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Mathias Hukkelhoven PhD

Former Senior Vice President, Global Regulatory, Safety & Biometrics

Bristol Myers Squibb (BMS)

Dr. Mathias Hukkelhoven, PhD, is an experienced global regulatory and drug development leader. He previously served as Senior Vice President, Global Regulatory, Safety & Biometrics at BMS and was also responsible for the R&D Group in BMS China and the Clinical Pharmacology and Pharmacometrics group. Math was accountable for setting regulatory strategy and driving execution of global regulatory and pharmacovigilance plans for BMS. He led the regulatory and development efforts across the product development and commercialization process to ensure optimal regulatory strategy and interactions at each step of the process.

Prior to joining BMS, Math held the role of Chairman Portfolio Stewardship Board at Novartis Pharmaceutics and served as the Senior Vice President, Global Head Drug Regulatory Affairs at Novartis from 2001 to 2009. He also worked at Hoffmann LaRoche (Switzerland) and Organon (The Netherlands). Over the course of his career, Math contributed to more than 50 NCEs and hundreds of new indications and line extensions.  Math has participated in activities that have shaped Health Authority interactions, including serving as chairperson of the Regulatory Affairs Coordinating Committee at PhRMA, and recently as a PhRMA negotiator for the PDUFA VII negotiations with the FDA.

Math received his BS and PhD honors degrees in Biology and Biochemistry from the University of Nijmegen, the Netherlands.

Math also serves on the Board of Directors of Compugen Ltd, and since his retirement from BMS in July 2021, is a Senior Advisor to McKinsey and a R&D Strategy Advisor to LianBio.

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SerpinPC

Overview
SerpinPC is a subcutaneously administered novel inhibitor of APC being developed as a potential treatment for hemophilia, regardless of severity or inhibitor status, and may also prevent bleeding associated with other bleeding disorders. Centessa is advancing the registrational program for SerpinPC in hemophilia B, which includes a set of clinical studies with multiple components. PRESent-5, initiated in late 2022, is an observational feeder study to collect prospective observational data for minimum defined periods before switching to dosing subjects in the interventional studies. The interventional studies include PRESent-2 (moderately severe to severe hemophilia B without inhibitors, and severe hemophilia A with and without inhibitors) and PRESent-3 (hemophilia B with inhibitors). Additional information on the trials can be accessed at www.clinicaltrials.gov  (NCT05605678NCT05789524NCT05789537). SerpinPC is an investigational agent that has not been approved by the FDA or any other regulatory authority.

Reason to Believe in Target
Human Genetics Support

Epidemiology
~20,000 persons with hemophilia in the United States
450,000 estimated global prevalence
Disease

Hemophilia B