Collaborations, effective communication, and clear objectives will lead the world to obtaining vaccines and therapies against COVID-19. Much concern has been raised regarding the balance between quickly providing a vaccine/effective therapies for COVID-19 and ensuring safety and quality standards have not been compromised. The webinar will provide an overview from a toxicologist perspective of the quality, efficacy, and safety aspects of how potential vaccines and therapies for COVID-19 are progressing to market.

Background on coronaviruses • Quality, efficacy, and safety aspects o Preclinical and clinical trials o Redirection of resources – people, manufacturing space, supplies • Supply chain hurdles • Resources • Conclusions

Dr. Wendy Haines is the Associate Director of Technical and Scientific Services at PharmEng Technology and has over 20 years of toxicology experience in both the research and biopharmaceutical arenas, encompassing process design, analysis, validation, project/protocol management and scientific writing.  She has BS Degrees in Pharmaceutical Sciences & Biology from Campbell University, PhD in Toxicology from University of North Carolina, Chapel Hill and is a board-certified toxicologist (Diplomate of the American Board of Toxicology, DABT) and a Certified Quality Auditor (ASQ CQA). Wendy has impacted human health laws at Environmental Protection Agency (EPA) starting in 1997, worked on the Genome Project between EPA and National Institute of Health (NIH), and later conducted her PhD at EPA performing directed research for the Office of Pesticides of EPA.  Wendy was a study director and acted as single point of contact for all aspects of a study; oversaw both in vivo and in vitro experimental studies for both commercial clients and the National Toxicology Program (NTP). Wendy moved from a contract laboratory setting to a consultant company providing toxicology, project management, and validation services to pharmaceutical and biotechnology manufacturers.  Wendy has conducted close to 250 product toxicology safety assessments for contract manufacturers and provides guidance on extractable and leachable projects, product testing, and worker safety programs.