Faculty – 12th REMS Summit


Michele V. Davidson
Senior Manager, Pharmacy Technical Standards, Development and Policy, Government Relations, WALGREENS CO

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Michele is the Senior Manager, Pharmacy Technical Standards, Development and Policy, Government Relations, Walgreen Co. In her current role at Walgreens, she leads efforts to ensure the company is properly informed and engaged in trends and developments with pharmacy technical standards. She coordinates with other members of the GR team and key business units to facilitate their engagement and compliance will all applicable standards. She has been extremely active in NCPDP over the past 17 years and served as chair of the Board of Trustees in 2015-2016. She graduated from the University of Florida with a B.S in Pharmacy.


Jacqueline Gerena
Director, REMS Program and Drug Safety Compliance, TITAN PHARMACEUTICALS


Romana Hosain
Head of Risk Management, REGENERON PHARMACEUTICALS, INC.


Cynthia Kear, MDiv
Senior Vice President, CALIFORNIA ACADEMY OF FAMILY PHYSICIANS

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Cynthia Kear, Senior Vice President and CCMEP, has worked with the California Academy of Family Physicians for over thirteen years. Since joining the Academy, the CAFP has become a nationally recognized provider of quality, innovative and effective educational initiatives for primary care physicians, especially family physicians.

Ms Kear spearheads many of the professional educational initiatives which CAFP develops, the most notable being CO*RE, The Collaboration for REMS Education. Ms Kear is project lead for CO*RE and a member of the Executive and Operations Teams. CO*RE’s thirteen constituent partner organizations, among which are APS,ASAM, AOA, AANP, AAPA, AAFP and Medscape, represent more than 682,000 physician, nurse practitioner and physician assistant members, the clinician types targeted by the FDA for this voluntary accredited education. Ms. Kear is a Distinguished Member of ACEHP, the Alliance for Continuing Education in the Health Professions and is a recognized leader in adult medical education, often serving as faculty on related topics.

Prior to joining the CAFP Ms. Kear was Founder/President of Ibis Software, an educational software company she managed for six years and subsequently sold in 2000. She has worked extensively in education and technology serving as VP & General Manager of PC-SIG, a software, video and book publisher in Silicon Valley and as VP /Co-General Manager of a $20 million medical, nursing and science business unit for Addison Wesley/Pearson Publishing Company.


John Klimek, R.Ph.
SVP Standards and IT, NATIONAL COUNCIL FOR PRESCRIPTION DRUG PROGRAMS, INC.

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John Klimek, R.Ph., is Senior Vice President, Standards and Industry Information Technology of NCPDP, the not-for-profit, ANSI-accredited, Standards Development Organization. Mr. Klimek leads the charge to use standards to advance interoperability in healthcare and protect patient safety. He was recently Chair of the Health Standards Collaborative (HSC), a collaboration among SDOs working to facilitate the industry-wide, interoperable standards to support a sustainable HIT infrastructure. Mr. Klimek was a practicing pharmacist in the retail setting for 30 years, and also sat on the HIT Standards Committee, which was created by the Office of the National Coordinator, for three years.


Duyen Mai
Director, U.S. REMS Strategy and Policy, CELGENE


Reema Mehta
Head of Risk Management Center of Excellence, PFIZER INCORPORATED

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Reema Mehta, PharmD, MPH is Head of the Risk Management Center of Excellence at Pfizer, Inc. where she is responsible for providing strategic guidance for the development and execution of global risk management for Pfizer’s portfolio of products, innovation and research for risk management, and defining best practices for risk management planning at Pfizer.

Prior to joining Pfizer, Dr. Mehta worked at the United States Food and Drug Administration for the Division of Risk Management and subsequently the Deputy Division Director. She provided oversight and expertise for regulatory requirements and appropriate risk mitigation measures for drug related safety issues as they related to risk evaluation and mitigation strategies (REMS). Dr. Mehta also worked at Johnson and Johnson in pharmacovigilance, where she completed her Six Sigma Certification for Design Excellence by leading the initial development of the risk management implementation process for Johnson & Johnson.

Dr. Mehta has also lectured at various universities in product labeling and epidemiology, including having served as adjunct faculty at the University of Florida and Rutgers University. She is a licensed pharmacist with a BS and Doctor of Pharmacy from Rutgers University and a Master of Public Health degree from Johns Hopkins University.


Seth Morgan
Chair and Advocate, NATIONAL MULTIPLE SCLEROSIS SOCIETY

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After treating hundreds of people with MS during his 23-year career as a clinical neurologist, Dr. Seth Morgan was diagnosed with MS in 2004. He retired two years later and turned his focus to MS activism. Seth has attended the Society’s Public Policy Conference and Maryland State Action Day, and serves as a District Activist Leader. Seth is a long-time member and now chair of the Montgomery County, Maryland Commission on People with Disabilities, which works to increase awareness of and action on disability issues, including the Americans with Disabilities Act. Seth is a consumer reviewer for the Department of Defense MS Research Program, has testified at U.S. Food and Drug Administration hearings and joined the Rally for Medical Research. Seth was inducted into the National MS Society’s Advocacy Volunteer Hall of Fame.


Elaine H. Morrato
Special Government Employee FDA, Associate Dean for Public Health Practice, COLORADO SCHOOL OF PUBLIC HEALTH

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Elaine Morrato, DrPH MPH CPH is a professor in the Department of Health Systems, Management and Policy and Associate Dean for Public Health Practice at the Colorado School of Public Health. Trained as an epidemiologist and board-certified in public health, her passion is accelerating the translation of evidence into practice with a focus on drug safety. She directs the Innovation-Bioentrepreneurism and Dissemination-Implementation Science programs for the NIH-funded Colorado Clinical & Translational Sciences Institute. She has contributed to 50+ FDA advisory meetings on issues of pharmaceutical risk management and is currently on sabbatical with the Division of Risk Management, Office of Surveillance and Epidemiology.


Sharon Reid
Risk Management Product Lead, PFIZER INCORPORATED


Annette Stemhagen, MPH, DrPH,
Sr Vice President, Safety, Epidemiology, Registries and Risk Management, UBC

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Annette Stemhagen, DrPH, FISPE, provides strategic consultative services to pharmaceutical and biotechnology clients in epidemiology, safety surveillance and risk management. In addition, she assists other UBC groups in developing and implementing creative and innovative study design solutions to meet client needs.

Dr. Stemhagen has more than 25 years of public health epidemiological research experience, including 15 years in safety surveillance of pharmaceutical, biotech and vaccine products. Her specific expertise is in the design, implementation and analysis of epidemiologic studies, registries, large streamlined safety studies, and actual use and observational studies for products in Phase IIIb and postapproval. Further, Dr. Stemhagen has designed and evaluated risk assessment studies, including more than 50 regulatory-mandated long-term safety studies. She has also developed Risk Evaluation and Mitigation Strategies (REMS) risk minimization programs and risk management evaluation studies.

Dr. Stemhagen received her undergraduate degree from the University of Pennsylvania, and her master’s and doctoral degrees from the University of Pittsburgh Graduate School of Public Health in Epidemiology. She holds adjunct faculty appointments at both the University of Pennsylvania School of Medicine Center for Epidemiology and Biostatistics and the Temple University School of Pharmacy. Dr. Stemhagen is a Fellow of the International Society for Pharmacoepidemiology and is active in the Drug Information Association. In 2004, she was appointed as the industry representative to the FDA Drug Safety and Risk Management Advisory Committee.