Nina Malkevich | Senior Director and Product Development Lead - Emerging Infectious Diseases
International AIDS Vaccine Initiative

Nina Malkevich, Senior Director and Product Development Lead - Emerging Infectious Diseases, International AIDS Vaccine Initiative

Prior to IAVI, Nina worked as a senior nonclinical Subject Matter Expert in the Nonclinical Division at BARDA supporting SARS-CoV-2, Ebola, pandemic flu programs focusing on animal model development and testing Medical Countermeasures (MCMs).
Nina has 15 years of experience in scientific leadership and pharmaceutical product development, to include manufacturing/CMC, nonclinical, assay development, regulatory, quality, clinical to licensure of therapeutics and vaccines (botulinum, anthrax, tuberculosis, HIV).  Author of 20 scientific publications who successfully completed more than 60 animal studies (GLP and non-GLP) in support of licensure of MCMs under the FDA Animal Rule sponsored by USG (CBRN Medical, BARDA and NIAID) contracts. Nina’s previous employers were to include, a DynPort Vaccine Corporation, a GDIT company where she served as a Technical Lead overseeing development of a Recombinant Botulinum Vaccine; and Emergent BioSolutions, where she served as a Senior Manager on anthrax vaccines and therapeutics nonclinical programs.


Day 3 - November 30 @ 08:40

Keynote Panel: Beyond Borders: Collaborating for success in developing vaccines for emerging infectious diseases

  • Challenges around stock piling vaccines that are not yet licensed – 
    • need for (relatively small) stockpiles of “vialed and quality-tested vaccines that are ready to be clinically tested in populations as soon as the next outbreak strikes”.
    • Is stockpiling the victim of market failure?
    • Funding mechanisms decoupled from the market
  • Aligning programmatic interests during outbreaks and “peace times
    • Experiences getting Sudan Ebola vaccines to Uganda
  • Alternative regulatory pathways and accelerated development
  • Aligning interests & objectives of international funding partners

Day 3 - November 30 @ 11:15

Vaccine development programs for emerging infectious diseases; lassa, marbug, Ebola Sudan

last published: 02/Jan/24 12:15 GMT

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