EXPERIENCE
Over 30 years’ experience as a regulatory nonclinical professional in pharmaceutical research and development
Nonclinical regulatory subject matter expert (SME) for small molecule, large molecule programs; cell, tissue, and gene therapy, programs.
Development of nonclinical program strategies and study designs for all nonclinical programs
Management and oversight of nonclinical team within Parexel.
Responsible for nonclinical FDA communications
GLP compliance auditor for 20 years
EXPERTISE
Cell and gene therapy, biologics and small molecule regulatory consulting including IND, BLA and NDA applications and Meeting Briefing Documents
EDUCATION
Ph.D., Biochemistry and Medical Science, University of Aberdeen, Scotland, UK
B.A., Cell and Molecular Biology, San Francisco State University, CA
Over 30 years’ experience as a regulatory nonclinical professional in pharmaceutical research and development
Nonclinical regulatory subject matter expert (SME) for small molecule, large molecule programs; cell, tissue, and gene therapy, programs.
Development of nonclinical program strategies and study designs for all nonclinical programs
Management and oversight of nonclinical team within Parexel.
Responsible for nonclinical FDA communications
GLP compliance auditor for 20 years
EXPERTISE
Cell and gene therapy, biologics and small molecule regulatory consulting including IND, BLA and NDA applications and Meeting Briefing Documents
EDUCATION
Ph.D., Biochemistry and Medical Science, University of Aberdeen, Scotland, UK
B.A., Cell and Molecular Biology, San Francisco State University, CA
Speaking In
4:15 PM - 5:15 PM (PDT)
Wednesday, June 15
The number of cell and gene therapies entering clinical trials is growing at an increased rate…
BIO DOUBLE HELIX SPONSORS
BIO HELIX SPONSORS
