It’s funny you mention it, I just reread an article on the Keytruda story the other day and was struck by the lessons learned at the end of the article and the similarities with bisantrene.
I’m sure it has already been posted but here is the link if anyone is interested (well worth a read): https://www.forbes.com/sites/davidshaywitz/2017/07/26/the-startling-history-behind-mercks-new-cancer-blockbuster/
Lessons Learned Vast Distance Between Discovery and Commercialization - Talks about the difficulties research teams had getting approval to move pembro (Keytruda) forward in the early stages. Would be difficult to argue that bisantrene, if it gets there, will have had a shorter or less interesting journey.
History Linearized Over Time - Drug development is rarely linear but after the fact linearizing helps to create a compelling story.
People Matter - Many people championed pembro and pushed it forward especially when there was little support from top management. Perhaps the RAC preclinical team while DrT was in standby. Or even DrT when the board was not aligned on pursuing the bigger opportunities.
Circumstances Matter - Roger Perlmutter bet his career by going all in on pembro. This was possible because he was near the end of his career anyway, perhaps had less to lose. DrT coming out of retirement echoes this.
Relationships With Regulators Matter - Merck worked closely with the FDA to fast track approval. Two slides (project Optimus and Fast Track/Breakthrough designation) dedicated to this in the strategy presentation.
Agility Matters - Once Merck recognized the value, they developed it in an un-Merck-like way. Innovative trial design by Race to get the most value in the shortest period of time.
Ars Longa - At the time immunotherapy was in its infancy. As is the m6a space currently.
Translational Impact - Patient outcomes. We’ll have to wait and see for this but I don’t need to say the hope is that bisantrene will prove to be effective and in as many patients as possible as quickly as possible.
Other points that resonated: “Fortune favours the prepared mind” - DrT recognizing something in the historic cardiotoxicity data. “an unprecedented type of FDA approval for pembro–authorizing its use in a wide range of cancers, based on the presence of the MSI-high signature–“the FDA’s first tissue/site-agnostic approval,” according to the agency” - can there be a tissue/site-agnostic approval for bisantrene if it works?
(20min delay)