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Dr. C. Jo White has 34 years of clinical development, medical affairs, business development, regulatory affairs and pharmacovigilance experience in the pharmaceutical industry. Her experience has been focused in antimicrobial and vaccine development.
Over the past 34 years she has co-authored over 30 INDs, designed and conducted over 70 Phase 1-4 clinical trials, filed 6 BLA/MAAs, and one sNDA for a broad spectrum antibiotic, resulting in the licensure of 4 different vaccines and an indication for treatment of hospital acquired pneumonia with a broad spectrum antibiotic in the US and Europe. She has also designed Phase 1 and 2 studies for antivirals for RSV, HIV and hepatitis C. In addition, she is familiar the FDA guidances for product development under using the Animal Rule.
She has designed and conducted basic research related to immune responses in the laboratory and in laboratory animals while in medical school and while at the National Institutes of Health (NIH). During her professional career, she has supervised basic research staff activities and pre-clinical animal studies, performed pharmacovigilance on multiple marketed products, oversaw operation of a pilot plant for vaccines, and led medical affairs in the launch of two products internationally. She served on the Public Affairs staff of the IDSA and lobbied on Capitol Hill for legislation to promote development of new antimicrobials. She has also been an expert witness in several legal cases on marketed vaccines representing the industry perspective of the development and testing of vaccines and post-marketing surveillance.
In addition, she was instrumental in the licensing-in process of rotavirus vaccine from the Children’s Hospital of Pennsylvania and the human papilloma virus vaccine from CSL in Australia, while working at Merck. She continued with these projects for several years, writing and executing the clinical development plan for both of these vaccines.
While at Aviron, North American Vaccine and Inovio, she met with investors to raise capital. She was an officer of the company and involved in operations to take 2 small biotech company public: North American Vaccine -acquired by Baxter- and VGX Pharmaceuticals- reverse merger with Inovio Pharmaceuticals. In addition, she has extensive experience in negotiating with regulatory agencies worldwide for licensure of both vaccines and antimicrobials and for updating package labelling post-marketing following signal detection activities.
Dr. White had senior management positions at Merck, Aviron (now Medimmune/AstraZeneca), North American Vaccine (now Baxter), Wyeth (now Pfizer), VGX Pharmaceuticals (now Inovio Biomedical), and Plumbline Life Sciences (spinoff veterinarian company from Inovio-US office closed Jan 2018 due to financial difficulties). She has served on the affiliate staff of the University of Pennsylvania Infectious Diseases Department and has cared for patients with HIV in the Philadelphia VA Medical Center and drug addiction in the greater Philadelphia area.