings. She has also held advocacy roles to increase support for women-controlled HIV and pregnancy prevention methods.

Ms. Cohen also has a strong interest in global health bioethics and has most recently worked on issues pertaining to equitable access to human milk for vulnerable infants. She has served as guest faculty for the Fogarty International Center’s Training Program on Research Ethics and has served on multiple advisory boards, panels, and symposia on topics of global health research ethics, microbicide delivery, and HIV prevention methods for women.

Ms. Cohen received her M.H.S. in international health from Johns Hopkins University School of Hygiene and Public Health and her B.A.

Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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in cultural anthropology from the University of California at Santa Cruz. She has been a certified institutional review board (IRB) professional since 2011.

Veronica Gillispie-Bell, M.D., M.A.S., is a board-certified obstetrician and gynecologist and associate professor for Ochsner Health in New Orleans, Louisiana. She serves as the Senior Site Lead and Section Head of Obstetrics and Gynecology at Ochsner Kenner. Additionally, she serves as the Director of Quality for Women’s Services for the Ochsner Health System and is the Medical Director of the Minimally Invasive Center for the Treatment of Uterine Fibroids. She earned her medical degree from Meharry Medical College and completed her residency training at Ochsner Health System. She has a Master of Applied Science in patient safety and healthcare quality from the Johns Hopkins Bloomberg School of Public Health. Additionally, she has received certification in diversity and inclusion from Cornell University. Clinically, in addition to providing obstetric care, Dr. Gillispie-Bell performs advanced laparoscopic and robotic-assisted laparoscopic procedures and is known nationally for her expertise in management of heavy menstrual bleeding associated with fibroids.

Dr. Gillispie-Bell is also the Medical Director of the Louisiana Perinatal Quality Collaborative and Pregnancy Associated Mortality Review for the Louisiana Department of Health. In this role, she leads initiatives in the state of Louisiana to improve birth outcomes for all birthing persons in Louisiana and eliminate the Black–White disparity gap. Dr. Gillispie-Bell has testified before Congress and led congressional briefings to inform on the drivers of maternal mortality and legislative policy to improve maternal mortality and eliminate the Black-White disparity gap. Additionally, she serves in several leadership roles promoting efforts to achieve health equity. She has served in several local and national leadership roles and received many accolades for her clinical, academic, and community services contributions.

Thomas Hale, Ph.D., R.Ph., is the University Distinguished Professor of Pediatrics and assistant dean of research at Texas Tech University School of Medicine. He is the founder and director of the InfantRisk Center, a national call center for pregnant and breastfeeding mothers. He holds degrees in Pharmacy and a Ph.D. in pharmacology and toxicology and is widely experienced in pediatric and breastfeeding clinical pharmacology. He is a well-known international lecturer in the pharmacology of lactation and is the author of five books including Medications and Mothers’ Milk, the top-selling drug reference manual in the world. He has authored numerous papers, case reports, and abstracts, and more than 30 books chapters.

Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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David Haas, M.D., M.S., is a board certified OB-GYN physician. He is the Codirector and Editor of the US Satellite of the Cochrane Collaboration Pregnancy and Childbirth Group and has served on World Health Organization Guideline Development Groups. He has recently been appointed the Medical Director for Statewide Research for the Indiana Clinical and Translational Sciences Institute. As a practicing OB-GYN physician-scientist, his research interests revolve around prevention and treatment of medical and obstetric complications. He has a particular focus on medications and pregnancy and on long-term health outcomes stemming from pregnancy complications for both the pregnant individuals and their babies. He runs a research team with expertise in recruitment to obstetric cohorts, bio-banking, and clinical trials. He also directs the research mentorship program for OB/GYN residents. He collaborates on several multicenter trials and has a passion for team interdisciplinary science.

Zsakeba Henderson, M.D., is currently the Senior Vice President of MCH Impact and Interim Chief Medical Officer at March of Dimes, providing strategic direction and clinical expertise across the organization to help end the maternal and infant health crisis, including the direction of March of Dimes Mission programs and services, professional and patient education, and government affairs and advocacy. She is a board-certified obstetrician/gynecologist, and previously led the program in support of state-based perinatal quality collaboratives at the Centers for Disease Control and Prevention Division of Reproductive Health, including leading the establishment of the National Network of Perinatal Quality Collaboratives (NNPQC). Dr. Henderson currently serves as an Executive Committee Member and the Obstetric Cochair for the NNPQC. She received her B.S. degree in biochemistry from Oakwood University in Huntsville, Alabama, and her medical degree from Harvard Medical School in Boston, Massachusetts. She also completed her internship and residency at Harvard at the Brigham and Women’s Hospital/Massachusetts General Hospital Integrated Residency Program in Obstetrics and Gynecology. She subsequently entered the Epidemic Intelligence Service at the Centers for Disease Control and Prevention, in the Division of STD Prevention. Her work and experience includes program development and research in the areas of perinatal quality improvement to reduce maternal and infant morbidity and mortality, prevention of preterm birth, and the development of robust partnerships and networks to improve population-level outcomes for mothers and infants.

Wei Hua, M.D., Ph.D., is currently Acting Deputy Director of Division of Epidemiology-I in the Office of Surveillance and Epidemiology, CDER, FDA. She received her medical degree from China and Ph.D. from the

Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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Johns Hopkins University School of Public Health. Her areas of expertise include infectious disease epidemiology and pharmacoepidemiology with experience in both experimental and observational studies using primary and secondary data in the United States and through multisite international collaborations. Over the past 10 years, Dr. Hua has held multiple roles in the FDA centers for biologics and drugs leading and overseeing epidemiological research and review, including pregnancy safety, in the regulatory setting.

Ruth Karron, M.D., is a professor of international health in the Bloomberg School of Public Health with a joint appointment in the Department of Pediatrics in the School of Medicine, Johns Hopkins University. Dr. Karron is a pediatric infectious diseases physician, virologist, and vaccinologist, and is Director of the Johns Hopkins Vaccine Initiative. Dr. Karron has substantial experience in the evaluation of respiratory virus vaccines in adult and pediatric populations. Dr. Karron’s research interests also include the development of immune responses to respiratory viral infections in early life, the epidemiology of RSV and other respiratory viral diseases in low-resource settings, and public policy and ethical issues related to vaccine development and distribution. She co-led the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) Working Group, which released Pregnant Woman & Vaccines Against Emerging Epidemic Threats: Ethics Guidance for Preparedness, Research and Response, a guidance document with specific actionable recommendations to ensure that pregnant women are no longer excluded from receiving vaccines against emerging infectious diseases, and she was codeveloper of the COVID-19 Maternal Immunization Tracker (www.comitglobal.org). Dr. Karron has been a member of a number of national and international vaccine advisory committees and panels, including the CDC Advisory Committee on Immunization Practices (ACIP), the Gavi Vaccine Innovation Prioritisation Steering Committee (VIPS), and the COVAX ACT-accelerator COVID vaccine Maternal Immunization Working Group, and has chaired the FDA Vaccine and Related Biological Products Advisory Committee (VRBPAC) and the Vaccines Advisory Panel for the Wellcome Trust. She is currently deputy chair of the WHO Product Development for Vaccines Advisory Committee (PDVAC). In 2016, Dr. Karron received the Robert M. Chanock award for outstanding contributions to RSV research.

Maggie Little, B.Phil., Ph.D., is senior research scholar at the Kennedy Institute of Ethics, and professor of philosophy at Georgetown. Her research interests include issues in reproduction, clinical research ethics, data ethics, and the structure of moral theory. A Rhodes Scholar and

Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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fellow of the Hastings Center, she has twice served as Visiting Scholar in residence at the National Institutes of Health Department of Bioethics, and was appointed to the Ethics Committee of the American College of Obstetrics and Gynecology. She is cofounder of the Second Wave Initiative, which works to promote responsible research into the health needs of pregnant women.

In her previous role as Director of the Kennedy Institute, Dr. Little oversaw a time of transformative development, including the launch of the world’s first Introduction to Bioethics MOOC in April 2014; the inauguration of Conversations in Bioethics, an annual campus-wide event focused on a critical issue in bioethics; and the deployment of a series of experimental undergraduate courses utilizing project-based learning and design studio methods. Dr. Little is founder and Director of EthicsLab, a unique team of Philosophers and Designers at Georgetown University that develops new methods to help people build ethical frameworks to better address real-world problems. Ethics Lab works to help surface the moral values at stake in emerging, complex issues, including data ethics and AI, to help build responsible progress. She is a founding cochair of the Tech and Society Initiative at Georgetown.

Sarah Mancoll, M.S., joined the Society for the Psychological Study of Social Issues (SPSSI) as Policy Director in the fall of 2015. Her role at SPSSI is to develop opportunities for sharing relevant social science data with advocates and policy makers. Ms. Mancoll has worked on a range of issues, including expanding high-quality early care and learning, supporting children and families in disaster contexts, and creating safer school environments for LGBTQ students. Ms. Mancoll received her bachelor’s degree in human development from Cornell University and received her master’s degree in social policy and planning from the London School of Economics and Political Science.

Anna Mastroianni, J.D., M.P.H., is Charles I. Stone Professor of Law at the University of Washington (UW) School of Law and Associate Director of the university’s Institute for Public Health Genetics. She holds additional faculty appointments in the UW’s School of Public Health and School of Medicine. Before joining the UW faculty, she worked as a practicing health care attorney and served in a number of legal and governmental policy positions in Washington, DC. Her scholarly work examines the intersection of law, bioethics, public health, and health policy, with special emphasis on the legal and ethical challenges arising in research with pregnant women, the use of genetic technologies in public health, reproductive rights, and family building through assisted reproductive technologies.

Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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Professor Mastroianni is an elected Fellow of the American Association for the Advancement of Science, recognized for her contributions to health policy, law, and bioethics. She serves on consensus, advisory, and oversight committees, both nationally and internationally. For the National Academies of Sciences, Engineering, and Medicine, that work has included examining ethics and policy for oversight of social sciences research, policies for the National Immunization Program’s research procedures and data sharing, ethical and policy issues in the introduction of mitochondria replacement techniques, and ethics of health standards for long-duration space flight. She has served as a member of the National Institutes of Health Recombinant DNA Advisory Committee and as Trustee of the Population Council. She is a current member of the Standing Committee on Aerospace Medicine and the Medicine of Extreme Environments, and chaired the Wellcome Trust (UK) Medical Humanities & Social Science Selection Panel from 2014–2020.

Iona Munjal, M.D., is a senior director in Pfizer Vaccine Clinical Research and Development service as a medical monitor on vaccine trials. A board-certified pediatric infectious diseases physician and assistant professor of pediatrics at the Albert Einstein College of Medicine, she is a graduate of Georgetown University and Rutgers Medical School. She did her residency and chief residency in pediatrics at Mount Sinai Hospital. She followed that with a fellowship in infectious diseases at the Children’s Hospital at Montefiore where she was awarded the best scientific research abstract by the New York Infectious Diseases Society. Dr. Munjal worked in hospital administration in epidemiology and emerging infectious diseases, including the health system’s response to Ebola and Zika viruses. She founded and oversaw the hospital’s pediatric antimicrobial stewardship program, which seeks to promote sensible use to improve patient outcomes, decrease adverse events, and prevent the emergence of resistant pathogens. She served as a principal investigator in multiple anti-infective and vaccine clinical trials during her tenure in academia. Since she joined Pfizer Vaccine Clinical Research and Development in 2016, she has contributed and provided expertise and oversight to the Staphylococcus aureus vaccine program and the COVID-19 pediatric vaccine trials. She is currently the global clinical lead for Pfizer’s maternal RSV vaccine programs.

Jeff Roberts, M.D., joined Merck Research Laboratories (MRL) in November 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, such as HPV, CoV, HSV, Ebola, and chikungunya. Prior to joining MRL, Dr. Roberts was Associate Director for

Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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Scientific Affairs in the Office of Vaccines Research and Review at FDA. His focus included emerging disease threats/medical countermeasures and use of digital health tools, alternative clinical trial designs, and real-world evidence to support product development and licensure. He also led discussions and coordination on vaccine development with other regulatory authorities. Prior to that, and for most of his 14 years at FDA, Dr. Roberts served as Clinical Branch Chief in the Division of Vaccines and Related Product Applications (DVRPA), where he managed the clinical review activities for development programs and licensure applications for multiple products, including vaccines, allergenic products, phage therapy, and live biotherapeutics. Dr. Roberts received his M.D. from the University of Alabama School of Medicine. He spent several years at the National Cancer Institute at NIH doing basic research and animal modeling with HPV prior to moving to FDA.

Kathryn G. Schubert, M.P.P., joined the Society for Women’s Health Research (SWHR) as President and CEO in April 2020. Under Ms. Schubert’s leadership SWHR developed a strategic plan focused on fulfilling the organization’s mission of promoting research on biological sex differences in disease and improving women’s health through science, policy, and education. She previously worked for the Society for Maternal-Fetal Medicine (SMFM), where she served as the organization’s chief advocacy officer, growing SMFM’s role nationally and building its reputation in women’s health.

Ms. Schubert is a trusted leader and consensus builder among women’s health stakeholders, particularly in the policy arena. She has served in multiple board roles for nonprofit organizations in the Washington, DC-area, including as Chair of the Board of the Maternal Mental Health Leadership Alliance and as advisor to the John E. Lewy Fund for Children’s Health. She is a past president of Women in Government Relations.

Prior to SMFM, Ms. Schubert served as senior vice president at CRD Associates, where she advised clients—including nonprofit patient advocacy groups, medical professional organizations, and private companies—on government relations and public policy related to health and biomedical research issues, among others. She has also spent time working in key legislative roles on Capitol Hill. She received her B.A. from Mary Washington College and her Masters of Public Policy from George Washington University.

Catherine Sewell, M.D., M.P.H., is currently the acting deputy director and is the deputy director for safety in the Division of Urology, Obstetrics, and Gynecology, as well as cochair of the Drug Safety Team for Pediatrics, Rare Diseases, Obstetrics, Gynecology, Urology, and Maternal

Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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Health at the U.S. Food and Drug Administration (FDA). In these roles she provides leadership and technical direction to premarket scientific review staff engaged in the evaluation of Investigational New Drug Applications (INDs) and New Drug Applications and Biologic Licensing Applications. She also provides scientific, clinical, and technical authority on all medical and scientific decisions and judgments in connection with the review and evaluation of drugs. She also advances the Office of New Drugs’ policies, research agenda, training, and collaboration across other divisions, offices, and stakeholders, and contributed to the creation of division-level plans to meet these goals.

She further coordinates processes that span the division’s postmarketing safety activities including overseeing the development, tracking, and follow-up of safety studies and clinical trials, safety labeling changes, and Risk Evaluation and Mitigation Strategies for approved drugs. Dr. Sewell is part of the process modernization effort at FDA, aiming to improve the mechanisms for monitoring and evaluating premarket and postmarket safety signals. Additionally, she liaises with other FDA offices and other regulatory agencies, industry, professional organizations, academia, and the public. In prior roles at FDA she was a clinical reviewer and acting clinical team leader.

Dr. Sewell is a board-certified obstetrician/gynecologist. She graduated from Swarthmore College with Honors, the University of Pennsylvania Perelman School of Medicine, and the Johns Hopkins Bloomberg School of Public Health with Honors. She completed her Gynecology and Obstetrics residency at Johns Hopkins. She was a member of academic faculty, as Director of the Hopkins Fibroid Center in the Department of Gynecology and Obstetrics at Johns Hopkins and as Medical Director of the Jefferson Obstetrics and Gynecology Associates in the Department of Obstetrics and Gynecology at Thomas Jefferson University. She was also the Chief of the Department of Obstetrics and Gynecology at the University of Maryland St. Joseph Medical Center, providing full-scope direct gynecologic patient care and surgery, overseeing the department’s clinical care and patient safety initiatives, and mentoring and teaching medical students and Doctorate in Nursing Programs students. Dr. Sewell has been a coinvestigator for several research studies, has coauthored numerous publications, and crafted documents for Jhpieco, a nonprofit health organization affiliated with Johns Hopkins.

Ajoke Sobanjo-ter Meulen, M.D., M.Sc., is the vice president, medical affairs and policy at Icosavax. In her role she leads the medical affairs strategy for Icosavax’s vaccine programs. Prior to joining Icosavax, Dr. Sobanjo-ter Meulen led the global maternal immunization initiative with a focus on Group B streptococcus and pertussis maternal vaccine develop-

Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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ment at the Bill & Melinda Gates Foundation. Previously, Dr. Sobanjo-ter Meulen led the Group B streptococcus maternal immunization clinical development program at Novartis Vaccines. In response to the COVID-19 pandemic Dr. Sobanjo-ter Meulen cochaired the COVAX Maternal Immunization Working Group to enable access to COVID-19 vaccine for pregnant women worldwide. Dr. Sobanjo-ter Meulen is board-certified in pediatric and adolescent medicine from the Julius-Maximilian University in Wuerzburg, Germany, completed a pediatric infectious diseases fellowship at Mount Sinai School of Medicine New York, and holds an M.Sc. in infectious disease epidemiology from the London School of Tropical Medicine and Hygiene, UK. Dr. Sobanjo-ter Meulen serves as an affiliate associate professor in global health at the University of Washington.

Geeta Swamy, M.D., is professor of obstetrics/gynecology in the Division of Maternal-Fetal Medicine, having served as the director of the Duke Perinatal Research Center and vice chair for Research and Faculty Development in the Department of ObGyn. She has achieved international acclaim as a clinician researcher and expert in the field of maternal immunization and perinatal infection. As a consultant to the World Health Organization, Dr. Swamy contributes her knowledge to advance international work to evaluate the immunogenicity, safety, and efficacy of vaccines in pregnant women. The American College of ObGyn has grown to be the “collective voice” for women’s health, and Dr. Swamy has been a leader within that organization for the last 2 decades. She currently serves as the Co-Principal Investigator for the NIH-NIAID Vaccine Treatment and Evaluation and CDC Clinical Immunization Safety Assessment. In addition, she has been a leader at Duke and nationally in promoting a culture of scientific integrity and transparency in research. She has been instrumental in developing and leading the School of Medicine’s research initiatives in administration, regulatory oversight, and compliance. In 2018, she became Vice Dean for Scientific Integrity in the School of Medicine and Associate Vice President for Research for Duke University. In these roles she oversees the Duke Office of Scientific Integrity, which houses the Advancing Scientific Integrity, Services, and Training initiative, conflict of interest, clinical quality management, incident response in research, and research misconduct. She also oversees the Duke Office of Research Initiatives, the Duke Health IRB, Office of Research Administration, and Office of Research Contracts.

Aviva Wein, J.D., is an assistant general counsel at Johnson & Johnson where she is the Group Leader of the Litigation Policy and Risk Management Group within the Litigation Group. Ms. Wein is responsible for the development and implementation of proactive policy initiatives to protect and further the company’s interests. In her role, Ms. Wein is tasked with

Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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developing processes aimed toward anticipating and mitigating litigation risks that may arise during the lifecycle of the company’s products. She is also responsible for products liability litigation for several of the company’s medical devices and pharmaceutical products worldwide.

Ms. Wein joined Johnson & Johnson in 2012. Prior to joining Johnson & Johnson, she worked for an international law firm in New York City, as well as a law firm in Princeton, New Jersey, where she focused on securities litigation, consumer fraud, and products liability litigation matters. She received her bachelor’s degree with honors in political science from Brooklyn College—The City University of New York, and her law degree from Fordham University School of Law. She clerked for the Honorable K. Michael Moore in the United States District Court for the Southern District of Florida.

Katherine Wisner, M.D., M.S., obtained her M.S. in Nutrition and an M.D. from Case Western Reserve University, followed by a categorical pediatric internship and general and child psychiatry residency at Children’s Hospital of Pittsburgh and Western Psychiatric Institute and Clinic. She completed a postdoctoral fellowship in Epidemiology at the University of Pittsburgh Graduate School of Public Health, fellowships in Professional Ethics at Case Western Reserve University and in biomedical ethics at Northwestern University, and the Physician Leadership and Management Program at the Katz Graduate School of Business at the University of Pittsburgh. Dr. Wisner is board certified in general and child and adolescent psychiatry.

Dr. Wisner is a pioneer in perinatal psychiatry. Her research has advanced our understanding of the natural history of mood disorders across childbearing, benefit–harm decision-making for pharmacotherapy during pregnancy and lactation, and the pharmacokinetics of medications across pregnancy and lactation. She is internationally recognized as an expert in the treatment of mood disorders during pregnancy and the postpartum period. Dr. Wisner has received more than $21 million from NIH across her career, and has 250 peer-reviewed publications (h-index = 60) and 21 book chapters. Her work has far-reaching influence, and has been cited by authors in more than 90 countries.

She received the Woman in Science Award from the American Medical Women’s Association in 2011 and the Alexandra Symonds Award from the American Psychiatric Association in 2012. She was awarded the annual APA Award for Research at the meeting in 2017. Dr. Wisner was honored with the Distinguished Mentor Award from the Institute for Clinical Research Education, University of Pittsburgh School of Medicine, in 2012. She received the Marcè International Society for Perinatal Mental Health’s Medal for lifetime contributions to the field of Perinatal

Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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Psychiatry. Dr. Wisner has served on the editorial board of the American Journal of Psychiatry and currently serves on the editorial boards of JAMA Psychiatry and the Journal of Clinical Psychiatry. She is a fellow of the American College of Neuropsychopharmacology and a Distinguished Life Fellow of the American Psychiatric Association. With her experience as a past president of the Marcé International Society for Perinatal Mental Health, she developed the business startup plan for the North American Society for Perinatal Mental Health (now Marcé of North America—MONA) and served as its inaugural president.

Lynne Yao, M.D., is the Director, Division of Pediatric and Maternal Health 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, Virginia. She has been with FDA since 2008. The Division of Pediatric and Maternal Health oversees quality initiatives that promote and necessitate the study of drug and biological products in the pediatric population, and improves 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 persons.

STAFF BIOSKETCHES

Carolyn K. Shore, Ph.D., is a senior program officer with the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine. She is staff director of the Forum on Drug Discovery, Development, and Translation. Before joining the National Academies, Dr. Shore was an officer on Pew The Charitable Trust’s Antibiotic Resistance Project, leading work on research and policies to spur the discovery and development of urgently needed antibacterial therapies. She previously served as a foreign affairs officer at the U.S. Department of State, where she led an initiative on open data and innovation-based solutions to global challenges. She also served as the State Department’s representative to intergovernmental organizations focusing on food safety, plant and animal health, biosecurity, and agricultural trade policy. Previously, Dr. Shore was an American Society for Microbiology congressional fellow, working on science-based policy related to antibiotic stewardship and other public health issues. She holds a doctoral degree in microbiology

Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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and molecular genetics from Harvard University. As a graduate student, she studied antimalarial drug resistance in Senegal and worked jointly between the Medicines for Malaria Venture, Genzyme Corporation, and the Broad Institute of Harvard and MIT to discover new antimalarial compounds. Dr. Shore was awarded a Fulbright Fellowship for work at the University of Queensland in Brisbane, Australia, and a National Institutes of Health Training Grant for postdoctoral work at the University of Iowa.

Deanna Marie Giraldi, M.P.H., is an associate program officer on the Board on Health Sciences Policy. Prior to joining the Academies, she conducted health care research in Cuba, Scotland, Ireland, England, and Costa Rica, specifically on the intersections of trauma-informed care of refugees and mental health access. Ms. Giraldi holds two bachelor’s degrees in biology and political science from Vassar College and is a recent alumna of the Yale School of Public Health where she completed her Master of Public Health in health policy with a concentration in global health. Her work at Yale centered on gun safety legislation and community interventions to mitigate the effects of gun violence on survivors and their families. Ms. Giraldi will be continuing her studies at the University of Oxford in the D.Phil. in Social Intervention and Policy Evaluation program in Fall 2022.

Andrew March, M.P.H., is an associate program officer on the Board on Health Sciences Policy with the Forum on Drug Discovery, Development, and Translation. Mr. March joined the National Academies in 2018. He has provided research for consensus studies on diverse topics in health policy, including medical product supply chains, dementia care interventions, and the safety and effectiveness of compounded drug preparations. Prior to coming to the National Academies, he performed research on sickness absence in working women at the Center for Research in Occupational Health in Barcelona, and worked in the Epidemiology Department at the Hospital de la Santa Creu i Sant Pau. He obtained his M.P.H. at the Universitat Pompeu Fabra and his B.S. degree in biology and Spanish from Roanoke College.

Melvin Joppy is a senior program assistant on the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine. He previously served as a Program Assistant at the Department of Energy (DOE) in the Office of Basic Energy Sciences. Prior to joining DOE, Mr. Joppy served as the Committee Manager for the Presidential Advisory Councils on HIV/AIDS (PACHA) within the U.S. Department of Health and Human Services. Mr. Joppy received his B.S. in communications from Bowie State University.

Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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Page 117
Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
×
Page 118
Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
×
Page 119
Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
×
Page 120
Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
×
Page 121
Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
×
Page 122
Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
×
Page 123
Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
×
Page 124
Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
×
Page 125
Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
×
Page 126
Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
×
Page 127
Suggested Citation:"Appendix C: Biographical Sketches of the Workshop Planning Committee, Speakers, and Staff." National Academies of Sciences, Engineering, and Medicine. 2023. Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/26790.
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Page 128
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 Inclusion of Pregnant and Lactating Persons in Clinical Trials: Proceedings of a Workshop
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Approximately 4 million pregnant people in the United States give birth annually, and 70 percent of these individuals take at least one prescription medication during their pregnancy. Yet, due to a number of historical, ethical, legal, scientific, and societal issues, pregnant and lactating persons are often excluded from clinical trials. As a result, pregnant and lactating persons are often taking drugs based on limited information about the benefits and risks to themselves and their developing or newborn baby.

The National Academies Forum on Drug Discovery, Development, and Translation convened a workshop in June 2022 for stakeholders to examine the current state of evidence generation for drug products used by pregnant and lactating persons and discuss barriers and opportunities for including these populations in clinical trials. This publication summarizes the presentations and discussion of the workshop.

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