Planning for Success: Emerging GMP-Grade Raw Materials & Technologies for Cell TherapyPublished: March 18, 2019
March 27th 2019, 09:00 PDT; 12:00 EDT; 16:00 GMT; 17:00 CET
As more cell and gene therapies become approved for clinical use, there has been a rapid increase in the need for innovative cell manufacturing technologies that can improve product efficiency and maintain cell product integrity while meeting scale-up demands. To overcome this commercialization challenge, it is important to identify process development workflow stages where optimization is necessary, test and qualify new technologies that improve that stage of the workflow, and establish supplier relationships to secure raw materials for scale-up.
Join this webinar as our expert panel discuss how to plan the successful development of new cell therapies using emerging raw materials and technologies. During the webinar the panel will explore:
- Workflow steps where raw material optimization is needed – where can optimization be most beneficial to your cell therapy manufacturing process?
- The challenges of unique new raw materials and technologies in cell therapy processes
- When should you be “GMP ready”? Regulatory considerations when using emerging raw materials and technologies
- Scale up and production – unique raw material manufacturer supply challenges and solutions; the importance of establishing a secure raw material supply
- As innovative cell therapies often require multiple partnerships with new raw material and technology manufacturers, should commercialization models/supplier relationships be more collaborative?
Following a presentation by Sean Kevlahan, PhD, Senior Director of Cell and Gene Therapy at Bio-Techne, he will be joined by our expert panel for a lively Q&A discussion during which you will have the opportunity to pose your questions to our speakers:
- Lisa Fox, SVP, Cell Therapy Operations, Orchard Therapeutics North America
- Ángel Herrero Méndez, PhD, Head of Pharmaceutical Development, Takeda Madrid – Cell Therapy Technology Center, Takeda Pharmaceuticals International Co.
- Markéta Horálková, Supply Chain Manager, Sotio a.s.
Webinar attendance is free of charge, but places are limited, so register today to guarantee your participation. If you’re not sure if you’re free on the day, please register anyway and we will send you the link to the recorded webinar as soon as it is live.
Dr Sean Kevlahan, Senior Director of Cell and Gene Therapy, Bio-Techne
Sean Kevlahan is the Senior Director of Cell and Gene Therapy at Bio-Techne. He is a product driven entrepreneur, specialist in cell biology, and domain leader in cell/gene therapy bioprocessing. Prior to his role at Bio-Techne, he was the CEO and co-founder of Quad Technologies, which was recently acquired by Bio-Techne. Dr. Kevlahan has received numerous awards including being one of the top-26 finalist in MassChallenge, CASIS grant award, and 2017 emerging technology finalist by Bioprocessing International. He is a lead inventor of many patents and authored numerous publications utilizing Bio-Techne’s core QuickGel™ technology. Dr. Kevlahan holds a B.S in biochemistry from Hofstra University and received his Ph.D. in chemical engineering from Northeastern University.
Lisa Fox, SVP, Cell Therapy Operations, Orchard Therapeutics North America
More than 25 years of experience in development, cGMP manufacturing, and quality control for cell and gene therapy products. Successfully led development, manufacture and clinical delivery of ex vivo hematopoietic stem cells (HSCs), neural stem cells (NSCs), activated T cells, gene-modified T cells & gene-modified HSC products as well as in vivo adeno-associated virus (AAV) products at Orchard Therapeutics, Sangamo BioSciences, StemCells Inc, and Xcyte Therapies. Experience preparing CMC regulatory submissions with for cell and gene therapy submissions in US, Canada, Switzerland and Europe.
Ángel Herrero Méndez, PhD, Head of Pharmaceutical Development, Takeda Madrid – Cell Therapy Technology Center, Takeda Pharmaceuticals International Co.
Biochemist by training and PhD in Neurochemistry at the University of Salamanca, Spain with a research career in public institutions (University of Salamanca, Spain) and private entity (Histocell Regenerative Medicine). More than 9 years’ experience in cell therapy, specifically in the field of adipose stem cells. Currently Head of Pharmaceutical Development at TiGenix (part of Takeda). Involved in the development, validation and transfer of analytical methods, process development and investigations in the technical incidences, deviations, out of specifications and out of trends. Actively participating in CMC regulatory submissions in EU and US and in the preparation of comparability and stability protocols and reports.
Markéta Horálková, Supply Chain Manager, Sotio a.s.
Marketa Horalkova is the Supply Chain Manager of Sotio company. During last 6 years she oversaw procurement activities for Technical Operations and Research department for both Czech and Beijing production facilities. Marketa holds Master of Biomedical Engineering & Informatics degree from Czech Technical University in Prague.
Dr Patrick Ginty, Head of Regulatory Affairs, Cell and Gene Therapy Catapult
Patrick Ginty is Head of Regulatory Affairs at the Cell and Gene Therapy Catapult. Patrick has 13 years’ experience in research and development, including 12 years’ experience in regulatory affairs related to cell and gene therapy and regenerative medicine. Patrick has product development experience across large pharma, academic and med tech organisations and has been involved in over 20 clinical trials and 40 successful regulatory submissions to support both early and late stage development projects in Europe, the US and Canada.
Patrick has a MSc in Biomolecular Technology and a PhD in Pharmacy and Chemistry from the University of Nottingham and a Post-Graduate Certificate in Regulatory Affairs from San Diego State University. Patrick has held a certification in US regulatory affairs from the Regulatory Affairs Professionals’ Society (RAPS) since 2009.