CEPI (Coalition for Epidemic Preparedness Innovations)
Danielle Craig serves as the Regulatory Affairs Lead for the Americas at CEPI since June 2021, overseeing regulatory aspects of clinical trials and product approvals. Prior to this role, Danielle held various leadership positions in regulatory affairs at DynPort Vaccine Company LLC, including Sr. Director of Regulatory Affairs & Quality Systems, where responsibilities encompassed managing IND submissions and regulatory guidance for product development. Previous experience includes roles at Prometic, Emergent BioSolutions, and positions in document control and inventory management at Schuler Books and Music, and Michigan State University. Danielle holds a B.S. in Genomics and Molecular Genetics from Michigan State University and has completed graduate studies in Bioscience Regulatory Affairs at Johns Hopkins University.
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CEPI (Coalition for Epidemic Preparedness Innovations)
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CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines against future epidemics. Prior to COVID-19, CEPI’s work focused on developing vaccines against the Ebola Virus Disease, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and Chikungunya virus. It has over 20 vaccine candidates against these pathogens in development. CEPI has also invested in new platform technologies for rapid vaccine development against unknown pathogens (Disease X). During the COVID-19 pandemic, CEPI initiated multiple programmes to develop vaccines against SARS-CoV-2 and its variants with a focus on speed, scale, and access. These programmes leverage the rapid response platforms developed by CEPI’s partners prior to the emergence of COVID-19, as well as new collaborations. The aim is to advance clinical development of a diverse portfolio of safe and effective COVID-19 candidates and to enable fair allocation of these vaccines worldwide through COVAX. CEPI’s 5-year plan lays out a $3.5 billion roadmap to compress vaccine development timelines to 100 days, develop a broadly protective vaccine against COVID-19 and other Betacoronaviruses, and create a “library” of vaccine candidates for use against known and unknown pathogens. The plan is available at www.endpandemics.cepi.net