Biologics CMC, Gene therapy
Patient Centric Biologics CMC Executive | Established Leader in Advanced medicines development I Clinical Biochemist l Digital Health Leader.
PhD in Protein Biochemistry University of Surrey
MSc in Clinical Biochemistry and Molecular Biology, University of Surrey
BSc in Biochemistry and Molecular Biology, University of Greenwich
Experience
- 25 years of Analytical Development, Process Analytics, QC and CMC Leadership
- Developed >80 Monoclonal and Fusion Proteins (Pre-clinical to FIH, and late Phase development)
- >20 IND filing in Biologics and Small Molecules
- CMC and technical leadership
- Executive and Scientific leadership, Columbia University
- Personnel development and management trainer, Boston University
Expertise
- Gene Therapy (Phase I to Phase III: MPSIIIa, GSDIa and OTC, San Filipo and DMD)
- mRNA and ASO (GSDIII and Angelman Syndrome)
- Small Molecules (Phase I to Commercial Dojolvi, Copaxone, Enoxaparin)
- Mabs – Phase I to commercial: OPDIVO, Orencia, Yervoy, Borusomab, Evkeeza, Mepsevii, Humira and Orencia Biosimilars