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Dr. Yavuz Silay

Ceo
Labiopharma
14 ash drive
 

Brief Biography:


"International Pharmaceutical Executive", "Business, Strategy, Marketing Savvy Physician Scientist" - Known as Team player, Silobuster,Get Things Done- Entrepreneur, Physician, Scientist Current CEO of SILAY GROUP; consists of SILAY Regulatory and Medical Consulting, LLC, Labiopharma and LabioQuest Ventures A value-driven medical leader with successful track record.Core Competencies include: - Leadership & Team Building - Interpersonal Communication - Analytical Thinking - Crisis Management - Public Speaking - Strategic Planning - Clinical development - Medical Affairs - Innovation and entrepreneurialism - New product development and lifecycle management of existing products - Business development Previous experience w KV Pharmaceutical/ETHEX/Ther-Rx: Ensuring that clinical programs meet regulatory requirements for approval, satisfy corporate objectives and maximize marketing opportunities.Study designs are aligned with regulatory requirements, product concept, marketing objectives, corporate goals. Interaction with FDA.Development of generic and branded regulatory strategic plans for new product development, life cycle management of marketed products.Managing medical writers and vendors Providing clinical and scientific review and evaluation of potential products and in-licensing opportunities.Developing publication plans and directing the evaluation and analysis of clinical data to assist translation of data from clinical studies to promotional and educational materials and publications

 

Academic positions:


Education:

1. 2008 – 2010: Washington University in St. Louis - Olin Business School Executive MBA (Marketing, Strategy, Leadership)
2. October 2004: Certified Clinical Research Professional (CCRP)
3. 2000 - 2002: The University of Texas MD Anderson Cancer Center Houston, Tx
4. July 1999 – August 2000: Clinical Internship; Clinical Internship at Baylor College of Medicine, University of Texas Houston Medical School and University of Ankara Faculty of Medicine         
5. October 1993-July 1999: University of Ankara Faculty of Medicine Ankara, Turkey
6. 1986-1993: Iskenderun Anatolian High School Iskenderun, Turkey

Professional Experience:

1. September 2011-Present: Ipsen Biopharmaceutical Inc. Basking Ridge, New Jersey
Vice President, Medical Affairs, Neurology
2. May 2010-September 2011: Teva North America Branded Products (TNABP), Kansas City, MO
Medical Director (Therapeutic medical head) , Medical Affairs
3. May 2009-May 2010: Teva Neuroscience, Inc- Kansas City, MO Director, Scientific Affairs and Medical Research
4. February 2009: SILAY Regulatory and Medical Consulting, LLC- Neptune, NJ President, CEO and CMO
5. March 2008 – February 2009: KV Pharmaceutical, Ther-Rx Corporation and ETHEX corporation- St. Louis, MO Associate Director of Clinical Sciences
6. January 2007 – March 2008: Forest Research Institute, Forest Laboratories, Inc. CNS-    Jersey City, NJ Physician/Clinical Scientist , Clinical Development.
7. January 2005 – January 2007: Baylor College of Medicine Department of Medicine, Pulmonary/Critical Care Section-Houston, Tx Senior Research Coordinator/ Director of Lung transplant research program
8. September 2003 – January 2005: Baylor College of Medicine Department of Neurology Parkinson’s Disease Center and Movement Disorder Clinic –Houston, TX Senior Research Coordinator
9. July 2001 – August 2003: Baylor College of Medicine Department of Neurosurgery, Neuro intensive Care Unit Clinical Research Assistant

 

Research interests:


Clinical Research, Medical Entrepreneurship, Strategic management consulting, Regulatory and Medical Consulting, Clinical Development, Medical Affairs, drug and medical device development, clinical trial design, Neurology, Oncology

 

Any other information:


Publications

1. Drug eluting stents for acute myocardial infarction. Yeter E, Kurt M, Silay Y, HV Anderson, Denktas AE,  Expert Opinion in. Pharmacotherapy. (2009) 10(1)
2. Intravenous flumazenil for Parkinson's disease: A single dose, double blind, placebo controlled, cross-over trial. Mov Disord. 2006 Jul 7; [Epub ahead of print] PMID: 16830315
3. Subthalamic deep brain stimulation in patients with a previous pallidotomy. Ondo WG., Silay Y, Almaguer M, Jankovic J. Movement Disorders 2006[ PMID: 16673406]
4. The lack of activity of Imatinib mesylate in small cell lung carcinoma expressing c-kit protein. Altundag O, Altundag K, Boruban C, Silay YS, Turen S. Cancer 2005  [PubMed - in process]
5. Pure and mixed hormone receptor positive breast tumors: are they different from therapeutic point of view? Altundag K, Altundag O, Gunduz E, Silay YS, Boruban C.  Medical Hypotheses 2005  
6. HER/2 neu intragenic kinase domain mutations may be a major determinant of response to trastuzamab or specific kinase inhibitors in non-small cell lung cancer patients.  Ozden Altundag, Kadri Altundag, Bulent Ozcakar, Yavuz S. Silay   Lung Cancer 2005 [PubMed - in process]
7. Cross-Talk Between Cyclooxygenase-2 and Epidermal Growth Factor Receptor in Non-Small Cell Lung Cancer. Ozden Altundag, Kadri Altundag, Cem Boruban, Yavuz S. Silay   Lung Cancer 2005
8. Bisphosphonates may inhibit development of atherosclerosis formation through its bactericidal effect on nanobacteria. Yavuz S. Silay MD, CCRP, Kadri Altundag MD, Ozden Altundag MD, Mustafa A. Atik MD, Mustafa Ozen MD, PhD Medical Hypotheses 2005
9. Botulinum Toxin Treatment for Oromandibular Dystonia and Bruxism in Patients with Tourette Syndrome Yavuz S. Silay M.D., Joseph Jankovic MD 57th Annual Meeting of the American Academy of Neurology Miami Beach, Florida Neurology Volume 65 P03.145 April 2005
10. Emerging drugs in Tourette Syndrome Yavuz. S. Silay M.D., Joseph Jankovic MD Expert Opinion on Emerging Drugs 2005  
11. Parkinsonism associated with adalimumab in a patient with rheumatoid arthritis. Tintner R., Silay YS, Sessons S, Jankovic J. Mov Disord 2005;20(Suppl 10):S16.
12. Intravenous Flumazenil for Parkinson’s Disease: A Double Blind, Placebo Controlled, Cross-Over Trial William G Ondo, MD, Yavuz S. Silay, MD (Platform presentation) Symposia on Etiology, Pathogenesis, and Treatment of Parkinson’s Disease and Other Movement Disorders, October 3, 2004 Toronto, Ontario, Canada
13. SRL172 (killed Mycobacterium vaccae ) may augment the efficacy of trastuzumab in metastatic breast cancer patients Kadri Altundag M.D., Ali-Seyed Mohamed, Ozden Altundag M.D. , Yavuz Selim Silay M.D., Esra Gunduz M.D., Kadir Demircan M.D. Medical Hypotheses. 2005;64(2):248-51. PMID: 15607548 [PubMed - in process]
14. Selenium supplementation may increase the efficacy of cetuximab in metastatic colorectal cancer patients. Altundag K, Silay YS, Altundag O, Yigitbasi OG, Gundeslioglu O, Gunduz M. Medical Hypotheses [PubMed - in process]
15. The Safety of Deep Brain Stimulation in Patients with Patients with Parkinson’s Disease Essential Tremor and Other Movement Disorders Yavuz S. Silay, M.D., Joseph Jankovic, M.D. , Kevin D. Vuong, M.A. , Michael Almaguer, R.N. , William Ondo, M.D. , Ron Tintner, M.D. and Richard K. Simpson, M.D.,Ph.D..  129th Annual Meeting of the American Neurological Association 7th Annual Neurology Outcomes Symposium, October 3-6, 2004 Toronto, Ontario, Canada published in Annals of Neurology Volume 56, Issue 6 S54 (Pages 916-926) ISSN: 1531-8249 (Online) ISSN: 0364-5134 (Print)
16. Is Depression a Predictor of Outcome after Bilateral Subthalamic Deep Brain Stimulation in Patients with Parkinson’s Disease? Michele K. York, PhD, Yavuz S. Silay, M.D., Naomi S. Chaytor, M.S., Richard K. Simpson, M.D., Ph.D. , Joseph Jankovic, M.D. Movement Disorder Society's 8th International Congress of Parkinson's Disease and Movement Disorders June 13 - 17, 2004 Rome, Italy
17. The efficacy and tolerability of fluphenazine in patients with tourette  syndrome Yavuz S. Silay, M.D.,  Kevin D. Vuong,M.A., and Joseph Jankovic,M.D., Houston, Tx 4th International Scientific Symposium on Tourette Syndrome June 25-27 2004 Cleveland, Ohio
18. Botulinum toxin treatment for oromandibular dystonia and bruxism with tourette syndrome Yavuz S. Silay, M.D., Joseph Jankovic,M.D., Houston, Tx 4th International Scientific Symposium on Tourette Syndrome June 25-27 Cleveland, Ohio
19. The safety of deep brain stimulation in patients with Parkinson’s disese, essential tremor, and other movement disorders. Silay YS, Jankovic J, Vuong KD, Almageur M, Ondo W, Tintner R, Simpson RK.  Ann Neurol 2004;56 (Suppl 8):S54-55
20. The efficacy and safety of fluphenazine in patients with tourette syndrome Yavuz S. Silay, M.D.,  Kevin D. Vuong,M.A., and Joseph Jankovic,M.D., Houston, Tx, 56th Annual Meeting of the American Academy of Neurology San Francisco , California Neurology Volume 62 P06.128 April 2004 (Suppl 5)
21. Calcium and Vitamin D supplementation during bisphosphonate administration may increase osteoclastic activity in patients with bone metastasis Ozden Altundag M.D. Kadri Altundag M.D. Selim Silay Y M.D., Mehmet Gunduz M.D. PhD. , Kadir Demircan M.D. Ibrahim Gullu M.D. Medical Hypotheses 2004; 63(6):1010-1013  PMID: 15504568 [PubMed - in process]  
22. Evaluation  of Tissue Injury Underlying Acute Traumatic Subdural Hematoma Roman Hlatky M.D., Maria Briones, M.D., Yavuz Silay M.D., Alex B. Valadka M.D., Claudia S. Robertson, M.D. Trauma & Critical Care [Article ID: 19675] American Association of Neurological Surgeons May 3 2004
23. Significance of a reduced cerebral blood flow ultra-early after severe head injury  Hlatky R, Silay YS, Praharaj S, Valadka AB, Robertson CS Young investigator Clinical Research Symposium 1;12 2002 (Entitled for Young Investigator Clinical Research Award by Baylor College of Medicine)
24. Heterogeneity of Regional Cerebral Blood flow following severe head injury Galang M, Hlatky R, Praharaj S, Silay YS, Valadka AB, Robertson CS The Journal of Neurotrauma Volume 19 Number 10 P285 October 2002 ISSN:0897-7151
25. Evaluation of cerebral circulatory arrest by (transcranial) ultrasonography  Silay YS, Hlatky R, Praharaj SS, Galang M, Valadka AB, Robertson CS Young investigator Clinical Research Symposium 1;25 2002
26. Dynamic Autoregulatory Response following severe head injury   Hlatky R, Silay YS, Praharaj S , Valadka AB, Robertson CS Young investigator Clinical Research Symposium 1;11 2002
27. Time Course of Brain Tissue Hypoxia in the penumbra region after trauma Roman Hlatky,Yavuz S. Silay,Shanti Praharaj,Maria C Briones-Galang, Alex B Valadka,Claudia S Robertson The Journal of Neurotrauma Volume 19 Number 10 P257 October 2002 ISSN:0897-7151
28. ANCHOR-CD (AbobotulinumtoxinA Neurotoxin: Clinical & Health Economics Outcomes Registry in Cervical Dystonia): A multicenter, Observational study of Dysport in Cervical Dystonia: Baseline Data and Interim Outcomes Data American Academy of Neurology 64th Annual Meeting, April 21 to April 28, 2012
29. ANCHOR-CD (AbobotulinumtoxinA Neurotoxin: Clinical & Health Economics Outcomes Registry in Cervical Dystonia): A Multicenter, Observational Study of Dysport in Cervical Dystonia: Baseline Data and Cycle One Outcomes Data The Movement Disorders Society (MDS )16th International Congress of Parkinson's Disease and Movement Disorders
30. ANCHOR-CD (AbobotulinumtoxinA Neurotoxin: Clinical & Health Economics Outcomes Registry in Cervical Dystonia): A Multicenter, Observational Study of Dysport in Cervical Dystonia: Patient Demographic, History, and Health Economics Data The Movement Disorders Society (MDS )16th International Congress of Parkinson's Disease and Movement Disorders
31. ANCHOR-CD (AbobotulinumtoxinA Neurotoxin: Clinical & Health Economics Outcomes Registry in Cervical Dystonia): A Multicenter, Observational Study of Dysport in Cervical Dystonia: Baseline Data and Cycle One Outcomes Data The College of Psychiatric and Neurologic Pharmacists (CPNP)  2012 annual meeting
32. ANCHOR-CD (AbobotulinumtoxinA Neurotoxin: Clinical & Health Economics Outcomes Registry in Cervical Dystonia): A Multicenter, Observational Study of Dysport in Cervical Dystonia: Patient Demographic, History, and Health Economics Data The College of Psychiatric and Neurologic Pharmacists (CPNP)  2012 annual meeting 

 

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