In this free webinar, learn about the evolution of vaccine technologies over several decades, culminating in the current era of mRNA vaccines. Attendees will gain insights into the unique challenges associated with different vaccine platform technologies, particularly in terms of assessing product quality, immunogenicity and safety. The featured speakers will present a case study discussion.
TORONTO, Nov. 1, 2023 /PRNewswire-PRWeb/ -- Discover an informative webinar delving into the evolution of vaccine platform technologies to the current era of mRNA vaccines, with a discussion on the unique challenges they face in their advancements to clinical trials. The experts, Dr. Narendra Deshmukh and Dr. Kedar Purnapatre will discuss some of the many challenges facing the vaccine development industry today in the demonstration of product quality, immunogenicity and safety. They will share their experience working with various vaccine and adjuvant types emphasizing the importance of appropriately designed experiments, biomarker selection and choice of appropriate bioassays and bioanalytical tools.
The Challenge, A Case Study: A client successfully completed Phase I clinical trials on its mRNA vaccine candidate, but regulatory agencies mandated additional preclinical safety studies before proceeding to Phase II patient recruitment. This followed careful writing of exhaustive in-vivo and in-vitro experimental protocols that were compliant with the latest regulatory guidelines and advising the client to include an additional exposure route. Intricate assessments of immunogenicity and biodistribution profiles, meticulous clinical laboratory analyses along with acute phase protein response and exhaustive histopathological evaluations were all required within a timeframe of six months.
Join this webinar to gain insights into the challenges and innovations in mRNA vaccines in clinical trials.
Join experts from Aragen Life Sciences, Dr. Narendra Deshmukh, Executive Director; and Dr. Kedar Purnapatre, Director, Bioanalytical & Bioassay, for the live webinar on Wednesday, November 15, 2023, at 11am EST (4pm GMT/UK).
For more information, or to register for this event, visit Accelerating Vaccines to Clinical Trials — A Toolkit for Efficacy, Safety and Bioanalytical Studies.
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