Drug Development Consultant & Owner at Galenometrics AB at Recipharm
Level: LEVEL 02 (12 mo pts: 58 pts)
Rating: 5/5 stars (12 ratings)
Lifetime points: 363 pts
I am working as a CMC senior consultant within enabling formulation technologies, drug development. Broad experience of drug formulation in pharmaceutical industry, 25+ years, from macromolecules to small molecules, big pharma to small start-ups.
Involvement in early pre-clinical drug development in LO-phase to late drug development in clinical phase III and registration. Documentation experience from IND/NDA CMC part and experience of manufacturing according to GMP.
Broad knowledge of both writing and reading pharmaceutical patents. Inventor of several formulations with NCE pharmaceuticals nominated for CD. Co-inventor of a recombinant HDL particle containing Apolipoprotein A-1Milano.
Experience in chemometrics with 25+ years in the field: design of experiments, quality by design - experience of interaction with authorities and multivariate analysis. Publication used in chemometric textbook: Design of Experiments, principles and application, Umetrics Academy, Ed. Eriksson et al. (2008), chapter 21.
I have a broad know-how and understanding of nanotechnologies in drug delivery, 25+ years in the field: liposomes, nanosuspensions, mesoporous inorganic carriers, self-emulsifying drug delivery systems.
I am a multitalented teamplayer with a creativity to work independently. I have analytical skills and a responsive mind.
I can offer: - to formulate demanding drug substances in a product/formulation with optimal exposure and minimized side effects. - to perform a Process Validation, Control strategy or Quality by Design strategy using ICH/FDA guidelines and Design of Experiments
Achievements: QbD responsible expert of drug product leading to an improved and more robust process and FDA approval.
Specialties: Chemometric support, colloidal formulations, pre-clinical formulation of poorly soluble drug substances, solid-state characterization.
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