PD-1 Question

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  • Post
    • January 8, 2014 at 5:45 pm
    Mat
    Participant

      Can anyone speak to the topic of "compassionate use", perhaps using ipi as an example?  In other words, how does it work?  How is announced?  Is there still exclusionary criteria?  Is it confined to certain trial sites?  I'm not looking for predictions on when compassionate use for PD-1 will be available–rather I'm looking for info on what compassionate use might look like if and when it becomes available.  Thanks.

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        • January 9, 2014 at 2:31 pm
        Janner
        Participant

          I doubt it would ever be "announced".  It is usually on a case by case basis and often a trial doctor would often be the one to ask for an "exception" for a specific patient.  I'm sure patients could also specifically petition the company.  Not sure how much success that would have.  It often comes down to how much product the company has, how easy/difficult to manufacture more and how much is needed for current or future clinical trials.  If product is scarce or manufacturing practices difficult, then compassionate use is unlikely.  The company will want to keep all its resources for gaining FDA approval first – then anyone could get the product. 

          • January 9, 2014 at 2:31 pm
          Janner
          Participant

            I doubt it would ever be "announced".  It is usually on a case by case basis and often a trial doctor would often be the one to ask for an "exception" for a specific patient.  I'm sure patients could also specifically petition the company.  Not sure how much success that would have.  It often comes down to how much product the company has, how easy/difficult to manufacture more and how much is needed for current or future clinical trials.  If product is scarce or manufacturing practices difficult, then compassionate use is unlikely.  The company will want to keep all its resources for gaining FDA approval first – then anyone could get the product. 

              • January 9, 2014 at 8:11 pm
              Mat
              Participant

                Thanks Janner.  I wasn't aware that it was a "one-off"-type thing.  I thought it was some sort of Phase IV-type trial with published availability and criteria.  That's why I come here to learn!

                • January 9, 2014 at 8:11 pm
                Mat
                Participant

                  Thanks Janner.  I wasn't aware that it was a "one-off"-type thing.  I thought it was some sort of Phase IV-type trial with published availability and criteria.  That's why I come here to learn!

                  • January 9, 2014 at 8:11 pm
                  Mat
                  Participant

                    Thanks Janner.  I wasn't aware that it was a "one-off"-type thing.  I thought it was some sort of Phase IV-type trial with published availability and criteria.  That's why I come here to learn!

                  • January 9, 2014 at 2:31 pm
                  Janner
                  Participant

                    I doubt it would ever be "announced".  It is usually on a case by case basis and often a trial doctor would often be the one to ask for an "exception" for a specific patient.  I'm sure patients could also specifically petition the company.  Not sure how much success that would have.  It often comes down to how much product the company has, how easy/difficult to manufacture more and how much is needed for current or future clinical trials.  If product is scarce or manufacturing practices difficult, then compassionate use is unlikely.  The company will want to keep all its resources for gaining FDA approval first – then anyone could get the product. 

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