Title

• 35+ years experience in pharmaceutical research and development
• Independent consultant for 3 years to Big and medium sized Pharma, Start-up, Biotech and Venture Capital (VC) companies, contract research organisations (CROs).
• Senior management roles, senior scientist to Vice president of preclinical research

Specific Areas of Expertise

• Preclinical and clinical drug disposition and PK
• Small molecules and macromolecules (peptides, proteins and oligonucleotides)
• Bioanalytical method development
• Parental formulation development
• Immunogenicity evaluations

Projects

Preclinical PK/TK data analysis* and report preperations:
              - 9 nonGLP studies
              - 5 GLP studies
Consultation on clinical PK study designs
             - 3 Projects
Review and preperation of Regulatory IND/NDA : Preclinical and clinical PK summaries
            - 3 Projects
Revew and comment on FDA responses to clinical development plans, specifically related to PK issues
            - 2 Projects
Review and comments on draft research reports from CRO : specifically in the area of preclinical drug metabolism, biotransformation and PK.
            - 6 Projects
Preperation of research reports---scientific writing:
           - 4 Projects 

Publications and Memberships                   

·         25 Publications

·         Member of 4 scientific societies (AAPS, ASPET, ISSX, AAAS)

·         Participated actively in the North Jersey Drug Metabolism Discussion group (1984-1989), including a tenure as president

Positions                    

·         Vice President of Preclinical Research                     Theratechnologies Inc.

·         Director of Preclinical Development                         Lorus Therapeutics, Inc.

·     Scientific Director                                    Charles River Montreal

·         Head of Preclinical Development Dept.                   Berlex Laboratories, Inc.

·         Senior Research Associate                                             Wyeth Research