Dr Janet Macpherson
Clinical Senior Lecturer
Medicine, Central Clinical School
|Telephone||+61 2 9515 4867|
|Fax||+61 2 9815 4868|
Cell & Molecular Therapies at RPA
Experienced Team Leader and member of cross-functional project and product development teams, with demonstrated knowledge of regulatory requirements for cell & gene therapy in USA, EU and Australia, and skills to minimise risk on investment.
Cell & Gene Therapy; Project Management, Process Development, Manufacturing for Phase I and II Clinical Trials, CMO management, IP strategy. Small biotech experience within large pharma, leading to broad understanding of requirements for commercialisation of cell therapy products.
Trained in GMP, GLP, G(QC)LP, and GCP.
Prepared and submitted regulatory documentation in support of viral vector and autologous gene-modified cell manufacturing.
Managed translation of retroviral gene therapy from research project through clinical evaluation with staged Process Development.
Experienced in writing and executing Standard Operating Procedures for cel manufacture.
Project management of contract manufacturing and testing services.
Implemented safety and long-term follow-up of gene therapy clinical trial participants.
Due Diligence including technical, scientific and intellectual property evaluation, of both internal and external projects, locally and in USA and Europe.
Experienced in records management and retention, IP protection, review of confidentiality, service and research agreements,
Specialties: Process development, manufacturing, and clinical evaluation of cell therapies
Regional Vice President, International Society for Cellular Therapy Australia and New Zealand Region 2016-18
Councillor, Biotherapeutics Association od Australasia