Chalfont St Giles, England, United Kingdom
I am a passionate, transformative C-suite level leader of high functioning teams in the Translational Research and Early Clinical Development space with demonstrated history of progressing novel therapeutic entities from the pre-clinical stage into Ph1 and Ph2 clinical trials. I garnered experience in big & medium size pharma as well as in the start-up/biotech setting, covering a range of therapeutic areas (Immuno-Inflammation, Autoimmunity, Fibrosis and Senescence/Ageing) and therapeutic modalities (mAbs, peptides, cell therapy, small molecules and most recently oligonucleotides).
Member of the leadership team with board representation. Responsible for company transitioning from discovery to early clinical development stage, moving SENISCA's therapeutic oligonucleotide pipeline into clinical testing. SENISCA is an award-winning biotech spinout company from the University of Exeter, founded in 2020 and dedicated to the development of new approaches to reverse cellular senescence (senotherapeutics).
Member of the leadership team with board representation. Responsible for pre-clinical/translational research and early clinical development strategy to drive Sitryx' small molecule drug candidate progression into the clinic. Sitryx is a biopharmaceutical company focused on regulating cell metabolism to develop first-in-class disease modifying therapeutics in immuno-inflammation.
Successful company transitioning from research to clinical development stage: • Recruitment of key talent and consultants to support development efforts to tight deadlines for regulatory submission • Identification and implementation of critical activities and budget requirements across all R&D functions • Program leader for Tx200 CAR-Treg cell therapy program: Preparation of FTiH study in solid organ transplantation; establishment of KoL, investigator and clinical site network; presentations to regulators securing successful CTA approval Q4 2019 • Key role in company presentation to potential partners/buyers resulting in acquisition by Sangamo Therapeutics
Successful delivery of clinical and regulatory strategy for 2 drug development programs through leadership of Clinical and Regulatory Solution Teams and frequent decision enabling presentations for endorsement to all relevant internal decision-making boards: • UCB7858 anti-Transglutaminase-2 mAb Zampilimab: Planning and implementation of Ph1 HV trial NCT02879877 (completed) and follow-on Ph2 trial in adult Kidney Transplant Recipients with Chronic Allograft Injury (EudraCT 2017-004807-31) • UCB6673 (MultipepT1De) peptide immuno-therapy: Preparation of Ph2 trial in paediatric and juvenile Type 1 Diabetes patients in collaboration with the Immune Tolerance Network and the National Institute for Allergy and Infectious Disease, U.S.A. • Matrix management of 2 clinical and regulatory strategy teams with 15-18 members each.
Successful conception and implementation of biology strategy for several biopharm projects: • GSK2831781 ADCC-enhanced anti-Lag-3 depleting antibody: Research lead from in-licensing, over FTiH HV/Psoriasis patient study delivery (NCT02195349; completed) and target validation for progressing asset into Ph2 trial in Ulcerative Colitis patients (NCT03893565) • Belimumab (Benlysta™) Anti-BLyS antibody: Research lead driving successful indication expansion into Ph2 trial in patients with Idiopathic Membranous Nephropathy (NCT01610492; completed and published) • Novel technologies and collaboration management • Direct line management, strategic input and workflow prioritisation of a team of 6 principle scientists, successfully supporting 4 FTiH study starts, 1 Clinical PoM and 1 CS; project-driven matrix management of subspecialty drug development teams