Nonclinical Strategy & Development Planning for Therapeutics Heading to the Clinic
Independent expertise to help early-stage biotechs and spin-outs build credible clinical-entry packages, oversee CROs and make confident go/no-go decisions.
With over two decades of therapeutic research and development in global biopharma, Catherine contributed to taking a first-in-class antibody from discovery through a completed Phase 1 trial, authoring the nonclinical pharmacology sections of the Investigator's Brochure and regulatory dossiers along the way.
She provides targeted scientific input at the stages where it matters most. Independent due diligence for boards and investors is also available.
20+ years in biopharma R&D | Discovery through Phase 1 | Regulatory dossiers | CRO oversight | Melbourne, Australia
How I can help
01
Nonclinical Strategy & Development Planning
Nonclinical strategy for biotech teams approaching the clinic. Stress-testing target rationale, mechanism of action and biological feasibility before major capital commitment, and designing nonclinical study plans, biomarker strategies and pharmacodynamic endpoints.
02
Investigator's Brochures & Regulatory Dossiers
Investigator's Brochure writing and nonclinical regulatory dossier support for clinical trial applications, built to stand up to regulatory and ethics committee review. Gap reviews of nonclinical packages before submission.
03
CRO Oversight & Asset Evaluation
CRO oversight that gives outsourced preclinical studies clear scientific direction, protecting data quality and timelines. Independent asset evaluation for boards, investors and in-licensing decisions.
ABOUT CATHERINE
Bridging Discovery and Clinical Development
I've spent more than two decades in therapeutic research and development. My work spans target validation, mechanism-of-action studies and nonclinical pharmacology across immunology, respiratory disease, haematology, oncology and metabolic disease. I contributed to taking a first-in-class antibody from discovery through a completed Phase 1 trial.
My experience is deepest in biologics, but the questions that decide whether a programme is ready for the clinic are much the same whatever the modality: is the mechanism sound, do the nonclinical data support the clinical plan and what could go wrong? I've evaluated and advanced opportunities across biologics, small molecules and novel approaches, authored the nonclinical pharmacology sections of Investigator's Brochures and regulatory dossiers, designed toxicology strategies where standard models weren't available and directed CRO studies.
I now work independently with a small number of early-stage teams on nonclinical strategy, regulatory dossiers and CRO oversight, so that development decisions are built on robust, reproducible data. I'm based in Melbourne and work with biotechs across Australia and internationally.
Start a conversation
I work with a small number of teams at a time, as a fixed-scope project, an ongoing advisory retainer, targeted input on a specific question, or fractional research leadership, typically one to two days a week, for teams that need senior scientific direction without a full-time hire. Every engagement begins with a short, confidential conversation to understand your programme and whether I can help.
To get started, tell me a little about your therapeutic modality, development stage and what you need, whether that's nonclinical strategy for your biotech, Investigator's Brochure or dossier support, CRO oversight, or a second opinion on a go/no-go decision. Due diligence engagements begin with a signed confidentiality agreement and an agreed scope.
