Bluejay Therapeutics, a clinical-stage biopharmaceutical company focused on serious viral and liver diseases, has strengthened its executive leadership with the appointment of Mary Cromwell, Ph.D., as Senior Vice President and Head of Technical Operations. The strategic hire comes at a crucial time as the company advances its pipeline of liver disease therapeutics.
Dr. Cromwell brings more than three decades of biotechnology operations and technical leadership experience to Bluejay. Her expertise spans end-to-end process development, quality assurance, and manufacturing strategy – critical competencies as the company progresses its therapeutic candidates toward commercialization.
Extensive Industry Experience
Prior to joining Bluejay, Dr. Cromwell served as Chief Technology Officer at Allakos, where she spearheaded technical operations and manufacturing strategy. Her most notable experience comes from Genentech/Roche, where she rose to the position of Vice President and Head of Quality, Drug Substance. During her tenure, she played an instrumental role in the licensure of several breakthrough products, including Avastin® and Perjeta®, and served on the Genentech Foundation Board.
"Mary is a seasoned biotech executive with a track record of exceptional leadership in sciences, formulation, quality, management, process development and BLA submissions," said Keting Chu, M.D., Ph.D., Founder and Chief Executive Officer of Bluejay Therapeutics. "I am thrilled to welcome her to Bluejay Therapeutics as we continue our efforts to advance new therapeutic options for people living with chronic hepatitis D and chronic hepatitis B."
Advancing Breakthrough Therapies
The appointment comes as Bluejay's lead candidate, brelovitug (BJT-778), gains significant regulatory momentum. The drug recently received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis delta (CHD). This designation follows previous recognitions from the European Medicines Agency (EMA), including PRIME and Orphan designations.
Pipeline Development
Beyond brelovitug, Bluejay is advancing several innovative programs aimed at developing a combination regimen for chronic hepatitis B (CHB). These include a proprietary TLR9 agonist called cavrotolimod and a liver-targeted hepatitis B virus transcript inhibitor (BJT-628).
Dr. Cromwell's academic credentials include a Ph.D. from the University of Colorado, Denver, a master's degree in biophysical chemistry from the University of California, Berkeley, and a bachelor's degree in chemistry from West Virginia University. Her comprehensive educational background and extensive industry experience position her well to drive technical operations at Bluejay Therapeutics as the company advances its promising pipeline of liver disease treatments.