Allogeneic, or off-the-shelf, chimeric antigen receptor (CAR) T-cell therapies will bring new logistical challenges, said Aklilu Tedla, vice president, insights and engagement, regulatory science, cell and gene, Cardinal Health.
Allogeneic, or off-the-shelf, chimeric antigen receptor (CAR) T-cell therapies will bring new logistical challenges, said Aklilu Tedla, vice president, insights and engagement, regulatory science, cell and gene, Cardinal Health.
Transcript
How might the advent of allogeneic CAR T-cell therapies create new logistic problems for storing the treatments and being prepared for potential adverse events?
Logistics, I think you're going to need greater visibility into the supply chain. Right? And you're going to have to think about cold storage and visibility throughout the entire logistical journey. Okay? So, I think that's going to be new, and actually worth thinking about that long and hard about what role we can play there to make sure that the logistical aspects are being met.
This is one of the things that are actually high risk for manufacturers of these therapies, right, is they're innovating to bring them to the market, but then, how can they make sure that as they send them to the patient, that there's visibility into the supply chain, so you can make sure not just about the outcome, but the safety of the products.
You can think of adverse events in terms of at the time of administration, which I think where they're administered today, in hospitals, or in certain settings, you can have the type of monitoring that’s there. What I think is important is how do you monitor continuously? That raises questions about how do you monitor in the home, and in other areas that the patients are, and over what time? So, I think that is something that we're, for example, actively trying to solve.
Exploring Medicare Advantage Prior Authorization Variations
March 26th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the March 2024 issue of The American Journal of Managed Care® about their findings on variations in prior authorization use across Medicare Advantage plans.
Listen
Poor Well-Being Scores Linked to Early Treatment Stoppage in Multiple Myeloma
March 27th 2024Investigators used the Functional Assessment of Cancer Therapy-General General Physical Wellbeing Scale to collect data on patient-reported treatment-related adverse effects, to provide clinicians guidance on predicting risk of early treatment discontinuation among ECOG-ACRIN E1A11 trial participants.
Read More
FDA Issues CRLs for Odronextamab in R/R Follicular Lymphoma, R/R DLBCL
March 25th 2024The FDA issued complete response letters (CRLs) for the biologics license application for odronextamab in relapsed/refractory (R/R) follicular lymphoma and in R/R diffuse large B-cell lymphoma (DLBCL).
Read More
Increasing Lp(a) Awareness for Better Cardiovascular Health: Dr Mary McGowan
March 24th 2024For Lp(a) Awareness Day, Mary McGowan, MD, FNLA, chief medical officer of the Family Heart Foundation, highlights how most people with elevated Lp(a) are completely unaware that they have this increased risk and calls for increased testing.
Read More