Dr. C. Jo White has 37 years of clinical development, medical affairs, busines development, regulatory affairs and pharmacovigilance wxperience in the pharmaceutical industry. Her experience has focused on antimicrobial and vaccine development. Over the past 37 years, she has co-authored over 30 INDs, designed and conducted over 70 Phase 1-4 clinical trials, filed 6 BLS/MAAs, and one sNDA for a broad spectrum antibiotic, resulting in the licesure of 4 different vaccines and an indication for treatment of hospital acquired pneumonia in the US and Europe. She has also designed Phase 1 and 2 studies for antivirals for treatment of RSV, HIV and hepatitis C. In addition, she is familiar with the FDA guidances for product development using the Animal Rule. Dr. White had senior management positions in both large pharma companies and biotech companies. At present, she serves as a medical/regulatory consultant.