Pharmaceutical Regulatory Affairs and IPR

Biography

Dr. Silay serving as the Chairman of Labiopharma, LLC in US, providing clinical trial administration, market access, medical writing, patient recruitment, retention, regulatory and medical affairs support, drug repositioning for hospitals, academic institutions and pharmaceutical companies 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 and social security institute.Dr. Silay in US, 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 where he was key in building a Neurology Franchise by hiring many employees. Dr. Silay is a senior consultant, project manager, executive physician scientist, certified clinical research professional in the healthcare ( pharmaceutical, medical device, hospital chains) 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) , current secretary general of HEPA (Health Economics& Policy Association), 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 senior consultant executive in the public health, PPP, health economics and pharmaceutical industry with a track record of conducting successful, carefully designed outcomes trials as well as randomized double blind placebo controlled clinical trials in 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 (Cardiac stent, 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 Pharmaceutical companies such as Astellas, Chiron, Fugisawa, Nabi Biopharmaceutical, Forest Pharmaceuticals, KV Pharmaceuticals, Medtronics, Deep Breeze, Teva, Ipsen as well as governmental organizations such as NIH, Chest foundation, American heart association grants, FDA, Turkish minister of Health and the World Bank As a prolific scientific writer he published extensively with more than 15 peer reviewed article and more than 100 platform and abstract presentation at the academic and industry level in national and international meetings. Dr. Silay is currently serving as the Chairman of the Istanbul Consulting Group (ICG) . He provides guidance and support to Turkish Ministry of health through World bank project. As the former General Manager of the largest distributor of Siemens healthcare company with ~220 employees, he played key role in developing mobile Breast cancer screening program for Turkish and Syrian refugees in Turkey. As a BioPharma CEO, Carveout, Turnaround Specialist he is known as, Entrepreneur Doctor & "International Healthcare Executive (Pharmaceutical, Hospital Chain, Diagnostic & Medical Device)", Management Consultant, "Business, Strategy, Marketing Savvy Physician. He has Proven ability to build high performing teams and productive organizations, turn around brands, and build revenue in diverse markets. As the former 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 in Turkey.

Research Interest

Neurology, Pulmonary Critical Care, Rheumatology, Oncology and related therapeutic areas within academics and industry. regulatory processes, identifying and addressing risk management issues throughout lifecycle, presentation development to large payers, safety monitoring, designing and conducting clinical trials.