Beerse, Flemish Region, Belgium
- Process Chemistry: 15 years experience in an international pharmaceutical company (J&J) with as main accomplishments the development of the manufacturing route for the TMC-278 and the introduction of the Canagliflozin second-generation process in Chemical Production Geel. For TMC-278 development from kiloLab to Chemical Production (3 patents and 1 publication). TMC-278 (Rilpivirine) has been approved in May 2011 by the FDA (HIV treatment). Commercial name of TMC-278 is Edurant. For the Canagliflozin second-generation process, the introduction in Chemical production includes experience in chemical transfer/registration/validation/supplier qualification as well as in filing (QSYN/QRS/PAS/and other variations). Canagliflozin is approved in the US and Europe and the commercial name are Invokana and Vokanamet (combination with Metformin). - Medicinal Chemistry: 3 years of experience in a small Biotech Company (Euroscreen SA). Hit to Lead optimization in various internal programs (mainly working on the GPR43 project: 5 patents, 2 potential pre-clinical candidates identified). Specialties: Project Management. Organic Synthesis. Medicinal Chemistry. Process Chemistry. Transfer of Processes to Pilot Plant and Commercial Production Plant. Process Validation/GMP. Filing (Drug Substance sections). ICH guidelines. Lab-Work management. Chemical Nomenclature in Organic Chemistry.
Scientific Integrator - Drug Substance
Responsible for all development activities related to the small molecules drug substance at iTeos. This role includes: management of external R&D work and external manufacturing, cGMP, sourcing starting materials, budget, filing and answers to questions to health authorities, genotox assessment according to ICH-M7 or S9 guidelines, specifications setting in collaboration with the analytical leader, close collaboration with the drug product leader for the formulation development. Main accomplishments: development on new crystallizations for 3 compounds (EOS-850-inupadenant, EOS-984 and EOS-518). Supervision of GMP campaigns with delivery on time of multi-kilograms of drug substance for FiH and Phase 2. Successful delivery of Tox and GMP batches in less than 6 months for an accelerated project (EOS-518, additional challenge: deuterated compound).
During my Galapagos period my main task was to develop a suitable synthesis (adapted to the phase of development) with external CMOs in order to supply on time the clinical studies. I started to work on the CF projects (in collaboration with AbbVie) for which the drug substance supplies for 10 FiH were done in around 3 years. I worked on the GLPG1972 project in collaboration with Servier (Ph II supplies). I also worked the GLPG1690 project (ziritaxestat) which was unfortunately stopped during the Phase 3. This includes the Ph III clinical supplies as well as the development of a commercial manufacturing process including Registration and Validation Campaigns (Successful Registration Campaign in 2020: 1 MT API produced by external CDMO). Ziritaxestat was in co-development with Gilead.
CMC responsible of the API development for a late phase project: Canagliflozin second-generation process. Main accomplishment: the introduction of the 2nd gen. process in Chemical Production (Geel site) including successful Registration and Validation Campaigns. Additional experience in supplier qualification, external manufacturing, criticality analysis as well as in filing (drug substance section, comparability protocol and other variations). Canagliflozin is approved in the US and Europe and the commercial names are Invokana and Vokanamet (combination with Metformin).
Nearly 3 years of experience in Medicinal Chemistry in a small Biotech. Experience acquired in hit to lead optimization, SAR, Profiling. Management of research in MedChem (retrosynthetic analysis and synthesis in the lab, proposals of new targets based on SAR analysis, management of work for associates). 4 patents.