Bio

An experienced Cell & Gene Therapy Senior Leader and Board Member with a strong track record of leadership and teamwork in developing and commercialising innovative advanced therapies. My focus is on delivering positive ethical outcomes for patients and customers by utilising a commercially-minded and pragmatic approach to advanced therapy development. As a pharmaceutical physician and clinician I have extensive surgical and medical clinical experience with a strong patient focus. Additional Positions: Xintela AB (Sweden) - Board Member and Interim CMO & COO CCRM (Canada) - Board Member and Investment Committee member BIA Cell & Gene Advisory Committee Chair Standards Coordinating Body - Executive Board Member Senior Medical and business strategic expertise focussed on extensive Clinical Development and Medical Affairs expereince involving a broad range of activities including: Ethical promotion of Medicines and Devices (UK, EU, US, Asia, Australia); Clinical research (phase II/ III/ IV) and product registration and reimbursement activities. Therapy area Expertise: Cell Based Therapies, including Gene Therapies and Gene Modified cells Stem Cells Cartilage repair and regeneration Joint resurfacing Bone repair and growth Rare Diseases Renal Medicine (CKD- pre and dialysis) Cardiovascular medicine (Familial Hypercholesterolemia) Medical devices Surgical disciplines (Orthopaedics, Reconstructive surgery, Urology, GI Surgery, Neurosurgery, Vascular surgery, Cardiothoracic surgery) Specialties: Biotech business company formation, management and strategy Medical Affairs Research and Development Drugs safety, Device Safety and pharmacovigilance - (EU QPPV experience) Regulatory Strategies for medicines and ATMP products Product aquisition and due diligence activities Practical training (internal and external) EU licence application activities (MAA CTD, RMP and PiP) Risk & crisis management and communication Market access planning (NICE, SMC, AWMSG)