r&d and Product Development specialist
science, business, regulations, quality, Intellectual Property
my goal is to develop advanced therapeutic products and bring the brightest and most promising ideas and technologies that emerge from fundamental science to create effective and commercially viable products.
my expertise includes the development, Testing, Validation, bioproduction and biobanking of:
- human Stem Cells (MSc, hsc, adult tissues Stem Cells)
- extracellular vesicles
- artificial tissues (Biomaterials and Tissue Engineering)
my professional activity has been focusing on the most exciting phase of r&d process where basic ideas are maturing into therapeutic products. Innovation and creativity are the essence of Preclinical development and Clinical Translation process. i find this stage so exciting since all the aspects of Product Development must be planned and foreseen in advance in order to achieve a therapeutic and commercial success in the future:
> good science
> production process (quality, cost of goods)
> regulatory framework
> Clinical Translation
> Reimbursement options
to achieve these goals i need to combine over 10 years of my scientific experience with commercial, regulatory and Quality Control skills.
my main achievements are the development of:
• autologous MSc bioproduction,
• allogenic extracellular vesicles bioproduction,
• design of GMP Lab facilities for atmp production,
• implementation of glp Quality Control systems
Product Development is always a Teamwork. in the course of my Career, i have gradually moved from basic academic institutions in poland and the uk, through a non-profit institute in france towards a biotech company in belgium. this path has given me an excellent knowledge about how such institutions work, and how this could improve an effective network cooperation in Product Development.
i am looking for collaboration opportunities to bring new ideas into affordable therapies.
General Manager, R&D Director
Since November 2016
- Product development: ATMPs and Extracellular Vesicles (EVs) - Bioproduction: ATMPs and EVs - Development and implementation of GLP and GMP labs - Clinical translation and clinical trial project management - Business development - Quality Management Systems (ISO, GLP, GMP, GCP) - Patent and intellectual property management - International regulations - Staff management - Budget management - Biomarket analysis - International research projects coordination - Scientific and business networking - Research grants and project funding - Business and research contracts - Informed consents - Press releases - Scientific dissemination - Lectures and presentations - Conferences and workshops - Internal and external audits - Product selection and ordering
Doctor (PhD) of Medical Sciences in Neurology, Adult stem cells from Mossakowski Medical Research Institute of Polish Academy of Sciences, Warsaw in 2006
M.Sc. in Molecular Biology from University of Warsaw in 2002
Expert has 5 publications (Will be avalible with full profile)