LEE S. COHEN, MD

Dr. Lee Cohen is director of the Ammon-Pinizzotto Center for Women’s

Mental Health at Massachusetts General Hospital (MGH) and the Edmund

and Carroll Carpenter Professor of Psychiatry at Harvard Medical School.

He is a national and international leader in the field of women’s mental

health and was among the founders of the field of perinatal and reproductive

psychiatry. His work spans the domains of research, teaching and clinical

care in the area of treatment of mood and anxiety disorders with

subspecialty interest in psychiatric disorders associated with female

reproductive function. These include psychiatric disorders during pregnancy

and the post-partum period, depression in midlife women and issues related

to infertility and mental health. The research which he conducts and

oversees has helped to inform the care of patients who suffer from

psychiatric illness.

Dr. Cohen received his undergraduate degree from the University of

Michigan in Ann Arbor and his medical degree from Albany Medical

College. He completed his residency in psychiatry at MGH. After residency,

Dr. Cohen completed a fellowship in psychopharmacology with a specific

emphasis in reproductive pharmacology, and then founded the Center for

Women’s Mental Health at MGH. The program has expanded over the last

two decades and now includes junior and senior faculty, research fellows,

and residents from the psychiatry residency training program at the MGH.

(See www.womensmentalhealth.org)

Dr. Cohen has authored or coauthored more than 200 articles, abstracts, and

book chapters. His articles have been published in leading medical journals,

including American Journal of Psychiatry, Journal of the American Medical

Association, and Archives of General Psychiatry. Most recently his

publication on risk of using antidepressants during pregnancy received the

Clinical Research Achievement Award which recognizes the top ten most

informative research papers in the year’s scientific literature. Dr. Cohen has

been and continues to be funded by the National Institutes of Health (NIH)

and other funding agencies and has mentored numerous junior faculty. He

has received many awards, including the Outstanding Achievement Award

for Research from the Massachusetts Psychiatric Society and the Mentorship

Award for Exceptional Mentorship of Women Faculty from the Department

of Psychiatry at MGH. At the national level, he has served on the Advisory

Council to the Office of Research in Women’s Health at the National

Institute of Health. This office sets the agenda for research in women’s

health across the NIH. He has also served as the co-chair of the

Reproductive Mental Health Initiative within the Office of Reproductive

Health at the Department of Veterans Affairs. Dr. Cohen was also appointed

by Governor Deval Patrick of Massachusetts to serve on the Special

Committee Relative to Postpartum Depression which will set the standards

for screening and treatment of postpartum depression for women in

Massachusetts.

Director

Ammon-Pinizzotto Center for

Women’s Mental Health

Perinatal and Reproductive Psychiatry

Clinical Research Program

Massachusetts General Hospital

Edmund and Carroll Carpenter

Professor of Psychiatry

Harvard Medical School

Marlene P. Freeman, M.D.

Marlene P. Freeman, M.D. is an Associate Professor of Psychiatry, Harvard Medical School.

She is the Associate Director of the Perinatal and Reproductive Psychiatry Program at Massachusetts

General Hospital and the Medical Director of the MGH Clinical Trials Network and Institute (CTNI).

Dr. Freeman completed medical school at Northwestern University Medical School. She completed

residency at the Harvard Longwood Psychiatry Residency Program and a research fellowship in the

Biological Psychiatry Program at the University of Cincinnati College of Medicine. Her research and

clinical expertise is in the areas of mood disorders and women’s mental health. She previously directed

programs in women’s mental health at the University of Arizona College of Medicine and at UT-

Southwestern in Dallas.

She is Vice Editor-in-Chief for The Journal of Clinical Psychiatry. She was a Distinguished Fellow of

the American Psychiatric Association (APA), and chaired the APA Task Force on Complementary and

Alternative Medicine, and was a member of the APA’s workgroup on Major Depressive Disorder

treatment guidelines. She is on the Board of Directors of the American Society of Clinical

Psychopharmacology (ASCP) and is a Member of the American College of Neuropsychopharmacology

(ACNP). She also served as a Member of the Veterans Administration Reproductive Mental Health

Steering Committee.

Adele C. Viguera, M.D., M.P.H.

Dr. Adele C. Viguera, M.D., M.P.H., is co-PI of the National Pregnancy Registry for Atypical

Antipsychotics and holds a joint appointment at the Cleveland Clinic and Massachusetts General

Hospital. She completed her Internship in Medicine from Massachusetts General Hospital,

residency training in Psychiatry at McLean Hospital, and a fellowship in Perinatal and

Reproductive Psychiatry at Massachusetts General Hospital. Dr. Viguera’s research, teaching

and clinical activities focus on women’s mental health. She has published extensively in the area

of area of perinatal and reproductive psychiatry and continues to dedicate her time to teaching

and mentoring psychiatric residents, fellows, medical students, and junior faculty.

Bob Pitasi, PharmD, BCPP, MBA

Dr. Bob Pitasi is the Neuroscience Medical Science Liaison for MA,

NH, ME & VT and currently resides in Hopkinton, MA. He received

his Doctor of Pharmacy degree from the University of Florida and is

board certified in psychiatric pharmacy. Prior to working at Otsuka,

Bob worked as a Psychiatric Clinical Pharmacist for 6 years in the

MA Department of Mental Health which included in-patient work at

acute, long-term and forensic DMH facilities. He also worked with

neuroscience products in public health, long-term care, geriatric and

marketing positions at Eli Lilly & Company. Bob has been with

Otsuka since April of 2012.

Diana Hughes, MD

Diana Hughes is a Physician with a Master’s degree in Pharmaceutical Medicine, and 16 years of

biopharmaceutical safety and risk management experience. She worked as a General

Practitioner with additional trauma and critical care experience (UK), and is a board certified

Psychiatrist with a fellowship in Consultation-liaison Psychiatry (USA).

Diana is currently the Head of Global Pharmacovigilance at Sunovion Pharmaceuticals. Previous

to this her roles have included Head of Pharmacovigilance and Risk Management (Forum Inc).,

Head of the Labeling Strategy Group (Pfizer Inc.) and VP Safety, Primary Care Business Unit

(Pfizer Inc.). Diana has had the opportunity to work across the drug developmental lifecycle and

within multiple therapeutic areas, and has particular interest in risk minimization and benefit risk

assessment.

Gary Bloomgren, MD

Dr. Bloomgren is Head of Drug Safety and Pharmacovigilance at Alkermes, based in Waltham,

MA. He has more than 14 years of experience in drug safety, covering investigational and

globally marketed products across numerous therapeutic areas. Prior to joining Alkermes in

2016, he served as VP of Drug Safety at Biogen where he was responsible for overseeing drug

safety and benefit risk management for all MS and hemophilia therapies. His experience

includes collection and assessment of pregnancy outcome data across a number of products.

Judith C. Kando, Pharm.D., BCPP

Dr. Kando is currently a US Medical Lead in Neuroscience at Shire Pharmaceuticals.

Prior to joining Shire, she was a Regional Lead for the Medical Science Liaison team

with Sunovion Pharmaceuticals. She was an MSL for 12 years both with Sunovion and

Janssen. Dr. Kando has worked in the New England area for over 25 years holding

various clinical, academic and management positions at various institutions. These

include Harvard's McLean Hospital where she was a clinical and researcher. In addition,

she worked within the Departments of Mental Health, Public Health, Mental Retardation

and Correction within the Commonwealth of Massachusetts as Executive Director of

clinical, operational and financial pharmacy operations.

Dr. Kando received her Bachelor of Science degree from Duquesne University and her

Doctorate degree from the Medical College of Virginia. In addition, she completed a one

year general residency at the National Institutes of Health. She is a board certified

psychiatrist pharmacist with over 30 peer reviewed publications in medical journals.

Krista F. Huybrechts, MS, PhD

Krista F. Huybrechts, MS, PhD is an Assistant Professor of Medicine at Harvard Medical School

and a pharmacoepidemiologist in the Division of Pharmacoepidemiology and

Pharmacoeconomics at Brigham and Women’s Hospital. She received her doctoral degree in

epidemiology from Boston University School of Public Health, where she holds an appointment

as Adjunct Assistant Professor of Epidemiology. She has additional training and experience in

health economics and health services research. Dr. Huybrechts lectures in

pharmacoepidemiology at both Harvard and Boston University.

Dr. Huybrechts’ research centers on studying the utilization, comparative safety and

effectiveness of medications for mental disorders with particular reference to vulnerable

populations, including pregnant women. Using a nationwide cohort of publicly insured pregnant

women, Dr. Huybrechts has evaluated factors associated with the use of antidepressants during

pregnancy, as well as the impact of FDA safety warnings on this use; validated claims based

safety outcomes; and assessed the risk of various safety outcomes in the mother and newborn

associated with different antidepressant medications. She was the recipient of the Clinical

Research Forum Award in 2015 for this work. She received funding from the National Institute

of Mental Health to expand this work to include other psychoactive medications (i.e.,

antipsychotics, mood stabilizers, stimulants).

Dr. Huybrechts’ methodological research focuses on the development, adaptation, and rigorous

evaluation of techniques to mitigate biases in the conduct of non-randomized research in mental

health. She is the recipient of a career development award from NIMH to work on the

development of methods well-calibrated for use in a prospective safety monitoring framework

for mental health applications.

Leyla Sahin, M.D., FACOG

Leyla Sahin, M.D., FACOG, is an obstetrician gynecologist who is a senior medical officer in

the Division of Pediatric and Maternal Health in FDA’s Center for Drug Evaluation and

Research, Office of New Drugs. The focus of her work involves providing pregnancy and

lactation expertise to the FDA review divisions on issues such as assessment of pregnancy

medication safety data, labeling, study protocols, etc. She is involved in various FDA pregnancy

and lactation policy efforts, including Guidance development. Her principal area of interest is

promoting the public health of pregnant and breastfeeding women through improved data

collection of medications used in pregnant and lactating women. She received her medical

degree in 1992 from the University of Alberta, Edmonton, Alberta, Canada, and was in clinical

practice for twelve years before joining the FDA in 2008.

Lockwood G. Taylor, PhD, MPH

Lock Taylor, PhD, MPH is the deputy director in the Division of Epidemiology, in the Office of

Surveillance and Epidemiology, Center for Drug Evaluation and Research at the FDA.

Previously, at FDA, he served as an epidemiology reviewer as well as led a team working on

post-marketing safety issues related to neurologic, psychiatric, and non-prescription drug

products. He is also an investigator on several pharmacoepidemiologic research studies within

the agency. His research interests include the effects of medication use during pregnancy as well

as the use of large electronic healthcare databases for pharmacoepidemiologic studies. Prior to

joining the FDA, he worked at the Office of the Surgeon General (Department of the Army,

Department of Defense) as an investigator on epidemiologic studies of drug safety and a

collaborator in the development and application of rapid signal detection methods used in

military healthcare databases. Dr. Taylor holds adjunct faculty appointments at Georgetown

University School of Medicine and at the Texas A&M University School of Public Health.

Lynne P. Yao, M.D.

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. She has held this position since 2012.

The Division of Pediatric and Maternal Health oversees quality initiatives which promote and

necessitate the study of drug and biological products in the pediatric population; and improve

pregnancy and lactation-related information in product labeling. Dr. Yao started at FDA as a

Medical Officer and primary reviewer on the Inborn Errors of Metabolism team in the Division

of Gastroenterology and Inborn Errors Products (DGIEP) in 2008, and was a team leader in

DGIEP from 2009-2012. Dr. Yao graduated from the George Washington University School of

Medicine, completed residency in Pediatrics at Walter Reed Army Medical Center, and

fellowship in Pediatric Nephrology at the Georgetown University Children’s Medical Center.

Dr. Yao is board certified in both Pediatrics and Pediatric Nephrology.

Patrick Hu, M.D. Page 1

Patrick Hu, M.D.

AstraZeneca

Gaithersburg, Maryland

Patrick Hu, M.D. is a US-trained and licensed physician with broad expertise in internal

medicine. With more than a decade of pharmaceutical industry experience working with

companies such as Sepracor, Inc., Novartis Pharmaceuticals, Abbott Laboratories, and

Schering-Plough, primarily in patient safety and pharmacovigilance, Dr. Hu has delivered

safety strategy in a dynamic team-based environment. He also served as principal investigator

for various clinical trials and has extensive experience in the individual cases review, PSUR,

signal detection, RMP and REMS.

For over 4 years, Dr. Hu led an independent consulting firm established to provide guidance

and leadership to both large and small biotech and pharmaceutical clients within the Drug

Safety and Pharmacovigilance arenas.

Dr. Hu currently works as a senior safety physician for Astrazeneca located in Gaithursburg,

Maryland. Contracted since 2010, he was brought on full-time in November 2014 within the

same team as Senior Safety Physician.

Ruta Nonacs, MD, PhD

Editor in Chief womensmentalhealth.org

Dr. Ruta Nonacs received her M.D. from Cornell University Medical College and her Ph.D. from

Rockefeller University in New York. She completed her residency in psychiatry and her

fellowship in perinatal and reproductive psychiatry at Massachusetts General Hospital. Currently

she is a staff psychiatrist with the Perinatal and Reproductive Psychiatry Clinical Research

Program at MGH, with an appointment as an Instructor in Psychiatry at Harvard Medical School.

Dr. Nonacs has received several honors and awards, including a NARSAD (National Alliance

for Research on Schizophrenia and Depression) Young Investigators Award for her work on

postpartum psychiatric illness in women with bipolar disorder. Her current research has focused

on the course and treatment of major depression in women during pregnancy and the postpartum

period. She has expertise in the treatment of women with postpartum depression (using

medication, as well as psychotherapy).

Her work has been published in a number of scientific journals and books in the area of women’s

mental health. She is the author of A Deeper Shade of Blue: A Woman’s Guide to Recognizing

and Treating Depression in Her Childbearing Years (Simon & Schuster).

Samantha Zipp Dowd, CFRE

Samantha Zipp Dowd is a proud mommy to two children (4 and 2) and a two-time survivor of

Postpartum Anxiety. She is currently the Director of Development for Loyola University in

Maryland. Previously Samantha has held various positions in healthcare fundraising over a 16-

year career, most recently as the Vice President of Development for the Make-A-Wish

Foundation. She is an active advocate for maternal mental health and helped secure funding and

start the first postpartum mood disorders support group in Baltimore, Maryland. In addition to

her position at Loyola, Samantha will be entering their masters in psychology counseling

program next year to begin studying towards an LCPC so she can counsel women and families

on postpartum mood disorders.

Tiffany R. Farchione, MD

Tiffany Farchione, MD, received her medical degree from Wayne State University in Detroit, Michigan,

and completed adult residency and child & adolescent fellowship training at the University of Pittsburgh’s

Western Psychiatric Institute and Clinic. Dr. Farchione is board certified in both general and child &

adolescent psychiatry. Prior to joining FDA in 2010, Dr. Farchione was affiliated with the University of

Pittsburgh Medical Center, and was on the faculty of the University of Pittsburgh.

As the Deputy Director of the Division of Psychiatry Products at FDA, Dr. Farchione is involved in the

oversight of new drug review for all psychiatric drug development activities conducted under INDs, and

the review of all NDAs and supplements for new psychiatric drug claims.