BIOPHACT® : Pharmaceutical development and clinical
positioning expertise
Who we are ?
What we do ?
Our Expertise
DRUG DEVELOPMENT STRATEGY AND CLINICAL POSITIONING
Today therapeutic innovation is based on science. This high scientific value does not always fit with a full pharmaceutical vision. There is always a gap, between scientific concept and drug that could be registered by competent authorities.
BIOPHACT® provides skills and methods used currently in big pharma to Biotechs, Pharmas or Project Holders to optimize the R&D development plans keeping in mind:
- STRICNESS
- REGULATORY COMPLIANCE
- ETHICS
- COST OPTIMIZATION
A 35-years background in pharma industry provides to our prospective partners a major asset to define the clinical positioning and build the development plan of a new product or concept as well.
From target to bedside, we provide useful tools, techniques and network to finetune the project with high scientific level, ethical and regulatory compliance.
We are convinced that the analysis of competition is mandatory to define non-clinical and clinical strategies. Competitor differentiation-driven approach improves the value of the project for the patient first and then for the firm.
Our commitment is to share with our partners a strong experience in drug development worldwide with a triple goal:
- Define a strategy to address an unmet medical need by the design of the Target Product Profile (TPP),
- Increase probabilities of registration success within regulatory compliance,
- Manage thoroughly the budget and avoid pitfalls.
Our service proposal addresses the following items:
Program building, drug development plan set-up and clinical design
We support your business plan and your drug program by driving the complex process which involves many interdependent components. Whatever the line: pharmacology, toxicology, safety, chemical manufacturing and control, clinical design and patient selection, we can merge the data and write pivotal studies documents deliverable such as Investigator Brochure, IND, IMPD.
Having a strong background in outsourcing and a perfect knowledge of our Biotech/Pharma ecosystem, we can help CRO and CDMO in optimal selection. We also have a background of many first in man studies and can calculate and justify the first dose in human in various therapeutic areas.
Our network of KOL in each field is a clear asset to your project.
OUR PARTNERS/OUR CLIENTS
You are a Biotech with a new therapeutic solution, a Pharma starting a new project in a new field, a firm lacking manpower or expertise, a private (VC) or institutional investor, a Transfer Technology Accelerator (TTA), a project holder in a public or a private Institute: we help you in your project design whatever its development stage from target validation to PIII design until market authorization.
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