(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
Former Chief Ethics and Compliance Officer/ Medline Industries, Inc. Northfield, IL
Ann Ford recently served 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.
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.
Executive Director and Head of Global Scientific Communications/ Celgene Corporation
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.
Vice President, US Medical Affairs / Intercept Pharmaceuticals
Stephen Dodge is the Vice President, US Medical Affairs at Intercept Pharmaceuticals. Prior to joining Intercept, Stephen was 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
Anna Walz is a 25-year veteran in the pharmaceutical industry and is the CEO of MedEvoke which she founded in 1999. MedEvoke is dedicated to working with Medical Affairs leaders to drive alignment through development of clear medical strategies that can be globally communicated, measured, and analyzed. This has, for the first time, enabled Medial Affairs to track the impact of internal efforts on the external scientific and digital exchanges.
Anna, who often speaks on the topics of metrics for medical affairs, female entrepreneurship, and diversity in the biosciences, is also a regular guest-lecturer on the topic of Pharmacology & Drug Marketing at the Rutgers Medical School. In addition to speaking, Anna has a keen interest in her own continuing education and is a graduate of both the Tuck-WBENC Executive Education program and the Entrepreneurial Master’s Program (EMP), a joint collaboration of the Entrepreneurs’ Organization and MIT. She is also actively involved in her community, serving as a Chairman of the Board of Trustees for Hunterdon Regional Community Health, the Hunterdon Healthcare System, and is an active member the Hunterdon Medical Center Strategic Planning Committee. Outside of her professional achievements, Anna earned her black belt in Shito Ru karate, is multiple marathon runner, and enjoys weightlifting at her local crossfit gym.
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.
Jennie is a Global Chief Compliance and Risk Executive, with experience managing all aspects of compliance and enterprise risk management programs. She is a trusted member of Executive Management, and a results-driven and passionate business and compliance leader and key influencer with in-depth knowledge of business unit operations. Jennie focuses on being a strategic thinker and implementer of proactive compliance programs, with a goal to empower and excite employees about their role in compliance. With experience building high-performing teams and enhancing compliance programs in public company spin-offs and high-profile mergers and acquisitions, she is an adept change leader and inspiring builder of teams.
Jennie most recently served as Shire’s Chief Compliance & Risk Officer, with responsibility for all of Shire’s Compliance efforts globally and Enterprise Risk Management. In this role, she integrated Shire and Baxalta’s compliance programs post merger, building, leading and inspiring an approximately 70-person team. Prior to joining Shire, Jennie was Vice President & Associate General Counsel for Compliance at Baxalta, where she led the spin-off and development of the Ethics & Compliance program from Baxter.
Jennie earned her Juris Doctor, with Certificate in Health Law, from DePaul University College of Law and her Bachelor of Arts in International Affairs and Political Science from Marquette University.
Executive Director, HEOR and Data Analytics/ Novo Nordisk
Rahul brings more than 18 years of diverse experiences in the pharmaceutical industry spanning medical affairs, research, marketing and manufacturing. He is currently Executive Director, Health Economics and Outcomes Research (HEOR) & Real World Data analytics at Novo Nordisk Inc in the US. His team is responsible for conducting outcomes research and economic evaluations for Novo Nordisk products in the US, studies using real world data, and research partnerships with US centers of excellence. Before joining Novo Nordisk, he spent 11 years working in health economics and outcomes research/Health Technology Assessment (HTA) roles of increasing responsibility at GlaxoSmithKline pharmaceuticals. At GSK he supported multiple disease areas, products across the development life-cycle, and markets ranging from the US, key European and Asia Pacific countries. He has authored several scientific papers and presented in scientific congresses and holds a PhD in Pharmacoeconomics and Outcomes research.
Senior VP, Client Relationship Development / STEM Healthcare US
30 years plus of broad, U.S. commercial pharma experience in 16 roles impacting large segments of payerbusiness, internal functions, international projects, and selling teams through 3rd line leader – all with AstraZeneca and legacy organizations and now in client development function with STEM Healthcare
Executive Director, Global Field Medical Center of Excellence (CoE) / Merck & Co., Inc.
Donna Holder is the Executive Director, Global Field Medical Center of Excellence (CoE) at Merck. She joined Merck in January 2018 to lead the CoE where she is responsible for strengthening the field medical capability worldwide. Additionally, she leads the scientific and capabilities training function which resides in the CoE. Donna has over 25 years of experience in the pharmaceutical industry with a wealth of experience in Medical Affairs. She started her career at Marion Merrell Dow (now Sanofi) in Clinical Development and then joined AstraMerck (now AstraZeneca Pharmaceuticals) where she spent over ten years in senior leadership roles including leadership of MSL, Medical Information, and Contact Center teams. In her last role at AZ as Senior Director, MSL Excellence in Global Medical Affairs, Donna was accountable for the strategic direction of the MSL function. She led development, delivery, and measurement of initiatives to strengthen MSL capabilities worldwide. Donna left AZ at the end of 2014 and became a Medical Affairs consultant, partnering with pharmaceutical and biotech clients to deliver solutions including capability development, business process development, business strategy, operations management, and coaching. Donna earned her Doctor of Pharmacy from the University of Michigan.
Scientific Strategy Advisor / PAREXEL International
Jamie Kistler is a Scientific Strategy Advisor for PAREXEL International. She has nearly 15 years of experience supporting US and Global cross-functional teams in the biopharmaceutical and device industries across a wide array of therapeutic areas, including oncology, hematology, immunology, women’s health, cardiovascular disease, multiple sclerosis, psychiatry, pediatric infectious disease, and rare diseases. Specifically, Jamie provides support to Medical Affairs professionals in the development and execution of comprehensive strategic communication plans. Ensuring that patient insights and needs are considered as part of the medical communications planning process is a key area of focus, and she collaborates closely with members of PAREXEL’s Patient Innovation Center to bring new insights and innovative ideas to her Medical Affairs colleagues.
Jamie is a graduate of Susquehanna University, Selinsgrove, PA and earned a PhD in Molecular and Cellular Pathobiology from Wake Forest University School of Medicine, Winston Salem, NC. She completed a postdoctoral fellowship in Medical Oncology at Fox Chase Cancer, Philadelphia, PA. Jamie is an active member of the Medical Affairs Professional Society (MAPS) and served on the Practical Insights and Tools Committee from 2017-2018. Prior to joining PAREXEL, Jamie worked as a Sr. Director of Client and Strategic Services for ICON Global Medical Communications.
Tony has over 30 years of experience creating and delivering analytical products and services. In his prior career in the U.S. intelligence community, he directed intelligence operations in various strategic analysis organizations in the US and abroad. Subsequently, Tony used his insight to apply intelligence methodologies to pharmaceutical industry problems. Over the past decade, he has developed the leading-edge technologies that are now Voxx Analytics, creating easy-use advanced analytics for engagement-related challenges. Tony has an MS from National Intelligence University and an MBA from the Peter F. Drucker School of Business.
Ponni Subbiah, MD, MPH, is a neurologist with extensive pharmaceutical industry and public health experiences. She was most recently Chief Medical Officer for Indivior Inc., with responsibility for Pharmacovigilance and Medical Affairs globally. She was also the company spokesperson at policy discussions including testifying at the Presidential Commission on Combating Drug Addiction and Opioid Crisis and the hearing by the House Committee on Energy & Commerce on the Opioid Crisis. During her previous tenure of over 15 years at Pfizer, Inc., she held various leadership roles in Global Medical Affairs and led Pfizer’s Global Access program, which focused on improving access to medicines and healthcare for low-income populations in the developing world. Other experiences include serving as Program Leader for Drug Development for PATH, a nonprofit focused on the discovery and development of treatments for diseases affecting the developing world. Dr. Subbiah received her medical degree from Madras Medical College in Chennai, India and completed a residency in neurology at the Mayo Graduate School of Medicine in Rochester, MN. She completed a research/clinical fellowship in AIDS Neurology at Johns Hopkins University School of Medicine and earned a Master’s degree in Public Health from the Johns Hopkins Bloomberg School of Public Health in Baltimore, MD.
Marc Duey, Founder, President and CEO of ProMetrics, serves decision support needs of specialty biopharma executives, focusing on patient-level data impacting prescription efficiency. In business for over more than two decades, ProMetrics has Microsoft Azure-based technology platforms for data collection, aggregation, integration, analysis and reporting to cost-effectively bring systems of record systems of intelligence. He serves on the Board of several biopharmaceutical firms and non-profits. Marc earned an MSc in Toxicology from Ottawa University and an MBA from Western University, and is an adjunct professor at West Chester University. He is an avid hockey player and obstacle course runner.
Envision Pharma Group CMO, Joseph Kohles, PhD, is a dynamic leader with more than 20 years of research and industry-side pharmaceutical experience, both in medical marketing and clinical research. In addition to a broad range of experience across multiple therapeutic areas such as oncology, osteoporosis, pain and diabetes, Dr. Kohles has written and published more than 20 peer-reviewed manuscripts and over 60 abstracts and posters in areas such as basic research, preclinical, clinical, health outcomes, and pharmaco-economic analysis.
Dr. Kohles’ recent industry experience was in leading the oncology medical affairs team for a large Fortune 100 pharmaceutical company in the U.S. In this capacity, Dr. Kohles guided the overall medical strategy and led the team in execution of clinical trials, data analyses, publications plans, and overall commercial support.
Executive Director, Medical Services and Operations / Sandoz
Kirtida Pandya holds the position of Executive Director and Head of Medical Services and Operations within the Sandoz US Medical Affairs team. In this role, she has proactively facilitated the growth and transformation of USMA. She has built and led a best in-class medical affairs organization with oversight of Operations, Program Management, Medical information/Communications, Training and Compliance, Material Approval Process, and Grants/IIT functions. Prior to joining Sandoz, she had been at Novartis for almost 8 years and was responsible for laying the medical communications foundation for Cosentyx, where she led the strategic planning and implementation of the medical plans, scientific support for continuing medical education, medical communications, and medical expert engagement activities for Cosentyx.Kirtida has a strong medical background with expertise in several therapeutic areas and supporting products at various stages in their lifecycle. These skills have been honed based on her extensive experiences from both sides of the fence, i.e., working with pharmaceutical industry and medical communications agencies. In a previous role, she also led a strategic publication planning group and has held various other positions such as retail pharmacist, drug information specialist, and medical writer. Kirtida graduated from Rutgers University with a Bachelors and a Doctorate degree in Pharmacy, as well as Masters in Healthcare Management. She is a Certified Medical Publication Professional and demonstrated her commitment to enhancing medical publications and communications through her involvement as a volunteer across several committees within International Society of Medical Publication Professionals (ISMPP). She has been a panelist at the Publication Planning Forum of CBI in 2010 in the “Best Practices for Communication with Authors outside Your Organization” session and has hosted sessions and taught workshops at the ISMPP annual meetings.
Ian has over 30 years’ experience in pharmaceutical development and medical communications, including 4 years as a medical affairs consultant to pharmaceutical and medical communications agencies and 10 years as a global medical affairs leader in AstraZeneca oncology franchise delivering multinational communication programs
Developed communications strategy and medical education materials to support affiliate companies and healthcare professionals
Supported medical elements of regulatory submission and subsequent product launch and training
Planning and delivery of global advisory boards, symposia, conference activities, and stand-alone meetings
Preparation of supporting medical materials for brands, including promotional guidance, MoA, adverse-event management, and physician education materials
Oncology and publications experience
Development of strategic medical plans for a number of oncology products and translation into effective multinational programs to support communications by worldwide affiliate companies
Global medical affairs leader involved in the development of several targeted oncology molecules, including bicalutamide, goserelin, zibotentan, vandetanib, cedarinib, selumetanib, tremelimumab, and durvalumab
Covered many therapeutic areas including urological, lung, thyroid, ovarian and breast cancers.
Led cross-functional teams to deliver insight-driven, customer-focused, differentiated target product profile and claim documents to drive delivery of differentiated reimbursable medicines
Led delivery of a medical excellence training program to global and affiliate physicians and MSLs.
Nicole Yurgin is the Executive Director of US Medical Value and Access at Amgen Inc. In this role, Nicole leads a US medical team that communicates the clinical and economic value of Amgen’s biopharmaceutical innovations with payers and other formulary decision makers. Nicole is passionate about improving the lives of people at risk of with serious diseases by ensuring access to innovative therapies.
Nicole has extensive experience in creating real world evidence programs and developing FDAMA 114 materials. Nicole has held various roles in Global, US and European Health Economics and Access functions at Amgen Inc. and at Eli Lilly and Company. Prior to joining industry, Nicole was an Assistant Professor in the Department of Economics at University of Toledo. Nicole holds a Ph.D. in Economics from The Florida State University.
Todd Smith is a results-oriented and principled leader with more than 25 years of pharmaceutical, medical device and biotechnology leadership. Todd has a long track record of building companies and achieving commercial and business development excellence while helping companies serve patients by providing access, choice, and affordable products. He delivers immediate organizational impact leading to accelerated growth through aggressive prioritization and clear strategy as well as creating a culture of teamwork and accountability. His experience leading product launches, business turnarounds and start-ups allow Todd to create significant value for venture capital, private equity, and Fortune 100 businesses.
Brindan Suresh is a Partner with McKinsey and Company based in London. He leads the pharmaceutical practice in the UK & Ireland and co-leads the Firm’s work in Medical Affairs globally. He works primarily with innovator pharmaceutical and medical-device companies in Asia, Europe, and the United States.
Brindan focuses on strategy and organizational issues across R&D, Medical and Commercial. He works on a range of topics, helping organizations take a more “science forward, patient back” perspective. This includes recent work helping to set the long-range strategies of a number of clients, the application of digital and analytics across the pharmaceutical value chain, and applying our latest thinking on maximizing talent and leadership across the industry.
Brindan convenes our cross-industry medical-affairs leader roundtable and regularly presents our insights externally on innovation-related topics. He also worked as a physician before joining McKinsey, and holds an MD and JD.
Head of Multichannel Strategy / Complete HealthVizion
David is the Head of Multichannel Strategy at Complete HealthVizion, a McCann Health agency providing industry-leading medical communications services.
For the past 7 years, David has worked exclusively within medical communications in a number of senior agency-side digital and multichannel strategy roles. During this time, David has worked with large pharmaceutical as well as small biotech companies in the development, execution, and measurement of multichannel engagement strategy, focusing on both healthcare professional and patient needs. David has extensive experience working with a range of digital technologies and solutions, from websites and analytics tools through to client relationship management platforms and mobile applications. David has applied his knowledge across a wide range of therapy areas, including oncology, diabetes, gastrointestinal disease, cardiovascular medicine, neurology, nutrition, and rare diseases.
Prior to working in medical communications, David spent 12 years delivering digital communications across multiple sectors, including consumer, retail, and broadcast.
Jen Seda, MD excels in developing business-aligned medical strategies and translating these into proven tactical execution via strategic R&D, payer evidence generation, KOL relationships, influential publications, behavior changing education and medical messaging, with budgets ranging from less than $50k to over $20 million. She brings this expertise to SSI strategy, building custom medical landscape-based solutions with clients of all sizes and stages of development. Dr. Jen Seda most recently served as Vice President of Market Access, Government and Medical Affairs at TerumoBCT, a global device company with products in hematology, neurology, critical care, orthopedics and stem cell technologies. Previously, she led the Global Medical Affairs team at Baxter Healthcare, Biologics division through launches in rare disease in pulmonology and neurology. She has helped build strong and effective medical affairs and medical information teams from scratch at Coviden, Respiratory and Monitoring division and has led both medical affairs and marketing teams at Talecris Biotherapeutics to market leadership in orphan disease. Dr. Seda received her medical degree and training in neuroimmunology at the Mayo Clinic and undergraduate from U.C. Irvine, with additional experience running bench science and basic research experience at the clinic and at Amgen, allowing her insight to strategic and practical planning from bench to bedside in pharma, device and wellness.
Shauna brings more than a decade of extensive experience across the pharmaceutical, biotech, medical device and research markets. She has a passion for innovation and driving impact and has demonstrated that success through her strong collaborations and supportive partnerships across the healthcare continuum.
As the Senior VP of Strategic Accounts at MedEvoke, Shauna is a driven leader providing strategic support and best practices to the organization’s partners and clients. Using her extensive experience and knowledge of the market, clinical development and launch excellence, Shauna employs creative thinking, combined with data insight to deliver unique and strategic solutions.
Shauna received her bachelor of science in biology from Salisbury University, in Maryland, with a focus on premed studies and genetic research. She also holds a second bachelor’s degree in psychology from Towson University and earned her MBA degree with a specialization in management and marketing.
Vice President, Managing Director / MedThink SciCom
As VP, Managing Director, Todd is responsible for implementation of MedThink SciCom’s core organizational focus: always thinking, flawless execution, and outstanding customer service. In addition, Todd is responsible for financial management and business planning; overseeing team growth and staff development; and establishing and maintaining procedure, performance, and quality standards. Todd has over 12 years of medical communications agency experience overseeing scientific strategy (eg, scientific platforms, disease-state education plans, publication planning). Todd has also been involved in identifying and expanding new service offerings (ie, developing innovative approaches to address client needs). His areas of expertise include biochemistry, drug development, immunology, infectious diseases, inflammation, and oncology. Before he joined MedThink SciCom, Todd worked at a medical communications company in the Midwest, where he provided scientific direction for multiple products in the oncology space, including immunotherapy, supportive care, and targeted agents. Todd earned his PhD in Biochemistry and Molecular Biology from Mississippi State University. He completed his postdoctoral research at Ohio University studying the mechanism of action of 2 biological response modifiers.