(MAPS President) / EVP and Head of Medical Affairs / Astellas Pharma
Charlotte M. E. Kremer, MD, MBA is the Executive VP and head of Medical Affairs for Astellas. In this role, Dr. Kremer provides leadership for the Medical Affairs organization globally.
Dr. Kremer joined Astellas in 2012 with 20 years of experience in the pharmaceutical industry. Prior to Astellas, she held the position of Vice President, Therapeutic Area Head for Ophthalmology, PVD, Rare Diseases and Neuroscience at Pfizer. While at Pfizer, she successfully led and executed the clinical development and global medical programs in these respective areas. Prior to joining Pfizer, Dr. Kremer held positions of increasing responsibility providing medical support, developing Phase 3b/4 clinical trials, and initiating and directing a Medical Liaison program at Organon Pharmaceuticals, both in the Netherlands and in the United States. A native of the Netherlands, Dr. Kremer received her medical degree from the University of Utrecht, The Netherlands. She went on to receive her Diploma Pharmaceutical Medicine (DPM) from Universite Libre de Bruxelles. After transferring to the United States, Dr. Kremer completed the Executive MBA program at New York University’s Leonard N. Stern School of Business.
Danie is a senior pharmaceutical executive with 25 years’ experience mainly in medical affairs. He has a passion for modernising medical affairs and track record in leadership, people development, capability building and coaching. Danie is a qualified MD with a Masters in Clinical Pharmacology who combines medical and life science qualifications with an MBA. Danie has extensive experience building international teams, driving change and working in regulated markets for GlaxoSmithKline (GSK) across Europe, the Americas, Middle East, Africa, Australasia and Japan.He previously worked for Eli Lilly & Company for 17 years in different medical roles as well as marketing and sales. During his different roles, he was based in South Africa, United Kingdom and Australia. Before joining the Pharmaceutical Industry, Danie had his own primary care practice.
(MAPS JAPAC President) / Vice President and Region Head Medical, JAPAC/ Amgen
Prof Elegant is currently Vice President and Region Head Medical, JAPAC at Amgen, and is an adjunct professor in the Faculty of Medicine at the University of New South Wales in Australia. She joined Amgen in 2016 after previously serving as Vice President, Medical Affairs for Baxalta. Prior to Baxalta, Prof Elegant was at Baxter Healthcare for 9 years where she was Vice President of Medical and Regulatory Affairs, Asia Pacific.
Senior Director, Medical Scientific Affairs/ Ironwood Pharmaceuticals
Tricia Gooljarsingh is currently Senior Director of Medical and Scientific Affairs at Ironwood Pharmaceuticals based in Cambridge, MA where she oversees the therapeutic area leads responsible for scientific communications including congress activity, publication planning, data generation, medical information, medical affairs strategy, advocacy, promotional review and commercial support.
Prior to that Tricia led the medical communications groups at Baxter, Baxalta and then Shire pharmaceuticals spanning seven therapeutic areas from 2013-2017. Before joining Baxter Tricia held roles of increasing responsibilities at GSK, Wyeth and Bayer pharmaceuticals.
Tricia received her PhD in Biochemistry from Pennsylvania State University under the direction of Dr. Stephen Benkovic and has published several papers in the field of oncology basic research.
Former Vice President, Global Medical Excellence Global Medical Affairs / AstraZeneca
Mary Alice Dwyer, PharmD, was most recently Vice President of Global Medical Excellence (GME) in Global Medical Affairs (GMA). She led the GME organization which included Global Publications, Global MSL Excellence, Global Nominated Signatory, the Medical Academy, Medical Resources, and Patient Centricity (PaCe). In this role, she led the partnership between GME and Medical in the regions and countries to build and sustain medical capabilities, skills and knowledge. The Patient Centricity function under Mary Alice’s leadership was instrumental to AZ’s patient-driven science and achieving confident use of medicines in clinical practice.
Mary Alice first joined AstraZeneca in 2004 as the Executive Director of Scientific Affairs and was subsequently promoted to Vice President of Medical Affairs in the US. She has also led scientific and medical teams at Takeda, Pharmacia, and Searle. She previously worked in clinical drug development at Hoffmann-LaRoche and Glaxo.
Vice President, Head of Global Medical Affairs / Novartis/ Avexis
Dr. Ramin Farhood is a Senior Level Biotechnology and Pharmaceutical Executive with 20 years of experience in scientific and strategic operational leadership in Global Medical Affairs (GMA), Scientific Affairs and Shared Medical Excellence. His expertise is vast in building scalable world-wide organizational and operational capabilities of Medical Affairs while driving efficiencies and implementing best practices. His diverse therapeutic expertise spans across Oncology, Hematology, Immunology, and Ophthalmology.
Currently, Dr. Farhood is the Vice President, Head of Global Medical Affairs at AveXis. In this role, he is a key member of the senior leadership team accountable for World-Wide Medical Affairs organization. Previously, he served as the VP, Head of External Scientific Affairs for Shire who recently acquired Baxalta in July 2016. In this role, he was responsible for developing a strategic vision for the Medical Affairs Evidence Generation group. His accountabilities encompass Medical Evidence Generation, Continuum of Access to Medicines, Laboratory Services, Home Therapy Support, HCP Engagement Support & Educational Grants, Investigator Initiated Trials (IITs) and Professional Society Engagement Support. Here, he has been an inspirational leader who serves as a strategic business partner, cultural and change steward and operational expert.
Prior to his current role, he served as the Head of Medical Operations and Strategy at Baxalta. During his tenure, he built a flexible and scalable world-wide organizational and operational capability of Medical Affairs via centralizing common medical and operational activities globally with centralized hubs in the regions, driving efficiencies and productivities, and sharing and implementing best practices.
Earlier in his career, as Head of Global & US Medical Affairs for Immunology Franchise at Baxter, he was responsible for overseeing the Immunology franchise, leading the development and implementation of medical and commercial strategies, Life-Cycle Management and launch of products. This experience included diverse disciplines of medical and commercialization of drugs, such as leading medical communications and publications, Investigated Initiated Trials (IITs), educational activities (CMEs/IMEs), field-based medical teams (MSLs) and field-based outcome research teams (MSOLs), compliance and SOP developments.
Dr. Farhood acquired his Doctorate in Pharmacy from the University of Southern California (USC) and an MBA from the University of California, Los Angeles (UCLA). He currently holds the position of Adjunct Professor at the School of Pharmacy at USC and Keck Graduate Institute (KGI) and has established industry Post-Doctorate Fellowship programs in the US. He has been selected as the recipient of the Alumnus of the Year Award for his distinguished career, leadership, and contribution to the profession as a clinician, educator, and executive.
Dr. Farhood’s vast skills and knowledge have made him a leading and sought after expert in the industry. He is a frequent speaker at executive medical leadership forums and trainings, has multiple publications in industry journals and has written book chapters related to Medical Affairs. He is on the Board of Directors for the Medical Affairs Professional Society (MAPS) and holds membership in numerous professional affiliations
Chief Ethics and Compliance Officer/ Medline Industries, Inc. Northfield, IL
Ann Ford currently serves as Chief Ethics and Compliance Officer at Medline Industries, Inc., in Northfield, IL. After completing her nursing education at Marquette University in Milwaukee, WI, she received her Juris Doctor degree from DePaul University College of Law in Chicago, IL.
Until she became an attorney, Ms Ford worked in high-risk obstetrics, pediatric intensive care, and neonatal intensive care. Upon graduating from law school, she spent 11 years in private practice representing physicians, nurses, and hospitals. After private practice, Ms Ford transitioned to in-house legal and compliance roles, including Vice President, General Counsel for two Chicago-area hospitals. In her current role as Chief Ethics and Compliance Officer at Medline, she oversees the global ethics and compliance program. In addition, she has been intimately involved with the development of a medical affairs function at Medline.
Ms Ford has served on various committees throughout her career, including the hospitals’ Institutional Review Boards. She is a frequent speaker on healthcare legal and compliance topics.
Senior Vice President, Head of Global Medical Affairs Oncology / Eisai / (MAPS Board Member and Past President)
Dr. Kirk Shepard is a MAPS Board Member and Past President of MAPS, and has more than 25 years of experience in the pharmaceutical industry. He is a board-certified medical oncologist and hematologist physician. He is currently Senior Vice President, Head of Global Medical Affairs Oncology at Eisai Pharmaceutical Company.
Dr. Shepard’s experience in multiple therapeutic areas includes operational and strategic product development from Phases I through IV and the diverse disciplines of medical affairs and product commercialization, such as leading compliance and SOP/policy efforts, health economics & outcomes research & patient access, data generation, field-based medical teams (MSLs), PV/safety, medical communication & publications, patient advocacy, and public relations. In 2015, he was selected as one of the 100 Most Inspiring People in the Pharmaceutical Industry (PharmaVOICE).
Before his pharmaceutical career, Dr. Shepard served as a staff physician in the Department of Hematology and Medical Oncology at the Cleveland Clinic Foundation, where he supervised numerous studies in oncology and symptom control. He has more than 50 medical publications in journals and books. Dr. Shepard earned his bachelor’s degree from Cornell University in Ithaca, NY, and his medical degree from the University of Cincinnati Medical School in Cincinnati, OH. He completed both his internship and residency in internal medicine at Case Western Reserve University in Cleveland, OH, and fellowships in hematology and oncology at the University of Chicago Hospitals and Clinics in Chicago, IL.
VP, Field & Scientific Affairs/ Mallinckrodt Pharmaceuticals
Dr. Peter Piliero is currently the VP of Field and Scientific Affairs at Mallinckrodt Pharmaceuticals, having responsibility for a diverse field Medical team and medical education, investigator-initiated studies, and strategic alliances. Dr. Piliero is recognized as a Medical Affairs expert with over 14 years of experience having held various leadership positions at Merck & Co. and Boehringer Ingelheim Pharmaceuticals, Inc. At Merck, he initially led Global Medical Information and subsequently US Medical Affairs. Prior to joining Merck he was Vice President of General Medicine and Scientific Affairs in US Clinical Development and Medical Affairs. As such he was responsible for the Immunology, CNS, and Virology therapeutic areas in addition to Medical Education and Research Grants, Medical Publications, and Field Based Medicine Operations. Dr. Piliero is a board eligible Internal Medicine and Infectious Disease specialist who practiced for 11 years at Albany Medical College. He completed an accelerated 7-year BS-MD program at City College of New York and SUNY at Stony Brook School of Medicine. He completed an Internal Medicine residency at The Presbyterian Hospital in New York and Infectious Disease fellowship in the Harvard Combined Infectious Diseases program in Boston.
Head, Global Field Based Medical Excellence & Insights/ Global Medical Operations/ Sanofi Genzyme
Dr. Robin Winter-Sperry started working in the industry in the area of Dermatology. She has had a long and distinguished career including Sanofi/Genzyme Global Medical Affairs, Strategy & Tactics in the area of Multiple Sclerosis and President and CEO of Scientific Advantage, LLC. She created Novartis’ Medical Science Liaison (MSL) department of Scientific Operations and Sanofi-Synthelabo’s Medical Therapeutic Liaison division.
She has been involved in over 28 product launches. She has pioneered the recognition of MSLs as a specialty in the biopharmaceutical and device industry and is responsible for creating and developing many of the industry’s leading Medical Affairs and Medical Liaison teams.
Executive Director and Head of Global Scientific Communications/ Celgene Corporation Summit, NJ
Robert J. Matheis, PhD, MA is Executive Director and Head of Global Scientific Communications with Celgene located in Summit, NJ. He is Past President of the International Society for Medical Publication Professionals (ISMPP), a global organization headquartered in Tarrytown, NY. Prior to joining Celgene, Dr. Matheis was Head of Evidence Based Medical Communications for Sanofi, headquartered in Gentilly, France. He was trained as a clinical psychologist and obtained a masters degree in behavioral statistics.
Dr. Matheis has over 14 years of medical research and communications experience in both government and industry. He has conducted research, provided treatment, and instructed within a variety of clinical and academic capacities related to aging, brain and spinal cord injury, multiple sclerosis, diabetes, and other neurocognitive disorders. Dr. Matheis advocates for the evolution of medical communication tools to translate medical evidence for use by health care decision makers, providers, and patients. He champions innovation and novel technology in medical communications. Most recently, Dr. Matheis has been involved in conceptualizing and synthesizing performance indicators to support a strong value proposition for medical affairs organizations.
Dr. Matheis has an extensive bibliography of scientific congress presentations and peer-reviewed publications across various disease states, in addition to research and publication accomplishments in alternative medicine and psychosocial factors impacting healthcare.
VP, Medical Affairs /Assertio Therapeutics, Inc Chicago, IL
Dr. T McCall is presently Vice President of Medical Affairs at Assertio Therapeutics, Inc, Lake Forest, IL. She received a doctorate in clinical medicine from Trinity College in Dublin, Ireland, and a master’s degree in business administration from Northwestern University in Evanston, IL. She also holds a diploma in print journalism and radio broadcasting.
Dr. McCall has over 30 years of leadership experience with global companies in the fields of drug discovery, research and product commercialization strategy, clinical development, and regulatory approval. She has deep expertise in external stakeholder engagement and is focused on global medical affairs innovation, product commercialization, and medical communications transformation. During her career, Dr. McCall has consistently developed innovative medical and commercial strategies and solutions. She has led US and global initiatives involving external thought leader and reimbursement decision makers, investigator research programs, publications, medical information, and regulatory and compliance activities. Her therapeutic expertise includes oncology, immunology, gastroenterology, cardiology, neuroscience, and diabetes.
Dr. McCall has a long-standing interest in advancing the public’s understanding of science. To this end, she has developed and presented radio interviews and school presentations, and she has worked as a London-based science correspondent for the BBC. In addition, Dr. McCall has authored over 30 scientific publications, including newspaper and book chapters.
Associate Vice President, US MA Field Medical / Merck
Stephen Dodge is the Associate Vice President, Field Medical in US Medical Affairs at Merck and Co., Inc. He joined Merck in 2013 to start the Health Systems Medical Affairs team and moved into his current role, responsible for the full field medical function in 2017.
Stephen spent the last 17 years in medical aﬀairs leadership roles with time at Novo Nordisk and Novartis Pharmaceuticals Corporation prior to coming to Merck. Throughout his career in the pharmaceutical industry, he led key projects in organizational change management, collaborative innovation, social networking, medical affairs data analytics and exercise and fitness programs in the work and public sectors.
Before coming into industry in 2001, Stephen worked for a medical services organization (MSO) in Southern California, managing global risk and a self-funded health plan for an integrated healthcare delivery system. He started his career in hospital and outpatient clinical practice, followed by running his own company, supporting provider groups in management of their drug utilization and delivery under ﬁnancial risk arrangements.
Stephen completed a pharmacy practice residency with Kaiser Foundation Hospital in Fontana, CA after completing his Doctor of Pharmacy at University of the Paciﬁc and his Bachelors of Science at California State University, Bakersﬁeld. He also completed a MBA at Washington University in St. Louis.
Outside of work, he spends his time with his wife (Leslie), their three adult children (Lauren, Christian and Megan) and on his road bike, logging the miles in rural New Jersey. He is active with several universities of pharmacy, helping to develop students for futures in the managed care and pharmaceutical industries
Worldwide Integrated Leader, Medical Affairs, Pre-Clinical & Clinical Research, DePuy Synthes – Spine,/ Johnson & Johnson Medical Devices Companies
Dr. Pracyk joined DePuy Synthes, Spine | Johnson and Johnson Medical Devices Companies in February of 2016 as Franchise Medical Director, responsible for the innovation pipeline. In September of 2017 he was appointed Global Franchise Medical Leader where he provides deep clinical insights to accelerate meaningful innovation and drive value and safety for spine patients worldwide. He serves as a strategic medical partner with colleagues across Research and Development, Franchise Marketing, Clinical, Regulatory Affairs, Medical Safety and Business Development at Johnson & Johnson Medical Devices Companies. Additionally, Dr. Pracyk provides expert medical and scientific input to product ideation and development, including conceptual and hands-on evaluation, as well as clinical research perspectives throughout the innovation cycle. He also collaborates with Professional Education, Legal/HCC, QA/Risk Management and regional marketing/sales. Dr. Pracyk is a member of the Spine Platform Leadership Team.
Dr. Pracyk is a board-certified Neurological Surgeon who obtained his B.S., M.D. and Ph.D. degrees from Duke University, and completed pre- and postdoctoral fellowships at Cambridge University and the National Institutes of Health. He received his neurological surgery training at The George Washington University and spine fellowship at The University of Iowa Hospitals and Clinics. Prior to joining DePuy Synthes, he was the program architect and center director of a multidisciplinary spine center in the non-profit sector and served as a neuroscience consultant with Vega Healthcare. Dr. Pracyk is a fellow of the American Association of Neurological Surgeons and the American College of Surgeons. In 2015, he completed a Healthcare M.B.A. at The Haslam College of Business at the University of Tennessee.
Director, Field Medical Excellence Medical Affairs Americas / Astellas
Michelle Powell is the Director of Field Medical Excellence in Medical Affairs Americas at Astellas Pharma Global Development, Inc. She joined Astellas in 2006 as the head of the field medical program and has since served in numerous roles at Astellas in or supporting field medical teams during her 12+ year tenure. She was appointed head of the newly formed Field Medical Excellence function in March 2018 where she is responsible for strengthening field medical capabilities across the Americas region (inclusive of US, Canada, Brazil and Colombia).
Michelle spent the last 22 years in medical aﬀairs leadership roles at Novartis Pharmaceuticals Corporation and Searle Pharmaceuticals prior to coming to Astellas. Throughout her career in the pharmaceutical industry, she led teams and key projects in organizational team design, change management, field medical operations, process improvement, field medical governance, medical affairs data analytics, and field medical tools and system development.
Before coming into industry in 1996, Michelle was an Assistant Professor of Pharmacy Practice at the University of Illinois at Chicago College of Pharmacy, where she had a clinical ambulatory care practice in the Family Medicine and Student Health Clinics. She took pharmacy students on clinical rotation and taught didactic coursework on over the counter (OTC) medications.
Michelle completed a pharmacy practice residency in 1992 at the University of California Davis Medical Center in Sacramento, CA after completing her Doctor of Pharmacy at University of Nebraska Medical Center.
Outside of work, she spends her time with her husband (William), their dogs, and grandchildren (3). She enjoys boating, golfing, traveling, attending sporting events, and spending time with family and friends. She also volunteers at a local animal shelter.
Anna brings more than 16 years of progressive leadership experience in the pharmaceutical industry . She joined NNI in 2011 as Executive Director, Field Medical Affairs Diabetes, transitioning to oversee the Strategy and Operations area in 2014 and most recently heads up the department as VP, Field Medical Affairs. In this role, she has responsibility for Product strategies, field medical engagement and outcomes research with external partners.
Prior to joining NNI, Anna has experience in both small biotech companies as well as large Pharma, building and leading various Medical Affairs teams in the area of Cardiovascular, Respiratory and Ophthalmology.
Anna has a background in research, completing her PhD in insulin regulation at the University of Melbourne, Australia. She then completed a 3 year postdoctoral fellowship at UCSF, in the area of cellular biology and electrophysiology. She has also completed a number of executive training programs, including the BioExecutive Institute Program (focusing on innovation in clinical development) and Women in Leadership Program at the HAAS Business School at Berkeley. Anna lives with her husband and two children in Princeton.
Ralph is currently the Global Head for Field Medical Excellence at Abbvie. He has overall responsibility for operational and foundational skill support of 470 MSLs in around the globe. Prior to that he led the US MSL team across 9 therapeutic areas. He also led the launch of the Global Field Medical team for the oncology portfolio. Prior to his current position he was the director of oncology field medical sciences at Bristol Myers Squibb where he led a group of US MSLs in support of 4 marketed and 3 late stage pipeline products.
Ralph has over 24 years of field medical experience starting as an MSL for Pfizer in Denver, CO. He worked in many therapeutic areas at Pfizer (cardiovascular, metabolics, neuroscience, immunology and managed markets) and taken on roles of increasing responsibility including field manager and HQ group leader responsibilities.
After 13 years at Pfizer, Ralph joined Amgen as the executive director for US oncology field medical. In his 5 years at Amgen he took on additional leadership roles culminating in his overall leadership of the field medical function for all therapeutic areas (oncology, nephrology, bone health, inflammation and managed markets).
Prior to industry Ralph spent 13 years in clinical practice, focusing on critical care medicine.
Ralph received his BS and PharmD from Purdue University.
Associate Director, Field Medical Training/ Sanofi
Mary is currently Associate Director in Field Medical Excellence for the US Diabetes and Cardiovascular unit. As lead of Field Medical training, she has overall responsibility for clinical and functional skill support of MSLs and OLs in these therapeutic areas. She has optimized skills education through introduction of multiple learning platforms and adult learning techniques, cross-functional strategic alignment and leveraging global initiatives to support medical transformation.Other roles within Sanofi in the past 7 years have included area medical manager for metabolism (managed markets), outcomes liaison for oncology, and medical science liaison for diabetes. Prior to industry Mary spent 12 years in clinical practice, focusing on diabetes and anticoagulation practice performance improvement in internal medicine and 6 years in formulary and clinical guideline development in managed care.Mary received BS degrees from the University of Illinois and Massachusetts College of Pharmacy and PharmD from Medical University of South Carolina.
Omar has more than 25 years of leadership and strategic experience in HEOR, Market Access, Medical Affairs, Pharmacoepidemiology, and disease and safety registries in biotech, pharmaceutical, academia, and medical device settings. Currently, he is the VP, of HEOR & RWE at AveXis, a gene therpay company. Prior to joining AveXis he led the value and access activities at Halozyme. At GSK Omar developed and led the Global Value Evidence Analytics focusing on innovation and ensuring high quality of payer research including clinical trials and HEOR studies. Prior to joining GlaxoSmithKline he led the global health economics and outcomes research at Takeda, the Pharmacoepidemiology and Registry activities at J&J, and the Biostatistics/Epidemiology/Data Management and Analytics Departments at University of Massachusetts Medical School. He held a number of key industry roles and academic positions and is Adjunct Professor at the School of Pharmacy, University of Illinois, Chicago. Omar was recently recognized as one of the top 50 most influential people in Big Data. He is a leader in digital health. Omar is an author and co-author of more than 250 peer-reviewed publications.
Omar trained at Monastir School of Medicine in Tunisia, before taking his MPH at University of Massachusetts School of Public Health. He also has a Diploma in International Health and Medicine of Catastrophe from Tours Medical School in France. Omar also earned Certificates from Harvard University in Pharmacoeconomics and Outcomes Research and from Kellogg’s School of Business in Business Marketing Strategies and Marketing Healthcare Products. He lived in 5 continents and is fluent in 4 languages.
Rich heads US Medical Capabilities at Amgen, encompassing medical liaisons across five therapeutic areas, the US Med Info Call center, REMS, and US Medical events.
He has 20+ years of Biotech and Pharma experience ranging from discovery research to product launches and has spent most of his career building Medical Affairs capabilities.
Rich has been at Amgen since 2003 and prior to that worked for Organon-Sanofi Synthelabo and as a staff scientist in discovery research for Icogen.
He holds a Ph.D. in Biochemistry and Molecular Biology and completed an NIH post-doctoral fellowship in Hemoglobinopathies at the University of Washington, where he was a senior fellow in the division of Medical Genetics.