Cell therapies are advanced treatments that must be administered at accredited centers with experience and established quality processes, procedures, and practices to ensure patient safety. As of January 2021, 298 centers have been accredited by the Foundation for the Accreditation of Cellular Therapy (FACT) in the United States.
The emergence of the COVID-19 pandemic spurred the development of nearly 300 diagnostics aimed at detecting exposure to the SARS-CoV-2 virus.1 Many of these tests are available for use in multiple settings of care to identify the presence of virus, assess viral load, and determine whether a patient has been infected. As we near the end of the acute epidemiology phase of COVID-19 diagnostics, the next generation of diagnostics will address COVID-19 as an endemic disease.
Calculating viral vector yields is essential to determine how much drug product is needed for a specific gene therapy. This calculation will determine either how much internal manufacturing capacity is needed or how much it may cost to manufacture at an external contract development and manufacturing company (CDMO).
Given a candle, a box of thumbtacks, and some matches, can you affix a candle to the wall and light it so that it doesn’t drip on the floor? Known as Duncker’s Candle Problem, this puzzle is actually a cognitive performance test, measuring the influence of functional fixedness—the cognitive bias that makes it difficult to use familiar objects in unfamiliar ways.
This discussion will address the operational challenges in the cell and gene therapy space pertaining to supply chain operations and site activation.
You will hear from two leading investigators on the lessons learned, current trends, and insights relevant to the Multiple Myeloma (MM) US and EU research community.