Expert: Cell, Gene Therapy Research Has Weathered the Storm of COVID-19, Leaving a Bright Future Ahead
Aklilu Tedla, vice president of strategy and business development at Cardinal Health, discusses the cell and gene therapies in the pipeline for approval by the FDA.
Pharmacy Times interviewed Aklilu Tedla, vice president of strategy and business development at Cardinal Health, to discuss the future of pharmacies as more cell and gene therapy products become available to patients.
Question: What cell and gene therapies are in the pipeline that may be approved in the near future?
Aklilu Tedla: I think this is one of the periods where the FDA has a lot of cell and gene therapies on the docket for approval, and we expect that to accelerate over the coming years. Just to give 2 examples, there's BioMarin's hemophilia A gene therapy, which is promising; bluebird bio has a couple of novel therapies, one for beta thalassemia, and another one for very rare brain disorders. So a number of products that are coming—those are just 2 examples.
Question: What might be the impact of these upcoming approvals on the industry?
Aklilu Tedla: So let's start with a patient perspective. I mean, you're going to have patients that have outcomes that probably they couldn't have expected years ago. So quality of life, patient outcomes—but just think about the caregiver dimension—so huge impact on their families.
I think once you start stepping back and look at the disruption to health care, I think there's going to be a lot. These products, just go back to a tolerance therapies—out of my body, back into my body seems very simple, but there's a lot of chain of custody, chain of identity that you have to establish to make sure that the product integrity is maintained throughout. You have to ensure long-term safety monitoring, things that we don't do today. I think there's going to need to be innovations in cold storage and cryoshipping, for example.
So look at the impact, not just in terms of the patient, but also all of the service providers in the domain actually have to rethink the value that they bring to these types of companies.
Question: What is your outlook on the future of the cell and gene therapy space?
Aklilu Tedla: Bright. I would say that this market is poised to explode. It's not without its risks—it's a high risk, high reward. The industry has, in some cases, weathered the storm of COVID-19 and the delays, and now we're starting to see a lot of traction. So I think that the future of this industry is great.