Andrew Winkley Email & Phone Number

Montreal, Canada Area

Diplomate of the American Board of ToxicologyScientific Expert, Therapeutic Products Directorate, Health Canada

Montreal, Canada Area

Greater Boston Area

Toxicology representative on several multidisciplinary small molecule project teams from early discovery to late-stage development including submission. Therapeutic areas covered were pain control therapies, orphan indications, oncology, neuroscience, and anti-infectives. Responsibilities included the design, implementation, and interpretation of non-GLP and GLP toxicology and safety pharmacology studies (protocol development, study monitoring, reviewing study data, editing study reports, writing regulatory submissions including IBs, IND/CTA, PIPs, environmental risk assessment, NDA and MAA and responding to regulatory questions). Also supported CMC for impurity safety assessment/qualification activities. Set up the Discovery Toxicology team at Vertex in 2012 and helped lead the development of this discipline within the company to help support the early research pipeline. Managed in vitro toxicology lab with three direct reports (until 2016). Recipient of the Vertex Platinum special services award for significant contributions to the development of medicines to treat cystic fibrosis.

Montreal, Canada Area

• Responsible for the AstraZeneca neuroscience and pain portfolio in Montreal as the lead project toxicologist. • Evaluate the safety hazard profile of new therapeutic targets and early chemistries concurrently with their development. The intention being to design mitigation strategies around flagged hazards to help chemistry progress. An important tool in this endeavour is generating an understanding between (but not limited to) chemical SAR or pharmacology and safety hazard identification. • Assess the margins of risk associated towards human safety of new chemical assets as they advance into late preclinical development by planning and implementing a suitable/informative package of investigative toxicology studies. • Undertake due diligence activities for the neuroscience and pain research area as a toxicologist representative.• Support the biomarker strategy for the neuroscience and pain research area. This can involve utilising methods such as clinical biochemistry and technologies such as omic related platforms.

Ware, Hertfordshire, Uk

Toxicology project lead for small molecules with expertise in drug targets for anti-inflammaton and anti-infectives (discovery to FTIH). Also, an investigational toxicologist, evaluating mechanisms of toxicity for drug molecules that had presented toxicity during development (construction of in vitro and/or in vivo investigational toxicity models).

Investigational Toxicologist with expertise in molecular toxicology (designed and implemented gene microarrays for mechanistic toxicology studies)

Phd, Biochemistry

The role of the livers Kupffer cell population in moderating the toxicity of xenobiotics. A range of cell based models, molecular biology.

Msc, Toxicology

Bsc, Biological Sciences