Uwe Gudat has over 10 years of experience in the biosimilars industry and has worked at leading global pharmaceutical companies for nearly 30 years. As the Chief Medical Officer of Biocon Biologics, he heads Clinical Development, Medical Affairs, Pharmacovigilance, and Drug Safety, across geographies. He will drive clinical strategies, ensuring efficient progress of products through clinical trials and regulatory approvals. He is also responsible for establishing key scientific relations with experts in the U.S. and EU, forming a strong advisory board for Biocon Biologics’ pipeline products. Additionally, Uwe will oversee compliance and audit readiness in the areas of Pharmacovigilance and Clinical Development. A passionate advocate for technology, Uwe is committed to scaling up activities for medical education and increasing patient outreach exponentially using social media.
In a career spanning three decades, Uwe has worked with leading global pharmaceutical companies, including Eli Lilly, Actelion, Novartis, Merck KGaA, and Fresenius Kabi. Before joining Biocon Biologics, he served as Chief Medical Officer of Aretaeus Sarl, a drug discovery and development incubator focused on Type 1 and 2 diabetes mellitus and obesity.
Uwe is an experienced clinician specializing in internal medicine, diabetes, and obesity. He also has extensive hands-on experience of working throughout the entire lifecycle of both small molecules and biological entities, across various therapeutic areas such as cardiovascular and metabolism, neuroscience, oncology, hematology, rheumatology, and immunology. He has expertise in the assessment of non-clinical data, development of efficient clinical strategies and dynamic research methodologies, clinical safety oversight, evaluation of clinical safety data, design and compilation of dossiers (clinical sections), responding to queries from health authorities, and safety strategy encompassing Risk Management Plans (RMP) and Risk Minimization Measures (RMM). He also has experience in post-authorization medical product stewardship, including medical affairs and pharmacovigilance.
Uwe holds an MD from the Philipps University in Marburg, Germany. He is licensed in internal medicine and sub-specialized in metabolic disorders. As a clinician, he trained under Professor Michael Berger in Düsseldorf, Germany, at the WHO Collaborating Center for Diabetes Education.
