Olivier Favre-Bulle

Founder/ CEO/ Consultant in Drug Development @ 3Biotech

About

Most early-stage biotech programs don't fail on science. They slip on CMC decisions made too early — or too late. "We'll deal with CMC after Series A" is the most expensive bet I see in this industry. I've watched programs lose months over a cell line chosen in week three. I've seen IMPDs/ INDs delayed because a CDMO contract didn't cover what mattered. I've sat in diligence calls where a strong asset got marked down because the CMC plan didn't hold up to a 30-minute push. That's why I built 3Biotech. 15 years ago I was running CMC inside large pharma, watching biotechs burn cash on avoidable rework. The pattern repeated: decisions made between lead selection and IND defined everything downstream. No one was stress-testing them at the moment they mattered. 3Biotech closes that gap.What we do: → Stress-test your CMC plan before it costs you → Build IND/IMPD-ready trajectories from lead to clinical POC → Select and manage CDMOs (GMP and non-GMP) you can scale with → Pilot clinical supply, coordinate every stakeholder → Write the IMPD/IND that gets you through What clients see:92 programs supported from lead to clinic22 IND/IMPD filings de-risked6 months saved vs. typical CMC timelinesTrusted by teams backed by RA Capital, AN Venture Partners I work with: ✓ Pre-clinical to Phase 2 biotech — biologics, small molecules, ATMPs ✓ Founders and CSOs who want to be challenged, not flattered ✓ Programs where the next 12 months will define the next 5. I'm not the right call if: ✗ You're past Phase 2 ✗ You want cheap pairs of hands ✗ You want a consultant who agrees with the plan you already wrote Want to find your CMC blind spots before your next board meeting? Book a 45-min CMC gap analysis → https://app.lemcal.com/@ofbu

Country

France

City

Paris

Industry

Biotechnology

Skill

Biotechnology, Pharmaceutical Industry, Drug Development, CMC development, Business Development, Strategy, Project Management, Change Management, GMP, Management, Life Sciences, Executive Management, R&D, Clinical Development, CRO, International Project Management, Pharmaceutics, Commercialization, Biochemistry, Lifesciences

Experience

Founder/ CEO/ Consultant in Drug Development

3Biotech

2014-1 - Present · 12 yrs 10 mos

Paris

3Biotech to accelerate therapeutic innovations and create a new future. 3Biotech provides continuously Innovative solutions to challenge, support and accelerate the manufacturing of safe drug candidates. We are your colleagues, partner for the Chemistry, Manufacturing and Control (CMC) to succeed in your project and mission to create a new future and impact patient outcomes. Three Pillars; Safety, Efficacy, Manufacturing are our drivers to secure all steps from the research to the first in human stage with the most innovative project strategy and plan to execution. We have implemented an organization to provide you with the best support on the field. Our solutions to succeed: Challenging, risk assessment and, crash test (Due diligence, Gap analysis, Definition of the QTPP …) Lead optimization and selection, Translational Research Define and execute a “Chemistry Manufacturing and Control” strategy all along the drug development. Identify the most appropriate technological solutions (cell lines, manufacturing processes, analytical methods, ...) Select, worldwide, appropriate CRO / CDMOs none GMP and GMP grade Define the most cost-effective process development Lead and coordinate all stakeholders and ensure timelines, quality and cost • Program and monitor the production of clinical batches, Pilot Clinical supply Support in writing IMPD and IND A unique global project management - One point of contact 3Biotech, your best support on the Field, from Science to First in Human More information at http://www.3biotech.com

Expert France 2030

Le Cercle des experts Bpifrance

2024-1 - Present · 2 yrs 10 mos

Paris, Île-de-France, France

Dans le cadre de la doctrine du plan France 2030, l’Etat a décidé depuis 2022 de généraliser la participation d’experts indépendants issus de la société civile à l’évaluation des dossiers déposés auprès d’appels à projets financés par les différents ministères: Au sein d’un jury composé d’autres experts indépendants et d’experts sectoriels Bpifrance, lecture, audition et évaluation de projets afin de statuer ou non sur leur pré-sélection.

Chief Technology Officer

ABCELY

2023-10 - Present · 3 yrs 1 mo

Nantes, Pays de la Loire, France

Head of CMC

Domain Therapeutics

2022-7 - Present · 4 yrs 4 mos

Strasbourg, Grand Est, France

CMC Consultant

CEVA SANTE ANIMALE

2018-10 - Present · 8 yrs 1 mo

CMC Consultant

Amolyt Pharma

2022-9 - Present · 4 yrs 2 mos

Lyon, Auvergne-Rhône-Alpes, France

CMC Director

Apaxen

2020-3 - 2024-9 · 4 yrs 7 mos

Brussels, Brussels Region, Belgium

CMC adviser/ ADC

Advesya

2021-9 - 2024-2 · 2 yrs 6 mos

Head of CMC

AbolerIS Pharma

2020-11 - 2023-12 · 3 yrs 2 mos

Nantes, Pays de la Loire, France

AbolerIS Pharma is a pre-clinical stage biotech company specialized in the development of innovative immuno-modulators for the treatment of transplant rejection, graftversus-host-disease and auto-immune diseases. The company recently announced the successful completion of a seed financing round to help advance the pipeline and company.