Bio

• President & CEO, BIONAVIGEN, LLC, a biopharmaceutical virtual drug development company specializing in advising and consulting for all aspects of drug development, including discovery, preclinical development, CMC, translational sciences, clinical development and regulatory filing. • Selected by pharmaceutical peers as the 100 Most Inspiring People in Pharmaceutical Industry by PharmaVOICE in 2015 • Accomplished executive, inventor, and scientist with over 30 years of success with top biotechnology and pharmaceutical companies, including Merck, Johnson & Johnson, Medimmune, AstraZeneca. • Highly respected global leader known for building highly motivated safety assessment teams to advance small and large molecule biologics drug development programs and achieve company goals. • A key opinion leader in Safety Assessment with outstanding knowledge and proven experience in drug discovery, preclinical, and clinical development from IND/CTA, phase I, II, III, BLA/MAA, and approval. Strong track record in building business franchises and in building relationships with investors, media, and analysts. • A key contributor to successful marketing approval of 10 different marketed biopharmaceuticals, including for Medimmune (AstraZeneca Biologics): Imfinzi (anti-PD-L1 mab), Fasenra (anti-IL-5R afucsolytated mab), Brodalumab (anti-IL-17) in collaboration with Amgen, Moxetumomab (anti-CD22-PEA immunotoxin), multiple flu vaccines and for Merck: MAXALT (Anti-migraine)-1998, SINGULAIR (Anti-Asthma)-1998; CRIXIVAN (Anti-AIDS)-1998; VIOXX (COX-2 Inhibitor)- 2000, EMEND- 2003. Successful sunmission and approvals of over 100 INDs and over 15 BLAs-NDAs.