Name:  Robert G. Burford, Ph.D., FACA
Job Title:  Managing Director
Summary
Dr Burford offers expert advice and counsel in preclinical toxicology, early phase clinical development of new drug and medical device products and represents clients both domestic and foreign before the FDA and HPB. He is thoroughly familiar with the regulatory requirements of medical product approval in the US and Canada. Areas of experience and expertise include:

New product development strategies

Toxicology/pharmacology

Clinical research management

Regulatory strategies

Cardiovascular, CNS (Alzheimer’s)

Professional Experience

Aptuit Consulting Inc.
Managing Director: 2006-Present

Westfield Partners LLC
Managing Director: 2003-2005

American Clinical Research Consultants Inc.
President: 1989 – 2005

Clinfo Systems, LLC
Partner: 2000-2002

Axonyx Corporation
Vice President Product Development: 1999-2002

McGraw Hill Clinical Research International
President: 1988-1989

Biovail Corporation International
Vice President: 1994-1997

Trimel Corporation
Associate Director, Clinical Research: 1991-1994

Searle Laboratories
Director, Cardiovascular Drug Development: 1986-1988

Searle Laboratories
Director, Department of Scientific Affairs: 1981-1986
Education
1960; BS, University of Western Ontario
1963; MS, University of Western Ontario
1965; Ph.D., University of Western Ontario
Drug Development Experience
New Product Development, API to POC

• Vice President, Product Development - Axonyx Corporation - Responsible for all product development activities conducted by Axonyx Corporation New York NY. This company was focused on drugs and diagnostics for the treatment of Alzheimer’s disease and other diseases of cognition. The position managed all Chemistry, Manufacturing and Control, preclinical and clinical programs required for filing an NDA for phenserine tartrate.

• R&D Project Leader (SC 27166 - Nufenoxole), G. D. Searle and Company, Chicago, Illinois

Regulatory Strategy/Affairs

• Responsible for IND filings for a number of new chemical entities.

• Managed NDA filings for several cardiovascular products including Tiazac

• Act as US Agent for a number foreign pharmaceutical firms

Clinical Research Management

• Vice President, Scientific Affairs - Biovail Corporation International

• Associate Director, Clinical Research – Trimel Corporation, Mississauga, Ontario, Canada. Director, Cardiovascular Drug Development, Searle Laboratories, Chicago, Illinois. Director, Department of Scientific Affairs, Searle Laboratories, Chicago, Illinois. Medical Director, (Acting), Life Support Division, Searle Medical Products, Chicago, Illinois. Director, Clinical Research, G.D. Searle Canada Ltd

Selected Publications
A list of publications can be made available upon request.

Professional Activities
Society of Toxicology of Canada (President)

European Society of Toxicology (Member)

International Union of Toxicology (Secretary General)

Pharmacological Society of Canada

American Society for Clinical Pharmacology and Therapeutics

Canadian Society for Clinical Pharmacology

Canadian Cardiovascular Society

Canadian Hypertension Society