Functionnal expertise
Consulting Services for developing your new biotech drug product
We offer strategic and operational advice thanks to our network of seasoned experts from the pharma – biotech industry.
We support your pipeline development and provide guidance to navigate a complex organizational environment. We can support your activities in manufacturing and control, non-clinical development, translational research, regulatory affairs, early clinical development and program management.
Our main fields of expertise are cell and gene therapy, tissue engineering, live biotherapeutic products (microbial), recombinant proteins and antibodies.
Chemistry, Manufacturing and Controls (CMC)
We leverage our expertise in manufacturing and ICH, FDA and/or EMA regulations to develop robust processes and analytical methods customized to your specific drug development program to ensure successful CMC development and approval of drug product manufacturing process, characterization, quality control and stability.
- Lead and candidate selection
- Research and GMP cell banks
- Process development, scale up, clinical batch production, troubleshooting with manufacturing process robustness/change & comparability exercise.
- Analytical development: analytical package for testing raw materials, drug substance, drug product and in-process controls; method development and validation; specifications; establishment and characterization of reference standards; stability studies.
Preclinical Studies – Translational Research
We help you to define and execute non-clinical package for your new drug development in compliance with requirements from ICH, FDA and EMA before the first-in human trial, Phase III trial or biological license/market authorization application..
- Support for designing development plan
- Model selection, Proof of concept studies: choice of relevant in vitro and in vivo models for efficacy and safety testing; design of protocol, follow-up and data analysis and reports;
- IND/CTA enabling studies: clinical trial enabling studies have to be designed on a case-by-case basis following regulatory agencies’ guidelines and scientific rationale
- Assessment of the safety of the new therapeutic approach, toxicology studies
Clinical development
BP provides supports in the critical early stages of clinical development. The design of your study should allow optimal assessment of safety, efficacy and risk/benefit ratio, in a time and cost-effective manner. The choice of clinical sites is key for enrolling patients from the target population and for choosing sites with the right level of expertise. BP will also assist you in setting up the bioanalytical package: method development, validation & execution; sample management, logistics & laboratory manual
- Support for preparation of Clinical Trial Authorization (CTA) / Investigational New Drug (IND) packages
- Contribution to investigator brochure (IB)
- Bioanalysis support (PK, ADA, PD)
- Support for clinical synopsis
Regulatory Sciences
The regulatory landscape is evolving rapidly, especially in regard to Advanced Therapy Medicinal Products (ATMPs). The same is true for biologics. Our aim is to bring to you our expertise from both sides of the mirror (drug developer and former member of a regulatory body) to guide you through the regulatory maze including Scientific Advice (SA), PreCTA or preIND meetings. As part of the regulatory strategy, SA are critical to better understand the requirements of regulatory bodies regarding Clinical Manufacturing and Control (CMC), and non-clinical packages to apply for a Clinical Trial Authorization (CTA) / Investigational New Drug (IND) applications. We help you to formalize questions and your position as an applicant before interacting with National Competent Authorities (NCAs).
For regulatory submissions of CTA applications, a full dossier should be carefully designed and implemented to achieve successful application for early clinical studies. We provide you with dedicated advice to each major component of the dossier (IMPD, non-clinical package, IB, Synopsis …).
- Regulatory strategy
- PreCTA/preIND
- Scientific advice
- CTA/IND file
Program management
Drug Development is a challenging path, requiring multiple functions/skillsets and interactions with multiple resources & stakeholders (internal/external, Personnel/CROs/CDMOs, intern, Clinicians, NCAs…). The project manager’s contributions include maintaining smooth communications between functions, the project schedule, organizing project team meetings, writing meeting minutes and monitoring the completion of actions. Careful coordination, follow-up and planning is mandatory to reach success. Writing of the Target product profile, analysis of critical path and identification of risks allow mitigation & proper risk management. Biotherapy Partners provides you with operational Project Management support and corporate organization.
More generally, good corporate organization is key to provide efficient support to Drug Development, especially for support functions like Human Resources (HR), Finance or Quality Assurance (QA). Our seasoned experts support company creation & organization of startups.
- Target Product Profile (TPP)
- Project charter
- Drug Development Plan
- Project gantt & budget
- Project coordination
- CRO/CDMO supervision
- Company management support/organisation
