Yavuz Silay

Yavuz Silay



As the Associate Director of Clinical Sciences at KV Pharmaceutical - Ther-Rx and ETHEX Corporations,ensuring that clinical programs meet regulatory requirements for approval, satisfy corporate objectives and maximize marketing 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.Development of generic and branded regulatory strategic plans for new product development as well as life cycle management of marketed products.Maintain effective relationships with other functional areas (R&D, Quality, Assurance, Operations, Corporate Growth and Business Development, Pharmacovigilance).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 in the translation of data from clinical studies to promotional and educational materials and publicationsPrevious experience at Forest labs includes;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 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 as well as different internal departments such as marketing.Submitting NDA/sNDAWriting Clinical study reports, safety narratives and publicationsCurrent president of SOCRA New Jersey Chapter


Internal Medicine(Pulmonary & Critical Care, Asthma, Cystic fibrosis, Sarcoidosis, lung transplant, Diabetic Neuropathy), Neurology ( Movement disorders, Parkinson's, Huntington's, Tourette Syndrome, Alzheimer, Autism), Pain ( Fibromyalgia), CFS (Chronic Fatigue Syndrome), Oncology, Women's health, anemia, Head Trauma Phase I, II and III studies