Stephene Ford

Background

About Stephene Ford

I have over 29 years of experience working in the pharmaceutical industry. I have been a Consultant for 4 years but spent 17 years prior to that as a Study Director/Toxicologist. My area of expertise is in regulatory nonclinical studies and development of vaccines, infectious disease, and biologic programs up to BSL 2/3. As a Consultant, I provide expertise on nonclinical assessments for development of vaccines, biologics, and small molecules as well as drugs for ocular, oncology, and infectious disease indications. I provide preclinical and regulatory advice on scientific and regulatory issues in early- and late-stage drug development, due diligence, and strategic planning for drug development. I provide complete toxicology plans; study monitoring, planning and support; and regulatory support including data interpretation and presentation. I collaborate with several project teams and have experience with the preparation of government grants, IND, CTD, NDA, and pre-IND submissions as well as carcinogenicity and reproductive waivers with a focus on nonclinical strategy and scientific and regulatory content. I also serve as Sponsor company representative at Health Authority Meetings. As a Study Director at CRL (Reno, NV and Mattawan, MI sites), I was responsible for planning and conducting nonclinical studies in accordance with applicable regulatory guidelines and contemporary scientific practice. I served as the subject matter expert for vaccines at the CRL Mattawan site, building a robust vaccine program and providing advice and study designs to clients for nonclinical IND-enabling programs. I formed and chaired the Institutional Biosafety Committee and served as the Biosafety Officer. Prior to CRL, I served in various positions at increased levels of development/responsibility including technician, study coordinator, toxicologist, and toxicology supervisor over 8 years at Covance Laboratories in Vienna, VA.