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2022 Annual Meeting ATA Reception

Webinar

March 29, 2022

1 hour

AACT/ATA Webinar: Overview of Nonclinical Safety Assessment for Antiviral Drugs and Vaccines Development

Webinar

Drug Development is an integrated, multidisciplinary process that includes nonclinical safety assessment, manufacturing, clinical trials, and regulatory submissions. This presentation will provide an introductory overview of drug development and nonclinical safety assessment for drugs and biologics in general and specifically antivirals including COVID-19. Description of some of the challenges that can arise with diseases or conditions with potentially fatal outcomes, and/or for which there are no existing effective treatment options will be discussed. The nonclinical programs for Antivirals like COVID-19/Ebola indications are designed to be flexible, with the goal of facilitating entry into clinical trials and accelerating the development of promising pharmaceutical candidates while also protecting patients from adverse effects. The US FDA lately issued new draft guidance to address challenges related to COVID-19, one to facilitate a sponsor’s preparation of, and the US FDA review of, a pre-investigational new drug application (pre-IND) meeting request, and another with recommendations to develop drugs with direct antiviral activity, immunomodulatory activity, or other mechanisms of action. Case examples will be discussed.

Vaccines are considered to be one of the most cost-effective life-saving interventions in human history. Vaccine development requires preclinical toxicology studies, following good laboratory practice (GLP). Vaccines are developed as biological preparations to stimulate the recipient’s immune system to recognize targeted aspects of infectious organisms as foreign and generate host mechanisms to control or eliminate them. Toxicology studies are performed to support the establishment of nonclinical safety of vaccines prior to their use in clinical investigations. Careful consideration should be given to the collection of precise information from properly designed toxicology studies. Assessment of safety relies on various endpoints including, but are not limited to: measurement of inflammatory cells at the site of injection, changes in food consumption, body weight changes, body temperature changes, clinical chemistry measurements, and histopathology examination.

Speaker(s):

Hanan Ghantous PhD, DABTHanan Ghantous, PhD, DABT
Dr. Ghantous is the Division Director of Pharmacology/Toxicology for Infectious Diseases. She joined the US FDA as a reviewer in 2001 and was the supervisor at the Division of Antiviral Products, CDER, since 2007. Dr. Ghantous has served on several US FDA committees, has been involved in writing Guidance documents, and has represented the Agency at various public forums. She received a PhD in toxicology from the University of Uppsala, Sweden, and a postdoctoral training at the University of Arizona. Dr. Ghantous has over 30 years of combined experience in general and regulatory toxicology. She has been a member of SOT since 1989, served on many committees and specialty sections, and was the president of the ABT board for 2013–2014. She has been a member of ACT since 2000, served on many committees and Council over the years, and was the President of ACT in 2016.


Hanan Ghantous PhD, DABTNabil Al-Humadi, PhD
Dr. Al-Humadi is a pharmacologist/toxicologist at the Center of Biologics in the US Food and Drug Administration, where he reviews applications for biological licenses. He received his master’s degree and doctorate in pharmaceutical sciences from West Virginia University in 1992 and 2002, respectively. He has more than 30 years combined government and industry experience in toxicology. Dr. Al-Humadi has served on the Neurotoxicity assessment subcommittee [Member since 2014], Pharmacology/Toxicology working group [Co-Chair, 2013-present], and CBER Committee for Promotion of Researchers-Reviewers (2017-present). He presented more than 50 posters in scientific meetings and published more than 12 papers in peer reviewed journals. Dr. Al-Humadi’s recent publication is a review paper in Vaccine journal titled “Pre-Clinical Toxicology Considerations for Vaccine Development.” Also, Dr. Al-Humadi’s current publication is a chapter “pre-clinical toxicology of vaccines” in “comprehensive guide to toxicology in preclinical drug development” book. Currently, Dr. Al-Humadi is writing a second chapter in a book titled “Animal Models for Infectious Diseases”. He has been a full member of the SOT since 1992.

Materials:
AACT ATA Webinar Flyer
Webinar Recording
Presentation

May 26, 2021

9:00 AM Eastern Time (US and Canada; 1.5 hour)

2021 ATA-SIG Virtual Annual Meeting