In a case-study, the Nov '13 issue of HBR showcases the dilemma of a R&D head grappling with the prospect of a failing clinical program & simultaneously a likely re-positioning of the candidate in question as a dietary supplement and asks its readers if the company should market it as a supplement. The few 'responses' of some experts below the case-study expectedly range from saying aye to nay and in between.
Here's my response that I posted as a comment at the above link.
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Should Caliska market L-39 as a nutraceutical?.....
A unexpectedly simplistic question at the end of a rather
complex case-study by Toby E. Stuart. The question would’ve been a lot more appropriate
had the case-study focused more on Caliska’s capability & track-record in
development, marketing of probiotics instead of giving it a passing mention.
The question is also inappropriate since the immediate
decision is not about marketing, but is about developing – Since it has been
established that the launch of L-39 as a nutraceutical/ dietary supplement/
medical food is at least a year or two away (two independent, placebo
controlled, randomized trials), the question should’ve been “Should Caliska
develop L-39 as a nutraceutical”?
Nonetheless, here’s what I have to say against original
question;
My answer is a NO & YES!
NO --> Caliska should not market the current strain of L-39
since the translocation risk can prove a greater calamity in the uncontrolled
scenario of nutritional supplements.
YES --> Caliska should eventually & simultaneously market
L-39 as a nutraceutical too, the why, what & how of it is as follows;
Why?
- Few investigational drug candidates have the potential to be developed as a drug as well as a supplement & foregoing one against the other is sure a lost opportunity
- Caliska’s primary strength & track-record seems to be that of (successfully) developing and marketing nutraceuticals while also understanding the rigors of the pharmaceutical development (the very same ‘split-personality’ Hilde took an unkind and unnecessary dig at…)
- Given the super-high rates of clinical attrition in general & specifically for probiotics (quoted by the author in context of EMA never till date approving any probiotic as a therapeutic….) the odds of L-39, even as a new improved strain, of making it to the market are very low & it makes immense sense to let the consumer get some benefit of the scientific rigor that Genbac got to Caliska – If the plan-B for L-39 is a nutraceutical launch, the chances of Genbac’s science going waste are already minimized
- Finally, the fortunes L-39 would bring in as a therapeutic are limited by admission
- A new strain of L-39 that minimizes the risks associated with Bacterial Translocation (BT) – Since it’s a given that scope of translocation cannot be eliminated fully as it happens for most other native flora (within the gut) too when the subject is immunosuppressed, the developmental focus should be on the L-39's relative non-proliferative nature outside it's natural ecosystem.
How?
- Caliska should continue the current clinical program of L-39, while in parallel registering the dietary supplement trials with European Food safety Authority.
- The efforts of Hilde’s team at identifying the right strain will benefit both the trials above and that’s a good use of funds in these lean-times
- Caliska’s plan for both the above trials should factor-in the possibility of they having to repeat whenever the strain under evaluation is found to be inadequate & Hilde’s team comes up with a better strain
- Once some positive results are in place, Caliska should seek partners for the drug program with an intention to finance its trials (just drug not the supplement) & eventually out-license the same to the partner for marketing
