Laboratory Considerations for Clinical Trials
Science:Life Sciences
In this episode, he describes strategies for mitigating risk in the development of companion diagnostics (CDx) for immuno-oncology.
Depending on the bio-marker, there might be difficulties in developing an assay that correctly characterizes that bio-marker. There are also, there could be reduced ability to enter into markets due to the accessibility of that particular technology used to identify that bio-marker or test that bio-marker globally. For example, it's common throughout hospitals to have IHC or pathology review of particular of bio-markers but next-gen sequencing is a new and more expensive type of technology, so they might not be able to go after that as a particular companion diagnostic.
But, that being said, the trade-off or what they gain from getting a companion diagnostic, they have a greater chance of reaching the correct population of patients that will see the greatest benefit of their therapeutic.
The podcast conversation discusses an alternative to the traditional three-way partnership of a drug developer, an IVD manufacturer and a CRO. Single-site, pre-market approval can reduce the front-loaded investment needed for an IVD. It also can align better for the management of the project timeline.
More Episodes
2023-11-17
82
2022-06-22
247
2022-05-16
189
2021-09-14
230
2021-08-26
199
2021-07-30
170
2021-07-28
173
2021-07-28
164
2021-02-02
142
2020-09-15
187
2020-07-29
151
2020-07-29
96
2020-07-29
131
Get this podcast on your
phone, FREE
