Our Team
MD - Dr. Rebbecca Wilcox
Rebbecca is a clinician-scientist, nonclinical product development expert, regulatory and compliance professional, and academic and research manager, specialising in whole of lifecycle nonclinical drug development.
With over 20 years' experience as a clinical and boarded laboratory animal veterinarian, researcher, ethics and governance specialist, leader, and in private consulting, she has worked in benchtop molecular biology, infectious disease and across broad indications, including rare diseases, novel model development and multi-species toxicology.
Rebbecca specialises in whole of lifecycle nonclinical strategy and execution, working on programs that have progressed to approval (MAA/BLA/NDA), and veterinary field trials. She manages and advises on strategic development and regulatory approaches, hit to lead optimisation, in vitro and in vivo study design, non-GLP and GLP preclinical safety pharmacology and toxicology programs and provides bespoke regulatory support for small molecule and biopharmaceutical development.
She is an independent nonclinical CRO GLP regulatory compliance auditor and manages vendors and bid defence. As an academic, she worked in antimicrobial resistance and in vivo modelling, including New Approach Methodologies (NAMs). She has a special interest in human and veterinary commercial co-development as well as ATMPs, drug repurposing, biosimilars and reformulation.
Skills:
Strategic drug development, gap analysis, regulatory strategy, KOL and stakeholder engagement, due diligence, investor relations, CRO study management
Authoring/review of pre-IND FDA meeting requests and briefing submissions, (A, B, C, D, EOP2), expedited pathways and designations (FDA); requests and submissions for PRIME, ITF, Scientific Advice (EMA), IB/CTN/CTAs (Australia); ODDs and Animal Rule
Nonclinical dossiers, and modules
Sponsor-Agency representation
Animal welfare and IACUC/IRB/AEC/GMO (biosafety)
Nonclinical primary, secondary, safety pharmacology, pharmacokinetics, toxicology, toxicokinetics, FIH dosing
In vivo clinical and surgical support
Development and implementation of novel and established animal models and investigator training, SOP authoring, and review; IND-enabling study designs
Regulatory compliance, CAPAs, independent GLP audits (mock inspection and Sponsor due diligence), domestic and global
Whole of lifecycle support for drug filings