Translational development and manufacture of Cell and Gene Therapy as Advanced Therapy Medicinal Products for Phase I to III studies.Design and Commissioning of a new GMP 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 syndromeCell 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 studyOther GMP products- Multi-epitope hTERT peptide based vaccine for prostate cancer- Master Cell Banks

Senior Investigator - Immune Gene Therapy for Haematological Malignancies. A bench to bedside program involving basic, pre-clinical and translational development of a regulatory approved First-in-Man Advanced Therapy. The Whole Cell Vaccine is produced by Lentivirus transduction of autologous leukaemia cells with the immune modulators CD80 and IL-2 in combination. The 2x Phase I studies investigate effect of the whole cell vaccine both in an allogeneic setting on the potential to induce graft-vs-leukaemia or as an auto-reactive whole cell vaccine without transplant.

Commissioning of a multi purpose GMP Manufacturing Facility compliant to EU GMP standard. Played a lead role in the early development, qualification and validation of the facility to produce Advance Therapy Medicinal Products. Achieve successive MHRA / HTA site license accreditation - Manufacture and Import Authorisation for Cell & Gene Therapy as Investigational Medicinal Products (MIA IMP) and as Specials Products (MS).Established the first regulatory approved Lentiviral Vector manufacturing protocol under GMP in Europe.Oversaw GMP production of a range of Advance Cell Therapies including Dendritic Cells, Natural Killer Cells and Peptides.

Translational development of AML Whole Cell Vaccine as an Investigational Medicinal Product produced under GMP. Writing and compilation of Investigational Medicinal Product Dossiers (IMPD) for regulatory filing to MHRA. Regulatory Approval to initiate a First-in-Man study for Acute Myeloid Leukaemia.

Pre-clinical studies on immunogenicity of CD80/IL-2 transduced leukaemia blasts. Established in vivo leukaemia model to access efficacy. Carried out in vivo safety and pharmaco-distribution studies.

Investigated the use of immune modulators to induce anti-tumour effects in haematological malignancies. Developed novel constructs for the transduction of primary haematological targets.Developed novel production and purification strategies for viral vectors.

Faculty member of Translational Medicine on the development of Advanced Therapies for First-In-Man applications