Our Team
CEO and Principal Consultant - Dr Rebbecca Wilcox
Rebbecca is a clinician-scientist, nonclinical product development expert, regulatory and compliance professional, and academic and research manager, specializing in whole of lifecycle nonclinical drug development, in both human and veterinary medicine.
With over 20 years' experience as a clinical and boarded laboratory animal veterinarian, researcher, ethics and governance specialist, leader - and in private drug development consulting - she has worked in benchtop molecular biology, infectious disease, oncology 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 over 20 programs that have progressed to marketing approval in human and veterinary indications, in the EU, UK, US and Australia. She manages and advises on strategic development and regulatory approaches and represents sponsors during regulatory interactions. Rebbecca advises on development from hit to lead optimisation, in vitro and in vivo study design, and non-GLP and GLP IND-enabling and target animal PKPD, safety pharmacology and toxicology, 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 is an independent HREC nonclinical toxicology reviewer at Bellberry, Australia and advisor to animal ethics committees and veterinary drug regulators.
She has a special interest in human and veterinary commercial co-development as well as drug repurposing, veterinary repositioning and reformulation.
Skills:
Go/no-go assessment and recommendations
Strategic drug development, gap analysis, regulatory strategy, study list optimization, KOL and stakeholder engagement, due diligence, investor relations, CRO study management
Bespoke animal models, all species
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 (TGA)/CTAs (EMA); ODDs and Animal Rule
Nonclinical dossiers, and modules 2.4 and 2.6
Sponsor-Agency representation
Animal welfare and IACUC/IRB/AEC/IBC-GMO (biosafety)
Nonclinical primary, secondary, safety pharmacology, pharmacokinetics, toxicology, toxicokinetics, FIH dose selection
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
Co-development and repositioning for the veterinary market: feasibility assessment, indication selection, standard of care/competitor analysis, development and regulatory plans, study management, study design and oversight, conduct of pilot studies and management of TAS and pivotal field studies, veterinary submissions and designations
Regulatory compliance, CAPAs, independent GLP audits (mock inspection and sponsor due diligence), domestic and global
Fractional Head of Toxicology and Program Architect
Project management across whole of lifecycle including nonclinical, CMC, clinical and submission