Biography

Dr. Silay is an R&D expert,executive physician scientist,certified clinical research professional in the medical device & pharmaceutical industry with an Executive MBA degree from the Olin Business School at Washington University in St.Louis which is ranked #2 in United States of America by Wall Street Journal in 2010.Dr.Silay is a member of American Academy of Neurology,chief editor of Journal of Developing Drugs,an editorial board member of Expert opinion on Emerging Drugs, a current ad-hoc reviewer at the NIH (National Institute of Health) and NINDS, past speaker at DIA ( Drug Information Association)and member of DIA SIAC's for Good Clinical Practice/Quality Assurance Special Interest Activity Community (GCP/QA SIAC),Clinical Trial Registry/Results Disclosure Working Group(CTR/RD Working Group), Natural Health Products.MDS(Movement Disorder Society),charter and previous president of AMSA (American Medical Student Association) Turkey, previous president of SOCRA (Society of Clinical Research Associates) in New Jersey, board of directors member at the SoPE and founder of SoPE(Society of Physician Entrepreneurs) Turkey chapter. Dr. Silay is a recognized executive in the R&D area and medical device & pharmaceutical industry with a track record of conducting process improvements using lean six sigma methodology.He also is known as managing successful,carefully designed outcomes trials as well as randomized double blind placebo controlled clinical trials in Pharmaceutical and Medical Device areas.These include CNS (Central Nervous System)therapeutic area such as Parkinson's,MS(Multiple Sclerosis), Stroke,head trauma,Fibromyalgia,Tourette syndrome, Alzheimer's disease as well as Pulmonary Critical Care/ Lung transplant,Cardivascular(MI, Ambulatory Blood pressure monitoring trials) and Oncology therapeutic areas.Dr. Silay, a dual citizen of U.S.A. and Turkey was born in Turkey and educated in Turkey, Germany and U.S.A.He completed his medical School at The University of Ankara in Turkey and his internship at Baylor College of Medicine and University of Texas in Houston, Texas.He attended a Physician Scientist Training Program at The MD Anderson Cancer Center of University of Texas. Dr. Silay worked on projects with several Medical Device & Pharmaceutical company R&D projects such as Astellas,Chiron, Fugisawa,Nabi Biopharmaceutical,Forest Pharmaceuticals, KV Pharmaceuticals,Medtronics, Deep Breeze, Teva, Ipsen, Alvimedica, Siemens healthcare, as well as governmental organizations such as NIH, Chest foundation, American heart association grants and FDA. As a methodology and R&D process improvement expert as well as prolific scientific writer he published extensively with more than 15 peer reviewed article and more than 100platform and abstract presentation at the academic and industry level in national and international meetings.Dr. Silay is currently serving as the Director of R&D center at the Avcilar Hospital, which is the First and Only Hospital based R&D centre certified by Ministry of Science, Industry and Technology. He also serves as the Chairman of Istanbul Consulting Group as a Medical Device, BioPharma R&D expert, Carveout, Turnaround Specialist.He is well known as, Entrepreneur Doctor & "International Healthcare Executive (Pharmaceutical, Diagnostic & Medical Device)", Management Consultant, "R&D, Business, Strategy, Marketing Savvy Physician. Previously managed the largest distributor of Siemens Diagnostics in Turkey ; a healthcare company with ~220 employees transitioning to the Turkish Private Insurance Fund as part of a governmental duty which was completed in November 2016.He has proven ability to build high performing R&D teams and productive organizations, turn around brands, and build revenue in diverse markets.As the previous Director, Market Access & Health Policy for AIFD (Research Based Pharmaceutical Companies) which the 40 members represent all major global pharmaceutical companies, 650 billion dollars of 1 billion dollar Global Pharmaceutical market. He represented pharmaceutical companies and was in discussion with all ministerial levels, including ministry of health, finance, labor, development and science& technology. Dr. Silay also served as CEO of Labiopharma, LLC in US and as the CEO of ICG ( Istanbul Consulting Group) in Turkey . He provides guidance to Turkish Ministry of health through a World Bank project. His executive team is providing R&D process and methodology improvement, commercialization of the right portfolio for medical device companies as well as clinical trial administration, market access, medical writing, patient recruitment, retention, regulatory and medical affairs support, Medical Device & drug repositioning for Medical Device companies, academic institutions and pharmaceutical companies for the entire R&D process from preclinical to post marketing stages for several years. Dr.Silay is also providing comprehensive and strategic consulting services for the approval of Drugs and Medical Devices and attended several meetings with FDA,EMA,Health Canada and Turkish Health authorities as an R&D expert.Dr.Silay most recently worked as the Vice President, Medical Affairs, and head of Medical Affairs Neurology in the US headquarters Basking Ridge, New Jersey reporting to the President and CEO of Ipsen North America.Dr.Silay previously worked at Teva Neuroscience from May 2009 through September 2011 as the head of clinical and medical Parkinson's franchise and the Director of Scientific Affairs and Medical Research in U.S Headquarter in Kansas City reporting to Chief Medical Officer and VP of Medical Affairs. He was previously responsible for the Parkinson's disease Investigator Initiated Trials, Phase IIIB, Phase IV trials and for developing relationships with Key Opinion Leaders in the field of Neurology. In addition to managing several Investigator initiated trials, he was running several outcomes research trials as well as a double blind prospective study known as the ANDANTE study for 360 PD patients in 55 sites as well as STACCATO for 1507 patients in 37 sites. In addition to ANDANTE and STACCATO, he attended the steering committees for studies in MSA, ADAGIO Follow up as well as a Cognition study for non-demented PD patients. He was actively involved in global committees as a member of GIMAG (Global Innovative Medical Affairs Group) that convenes in US, Canada, Middle east and Europe regularly as well as Global Preclinical Forum consists of Lundbeck, Teva global and Teva North America clinical trial design experts.Previously, Dr.Silay served as the Associate Director at KV Pharmaceuticals in St. Louis, Physician Scientist in CNS Clinical Development department at Forest Laboratories in New Jersey, Director and Senior Research Coordinator at Baylor College of Medicine in Houston, Texas. He gained experience in R&D methodology, public health areas and therapeutic areas within medical device, cardiology, pulmonary critical care, transplant, CNS and rheumatologic conditions such as, Fibromyalgia, Alzheimer, MS, Epilepsy, Autism and Parkinson's disease. Dr.Silay currently resides with his wife Dr. Kamile SILAY who is board certified in internal medicine and geriatrics as a graduate of Jersey Shore University Medical Centre, affiliated with Robert Wood Johnson Medical School in New Jersey and their two daughters and one son (14 ,10 years old and 4 years old) Ravza Zeynep, Beyza Elif and Suleyman Bera part of the year in Neptune, New Jersey and part of the year in Cankaya, Ankara, Turkey.

---

Research Interest

Global R&D, Healthcare, Market Access, Health Policy, Clinical Studies and Scientific Experience—As a global R&D healthcare expert and driven physician scientist, 10+ years of R&D process improvement,clinical and research experience in medical device and pharmaceutical in Cardiology, Neurology, Pulmonary Critical Care, Rheumatology, Oncology and related therapeutic areas within academics and industry. Very familiar and experienced in the R&D process improvement, market access & health policy in Turkey. Strong medical device and clinical drug development, KOL interactions, advisory board meetings, CME development, speaker training, publication planning, Life Cycle Management, regulatory processes, identifying and addressing risk management issues throughout R&D life cycle, presentation development to large payers, safety monitoring, designing and conducting R&D process improvement and clinical trials. Strong practical grasp of R&D methodology, health economics and outcomes research as it applies to achieving strategic business goals for commercialization. Ability to inspire - By creating a dynamic environment that fosters transparency, collaboration and innovative thinking across the organization. Proven track-record of success in R&D expertise including different governments and industries- working across functions in a matrix environment as R&D expert with strong people management skills and an ability to foster teamwork across functions. Proven track record of scientific publications- As a prolific physician scientist published more than 15 peer reviewed articles cited in PubMed and presented in more than 50 national / international scientific and industry meetings. Strong project and process management - Orientation and be able to drive multiple projects through effective motivation and collaboration;improvement R&D projects within medical device & pharmaceutical factories, able to think through complex systems, and see the vision and align/simplify these systems to achieve this vision. Business Savvy & Drive - As a recent executive MBA graduate in providing fresh perspectives and quantifiable results in identifying business opportunities, develops a strategic plan, gaining buy-in and driving execution to capture those opportunities. "Gets it done" Attitude - As a practical thinker and genuine team player, while providing direction , able to identify simple, realizable solutions; identify and alleviate any potential hurdles to achieve corporate objectives. International Focus - Perceived as a world citizen in a global village, therefore has strong ability to interact on a regular basis with other organizations with different corporate cultures (such as Siemens, Ipsen,TEVA organizations in North America, Israel and Europe, Ther-Rx, ETHEX, Forest Pharmaceutical organizations, in U.S. and Europe as well as Lundbeck)