Dr.Yavuz Selim SILAY
Family Doctor
Doctor
Co-Founder & CEO of MAIN ( MaQasid Angel Investor Network) & Chairman of ICG (İstanbul Consulting Group) , president of SoPE (Society of Physician Entrepreneur) Turkey, Dr. Yavuz Silay previously joined FasterCapital as a #regional partner from #Turkey with an incredible passion for accelerating healthcare, Biotech, energy, IT and finance entrepreneurs .He lived 7 years in Germany and 14 years in the USA. He recently founded the first private Hospital R&D center , Avcılar Hospital R&D center where Engineers and Physicians work together to improve patients life with innovative technologies in Turkey. He is also the Corporate Communication Director of Sumitomo Group/Expel İlaç and several other companies Yavuz Selim Sılay MD, MBA Linkedin Profile http://www.linkedin.com/in/yavuzsilay Co-Founder & CEO of MAIN ( MaQasid Angel Investor Network) & Chairman of Istanbul Consulting Group (ICG) -BioPharma CEO, Carveout, Turnaround Specialist -Businessman, Entrepreneur Doctor & "International Healthcare Executive (Pharmaceutical, Diagnostic & Medical Device)", Management Consultant, "Business, Strategy, Marketing Savvy Physician -Board member of WIHU ICG,SKYDER, BID, -Previously Managed the largest distributor of Siemens Diagnostics in Turkey with ~220 employees - Worked in USA as Vice President of Ipsen Pharmaceutical, Director at Teva, Associate Director at KV, Physician Scientist at Forest Pharmaceutical & Clinical Research Director at Baylor - Team player, Silobuster,Get Things Done- - Formerly Providing strategic guidance to the Research Based Pharmaceutical Companies & at The World Bank for ministry of health in the area of organ transplant , cell & tissue banking - Proven ability to build high performing teams & productive organizations, turn around brands & build revenue in diverse markets A value-driven leader with successful track record. Core Competencies include: - Financial management & Leadership & Team Building - Interpersonal Communication - Analytical Thinking - Crisis Management - Public Speaking - Strategic Planning and Development - Clinical development - Medical Affairs - Market Access - Payer Strategy - Innovation and entrepreneurialism - New product development, commercialization & lifecycle management of existing products - Business development - Global Market Access - P&L - Change management and organizational design - Talent recruitment, selection, and development Interaction with FDA. Development of generic and branded regulatory strategic plans for new product development, life cycle management of marketed products Evaluation of potential products & in-licensing opportunities
Experience Years
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Educations
Ankara University
Ankara University School of Medicine
Ankara Yıldırım Beyazıt University
Doctor of Medicine - MD, Family Medicine Residency Program
Washington University in St. Louis - Olin Business School
Executive MBA, Global Marketing, Strategy, Leadership
Experiences
Senior Clinical Research Coordinator
Senior Research Coordinator of Lung transplant research program, Jan 2005 – Jan 2007 (Worked on projects with several pharmaceutical companies; Astellas, Chiron, Fugisawa, Nabi Biopharmaceutical, Deep Breeze as well as governmental organizations such as Chest foundation, American heart association grants) • Coordinates the process of clinical research, including the IRB process and budget negotiations. • Write and edit Clinical Study Reports (CSRs), Clinical Investigator Brochures (CIBs), and Regulatory Agency Response documents. • Recruits, screens, enroll and evaluate patients that participate in study. • Educates patients in significant aspects of study. Ensures that clinical studies are conducted in accordance with guidelines of the FDA and other regulatory agencies. • Serves as a liaison between physicians, patients, staff and sponsors. Develops the clinical trial agreements. Provides guidance and work direction to clinical research nurses. • Liaise with contract writers. • Coordinate outsourcing needs (i.e. preparing request for proposals [RFPs], reviewing contracts and cost estimates). • Responsible of all lung transplant program clinical research protocols including; • Origin of lung cells in women with pulmonary hypertension • Reversal of acute rejection using intravenous immunoglobulin (IVIG) in lung transplant recipients • Neurocognitive and behavioral functioning in children with Tourette syndrome and comorbid disorders. • Comparison of a Tacrolimus/Sirolimus/Prednisone regimen versus Tacrolimus/Azathioprine/Prednisone immunosuppressive regimen in lung transplantation (AIRSAC). National Lung Transplant Study. • A pilot study of serum markers for lung disease in children with cystic fibrosis, sickle cell, interstitial lung diseases, and post lung transplants. (B. O. Marker) Chest Foundation Study. • Multiple modality antibody reduction in highly sensitized lung transplant candidates Senior Research Coordinator of Lung transplant research program, Jan 2005 – Jan 2007 (Worked on projects with several pharmaceutical companies; Astellas, Chiron, Fugisawa, Nabi Biopharmaceutical, Deep Breeze as well as governmental organizations such as Chest foundation, American heart association grants) • Coordinates the process of clinical research, including the IRB process and budget negotiations. • Write and edit Clinical Study Reports (CSRs), Clinical Investigator Brochures (CIBs), and Regulatory Agency Response documents. • Recruits, screens, enroll and evaluate patients that participate in study. • Educates patients in significant aspects of study. Ensures that clinical studies are conducted in accordance with guidelines of the FDA and other regulatory agencies. • Serves as a liaison between physicians, patients, staff and sponsors. Develops the clinical trial agreements. Provides guidance and work direction to clinical research nurses. • Liaise with contract writers. • Coordinate outsourcing needs (i.e. preparing request for proposals [RFPs], reviewing contracts and cost estimates). • Responsible of all lung transplant program clinical research protocols including; • Origin of lung cells in women with pulmonary hypertension • Reversal of acute rejection using intravenous immunoglobulin (IVIG) in lung transplant recipients • Neurocognitive and behavioral functioning in children with Tourette syndrome and comorbid disorders. • Comparison of a Tacrolimus/Sirolimus/Prednisone regimen versus Tacrolimus/Azathioprine/Prednisone immunosuppressive regimen in lung transplantation (AIRSAC). National Lung Transplant Study. • A pilot study of serum markers for lung disease in children with cystic fibrosis, sickle cell, interstitial lung diseases, and post lung transplants. (B. O. Marker) Chest Foundation Study. • Multiple modality antibody reduction in highly sensitized lung transplant candidates Skills: Urgent Care · Global Health · New Hires · Ambulatory Care · Patient Care · Prevention · Electronic Medical Record (EMR) · Public Trust · System Monitoring · Medical Records · Chronic Illness · Preventive Medicine · Clinics · Primary Care Physicians · Clinical Practices · System Organization · Life Support · Patient Rights · Quality Of Care · Vaccinations · Working with Physicians · Market Planning · Electronic Health Records (EHR) · Nurse Call · U.S. National Committee for Quality Assurance · Supervisory Skills · Insurance Policies · Rural Health · Transcription · Medicare · Substance Abuse Prevention · Prenatal Care · Payer · Intellectual Property Law · Community Health · Mental Health · Quality Assurance
Physician Scientist
Forest Laboratories Participate in all aspects of clinical development and study management, which includes providing scientific, medical, and/or logistical direction and support to planned and ongoing studies. Clinical development in CNS/Pain therapeutic area Managing Phase 2-4 clinical trials, Contributing to the implementation of Phase IIIb program at Forest including study design discussions with partner companies, key opinion leaders. Submitting NDA/sNDA Writing Clinical study reports, safety narratives and publications Worked on an antidepressant for a new CNS/Pain indication Participate in all aspects of clinical development and study management, which includes providing scientific, medical, and/or logistical direction and support to planned and ongoing studies. Clinical development in CNS/Pain therapeutic area Managing Phase 2-4 clinical trials, Contributing to the implementation of Phase IIIb program at Forest including study design discussions with partner companies, key opinion leaders. Submitting NDA/sNDA Writing Clinical study reports, safety narratives and publications Worked on an antidepressant for a new CNS/Pain indication Skills: Electronic Medical Record (EMR) · Working with Physicians
Clinical Scientist
Clinical Scientist Forest Research Successfully contributed to a NDA submission and to the design and implementation of Phase IIIb program , involved in the clinical development of drug trials related to several rheumatologic, neurological and psychiatric disorders • Participates in all aspects of clinical development and study management, which includes providing scientific, and/or logistical direction and support to planned and ongoing trials. • Clinical development in CNS and Rheumatology therapeutic area. • Managing Phase 2-4 clinical trials, • Contributing to the implementation of Phase IIIb program at Forest including study design discussions with partner companies, key opinion leaders as well as different internal departments such as marketing. • Submitting NDA/sNDA. • Wrote and edited CSRs and sections of a New Drug Application (NDA). • Writing Clinical study reports, safety narratives and publications. • Experienced in Clinical trial management and protocol development with medical and scientific knowledge in assigned Central nervous system therapeutic area. Strong written and verbal communication skills as well as proven ability to interact with different functional groups. • Knowledge of GCP/ICH guidelines and FDA regulations, experience with clinical trial design and basic knowledge of statistics, good organizational, interpersonal and presentation skills, proficiency in computer and software skills (Word, Excel, PowerPoint). • Supervises two (2) or more clinical study team members. • Knowledge of CNS related scales specific to variety of diseases including Alzheimer, Parkinson’s, Tourette Syndrome and Huntington’s disease. • Author drafts of study synopses, protocols, protocol amendments, Monitoring Plan and informed consents for Phase II-IV studies. • Contributes to the preparation of Investigator's Brochures and IND annual reports and study reports. Successfully contributed to a NDA submission and to the design and implementation of Phase IIIb program , involved in the clinical development of drug trials related to several rheumatologic, neurological and psychiatric disorders • Participates in all aspects of clinical development and study management, which includes providing scientific, and/or logistical direction and support to planned and ongoing trials. • Clinical development in CNS and Rheumatology therapeutic area. • Managing Phase 2-4 clinical trials, • Contributing to the implementation of Phase IIIb program at Forest including study design discussions with partner companies, key opinion leaders as well as different internal departments such as marketing. • Submitting NDA/sNDA. • Wrote and edited CSRs and sections of a New Drug Application (NDA). • Writing Clinical study reports, safety narratives and publications. • Experienced in Clinical trial management and protocol development with medical and scientific knowledge in assigned Central nervous system therapeutic area. Strong written and verbal communication skills as well as proven ability to interact with different functional groups. • Knowledge of GCP/ICH guidelines and FDA regulations, experience with clinical trial design and basic knowledge of statistics, good organizational, interpersonal and presentation skills, proficiency in computer and software skills (Word, Excel, PowerPoint). • Supervises two (2) or more clinical study team members. • Knowledge of CNS related scales specific to variety of diseases including Alzheimer, Parkinson’s, Tourette Syndrome and Huntington’s disease. • Author drafts of study synopses, protocols, protocol amendments, Monitoring Plan and informed consents for Phase II-IV studies. • Contributes to the preparation of Investigator's Brochures and IND annual reports and study reports. Skills: Working with Physicians
Associate Director of Clinical Sciences, Clinical and Medical Affairs Associate Director of Clinical Sciences, Clinical and Medical Affairs KV Pharmaceutical
As the Associate Director of Clinical Sciences, ensuring that clinical programs meet regulatory requirements for approval, satisfy corporate objectives and maximize marketing & market access opportunities. Non-clinical and clinical study designs are effectively aligned with regulatory requirements, product concept, marketing objectives and corporate goals. Directing the development of clinical regulatory documents (including IND, NDA and ANDA submissions, ENDs. clinical protocols and clinical study reports) and regulatory correspondence necessary to address issues related to clinical and regulatory strategies. Interaction with FDA. Providing market access, clinical and scientific review and evaluation of potential products and in-licensing opportunities. Managing medical writers and vendors.Developing publication plans and directing the evaluation and analysis of clinical data to assist in the translation of data from clinical studies to promotional and educational materials and publications.
Teva Neuroscience
Medical Director • Due to successful execution, promoted to the Therapeutic medical head position with larger geographic coverage and therapeutic responsibility within 1 year of tenure at Teva Neuroscience. • Provides the scientific and strategic leadership throughout the lifecycle and post-marketing support for marketed products.as the therapeutic medical head in North America • Due to successful execution, promoted to the Therapeutic medical head position with larger geographic coverage and therapeutic responsibility within 1 year of tenure at Teva Neuroscience. • Provides the scientific and strategic leadership throughout the lifecycle and post-marketing support for marketed products.as the therapeutic medical head in North America Skills: Working with Physicians
Teva Neuroscience
Director, Scientific and Medical Affairs Directed Rasagiline clinical trials, Investigator Initiated Studies and other external investigations conducted in United States. Provided clinical input throughout the various business units of the organization. Developed and executed clinical programs for company products. Directed study design, protocol development and executed clinical studies. Acted as a liaison between the company and clinical investigators, domestic & international neurology societies. Developed credible relationships with Key Opinion Leaders, medical directors, and key medical societies domestically in North America and internationally (including Asia Pacific, Latin American, Europe, Middle East). Participated on cross-functional teams and contributed to publication planning, health economic outcome study initiatives and implementing franchise business strategies. Teva Neuroscience, Inc. markets COPAXONE® (glatiramer acetate injection) and AZILECT® (rasagiline tablets). Our vision is to be the North American leader in neurology through the quality of our people, the quality of our products, and our focus on the patient. http://www.tevaneuroscience.com/ http://www.tevapharm.com/Azilect/ Teva Pharmaceutical Industries Ltd. is a top 20 global pharmaceutical company and the largest generic pharmaceutical company in the world with 38,000 employees. 80% of Teva's sales, which totaled US$11.1 billion in 2008, are in North America and Europe.
Vice President, Medical Affairs Neurology
Ipsen Biopharmaceuticals Sep 2011 - Jan 2013 · 1 yr 5 mosSep 2011 to Jan 2013 · 1 yr 5 mos Basking Ridge, New JerseyBasking Ridge, New Jersey • Lead Medical affairs Neurology department in US. Support US franchise portfolio development through medical guidance & coordination, in short and long term strategic planning, alignment of projects, clinical studies and medical information, in close cooperation with all medical functions across organization with US Franchise Marketing and Market access team and with global headquarters. • Manage current Phase 4 study ( Anchor-CD and drive the design and implementation of late-stage development studies - phase IIIb and IV- as well as support clinical development studies through Neurology MSL teams) • Oversee, develop and manage relationships with external stakeholders in US ( Cervical dystonia foundations, Key opinion leaders, key academic institutions and payers as needed) • Oversee Sr. Medical Advisor, Medical Science Liaison team head and associate clinical director for building scientific credibility for Ipsen within US. • Support generation of fair and balanced medical information letters of Dysport in coordination with internal medical, cross-functional and global Medical community • Recruit, develop and manage US Medical Affairs Neurology team( Recently promoted 2 associate to Associate Director level and support hiring of 3 new Medical Science Liaisons) • Manage Medical Affairs Neurology department budget • Oversee US publications strategy and execution for Neurology medical affairs department with an aggressive goal of 8 abstract and 5 manuscript submission for 2012 • Support Global Franchise Medical Affairs department by reviewing protocols that are submitted globally to PEC(Protocol Evaluation committee) with Franchise Medical Lead and Statistician; providing input, presentations and representation for US Neurology department at the Global Franchise and Medical Community meetings as needed • Provide representation of Ipsen US and Dysport at National Franchise meetings as well as at the Market access, medical, academic and industry meetings
Faculty Advisory Board Sectoral External Senior Expert
International Science and Technology University Poland · HybridPoland · Hybrid Faculty Advisory Board member Sectoral Senior Advisor at a Google + New Generation Global University
Board Member & Dean
AI Vision UniversityAI Vision University Greater London, England, United Kingdom · HybridGreater London, England, United Kingdom · Hybrid Dr.Yavuz Selim Silay,MD,MBADr.Yavuz Selim Silay,MD,MBA Honored to serve as the Board Member and Dean , Healthcare Department https://aivisioninstitute.com/teams/yavuz-selim-silaymdmba/
Managing Partner & Chief Medical Officer
Turquaz Health - Medical Tourism Services
Board Member Board Member
TÜMMİAD TÜMMİAD, Turkish Inventors Association, is an organization established to ensure the knowledge and technology transfer in the scientific world to future generations and to contribute to the development of more "Inventors and Entrepreneurs" as the sole representative of WIIPA (World Invention Intellectual Property Associations) in Türkiye.
AFROTURK TV
Co- Founder & Managing Partner International TV Talk Show Host known as 5TN "5 Technology News" including technology and ITB for investment, Trade World for business & SIT Study in Türkiye & NEWS + as well as other original content & shows to enhance technology & Finance ecosystem between Africa & Turkey broadcasting more than 1 billion people over 49 countries at AFROTURK TV
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