Accelerating Vaccines to Clinical Trials — A Toolkit for Efficacy, Safety and Bioanalytical Studies

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 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.

Speakers

Dr. Narendra Deshmukh, Executive Director, Aragen Life Sciences

Narendra Deshmukh is one of the co-founders of Intox Pvt. Ltd., a wholly owned subsidiary of Aragen. He has over three decades of experience in regulatory toxicology and toxicologic pathology and has executed several safety assessment studies for a diverse range of products including chemicals, pharmaceuticals, vaccines, crop protection and medical devices. He has previously worked with Ranbaxy Laboratories Ltd.

He is the former Director and Charter Diplomate of the Indian Board of Toxicologic Pathology (IBTP), Diplomate of the American Board of Toxicology (DABT) and Vice President of the Society of Toxicologic Pathology in India.

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Dr. Kedar Purnapatre, Director, Bioanalytical & Bioassay, Aragen Life Sciences

Dr. Kedar Purnapatre holds a PhD in Molecular Biology from the Indian Institute of Sciences. He has over 40 publications and two patents. Dr. Kedar has served as a visiting editor for journals like Cancer Research, Drug Design Development and Therapy and International Journal of High Throughput Screening.

He has over 22 years of experience in the pharmaceutical industry and contract research organizations (CROs), specializing in bioanalysis of small and large molecule therapeutics. Currently, as the Director of Bioanalytical Operations at Intox, Dr. Kedar focuses on providing effective bioanalytical solutions to support clients’ regulatory submissions for various therapeutic entities. In the past three years, he has developed and validated over 50 new bioanalytical methods for assessing Immunogenicity and pharmacokinetics of vaccines and biotherapeutics in preclinical and clinical samples, advancing our drug development and safety assessment capabilities.

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