Faculty – 10th Risk Evaluation & Mitigation Strategies Summit

Stacy Cooper Bailey, Ph.D., MPH
Assistant Professor, Division of Pharmaceutical Outcomes and Policy, UNC ESHELMAN SCHOOL OF PHARMACY

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Stacy Cooper Bailey focuses on the definition and measurement of health literacy, its extent and associations with various health outcomes, and the testing of innovative and viable ‘low-literacy’ intervention strategies to help individuals promote, protect, and manage their health. Her research experience and interests extend across the contexts of disease prevention, medication safety and adherence, and chronic disease management. Bailey’s work also focuses on the broader theme of health inequalities, especially those experienced by immigrant groups and individuals with limited English proficiency.

Kim H. Bullano, B.S., Pharm.D.
Senior Director, Risk Management Team Lead, SHIRE

May Chan-Liston, Director REMS Strategy, CELGENE CORPORATION

May Chan-Liston
Director, REMS Strategy and Policy, CELGENE CORPORATION

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May Chan-Liston, PharmD, MPH, is the Director of REMS Strategy at Celgene Corporation. At Celgene, May strives to ensure that the Celgene REMS programs are meeting their goals through her responsibility of strategic program planning and communications associated with their continuous development and implementation. Previously, May developed and managed global RMPs, single-product risk management programs and the sponsor responsibilities of class-wide REMS programs for Allergan (formerly Actavis Pharmaceuticals). Prior to her joining the REMS industry, May was dedicated to the cardiovascular, neurology and urology therapeutic areas with a focus in medical affairs. May had the opportunity to drive medical strategies, manage medical communication teams, deliver medical education programming and execute publications plans. May also has gratefully practiced as a retail and volunteer disaster relief pharmacist, both of which continue to strongly influence her professional and personal interests in patient safety, local community health and general public health issues. May earned her degrees from Rutgers University: her Bachelor of Science and Doctor of Pharmacy degrees from the Ernest Mario School of Pharmacy and her Master of Public Health degree from the Rutgers School of Public Health. May hopes to effect positive and meaningful change as a volunteer on her local civilian Medical Reserve Corps, by serving as a Rutgers School of Public Health Alumni Board Member, and is always interested in partaking in local public health initiatives.

Pat daCosta, Pharm.D.
REMS Sr. Product Manager, RELAYHEALTH

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Dr. Pat daCosta completed her PharmD at Mercer University. She is currently the REMS Product Manager at RelayHealth in Atlanta. Before joining RelayHealth in 2008, she provided clinical expertise in various pharmacy practice settings, such as MTM, anticoagulation and new member services during her five years with Kaiser Permanente. She specialized in HIV/AIDS ambulatory services with Grady Hospital’s Infectious Disease Clinic and geriatric services at a closed door pharmacy that served assisted living patients. She has also worked for various retail pharmacies throughout Atlanta.

Ruth S. Day, Ph.D.
Director, Medical Cognition Lab, Senior Fellow, Center for Aging and Human Development, DUKE UNIVERSITY

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Professor Ruth Day is the Director of the Medical Cognition Laboratory at Duke University. Since receiving her Ph.D. at Stanford in cognitive science, she has been on the faculty at Stanford, Yale and Duke Universities; a Visiting Scholar at Carnegie Mellon; and a Fellow at the Center for Advanced Study in the Behavioral Sciences.

Dr. Day was a charter member of the FDA Risk Management Advisory Committee and has served as a voting member on many other FDA advisory committees concerning the safety and efficacy of drugs for a wide variety of health conditions, including the gastrointestinal, nonprescription, arthritis, dermatologic and ophthalmic, pediatric, endocrinological and metabolic, cardiac and renal, oncology, anesthetic and life support, peripheral and central nervous system, psychopharmacologic, pharmaceutical science and clinical pharmacology advisory committees. She has given hundreds of research presentations to a wide variety of healthcare stakeholders and short courses on “Cognition and Teaching” to university faculty across all disciplines throughout the United States. She was designated one of the “Ten Best Teachers” at Yale and a Distinguished Teacher at Duke.

Her research examines the cognitive accessibility of drug information and how to improve it, and how professionals (e.g., physicians, pharmacists) and laypersons (e.g., patients, caregivers) understand, remember and use drug information. This research includes comprehension and memory for physician information (the package insert), pharmacy leaflets, patient package inserts and direct-to-consumer advertising of prescription drugs. She has developed new ways to display key drug information and found that they can improve comprehension and memory substantially.

Michael von Forstner
Co-Chair, Pharmacovigilance Working Group, MEDICINES FOR EUROPE

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Dr. Michael von Forstner serves as co-chair of Medicine for Europe’s Pharmacovigilance Working Group and is also Managing Director and Head of Risk Management and Pharmacoepidemiology at Mesama Consulting. Michael’s primary activities are in areas of planning, development, implementation and evaluation of (benefit-)risk management solutions, as well as the optimization of processes around benefit-risk management. He is developing and applying (benefit-)risk analysis methodologies in order to make RM planning more formally reproducible. Furthermore, he supports the development and implementation of additional risk minimization and PV measures in the context of RMPs, and is involved in teaching and training activities on pharmacovigilance and pharmacoepidemiology at various European institutions. Michael is former Global Head of Pharmacovigilance at Acino Pharma in Switzerland, where his key responsibility was the creation and maintenance of a compliant global PV system.

Before entering his current role, Dr. Forstner was Head of Regional Pharmacovigilance Europe at Boehringer-Ingelheim. His main focus at BI had been to establish a proactive and highly integrated benefit-risk management organization with strong links to other functions, while maintaining compliance with all local regulations in the 35 countries of his region.

From 2009 to 2013, he was Process Development Leader in Drug Safety and Chair of the global Risk Management Working Group at Roche, Basel, where he was — amongst other duties — responsible for all aspects of global benefit-risk management planning and implementation of RMPs

Prior to this he worked in a variety of positions in pharmaceutical R&D at Pharmacia (Nerviano, Italy) and Novartis (Basel, Switzerland), focusing mostly on signal transduction pathways in oncology and CNS disorders, and in drug liability risk management at Zurich Financial Services. He studied biochemistry and medicine in Graz, Austria; holds a Ph.D. in biochemistry from the Swiss Federal Institute of Technology (ETH) Zurich, Switzerland; did postdoctoral work at UC Berkeley/Lawrence Livermore National Laboratory, California in the area of structural enzymology and biophysics; and was Assistant Professor of Molecular Structural Biology at Sveriges Lantbruksuniversitetet in Uppsala, Sweden. Recently, he also obtained a postgraduate certificate in pharmacovigilance and pharmacoepidemiology from the London School of Hygiene and Tropical Medicine.

In his spare time, Michael loves to spend time outdoors with his children and dogs, and to engage in various activities from skiing and hiking to fishing, hunting, horseback riding and gardening. He is also an avid reader, and loves the opera and music in general.

Emily Freeman, Ph.D.
Director, Risk Management Sciences, ABBVIE

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Dr. Emily Freeman is a social/behavioral scientist interested in the development of evidence-based communication tools to facilitate decision-making between patients and healthcare providers. Dr. Freeman is exploring how medical evidence (e.g., risk, benefit and health outcomes) is constructed and communicated within a patient-healthcare provider clinical encounter. She is also interested in the intersection of medical evidence and patient preferences, and its impact on shared treatment decisions. Her research has focused on the impact of shared treatment decision-making on the quality of care received by patients and using shared decision-making as a tool for patient engagement. Finally, she is interested in bringing a more patient-centered approach to drug development through the use of patient-reported and defined outcomes.

In her roles at Bristol-Myers Squibb and more recently Pfizer, Dr. Freeman conducted research to assess the effectiveness of the FDA mandated REMS and EMA RMMs on patient and healthcare provider communication and knowledge and the impact of regulatory science on both groups. Dr. Freeman has been the principal investigator on various health outcomes studies within the pharmaceutical industry focused on improving the effectiveness of communication to HCPs/patients, understanding the experience of treatment on the patient’s quality of life/survival, improving medication adherence, and qualitative understanding of benefit-risk from the patient’s perspective. Dr. Freeman received her Ph.D. in health geography from McMaster University with postdoctoral training in psychosocial oncology from the University of Toronto. Her substantive research interests include patient engagement (social media, behavioral interventions and health literacy), qualitative health research, clinical epidemiology, medication adherence improvements, patient-reported outcomes, risk communication, and shared treatment decision-making.

Kevin Holman
Senior Director, Drug Regulatory Affairs, ACTELION

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Kevin Holman is a Senior Director of Drug Regulatory Affairs at Actelion. He has spent his career designing, creating, implementing and measuring the effectiveness of risk management plans in the US and European Union. He has more than 10 years’ experience in the pharmaceutical industry, primarily in the consulting and design activities for REMS submissions, including education and communication materials, REMS and Supporting Documents, and REMS Assessment Reports. Kevin has successfully led and advised companies in four separate class-wide programs and more than 25 individual REMS and EU-RMP programs for branded, generic and hybrid pharmaceutical companies. Kevin most recently worked as the Director, REMS Strategy at McKesson, with previous positions in the Risk Management Center of Excellence at Pfizer, in Regulatory Solutions at PDR Network, and in Patient & Product Safety and Research & Development at Mallinckrodt Pharmaceuticals.

Cynthia Kear
Lead, Collaboration Management, CO*RE

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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.

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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.

Nathan Kopper, Pharm.D
Director, REMS Consulting and Strategy, MCKESSON

Cheryl Renz, M.D.
Head, Benefit-Risk Management Pharmacovigilance and Patient Safety (PPS), ABBVIE

Larry Risen, MBA

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Mr. Risen has 30 years of medical industry commercial experience and founded BioTrak in 1999 to provide pre- and post-market commercial support services to the pharmaceutical industry. Mr. Risen has served as research director on over 400 healthcare professional and patient survey and interview programs. These programs have encompassed 45 individual REMS and 85 REMS assessments and numerous labeling comprehension and human factors research studies.

Prior to BioTrak Mr. Risen was Vice President of Commercial Development at Cypros Pharmaceutical Corporation (now Questcor) from 1994 to 1999, where he coordinated licensing and built a sales and marketing organization to relaunch several approved drugs.

Suzanne Robottom, Pharm.D.
Regulatory Health Policy Analyst, Division of Risk Management, Office of Medication Error Prevention and Risk Management, Office of Surveillance and Epidemiology, FDA

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Suzanne graduated from the University of Iowa College of Pharmacy and completed a general pharmacy practice residency and solid organ transplant fellowship at the Medical University of South Carolina. From 2004 to 2007, she worked as a reviewer in CDER’s Office of Prescription Drug Promotion. While in OPDP she worked extensively on the development and approval of the Ipledge Program. For the last 10 years, she has worked in the Office of Medication Error Prevention and Risk Management as a risk management analyst, team leader, and most recently a policy analyst. Over the last decade, while working as a reviewer and team leader, Suzanne worked on 15 different REMS with ETASUs, 15 different REMS with communication plans, and four single shared systems — covering every therapeutic area.

Adam E. Saltman, M.D., Ph.D., FACS, FACC, FACP, FAHA
Medical Officer, CDRH Office of Compliance, FOOD AND DRUG ADMINISTRATION

Linda Scarazzini, M.D.
Vice President, Pharmacovigilance and Patient Safety (PPS), ABBVIE

Rachel Sobel

Rachel Sobel
Senior Director, Epidemiology - Group Lead Global Innovative Pharma, PFIZER

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Rachel Sobel, DrPH is a Senior Director and the Specialty Care and Established Products Business Unit Team Lead for Epidemiology at Pfizer, Inc. in New York, NY.

Since joining Pfizer in 2001, Dr Sobel’s responsibilities have included general epidemiology support and contributing to the design and implementation of risk management strategies for medicines in several therapeutic areas. She negotiated, designed, and led the implementation of various epidemiologic commitments with the US FDA and EMA, and oversees a team of epidemiologists.

Before coming to industry, Dr. Sobel was an Autoimmune Disease Registry and Repository Coordinator at the Hospital for Special Surgery/Weill Cornell Medical Center in New York.

She has published and presented numerous articles and abstracts on epidemiology and risk management, and co-authored a chapter in Strom’s Textbook of Pharmacoepidemiology.  Rachel holds her degrees from Columbia University: a DrPH and MPH from the Mailman School of Public Health and a BA from Barnard College.

Deborah Tiffany
Director, Global Risk Management Product Lead, Process Analyst, Worldwide Safety and Regulatory, PFIZER

Gita Toyserkani, Pharm.D., MBA
Regulatory Health Policy Analyst, Division of Risk Management, Office of Medication Error Prevention and Risk Management, Office of Surveillance and Epidemiology, FDA

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Gita Toyserkani is a policy analyst in the Division of Risk Management (DRISK) in FDA’s Office of Medication Error Prevention and Risk Management. In this role, she advises on risk mitigation strategies for products regulated by CDER and works extensively on REMS’ guidances. Gita received her doctoral degree from the University of Maryland and completed the joint MBA program at the University of Baltimore School of Business. Gita has been with the FDA since 2005 as a postmarketing safety evaluator, joined DRISK in 2008 as a risk management analyst then team leader. Prior to joining FDA she was a clinical pharmacist at Walter Reed Army Medical Center and practiced at CVS Pharmacy.

Andrew Wasson
Partner, HAUG

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Andrew Wasson’s broad range of experience in both the brand and generic side of pharmaceuticals has benefited a substantial roster of clients in the pharmaceutical and biotechnology industries, especially with respect to issues involving intellectual property law and regulatory law. Andrew is registered to practice before the U.S. Patent and Trademark Office and have published extensively in both scientific and legal literature.

Scott Wirth, Clinical Assistant Professor, Clinical Pharmacist, Oncology, UNIVERSITY OF ILLINOIS HOSPITAL AND HEALTH SCIENCES SYSTEM

Scott Wirth, Pharm.D.
BCOP, Clinical Assistant Professor, Department of Pharmacy Practice Clinical Pharmacist, Oncology, UNIVERSITY OF ILLINOIS AT CHICAGO COLLEGE OF PHARMACY

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Scott Wirth, PharmD, BCOP, is a Clinical Hematology/Oncology Pharmacist at the University of Illinois at Chicago (UIC) Cancer Center and a Clinical Assistant Professor at the UIC College of Pharmacy. Dr. Wirth received his Doctor of Pharmacy degree (PharmD) at the University of Illinois at Chicago College of Pharmacy and has completed a Postgraduate Year one (PGY1) general pharmacy residency program and a Postgraduate Year two (PGY2) Hematology/Oncology pharmacy residency program at the University of Kentucky. Dr. Wirth performs clinical responsibilities including chemotherapy/biotherapy monitoring and administration, supportive care, patient education, and assistance with Risk Evaluation and Mitigation Strategies (REMS) programs for specialized medications. Additionally, he performs clinical research and is involved in didactic lecturing and training pharmacy students and residents within a clinical setting.

Michael Wolf, Ph.D., MPH
Professor, Medicine and Learning Sciences, Associate Chair, Department of Medicine, Associate Division Chief, Research, General Internal Medicine and Geriatrics, FEINBERG SCHOOL OF MEDICINE, NORTHWESTERN UNIVERSITY

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Dr. Michael Wolf is a Professor within the Feinberg School of Medicine at Northwestern University. He serves as Associate Division Chief for General Internal Medicine and is the Associate Chair-Research for the Department of Medicine. In 2004, Dr. Wolf founded the Health Literacy & Learning Program (known as HeLP). Its goal is to make meaningful changes in the way healthcare is delivered in order to confuse patients less. His team of researchers currently lead several National Institutes for Health (NIH) – funded studies, many of which are testing ways to help patients better understand their personal health, stay connected with their doctor outside of encounters, and to signal to healthcare providers if a patient needs assistance in self-managing their medical regimen. He has published over 200 peer-reviewed articles on the topic of ‘health literacy’ and deconstructing what it means to be a patient — and more importantly, the unnecessary complexity placed on individuals and families by the healthcare system when attempting to assume that role. Whether it be leveraging new health technologies or simply promoting a better drug container label, Dr. Wolf’s work is all focused on simplifying healthcare for everyone.