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schoonder · 10-21-2010, 07:07 PM

Early stages both preclinical and clinical of Genentech’s effort to develop T-DM1 as a new treatment for 3-line Her2+ metastatic breast cancer occurred when Susan Desmond-Hellman, now chancellor at UCSF, was still in charge of product development. During that time the company designed and conducted a couple clinical phase I trials to establish an optimum dosing regimen and followed this up with two phase II trials; the second of which required participants to have failed or not respond to Herceptin and Tykerb/Xeloda medication which are regarded as leading therapeutics for this indication.
Susan chose to leave Genentech when Roche took over control of company. I don’t know if change in leadership of product development at that time in any way impacted conduct, participation, completion of that 2nd phase II trial.
It might however be beneficial to touch base with Susan and get her views as to what she thinks went wrong with Roche’s filing and possibly get some inputs from her as to best possible way to rectify this situation.

10-21-2010, 07:07 PM	#4
schoonder Senior Member Join Date: Jul 2008 Posts: 186	Re: What's the latest on TDM1? Early stages both preclinical and clinical of Genentech’s effort to develop T-DM1 as a new treatment for 3-line Her2+ metastatic breast cancer occurred when Susan Desmond-Hellman, now chancellor at UCSF, was still in charge of product development. During that time the company designed and conducted a couple clinical phase I trials to establish an optimum dosing regimen and followed this up with two phase II trials; the second of which required participants to have failed or not respond to Herceptin and Tykerb/Xeloda medication which are regarded as leading therapeutics for this indication. Susan chose to leave Genentech when Roche took over control of company. I don’t know if change in leadership of product development at that time in any way impacted conduct, participation, completion of that 2nd phase II trial. It might however be beneficial to touch base with Susan and get her views as to what she thinks went wrong with Roche’s filing and possibly get some inputs from her as to best possible way to rectify this situation.