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. 

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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

     What?

• 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

I'm dumb with cool apps 'cos my phone ain't smart when I'm travelling overseas!

Ever heard an international traveler bitch about how cruel the data roaming tariffs can be - well, here i go...

My comment on a recent post on the HBR Group on LI;

Link to the LI discussion:

Follow Ania

Have you ever used Airbnb, Hailo, Uber, or other "sharing economy" innovations?

Or are you opposed to or wary of them because of the legal implications? In this blog post, HBR author Larry Downes explores how these innovations are disrupting traditional economies--and at what price.

Airbnb: A Spare Room for Debate 

Airbnb's legal travails raise the question: how free should you be to rent out your place?

6 days ago

My comment:

Never heard of any till now……. checked them out & loved 'em all.

AirBNB: Sure sounds like something i'll try when i'm travelling and looking for an overnight accommodation next time.

Uber: I am guessing I may not need a chauffeured sedan anytime soon, but am sure excited by the opportunity it provides to make a rather grand exit from a sad rendezvous :-)

Hailo: Hello... this is something I could use when i'm in London or NYC next - my only issues are; a) When in the near future would the corporations of London & NY enable city wide Wifi?.... enabling data on my international roaming plan can be pretty killing. AND b) What if I don't actually know where to stand while 'Hailo'ing the cab? .... just kidding :-)

Getting serious, the bottom-line is that till the time WiFi is all prevailing and FREE in all cities (are you listening Google??..), an international traveler like me will not be able to use many of these cool apps for want of connectivity....

Plan B anyone?

Cipla Ventures - What's the real story Gen-3?

Greed for quality & comprehension makes one less effective & less productive.........
........... Stash away those cudgels people, this is NOT about pharmaceutical manufacturing, this IS about my realization after a month of sub-par blogging that resulted in my number of posts going low (just one article to be precise in June 2013!) and the number of views I get per a month hitting the nadir! - A promise to myself... will try to type out a few "casually turned out" articles every now n then, instead of generating it through my oft employed time-consuming approach of Mull-it-over-for-a-week-Type-it-on-Word-Edit-it-as-though-HBR-were-publishing-it-and-finally-Paste-it-on-the-blog....... Spontaneity ain't dead yet!

Now the REAL topic...

The recent news of Cipla charting new course to achieve a $5 billion revenue in next ten years caught my attention & got me thinking.... Not because a 10 year objective as this is anything novel, but the simultaneous creation of a dedicated investing arm Cipla Ventures, towards this vision, is what interests me. 

Now again, what's so novel about corporate venture capital? its's been around for some time and the trend is bound to catch-on with whichever company that's sitting on surplus cash reserves jumping into the fray if not anything else, as someone said (Super LP??) for the blood & gore and the adrenalin rush that venture investing & enterprise incubation gives.

What interests me is.... 

........ the brief agenda of this arm of Cipla, as reported by Economic times, that says will "weigh the prospect of investing in companies from start-up hubs like Boston and London among other places, in areas such as biotechnology, medical devices and new chemical entity

What interests me is.... 

....... the expansive & prophetic way in which the new CEO Subhanu Saxena says "Out of the five or six bets I place, only two or three need to pay off"

What interests me is.... 

....... what is this "pay off" for which Cipla is ready to take "sensible risk", a novel term for a generic Indian company that has taken the traditionally low risk option of staying close to the home turf?

What interests me is.... 

...... what key takeaway Saxena is walking away with from Novartis & bringing to Cipla?

Let me be clear, I am not insinuating anything unethical here nor I am attaching ulterior motives to a darn-clear writing-on-the-wall business opportunity, all I am doing is trying to get to the heart of matter as to what will Cipla gain eventually through these investments..

Two theories that strike me right away are as follows;

i) TOOL FOR NEGOTIATION:  

The multiple niche stakes & thereby the 'possible' control on the licensing /sale of the pipeline candidates & technologies of the portfolio companies in the NCE, Biotechnology & Diagnostic space will potentially help Cipla negotiate/ barter generic deals with the big pharma companies whose drugs Cipla is/ will/ would aggressively pursue to market in the US & European markets

Will this fly...? despite the generous window of hit-miss offered by Saxena, this is an opportunity completely out in the ether & my guess is as good as Cipla's :-)

ii) EXIT PREPPING OF FOUNDER PROMOTERS: 

Before I am clobbered for suggesting India's most nationalistic  private pharmaceutical company would sell-out, let me remind that no one's above liquidity & no company is unattainable in this corporate game. Let's also remember that the new leadership of Cipla is, surprise, surprise.... of all places, from Novartis, the bête noire of Cipla in many a litigation?? - Let's also remember that the new leadership of Cipla in US & EU is Ex-Teva... the generic behemoth that can make big-ticket acquisitions every now and then (read: $6.5 billion Cephalon; $7.5 billion Barr et al..)

Will this fly...? Of course it'll - the lure is the access to a 1.24 billion strong Indian market.

Anymore theories? 

Dear HBR, defend your research!

In the May 2013 issue of HBR that has a ‘spotlight on entrepreneurship’, Adi Ignatius observes in the very first paragraph of his editorial that the “IPO market has been soft for years” & on a closing note hoped for ‘a steadier flow of IPOs’ as the economy is on the path to recovery.

This angst I thought pretty much reinforces the dominant LP complaint of an ‘absent IPO market in venture backed firms’ these days. Given this, I expected the articles to focus on elucidating about scalability of an early enterprise to the entrepreneurs – which I realized wasn’t the case after reading through the same.

Each of the four articles & the one interview instead seemed standalone in content & interestingly anti-VC in tone & tenor – not sure why. Since an elaborate hypothesis on these already elaborate academic articles didn’t appeal to me, I felt capturing the essence of each article in a single line would make it crisper - but given the duality of the message in the articles/ interview, I decided that the take-away messages should be in two sets, one for the entrepreneur & one for VC.

Here goes;

FOR THE ENTREPRENEUR

Go the Lean-way or Fade away¹

Seek out the client, not just an investor²
To err is VC – YOU, be the driver³
Marry the VC if you must, just make sure the pre-nup is not one-sided!⁴
If you are good, a Top VC will find you / If a Top VC funds you, you must be good!⁵

FOR THE VC

Lean is in – Junk the flab (read: 5yr business plan et al.)¹
Failing early is a virtue, at times, most times²
Focus on great returns, not on large fees – Stay relevant³
VCs are good but dated – Brace up for the Gen-Y entrepreneur⁴
If you aren’t a top-quartile VC, tough luck!, great deals don’t happen to you⁵

Article reference:

Click link to access the article, (I pay for my Kindle edition tho’..)

1.        Article “Why the Lean Start-Up Changes Everything” by Steve Blank

2.        Article “What Entrepreneurs Get Wrong” by Vincent Onyemah, Martha Rivera Pesquera, and Abdul Ali

3.        Article “Six Myths About Venture Capitalists” by Diane Mulcahy

4.        Article “How to Negotiate with VCs” by Deepak Malhotra

5.        “In Search of the Next Big Thing, Interview of Marc Andreessen

Most of the above messages have been around for some time now, only this comes across as a tacit academic endorsement of the market grapevine - If I forget scalability for a moment, my summarized takeaway from the above is;

Whether or not there’s something basically and drastically wrong with the current VC model, the emerging new trends in the start-up strategies make it pertinent that the early investors, in particular the VCs, should evolve in tandem – This is important not only for sustaining the radically different new-gen start-ups but also for the sustenance of the VC domain itself.

I always liked the way the professors are called out to defend their research in “Idea Watch” section of HBR, So do I now say; 

Dear HBR, defend your research? 

Game on…


After thought:

Ponder the following exchange between Adi Ignatius (Editor HBR) and Mark Andreessen (Venture Capitalist) - ref: “In Search of the Next Big Thing

Adi:    You’ve developed a strong philanthropic focus. Is the next generation of investors thinking about social investment?

Marc:   No. [Laughs.]

Adi:    So much for my hopes for the next generation.

Marc:   Many younger entrepreneurs have a social mission or a philanthropic agenda. They start early. Investors, not so much.

Considering this is towards the end of the conversation, I thought Marc was pretty dismissive about another aspect that investors both big and small HAVE to eventually look at "Corporate Social responsibility" of financial organizations. I pondered on this in my earlier article titled "IRR v/s Social Impact: Do financial institutions necessarily go through this dilemma?" - No answers tho'.

What could VCs learn from the recent pharma deals involving biotechs with very early-assets?

My response on the blog post "Preclinical Biotech Structured Deals: Reflections on 2013′s Solid Start" by Bruce Booth - posted on 01/Mar/2013
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The news of structured-deals/ buy-outs of ‘tight/ single-EARLY-asset’ biotechs both pleases & scares me… pleases, as I feel this will trigger a healthy change in the way start-ups choose their programs & scary because I (CRO/ CMO) will now start losing clients/ programs much before the conventional PIIA - read-on…..

While I totally agree with the points you’ve raised & the surmises made, I’d like to add the following;

• This in some fashion is an endorsement of the importance of early venture seeding by the very same stakeholders that typically enable the high value exits for VCs, viz., the mid-sized/ big pharma companies.
• As you say, there seems to be a promise of reward for innovative organizations that know their science – however I’m not sure if there’s any message about preference for a single asset/ tight set of assets, It is rather a niche focus/ platform & this aspect I’d think always mattered to the investors.
• Do I also see some de-risking in the form of going in for companies who’s lead/ pipeline candidates are inherently safer (recombinant proteins; antimicrobials et al) & hence highly likely to breeze through Phase-I
• Interestingly, though the indications are rare/ orphan, the therapies themselves seem to be more maintenance than curative & hence more attractive to the investing company
• This lure of an early alliance/ deal may now encourage the new enterprises to come up with more compelling technologies rather than me-toos… & thus help put drug discovery enterprise model on a correction course
• Is this the emerging new avatar of the CVC? - CVC 2.0? (Perdona, Baron.... :-))

Now, having seen a lot of my clients getting lapped up by mid/ big pharma & their programs either killed, shelved in favour of the larger companies competing pipeline, I would be a little cynical till I see the next instalment is released/ option executed.

Finally I would like to ask if there is a message in here for the VCs? – towards an opportunity, a need to structure the initial funding deals differently so that they could still keep an option to enhance their share whenever such early alliances crop-up eliminating  avenue of series-B funding?

Post Thought:

Quite a coincidence that I was just reading an article in HBR (Mar 2013) titled “How Competition Strengthens Start-ups” by Andrew Burke and Stephanie Hussels of Cranfield University.  The authors postulate that exposure to competition in the early stages of a firm’s life increases its long-term survival prospects – competition in this context including competing against a lean-funding scenario & hence learning to stay creative, efficient & productive – Since for all four companies here the early pressure is almost eliminated of by the reasonable/ comfortable funds received (upfront instalment OR buy-out), I was wondering if that makes these companies less long-term in light of the above study.

Of course I do understand that it’d be foolhardy to apply an academic study arbitrarily to any context, particularly in life sciences, where the author’s themselves have made a provision indirectly through their statement “Of course, early competition has a downside: Some new businesses fail before they have time to build up the immunity we describe” which sure sounds like the business of designing drugs.