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
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
· 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