Novel therapies, including cell and gene therapies, continue to be central to innovation in healthcare and represent the fastest-growing area of therapeutic medicine. As a consequence, the number of gene therapies undergoing clinical trials has increased significantly in the last five years. Manufacturing processes for these novel therapeutics are very complex with a high risk of contamination. Regulatory agencies worldwide have responded by issuing guidance to outline their expectations for the development and manufacturing of cell and gene therapies. Currently, regulatory guidance is not harmonized globally and can often lead to confusion within the industry, thus increasing the risk of non-compliance.
In this webinar, we'll answer:
- Which regulatory guidelines do you need to comply for your INDs?
- When do you start implementing GMPs and validated assays?
- How do you get your QC testing strategy "right the first time"?
- How do you ensure testing is not your rate-limiting step for the IND submission?
Speakers
Alison Armstrong, Ph.D.
{hcompany}
Sr. Director, Technical and Scientific Solutions
Alison Armstrong is the global head of the field technology management team. She was appointed senior director, UK development services in 2009, and established a client-facing technology management team in 2015. This team is responsible for scientific and regulatory advice and fully supports clients. Alison has authored several articles on trends in biosafety testing and is a member of regulatory taskforce groups related to rapid technologies. She is an invited speaker at global conferences. She holds a Ph.D. in molecular virology from the University of Glasgow.
Manjula Aysola, Ph.D.
{hcompany}
Senior Regulatory Consultant
Manjula Aysola is a senior regulatory consultant in the global regulatory management team. She is an expert on regulatory requirements for quality control of biopharmaceuticals including cell and gene therapies, and she has expertise in regulatory expectations for single-use manufacturing systems and cell/gene therapies manufacturing. With {hcompany} for more than 16 years, Manjula led several R&D projects for bioreactor process development and cell culture media evaluations for stem cell therapies with the organization.
She was previously with Millennium Pharmaceuticals, focused on oncology target and biomarker discovery. Manjula earned her M.S. degree in genetics from Clemson University.
Pharma and biopharma manufacturing
- Gene therapy manufacturing
Duration:1h
Language:English
Session 1:presented July 28, 2022
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