Jerome Bressi, Ph.D.
About Jerome Bressi, Ph.D.
Jerome Bressi Professional Background
Jerome Bressi, Ph.D., currently holds the position of Senior Vice President, Regulatory & Quality. He has over 25 years of experience in the biotechnology and pharmaceutical industries, focusing on drug discovery and development. His expertise spans across oncology, autoimmune, and inherited genetic disorder therapeutic areas. His career includes significant roles at BioPharma Regulatory Solutions, Janssen Research & Development, Hyperion Therapeutics, and Mast Therapeutics.
Jerome Bressi Education Background
Jerome Bressi earned his Ph.D. from the Department of Chemistry at the University of Washington. Prior to that, he completed his B.S. in Chemistry at the University of California, San Diego. His academic background has provided a strong foundation for his extensive career in regulatory and quality aspects within the biotech and pharmaceutical sectors.
Jerome Bressi Role at BioPharma Regulatory Solutions
Jerome Bressi served as the President of BioPharma Regulatory Solutions. In this role, he was responsible for guiding the company's regulatory strategies. His leadership played a pivotal role in navigating complex regulatory landscapes, ensuring compliance, and streamlining the approval processes for therapeutic products.
Jerome Bressi Experience at Janssen Research & Development
While at Janssen Research & Development, Jerome Bressi contributed as a Dossier Development and Operations Lead for the TREMFYA™ (guselkumab) BLA, MAA, and NDS applications. He also worked on the sBLA for the TREMFYA™ One-Press patient-controlled injector. His efforts were instrumental in the submission and regulatory approval processes for these significant pharmaceutical products.
Jerome Bressi Regulatory Leadership at Hyperion Therapeutics and Mast Therapeutics
Jerome Bressi has held key regulatory positions at Hyperion Therapeutics and Mast Therapeutics. In these roles, he was integral to the development and successful regulatory approval of several therapeutics. His extensive experience and strategic insights were pivotal in advancing the regulatory processes and ensuring compliance with industry standards.