Marina Weisfelner is an Attorney at Law specialized in Commercial & Regulatory Law in Biopharmaceutical and Medical Device R&D field.
Marina holds an LL.B and Master’s degree in Law Studies.
Professionally, Marina grew up at Innovative R&D Division in TEVA Pharmaceutical Industries LTD., there she served in operations of multi-national, multi-center clinical trials. Marina also served as an Chief Operating Officer of Clinical & Regulatory Affairs in bio-pharmaceutical start-up.
She brought her vast experience in the clinical and regulatory into her legal practice while working as an attorney for the one of the leading Law Firms in the field.
As an Attorney she is specialized in commercial and contracts law, focusing compliance with major regulatory authority’s guidelines and regulations. Marina also has expertise in the full range of product development stages challenges, such as interactions and contracting with contract manufacturing organizations (CMOs), nonclinical and clinical lab services and other service providers.
Marina has a vast experience in identifying and assessing compatibility of contract research organizations (CROs) to Sponsor’s needs and identifying and contracting Key Opinion Leaders (KoLs) in various clinical indications.
In addition, in a framework of commercial aspects of bio-pharmaceutical development Marina has an expertise in performing clinical and legal-regulatory due diligence (including Trial Master File reviews) in connection with licensing transactions related to biotechnology, medical devices and pharmaceuticals at all stages of development, and in advising on regulatory aspects and challenges to be expected for potential targets for clients investment, by reviewing and assessing the overall development strategy, both in terms of funding, development status and timelines.