Faculty

Learn more about our faculty by clicking on their name below.

  • Kirk Shepard, MD

    Senior Vice President, Head of Global Medical Affairs Oncology
    Eisai
    President 2016-2017, Medical Affairs Professional Society

    Dr. Kirk Shepard is the 2016-2017 President of the Medical Affairs Professional Society 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.

  • Gail Cawkwell, MD, PhD

    Chief Medical Officer and Vice President of Medical Affairs
    Purdue Pharma
    Stamford, CT

    Dr. Gail Cawkwell currently serves as Chief Medical Officer and Vice President of Medical Affairs at Purdue Pharma in Stamford, CT. After earning her medical degree at McGill University in Montreal, Canada, Dr. Cawkwell received her doctorate from the Department of Environmental Health, Division of Biostatistics and Epidemiology at the University of Cincinnati in Ohio. She completed a residency in Pediatrics at Duke University Medical Center in Durham, NC, and a fellowship in Pediatric Rheumatology at Cincinnati’s Children’s Hospital Medical Center.

    Dr. Cawkwell and her team provide medical and scientific expertise to healthcare professionals, payers, patients, and health systems. They also focus on ensuring that medical and regulatory decision makers understand the company’s medicines and therapeutic areas.

    Dr. Cawkwell’s research has been published in such journals as Arthritis and Rheumatism, Current Medical Research and Opinion, Annals of the Rheumatic Diseases, and the Journal of Pain and Symptom Management.

  • Robert J. Matheis, PhD, MA

    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.

  • Terry Griesing, PhD

    Vice President, North America Medical Affairs
    Pfizer

    Her team provides medical and scientific expertise to healthcare professionals, payors, and large integrated health systems. She is focused on building leading edge capabilities in medical communications, data, evidence and medical insights generation, population health, quality and product access.

    Prior to her current role she was VP, US Field Based Medical for Pfizer’s Primary Care Business Unit. She has been in the pharmaceutical industry for 20 years and has been involved in clinical drug development phases III and IV. Recent positions held at Pfizer include Executive Director/Global Medical Team Leader for Viagra and Revatio, Sr. Director/US Medical Team Leader for Lyrica and Clinical Director for Aricept. She is a trained neuropsyhchologist and has experience working in multiple therapeutic areas including, Alzheimer’s Disease, Mild Cognitive Impairment, Pain, Epilepsy, Depression and Anxiety, Urology and Cardiovascular .

    After receiving her Bachelor of Arts degree at Hunter College in New York City, she obtained her masters degree and doctoral degree at the Graduate Center of the City University of New York in New York City. She completed her training as a neuropsychologist at New York University, Aging and Dementia Research Center. She remained on the faculty at New York University as an Assistant Professor for approximately 5 years prior to joining Pfizer Pharmaceuticals. Her main areas of clinical and research focus at New York University included the treatment and management of Alzheimer’s Disease and Mild Cognitive Impairment.

  • Charlotte Kremer, MD MBA

    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.

  • John Orloff, MD

    Executive Vice President
    Head of Global Research & Development
    Alexion Pharmaceuticals

    Dr. Orloff, M.D., is a global R&D/business leader with 20 years of experience in the bio-pharmaceutical industry at leading organizations. His expertise in research, non-clinical and clinical development, medical affairs, health economics & outcomes research, and regulatory affairs has informed all his work.

    As EVP, Head of Global Research & Development at Alexion, Dr. Orloff oversees the rebuilding of the organization and defining the path to value creation through focused development in the metabolic space. Prior to Alexion, Dr. Orloff served as EVP, Head of R&D, and Chief Scientific Officer at Baxalta. During his tenure he advanced its pipeline by employing an external innovation model; led ~1300 people spanning discovery research to LCM; and served as a Section 16 Officer, representing R&D at all Executive Committee meetings, Board interactions, and investor/external community engagements. During a span of 2 years, Dr. Orloff oversaw regulatory approval of 10 unique products and 2 devices in the US and Europe.

    Before Baxalta was spun-off from its parent, Baxter International, in 2015, Dr. Orloff served as Executive VP, Global Head of R&D, BioSciences International at Baxter, and as a member of the Division’s Senior Management Team, reporting to the President. In this role he advanced the BioScience pipeline; led all R&D functions, enhanced the R&D operating model; and pursued additional innovative opportunities. He also represented Baxter BioSciences externally in fora interfacing with scientific/academic communities, payer organizations, HTAs, health authorities, health care policy makers, and scientific congresses.

    Before joining Baxter in 2014, Dr. Orloff served as SVP, Global Head of Clinical Development at Merck Serono Pharmaceuticals (2014), leading design and execution of global clinical development programs and projects, and oversaw pipeline management and development.

    Dr. Orloff joined Novartis Pharma in 2003 in a leadership role, quickly rising to positions of greater responsibility. As SVP, Head, US Medical & Regulatory Affairs at Novartis Pharmaceuticals, he provided executive leadership of U.S. Clinical Development, Medical Affairs, Evidence-based Medicine, and North American Regulatory Affairs. He oversaw the successful development of/received regulatory approval for a wide range of products, often for multiple indications.

    From 2010 to 2013, Dr. Orloff served as SVP, Chief Medical Officer for Novartis Pharma’s Pharmaceutical Division, where he provided strategic and scientific leadership for all Global Development processes, continuous process improvement, clinical training & education, oversight of protocol and CDP reviews, and clinical policy setting. He led an overhaul of the quality organization and all R&D SOPs; established company policy for data sharing, aligned with Sandoz on a corporate position for biosimilars development, and drove implementation of innovative approaches to clinical development across key projects.

    From 1997 to 2003, Dr. Orloff served in several leadership roles with Merck Research Labs, supporting clinical development of products for osteoporosis, bone-related disorders, and arthritis, leading a Fosamax clinical program and efforts for clinical development of new compounds (novel MOAs) for osteoporosis and other bone- and arthritis-related conditions.

    Earlier, Dr. Orloff taught at Yale University School of Medicine as an Instructor, Assistant Professor, and Associate Professor of Medicine. He has been a member of industry Advisory Boards, and is a member of numerous professional societies and associations.

    Dr. Orloff is Board Certified in Endocrinology & Metabolism and Internal Medicine, and is a Diplomate, National Board of Medical Examiners.

    Dr. Orloff earned an M.D. from the University of Vermont’s College of Medicine, and an AB in Chemistry from Dartmouth College. He completed his Internal Medicine Internship, Residency, and Chief Residency at the University of Pittsburgh Medical Center, and, from 1987 to 1989, he held an Endocrinology & Metabolism Fellowship at Yale University School of Medicine.

  • Ann Ford, BSN, JD

    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.

  • Ramin Farhood, PharmD, MBA

    Vice President, Head of Global Medical Affairs
    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.

  • Thérèse McCall, PhD, MBA

    Global Medical Affairs Strategy and Communications Leader
    Chicago, IL

    Dr. Thérèse McCall is the former Vice President of Global Medical Communications and Professional Strategies AbbVie, Inc. in Chicago, 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.

  • Martin Rees, PhD (Medicine)

    Executive Committee member, APPA – www.appa.net.au
    Senior Medical Science Liaison, Gastroenterology
    Shire Australia

    Dr Martin Rees serves on the Executive Committee of APPA, the representative association for Medical Affairs professionals in Australia. APPA is closely aligned with key industry and academic stakeholders (ARCS Australia, UNSW and Medicines Australia) and provides a national forum for its diverse and geographically dispersed membership to come together and advance their interests through professional development, networking and advocacy.

    Over the last 2 years, APPA has undergone a period of considerable growth and evolution: APPA has seen a tripling of its membership as it has renewed its focus on the needs of MSLs and Medical Managers/Medical Advisors and has expanded its geographical reach. A recent comprehensive survey of our members (the first of its kind in Australia, covering over a third of the national workforce in Medical Affairs) has provided valuable insights into current roles and practices and has identified areas of key need to drive future policy.

    Dr Rees is Senior MSL at Shire Australia and his career in medical research and in Medical Affairs combines 17 years experience in therapeutic areas including cardiology, haematology, trauma/emergency medicine, intensive care, anaesthetics, neurology and gastroenterology. His peer-reviewed research output – most recently from a research program he led as a Lecturer at the UNSW Faculty of Medicine – has attracted over 1100 citations. His professional role within the pharmaceutical industry builds on his longstanding experience in science communication and passion for promoting science and innovation through traditional and social media channels, e.g. a successful crowdfunding campaign for his research program, which was featured in The Lancet.

    Dr Rees also serves on the Executive Committee the Australian Science & Innovation Forum, an association of STEMM professionals in industry and academia that focusses on encouraging the development and teaching of entrepreneurial skills to emerging young researchers and business people.

  • Robin L. Winter-Sperry, MD

    Head, Global Field Based Medical Excellence

    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.

  • Ornah Levine-Dolberg, MD

    Vice President & Global Head of Medical Affairs
    Research & Development
    Glenmark Pharmaceuticals

    Dr. Ornah Levine-Dolberg graduated from the Ben Gurion University, Medical School in 1990. Following her residency in Psychiatry completed cum laude, she was the Director of the Day Hospital at the Sheeba Medical Center in Israel for 7 years. His first industry role was in 2003 as a Country Medical Director for Lundbeck. After 3 years in that role she moved to Copenhagen to take up various roles in Global Medical Affairs, including heading the department of Scientific Communications, responsibility for a competitive ISS program, and being the Global Medical Director for escitalopram, a highly successful treatment for Mood and Anxiety Disorders. One of her final roles in Lundbeck was the launch of escitalopram in China.

    Dr Ornah Levine-Dolberg joined Teva Pharmaceuticals in mid-2013 to head the newly formed Medical Affairs, Growth Markets. From a team of 2 this department has grown to more than 100 employees. Dr Levine-Dolberg established all functions in this team including Medical Operations and Excellence, Therapeutic Area Leads and their operating model, Country Medical Directors and their departmental structures and deliverables. On a regional level, she built various infrastructure capabilities such as Medical Information, promotional material review, governance bodies, operating models, KPIs, financial structures, and a strategic project called Signature Medical Moves. In addition, Ornah was part of the leadership team of Growth Markets and a prominent member of the Global Medical Affairs Leadership team.

    In September 2016 Ornah joined Glenmark Pharmaceuticals in their London headquarters to establish and launch Global Medical Affairs and to help the company in its transition from a medium sized Indian company to a global presence with expertise in all facets of drug development and commercialization.

     


  • Tracy Mayne, PhD

    Head of Medical Affairs Strategic Research
    Purdue Pharma L.P.

    Tracy J. Mayne, PhD received his doctorate in clinical health psychology from Rutgers University and completed his clinical training in the Psychiatry Residency Program at the University of California – San Francisco. He went on to a research fellowship at the Institut National de la Santé et de le Recherché Medical where he designed and executed the first national study of HIV among injection drug users in France. Upon return to the US, Dr. Mayne served as the Director of HIV Epidemiology and Surveillance at the New York City Department of Health. Dr. Mayne joined the pharmaceutical industry at Pfizer, where he launched Bextra, served as economic lead for the Celebrex/Bextra portfolio, then become the economic lead for Lipitor. He next joined Amgen and became the Global Renal Anemia Lead for Epogen/Aranesp, also supporting the launches of Kepivance and Vectibix. Dr. Mayne spent the following decade in pharmaceutical consulting, ending as the vice president of Covance Market Access. He returned to the industry as Head of Medical Affairs Strategic Research at Purdue Pharma. Dr. Mayne has over 40 peer-reviewed publications and has authored books on clinical psychology, health and emotion. Dr. Mayne has received several awards for his work, including:

    • Hyacinth Foundation President’s award for outstanding service to people with AIDS
    • Society for Behavioral Medicine award for outstanding research
    • New York City Department of Health award for community and collaborative research
    • Amgen “Fulcrum” award for successfully defending quality of life claims in the EPOGEN label
    • DaVita “It takes a Village” award for top sales
    • Association for the Advancement of the Study of Liver Disease president’s Award for innovative research
  • Daniel R. Stevens, PharmD, BCPS

    Director, Medical Affairs
    Veloxis Pharmaceuticals, Inc.

    Dr. Daniel Stevens currently serves as the Director of Medical Affairs for Veloxis Pharmaceuticals. Daniel joined the pharmaceutical industry three years ago as the national MSL for Veloxis, where he was responsible for building the field medical affairs team to support the launch of a new product in the US. Prior to entering the pharmaceutical industry Daniel received extensive, specialized residency training in the area of solid organ transplant immunology with a focus on clinical research at the Hospital of the University of Pennsylvania. Daniel is formally educated as a pharmacist and completed his undergraduate and graduate studies at Northeastern University in Boston, Massachusetts.

  • Steven Tomlinson, PhD, MBA

    Senior Director, Immunology MSLs
    Janssen Scientific Affairs

    Steven Tomlinson currently serves as the Senior Director of Immunology Medical Science Liaisons (MSL) for Janssen Scientific Affairs.  Steven joined the pharmaceutical industry 13 years ago and has supported therapeutic areas of bone health, female sexual function, and rheumatology.  In his current position, he leads 3 national MSL teams providing scientific/clinical support in the areas of rheumatology, dermatology, and gastroenterology.  An area of special interest is to help facilitate the development of Medical Affairs personnel to develop as first-time leaders.  Prior to entering the pharmaceutical industry, Steven was a Visiting Assistant Professor in the Department of Chemistry and Biochemistry at Texas Tech University.  Steven is formally educated as a protein biochemist and completed is PhD in biochemistry at Texas Tech University and also holds an MBA with a concentration in Management.

  • Tricia L. Gooljarsingh, PhD, CMPP

    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, 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.

  • Stan Bernard, MD, MBA

    President
    Bernard Associates, LLC
    Morristown, NJ

    Stan Bernard, MD, MBA is President of Bernard Associates, the leading global competition consulting firm for the pharmaceutical and health care industries. The firm offers Competitive Simulations, the new, improved version of business war games; Competitive Product Launch and Counter-Launch Services; Competitive Strategy and Planning; Competitive Analysis; Competitive Training Workshops; and Customized Competitive Workshop and Seminars. The firm works across products/technologies, therapeutic areas, lifecycle stages, markets, stakeholders, and competitive landscapes. Bernard Associates has worked with nine of the top ten global pharmaceutical companies and with over 125 other leading pharmaceutical and health care companies across five continents.

    Dr. Bernard is internationally recognized as a health care and pharmaceutical industry consultant, speaker, and author. He has been featured on national television and in leading publications, including the Wall Street Journal, Business 2.0, and Business Week. Dr. Bernard has published over 75 book chapters, syndicated reports, and articles. He currently writes two different columns on competition for the journals Pharmaceutical Executive and Pharmaceutical Executive Global Digest.

    Previously, Dr. Bernard held several executive positions at Bristol-Myers Squibb Pharmaceutical Company, including serving as U.S. Product Manager for the launch of the cholesterol-lowering drug Pravachol and as U.S. Medical Director – Anti-Infectives. He also served as a Consulting Principal in the Pharmaceutical Industry Practice at A.T. Kearney. Dr. Bernard was a Senior Fellow at The Wharton School of Business where he initiated and lectured in the “Pharmaceutical Management” course for 14 years.

    Dr. Bernard has served on the boards of several companies, organizations, and journals, including Pharmaceutical Executive magazine, the Metro Chapter of the Healthcare Business Women’s (HBA), and the Dorothy B. Hersh Foundation which provides grants to help New Jersey children with handicaps and special needs. Dr. Bernard has a Medical Degree from Baylor College of Medicine and an MBA in marketing and health care management from the Wharton School of Business.

     


  • Norm Enriquez, PharmD

    Senior Vice President
    TMAC Advisors

    Dr. Norm Enriquez is Senior Vice President for TMAC-Advisors and has over 30 years of experience as a pharmaceutical industry executive, clinician, researcher, and academician. Dr. Enriquez most recently has had executive leadership roles and built Medical Affairs and field-based medical teams in multiple therapeutic areas at Amgen & Sanofi-Aventis. Dr. Enriquez has been highly awarded for his medical team’s successes.

  • Carl Thoresen, PhD

    President
    Cornerstone

    Dr. Carl J. Thoresen is internationally published author and President of Cornerstone Management Resource Systems (www.leadwithcornerstone.com), a leadership development consulting firm located in Carnegie, PA. Carl specializes in the development and implementation of processes for helping highly talented employees transition smoothly into leadership roles. Prior to joining Cornerstone in 2003, Carl was Assistant Professor of Industrial-Organizational Psychology at Tulane University in New Orleans, LA, where he conducted studies in employee assessment, personality in organizations, and causes and consequences of work-related stress. Carl holds a B.A. in Philosophy from Northwestern University, an M.S. in Organizational Behavior from Cornell University, and a Ph.D. in Human Resource Management from the University of Iowa.

  • Stephen Douthwaite

    AlphaBioCom

    Stephen has many years in the industry, leading operations in the UK and US and directing global communications. He attended the not-very-prestigious London South Bank University and was at that time an entirely average student focused on many things, nothing very academic. He did however graduate, to the chagrin of his dissertation supervisor, but to the delight and relief of his parents. He joined the pharmaceutical industry where his penchant for challenging rules was poorly received. He learnt quickly to obey policies in order to preserve his career and started to climb the corporate ladder, until one day 18 years later when he looked around and realized he was entirely ineffective in his life’s work and decided in the words of Michael Jackson to “Make a Change”.

    In 2005 Stephen left pharma and started AlphaBioCom, which today is one of the country’s leading independent medical communication agencies, where his passion is inspiring and leading change. He asks his team to consider new approaches and become agents for change.  He works to improve the communication of science, pioneering the application of technology in engaging audiences in the process of scientific communication development, discourse and delivery.  He believes we all need to be lifted out of our comfort zone and challenged with new ideas and approaches in order to transcend the boundaries of our engrained thinking and working practices

     

  • Michael Fiedler, PhD

    Scientific Director
    Ashfield Healthcare

    From a scientific perspective, Michael has experience with a broad range of disease states and therapeutic areas including neurology (multiple sclerosis, autism, Alzheimer’s disease, epilepsy), psychiatry (schizophrenia, addiction), cardiovascular disease (atherosclerosis, type 2 diabetes, stroke, heart failure), blood disorders (hemophilia A and B) and rare diseases (infantile spasms, acromegaly, paroxysmal nocturnal hemoglobinuria [PNH], atypical hemolytic uremic syndrome [aHUS]). Within these areas, Michael has developed a wide array of educational, instructional, and strategic materials that serve medical, commercial and/or competitive needs and he is known for his innovative and creative abilities.

    Michael has supported the development of a number of global scientific platforms (GSP) that span multiple therapeutic areas, formats, and development strategies. Within the multiple sclerosis space, he was the GSP lead for TYSABRI® and Opicinumab (investigational). Michael provided GSP support for TECFIDERA® (multiple sclerosis), ELOCATATE® (hemophilia), ALPROLIX® (hemophilia), Oral Octreotide (acromegaly; investigational), and Aducanumab (Alzheimer’s disease; investigational). From a deliverable perspective, he has developed GSPs into formal Word and Adobe Acrobat documents as well as into interactive PowerPoints. He has experience with a variety of processes including stakeholder engagement, consensus meetings, collaborative workshops, external validation, and periodic updates.

    As a formally trained moderator, Michael has participated in the design, execution, and reporting of >30 advisory boards, roundtable discussions, and workshops. He is a skilled facilitator with extensive experience navigating interactions between healthcare providers and pharmaceutical professionals towards specified objectives. Michael also has significant experience with innovative engagement strategies for internal and external meetings (eg, competitive war games, case study scenarios, consensus projects). He excels in quickly processing and communicating complex scientific and medical information and has an energetic and infectious presence that drive his dynamic and productive capacities.

    Michael received his BS in Biochemistry/Cell Biology from UC San Diego and his PhD in Cell Biology from Yale University. He began is medical communications career while still in graduate school in entrepreneurial, freelance, and contract research capacities. He has an exceptional presence as evidenced by his championing of the Ashfield Healthcare Moderator Academy, his role as an Ashfield Marketing Ambassador, and his numerous career speaking engagements at Yale University, Harvard University, and UC San Diego.

  • Robyn S. Shapiro, JD

    Founder and Attorney
    Health Sciences Law Group LLC
    Fox Point, WI

    Robyn S. Shapiro, Founder and Attorney at Health Sciences Law Group LLC, has significant experience in representing clients with respect to research compliance issues, healthcare compliance issues, bioethics issues, health information privacy issues, informed consent, medical staff issues, regulatory and licensing matters, and corporate and commercial issues faced by pharmaceutical and medical device manufacturers and hospitals and academic medical centers engaged in research. Attorney Shapiro’s past position as Ursula von Der Ruhr Professor of Bioethics at the Medical College of Wisconsin, and her 26-year leadership as Director of the Center for the Study of Bioethics at the Medical College of Wisconsin complement her wide-ranging experience in health law. Ms. Shapiro is listed in the Best Lawyers in America, Who’s Who in American Law, Who’s Who in America, Who’s Who of American Women, Who’s Who of Emerging Leaders of America, Who’s Who in the Midwest, International Who’s Who, Who’s Who in the World, Who’s Who in American Education, and Wisconsin Super Lawyers; she was included in Nightingale’s 2006 list of “Outstanding Hospital Lawyers” in the nation; in 2006 she was one of 12 honorees selected as a “Leader in the Law” by the Wisconsin Law Journal; in 2011 she was named a “Woman of Influence” by the Milwaukee Business Journal; in 2011 she was named Milwaukee’s Health Care Law “Lawyer of the Year” by Best Lawyers; and in 2013, 2014 and 2015 she was ranked by Chambers USA as “Leaders in their Field/Life Sciences: Regulatory/Compliance (Nationwide)”.

    Attorney Shapiro is a frequent presenter at national seminars and conferences on research compliance and health law issues, and she is the author of more than 50 publications on these and other topics.

  • David A. Jencen, PhD

    Principal
    Jencen Field Medical Consulting LLC

    Dr. Jencen is Principal of Jencen Field Medical Consulting LLC, and a Senior Consultant with Cornerstone. As a Medical Affairs consultant with more than 20 years industry experience, Dr. Jencen partners with clients on projects such as: assuring global excellence in medical science liaison (MSL) performance; stakeholder engagement planning, developing global SOPs on medical insight process; recruitment and facilitation of Medical Advisory boards, and the development of business acumen in medical affairs personnel. He has delivered Medical Affairs training programs in the US, Singapore, Taiwan, and China. He also offers fee-paid coaching and mentoring to Aspiring MSLs, in addition to mid-career Medical Affairs professionals considering a change. He blogs (MSLife) and also hosts a LinkedIn discussion group “Medical Science Liaison (MSL) of the Future”.

    Dr. Jencen’s industry career included a variety of Medical Affairs / MSL assignments with Procter & Gamble Pharmaceuticals, Boehringer Ingelheim, and Novo Nordisk. He has directed both therapeutic MSL teams and a dedicated managed markets MSL team during both pre- and post-launch product lifecycles. While at Boehringer Ingelheim he was chief architect of the original MSL training and development program.

  • Anna Walz

    CEO
    Medisys Health Communications, LLC

    Anna Walz founded Medisys Health Communications in 1999 to provide strategic healthcare communications through collaboration with industry partners, physicians, teaching institutions, and medical associations.

    As an industry veteran focused on partnering with Medical Affairs, Anna launched MedEvoke, a division of Medisys Health dedicated to the company’s proprietary OPEN® Scientific Alignment Platform. OPEN was created specifically to achieve global alignment for Medical Affairs leadership teams in biopharma that are challenged to reconcile competing strategies and objectives across organizational functions and affiliates.

    A strong believer in continuing education, Anna is a graduate of the TUCK-WBENC Executive Education program and the Entrepreneurial Master’s Program (EMP), a joint collaboration between the Entrepreneurs’ Organization and MIT. Anna is actively involved in her community, serving as Chairman of the Board of Trustees for Hunterdon Regional Community Health, Trustee for the Hunterdon Healthcare System, and member the Hunterdon Medical Center Strategic Planning Committee. Outside of her professional achievements, Anna loves physical fitness. She is black belt in Shito Ru karate, an avid distance runner, and enjoys weightlifting at her local crossfit gym.

  • Mary Holloway

    President
    DMH BioPharm Advisors LLC

    Mary Holloway is the President of DMH BioPharm Advisors, a boutique biopharmaceutical, medical device and life science consulting and training firm that was founded in 2008. Mary draws from her extensive biopharmaceutical experience and industry knowledge to deliver real-world consulting solutions and training strategies that maximize the value of commercial and field medical operations and improve field force effectiveness.

    DMH is a recognized leader in the creation and delivery of real-world training for marketing, sales, account teams and field-based medical colleagues. DMH has authored over 7 industry published articles and is an invited main podium speaker at industry events in the biopharmaceutical, medical affairs, biopharmaceutical training and compliance space.

  • Thomas Gesell, PharmD

    Medical Affairs Leader
    Envision Pharma Group

    Tom is the Medical Information and Medical Affairs Domain Lead for Envision Pharma Group responsible for creating and improving systems and services across medical affairs. He joined Envision Pharma from Novartis where he was Head of Global Medical Information & Communications responsible for both medical publications and medical information.

    During more than 20 years in the pharmaceutical industry he led both U.S. and global departments within medical affairs at several companies, including Abbott Laboratories, Warner Lambert / Parke‑Davis, Pfizer, and Novartis. Prior to working in the pharmaceutical industry he was Assistant Professor of Pharmacy Practice and Associate Director of Samford University School of Pharmacy Regional Drug Information Center.

    Tom is active in several international organizations. He served on the International Society of Medical Publication Professionals (ISMPP) Board of Directors and is a Steering Committee member for the Medical Publishing Insights and Perspectives (MPIP) Initiative. He is a member of the DIA Medical Affairs and Scientific Communication organization and was a member of the USP Expert Committee for Information Development and Dissemination.  He often serves as program chairperson, member of the program committee, session chairperson, and speaker for these organizations.

    Tom received both his B.S. and Doctor of Pharmacy degrees from the University of Iowa.  He then completed a specialty residency in Drug Information Practice, at the North Carolina Memorial Hospital and University of North Carolina School of Pharmacy, Chapel Hill, North Carolina.

  • Chris Bogan

    Chief Executive Officer
    Best Practices, LLC

    Chris Bogan is the Chief Executive Officer and Founder of Best Practices, LLC, a leader in the field of best practice performance improvement. Based in Chapel Hill, North Carolina, Best Practices, LLC specializes in providing pharmaceutical, biotechnology and medical device corporations throughout the world with business intelligence, research, benchmarking studies, and consulting services. The company’s products and services provide corporations with “Access And Intelligence For Achieving World-Class Excellence.” Mr. Bogan received his MBA with honors from the Harvard Business School and his bachelor’s degree magna cum laude from Amherst College. He was a Nieman Fellow at Harvard University.

    Mr. Bogan’s work has focused on bio-pharma business model evolution, blockbuster product launches, marketing excellence, sales force effectiveness, clinical operations and best practice improvement strategies. He has written about numerous aspects of performance excellence and continuous improvement. In recent years, he has concentrated on ways that companies can use best practice insights to create economic value, accelerate revenue and profit growth, and drive rapid performance improvement. He is coauthor of the widely acclaimed books, Benchmarking For Best Practices: Winning Through Innovative Adaptation, published by McGraw-Hill, and The Baldrige: What It Is, How It’s Won, and How To Use It To Improve Quality In Your Company.

    Mr. Bogan has consulted on performance improvement and best practice competitiveness issues for a wide range of pharmaceutical, biotechnology and medical device companies, including Abbott / AbbVie, Baxter Healthcare, Merck, Pfizer, GlaxoSmithKline, Novartis, J&J, Genentech, Eli Lilly, Roche, AstraZeneca, Amgen, Celgene, Sanofi, Bayer, Boehringer-Ingelheim, Novo Nordisk, Astellas, Takeda, Daiichi Sankyo, LifeScan, and many others.

    Mr. Bogan led the consulting teams that assisted both Federal Express and GTE Directories (now Verizon) in winning the prestigious Malcolm Baldrige National Quality Award. He has also advised many leading corporations outside the healthcare sector, including industry leaders such as Microsoft, American Express, AT&T, General Motors, BellSouth, Chevron, Exxon, Xerox, Verizon, Marriott, Merrill Lynch, Siemens, KPMG, the New York Times Company, J.P. Morgan Chase & Co., TIAA-CREF, Nortel Networks, Pitney Bowes, Bank of America, Wells Fargo / Wachovia, and many others.

    A guest lecturer at Northwestern University’s Kellogg School of Management and the University of North Carolina’s (UNC) Kenan Flagler Business School, Mr. Bogan has spoken widely before business audiences in North America, Europe, Asia and Latin America. He is an advisor to various management magazines on best practice and management issues. He has served on the University of North Carolina’s Academic Leadership Institute’s National Advisory Board. Previously, he served on the Board of Directors of Ontogeny, Inc., a stem cell and functional genomics company now named Curis, Inc. that develops cancer therapies.

    Prior to founding Best Practices, LLC, Mr. Bogan was a principal and founding member of The TQM Group, Ltd., a Boston-based consultancy. Mr. Bogan also spent many years working at various media companies, including Times Mirror Corp., Knight-Ridder Inc., Howard Publications and Cowles Publishing Co. He has contributed articles to many newspapers and magazines, including The Harvard Business Review, Time, Pharmaceutical Executive, PharmaVoice, MedAd News, Planning Review, The Los Angeles Times, The Boston Globe, The Miami Herald, The Chicago Tribune and The Philadelphia Inquirer. Through his work, Mr. Bogan has toured manufacturing and service companies throughout the world.

  • Aamir Shaikh, MD, DPBM

    Founder, Health Care Consultant
    Assansa

    Dr. Aamir Shaikh obtained his graduate medical degree (MBBS) in 1992, his post-graduate Diploma in Pharmaceutical Business Management (DPBM) in 1995, and his post-graduate medical degree (MD Pharmacology) in 1997. He began his career as a “Pharmaceutical Physician” with Pfizer India Medical & Research Division in 1998, where he took on the responsibility of a Medical Advisor. Over the next decade, Aamir successfully delivered in positions of increasing responsibility and leadership, culminating in his role as Director, Medical Affairs & Research for Pfizer India.

    In 2007, Aamir moved on from Pfizer to start his own small Health Care Consultancy – Assansa. Based out of Mumbai, India, Assansa offers its services to the health care industry and its professionals. Assansa specializes in designing and delivering Professional Development Programs and Customized Learning Experiences for industry and academia in the following core health care and pharmaceutical industry domains: Pharmaceutical Medicine; Medical / Clinical Research, Education & Practice; and Leadership Development.

    Aamir is an accomplished health care professional, and enjoys consultancy, faculty, and speaking assignments in his areas of interest and expertise. Throughout his health care career, and now through Assansa, Aamir’s key endeavor is “Helping Health Care Professionals Grow.” He believes this can be achieved through an identified personal philosophy and mindset – one which embraces lifelong learning, and seeks alignment in the areas of knowledge, science, business and ethics.

  • Shailesh Chavan, MD

    Vice President, Clinical Research
    Medical Affairs and Drug Safety
    Biotest Pharmaceuticals

    Dr. Chavan brings more than 15 years of leadership and management experience within the bio-pharmaceutical industry. After playing leadership roles at ClinTec International, Tengion, Cephalon, and University of Florida, in 2008, he joined Biotest Pharmaceuticals where he leads clinical development, drug safety, medical affairs and regulatory affairs. Dr. Chavan’s expertise spans drug and device development and lifecycle management in multiple therapeutic areas including Immunology, Oncology, Transplantation, Neurology, Cardiology, and Regenerative Medicine. Apart from Clinical trial management he has been active in biotech business development, due diligence process, commercial strategies, strategic alliances and partnerships.

    Dr. Chavan received his M.B.B.S degree from Seth G.S. Medical College, India followed by residency in Internal Medicine at the Bombay Hospital Institute of Medical Sciences, India.

  • Emily Lemiska

    Associate Director of State Advocacy & Director of Communications
    U.S. Pain Foundation

    Emily Lemiska is associate director of state advocacy and director of communications for U.S. Pain Foundation, the leading patient advocacy organization for individuals living with chronic pain. The role is highly personal to her: in 2011, Emily began experiencing debilitating pain due to a rare, degenerative spine defect, known as Klippel-Feil Syndrome, and a spinal cord defect. Despite her health issues, Emily has presented in front of members of Congress, testified at multiple state hearings and spoken to national media on key issues affecting the chronic pain community.

    Emily previously worked in public affairs and communications at Massachusetts General Hospital, where she focused on quality and safety, community health care and disparities. Outside of her work with U.S. Pain, Emily is associate director of a small patient support organization, Klippel-Feil Syndrome Freedom, and blogs about her health under the name “Bravest Little Toaster.” She currently lives in Connecticut with her husband, Dan, and tuxedo cat, Henry.

  • Diane Cleverley, PhD

    Founder
    Concierge Conversations

     

    Diane Cleverley, PhD, has 20 years’ experience in medical communications, working with pharmaceutical companies to build comprehensive multi-media programs for patients and healthcare providers. She also serves as an adjunct professor for Southern New Hampshire University. Dr. Cleverley is the founder of Concierge Conversations, a web-based video on-demand program that teaches patients how to communicate with their physicians more effectively. In her healthcare advocacy role, she works one-on-one with patients who are undiagnosed, have received devastating diagnosis, or who have communication dysfunctions and their physicians to help them move forward with treatment.

  • Gwen Darien

    Executive Vice President for Patient Advocacy
    Patient Advocate Foundation

     

  • Peter Piliero, MD

    Associate Vice President
    Global Medical Information
    Global Medical Affairs
    Merck

    Dr. Peter Piliero currently leads the Global Medical Information (GMI) group within Global Medical Affairs (GMA). GMI is a collaborative group of scientifically-trained professionals who are therapeutically-aligned. The group’s core activities are (1) to support the development and approval of appropriate scientifically accurate and clinically relevant medical information that may be disseminated to Health Care Providers (HCPs) world-wide or used by GMA personnel for their interactions with HCPs; (2) to conduct medical review of US and global promotional materials; and (3) to provide scientific training and knowledge management for GHH.Dr. Piliero is recognized as a Medical Affairs expert having held various leadership positions at Boehringer Ingelheim Pharmaceuticals, Inc. for over 12 years. 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. Previously, he led groups responsible for Virology, Metabolism, Women’s Health, and Consumer Health Care.

    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.

  • Joseph Laudano, BS Pharm, Pharm D

    Vice President
    Medical Affairs Strategy
    Medmeme, LLC
    Madison, NJ

    Joseph B. Laudano, BS Pharm, Pharm D, is Vice President, Medical Affairs Strategy at Medmeme LLC. Dr. Laudano has over 30 years’ experience in the pharma industry. Before joining Medmeme, he was Vice President of Medical Affairs at Alliqua Biomedical. Before joining Alliqua Biomedical, Dr Laudano was Senior Director of Medical Affairs and head of Publication Planning at Forest Research Institute. Prior to this he spent 20 years at Roche Laboratories in Medical Affairs and Marketing in various roles including; Director of Medical Information, Product Director and Medical Liaison. Dr. Laudano has extensive research experience in several different therapeutic areas including infectious diseases, dermatology and oncology and has authored numerous publications and scientific posters.

    Whether in research projects or project assignments, Dr. Laudano has always had a passion for recognizing trends and signals in data and product information. As director of Medical Information at Roche, he was the first to develop a qualitative reporting system on product inquiries which provided product teams trends in medical inquiries and other information. His passion for “analytical inquiry” serves him well at Medmeme where he works with the leadership team on developing Medical Affairs strategies and creating of new processes and applications for Medical Affairs Professionals.

    When not at work, Dr. Laudano enjoys time with his wife, Kathleen and family. His hobbies include fishing, winemaking, cooking, gardening and wood working. He maintains a Master’s Captains Licence and volunteers hundreds of hours each year as a coxswain, vessel examiner and aids to navigation verifier with the United States Coast Guard Auxiliary.

  • Jaime A. Arvizu, MD, MPH

    Head of Medical Affairs LATAM
    Ultragenyx

    Jaime is a Senior Executive Pharmaceutical Physician with 26 years of comprehensive Medical Affairs experience leading Medical Affairs teams, developing medical structures, and implementing systems at country, regional and global levels. He is focused on laying the foundation for patient-centered Medical Affairs Operational Excellence. In his tenured career, he has been responsible for over 15 different therapy areas and has had the honor to serve companies such as GSK, Wyeth, Pfizer, Ivax, Baxter, Baxalta and most recently, Ultragenyx Pharmaceutical, were he has held positions such as VP of Medical Affairs. He also has served as CMO for RxER Communications.  He has over 10 years of experience leading the Medical Affairs functions for LATAM along with all global emerging markets. He is passionate about working with patients with rare diseases.

  • Peter Shaw, MD

    Sr Director, Medical Affairs – Orthopaedics
    Ferring Pharmaceuticals

  • Stanislav Glezer, MD, MBA

    Former VP Medical Affairs
    Novo Nordisk

    Stan Glezer, MD, MBA is an industry physician, passionate in optimizing value of pharmaceutical innovation for the patients, through partnering with the healthcare system.
    Until recently, he served as Vice President of US Medical Affairs at Novo Nordisk Inc. Prior to joining Novo Nordisk, Stan has worked at Sanofi where, most recently, he led the development, regulatory submission, and launch preparation of Toujeo.
    He brings with him extensive knowledge of medical affairs at an affiliate and Global level, as well as of the commercial areas of pharmaceutical business and has held leadership roles in post-marketing research, epidemiology, medical information, medical communications, HEOR, interfacing with regulatory agencies, market access, and overall lifecycle management. Stan has also worked in the commercial roles, leading sales & marketing, as wells as market access activities.
    Although his activities in the past few years were predominantly focused on diabetes, Stan has worked in multiple therapeutic areas, including oncology, immuno-inflammation, obesity, thrombosis, bleeding disorders, rheumatology and rare diseases. He has a strong track record of leading the teams in establishing collaborations with healthcare providers, key opinion leaders, payers, and professional associations.
    Stan received his medical training in Russia and has worked in Canada and in France for the past 20 years. He has an MBA from California Coast University and completed his graduate work in Clinical Research at McGill University.
  • Randall Kaye, MD

    Global Head of Medical Affairs
    SSI Strategy

    Dr. Randall Kaye serves as the Global Head of Medical Affairs at SSI Strategy. He focuses on providing a medical and scientific perspective to our transformative initiatives in Medical Affairs and Pharmacovigilance. Dr. Kaye also plays a key role in SSI’s bespoke advisory services and regulatory compliance offerings.

    Randall Kaye, MD serves as Chief Scientific Officer at SSI Strategy, a boutique consulting firm focused on Medical Affairs, Pharmacovigilance and Clinical Development.  In Dr. Kaye’s role at SSI Strategy, he focuses on providing a medical and scientific perspective to transformative initiatives in Medical Affairs and Pharmacovigilance. He plays a key role in SSI’s bespoke advisory services and regulatory compliance service offerings.

    Most recently, Dr. Kaye was Chief Medical Officer at Axsome Therapeutics, a biopharmaceutical company developing novel therapies for the treatment of pain and other neurological diseases.  While at Axsome, Dr. Kaye developed and executed all Clinical Research functional areas that resulted in the initialization of three clinical programs (IND Filing, FPI) in less than one year.   Prior to joining Axsome, Dr. Kaye was Chief Medical Officer at Avanir Pharmaceuticals (acquired by Otsuka), a CNS specialty company.  While at Avanir, Dr. Kaye provided leadership and vision to the clinical, regulatory and medical affairs areas, and supported the commercialization of new products from a medical, scientific, regulatory, technical and quality perspective. Prior to Avanir, Dr. Kaye served in a variety of medical affairs leadership positions at Scios Inc. (acquired by Johnson and Johnson) a cardiovascular specialty company, InterMune Inc. (acquired by Roche), a specialty company focusing on Idiopathic Pulmonary Fibrosis and Pfizer Inc.

    Dr. Kaye earned his Doctor of Medicine, Masters in Public Health and Bachelor of Science degrees at The George Washington University in Washington, D.C. Dr. Kaye trained in Pediatrics at the University of Massachusetts Medical School and was a Research Fellow in Allergy and Immunology at Harvard Medical School.

Kirk Shepard, MD

Senior Vice President, Head of Global Medical Affairs Oncology
Eisai
President 2016-2017, Medical Affairs Professional Society

Dr. Kirk Shepard is the 2016-2017 President of the Medical Affairs Professional Society 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.

Gail Cawkwell, MD, PhD

Chief Medical Officer and Vice President of Medical Affairs
Purdue Pharma
Stamford, CT

Dr. Gail Cawkwell currently serves as Chief Medical Officer and Vice President of Medical Affairs at Purdue Pharma in Stamford, CT. After earning her medical degree at McGill University in Montreal, Canada, Dr. Cawkwell received her doctorate from the Department of Environmental Health, Division of Biostatistics and Epidemiology at the University of Cincinnati in Ohio. She completed a residency in Pediatrics at Duke University Medical Center in Durham, NC, and a fellowship in Pediatric Rheumatology at Cincinnati’s Children’s Hospital Medical Center.

Dr. Cawkwell and her team provide medical and scientific expertise to healthcare professionals, payers, patients, and health systems. They also focus on ensuring that medical and regulatory decision makers understand the company’s medicines and therapeutic areas.

Dr. Cawkwell’s research has been published in such journals as Arthritis and Rheumatism, Current Medical Research and Opinion, Annals of the Rheumatic Diseases, and the Journal of Pain and Symptom Management.

Robert J. Matheis, PhD, MA

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.

Terry Griesing, PhD

Vice President, North America Medical Affairs
Pfizer

Her team provides medical and scientific expertise to healthcare professionals, payors, and large integrated health systems. She is focused on building leading edge capabilities in medical communications, data, evidence and medical insights generation, population health, quality and product access.

Prior to her current role she was VP, US Field Based Medical for Pfizer’s Primary Care Business Unit. She has been in the pharmaceutical industry for 20 years and has been involved in clinical drug development phases III and IV. Recent positions held at Pfizer include Executive Director/Global Medical Team Leader for Viagra and Revatio, Sr. Director/US Medical Team Leader for Lyrica and Clinical Director for Aricept. She is a trained neuropsyhchologist and has experience working in multiple therapeutic areas including, Alzheimer’s Disease, Mild Cognitive Impairment, Pain, Epilepsy, Depression and Anxiety, Urology and Cardiovascular .

After receiving her Bachelor of Arts degree at Hunter College in New York City, she obtained her masters degree and doctoral degree at the Graduate Center of the City University of New York in New York City. She completed her training as a neuropsychologist at New York University, Aging and Dementia Research Center. She remained on the faculty at New York University as an Assistant Professor for approximately 5 years prior to joining Pfizer Pharmaceuticals. Her main areas of clinical and research focus at New York University included the treatment and management of Alzheimer’s Disease and Mild Cognitive Impairment.

Charlotte Kremer, MD MBA

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.

John Orloff, MD

Executive Vice President
Head of Global Research & Development
Alexion Pharmaceuticals

Dr. Orloff, M.D., is a global R&D/business leader with 20 years of experience in the bio-pharmaceutical industry at leading organizations. His expertise in research, non-clinical and clinical development, medical affairs, health economics & outcomes research, and regulatory affairs has informed all his work.

As EVP, Head of Global Research & Development at Alexion, Dr. Orloff oversees the rebuilding of the organization and defining the path to value creation through focused development in the metabolic space. Prior to Alexion, Dr. Orloff served as EVP, Head of R&D, and Chief Scientific Officer at Baxalta. During his tenure he advanced its pipeline by employing an external innovation model; led ~1300 people spanning discovery research to LCM; and served as a Section 16 Officer, representing R&D at all Executive Committee meetings, Board interactions, and investor/external community engagements. During a span of 2 years, Dr. Orloff oversaw regulatory approval of 10 unique products and 2 devices in the US and Europe.

Before Baxalta was spun-off from its parent, Baxter International, in 2015, Dr. Orloff served as Executive VP, Global Head of R&D, BioSciences International at Baxter, and as a member of the Division’s Senior Management Team, reporting to the President. In this role he advanced the BioScience pipeline; led all R&D functions, enhanced the R&D operating model; and pursued additional innovative opportunities. He also represented Baxter BioSciences externally in fora interfacing with scientific/academic communities, payer organizations, HTAs, health authorities, health care policy makers, and scientific congresses.

Before joining Baxter in 2014, Dr. Orloff served as SVP, Global Head of Clinical Development at Merck Serono Pharmaceuticals (2014), leading design and execution of global clinical development programs and projects, and oversaw pipeline management and development.

Dr. Orloff joined Novartis Pharma in 2003 in a leadership role, quickly rising to positions of greater responsibility. As SVP, Head, US Medical & Regulatory Affairs at Novartis Pharmaceuticals, he provided executive leadership of U.S. Clinical Development, Medical Affairs, Evidence-based Medicine, and North American Regulatory Affairs. He oversaw the successful development of/received regulatory approval for a wide range of products, often for multiple indications.

From 2010 to 2013, Dr. Orloff served as SVP, Chief Medical Officer for Novartis Pharma’s Pharmaceutical Division, where he provided strategic and scientific leadership for all Global Development processes, continuous process improvement, clinical training & education, oversight of protocol and CDP reviews, and clinical policy setting. He led an overhaul of the quality organization and all R&D SOPs; established company policy for data sharing, aligned with Sandoz on a corporate position for biosimilars development, and drove implementation of innovative approaches to clinical development across key projects.

From 1997 to 2003, Dr. Orloff served in several leadership roles with Merck Research Labs, supporting clinical development of products for osteoporosis, bone-related disorders, and arthritis, leading a Fosamax clinical program and efforts for clinical development of new compounds (novel MOAs) for osteoporosis and other bone- and arthritis-related conditions.

Earlier, Dr. Orloff taught at Yale University School of Medicine as an Instructor, Assistant Professor, and Associate Professor of Medicine. He has been a member of industry Advisory Boards, and is a member of numerous professional societies and associations.

Dr. Orloff is Board Certified in Endocrinology & Metabolism and Internal Medicine, and is a Diplomate, National Board of Medical Examiners.

Dr. Orloff earned an M.D. from the University of Vermont’s College of Medicine, and an AB in Chemistry from Dartmouth College. He completed his Internal Medicine Internship, Residency, and Chief Residency at the University of Pittsburgh Medical Center, and, from 1987 to 1989, he held an Endocrinology & Metabolism Fellowship at Yale University School of Medicine.

Ann Ford, BSN, JD

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.

Ramin Farhood, PharmD, MBA

Vice President, Head of Global Medical Affairs
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.

Thérèse McCall, PhD, MBA

Global Medical Affairs Strategy and Communications Leader
Chicago, IL

Dr. Thérèse McCall is the former Vice President of Global Medical Communications and Professional Strategies AbbVie, Inc. in Chicago, 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.

Martin Rees, PhD (Medicine)

Executive Committee member, APPA – www.appa.net.au
Senior Medical Science Liaison, Gastroenterology
Shire Australia

Dr Martin Rees serves on the Executive Committee of APPA, the representative association for Medical Affairs professionals in Australia. APPA is closely aligned with key industry and academic stakeholders (ARCS Australia, UNSW and Medicines Australia) and provides a national forum for its diverse and geographically dispersed membership to come together and advance their interests through professional development, networking and advocacy.

Over the last 2 years, APPA has undergone a period of considerable growth and evolution: APPA has seen a tripling of its membership as it has renewed its focus on the needs of MSLs and Medical Managers/Medical Advisors and has expanded its geographical reach. A recent comprehensive survey of our members (the first of its kind in Australia, covering over a third of the national workforce in Medical Affairs) has provided valuable insights into current roles and practices and has identified areas of key need to drive future policy.

Dr Rees is Senior MSL at Shire Australia and his career in medical research and in Medical Affairs combines 17 years experience in therapeutic areas including cardiology, haematology, trauma/emergency medicine, intensive care, anaesthetics, neurology and gastroenterology. His peer-reviewed research output – most recently from a research program he led as a Lecturer at the UNSW Faculty of Medicine – has attracted over 1100 citations. His professional role within the pharmaceutical industry builds on his longstanding experience in science communication and passion for promoting science and innovation through traditional and social media channels, e.g. a successful crowdfunding campaign for his research program, which was featured in The Lancet.

Dr Rees also serves on the Executive Committee the Australian Science & Innovation Forum, an association of STEMM professionals in industry and academia that focusses on encouraging the development and teaching of entrepreneurial skills to emerging young researchers and business people.

Robin L. Winter-Sperry, MD

Head, Global Field Based Medical Excellence

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.

Ornah Levine-Dolberg, MD

Vice President & Global Head of Medical Affairs
Research & Development
Glenmark Pharmaceuticals

Dr. Ornah Levine-Dolberg graduated from the Ben Gurion University, Medical School in 1990. Following her residency in Psychiatry completed cum laude, she was the Director of the Day Hospital at the Sheeba Medical Center in Israel for 7 years. His first industry role was in 2003 as a Country Medical Director for Lundbeck. After 3 years in that role she moved to Copenhagen to take up various roles in Global Medical Affairs, including heading the department of Scientific Communications, responsibility for a competitive ISS program, and being the Global Medical Director for escitalopram, a highly successful treatment for Mood and Anxiety Disorders. One of her final roles in Lundbeck was the launch of escitalopram in China.

Dr Ornah Levine-Dolberg joined Teva Pharmaceuticals in mid-2013 to head the newly formed Medical Affairs, Growth Markets. From a team of 2 this department has grown to more than 100 employees. Dr Levine-Dolberg established all functions in this team including Medical Operations and Excellence, Therapeutic Area Leads and their operating model, Country Medical Directors and their departmental structures and deliverables. On a regional level, she built various infrastructure capabilities such as Medical Information, promotional material review, governance bodies, operating models, KPIs, financial structures, and a strategic project called Signature Medical Moves. In addition, Ornah was part of the leadership team of Growth Markets and a prominent member of the Global Medical Affairs Leadership team.

In September 2016 Ornah joined Glenmark Pharmaceuticals in their London headquarters to establish and launch Global Medical Affairs and to help the company in its transition from a medium sized Indian company to a global presence with expertise in all facets of drug development and commercialization.

 


Tracy Mayne, PhD

Head of Medical Affairs Strategic Research
Purdue Pharma L.P.

Tracy J. Mayne, PhD received his doctorate in clinical health psychology from Rutgers University and completed his clinical training in the Psychiatry Residency Program at the University of California – San Francisco. He went on to a research fellowship at the Institut National de la Santé et de le Recherché Medical where he designed and executed the first national study of HIV among injection drug users in France. Upon return to the US, Dr. Mayne served as the Director of HIV Epidemiology and Surveillance at the New York City Department of Health. Dr. Mayne joined the pharmaceutical industry at Pfizer, where he launched Bextra, served as economic lead for the Celebrex/Bextra portfolio, then become the economic lead for Lipitor. He next joined Amgen and became the Global Renal Anemia Lead for Epogen/Aranesp, also supporting the launches of Kepivance and Vectibix. Dr. Mayne spent the following decade in pharmaceutical consulting, ending as the vice president of Covance Market Access. He returned to the industry as Head of Medical Affairs Strategic Research at Purdue Pharma. Dr. Mayne has over 40 peer-reviewed publications and has authored books on clinical psychology, health and emotion. Dr. Mayne has received several awards for his work, including:

  • Hyacinth Foundation President’s award for outstanding service to people with AIDS
  • Society for Behavioral Medicine award for outstanding research
  • New York City Department of Health award for community and collaborative research
  • Amgen “Fulcrum” award for successfully defending quality of life claims in the EPOGEN label
  • DaVita “It takes a Village” award for top sales
  • Association for the Advancement of the Study of Liver Disease president’s Award for innovative research

Daniel R. Stevens, PharmD, BCPS

Director, Medical Affairs
Veloxis Pharmaceuticals, Inc.

Dr. Daniel Stevens currently serves as the Director of Medical Affairs for Veloxis Pharmaceuticals. Daniel joined the pharmaceutical industry three years ago as the national MSL for Veloxis, where he was responsible for building the field medical affairs team to support the launch of a new product in the US. Prior to entering the pharmaceutical industry Daniel received extensive, specialized residency training in the area of solid organ transplant immunology with a focus on clinical research at the Hospital of the University of Pennsylvania. Daniel is formally educated as a pharmacist and completed his undergraduate and graduate studies at Northeastern University in Boston, Massachusetts.

Steven Tomlinson, PhD, MBA

Senior Director, Immunology MSLs
Janssen Scientific Affairs

Steven Tomlinson currently serves as the Senior Director of Immunology Medical Science Liaisons (MSL) for Janssen Scientific Affairs.  Steven joined the pharmaceutical industry 13 years ago and has supported therapeutic areas of bone health, female sexual function, and rheumatology.  In his current position, he leads 3 national MSL teams providing scientific/clinical support in the areas of rheumatology, dermatology, and gastroenterology.  An area of special interest is to help facilitate the development of Medical Affairs personnel to develop as first-time leaders.  Prior to entering the pharmaceutical industry, Steven was a Visiting Assistant Professor in the Department of Chemistry and Biochemistry at Texas Tech University.  Steven is formally educated as a protein biochemist and completed is PhD in biochemistry at Texas Tech University and also holds an MBA with a concentration in Management.

Tricia L. Gooljarsingh, PhD, CMPP

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, 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.

Stan Bernard, MD, MBA

President
Bernard Associates, LLC
Morristown, NJ

Stan Bernard, MD, MBA is President of Bernard Associates, the leading global competition consulting firm for the pharmaceutical and health care industries. The firm offers Competitive Simulations, the new, improved version of business war games; Competitive Product Launch and Counter-Launch Services; Competitive Strategy and Planning; Competitive Analysis; Competitive Training Workshops; and Customized Competitive Workshop and Seminars. The firm works across products/technologies, therapeutic areas, lifecycle stages, markets, stakeholders, and competitive landscapes. Bernard Associates has worked with nine of the top ten global pharmaceutical companies and with over 125 other leading pharmaceutical and health care companies across five continents.

Dr. Bernard is internationally recognized as a health care and pharmaceutical industry consultant, speaker, and author. He has been featured on national television and in leading publications, including the Wall Street Journal, Business 2.0, and Business Week. Dr. Bernard has published over 75 book chapters, syndicated reports, and articles. He currently writes two different columns on competition for the journals Pharmaceutical Executive and Pharmaceutical Executive Global Digest.

Previously, Dr. Bernard held several executive positions at Bristol-Myers Squibb Pharmaceutical Company, including serving as U.S. Product Manager for the launch of the cholesterol-lowering drug Pravachol and as U.S. Medical Director – Anti-Infectives. He also served as a Consulting Principal in the Pharmaceutical Industry Practice at A.T. Kearney. Dr. Bernard was a Senior Fellow at The Wharton School of Business where he initiated and lectured in the “Pharmaceutical Management” course for 14 years.

Dr. Bernard has served on the boards of several companies, organizations, and journals, including Pharmaceutical Executive magazine, the Metro Chapter of the Healthcare Business Women’s (HBA), and the Dorothy B. Hersh Foundation which provides grants to help New Jersey children with handicaps and special needs. Dr. Bernard has a Medical Degree from Baylor College of Medicine and an MBA in marketing and health care management from the Wharton School of Business.

 


Norm Enriquez, PharmD

Senior Vice President
TMAC Advisors

Dr. Norm Enriquez is Senior Vice President for TMAC-Advisors and has over 30 years of experience as a pharmaceutical industry executive, clinician, researcher, and academician. Dr. Enriquez most recently has had executive leadership roles and built Medical Affairs and field-based medical teams in multiple therapeutic areas at Amgen & Sanofi-Aventis. Dr. Enriquez has been highly awarded for his medical team’s successes.

Carl Thoresen, PhD

President
Cornerstone

Dr. Carl J. Thoresen is internationally published author and President of Cornerstone Management Resource Systems (www.leadwithcornerstone.com), a leadership development consulting firm located in Carnegie, PA. Carl specializes in the development and implementation of processes for helping highly talented employees transition smoothly into leadership roles. Prior to joining Cornerstone in 2003, Carl was Assistant Professor of Industrial-Organizational Psychology at Tulane University in New Orleans, LA, where he conducted studies in employee assessment, personality in organizations, and causes and consequences of work-related stress. Carl holds a B.A. in Philosophy from Northwestern University, an M.S. in Organizational Behavior from Cornell University, and a Ph.D. in Human Resource Management from the University of Iowa.

Stephen Douthwaite

AlphaBioCom

Stephen has many years in the industry, leading operations in the UK and US and directing global communications. He attended the not-very-prestigious London South Bank University and was at that time an entirely average student focused on many things, nothing very academic. He did however graduate, to the chagrin of his dissertation supervisor, but to the delight and relief of his parents. He joined the pharmaceutical industry where his penchant for challenging rules was poorly received. He learnt quickly to obey policies in order to preserve his career and started to climb the corporate ladder, until one day 18 years later when he looked around and realized he was entirely ineffective in his life’s work and decided in the words of Michael Jackson to “Make a Change”.

In 2005 Stephen left pharma and started AlphaBioCom, which today is one of the country’s leading independent medical communication agencies, where his passion is inspiring and leading change. He asks his team to consider new approaches and become agents for change.  He works to improve the communication of science, pioneering the application of technology in engaging audiences in the process of scientific communication development, discourse and delivery.  He believes we all need to be lifted out of our comfort zone and challenged with new ideas and approaches in order to transcend the boundaries of our engrained thinking and working practices

 

Michael Fiedler, PhD

Scientific Director
Ashfield Healthcare

From a scientific perspective, Michael has experience with a broad range of disease states and therapeutic areas including neurology (multiple sclerosis, autism, Alzheimer’s disease, epilepsy), psychiatry (schizophrenia, addiction), cardiovascular disease (atherosclerosis, type 2 diabetes, stroke, heart failure), blood disorders (hemophilia A and B) and rare diseases (infantile spasms, acromegaly, paroxysmal nocturnal hemoglobinuria [PNH], atypical hemolytic uremic syndrome [aHUS]). Within these areas, Michael has developed a wide array of educational, instructional, and strategic materials that serve medical, commercial and/or competitive needs and he is known for his innovative and creative abilities.

Michael has supported the development of a number of global scientific platforms (GSP) that span multiple therapeutic areas, formats, and development strategies. Within the multiple sclerosis space, he was the GSP lead for TYSABRI® and Opicinumab (investigational). Michael provided GSP support for TECFIDERA® (multiple sclerosis), ELOCATATE® (hemophilia), ALPROLIX® (hemophilia), Oral Octreotide (acromegaly; investigational), and Aducanumab (Alzheimer’s disease; investigational). From a deliverable perspective, he has developed GSPs into formal Word and Adobe Acrobat documents as well as into interactive PowerPoints. He has experience with a variety of processes including stakeholder engagement, consensus meetings, collaborative workshops, external validation, and periodic updates.

As a formally trained moderator, Michael has participated in the design, execution, and reporting of >30 advisory boards, roundtable discussions, and workshops. He is a skilled facilitator with extensive experience navigating interactions between healthcare providers and pharmaceutical professionals towards specified objectives. Michael also has significant experience with innovative engagement strategies for internal and external meetings (eg, competitive war games, case study scenarios, consensus projects). He excels in quickly processing and communicating complex scientific and medical information and has an energetic and infectious presence that drive his dynamic and productive capacities.

Michael received his BS in Biochemistry/Cell Biology from UC San Diego and his PhD in Cell Biology from Yale University. He began is medical communications career while still in graduate school in entrepreneurial, freelance, and contract research capacities. He has an exceptional presence as evidenced by his championing of the Ashfield Healthcare Moderator Academy, his role as an Ashfield Marketing Ambassador, and his numerous career speaking engagements at Yale University, Harvard University, and UC San Diego.

Robyn S. Shapiro, JD

Founder and Attorney
Health Sciences Law Group LLC
Fox Point, WI

Robyn S. Shapiro, Founder and Attorney at Health Sciences Law Group LLC, has significant experience in representing clients with respect to research compliance issues, healthcare compliance issues, bioethics issues, health information privacy issues, informed consent, medical staff issues, regulatory and licensing matters, and corporate and commercial issues faced by pharmaceutical and medical device manufacturers and hospitals and academic medical centers engaged in research. Attorney Shapiro’s past position as Ursula von Der Ruhr Professor of Bioethics at the Medical College of Wisconsin, and her 26-year leadership as Director of the Center for the Study of Bioethics at the Medical College of Wisconsin complement her wide-ranging experience in health law. Ms. Shapiro is listed in the Best Lawyers in America, Who’s Who in American Law, Who’s Who in America, Who’s Who of American Women, Who’s Who of Emerging Leaders of America, Who’s Who in the Midwest, International Who’s Who, Who’s Who in the World, Who’s Who in American Education, and Wisconsin Super Lawyers; she was included in Nightingale’s 2006 list of “Outstanding Hospital Lawyers” in the nation; in 2006 she was one of 12 honorees selected as a “Leader in the Law” by the Wisconsin Law Journal; in 2011 she was named a “Woman of Influence” by the Milwaukee Business Journal; in 2011 she was named Milwaukee’s Health Care Law “Lawyer of the Year” by Best Lawyers; and in 2013, 2014 and 2015 she was ranked by Chambers USA as “Leaders in their Field/Life Sciences: Regulatory/Compliance (Nationwide)”.

Attorney Shapiro is a frequent presenter at national seminars and conferences on research compliance and health law issues, and she is the author of more than 50 publications on these and other topics.

David A. Jencen, PhD

Principal
Jencen Field Medical Consulting LLC

Dr. Jencen is Principal of Jencen Field Medical Consulting LLC, and a Senior Consultant with Cornerstone. As a Medical Affairs consultant with more than 20 years industry experience, Dr. Jencen partners with clients on projects such as: assuring global excellence in medical science liaison (MSL) performance; stakeholder engagement planning, developing global SOPs on medical insight process; recruitment and facilitation of Medical Advisory boards, and the development of business acumen in medical affairs personnel. He has delivered Medical Affairs training programs in the US, Singapore, Taiwan, and China. He also offers fee-paid coaching and mentoring to Aspiring MSLs, in addition to mid-career Medical Affairs professionals considering a change. He blogs (MSLife) and also hosts a LinkedIn discussion group “Medical Science Liaison (MSL) of the Future”.

Dr. Jencen’s industry career included a variety of Medical Affairs / MSL assignments with Procter & Gamble Pharmaceuticals, Boehringer Ingelheim, and Novo Nordisk. He has directed both therapeutic MSL teams and a dedicated managed markets MSL team during both pre- and post-launch product lifecycles. While at Boehringer Ingelheim he was chief architect of the original MSL training and development program.

Anna Walz

CEO
Medisys Health Communications, LLC

Anna Walz founded Medisys Health Communications in 1999 to provide strategic healthcare communications through collaboration with industry partners, physicians, teaching institutions, and medical associations.

As an industry veteran focused on partnering with Medical Affairs, Anna launched MedEvoke, a division of Medisys Health dedicated to the company’s proprietary OPEN® Scientific Alignment Platform. OPEN was created specifically to achieve global alignment for Medical Affairs leadership teams in biopharma that are challenged to reconcile competing strategies and objectives across organizational functions and affiliates.

A strong believer in continuing education, Anna is a graduate of the TUCK-WBENC Executive Education program and the Entrepreneurial Master’s Program (EMP), a joint collaboration between the Entrepreneurs’ Organization and MIT. Anna is actively involved in her community, serving as Chairman of the Board of Trustees for Hunterdon Regional Community Health, Trustee for the Hunterdon Healthcare System, and member the Hunterdon Medical Center Strategic Planning Committee. Outside of her professional achievements, Anna loves physical fitness. She is black belt in Shito Ru karate, an avid distance runner, and enjoys weightlifting at her local crossfit gym.

Mary Holloway

President
DMH BioPharm Advisors LLC

Mary Holloway is the President of DMH BioPharm Advisors, a boutique biopharmaceutical, medical device and life science consulting and training firm that was founded in 2008. Mary draws from her extensive biopharmaceutical experience and industry knowledge to deliver real-world consulting solutions and training strategies that maximize the value of commercial and field medical operations and improve field force effectiveness.

DMH is a recognized leader in the creation and delivery of real-world training for marketing, sales, account teams and field-based medical colleagues. DMH has authored over 7 industry published articles and is an invited main podium speaker at industry events in the biopharmaceutical, medical affairs, biopharmaceutical training and compliance space.

Thomas Gesell, PharmD

Medical Affairs Leader
Envision Pharma Group

Tom is the Medical Information and Medical Affairs Domain Lead for Envision Pharma Group responsible for creating and improving systems and services across medical affairs. He joined Envision Pharma from Novartis where he was Head of Global Medical Information & Communications responsible for both medical publications and medical information.

During more than 20 years in the pharmaceutical industry he led both U.S. and global departments within medical affairs at several companies, including Abbott Laboratories, Warner Lambert / Parke‑Davis, Pfizer, and Novartis. Prior to working in the pharmaceutical industry he was Assistant Professor of Pharmacy Practice and Associate Director of Samford University School of Pharmacy Regional Drug Information Center.

Tom is active in several international organizations. He served on the International Society of Medical Publication Professionals (ISMPP) Board of Directors and is a Steering Committee member for the Medical Publishing Insights and Perspectives (MPIP) Initiative. He is a member of the DIA Medical Affairs and Scientific Communication organization and was a member of the USP Expert Committee for Information Development and Dissemination.  He often serves as program chairperson, member of the program committee, session chairperson, and speaker for these organizations.

Tom received both his B.S. and Doctor of Pharmacy degrees from the University of Iowa.  He then completed a specialty residency in Drug Information Practice, at the North Carolina Memorial Hospital and University of North Carolina School of Pharmacy, Chapel Hill, North Carolina.

Chris Bogan

Chief Executive Officer
Best Practices, LLC

Chris Bogan is the Chief Executive Officer and Founder of Best Practices, LLC, a leader in the field of best practice performance improvement. Based in Chapel Hill, North Carolina, Best Practices, LLC specializes in providing pharmaceutical, biotechnology and medical device corporations throughout the world with business intelligence, research, benchmarking studies, and consulting services. The company’s products and services provide corporations with “Access And Intelligence For Achieving World-Class Excellence.” Mr. Bogan received his MBA with honors from the Harvard Business School and his bachelor’s degree magna cum laude from Amherst College. He was a Nieman Fellow at Harvard University.

Mr. Bogan’s work has focused on bio-pharma business model evolution, blockbuster product launches, marketing excellence, sales force effectiveness, clinical operations and best practice improvement strategies. He has written about numerous aspects of performance excellence and continuous improvement. In recent years, he has concentrated on ways that companies can use best practice insights to create economic value, accelerate revenue and profit growth, and drive rapid performance improvement. He is coauthor of the widely acclaimed books, Benchmarking For Best Practices: Winning Through Innovative Adaptation, published by McGraw-Hill, and The Baldrige: What It Is, How It’s Won, and How To Use It To Improve Quality In Your Company.

Mr. Bogan has consulted on performance improvement and best practice competitiveness issues for a wide range of pharmaceutical, biotechnology and medical device companies, including Abbott / AbbVie, Baxter Healthcare, Merck, Pfizer, GlaxoSmithKline, Novartis, J&J, Genentech, Eli Lilly, Roche, AstraZeneca, Amgen, Celgene, Sanofi, Bayer, Boehringer-Ingelheim, Novo Nordisk, Astellas, Takeda, Daiichi Sankyo, LifeScan, and many others.

Mr. Bogan led the consulting teams that assisted both Federal Express and GTE Directories (now Verizon) in winning the prestigious Malcolm Baldrige National Quality Award. He has also advised many leading corporations outside the healthcare sector, including industry leaders such as Microsoft, American Express, AT&T, General Motors, BellSouth, Chevron, Exxon, Xerox, Verizon, Marriott, Merrill Lynch, Siemens, KPMG, the New York Times Company, J.P. Morgan Chase & Co., TIAA-CREF, Nortel Networks, Pitney Bowes, Bank of America, Wells Fargo / Wachovia, and many others.

A guest lecturer at Northwestern University’s Kellogg School of Management and the University of North Carolina’s (UNC) Kenan Flagler Business School, Mr. Bogan has spoken widely before business audiences in North America, Europe, Asia and Latin America. He is an advisor to various management magazines on best practice and management issues. He has served on the University of North Carolina’s Academic Leadership Institute’s National Advisory Board. Previously, he served on the Board of Directors of Ontogeny, Inc., a stem cell and functional genomics company now named Curis, Inc. that develops cancer therapies.

Prior to founding Best Practices, LLC, Mr. Bogan was a principal and founding member of The TQM Group, Ltd., a Boston-based consultancy. Mr. Bogan also spent many years working at various media companies, including Times Mirror Corp., Knight-Ridder Inc., Howard Publications and Cowles Publishing Co. He has contributed articles to many newspapers and magazines, including The Harvard Business Review, Time, Pharmaceutical Executive, PharmaVoice, MedAd News, Planning Review, The Los Angeles Times, The Boston Globe, The Miami Herald, The Chicago Tribune and The Philadelphia Inquirer. Through his work, Mr. Bogan has toured manufacturing and service companies throughout the world.

Aamir Shaikh, MD, DPBM

Founder, Health Care Consultant
Assansa

Dr. Aamir Shaikh obtained his graduate medical degree (MBBS) in 1992, his post-graduate Diploma in Pharmaceutical Business Management (DPBM) in 1995, and his post-graduate medical degree (MD Pharmacology) in 1997. He began his career as a “Pharmaceutical Physician” with Pfizer India Medical & Research Division in 1998, where he took on the responsibility of a Medical Advisor. Over the next decade, Aamir successfully delivered in positions of increasing responsibility and leadership, culminating in his role as Director, Medical Affairs & Research for Pfizer India.

In 2007, Aamir moved on from Pfizer to start his own small Health Care Consultancy – Assansa. Based out of Mumbai, India, Assansa offers its services to the health care industry and its professionals. Assansa specializes in designing and delivering Professional Development Programs and Customized Learning Experiences for industry and academia in the following core health care and pharmaceutical industry domains: Pharmaceutical Medicine; Medical / Clinical Research, Education & Practice; and Leadership Development.

Aamir is an accomplished health care professional, and enjoys consultancy, faculty, and speaking assignments in his areas of interest and expertise. Throughout his health care career, and now through Assansa, Aamir’s key endeavor is “Helping Health Care Professionals Grow.” He believes this can be achieved through an identified personal philosophy and mindset – one which embraces lifelong learning, and seeks alignment in the areas of knowledge, science, business and ethics.

Shailesh Chavan, MD

Vice President, Clinical Research
Medical Affairs and Drug Safety
Biotest Pharmaceuticals

Dr. Chavan brings more than 15 years of leadership and management experience within the bio-pharmaceutical industry. After playing leadership roles at ClinTec International, Tengion, Cephalon, and University of Florida, in 2008, he joined Biotest Pharmaceuticals where he leads clinical development, drug safety, medical affairs and regulatory affairs. Dr. Chavan’s expertise spans drug and device development and lifecycle management in multiple therapeutic areas including Immunology, Oncology, Transplantation, Neurology, Cardiology, and Regenerative Medicine. Apart from Clinical trial management he has been active in biotech business development, due diligence process, commercial strategies, strategic alliances and partnerships.

Dr. Chavan received his M.B.B.S degree from Seth G.S. Medical College, India followed by residency in Internal Medicine at the Bombay Hospital Institute of Medical Sciences, India.

Emily Lemiska

Associate Director of State Advocacy & Director of Communications
U.S. Pain Foundation

Emily Lemiska is associate director of state advocacy and director of communications for U.S. Pain Foundation, the leading patient advocacy organization for individuals living with chronic pain. The role is highly personal to her: in 2011, Emily began experiencing debilitating pain due to a rare, degenerative spine defect, known as Klippel-Feil Syndrome, and a spinal cord defect. Despite her health issues, Emily has presented in front of members of Congress, testified at multiple state hearings and spoken to national media on key issues affecting the chronic pain community.

Emily previously worked in public affairs and communications at Massachusetts General Hospital, where she focused on quality and safety, community health care and disparities. Outside of her work with U.S. Pain, Emily is associate director of a small patient support organization, Klippel-Feil Syndrome Freedom, and blogs about her health under the name “Bravest Little Toaster.” She currently lives in Connecticut with her husband, Dan, and tuxedo cat, Henry.

Diane Cleverley, PhD

Founder
Concierge Conversations

 

Diane Cleverley, PhD, has 20 years’ experience in medical communications, working with pharmaceutical companies to build comprehensive multi-media programs for patients and healthcare providers. She also serves as an adjunct professor for Southern New Hampshire University. Dr. Cleverley is the founder of Concierge Conversations, a web-based video on-demand program that teaches patients how to communicate with their physicians more effectively. In her healthcare advocacy role, she works one-on-one with patients who are undiagnosed, have received devastating diagnosis, or who have communication dysfunctions and their physicians to help them move forward with treatment.

Gwen Darien

Executive Vice President for Patient Advocacy
Patient Advocate Foundation

 

Peter Piliero, MD

Associate Vice President
Global Medical Information
Global Medical Affairs
Merck

Dr. Peter Piliero currently leads the Global Medical Information (GMI) group within Global Medical Affairs (GMA). GMI is a collaborative group of scientifically-trained professionals who are therapeutically-aligned. The group’s core activities are (1) to support the development and approval of appropriate scientifically accurate and clinically relevant medical information that may be disseminated to Health Care Providers (HCPs) world-wide or used by GMA personnel for their interactions with HCPs; (2) to conduct medical review of US and global promotional materials; and (3) to provide scientific training and knowledge management for GHH.Dr. Piliero is recognized as a Medical Affairs expert having held various leadership positions at Boehringer Ingelheim Pharmaceuticals, Inc. for over 12 years. 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. Previously, he led groups responsible for Virology, Metabolism, Women’s Health, and Consumer Health Care.

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.

Joseph Laudano, BS Pharm, Pharm D

Vice President
Medical Affairs Strategy
Medmeme, LLC
Madison, NJ

Joseph B. Laudano, BS Pharm, Pharm D, is Vice President, Medical Affairs Strategy at Medmeme LLC. Dr. Laudano has over 30 years’ experience in the pharma industry. Before joining Medmeme, he was Vice President of Medical Affairs at Alliqua Biomedical. Before joining Alliqua Biomedical, Dr Laudano was Senior Director of Medical Affairs and head of Publication Planning at Forest Research Institute. Prior to this he spent 20 years at Roche Laboratories in Medical Affairs and Marketing in various roles including; Director of Medical Information, Product Director and Medical Liaison. Dr. Laudano has extensive research experience in several different therapeutic areas including infectious diseases, dermatology and oncology and has authored numerous publications and scientific posters.

Whether in research projects or project assignments, Dr. Laudano has always had a passion for recognizing trends and signals in data and product information. As director of Medical Information at Roche, he was the first to develop a qualitative reporting system on product inquiries which provided product teams trends in medical inquiries and other information. His passion for “analytical inquiry” serves him well at Medmeme where he works with the leadership team on developing Medical Affairs strategies and creating of new processes and applications for Medical Affairs Professionals.

When not at work, Dr. Laudano enjoys time with his wife, Kathleen and family. His hobbies include fishing, winemaking, cooking, gardening and wood working. He maintains a Master’s Captains Licence and volunteers hundreds of hours each year as a coxswain, vessel examiner and aids to navigation verifier with the United States Coast Guard Auxiliary.

Jaime A. Arvizu, MD, MPH

Head of Medical Affairs LATAM
Ultragenyx

Jaime is a Senior Executive Pharmaceutical Physician with 26 years of comprehensive Medical Affairs experience leading Medical Affairs teams, developing medical structures, and implementing systems at country, regional and global levels. He is focused on laying the foundation for patient-centered Medical Affairs Operational Excellence. In his tenured career, he has been responsible for over 15 different therapy areas and has had the honor to serve companies such as GSK, Wyeth, Pfizer, Ivax, Baxter, Baxalta and most recently, Ultragenyx Pharmaceutical, were he has held positions such as VP of Medical Affairs. He also has served as CMO for RxER Communications.  He has over 10 years of experience leading the Medical Affairs functions for LATAM along with all global emerging markets. He is passionate about working with patients with rare diseases.

Peter Shaw, MD

Sr Director, Medical Affairs – Orthopaedics
Ferring Pharmaceuticals

Stanislav Glezer, MD, MBA

Former VP Medical Affairs
Novo Nordisk

Stan Glezer, MD, MBA is an industry physician, passionate in optimizing value of pharmaceutical innovation for the patients, through partnering with the healthcare system.
Until recently, he served as Vice President of US Medical Affairs at Novo Nordisk Inc. Prior to joining Novo Nordisk, Stan has worked at Sanofi where, most recently, he led the development, regulatory submission, and launch preparation of Toujeo.
He brings with him extensive knowledge of medical affairs at an affiliate and Global level, as well as of the commercial areas of pharmaceutical business and has held leadership roles in post-marketing research, epidemiology, medical information, medical communications, HEOR, interfacing with regulatory agencies, market access, and overall lifecycle management. Stan has also worked in the commercial roles, leading sales & marketing, as wells as market access activities.
Although his activities in the past few years were predominantly focused on diabetes, Stan has worked in multiple therapeutic areas, including oncology, immuno-inflammation, obesity, thrombosis, bleeding disorders, rheumatology and rare diseases. He has a strong track record of leading the teams in establishing collaborations with healthcare providers, key opinion leaders, payers, and professional associations.
Stan received his medical training in Russia and has worked in Canada and in France for the past 20 years. He has an MBA from California Coast University and completed his graduate work in Clinical Research at McGill University.

Randall Kaye, MD

Global Head of Medical Affairs
SSI Strategy

Dr. Randall Kaye serves as the Global Head of Medical Affairs at SSI Strategy. He focuses on providing a medical and scientific perspective to our transformative initiatives in Medical Affairs and Pharmacovigilance. Dr. Kaye also plays a key role in SSI’s bespoke advisory services and regulatory compliance offerings.

Randall Kaye, MD serves as Chief Scientific Officer at SSI Strategy, a boutique consulting firm focused on Medical Affairs, Pharmacovigilance and Clinical Development.  In Dr. Kaye’s role at SSI Strategy, he focuses on providing a medical and scientific perspective to transformative initiatives in Medical Affairs and Pharmacovigilance. He plays a key role in SSI’s bespoke advisory services and regulatory compliance service offerings.

Most recently, Dr. Kaye was Chief Medical Officer at Axsome Therapeutics, a biopharmaceutical company developing novel therapies for the treatment of pain and other neurological diseases.  While at Axsome, Dr. Kaye developed and executed all Clinical Research functional areas that resulted in the initialization of three clinical programs (IND Filing, FPI) in less than one year.   Prior to joining Axsome, Dr. Kaye was Chief Medical Officer at Avanir Pharmaceuticals (acquired by Otsuka), a CNS specialty company.  While at Avanir, Dr. Kaye provided leadership and vision to the clinical, regulatory and medical affairs areas, and supported the commercialization of new products from a medical, scientific, regulatory, technical and quality perspective. Prior to Avanir, Dr. Kaye served in a variety of medical affairs leadership positions at Scios Inc. (acquired by Johnson and Johnson) a cardiovascular specialty company, InterMune Inc. (acquired by Roche), a specialty company focusing on Idiopathic Pulmonary Fibrosis and Pfizer Inc.

Dr. Kaye earned his Doctor of Medicine, Masters in Public Health and Bachelor of Science degrees at The George Washington University in Washington, D.C. Dr. Kaye trained in Pediatrics at the University of Massachusetts Medical School and was a Research Fellow in Allergy and Immunology at Harvard Medical School.

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