Sterenn Goubin

To start-ups and biotech companies venturing into drug development:

Do you have promising results with your molecule? You will need help with the preclinical development of your drug candidate!

Thanks to my expertise, I can support you at every stage of this development, from proof of concept to regulatory toxicology.

My strengths:

- Veterinarian by training

- 22 years of experience in preclinical development, both in CROs and biotech

- 4 years of experience in start-ups

- Toxicology expertise recognized by my peers, as evidenced by my registration in the European Register of Toxicologists (ERT)

- Specialization in ophthalmology

These strengths allow me to have a pragmatic view of preclinical drug development, to be flexible and efficient. I have acquired extensive experience in regulatory affairs (guidelines), quality (GLP), preclinical strategy, and project management. I have in-depth knowledge of NAMs, in vitro, ex vivo, and in vivo models.

What I can offer you:

- Develop a preclinical strategy for your drug (list of studies, roadmap, budget) based on its therapeutic indication, specificities, and target market

- Design the studies to be carried out, select CROs (for outsourcing), coordinate and monitor the studies, analyze the results, review study reports

- Write the non-clinical sections of regulatory documents (CTD, briefing book, scientific advice)

- Conduct a critical review of academic results (Go-No Go decision, valuation)

This phase of drug development requires specific expertise. Furthermore, now is not the time to hire, as it increases your fixed costs and makes you less agile in case of unforeseen events.

To succeed in this critical phase, call on a consultant, call on an expert!