During the COVID-19 pandemic, several pharma companies moved so fast to develop vaccines that the amount of time between the sequencing of the virus to the introduction of the first three vaccines was less than a year. It was a feat that was facilitated by unprecedented collaboration between the government and private industry, as well as efficient research and development processes—all of which could be leveraged in the future to improve vaccine development.
The processes that enabled that ultrafast clinical development of COVID-19 vaccines included real-time data sharing among academic research groups and companies; the standardization of reagents and models used in preclinical testing; a streamlined approach to clinical trials and manufacturing, and more. All of those practices could be embraced to improve and accelerate vaccine development going forward.
This Fierce webinar will include input from vaccine R&D professionals, including experts in clinical trial design, regulatory affairs and manufacturing. They will draw upon their own experiences in vaccine development to offer tips for incorporating elements of the successful COVID-19 vaccine rollout into future vaccine programs.
Don J. Diamond, Ph.D., is a professor in the Department of Hematology & Hematopoietic Cell Transplantation at City of Hope, a comprehensive cancer center near Los Angeles. His research includes developing vaccines to combat hematologic malignancies, solid tumors and infectious pathogens such as SARS-CoV-2, HIV, and the herpesvirus cytomegalovirus (CMV) that can lead to birth defects and complications in all transplant patients and people living with HIV.
Diamond and his colleagues will soon open a Phase 2 clinical trial to compare City of Hope’s investigational COVID-19 vaccine to an emergency use authorized COVID-19 vaccine in blood cancer patients who have received a stem cell transplant or cellular therapy. He is also pursuing a booster trial in different settings for the investigational City of Hope COVID-19 vaccine. In addition, the prospect of an effective CMV vaccine, which is a high priority of the United States Public Health Service, means significant benefits for immunocompromised patients such as for people living with HIV or those who have received stem cell and solid organ transplants. Diamond is collaborating with the Division of AIDS to test if his CMV vaccine lowers inflammation and viral symptoms in people living with HIV.
Ethan Settembre, Ph.D. is the VP & Head of Research for Seqirus, one of the world’s largest influenza vaccine producers. At Seqirus, Ethan leads the R&D team responsible for developing vaccines that offer the greatest protection possible against infectious diseases, with a specific focus on influenza, by both improving current approaches and pursuing new vaccine technologies. These new innovations include approaches to RNA vaccines, cell-based manufacturing methods, adjuvants, and protein-based antigens.
Ethan received post-doctoral training in Structural Vaccinology at Harvard Medical School, where he helped elucidate the structure of key viral proteins at the atomic level. Previously, Ethan worked at Novartis Vaccines and Diagnostics where he led projects in multiple disease areas (e.g. RSV, Influenza, Parvovirus B19, etc.).
Ms. Walcott has over 19 years of experience in the Biopharmaceutical industry. Today, she is responsible for corporate quality system policy, compliance and regulatory affairs support for a broad product portfolio across Catalent’s global network of 40+ facilities. She previously served as Vice President of Quality and Regulatory Affairs for Catalent Indiana, LLC (formerly Cook Pharmica) from 2007 to 2018 and was responsible for oversight of quality assurance, analytical services, validation and regulatory affairs for the state-of-the-art Bloomington, Indiana CDMO facility providing development, mammalian cell culture, formulation, parenteral filling, inspection, and packaging capabilities. She has extensive experience in managing Health Authority inspections, supporting design and qualification of major expansions, and implementing Quality Systems. She is also passionate about mentorship and is an active member of the Catalent Women’s Network. Veda holds a bachelor’s degree from Indiana State University in Clinical Laboratory Science, as well as a MBA from Indiana Wesleyan University.
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