Friday, March 16, 2012

NCATS' vs. Calibr (public vs. private translational medicine)

The NIH's National Center for Advancing Translational Sciences - has been controversial since first promoted a year ago by Francis Collins, head of the NIH. The controversy is due, in essence, because the NIH isn't the right vehicle for drug discovery. (See Derek Lowe @ In The Pipeline for a very sharp, accurate, extended opinion.)

As NCATS is still being formed, there hasn't been a lot of news or action taken on their stated strategy, but they announced their initial partnership this week: NCATS and Eli Lilly will work together to profile almost 4,000 compounds either FDA approved or under investigation. The main goal seems to be to establish other possible applications for these compounds (What does this compound for kidney cancer do in CV models?)

As a first deal, the NCATS-Lilly partnership is a solid one, as disseminating the resulting info in the public will add to the characterization of existing drugs, and hopefully the development of new therapeutic applications, very possibly at a high speed, as many of the drugs in the NIH database will have already received she level of clinical scrutiny.

As an indication of NCATS' direction, however, this deal is underwhelming. It's an easy extension of NIH assets and activities that doesn't justify the dedicated infrastructure of NCATS. The partnership could have been undertaken by the existing extensive NIH compound profiling efforts (the NCI-60, for example), or externally as grant funded research.

(Given that some partnerships take more than a year to negotiate, one could wonder if the idea for the NCATS-Lilly partnership actually pre-dates NCATS.)

With the announcement of NCATS last year, the NIH announced the termination of the NCRR (National Center for Research Resources - I'd never heard of it either), and in principle, I like the idea of taking a look at current NIH missions and assets and restructuring when ideal. (Science changes regularly - shouldn't the NIH change with it?) However, I still don't see what the NIH is bringing to drug discovery/translational medicine that doesn't already exist. I hope NCATS' next deal proves that they are not a solution looking for a problem to solve.

(btw: congrats and thanks to Janet Woodcock and others at the FDA who are similarly progressively looking for opportunities to restructure the drug approval process. The current FDA/NIH leadership is to be commended for their commitment to progress and regulatory process improvement.)

In marked contrast is the just-announced private, not-for-profit translational medicine institute sponsored by Merck, Calibr (short for California Biomedical Research). There is a huge need for somebody to shepherd along promising molecules between their discovery in a basic research environment (universities) and when they are "ripe" for commercial development by a pharma/biotech company, and while NCATS is a step by the government to address this need, I think it is much more the responsibility of for-profit life science stakeholders.

Merck is seeding Calibr with $90M (likely feeling to Merck like a ~$60M expense, after accounting for the tax deduction), and will receive a right-of-first refusal for resulting technologies. The investment by Merck will also be leveraged by government grant funding of Calibr R&D. I'm sure Merck could put more exact numbers to it, but they'll probably get the benefits of say $120M in R&D over the next few years, for a $60M investment. This makes TONS of sense, and to any economic development folks out there, this also results in lots of new US jobs.

In contrast, NCATS' budget in 2012 will be $722M, with $553M to come from retitling existing programs. (In effect, NCATS = ~ $169M in incremental translational programs, less start-up costs).

Anyone want to bet which is ultimately more productive, per dollar, NCATS or Calibr?

(BTW: to make my criticism more constructive, what I'd instead nudge the NIH more towards is post-approval research. I think there's a need for impartially-sponsored Phase IV testing, and also a need for simply more Phase IV testing. As an example, consider a new compound approved for a particular solid tumor cancer. Post-approval, the pharma concentrates on marketing the new cure, and clinicians begin experimenting on off-label uses on an ad hoc basis. The NIH could better organize this research, expand upon it by scaling, and mitigate the inherent conflict of pharma-run Phase IV trials.

Alternatively, I'd be in favor of taking the NCATS $$$$ and using it to re-restablish R&D at an abandoned Pharma site. (Such as the old Parke-Davis/Pfizer campus in Ann Arbor, MI.) There's plenty of R&D talent, experience, and assets already available, with a big bang-for-the-buck.)

No comments:

Post a Comment