for those still with open minds18 Apr 2018 13:52
Following on from my satirical piece earlier today have read economist article. Here are some paragraphs from it.
Seems to me that if there high unmet clinical need, there is a desire from clinicians and patients and the product is safe then there may be a path to approval under the new regime.
Understand that devotees of P will not agree. That's up to them.
Extracts
Mr Gottlieb�s second idea is to extend to other areas the innovative trial design that the FDA has pioneered in recent years for cancer drugs. This may involve doing away with the traditional hard boundaries of the drug-testing process (known as phases 1, 2 and 3). Instead, trials constantly adapt by expanding and shrinking cohorts of patients depending on their response to treatment. This makes the process more efficient. The agency is also open to the inclusion of non-trial data (from wearables or patient records, say).
A few duds may be worth the risk if overall more good medicines reach patients. Pharma firms certainly think so. They have welcomed Mr Gottlieb and his ideas with �almost uniform pleasure and happiness�, says John Maraganore, the boss of a biotech company called Alnylam who also chairs BIO, an industry group.
That is unsurprising�lower development costs should mean higher returns. What is less clear how much these savings will help the industry�s giants, whose research-and-development efforts are spread thinly across many fields, without deeper changes to their business models.
Even today inexpensive drug development is perfectly possible. If you understand the biology and can identify the patients who will benefit from your drug, Mr Gottlieb says, trials can already be shorter and cheaper. Midsized and biggish bio-pharma firms, for instance, have done far better than the very largest ones. According to Deloitte, biotech companies such as Celgene, Gilead, AbbVie and Biogen enjoyed returns of around 12% last year. Many of them have already benefited from past efforts by the FDA to lubricate the approval of potential breakthrough drugs for cancer and some other diseases. But they are also much less diversified than the likes of Pfizer or GSK. It may be that this narrower focus makes them more efficient.
It therefore remains to be seen if Mr Gottlieb�s approach can improve efficiency and innovation across the industry. His tenure may be judged a success if he manages to slow their decline. The rest is up to the industry itself.
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