ART STOCK CREATIVE/
Shutterstock.com
Clinical supplies & logistics
Innovations and hurdles
The discovery and development of CAR T-cell therapies will go down in the annals of medical history. But while remarkably effective against a range of cancers, these advanced therapies require a complex pipeline of production – one that fi rst includes extracting components from the blood of patients. Andrea Valentino speaks to Federico Rodriguez Quezada, an industry veteran and consultant, and Dr Jeffrey Winters of the Mayo Clinic, to learn how the complexity presents challenges in the supply chain, and what can be done to get the fi nished product to patients quicker.
he first CAR T-cell therapies were only approved by the FDA in 2017. Yet over less than a decade they’ve already transformed the fight against some of the nastiest diseases around. Consider B-cell lymphomas, a vicious form of blood cancer that could often see patients live for just six months after diagnosis. With CAR T-cell therapies, 50% of patients have seen the disease go into remission, with many surviving for 18 months or more. It’s a similar story with the most aggressive forms of leukaemia. From an average life expectancy of just seven months, the majority of victims can now expect to live for a year or more.
T
With statistics like this it’s no wonder experts are so excited by the technology. For Federico Rodriguez Quezada, an expert in the CAR T-cell therapy supply chain, it represents nothing less than “a second chance in life to conquer cancer.” Fundamentally, these successes can be understood in terms of the unique way CAR T-cell therapies operate. Rather than being fed mass- produced medications, or else doused with radiation, therapies are instead deeply personalised. T-cells are taken from patients’ blood and genetically modified to find and kill cancer cells. Once medical professionals return these adapted
18
Clinical Trials Insight /
www.worldpharmaceuticals.net Clinical Trials Insight /
www.worldpharmaceuticals.net
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41
