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Raphael Tan
Raphael is founder of a consulting firm that supports medical device companies with high quality services in the areas of Medical Affairs & Governance, Clinical Research, Regulatory Affairs and Business Development. In addition, with access to a continuously growing international network of industry professionals and by partnering with chartered psychologists, his firm provides unique headhunting services for start-ups, scale-ups as well as mature companies.
During his 20+ years corporate career he has held a variety of leadership positions in Medical Affairs and Clinical Research. While working for Medtronic, Boston Scientific, KCI/Acelity and Mölnlycke Healthcare he gained vast experience in designing, building and leading international teams. In his last role as Chief Medical Officer he was the architect of a synergetic global cluster consisting out of Global Medical Affairs, Clinical Research, Clinical Evidence Strategy and Health Economics & Reimbursement. In that capacity and with new regulations in Europe, new technologies entering the healthcare realm and stringent reimbursement requirements, he has initiated and led initiatives strengthening and expanding Medical Affairs capabilities.
With his corporate experience and current involvement in organizations that are in the process of redefining the role of Medical Affairs as a business function, Raphael provides advice on establishing a Medical Governance structure to ensure medical-scientific oversight over processes ranging from new product development to the skills training of new users. As member of the MAPS MedTech FAWG he aims to promote the exchange of experiences among Medical Affairs professionals both in pharma and MedTech.
Raphael holds a medical degree from the Free University in Amsterdam, The Netherlands.
Gail Cawkwell, MD, PhD
Dr. Gail Cawkwell has served as SVP, Medical Affairs, Safety & Pharmacovigilance of Intercept Pharmaceuticals since September 2018, having previously served as SVP, Medical Affairs since February 2018. Prior to joining Intercept, Dr. Cawkwell worked for Purdue Pharma L.P., where she served as Special Advisor to the Board of Directors from September 2017 to February 2018, Chief Medical Officer from January 2015 to September 2017 and VP, Medical Affairs from November 2014 to January 2015. From 2000 to November 2014, Dr. Cawkwell served in a number of roles of increasing responsibility at Pfizer Inc., including most recently as Vice President Medicine Team Lead for Pfizer’s tofacitinib franchise. Dr. Cawkwell also served as a Clinical Instructor of Pediatrics at Columbia Presbyterian Health Center from 2002 to 2015 and previously held several other clinical and academic posts. Dr. Cawkwell received her Ph.D. from the University of Cincinnati, her M.D. from McGill University in Montreal, Canada and her bachelor’s degree from Duke University
Canna Ghia
Dr. Canna Ghia is a physician and has cumulative experience of 15 years including extensive experience in medical and scientific affairs in the pharmaceutical industry besides academic teaching and clinical research experience. She has completed her MD with a fellowship in Immunology and has conducted several international advisory board meetings, best practice sharing session, innovative new product launched and product related trainings. She has led award winning healthcare strategies to support patients and increase access in health ecosystems and is trained in medical writing, health research in vulnerable populations, health economics and outcomes research and intellectual property law. She has more than 40 publications/presentations in international/national forums to her credit.
Prem Sundivakkam
Prem is a board-certified medical affair’s professional and a thought leader who is committed to developing effective medical strategies and scientific content with actionable insights.
Prem has studied and practiced science because he has always been motivated to create things that are newer and better. He strongly believes that his training prepared him to be an adaptable problem solver and capable of taking on a wide range of demanding assignments with little assistance.
For more than 15 years, Prem has successfully led numerous scientific excellence programs and has established new value-creation opportunities to provide the right information to the right people at the right time. In the long term, Prem is interested in identifying the structures, processes and capabilities that are essential to improve the stakeholder engagement, while working towards developing the core value-added activities in medical affairs’ function. The activities include but are not limited to addressing how to embrace the power of technology to position the science and to inform their interactions with stakeholders, how to maximize the role of real-world data to drive scientific excellence, and to build strategic leadership know-how to achieve strong partnerships.
Prem has a PhD in pharmacology and vascular biology from The Tamil Nadu Dr. M.G.R Medical University, India. He received his MBA from the Gies College of Business at University of Illinois at Urbana-Champaign with concentrations in strategy and leadership. He has published over 25 highly cited peer-reviewed research manuscripts and has served on the editorial review boards of several journals. He was a distinguished fellow of American Heart Association (2011-2013) and American Endodontics Association (2014-2015).
Prem leveraged his expertise to serve at several professional and nonprofit organizations. He has held committee appointments and memberships on advisory councils to promote innovation and community engagement. During the COVID-19 pandemic, he founded an online music school to support the families of 27 visually impaired musicians in India.
Deena Bernholtz-Goldman
Deena Bernholtz-Goldman, PharmD, is a Medical Communications Professional with over 30 years experience, providing leadership and delivery of informational needs, ensuring optimal quality and access to information for Health Care Professionals and patients. In Deena’s most recent position as Vice President, Medical Communications at Astellas Pharma, Deena’s remit spanned the areas of Medical Information, Scientific Publications, Insights analyses, Knowledge Training and Library and Information Services. In that position, Deena built a comprehensive, matrix-based global Medical Communications community.
Throughout Deena’s career, she built and led effective Medical Communications teams within an ethical and compliant governance framework, implementing premium information solutions to positively impact patients. Throughout Deena’s career at Astellas, she led roles of increasing responsibility starting in the US, expanding to the Americas and finally, leading the global Medical Communications department.
She recently accepted the role as member of the MAPS inaugural Editorial Board whose purpose is to ensure quality and independent peer review of MAPS Elevate articles and White Paper submissions.
Deena received her Bachelors degree in Pharmacy (RPh) from the University of Toronto and a doctorate in pharmacy (PharmD) and Ambulatory Care specialty residency from the University of Illinois College of Pharmacy.
Gabriele Nicolini
Gabriele Nicolini, PharmD, PhD is Head of Global Medical Affairs & Patient Advocacy for Chiesi Farmaceutici S.p.A. since 2018. Gabriele is a senior manager with 20 plus years of experience including R&D, Medical Affairs, training and sales. He’s enthusiastic, energetic, strategic thinking leader with academic background, skilled in people management, with strong problem solving, decision making, networking and communication skills. Leading the Global Medical Affairs team, his purpose is to ensure strategic guidance at both Global and local level (Chiesi affiliates), alignment, sharing of knowledge and transparency in communication with external stakeholders, by acting as facilitator of scientific evidence generation and dissemination leveraging on medical expertise and ethics. Gabriele joined Chiesi in 1999 starting his career as a sales representative and quickly moving to the role of trainer of the field force and medical advisor for the respiratory area. He spent more than 20 years in medical affairs with the main focus on respiratory diseases both for the Italian affiliate and the global structure, including a period in research and development leading a Phase 4 studies unit in the clinical development department. During his career Gabriele had the opportunity to design, manage and publish more than 20 research projects both on in vitro effect of drugs and clinical trials from phase 2 onwards, including post approval Real World Evidence observational studies. At the top of his editorial career he acted as a reviewer for 7 peer-reviewed international journals in respiratory field and was member of the editorial board for 2 international journals. He is author and co-author of more than 40 original articles and reviews in peer reviewed journals including the New England Journal of Medicine, Lancet Respiratory Medicine, Thorax, ERJ, Respiratory Medicine, PLOS One and other important journals.
Most recently, on top of the Head of Global Medical Affairs & Patient Advocacy role, he was appointed as Chief Scientific Officer for Chiesi Global being accountable for medical compliance of the global team promotional activities with reference to the Italian regulation and code of practice.
Gabriele received a degree in Pharmacy (PharmD) from the University of Milan and a doctorate (PhD) in Experimental Respiratory Pathophysiology from the University of Parma.