Name
Andrew Fowlie
Educational Degrees
PhD
Expertise
Biologics/Biotherapeutics/Biotechnology, Carcinogenicity, Developmental and Reproductive Toxicology, Drug/Pharmaceutical Development, GLP Study Auditing, Hematologic Toxicology, Hepatic Toxicology, In Vitro Toxicology, Inhalation and Respiratory Toxicology, Pharmacokinetics/Toxicokinetics, Regulatory Toxicology, Renal Toxicology, Risk Assessment, Safety Pharmacology
Specialties
Extensive experience in design, management and execution of nonclinical safety assessment programs, providing for effective development of innovative medicines from discovery through registration. Expertise in small molecule and cell-based therapeutics in the treatment of diverse disease areas including cystic fibrosis, oncology, anti-bacterial, anti-viral, ion channels, and anti-inflammatory agents.

- Planning, budgeting, and implementation of IND-enabling and post-IND strategies.

-Vendor selection, qualification, management and study monitoring, including contract negotiation.

- Protocol development and review.

- Report review and editing.

- Assessment of data from ongoing studies.

- Summarizing and presentation of key study outcomes to drive decisions and guide program prioritization.

- Leadership of high-performance multidisciplinary drug development teams.

- Preparation and review of Regulatory documentation e.g. Investigator Brochures, responses to Regulatory agency inquiries, Annual Reports, CTAs, INDs
Experience
Andrew obtained a BSc (Hons) in Biochemistry with Toxicology, and was then awarded a PhD through the Robens Institute of Environmental Health and Safety of the University. Following postdoctoral research at the MD Anderson System Cancer Center Science Park in Bastrop, Texas, Andrew has worked as a Study Director with CTBR Bioresearch (now Charles River Montreal), and as a toxicologist with large and small biopharmaceuticals companies including Glaxo, Seragen, Millennium Pharmaceuticals, Vertex Pharmaceuticals, and Proteostasis Therapeutics; He has been an independent consultant since 2009.
Address
Stonehaven Nonclinical Consulting
Address 2
164 Hobart st
City
Danvers
State
MA
Zip Code
01923
Telephone
305-393-9361