Jaime E. HernandezExecutive Medical Director, Infectious Disease and Vaccines at Syneos Health
An Infectious Disease specialist with extensive leadership experience in all facets of clinical development, medical affairs, safety & pharmacovigilance, and business development •Over 25 years of experience in academic medicine, large pharmaceutical, small biotechnology companies and CROs. •Experience in Phase I-IV clinical trials for both small molecules and biologics, including the first use of pharmacogenomics in HIV •Led the development, regulatory approval and global launch of several antiviral compounds including the first triple combination tablet in HIV, as well as multiple antimicrobials and vaccines. Anti-bacterial experience includes complicated hospital infections such as HABP/VABP, sepsis, bacteremia and others •Antiviral and vaccine experience during the 2009 H1N1 influenza A pandemic, and the Ebola and Zika epidemics, including the first Emergency Use Authorization for an unapproved drug in the US. Currently the medical lead for the Syneos Health COVID-19 accelerator response team •In depth experience with global regulatory strategy, with multiple successful FDA, EU, Health Canada, Japanese, and other Health Authority interactions •Author of multiple peer reviewed publications, abstracts and oral presentations, ad hoc reviewer for several peer reviewed ID and HIV journals
At Syneos Health:
Leads the Vaccines and ID medical group, responsible for providing therapeutic advise to client companies and discuss medical strategy for development programs in Infectious Disease and Vaccines. •Builds relationships with Medical counterparts in client organizations.