About PDI
About PDI
PDI provides training and consulting on formulation and pharmaceutical development of biotech molecules.
Industry Challenges
The pharmaceutical development of Biotech entities is a key process where the development of the drug substance , of the drug product and of the analytical concept need to happen in parallel , without compromising the timelines to clinical studies and market.
Companies frequently face hurdles during this development especially when dealing with original and complex biotech entities, such as multi-specific antibodies, antibody-drug conjugates, nucleic acid therapeutics or nanoparticles drug delivery systems.
Big pharma companies have large and experienced CMC departments, while small business partners generally rely on CMO/CDMO for these development activities, and may face scientific and technical challenges they don't have the internal expertise and experience to tackle.
In the pharmaceutical development market, many solutions are proposed to address formulation or drug delivery challenges. The proposed solutions may not fit with the specific scientific problem that a company encounters.
CMC development teams need to delineate the challenges they are facing to define a scientifically sound formulation and pharmaceutical development strategy, structure and decision making process.
What makes PDI different
Favor team work by gathering all your experts and challenge them in a maieutic spirit.
Develop scientific recommendations based on examination of the specific challenges and avoid a « one size fits all » approach.
Define the problem and find the adequate solution to it, rather than buy solutions and look for the problem.
A pedagogical approach built on experienced-based case studies.
An experienced leader who has contributed to CMC development of different approved drugs.
Pierre Wils — Founder, PDI
PDI missions
PDI provides training and consulting on formulation and pharmaceutical development of biotech molecules.
Help pharmaceutical and biotechnology organizations, especially start-ups or small companies, develop scientifically solid CMC development strategies.
Address the scientific and technical challenges brought by complex biotech molecular entities, and propose solutions to these challenges that are adapted to the company needs and molecule development stage.
Strengthen long-term capabilities of the CMC development teams through practical and experience-based learning.