LEE S. COHEN MDmedia-ns.mghcpd.org.s3.amazonaws.com/pllr2017/2017-pllr... · 2017-04-27 · LEE S....
Transcript of LEE S. COHEN MDmedia-ns.mghcpd.org.s3.amazonaws.com/pllr2017/2017-pllr... · 2017-04-27 · LEE S....
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.