PhD in Biochemical toxicology from the University of Toronto, Canada. PostDoctoral Fellow at the Universite Rene Descartes in Paris, France under the supervision of Dr. Daniel Mansuy.
Business Address:
4311 24th Street San Francisco, California 94114
Contact Information:
Telephone:
415-282-6035
Mobile Number:
415-902-0705
Email Address:
veronique@comcast.net
Specialties
Objective: To provide high quality scientific (toxicology) and regulatory consulting for early development to NDA filing of innovative human therapeutics. · Experience with small molecules and biologics · Participate as toxicology representative on development teams · Design of pre-clinical programs for potential development candidates o Exploratory toxicology in-house or at CRO (Contract Research Organizations) o IND- and NDA-enabling programs · Select CROs to perform safety studies · Review protocols, reports, and monitor conduct of studies by CROs. Sponsor Representative for these studies. · Prepare non-clinical documentation (INDs, NDAs and CTDs) required for international regulatory submissions · Conduct various risk assessments (excipients, “old” drugs with new therapeutic indications) · Conduct due diligence pre-clinical reviews of potential new projects and collaborations. · Participate in management of small CRO.
Experience
I have 16 years of toxicology experience primarily in industrial, biotechnology and pharmaceuticals. During this time I have worked for various companies in the Bay Area – Genencor International, Theravance, Inc., the Institute for OneWorldHealth and most recently Genentech. I have interacted with regulatory agencies around the world, including the FDA, EMEA and the Drug Controller General (DCG) of India. Her experience enables her to design strategic toxicology programs for our clients. I hold a Ph.D. in Biochemical Toxicology from the University of Toronto, Canada, a MSc in Toxicology from the University of Surrey in the United Kingdom and a B.Sc in Toxicology from the University of Guelph in Canada. I am a Diplomate of the American Board of Toxicology (since 1999). I also completed a PostDoc in 1992 at the University Rene Descartes, School of Medicine in Paris, France. Finally, I am bilingual in French and English.