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  • Dr Alex Kudrin, MD, MBA, PhD
  • Biopharmaceutical Consultant
  • United Kingdom

Dr. Alex Kudrin brings 20 years’ experience in global clinical development and clinical research. His expertise is recognized at the global level as one of the most prominent figures in biosimilar and biologics development and non-conventional development strategies, maximizing the use of regulatory mechanisms and innovative approaches to drug development, to bring innovative and affordable technologies to patients. Dr. Kudrin also provides strategic advice for interacting with FDA and EMA. He participates in due diligences and negotiations for licensing, mergers and acquisitions. Most recent highlight was his role as presenter for the clinical development of the first biosimilar rituximab CT-P10 considered by FDA Oncologic Drug Advisory Committee (ODAC) held on 10th October 2018.Previously, Dr Alex Kudrin was a Head of Global Development at Celltrion and has led biosimilar development programs through conception phases of clinical studies through negotiations with FDA and EMA towards the global approvals in multiple territories: biosimilar infliximab CT-P13 (Remsima/Inflectra), biosimilar rituximab (Truxima), biosimilar trastuzumab (Herzuma). Dr Kudrin led preparation and was a main presenter and chair for the CT-P13 (Inflectra) FDA Arthritis Advisory Committee preparation that was held in February 2016. He assembled numerous expert advisory boards and DSMB panels composed of global clinical experts in rheumatology, gastroenterology, oncology, immunology, influenza and orphan diseases. During his assignment as Global Therapeutic Lead at Takeda/Millennium, Dr Alex Kudrin also led efforts for development and approval of Entyvio (vedolizumab) in inflammatory bowel diseases. During his time at MHRA Dr Kudrin led on >150 various scientific advice procedures and assessments for the CHMP, and the Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh) and frequently presented at MHRA , CHMP, EMA expert advisory group and joint FDA – EMA meetings. Alex is also responsible for providing medical and regulatory input for safety efficacy and pharmacovigilance activities including Risk Management Plans for various products. Dr Kudrin has been involved in designing and scientific advice for >100 clinical studies across rheumatology, gastroenterology, oncology and haematology. Dr. Kudrin is regularly invited as a key expert speaker in international conferences. Alex earned multiple degrees includingma MD from the Orenburg Medical School in Russia, PhD from Moscow Medical University, MBA with Distinction from Westminster Business School in London, MSc in Toxicology with Distinction from Imperial Colleague in London, MRCP (UK) and Fellowship from the Faculty of Pharmaceutical Medicine. Dr Kudrin is author of >70 publications including 5 books.