"ENTREPRENEURS, we have a message for you"
“In the medical field, the process of transitioning from a theoretical or technological model to a functional business model requires careful consideration and planning.
Additionally, in drug development, demonstrating proof of concept is only the beginning of the process, as there are numerous critical stages to follow."
Taking shortcuts and rushing through the development process is not a viable option, as this can lead to costly failures. Therefore, it is essential to adhere to the fundamental principles of drug development and have a well-defined Chemistry Manufacturing and Control strategy. Failing to do so due to time constraints or a lack of knowledge can result in prolonged development timelines and increased costs.
It is critical to execute drug development effectively to avoid failure and maximize success.
WHY US?
"By failing to prepare, you are preparing to fail"
benjamin franklin
Is it feasible for a large corporation to acquire a technology or process that cannot be efficiently scaled up? Considering the perspective of Big Pharma, it is imperative to conduct thorough Chemistry Manufacturing and Control (CMC) due diligence before acquiring an asset to safeguard their investment. This entails assessing the manufacturing process, guaranteeing compliance with regulatory standards, evaluating scalability potential, and identifying potential risks or challenges. The comprehensive evaluation of CMC before asset acquisition enables Big Pharma to reduce the risk of investing in an asset that cannot be effectively scaled up or fails to meet regulatory requirements, thereby maximizing the potential for success in drug development.
So, what do you NEED?
OUR TEAM
We are an operational team of international experts
with a network process all over Europe.
A dedicated team is set up for each project.
We are committed to create an open environment, where all individual contributions are valued, all voices are listened to and respected.
We are an accelerator, not a consultancy firm, devoted to supporting your performance by adhering to the pharmaceutical industry's high-level standards. Think of us as part of your team, passionately dedicated to resolving the most intricate drug development obstacles on a daily basis. Our expertise in transforming innovative ideas into viable and thriving companies is a valuable asset that we bring to the table.
At 3Biotech, our objective is to enhance the lives of patients and advance healthcare by promoting the growth of innovative companies - perhaps yours.
Olivier Favre-Bulle
Olivier has worked in the biotechnology industry for more than 25 years, first as a researcher, then in international project management, and finally as CEO of companies such as Novo Nordisk Engineering France and Covance France.
Olivier holds a PhD in biotechnology and an MBA. Olivier is known for his ability to quickly analyse key business drivers, develop and execute strategies that achieve leadership positions and improve the bottom line in the biotech and pharmaceutical industries.
His passion, which has been his guiding principle, is medical research with a genuine commitment to serve the patients and to bring new, advance and safe innovative therapies to the market. He’s driven by making an impact that matters in the patients’ life.
Olivier is a member of the "Cercle des experts Bpifrance" and is involved in the assessment of biotech projects applying to the #France2030 calls for project"s.
CEO and
founder
Frequently Asked Questions
What is lead optimization in drug development?
Lead optimization is the process of refining drug candidates, whether small molecules or biologics, to improve their efficacy, safety, and manufacturability before advancing to clinical development. For small molecules, this involves structure-activity relationship (SAR) studies, absorption, distribution, metabolism, excretion, and toxicity (ADME-Tox) profiling.
For biologics, optimization includes protein engineering, immunogenicity assessment, expression system refinement, and stability evaluation. Comprehensive preclinical assessments are performed to ensure the highest likelihood of success in human trials.
What is translational research in drug development?
Translational research bridges preclinical discoveries to human trials by optimizing drug candidates for clinical evaluation. It includes dose selection, biomarker identification, and first-in-human study design to ensure successful clinical translation.
What is Chemistry, Manufacturing, and Control (CMC) in pharma?
Chemistry, Manufacturing, and Controls (CMC) encompasses all activities related to the development of drug substances and products. This includes formulation, process optimization, analytical testing, and ensuring regulatory compliance.
CMC ensures the physical and chemical characteristics of drug products are assessed to maintain quality and consistency throughout manufacturing.
What is continued process verification (CPV) and why is it required?
Continued Process Verification (CPV) is the ongoing monitoring of a manufacturing process to ensure it consistently produces products with the desired quality attributes throughout the product lifecycle.
CPV is required for regulatory compliance and helps maintain product quality and consistency during commercial production.
What are accelerated regulatory pathways (e.g., Fast Track, Priority Medicines [PRIME])?
Accelerated regulatory pathways, such as Fast Track (FDA) and Priority Medicines (PRIME, European Medicines Agency), are programs designed to speed up the development and approval of drugs for serious conditions or those addressing unmet medical needs.
These pathways aim to provide patients with faster access to potentially life-saving therapies.
