Senior Med Affairs Professional/ Formerly GSK, SVP Global Medical Affairs
Danie is a senior pharmaceutical executive with 25 years’ experience mainly in medical affairs. He has a passion for modernising medical affairs and track record in leadership, people development, capability building and coaching. Danie is a qualified MD with a Masters in Clinical Pharmacology who combines medical and life science qualifications with an MBA. Danie has extensive experience building international teams, driving change and working in regulated markets for GlaxoSmithKline (GSK) across Europe, the Americas, Middle East, Africa, Australasia and Japan.He previously worked for Eli Lilly & Company for 17 years in different medical roles as well as marketing and sales. During his different roles, he was based in South Africa, United Kingdom and Australia. Before joining the Pharmaceutical Industry, Danie had his own primary care practice. Danie started his own mentoring, coaching and consulting business, TheNextVersion Ltd, in Jul 2018.
Former Medical Director and Head of Medical Affairs (Russia) / Boehringer-Ingelheim
Alexandra Safronova, MD is currently Medical Director and Head of Medical Affairs at Boehringer-Ingelheim, Russia.
Dr. Safronova earned her medical degree from Moscow Medical Academy cum laude. She completed her residency in internal medicine at Moscow Medical Academy, and fellowships in intensive care at Pirogov Medical University and endocrinology at the Russian Medical Postgraduate Academy.
Before her pharmaceutical career, Dr. Safronova served as a staff physician in the Cardiology and Intensive Care Department at Medical Center of the Russian Academy of Science.
Dr. Safronova started her career in the pharmaceutical industry in 1999 as Clinical Research Scientist at GlaxoSmithKline, then she worked as Manager of Clinical Operations at Quintiles (now IQVIA).
In 2010 she joined Teva as Director of Clinical Research. Her primary task there was to set up Clinical Research Department from the scratch to support registration of new products and supervise global studies. Within two years Teva became #1 in clinical research in Russia. The company received 7 new market authorizations supported by the results of clinical program developed and executed by the department headed by Dr. Safronova. In 2013 Dr Safonova focused on building Medical Affairs function as Medical Director of Russia and CIS, Teva Pharmaceutical.
Dr. Safronova’s experience in multiple therapeutic areas includes Phases I-IV and diverse disciplines of medical affairs and product commercialization, such as leading office based and field-based medical teams (MSLs), PV/safety, Regulatory Affairs, Medical information, Patient Advocacy.
Head of Medical Affairs Turkey & Israel / Sanofi Pasteur
Dr. Baris Ugur is currently Head of Medical Affairs Turkey & Israel at Sanofi Pasteur. He has worked in various therapeutic areas and companies including national and international medical affairs positions (Pfizer / Emerging Markets Europe). He has studied medicine and involved in Public Health doctorate program at Istanbul University. He has an ongoing PhD in Clinical Psychology. He also holds a diploma in business administration.
Malcolm is Managing Director, of PharmaMedic Consultancy Ltd a London based International biosciences consultancy company, and Immediate Past President of the Section of Pharmaceutical Medicine and Research of The Royal Society of Medicine, London, UK.
With over 20 years experience as a Consultant Pharmaceutical Physician to Industry and Government, Malcolm advises bioscience and pharmaceutical companies on Product Development, Regulatory Strategy and Medical Affairs, focusing on Start-Ups and SMEs. He acts as a Clinical Specialist and Chair to the European Commission’s Biomedical Research Programme (Horizon 2020), lectures in both Europe and the United States on medicinal development, and teaches on the Pharmaceutical Medicine and Regulatory MSc Course of Copenhagen University.
Following a first degree in Physiology at King’s College London, Malcolm qualified in medicine from St Bartholomew’s Hospital, in 1993. After postgraduate training in General and Intensive Care Medicine he joined the UK Government as a Medical Assessor in new medicines in 1997. After senior industry roles at Pfizer and AstraZeneca he re-joined Government as Lead Medical Assessor to the UK Dept of Health’s Clinical Trials Unit on it’s formation in 2005, and worked with the European Medicines Agency (EMA) on the development of a trans-European clinical development process in the pharma and biotech sectors. Leaving full time employment with the Government in February 2007, Malcolm was appointed as an Independent Consultant to the Dept of Health.
He has worked extensively in senior UK and Global consultancy positions with most of the top ten pharma companies including AstraZeneca, Eisai, Roche, Novartis, Schering-Plough / MSD and GSK, in addition to having advisory development roles in the biotech, device and generic pharma sectors.
In 2012 he was appointed President to the Section of Pharmaceutical Medicine and Research at the Royal Society of Medicine, London and in 2014, a Fellow of The Royal Society of Biology.
Vice President, Global Medical Affairs Services / Ipsen Pharma SA
Dr Mónica de Abadal is an Executive Leadership Committee Member of the Medical Affairs Professional Society EMEA with more than 16 years of experience in the pharmaceutical industry
Dr de Abadal has experience in multiple therapeutic areas, including oncology, endocrinology and movement disorders as well as operational and strategic Medical Affairs experience in diverse disciplines of medical affairs and product commercialization, such as leading compliance and SOP/policy efforts, quality management systems, data generation, field-based medical teams (MSLs), safety, medical communication & publications
She has served as a board member in companies specialized in telemedicine and has international Medical Affairs experience in Europe, APAC (Australia) and global positions, including deputy Chief Medical Officer, Global Head of Publications. She currently holds the VP Global Medical Affairs Services group position at Ipsen.
Dr de Abadal obtained her medical degree from the University of Barcelona and entered residency in Anaesthesiology in Hospital Vall d´Hebron (Barcelona) ). She validated her medical degree in the US (USMLE) and obtained an MBA specialized in Healthcare administration from (USF) and a postgraduate diploma in Pharmaceutical Medicine (UAB).
She feels passionate about Medical Excellence.
(MAPS President) / EVP and Head of Medical Affairs / Astellas Pharma
Charlotte M. E. Kremer, MD, MBA is the Executive VP and head of Medical Affairs for Astellas. In this role, Dr. Kremer provides leadership for the Medical Affairs organization globally.
Dr. Kremer joined Astellas in 2012 with 20 years of experience in the pharmaceutical industry. Prior to Astellas, she held the position of Vice President, Therapeutic Area Head for Ophthalmology, PVD, Rare Diseases and Neuroscience at Pfizer. While at Pfizer, she successfully led and executed the clinical development and global medical programs in these respective areas. Prior to joining Pfizer, Dr. Kremer held positions of increasing responsibility providing medical support, developing Phase 3b/4 clinical trials, and initiating and directing a Medical Liaison program at Organon Pharmaceuticals, both in the Netherlands and in the United States. A native of the Netherlands, Dr. Kremer received her medical degree from the University of Utrecht, The Netherlands. She went on to receive her Diploma Pharmaceutical Medicine (DPM) from Universite Libre de Bruxelles. After transferring to the United States, Dr. Kremer completed the Executive MBA program at New York University’s Leonard N. Stern School of Business.
Senior Director, Global Medical Affairs / AstraZeneca
Dr. Ogün Sazova has graduated Istanbul University Faculty of Medicine and has a specialization degree for family medicine. After spending 5 years in clinical and research setting, he joined pharmaceutical industry in 2003 and worked in local medical and commercial roles before joining AstraZeneca (AZ) Turkey as the Head of Primary Care Medical Affairs. In this role, Ogün has built the MSL function in AZ Turkey amongst other medical affairs deliverables.
In 2009, Ogün moved to EU regional organization in Brussels and was the EU Medical Affairs Director for Cardiovascular Diseases. In 2012, he was appointed as the Global Nominated Signatory Practice Director in Global Medical Excellence group, and moved to London with his family. In this role, Ogün has set standards for Nominated Signatory operations worldwide, including risk & control framework, training, accreditation, and many examples of simplification. After this role, Ogün has taken over the lead of the Global Medical Academy and established it as one of the important tools in AZ to drive world-class scientific engagements by medical teams in the countries.
After working in Turkey, Germany and Belgium, Ogün now lives in the UK and works as the Enterprise External Scientific Engagement Lead in AZ Global Medical Affairs.
Global Medical Lead – Orphan Diseases / Vifor Pharma
Peter Rutherford is Global Medical Lead for Renal Rare Disease at Vifor Pharma in Zurich, CH. He qualified in Medicine at the University of Newcastle upon Tyne, UK and completed postgraduate medical training to obtain MRCP in 1989. He entered an academic training pathway in Nephrology with an MRC Training Fellowship allowing him to complete a PhD in cell physiology as well as completing clinical training in Nephrology and Internal Medicine. He was then an MRC Travelling Fellow at Yale University School of Medicine gaining additional academic experience in molecular biology.
After return to the UK as Lecturer in Medicine at the Unversity of Newcastle, he was appointed as Senior Lecturer in Nephrology at the University of Wales College of Medicine and Consultant Nephrologist. In this role, he combined clinical practice in delivering a full range of nephrology services with academic work. Peter then developed expertise as a clinical leader in the hospital and became the Medical Director of a combined acute, community and mental health NHS organization leading on patient safety, clinical effectiveness, service improvement and research. In addition he was a Clinical advisor at NICE and chaired their Guidelines Review Panel until he joined Pharma in 2007.
From 2007 to 2015 he was Medical Director Renal for Europe, Middle East and Africa at Baxter Healthcare – being responsible for all aspects of Medical Affairs activities across the region. He worked on research projects in patient support, decision making and education as well as new product development for home dialysis. From 2015 to 2017 he was Head of Integrated Market Access at Quintiles in Europe and Emerging Markets – supporting small and large Pharma and emerging biotech companies with medical affairs, medical communications, market access and patient centric services. Focused on launch brands, Peter support a range of companies across a range of therapeutic areas. Since joining Vifor Pharma, he is back on home ground in Nephrology but working in systemic diseases affecting every organ system.
Dr. Maru is an academic physician, Neuroimmunologist and health economist with extensive global experience in clinical research and development, translational medicine, health economics, real-world evidence, and medical affairs.
With a specialty in economic modeling and real-world evidence generation, Benit’s scientific and industry career has primarily focused around neurology, neuroimmunology, immuno/haemato- oncology, and biological therapies for inflammatory diseases, nephrology, dermatology and rheumatology, and rare/ultra-rare disease.
Dr. João Dias is an honors graduate of the University of Helsinki. He received his Licentiate/MSc in biochemistry from the Universities of Porto, Portugal and Wageningen, the Netherlands; and his PhD studies in Immuno-Oncology and Gene Therapy at Helsinki University Central Hospital and Helsinki University, faculty of Medicine.
He is currently responsible for international medical affairs and clinical development for the medical devices and diagnostics portfolio at Haemonetics which includes Hemostasis Management, Cell Salvage and Transfusion Management products. Prior to this role, João had a variety of roles of increasing responsibility in the areas of both market access and medical marketing.
He has authored several peer-reviewed publications and white papers in the fields of Hemostasis, Patient Blood Management, Immuno-Oncology, Gene Therapy, Hematology, and Molecular Biology.
Prior to his tenure at Haemonetics, João worked as a scientist in the development of new products in Cancer Gene Therapy and served as a Life Sciences Consultant working together with multiple global life-science companies.”
Senior Vice President, Head of Global Medical Affairs Oncology / Eisai / (Former 16'-17' MAPS President)
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.