Singapore
I’m a Molecular and Cellular Scientist with 20+ years experience in R&D and Translational development, GMP manufacture of Cell and Gene Therapy Products in clinical applications in oncology and rare diseases. With a deep interests in development and manufacture of viral vectors for human gene therapy, I have presided over viral vector technology, cell line, IP, process development and translational/clinical manufacture of Retro/Lentiviral vectors for a range of applications from CAR-T oncology to rare disease to gene-modified cellular vaccines from early to mid-phase clinical development in UK, EU, US and APAC regulatory regions. As a founder and entrepreneur, I established APAC region’s first regulatory accredited Viral Vector specialist CDMO in Singapore, overseeing the foundational technical platform establishment, manufacturing operation, business and commercial development of the company. Leading it to achieve GMP certification and revenue generation within 3 years of company incorporation. As a former senior investigator, I have led R&D and translational clinical bench-to-bedside development and GMP manufacture of gene-modified cellular therapies for regulatory approved clinical trials in UK. As Head of Manufacture for Advanced Therapies in London, involved in successive UK regulatory accreditation and manufacturing authorisation in CGT manufacture. I oversaw the delivery of a range of CGT products for Phase I to Phase III clinical development, including a successful viral vector manufacturing agenda and establishment of UK’s GMP viral vector core achieving a majority European market share for Clinical grade Retro/Lentiviral vectors suppling both academic and industry contracts including those resulting in eventual IPO and successful BLA submission. With a track record in GMP regulatory compliance in CGT, I’m an invited speaker, advisor and reviewer including for UK National Research Councils in establishing national CGT manufacturing hubs and an appointed advisory committee member in drafting Singapore national CGT regulations. I’ve had a successful track record on CGT/Viral Vector product IND regulatory filing and GMP accreditation in PIC/S, EMA, UK MHRA, Singapore HSA, TGA and US FDA regulatory regions.
I work with CGT developers to translate pre-clinical scientific concepts into clinical realities through expert technical and regulatory guidance. My specialised knowledge helps clients navigate the complex manufacturing and CMC roadmap for CGT product development, streamlining preparation for clinical trial submissions. Our comprehensive support spans the entire development cycle — from raw material selection, process development to tech transfer, analytical development, GMP facility concept design, regulatory support, operation, and CDMO vendor selection.
Incubating novel CGT modalities
Successful launch of APAC region's first viral vector specialist CDMO. I played the foundational roles as CSO/CTO/COO and led the scientific establishment of the company's IP and platform technologies. Establishing and trained R&D, MSAT, Manufacture and Quality department personnel, culminating to the first GMP accreditation and certification of its kind in APAC by Singapore's Health Science Authority under PIC/S standard. Built company's foundation in cohesive operation in development, manufacture & product delivery and continual GMP compliance. Established company's global client base and business development in achieving contractual awards and revenue generation within 3 years of company incorporation
Established Advanced Therapy Group and assemble scientific team to build innovative CGT platform solutions and processes and fund raising. This served a pre-requisite to the establishment of CellVec
Translational development and manufacture of Cell and Gene Therapy as Advanced Therapy Medicinal Products for Phase I to III studies. Design, C&Q and Manufacturing Authorisation of KHP's new GMP manufacturing facility for CGT Products and successive GMP accreditation by UK MHRA for KCL's vector manufacturing facility Established proprietary GMP manufacturing procedures for viral vectors for Gene Therapy. Oversaw an active GMP manufacture programme for Retro/Lentiviral vectors for both academia and industry. Delivered >30 batches for clinical applications. Examples of ATMPs produced: Virus vectors - Lentiviral vector encoding CD80 and IL-2 to induce GVL in AML (the first clinical grade lentivirus produced in Europe) - Retro/Lentiviral vectors expressing chimeric antigen receptor (CAR) targeting Haematological Malignancies - Lentiviral vector expressing a ligand for the modification of Mesenchymal Stem Cells for solid tumour targeting - Lentiviral vector for MPS III neurodegenerative disorder - Retroviral vector encoding T cell receptor targeting HepB surface antigen in HCC - Retroviral vector encoding HSV-tk for the control of GvHD - Lentiviral vector expressing Collagen VII for Dystrophic Epidermolysis Bullosa - Lentiviral encoding SPINK5 for Netherton syndrome Cell therapies - CD80/IL-2 gene modified whole cell vaccine for AML – Phase I - Tumour pulsed DCs for Glioblastoma Multiforme – Phase III (first cellular therapy entering Phase III) - hTERT peptide pulsed DCs for in solid tumours - Phase I - Donor NK cells for AML - Pilot study Other GMP products - Multi-epitope hTERT peptide based vaccine for prostate cancer - Master Cell Banks