Third Cell Therapy Insights event
The third Cell Therapy Insight event was held at the Novo Nordisk Foundation Headqauters in Hellerup on April 8th.The event, which was co-hosted by Novo Nordisk Foundation Cellerator and ThermoFisher, focused on advancing cell therapies from proof of concept in animal model to first human dose. The importance of collaboration, knowledge sharing and innovation accelerate the development of cell therapy projects was highlighted through the presentations and discussion. Thomas Carlsen, CEO Cellerator, welcomed the participants in the auditorium and on-line – more than 200 cell culture people signed up for the event and representing academia, industry, suppliers of goods and services to the field as well as investors and regulators.
Anthony Ting, CSO Kiji Therapeutics, lead by example, presenting his learnings from more than two decades of developing mesenchymal stem cell (MSC) based therapies and following the entire MSC field closely. More than 1000 clinical studies have been conducted, and more than 10.000 patients have been treated with MSC based products. Ten products have been approved for marketing by regulatory authorities – one in the USA, one in the EU and most of the product in Asian countries. Products have been developed for treatment of heart failure, stroke and diseases related to the immune system. Development, standardization and scale-up of cell culture processes to deliver consistent and potent cell products is difficult, and the products are sensitive to all kinds of handling from harvesting over freeze/thaw to administration to patients. As an example, Anthony Ting shared that for one particular cell product he and his team discovered that skipping a wash step between thaw and administration of the cell lead to increased quality of the cells, which the patient received.
An interactive session facilitated by Mauro Sbroggiò, Senior Project Manager, Cellerator, addressed the broad range of difficult decision-making cell therapy developers are faced with when moving a product from successful animal studies into clinal development. The participants shared their views on making the choices of starting material, cell culture format and raw materials for the process by voting and providing comments. It was clear for all after the session, that there are no simple and generic answers, and you always have to balance a number of pros and cons.
Bo Wiinberg, Chief Business Development Officer, Cellerator, presented the early engagement program, Cellerator is offering to cell therapy developers, the PACE (Product Acceleration to Clinical Evaluation) program. Focus for the program is to accelerate the product development through collaboration across industry, academia and regulatory agencies and by investing in innovative solutions to all the challenges throughout cell therapy translation.
