Joy Cavagnaro, Ph.D., DABT, ATS, RAC, FRAPS
- President, Access BIO
- Areas of expertise include translation of novel therapeutic modalities:
vaccines, cellular and gene therapies, animal-based and plant-based biotherapeutics, biotechnology-derived and tissue engineered products. Over 25 years of experience in biotech spanning academia, the CRO and biotech industries, and government (CBER/FDA)
- Serves as an SAB Member for several companies globally
- Education: Ph.D. in Biochemistry, UNC Chapel Hill; postgraduate work at Duke and Boston University Medical Centers
James R. Herman, Ph.D., DABT
- President and Partner, INDS, Inc.; Consultant, Preclinical Science
- Previously, Drug Safety Research Site Lead at Pfizer Global Research and Development in Ann Arbor, MI, responsible for all personnel, resources, policies and procedures in General Toxicology, Pathology, and Investigative Toxicology (including Clinical Pathology labs)
- Authored and/or critically reviewed nonclinical portions of over 100 IND and NDA submissions, including sections required for IBs and product labeling, and in addressing impurity issues
- Education: Ph.D., University of Wisconsin, Madison
Douglas G. Johnson, Ph.D.
- President, OCAM Solutions, Inc.
- Consultant, Chemistry and Manufacturing. Over 20 years of experience in the pharmaceutical industry
- Previously led chemistry and manufacturing for 10+ years at Allos Therapeutics where he was Vice President of Manufacturing and Vice President of Pharmaceutical Sciences
- Education: B.A. in Philosophy, Wheaton College; Ph.D., Organic Chemistry, University of Minnesota
Frances Kane, Ph.D.
- President of Apropos Pharmaceutical Consulting, LLC.; Consultant, Regulatory Affairs and Clinical Science. Extensive experience in the pharmaceutical industry, with a wide range of experience in regulatory, project management, clinical and preclinical functions
- Dissertation research examined the effects of diabetes mellitus on the retina. Led preparation of clinical portions of NDA for AMD at Alcon
- Education: B.S. in Chemistry, University of Central Florida; M.S., Chemistry, University of South Carolina; Ph.D., Pharmacology, University of Rochester
Jami R. Kern, M.B.A., Ph.D.
- Clinical Development and Medical Affairs Consultant, Kern Consulting
- Over 15 years of experience in the pharmaceutical and medical device industry
- Areas of expertise include medical strategy, ophthalmology and vision science, clinical research, medical promotion and education, scientific writing and strategic partnerships
- Education: B.A. in Chemistry, Austin College; M.B.A., Neeley School of Business at Texas Christian University, Ph.D. in Biomedical Science, Molecular Biology & Biochemistry, University of North Texas Health Science Center
Angela Kothe, O.D., Ph.D.
- Clinical and Regulatory Affairs Consultant, Silver Pharma Consulting, Inc.
- Previously, an 18-year tenure at Alcon Laboratories in clinical research and regulatory affairs, where she was responsible for development and implementation of global regulatory strategy and operations
- Extensive experience in ophthalmic drug development, with over 18 years of experience in the pharmaceutical industry
- Education: B.Sc. Life Sciences, Queen’s University; O.D., Optometry and Ph.D., Visual Electrophysiology, University of Waterloo