Geneviève Gaucher

Partnering with biotechnology and pharmaceutical organizations to advance the preclinical and clinical development of biologics and small molecules. Experience spans translational strategy through program execution, supporting the progression of innovative therapies across a range of medical conditions.

Contributed to the nonclinical development strategy for a biologic asset as therapy for a rare pediatric disease, including ADME/PK, safety pharmacology, and toxicology. • Collaborated with CROs and internal teams to align on key deliverables and timelines. • Supported communication of key findings to senior leadership, aiding informed decision-making. • Provided input on risk mitigation approaches in line with regulatory expectations.

• Supported the design of a comprehensive clinical roadmap for Hirschsprung disease, enhancing treatment pathways for this rare pediatric condition. • Initiated the selection of a Contract Research Organization (CRO) and standardized project workflows, improving operational efficiency. • Organized and facilitated advisory board meetings, fostering strong relationships with key opinion leaders (KOLs) in the field.

With six years of experience at Inversago Pharma, progressing from Director to VP of Preclinical Development, I have spearheaded strategic planning to align preclinical efforts with company goals. I've built and led a high-performing team, resulting in successful collaborations with CROs and academic institutions. I directed preclinical studies that advanced two drug candidates from IND-enabling toxicology to Phase 1 in under a year. My role involved innovative resource management, expert guidance on drug safety and efficacy, and ensuring regulatory compliance with critical documentation for clinical trials. In 2023, Inversago was acquired by Novo Nordisk for up to $1.1B USD.

Collaborated with prescribers to enhance patient safety and treatment efficacy. Lead comprehensive health counselling and optimizing the use of both prescription and over-the-counter medications. Experienced in managing and refining patient record systems to ensure accuracy and compliance with current health standards and treatment protocols.

Completed specialized training in clinical trial data monitoring for a Phase 1b trial and earned GCP certification in November 2014, underscoring a commitment to industry standards and best practices in clinical trials.

Managed personnel and resources to drive efficiency and align with project goals and company objectives. Contributed to the development of pharmaceutical, nutritional, and veterinary products in various forms, including solid, liquid, and semi-solid. Oversaw formulation trials, scaled-up processes, and site transfer projects to ensure smooth transitions from development to production. Conducted reviews of scientific literature and intellectual property to guide strategic development. Reviewed and approved engineering protocols and reports for industry compliance. Provided technical support for production processes, addressing issues and conducting investigations to resolve challenges.

Completed a dissertation on "Biodegradable Nanoparticles for the Parenteral Delivery of Hydrophobic Anticancer Drugs," utilizing techniques such as light scattering, zeta potential analysis, spectroscopy, HPLC, DSC, AFM/SEM, cell culture, and flow cytometry. Conducted biodistribution and pharmacokinetic studies in rodent models and led a comprehensive research project encompassing literature reviews, experimental planning, data analysis, and scientific writing. Successfully communicated research findings to Labopharm Inc., fostering collaboration between industry and academia.

Completed a one-year pharmacy residency program with the University of Toronto. Managed a project using near-infrared (NIR) spectroscopy for in situ analysis of blend and tablet uniformity. Utilized NIR and UV spectroscopy for characterizing blends and tablets, including during blending and compression processes. Collaborated with NIR technology suppliers, such as Bϋchi and ABB, to refine analytical methods and ensure accuracy.