Yavuz Selim Silay , Md , Mba Email and Phone Number
New York, NY, US
Yavuz Selim Silay , Md , Mba's Location
New York City Metropolitan Area, United States, United States
Yavuz Selim Silay , Md , Mba's Contact Details
Yavuz Selim Silay , Md , Mba work email
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About Yavuz Selim Silay , Md , Mba
Physician Entrepreneur & Venture Architect, Satellite TV Owner, Pharmaceutical Executive , Crowdfunding Platform Managing Partner, Family Physician“Senior Medical Affairs Director & Clinical Research Physician in CNS & Respiratory Pharmaceutical with track record of managing Preclinical through Phase 4" in US- Worked in USA as VP of Ipsen, Director at Teva, Associate Director at KV, Physician Scientist at Forest Pharmaceutical & Clinical Research Director at Baylor College of medicine "- 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 marketsA value-driven leader with successful track record. Core Competencies include:- 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 developmentInteraction with FDA. Development of generic and branded regulatory strategic plans for new product development, life cycle management of marketed productsEvaluation of potential products & in-licensing opportunities & Clinical studiesChairman of Istanbul Consulting Group (ICG) Managing Partner at NTR TV & AFROTURK AGRO TVhttps://linktr.ee/drysilaySeveral International TV Talk Shows Host NEWS + 5TN " 5 Technology News" , WHN "World Health News" & ITB "Innovation To Brand" broadcasting to more than 900 million + people over 40+ countries Co-Founder & CEO , Ral Kitle Fonlama AŞ known as FONKOLAY Crowdfunding platformMedical & Healthcare Investments Advisor, Opulent Investments Group (OIG) in London, U.K. -Finance & BioPharma, Carveout, Turnaround Specialist-Businessman, Entrepreneur Doctor & "International Healthcare Executive (CNS Pharmaceutical, Diagnostic & Medical Device)", Management Consultant, "Business, Strategy, Marketing Savvy Physician-Board member of ICG,SKYDER, BID,WIHU,SADEFE-Previously Managed the largest distributor of Siemens Diagnostics with ~220 employees
Yavuz Selim Silay , Md , Mba's Current Company Details
Yavuz Selim Silay , Md , Mba Work Experience Details
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Co- Founder And Managing PartnerAfroturk TvNew York, Ny, Us
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Managing PartnerAfroturk Agro Tv Oct 2024 - PresentManaging Partner of Afroturk Agro TV broadcasting to more than 900 million in 42 countries. -
Managing PartnerFonkolay Nov 2021 - PresentYenimahalle, Ankara, TrFonkolay also known as SimpleFund is one of the fastest growing crowdfunding Platform backed by a Digital Angel Investment Network & Venture Capital Fund owned and operated by an Istanbul Stock Exchange listed Global Investment holding Ral Investment Holding established by Chairman Rıza Kandemir operating in Finance, Renewable Energy , Construction & Technology sectorshttp://www.fonkolay.comhttp://ralyatirim.com.tr -
Founder & Chairman İstanbul Consulting Groupİstanbul Consulting Group (Icg) A.Ş. Jan 2013 - PresentÇankaya, Ankara, Tr"Your bridge to Global markets""From Original idea to patented products, your partner in becoming a truly Global Brand"Call now +90-312-906 07 66 or email ysilay@icg.ist to enter US, Europe,Turkey and emerging marketsCheck out http://www.icg.istanbulhttp://www.icg.isthttp://www.istanbulconsultinggroup.comYour TRUSTED New Generation Government Engagement and representation partner if you are in Healthcare , Pharmaceutical, Biotech & Medical Device spaces to be represented in Ankara, Brussels & Washington DCConsulting for global companies to design their innovation strategies and roadmaps Developing and Carrying out projects on innovation & technology investmentDesigning and implementing startup accelerator & investor meetup programs (BIOCube Bioentrepreneurship & Innovation Program, BioStar Program)Multi-sector business experience including the healthcare,finance and energy sectors. ICG is a seeker of knowledge and trend watcher. ICG's areas of interest are interdisciplinary, with deep expertise in new market entry & new product development in healthcare (pharmaceutical products,nutraceuticals,biotechnology,biologicals,medical device, healthcare policy, public health, pharmacoeconomics, clinical studies Phase1 through Phase 4) ,energy and finance sectorsSpecialties: Pharmaceutical & medical device portfolio management, Laboratory management, R&D center accreditation and management, Lean Start-ups, M&A,Roll Up,International Marketing and Business Development, Technology due diligence, Medical Tourism, Project Management, Market Research, Market Segmentation, Data Driven Strategy, New Formulations, Entrepreneurship, enterprise management, startup management, new market entry management, new product managementCall now +90-312-906 07 66 or email ysilay@icg.ist to enter US, Europe,Turkey & emerging markets for an initial discussionWe assist companies with launching their healthcare products worldwide. -
Faculty Advisory Board Sectoral External Senior ExpertInternational Science And Technology University Oct 2024 - PresentFaculty Advisory Board member Sectoral Senior Advisor at a Google + New Generation Global University -
Senior Medical Affairs Director , Neuroscience & RespiratoryGlobal Allied Pharmaceuticals(Gap) Jan 2013 - PresentGlobal Allied Pharmaceutical Orlando, FloridaSenior Medical Affairs Director , Neuroscience & Respiratory: Jan 2013-Present• Lead Neuroscience & Respiratory Medical affairs Services department in US from New Jersey and from Turkey in emerging markets overseas onsite and remotely per project as required. Alignment of projects, clinical studies and medical information, in close cooperation with all medical functions across organization with US and emerging markets• Support Management of Neuroscience clinical development studies through the lifecycle• Oversee, develop and manage relationships with external stakeholders and key opinion leaders in US & emerging markets. Building scientific credibility and relations through unique programs.• Join CNS trainings ,scientific meetings to update therapeutic knowledge as required, adheres to SOPS to ensure compliance within different functional team members.• Support generation of fair and balanced medical information letters in coordination with internal medical, cross-functional and global Medical community. Join team review meetings, project budget meetings, product team alignment meetings and status update meetings regularly• Use necessary digital software based on needs such as Microsoft Office Package, Statistical softwares, Microsot Teams, SharePoint, Oracle and related portals to support a seamless coordination within teams . Manages Drug supplies, financial spending with clients as needed.• Recruit, develop and manage CNS Medical Affairs and Medical Operation teams as needed• Provide representation at the Market access, medical, academic and industry meetings as a speaker, presenter and/or participant• Provide financial update of programs and align with stakeholders Provide clinical monitoring and site management as needed -
Council MemberGlg (Gerson Lehrman Group) Jul 2012 - PresentNew York, Ny, UsGLG is a technology-enabled learning platform that connects top professionals with experts.More than 1,400 companies use GLG to help solve complex strategic and operational challenges, test hypotheses, gain market feedback, and seek mentorship, all within our rigorous compliance framework. -
Strategic AdvisorThe Opulent Investments Group Jul 2020 - PresentLondon, England, GbThe Opulent Investments Group, a connoisseur in Infrastructure Development and International Trade, specialising in structuring projects and providing predominantly sell side advisory to project owners to ensure their projects are bankable, across the emerging markets in regions such as Africa, LATAM and Asia. Through the groups holdings Opulent has the ability to complete the entire ecosystem of the any infrastructure project, from advisory, supply-chain, construction and EPC services to project finance and arranging key off-take agreements through their trade desk. All whilst bridging the cultural and corporate gap through its teams strategically located across the globe in key hubs such as London, Istanbul, Seoul, Zug, Luanda, Lagos and Milan. -
Board Of Directors, Member & Founder Of The Society Of Physician Entrepreneurs(Sope) Turkey ChapterSociety Of Physician Entrepreneurs Jul 2011 - PresentSouth Norwalk, Ct, Ushttps://www.sopenet.org/chapter/turkeyhttp://sopenet.org/board-of-directorsSociety of Physician Entrepreneurs(SoPE) Turkey Chapter is a biomedical and healthcare collaborative innovation network functioning as a chapter of a not-for-profit global network called SoPE. Members include healthcare providers, investors, industry and service providers. The goal is to help Turkish bioentrepreneurs get their ideas to the global market and global entrepreneurs get their ideas to the Turkish market while developing and implementing innovative service platforms, market access or business models. -
Board MemberDünya İslam Sağlık Birliği / World Islamic Health Union Mar 2021 - PresentServing the entire humanity by Supporting Muslim Health Professionals & NGOs around world -
Advisory Board MemberRutgers University May 2017 - Nov 2024New Brunswick, Nj, UsAdvisory Board Member at the Rutgers University Center for Innovation Education Big Data Certificate ProgramRutgers fuels the New Jersey economy by generating $5.2 billion in economic activity as a leading research institution and as the state's third largest nongovernmental employer. Watch our video to learn more.https://lnkd.in/d8DkHtfICG (Istanbul Consulting Group) is planning to provide internship opportunities with Rutgers University for the graduate of this exciting programhttp://bigdata.rutgers.edu/yavuz-silay.html -
Managing PartnerNaturaltvtr Jun 2020 - Oct 2024Çankaya, Ankara, Tr -
International Tv Talk Show HostNaturaltvtr Feb 2020 - Oct 2024Çankaya, Ankara, TrInternational 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 900 million people over 40 countries at NTR TV.
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Co-Founder & PartnerMaqasid Angel Investors Network Feb 2019 - Oct 2024MaQasid Angel Investors Network -
Regional PartnerFastercapital Jan 2018 - Oct 2024With FasterCapital the entrepreneurs are not left alone and the incubator is ready to support the startup and finance it over a period of one to two years until it starts to generate income.As an incubator we provide idea validation, feasibility study, market analysis, product development, help in sales/marketing, mentorship & financial help until the startup is cashflow positive.As a virtual incubator with a unique approach based in Dubai Internet City(UAE). Currently, FasterCapital has more than 20 startups graduated and moe than 10 in the incubation program. FasterCapital has invested more than $10m in the startups that it has. FasterCapital has already more than 200 companies in its acceleration program. FasterCapital presence is worldwide.FasterCapital's focus is on non-technical entrepreneurs. Those entrepreneurs are not usually accepted in standard incubation programs & difficult for them to find the right technical co-founder. We will empower them by offering everything a standard incubator will offer plus becoming their co-funders and technical co-founders. We will be ready to build the product per equity and we are ready to invest between $200k-$2M per startup.FasterCapital has two main programs: - "Acceleration program" where we help startup in mentoring, business validation and financing - "Incubation program" where we provide all the advantages in acceleration program plus becoming a technical co-founder and co-investing up to 75% of the funding required.We were established in 2010 by the name NextStep Systems. We have validated the model with more than 20 successful startups.FasterCapital offers four round of funding per year where entrepreneurs can submit their startup and those accepted can join our "acceleration" or "incubation" programs for free. Internet Startups, Raising funds, Technical development, Wide network of mentors, Co-Funding, Co-Founding, and Virtual Incubator. http://fastercapital.com/regionalpartners/yavuz_selim_silay.html
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ExpertOnfrontiers (Techstars Nyc '16) Oct 2016 - Oct 2024Ny, Ny, UsOnFrontiers is a peer to peer knowledge marketplace for business professionals. Headquartered in New York. -
Board MemberGp Holding A.Ş. Dec 2021 - Apr 2022London, England, GbGreen Power (GP) Holding is set to make the world a better place and to create better opportunities through effective use of innovation, technology, creativity, diversity, and integrity, all in a professional manner. GP Holding was founded by a group of diverse businessmen who has an extensive experience and a successful track record of investment management as well as building and operating businesses in various sectors in four continents. GP Holding is currently operating in Turkey, KSA, UAE, Iraq, Egypt, Kenya, Malaysia, and the USA. GP aims to be a leading company in each sector of its diversified portfolio.GP Holding is managing investments in six main sectors: energy, estate development, trading, services, oil & gas, and hotel management. GP Holding’s strategy is to invest in sectors with high growth potential during the next five years with the ultimate goal of enlarging its investment portfolio and maximizing benefits for all shareholders and stakeholders.We made our decision to lead the scaling phase of our business from the only city that is part of two continents, the bridge between heritage and the future; Istanbul. As it is expected to be the new financial center of the MENA region and Mid-Asia during the next 5 years, besides the fast-paced economic growth taking place in Turkey and the mega projects as a part of this development, Istanbul brings in massive investment opportunities and growth potential.“We, at GP Holding aim to be influential players in the region by leveraging technology in order to be a part of the fast and innovative transformation taking place in the world in general and in the MENA region in particular.http://www.gpholding.net -
Co-Founder Biocube İstanbul, Bioentrepreneurship & Innovation Centerİstanbul Aydin University Dec 2017 - Jul 2020İstanbul, Florya, TrCo-Founder, BioCube İstanbul Bioentrepreneurship & Innovation Center -
General ManagerGurmed Group Jun 2015 - Nov 2016İstanbul, İstanbul, TrManaging the largest distributor of Siemens Diagnostics in Turkey ; a healthcare company with ~220 employees,Strategy and all managerial operations, International and National Sales and Marketing management , Production management, R&D and Innovation, Business development, Supply Chain, Warehouse , Logistic, Import-Export, HR & Recruitment management, Team Building & Change management, Acquisition & Merger ManagementYour solution partner in Laboratory & HealthcareFounded in 1997; Samsun/Turkeyoffices in 4 different cities as İstanbul, Ankara, Samsun and Trabzonoffice and hospital staff total ~220representing Siemens Diagnostics for 8 yearsMain Products Brands:Siemens Healthcare Diagnostics (Regional) Fuji (Project Partner)Biomerieux Diagnostics (Regional)Becton Dickinson(Regional)Sectra (Turkey)2012 Turnover est to USD ~21 million2013 Turnover est to USD ~27 million2014 Turnover est to USD ~30 millionExtensive Product PortfolioWe supply turn key projects in healthcare including establishing hospitals, laboratories and management of National cancer screening in Turkey ( breast cancer, HPV) & therapy projects...Sales, marketing, technical service and application service for Clinical Chemistry, Immunoassay, Urine Analysis, Hematology, Nephelometer, Bacteria ID/AST product range.Managing ~200 customers including Public and Private University Hospitals, Labs. ~550 devices settled in these institutions and growing rapidly. -
CeoLabiopharma & Istanbul Consulting Group 2013 - 2016Istanbul Consulting Group & Labiopharma provides services for the approval of Drugs and Medical Devices by the Food and Drug Administration (FDA). Several consultants formerly FDA and Pharmaceutical experts involved in the drug and devices approval process. We serve clients in the need of an initial or second opinion for navigation of Clinical trials, Market Access, regulatory issues and government submissions,particularly in the areas of US, European and Turkish drug and medical device development and registration, Market Access, Orphan product designation, Regulatory strategy, Market access strategy, Dossier preparation, Project management, Pharmacovigilance, clinical development and medical compliance from early stage development to post marketed products. We provide personal service and exceptional quality. We look forward to serving you for any of your Market Access, regulatory, medical, clinical development, clinical trial recruitment and retention strategy needs.Check our website at http://www.istanbulconsultinggroup.com -
Director, Market Access And Health PolicyAssociation Of Research Based Pharmaceutical Companies (Ai̇fd) Oct 2013 - Jun 2015Reports to the Secretary General and COOSupport Market Access & Health Policy efforts of pharmaceutical companies(Abbott, Abbvie, Actelion, Alcon, Alexion, Allergan, Amgen, Astellas, Astra Zeneca, Bausch and Lomb, Bayer, Boehringer Ingelheim, Briston, Myers Squibb, Celgene, Chiesi, Daichi Sankyo, Eczacibasi Baxter, Ferring, Fresenius Kabi, Gilead, GSK, IE Ulagay, Johnson & Johnson, Lilly, Lundbeck, Merck Serono, MSD, Nestle, Novartis,Novonordisk, Nutricia, Pfizer, Roche, Sanofi, Servier, Shire, Takeda, UCB) based in TurkeyClosely monitors changes and developments in Social Security Instittute (SSI) policies & practices and in reimbursement processes & proposes relevant recommendations for AİFD in a formal report. Analyzes data related to healthcare expenditure, demographics, socio-economic situation & market access & proposes relevant solutions in a formal report. Work together with stakeholders in development & follow up of regulation changes related to regulatory, pricing and reimbursementFacilitate, manage and keep minutes of Access Strategic Management Committee and Registration, Pricing and Reimbursement Committee activitiesParticipate in pricing and registration negotiations and discussions with the Ministry of Health (MoH) to represent AIFDPreparation of AIFD-related position papers, education materials, presentation, web-site content related to reimbursement issues.To collect Members’ feedback/data as requested by the Ministries or other official bodies.To conduct surveys in related areaTo ensure the cooperation and information-exchange with EFPIA, IFPMA, PhRMA and other International and local (sectoral and sector related) institutions, Ministries,etc.To participate and/or accompany Secretary General to sectoral and sector related meetings within Turkey, US and EuropeTo coordinate AIFD Workgroup activities such as patients support group, pharmacovigilance, otc, biologics and biosimilars, orphan productsTo coordinate projects and workshops.
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ConsultantThe World Bank Sep 2013 - May 2015Washington, Dc, UsAs part of a project funded by The World Bank for the reform in Turkish health care sector providing strategic guidance in the development of Cell and Tissue banking infrastructureThe World Bank has a multidisciplinary staff of more than 9,000 employees from more than 160 countries specializing in economics, public policy, international finance, education, management, social sciences, environmental sciences, healthcare and many other fields. Our headquarters are in Washington, D.C., but more than a third of our staff is based in 100+ regional country offices worldwideThe World Bank carries out projects and provides a wide variety of analytical and advisory services to help meet the development needs of countries and the international community. Get easy access to detailed information on over 11,000 lending projects in over 100 countries from 1947 onwards http://www.worldbank.org/projectsThe World Bank mission is to fight poverty with passion and professionalism for lasting results and to help people help themselves and their environment by providing resources, sharing knowledge, building capacity and forging partnerships in the public and private sectorsThe World Bank is made up of two unique development institutions owned by 188 member countries: the International Bank for Reconstruction and Development (IBRD) and the International Development Association (IDA)Each institution plays a different but collaborative role in advancing the vision of inclusive and sustainable globalization. The IBRD aims to reduce poverty in middle-income and creditworthy poorer countries, while IDA focuses on the world's poorest countries. Their work is complemented by that of the International Finance Corporation (IFC), Multilateral Investment Guarantee Agency (MIGA) and the International Centre for the Settlement of Investment Disputes (ICSID) -
Vice President, Medical Affairs, NeurologyIpsen Sep 2011 - Jan 2013Boulogne Billancourt, FrLead Medical affairs, Neurology in the US for Ipsen, a midsize French specialty biopharmaceutical companyIpsen is a global specialty-driven pharmaceutical company with total sales exceeding €1.1 billion in 2010. Ipsen’s ambition is to become a leader in specialty healthcare solutions for targeted debilitating diseases. Its development strategy is supported by four franchises: neurology / Dysport®, endocrinology / Somatuline®, uro-oncology / Decapeptyl® and hemophilia. Moreover, the Group has an active policy of partnerships. R&D is focused on innovative and differentiated technological patient-driven platforms, peptides and toxins. In 2010, R&D expenditure totaled more than €220 million, above 20% of Group sales. The Group has total worldwide staff of close to 4,500. For more information on Ipsen, visit www.ipsen.com.Company Specialties:Pharmaceuticals, Specialty care: neurology, endocrinology, uro-oncology, hemophilia, Company Research: Peptides, toxins, Manufacturing http://www.ipsenus.com/ -
Vice President, Medical Affairs NeurologyIpsen Biopharmaceuticals Sep 2011 - Jan 2013• 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
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Director, Scientific And Medical AffairsTeva Neuroscience May 2009 - Sep 2011Tel-Aviv, IlDirected 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.http://www.tevapharm.com/ -
Medical DirectorTeva Neuroscience May 2009 - Sep 2011Tel-Aviv, Il• 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
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Associate Director Of Clinical Sciences, Clinical And Medical AffairsKv Pharmaceutical Mar 2008 - Feb 2009Chesterfield, Mo, UsAs the Associate Director of Clinical Sciences, ensuring that clinical programs meet regulatory requirements for approval, satisfy corporate objectives and maximize marketing & market accessopportunities. 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. -
Clinical ScientistForest Research Jan 2007 - Mar 2008Jersey City, Nj, UsSuccessfully 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. -
Physician ScientistForest Laboratories Jan 2007 - Mar 2008UsParticipate 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 areaManaging 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/sNDAWriting Clinical study reports, safety narratives and publicationsWorked on an antidepressant for a new CNS/Pain indication -
Senior Clinical Research CoordinatorBaylor College Of Medicine Jul 2001 - Jan 2007Houston, Texas, UsSenior 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
Yavuz Selim Silay , Md , Mba Education Details
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Washington University In St. Louis - Olin Business SchoolLeadership -
Ankara UniversityMedicine
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Ankara Yıldırım Beyazıt ÜniversitesiFamily Medicine Residency Program
Frequently Asked Questions about Yavuz Selim Silay , Md , Mba
What company does Yavuz Selim Silay , Md , Mba work for?
Yavuz Selim Silay , Md , Mba works for Afroturk Tv
What is Yavuz Selim Silay , Md , Mba's role at the current company?
Yavuz Selim Silay , Md , Mba's current role is Co- Founder and Managing Partner.
What is Yavuz Selim Silay , Md , Mba's email address?
Yavuz Selim Silay , Md , Mba's email address is yavuz.e.1@pg.com
What schools did Yavuz Selim Silay , Md , Mba attend?
Yavuz Selim Silay , Md , Mba attended Washington University In St. Louis - Olin Business School, Ankara University, Ankara Yıldırım Beyazıt Üniversitesi.
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