Is YODA-enabled clinical data-transparency more than smart externalization of clinical data-mining & analysis?

The day started with a news item on Xconomy declaring "J&JOpens Data Vault to Yale, in ‘Unprecedented’ Transparency Move" - Surely an important development on something that's been propounded for long - below is my comment on this piece;

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Way back in March 2008 a fellow member initiated a discussion topic titled ”Radical Transparency for Drug Safety?” on Pharmaceutical Discussion Group that I manage. The brief engagement that this topic generated ended up identifying the following as ‘key aspects that need to be addressed’ before radical transparency becomes acceptable to pharma;

• Enabling climate (safe harbor) &
• Some incentivization

Well, it appears Yale cracked this code, of de-risked data-sharing after beta-testing it on rhBMP-2 Project based on Medtronic’s data-sharing, well enough to get J&J aboard this transparency express.

A brief read of the Data Use Agreement of the rhBMP-2 project shows what emboldened, motivated J&J with agreeing to share all its data publicly. Below is a list of clauses within the data use agreement broadly catagorized into the key aspects stated above;

Safe Harbor
Reproduced Text in “quotes”

Section 2.3 - No Direct Identifiers

“The Data will not include any direct personal identifiers ofthe study subjects to whom the information relates, nor will it identify which clinical investigators or sites contributed the data for a particular subject. Within the Data, subjects and investigators are identified by unique identification numbers, and User will not have access to the keys that relate the identification numbers to the identities of the subjects or investigators”

Section 5 - Confidentiality of Data

Across sub-sections 5.1 (obligations of Confidentiality) through to 5.4 (Survival of Obligations)

Section 6 - Subject Protection

“The Data may contain certain information that can be used by itself or in combination with other available information to identify a specific study subject (“Study Subject Personal Data”)”

This section is detailed further through sub-sections/ clauses 6.1 (no re-identification) through to 6.4 (safeguards)

Section 8 – Publications

Prevents user sharing any ‘redacted portions’ of the data fro being referred in any publication.

To the credit of Medtronic & YODA though section 6.3 (Non-Disclosure) allows user to share study subject personal data with the “regulatory authorities, upon lawful request by such authority” – It will be interesting though if a similar openness would be retained in the J&J data use agreement, given the much larger data set & hence greater regulatory implication.

Incentivization
Reproduced Text in “quotes”

Section 7 - Reporting and Use of Results

Obligates user to share all data generated from the analysis/ reserach into the sponsor data with YODA and the sponsor. Further YODA retains the right to make this report public (or not…)

Section 9 - Inventions

“In the event that User utilizes the Data to develop any inventions or discoveries, whether patentable or not (“Inventions”), User will assign to Medtronic all proprietary interests in said Inventions and in the event that User is statutorily prohibited from assigning its interest, User will grant, or ensure that the inventor grants, to Medtronic a fully paid, perpetual, worldwide, exclusive, royalty-free irrevocable transferable license for all purposes, including sub license and assignment to each such Invention without further consideration. User will cooperate with Medtronic to ensure execution and delivery of all documentation that Medtronic reasonably deems necessary to perfect Medtronic’s rights in the Inventions.”

The sheer scope of the section 9 along with the safe harbor provisions listed above makes this exercise come across more as externalization of clinical data-mining & analysis by the sponsor organization – I have no reason to believe J&J will have it any different except that the safe-harbor provisions may be more detailed, as mentioned above.

Finally, the one unstated intent of any pharma opening up its own data banks is to build pressure on the other peers and thus have insight into competitor clinical data that till date eluded them.

All said, it’s great to see transparency starting to be practiced rather than just debated about & hopefully this’ll give pharmaceutical research a chance to impact lives better than it could before.

More power to radical transparency.

Funds-on-Tap is passé & Drip-Funding is the new reality.

It’s probably been true for IT/ ITES (particularly for e-commerce and social media & app-developers) much longer, but for the drug discovery start-ups hitherto unaccustomed to expecting anything under a mio given their rather pricey research, the writing on the wall is abundantly clear - Funds-on-Tap is a pipe dream & Drip-Funding is the new reality.

Over the past year, more and more VCs have started to unveil & employ their own versions of a ‘return-maximizing, risk-mitigated investment model’ that typically involves multiplying the early-stage portfolio & bringing down the average-size of seed-investment while maintaining the overall seed-stage investment at no greater levels than earlier - A case-in-study being the recent Seed-class of Atlas Ventures & equally demonstrated by Index Ventures developing its proprietary version of MonteCarlo simulation for optimally distributing precious funds across its portfolio of biotechs' with assets across different phases of clinic.

This holds largely true for the increasingly active Pharma CVCs too that not only are mimicking the VCs in increasing their early-asset portfolio, but have taken derisking a notch higher with their joining forces* with other CVCs (competing pharma) in funding rounds, quite apparently compromising on the eventual ownership of the commercial potential &/or IP generated in the bargain.

* OPSONA (Novartis, Roche, Baxter among other VCs) AILERON (Novartis, Roche & Lilly among other VCs); MERUS (Novartis, J&J & Pfizer among other VCs)

While this may sound like life sciences venture funding is slowly turning into a mere statistical exercise (venture-farming…?), a la the stock market, knowing what it takes to separate wheat from the chaff in the complex world of drug discovery, the users of these models will surely need a lot more than a practical knowledge of the probability theory – which even a cursory read of the above posts again will make it very evident. Just may be, a biotech VC can still showcase ‘proprietary deal-flow’ as a core-strength while making a pitch to the LPs.

Now how does this lean-funding scenario impact the development strategy of the start-up? – while a few indicators of change are already out there like the CROs being encouraged (~arm-twisted) to share risk with the biotech while providing services, I believe this'll trigger bigger changes & hopefully nudge the drug-discovery towards an innovation pathway that’s a lot more rational & predictable – but then this is something Drug Baron should talk about.

Manna from the mud - Daliya!

No, I’m not transforming my venture-blog into a food-blog!

Despite a rather underwhelming 2013, I am just not ready to give up chasing pavements and this post is but a tasty interlude in an otherwise bland biz-talk that still is my lifeline to a new tomorrow.

Daliya – Manna from the Mud

My hunt for a perfect vegetarian breakfast meal brought me to this amazingly versatile north Indian option called Daliya, which is nothing but broken whole-wheat grain & very likely the more nutritious cousin of the popular Bulgur, which is semi-polished and parboiled durum wheat.

To my south-Indian sensibilities, breakfast & sweet don’t go together and thus porridge with milk and sugar wasn’t an option at all. I also wanted vegetables & legumes to be more than a decoration in my breakfast & hence the ubiquitous Upma or Khichdi too didn’t present themselves as the true alternatives, thus inspiring me to come up with my own multiple variants of daliya, which for the sake of this post I christened “Daliya Quick Meals” (DQM), that now enable me to have this meal for breakfast three times a week without getting bored once.

So overwhelmed I am with the sheer convenience of this nutritious preparation, that I decided to turn a daliya-messiah and share my most prized recipe through this blog;

Daliya Quick Meal – Thai variant

Serves – 2

Ingredients:

The core-elements of DQM are Daliya (understandably so..) & Split Moong dal (not too obviously so…) and these two ingredients hence are non-negotiable.

The vegetables suggested are based on ease of availability & on mutual compatibility and last but not the least, for visual appeal. 

Finally, since this is a ‘Thai’ variant, I wouldn’t however compromise on using coconut, red chilly & lemon grass.

• Daliya – 100g ~1 small stainless steel tumbler (SST) (shown in pictures)
• Split green gram (split moong dal) – 50g ~1/2 SST
• Carrot – 1, peeled & cut into 1in pieces (optional & can be replaced with Zucchini too.. the pictures don’t show carrot btw..)
• Tomato – 2, deseeded, sliced into crescents
• Green Beans – 6, cut into 1in pieces
• Corn Kernel (Maize) – quarter cup
• Garlic cloves – 6, peeled & whole
• Red chilli flakes - ½ tsp.
• Jaggery (Gurh) – a small piece/ grated, 1 tsp.
• Turmeric powder (Haldi) – ¼ tsp.
• Coconut kernel (Fresh/ dried) Small piece, grated OR Coconut milk – I tbsp.
• Lemon Grass (dried) – ½ tsp. OR Lemon Grass Oil – 10 drops
• Peanut powder – 1 tsp., optional
• Almonds – 6, chopped, optional
• Oil (sunflower/ rice bran/ olive) – 2 tsp.
• Salt to taste

Preparation:

This is the best & easiest part!

Put all ingredients in a microwavable ceramic or glass bowl (~Borosil cookware), add water (4 times the measure of daliya + dal, which in this recipe translates as 6 SST), cover it with a microwavable glass top and microwave for 14 minutes. When cooking larger quantities the cooking time should be increased accordingly - Once cooked, let it idle for 10 minutes. 

Mix well and serve hot with half a cup of curd/ yogurt.

Preparation time
-> 15 minutes (not counting microwave time)

Eating time
-> 10 minutes (hey, it's break'fast'...)

Quick, nutritious & tasty – give it a try!

Wishing all a Happy, Healthy & Successful 2014!

A suitably bootstrapped perspective

As someone who routinely wears boots under Levi’s 511s, I understand the sheer utility of those small loops called bootstraps - Sramana Mitra’s high focus on an entrepreneur bootstrapping the start-up in her book “Seed India -How To Navigate the Seed Capital Gap In India (Entrepreneur Journeys)” helped me appreciate the criticality of this aspect in the Indian venture funding context.

The book’s USP is its brevity and the matter-of-fact, blog-like style but what keeps your interest on is the verbatim reproduction of the interviews. Spurred by the author’s knowledgeable querying, the interviewed entrepreneurs come up with some honest reflections & very useful insights into their successful entrepreneurial journey. Some statements though come across as anachronistic, particularly when Sachin Bansal of Flipkart seemingly undermines the adaptation, penetration & potential of digital books and affordability of e-readers in India - the fact that I was reading this book on my Kindle Fire HD made the assertion even more ironic.

While it is a welcome trend that Indian start-up stories are getting written about, I once again can’t help but notice that the term ‘start-up’ is gradually getting equated with IT/ITES/ Cloud enterprise.  Most other enterprise categories such as biotech, green-tech are clearly missing out being written about as interesting case-studies since they can’t quite compete with a typical cloud based start-up which (can..) starts generating income within few months of existence – As Sramana did admit passingly, the logic of bootstrapping one’s business is a very different ball-game if the start-up product offering is physical (~biotech) as against being virtual (~SaaS)

Coming back to the book, I felt that what was perhaps intended to be showcased by the author but not quite articulated is an observation that ‘bootstrapping an early enterprise’ comes quite naturally to Indian entrepreneurs given the culturally ingrained reluctance to diluting ownership/ stake of a start-up business early on & the practical jugaad (in a fair sense) mind-set of sailing in two boats before hitching on to the one of choice.

Considering this being a cluster/ market dominated by such lean business ethos & relatively more fiscally-conservative entrepreneurial attitude which by default de-risk the investor’s moolah, one’d have expected India to be a hot destination for an alternate asset fund manager looking for a safe-harbour for her/ his precious dollars, but quite obviously it is not. Of course it is also apparent that there isn’t enough fish in the pond for any LP to develop a serious strategy betting on Indian start-up scene & perhaps the only way to make this ‘LP-friendly entrepreneurial ethic’ work in India’s favour at scale is to seed more & more promising enterprises, bootstrapped or otherwise.

Afterthought

Just wondering.... the Global LPs could be a lot more interested if the Indian VCs claim to be ‘Conservative’ rather than being ‘Contrarian’ in their choice of deals :-)

Crowdfunding good governance

Like many other educated, emancipated, intelligent, idealistic denizens out there, I too tended to avoid politics and considered the omnipresent, overt & covert culture of politicking the bane of this country – and this till I came across the cleansing potential of the broom and relished the realization that the eye-of-the-storm is the best vantage point for any one claiming to wanting to scrub-out the corrupt political typhoon & that staying on the fringes would have only increased the chances of their getting blown away.

Like many of the aforementioned illuminati, I too was cynical about what these Gandhi-capped, broom-wielding weirdos would achieve in their fanciful war against the high and mighty of the Indian political class – and this till I came across their online campaign to collect funds to fight the elections & the success of this Obama-like model that I never assumed will gain any traction in India.

Crowdfunding models fascinated me always and I’ve been tracking this model of enterprise creation and sporadically touched upon these aspects on my blog. While I can’t really prophesize on whether crowdfunding is indeed the paradigm-shift or is more a tectonic-shift in the entrepreneurial terrain, I’m but all sold on what the broom-wielders have demonstrated, the possibility of crowdfunding clean governance or more appropriately, the possibility of crowdfunding the promise of clean governance.

What kicks me up is the fact that in order to invest in this promising enterprise, I don’t need to be an accredited investor nor comply with the lower and upper limits of individual funding - What warms my cockles is the fact that I don’t need to bother measuring my returns in absolute quantitative terms and yet cherish the qualitative outcome. And what comforts me is the fact that my exit would also mean the exit of a stagnant enterprise & that would pave way for another cycle of funding a promise.

I like change, I love the promise of a change & now I dig crowdfunding the promise of a change.

Like hell, I-am-a-glass-is-half-full guy – Cynics, eat your heart out.

Disclaimers & Disclosures:

• I have donated Rs.1000/- to AAP, against an email appeal received from Arvind Kejriwal, vide online transaction number 6996652 on 09 May 2013 15:33.
• Neither I nor any members of my family, friends & acquaintances have contested the recently concluded Delhi elections nor any are members of AAP 

Will Google deliver on the promise of a Uphone**?

A smart phone you can put together like one’d assemble Lego bricks?

When I looked up the Phonebloks link my niece sent, it all sounded quite phony (pun intended..) to me, a prejudice probably not helped by my ignorance & helped in a large measure by the prominent donate button on the blog-like website. I was cynical to the extent that I didn’t quite believe the site’s claim of Motorola collaborating with them, cross verified this on Motorola site and figured it’s indeed true – apologies Dave (Hakkens), my bad!!

I then stumbled upon Project Ara, a free, open hardware platform for creating highly modular smartphones which Motorola hopes will turn out to be the Android of Hardware. If I set aside the confusion of if Project Ara is a googlified version of Phonebloks OR if Motorola was indeed working on it for the past one year, as a user the concept of a modular phone that can be customized and reinvented unendingly does sound wow!

Then again, the whole promise is based on open source hardware development & the current phase of the collaboration seems to be still at the user level (Ara Scouts & Volunteers respectively). Assuming it’s rather early to expect the real collaboration of initiating projects to build the endoskeleton/ base & bloks/ modules to start, I’d still think before embarking on development & if indeed Google has to be successful in creating, in its own words, ‘a vibrant third-party developer ecosystem’ through project Ara, the more imminent need is for the creation of the right ecosystem that supports ‘open hardware development’.

Sure there seems to be some semblance of ecosystem out there wherein the open source hardware developers adapt/ use closely representative OSS licenses &/ or use hardware specific licenses like TAPR Open Hardware License. But given the massive commercial potential of the Project Ara & the implications and complications thereon, an open slot seems to exist for a specific purpose license that carefully addresses the scope & limitations of all applicable laws (patent, copyright, distribution et al) & standards and one that simultaneously enables collaboration and protects the commercial interests of the smallest member of the ecosystem - This responsibility I guess Google’s invited upon itself now.

Another possible challenge the previous generation of OS Incubators like Apache till date didn't have to worry too much about but Google/ Motorola will need to address proactively is the issue with potential for conflict of interest** owing to their mutually contrasting roles, one that of an investor funding (& thus part-owning) newer technologies of promising start-up enterprises & another, that of an impartial administrator/ incubator of an open development platform – while Android can be showcased as a precedent, I’m sure Google will admit hardware is a different devil altogether.

**I did a quick check on the portfolio companies of both Google ventures & Motorola Solutions Ventures but did not find any investment into any hardware start-ups – simultaneously reassuring and confounding J - what say Limor “Ladyada” Fried?

While I won’t certainly join the band of naysayers (like here..), I won’t hold my breath either - I will surely watch out though for the promise to materialize.

Afterthought

Why ARA?

Wikipedia offers two options 1) Ara, a southern constellation situated between Scorpius and Triangulum Australe AND 2) Ara, a neotropical genus of macaws with long striking tails, long narrow wings and vividly multi coloured plumage.

I choose Ara the Macaw, since this beautifully assembled by the primordial open-source development platform called evolution! & exotic creature sure looks like it could represent an assorted group of engineers putting together an equally assorted and exotic device. But knowing how project names work, Ara just can’t be a bird alone.. it should be an acronym too…… Android Rear-ending (into hardware) Alliance? :-)

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Disclaimer

**Uphone is a moniker I coined solely for the sake of using in this article that discusses the proposed modular smartphone from the recently launched Project Ara.

Much appreciated, Namaskaar!

I would be kidding if I say the thought never crosses my mind, it does too…..,

Like many, I’m privy to regular counsel on what’s actually right for me vis-à-vis’ what I feel is right for me. A lot of what comes my way is a casual reflection, some of it indeed is a studied observation and all of it out of genuine concern --- Like hell I’d like to believe, but didn't George Carlin say, it’s all about ‘their stuff is shit & my shit is stuff’? & the other way around?……..this is when the thought sweeps-in, of resorting to the very western gesture involving closing my fingers tightly & raising the middle one.

Then again equanimity trumps aggression and of late I’m tending to using more (mentally) this very eastern gesture of closing my palms together & raising them to my head - after all, Thyagaraja swami did say a long time ago, ‘endaro mahaanubhaavulu, andarikee vandanamulu’, to mean  ~Great souls galore, I salute them all.

Namaskaar!

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