Showing posts with label Functional Foods. Show all posts
Showing posts with label Functional Foods. Show all posts

Sunday, November 10, 2013

So what's wrong if your drug-candidate is likely better-off as a dietary-supplement?

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.

* I actually first accessed the full article through my Kindle subscription of HBR & not through the blog, hence the delay in my comment. 


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;

  • 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.

  • 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

Thursday, September 12, 2013

Ambrosia for food, Palm-top engagement, Iterative decision making – A preview into evolving expectations of the healthcare consumer

Understanding consumer preferences has always been of paramount importance in most product segments. Within the pharmaceutical domain however even as there’s a constant ideation, speculation on future of healthcare; outlook on disease incidence, burden and pharmaceutical consumption patterns, this particular aspect has not been focused on, possibly owing to the prescriptive nature of the medicine where decision-making seldom lies with the patient & the power to influence product development lies more with the medical professionals & payers. To an extent this disengagement of consumer does justify the disinterest of Industry to understanding the consumer as against understanding the prescriber & the payer/ insurer.

Having said that, a number of disorders these days are getting close to being categorized as lifestyle-diseases & with early detection, diagnosis and routine monitoring getting simpler, it’s only imminent that the insurer will increasingly resort to rationalizing what treatment-regimens can be covered thus significantly shifting the onus of payment to consumer. Then again, owing to the abundance of open-source information and availability of validated healthcare gamification apps, the consumer is getting more knowledgeable & hence empowered. Seen together, these trends indicate that the average pharmaceutical consumer is well poised to be the key decision-maker on therapeutic choices, particularly on maintenance therapies that form a predominant portion (vis-à-vis’ the curative therapies) of all pharmaceutical revenues.

It also hence would not be overtly speculative to state that the hitherto quintessential practitioner-dependent healthcare consumer is evolving quick & is looking at an iterative role for her/ him-self rather than merely wanting to being ‘prescribed health’, literally & figuratively. Continued negligence of factoring-in consumer behaviour in the product development process can thus be a serious lapse of judgement in an industry that’s been groping around for the next paradigm shift for a few years now.

The Health 2025 survey I floated in early July is a token attempt to gain some basic perspective into the altering behaviour of an ‘aware pharmaceutical consumer’ which I hope either in its promise OR in its inadequacy will instigate more such studies in-depth and at a larger scale. While I can’t claim to have gotten a great number of responses, I fortunately received quality responses (& some incidental endorsement*) as indicated by consistency of the trend that was showing up right from early stages to till plateauing of response flow.

Even as I was compiling the final results I came across this rather well received fund raising pitch of Stefan Broda (Founder/CEO of BeforeWeDo) at the end of which one particular GP lauded the Consumer Iteration built into the business model which is worth emulating by other healthcare start-ups! – If not a sign from the heavens, a sweet coincidence nonetheless.


I chose the sample population of pharmaceutical professionals who I believe are very representative of the above breed of ‘aware pharmaceutical consumers’ & to whom I have ready access through the Pharmaceutical Discussion Group I founded and manage on Linkedin & Groupsite.

Based on a guestimate of ~5million pharmaceutical professionals world-wide, I derived my target sample size as 350, using a Confidence level of 95%, which is the mostly used default level & a Confidence interval of 5, which again is the oft-employed default figure. By the time I chose to start the compilation (the survey is still active) I however had only 159 responses which translated amount to a confidence interval of 7.7 while the confidence level remains at 95% - That, I guess is my cue to you for taking the results with a pinch of salt :-)

Finally, I am neither a professional statistician nor a qualified analyst and it’s likely the design of survey may not fully please many out there. I however did consciously try and keep the questionnaire short, the questions specific & the choice of answers broad in order to minimize any chance of a bias setting-in – the trends indicated by the responses, as I see, justify some if not all questions.


The survey is based on ten questions out of which the first three are essentially filters namely age, sex & nationality that enable some level of demographic segmentation of responses. While the charts of responses to individual questions looked very pretty on Surveymonkey dash-board, I agonized nonetheless quite a bit deciding on an ideal approach to presenting the results on my blog without sounding too pedagogic – I hence chose to weave the details around certain KEY OBSERVATIONS and then go about detailing on those further.

Since it may help put things in perspective, I have uploaded the primary results document* to file cabinet on Pharmaceutical Discussion Group – please note that this link opens the document only when you are logged in, (i.e. if not a member already, you will have to join the group)

**I’ll be happy to share the master data file too with anyone interested.


In hindsight I realize some of the questions are pretty skewed & some fairly meaningful, but overall they seemed to fall in two broad categories, one set wherein the standalone overall response is itself strongly indicative of a trend & a second set wherein an interesting picture emerges only when the responses are separated out and compared across demographics. I however will spare the mundane trends and go straight to top observations based on the percentage response towards a trend-indicating response;

Not just food, Ambrosia is what the consumer wants - a huge thumbs-up for Functional Foods!

Quite ironic that the top trend in a health survey is food & not medicine! - A whopping 87% of the respondents see/ want the food in 2025 to be more than nutrition, out of which 46% see a potential for food being a curative!

Women make up the majority of the ‘food as a curative’ advocates (60% as against 30% among men) – which simultaneously underscores & endorses the greater influence of women in the functional food promise.

More Indians (56%) believe in the promise of curative food than the North Americans (40%) or Europeans (44%) – a possible connection to the expectations influenced by prevailing, predominant ethno-cultural dietary practises?

Consumers want to take things into their hands, literally – Mobile Health Tools all set to Rule

At 68%, a clear majority of the respondents are bullish on the role & significance of personal mobile apps in an individual’s health management. (25%, Indispensable & 43%, Very crucial)

Once again this is a trend driven primarily by women, the percentage of women who chose ‘Indispensable’ (40%) being significantly higher than the men, a majority of whom (67%) chose the mildly-tempered but still bullish, ‘Very crucial’ as their answer. This clearly establishes women as the ‘early adaptors of the health mobile tools & apps’ & possibly that mobile apps are more amenable to woman’s health management and finally that factoring-in gender into the development of a mobile healthcare app can be a key determiner of the success of the same.

When the Geography filter is applied, the trend expectedly peaks in North America with an overall bullish-ness at 76% - within which women once again stand-out strongly with 55% responding ‘Indispensable’. The dominant European response is however ‘Very crucial’ (60%) which probably indicates a currently lower penetration of mobile health apps within this geography – this holds good for India too.


They seem to say, keep the Doctor away – Eating an apple isn't the only way

While the question has some unfortunate bias & choice of ‘You’ sounds like a given…, the responses still indicate an increasing role for non-physician health professionals. If the choice of ‘You’ (53%) is ignored, only 12% see the physician playing the single most crucial role towards an individual’s health much below the diagnostician at 18%.

There’s an interesting contrast in choice of physician v/s diagnostician among the female & male respondents’ viz., Female: 7% (P) v/s 21% (D) & Male: 14% (P) v/s 16% (D) – probably again owing to the essential nature of women’s health issues vis-à-vis’ male issues – nonetheless, a potentially important alert to the healthcare industry.

In-line with the number one trend above, the nutritionist polled 10% of the vote. Quite surprisingly, of all respondents who chose Nutritionist, 70% belong to the age group of 35-44 yrs. This read together with the first trend gives a great demographic insight into who could be the prime target demographic segment for promoting functional foods – Women between the age group of 35-44.


Apart from the above three observations, the rest of the observations though interesting aren’t necessarily great insights into the health consumer psyche - the same are listed below in no specific order;

  • 78% of the respondents feel medicines should target cure as against 22% that are okay with maintenance – expectedly, the 78% group is populated majorly with people under 55 years of age.
  • 87% of the respondents prefer oral medications to parenterals – Interestingly though, there’s a strong geographical variation with NA & EU preferring oral medications at 92%, while the Indian respondents still retain some of the cultural trust of ‘injections’ (26%) 
  • 89% of all respondents still believe the necessity of medicines per se’ in-spite or despite the preference of the ambrosial foods – if anything, this seems to showcase the omnipresence of the pills.

While the results may not qualify as astonishing findings, the unmistakable relevance of the trends thrown up by a mere seven-question survey still underscores the value of understanding the health consumer’s perspective and using the knowledge to build, refine the road-map of pharmaceutical product development.

Functional Food for thought! :-)