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;

---------------------------------------------------------------------------------------------

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!