Kristian Agnew
- Role
- Executive Director, Technical Operations at Dynavax Technologies
- Location
- Boulder, CO, US
- LinkedIn followers
- 500 followers
About Kristian Agnew
Experienced pharmaceutical leader in cGMP development, manufacturing and licensure of…
Experience
Executive Director, Technical Operations
Jun 2017 — Present
Responsible for providing strategic direction, technical oversight and leadership of internal and external (CMO) manufacturing. Dynavax Technologies Corporation is a fully-integrated biopharmaceutical company focused on leveraging the power of the body’s innate and adaptive immune responses through Toll-like Receptor (TLR) stimulation. Dynavax develops, and commercializes novel vaccines. We are committed to a rigorous approach to drug development in the field of TLR biology so that we may help physicians and patients address unmet needs. Commercial Product: HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] HEPLISAV-B® is an adult hepatitis B vaccine that was approved by the U.S. Food and Drug Administration (FDA) on November 9, 2017 and European Commission Marketing Authorization on February 18, 2021. CpG 1018 Adjuvant CpG 1018 is the adjuvant used in HEPLISAV-B®. Dynavax developed CpG 1018 to provide an increased vaccine immune response, which has been demonstrated in HEPLISAV-B®. CpG 1018 provides a well-developed technology and a significant safety database, potentially accelerating the development and large-scale manufacturing of vaccines. COVID-19 CpG 1018 Adjuvant Supply Business: Clover Biopharmaceuticals (COVID-19 vaccine SCB-2019), Biological E. Limited (COVID-19 vaccine CORBEVAX), Valneva (COVID-19 vaccine VLA2001), and Medigen Vaccine Biologics Corp (MVC-COVID-19 vaccine). Vaccine Development/Clinical Pipeline: Pertussis-Tdap vaccine, Shingles vaccine, and Plague vaccine. Collaborations include: The Coalition for Epidemic Preparedness (CEPI), the Bill & Melinda Gates Foundation, U.S. Department of Defense (plague vaccine), and the Icahn School of Medicine at Mount Sinai (universal influenza vaccine funded by National Institute of Allergy and Infectious Diseases and National Institutes of Health (NIH)).
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