Decisions R&D consulting is providing expertise in the field of translational medicine, clinical pharmacology and early clinical development to pharmaceutical/healthcare companies, small to large, clinical research organizations and public organizations, when expertise or resources is missing.
Decisions R&D consulting main service is to support translational
medicine and early development strategy of drug candidates. This is covering late discovery (target validation, lead optimization) up to clinical proof of concept. These steps are crucial in the
value chain as the right “decisions” are absolutely critical for success, keeping in mind the very high attrition rate at
these stages, e.g. indication(s), population(s), dose(s), regimen(s), biomarkers, go no-go criteria(s)
…
At this early stages pharmaceutical companies, particularly young/small biotech, but not limited to, may lack the appropriate expertise and/or resources that Decisions R&D consulting provides.
The proposed approach is based on an integrated risk-benefit analysis focused on human pharmacology, drugability properties and disease(s), leading to a lean, rapid and cost effective clinical development plan, with a step-wise de-risking strategy.
In addition to this early development strategy support, Decisions R&D consulting is also
offering more focused support on
- Evaluation of external opportunity , including due diligence
- Clinical pharmacology profiling
- Program for mid and late stage development to support phase III, labeling, differentiation and claims.
- Clinical pharmacology overview as part of regulatory strategy, documents and filing, including meeting with agencies (effective and mock).
- Studies from concept and execution (DMC) to analysis, such as first in human, thorough ECG study, pharmacodynamics and biomarkers / bio-imaging (Proof of Mechanism), drug abuse liability, Drug-Drug interaction, special population, Clinical Proof of Concept, …
- Organization and process adaptations to efficient translational medicine and early clinical development.
- Training in translational medicine, early development and clinical pharmacology
Decisions R&D consulting has been founded by Jean-Louis Pinquier, MD
who has been involved in more than hundred drug development programs over those past 30 years, particularly in early clinical program covering multiple therapeutics areas but also
several worldwide filing. Dr Pinquier as a member of ASCPT, ACCP and Club Phase
I, has always been at the forefront of innovation in clinical pharmacology field and in early clinical development , leading to implement new methods, new mindset and optimized
practices in his environment e.g. integrated first in human protocol, optimized QT evaluation, pharmacological
models, biomarkers, bioimaging, early patient studies, adaptive designs, pharmacometrics among
others.
His current interest is focused on the implementation of reliable translational
medicine program and the optimization of early clinical development up to clinical proof of concept, using innovative methodologies and rigorous learning-confirming de-risking
strategies.
DECISIONS R&D Consulting