Chief Regulatory Officer
As Chief Regulatory Officer at Imvax, Inc., Catherine Kessler is responsible for oversight and management of regulatory affairs including nonclinical, clinical and CMC regulatory strategies and compliance within the company. Catherine has over 20 years of experience in the biotechnology and pharmaceutical industry, and has been working in regulatory affairs, quality assurance, regulatory compliance and operations activities since 2001. She has supported early and late-stage drug development in multiple therapeutic areas including oncology, inflammatory and cardiovascular diseases, and contraception and women’s health.
Ms. Kessler’s experience and knowledge of human blood therapeutics, biologics, and small molecules was gained while working in companies including Clinipace Clinical Research, Array BioPharma, Amgen, Aventis Behring, Centocor, and SmithKline Beecham Pharmaceuticals. She is well-versed in regulatory research and surveillance, developing regulatory paths to market for unique and complex investigational products, and engaging health authorities through the complex stages of clinical development. Ms. Kessler holds a BS in Biochemistry from the University of Delaware in Newark, DE and an MS in Quality Assurance and Regulatory Affairs from Temple University in Ambler, PA.