Clinical trials of vaccines differ from those of drugs and can pose additional challenges due to disease seasonality.
Seasonal studies present unique challenges to ensure successful execution, enrollment in advance of the season, and thorough disease surveillance. Join us for this webinar to learn best practices and considerations for effective execution of seasonal vaccine studies. Get insights from four seasonal vaccine efficacy case studies that demonstrate best practices across the duration of the study; from country and site identification, through enrollment and surveillance to database lock.
Topics covered include:
- Study planning
- Achievement of study start up/regulatory activities to activate all sites simultaneously
- Creative execution of risk based activities
- Importance of aggressive disease surveillance
- Acquisition of quality data
- Leveraging technologies that enhance data quality
- Clinical operations staff (VPs, Directors, PMs, CTMs, CRAs)
- Staff supporting site start up
- Management staff overseeing seasonal studies
- Other operational staff of all levels (Data Management, IWRS, Labs, ePRO, Clinical/Non-Clinical Supply, etc.)
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Cynthia Dukes, PA-C, MT
Vice President, Drug Development Services, Vaccines, Infectious Disease
Cindy Dukes has over 40 years of diversified clinical experience, including 34 years of clinical research focused in infectious disease, vaccines, oncology, women’s health and rare disease. At ICON she is the therapeutic expert for vaccines and leads ICON’s Vaccine Centre of Excellence. She also provides strategic management and oversight for studies across a number of therapeutic areas, including pivotal phase III trials that have supported the approval of 14 vaccines as well as numerous drugs in other therapeutic areas. PharmaVoice recognized Cindy as one of the “Top 100 Leaders in the Industry” in 2016 and as one of the “Top 50 Influential People in Vaccine Development, in 2014. In 2016, Cindy received the SAHS Distinguished Alumnus Award from Baylor College of Medicine for her leadership in vaccine development. Under her leadership, ICON received the “Best CRO” award at the Vaccine Industry Excellence Awards in 2014 and 2017.
Senior Director, Project Management, Vaccines, Infectious Disease
Michele has over 28 years of clinical research experience in the laboratory, pharmaceutical and CRO industries, and 20 years of tenure with ICON. She has spent the last 14 years focused exclusively in vaccines clinical development. Her vaccine therapeutic expertise includes seasonal and pandemic influenza, meningococcal, pneumococcal, herpes zoster, anthrax, RSV, and small pox. She has extensive clinical and project management expertise encompassing Phase II-III studies for pharma and government clients immunizing 200 to over 13,000 participants in healthy adult, elderly, and pediatric populations. Her experience includes the strategic oversight of vaccine portfolios.