Name
Andrew Sonderfan
Educational Degrees
BS, PhD
Certifications
DABT - Diplomate American Board of Toxicology
Education
PhD, Toxicology, University of Kansas Medical Center
BS, Toxicology, Philadephia College of Pharmacy and Science
Expertise
Drug/Pharmaceutical Development, GLP Study Auditing, Regulatory Toxicology
Specialties
Support diligence activities; perform gap analyses
Create and apply compound-selection and -progression criteria to identify suitable leads and candidates
Create and refine plans and budgets for candidate nomination, clinical trial initiation, and registration
Respond to unexpected development challenges
Facilitate qualification and selection of suitable CROs
Obtain, review CRO study and cost proposals; prepare recommendations
Design and monitor nonclinical studies
Evaluate, summarize study results; recommend next steps
Review draft study reports; provide comments and direction for finalization
Prepare pre-IND questions and briefing documents
Create and review regulatory documentation
Participate in discussions, meetings with regulatory authorities
Experience
More than 30 years of experience in small- and mid-size pharma, and in biotechnology; therapeutic areas include oncology, infectious diseases, CNS disorders, immunosuppression, metabolic and rare diseases. Roles from Toxicologist/ Study Director, through team and department leadership and direction, product and portfolio management, to Vice President. Design, conduct, oversight, and report preparation/ review for non-GLP and GLP studies from discovery to First-In-Human enabling to registration. Preparation of regulatory briefing documents and submissions; discussions with and responses to regulatory authorities. Full member of the Society of Toxicology, the American College of Toxicology, and the Safety Pharmacology Society.
Address
55 Pine Street
City
Sudbury
State
MA
Zip Code
01776
Country
USA
Telephone
1.978.505.7138