HOW CAN WE STREAMLINE THE VACCINE DEVELOPMENT PROCESS?
To address the urgency of vaccine development during a pandemic, innovative strategies are implemented across study design, regulatory processes, recruitment process and more. In this e-book, we describe some of those innovations and argue for incorporating these into the fabric of clinical trials – to establish a “new normal.”
What we cover in this e-book:
Vaccine development is inherently lengthy, which creates challenges for addressing infectious disease outbreaks. Although sufficient time must be dedicated to ensuring a vaccine’s safety and efficacy, there are opportunities to streamline processes throughout the study lifecycle.
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In this e-book, we discuss some of the innovative strategies that have been implemented in previous outbreaks as well as the current COVID-19 pandemic to help speed vaccine approval.
- Considerations within clinical trial design
- Establishing and utilizing research networks and partnerships
- Implementing remote monitoring
- Developing flexible review and approval processes
About the contributors
Latrina Watkins, MSc, Director of Global Site Management at FHI Clinical
With more than 14 years of experience, Latrina Watkins, has held positions with multiple CROs and has experience managing complex clinical trials, building site capacity and developing rapid response for trials across multiple therapeutic areas, including infectious diseases, rare disease, and oncology. She also has extensive experience in clinical research and vaccines that includes rapid site start-up process and strategy.
As Director, Global Site Management, Latrina leads the overall direction and strategic implementation of site start-up and trial document management clinical research activities at FHI Clinical.
Latrina holds a bachelor’s degree in Exercise Sports Science from the University of North Carolina at Chapel Hill and a Master’s of Science in Health Sciences – Clinical Research Administration from George Washington University.
Claudia Christian, Senior Vice President of Clinical Operations at FHI Clinical
With more than 25 years of experience, Claudia Christian has held positions in pharmaceutical, biotech and CROs across multiple indications. Since 2014, she has devoted her expertise full-time to infectious disease research, including managing multiple study protocols and developing sites across West Africa during the Ebola outbreak response. Since that time, she has managed millions of dollars in federally and privately funded grants as well as commercially funded vaccine and other therapeutic studies.
As Senior Vice President, Clinical Operations, Claudia leads the overall direction and strategic implementation of program execution for all clinical research activities at FHI Clinical.
Claudia holds a bachelor’s degree in Biology from Trinity College-Hartford and a master’s certification in Education from Saint Joseph College.
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