Stacey Cromer Berman, Phd Email and Phone Number

Vaccines & Immune Therapies

Global Regulatory Lead / Team Lead in the Vaccine & Immune Therapies regulatory group. I led the global regulatory team working on EVUSHELD (AZD7442; two monoclonal antibodies for COVID-19). I started on the program in February 2020 at the beginning of the COVID-19 pandemic. During my time as regulatory lead, the COVID-mAbs went from the lab, to the clinic, and through multiple PhIII studies in different indications. Under my regulatory strategic leadership and successful regulatory defense, EVUSHELD achieved over 50 approvals or authorizations for emergency use/early access, including US EUA, EU and Japan approvals in two indication, pre-exposure prophylaxis and treatment of COVID-19.

RIA global regulatory affairs, working on biologics for autoimmune, inflammation and infectious diseases.

Regulatory Project Manager working in clinical and nonclinical regulatory affairs for biologics in the oncology, neuroinflammation, and infectious disease therapeutic areas at MedImmune/AstraZeneca.

Clinical/Nonclinical Regulatory Affairs for Benlysta.

Graduate biomedical research in the areas of cellular engineering, stem cell biology, radiology/imaging, and neuroscience.

Laboratory of Molecular Biophysics in the National Heart, Lung, & Blood Institute