The discussion rooms have pointed toward recent developments at BARDA outlined in the following two releases:
http://www.hhs.gov/news/press/2014pres/04/20140416a.html
http://www.hhs.gov/news/press/2014pres/03/20140311b.html
I have also raised the recent controversy around Tamiflu and the call by British researchers for independent clinical trials of NIs.
I agree that it's plausible that BARDA will take over the conduct of the rest of the clinical trial program for LANI. It will simply use the committed funds for the rest of the program and shift those to conduct the studies themselves.
They will have nationalised clinical research! In the USA!
Advantages
BARDAs clinical research network might be of higher quality and therefore able to deliver better than BOTAs selected groups. It likely that BARDAs selected contractors are not the lowest bidders when these projects are tendered.
That the take over of conduct of the trials should mean that if the drug shows effectiveness and safety, it is automatically granted FDA approval (since they in essence designed and conducted the trial)
The SP will increase 50% in the short term on that sort of announcement
Disadvantages
They have not done this before, so processes will be slow and...
Bureaucratic: I imagine the trials will take longer to complete - will they guarantee patent extensions?
Will BOTA still get it's 7% management fee?
BARDA/FDA/CDC will interpret the results; however they would do that post-hoc anyway at registration
Undoing manufacturing and other contracts - BARDAs problem I guess.
No understanding of shareholders - witness issuing a stop work order before an explanation of the reasons, decimating shareholder value. Hamfisted and stupid.
The clinical trials would need to cover seasonal influenza use not just pandemic. There are some potential differences in clinical outcomes. But the trials for registration would need to be the same and delays in trials mean delay in deals and marketing of LANI as a seasonal drug.
Unless the company has to do other trials for seasonal use/registration. That would be unacceptable.
In essence, if BARDA are taking compounds and paying for the clinical research and manufacturing for pandemic products, and then purchasing them, they are effectively acting as big pharma and consumer. They could go ahead and sign a contract direct with BOTA for rights to the compound in stockpile use. There would be no middlemen.
Problem is, they haven't made a commitment to the compound's creators/IP. And they aren't actually committing to a stockpile order.
An interesting new world for similar product development. Question is: is BOTA the golden child or the guinea pig?
I wonder how this stop work order impacts Igloo trial's powering and the FDA's views on recruitment targets not being reached? I find it strange Biota has taken the step to release top line results. Was this decision vetted by the FDA?
ReplyDeleteBOTA own the trial (not FDA) and they should release the results asap, because my expectation is that LANI is effective. This will pressure the regulators to proceed to Phase 3. Powering in the current Phase 2 will be an issue, but maybe not if the 40 and 80 mg dose interventions are combined and if the benefit effect was large. 80mg dosing was BARDAs idea (I think), striving for more effective dosing in a pandemic situation, rather than just seasonal flu symptom improvement. But introducing it (80mg) has put pressure on recruitment numbers. I don't think they were getting many more enrolments from US now, and they didn't do so well in their previous Sth Hemi round: so no great loss as long as we skip straight to Phase 3.
DeleteIf the drug is very effective in the current Igloo trial, BOTA should argue for movement straight to Phase 3. My guess is FDA cares little about japanese data, but they should give some credit to Phase 2 level for the 40mg dose.
Here's part of the problem: companies want to do just enough to get past FDA. FDA will want the gold standard from the outset. If BARDA/FDA don't hold to a reasonable research plan, they can drag this out for a long time, holding up the return on investment.