ePT--the Electronic Newsletter of Pharmaceutical Technology
NIAID Boosts Vaccine Innovation but Draws Controversy
Vaccine start-up companies hoping for funding from the National Institutes of Health (NIH, www.nih.gov) may want to keep on the “nice” list of Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID). As reported earlier this week in The Wall Street Journal (Dec. 6, p.1), the director is granting $500–600 million per year to companies that can deliver on promising developments in novel vaccines.
The article reports that Fauci “draws on the vast scientific expertise within NIH to come up with products and companies worthy of funding,” with the goal of preparing companies ready to bid on contracts under the BioShield program, currently run by the Department of Health and Human Services. The article also points out, however, that Fauci often grants funds to rival companies, including grants to both Sanofi-Aventis and Chiron for the development of a treatment against the H5N1 (avian flu) virus, thereby “pitting them against each other for federal contracts.”
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.