Name:  Leslie Patmore, Ph.D.

Job Title:  Managing Director

Summary

Responsible for management of Aptuit Consulting, the consulting division of Aptuit, a global pharmaceutical development services company. Provides personal consulting services in the areas of QT Prolongation Risk Assessment, Safety Pharmacology and Integrated Drug Development Programmes. Areas of experience and expertise include:

Drug Development Strategy and Management

Lead Candidate Optimisation

Safety Pharmacology

QT Prolongation Risk Assessment

Preclinical Safety Assessment

Professional Experience

Education

1976; BSc, University of East Anglia
1979; Ph.D., University of East Anglia

Drug Development Experience

QT prolongation Risk Assessment

• PhD in Electrophysiology and involved in discovery research on ion channel modulators over 15 years with Syntex. Responsible for discovery projects of calcium channel modulators, central and peripheral sodium channel blockers and potassium channel antagonists and agonists. Inventor on patent for potassium channel blockers to be used as antiarrhythmics.

• With Quintiles established centre of expertise for preclinical QT prolongation risk assessment with development of assays for HERG channel block using conventional and automated patch clamping, action potential duration in vitro and QT measurements in animals.

• Project leader for Quintiles participation in ILSI/HESI initiative to evaluate in vitro and in vivo models to assess risk of QT prolongation. Initiated and involved in a series of industry surveys on practice in Safety Pharmacology and in particular QT prolongation risk assessment sponsored by the Safety Pharmacology Society.

• In addition to publications in this area (see listing), speaker at industry and regulatory opinion forming forums in US, EU and Japan.

• During time with Quintiles provided consulting for various companies in the interpretation of data from preclinical QT prolongation risk assessment studies.

Safety Pharmacology

• Responsible at Syntex Pharmaceuticals for regulatory pharmacology, conduct of safety assessment studies and preparation/submission of regulatory documents.

• Manager of the Safety Pharmacology group at Quintiles 1995-2001 and involved in safety pharmacology studies under JHMOW and ICHS7A regulations for biotech, small, medium and large pharma companies around the world.

• Initiated and involved in a series of industry surveys on practice in Safety Pharmacology sponsored by the Safety Pharmacology Society.

• Co-author of a Handbook of Safety Pharmacology (published 2003)

Integrated Drug Development Programmes

• Project team leader for development of Imiloxan and Delequamine from lead candidate identification through to Phase III clinical trials (Delequamine) with Syntex Pharmaceuticals.

• Preclinical Project Leader for Periostat NDA for Collagenex Pharmaceuticals and Integrated Development Programme leader for development of an anti-convulsant currently entering Phase III clinical trials.

• Manager of Preclinical groups involved in Integrated Development Programme work on over 90 products both small molecules and biologics conducted with Quintiles 1995-2005.

• Managed Pharmaceutical Drug Safety operations in US, UK and Japan

• 125 INDs and 14 MAAs/NDAs

• Published and lectured extensively on drug-induced cardiovascular toxicity in animals

• Managed API through Phase 2 POC clinical studies for many emerging companies

• Extensive experience working with all divisions at FDA

Selected Publications

Author or co-author of 26 full papers, 4 reviews and over 100 abstracts for oral or poster presentations. In addition to be a Co-inventor on 2 patents.

Friedrichs GS, Patmore L, Bass A. Non-clinical evaluation of ventricular repolarization (ICH S7B): results of an interim survey of international pharmaceutical companies. J Pharmacol Toxicol Methods. 2005 Jul-Aug;52(1):6-11.

Harris D, Graham M, Price J, Munro F, Templeton A, Young R, Paterson K, Anderson L, Gillies S, McKendrick S, Low G, Patmore L, Bodine R, Jeanne Kallman M, Hoffman WP, Lee C, Wolff RK. Respiratory function in rats restrained for extended periods: assessment of the effects of bethanecol. J Pharmacol Toxicol Methods. 2005 Jul-Aug;52(1):83-9.

Professional Activities