Biocon Biologics  /  About Us  /  Leadership Team  /  Uwe Gudat

Uwe Gudat

Chief Medical Officer

Uwe Gudat

Chief Medical Officer

Dr. Uwe Gudat is the Chief Medical Officer of Biocon Biologics and heads Clinical Development, Medical Affairs, Pharmacovigilance, and Drug Safety across geographies.

Uwe joined Biocon Biologics in September 2023. He has over 10 years of experience in the biosimilars industry and has worked at leading global pharmaceutical companies for nearly 30 years.

Uwe will be instrumental in driving Biocon Biologics’ clinical strategies, ensuring efficient progress of its products through clinical trials and regulatory approvals.

In this role, he will also work closely with Biocon Biologics’ commercial teams across regions and provide them invaluable medical support and insights, thus contributing to the success of the Company’s commercialized products.

He will also be 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, he will oversee compliance and audit readiness in the areas of Pharmacovigilance and Clinical Development.

A passionate advocate for technology, he is also committed to scaling up activities for medical education and increasing patient outreach exponentially using social media.

Uwe brings a wealth of experience to the Company. Before joining Biocon Biologics, Uwe served as Chief Medical Officer of Aretaeus Sarl, a drug discovery and development incubator focused on Type 1 and 2 diabetes mellitus and obesity.

In a career spanning 28 years, Uwe has worked with leading global pharmaceutical companies such as Eli Lilly, Actelion, Novartis, Merck KGaA, and Fresenius Kabi.

Uwe is an experienced clinician specializing in internal medicine, diabetes, and obesity. He also has extensive hands-on experience of working throughout the entire life cycle 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 a M.D. degree 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 Prof. Michael Berger in Duesseldorf, Germany, at the WHO Collaborating Center for Diabetes Education.