Dr Janet Macpherson

Clinical Senior Lecturer
Medicine, Central Clinical School

Telephone +61 2 9515 4867
Fax +61 2 9815 4868

Website Cell & Molecular Therapies

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Biographical details

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.

Project management, process development, and manufacturing of cell delivered gene therapies for Phase I and II clinical trials in a small biotech environment within large pharma, leading to broad understanding of requirements for commercialisation of cell therapy products including IP strategy. Currently developing novel cell and gene therapy products in the public health sector.

Experience recruiting and managing scientific, technical, quality and clinical teams for basic research and clinical development in line with GMP, GCP, GLP, and G(QC)LP and OGTR requirements.

Experienced in writing and executing Validations and Standard Operating Procedures and regulatory documentation (CMC, IB) for viral vector and autologous gene-modified cell manufacturing.
Experienced in records management and retention, IP protection, review of confidentiality, service and research agreements.
Project management of contract manufacturing and testing services.
Due Diligence including technical, scientific and intellectual property evaluation, of both internal and external projects, locally and in USA and Europe.

Specialties: Process development, manufacturing, and clinical evaluation of cell and gene therapies.

Teaching and supervision

Cell & Gene Therapy GMPmanufacturing

Associations

International Society Cell & Gene Therapy (Australia and New Zealand Region Vice President,2016-18)

Biotherapeutics Association od Australasia (Council member 2013-16)

American Society for Gene and Cell Therapy

Australian Gene and Cell TherapySociety

Selected publications

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Journals

  • Macpherson, J., Rasko, J. (2014). Clinical potential of gene therapy: towards meeting the demand. Internal Medicine Journal, 44(3), 224-233. [More Information]
  • De Ravin, S., Ling, S., Theobald, N., Choi, U., Macpherson, J., Poidinger, M., Symonds, G., Pond, S., Ferris, A., Hughes, S., et al (2014). Enhancers Are Major Targets for Murine Leukemia Virus Vector Integration. Journal of Virology, 88(8), 4504-4513. [More Information]
  • Wright, C., Velickovic, Z., Brown, R., Larsen, S., Macpherson, J., Gibson, J., Rasko, J. (2014). Raising the standard: changes to the Australian Code of Good Manufacturing Practice (cGMP) for human blood and blood components, human tissues and human cellular therapy products. Pathology, 46(3), 177-183. [More Information]

2014

  • Macpherson, J., Rasko, J. (2014). Clinical potential of gene therapy: towards meeting the demand. Internal Medicine Journal, 44(3), 224-233. [More Information]
  • De Ravin, S., Ling, S., Theobald, N., Choi, U., Macpherson, J., Poidinger, M., Symonds, G., Pond, S., Ferris, A., Hughes, S., et al (2014). Enhancers Are Major Targets for Murine Leukemia Virus Vector Integration. Journal of Virology, 88(8), 4504-4513. [More Information]
  • Wright, C., Velickovic, Z., Brown, R., Larsen, S., Macpherson, J., Gibson, J., Rasko, J. (2014). Raising the standard: changes to the Australian Code of Good Manufacturing Practice (cGMP) for human blood and blood components, human tissues and human cellular therapy products. Pathology, 46(3), 177-183. [More Information]

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