Drug Discovery World wants to know and has asked the Pistoia Alliance to submit an article next month on this subject. And while we have some ideas already, we’d love to open this question to the floor. What do you see as the obstacles to innovation in the pharmaceutical industry?
We’d prefer for the moment to hold our own thoughts close to our chests and instead ask how you’d characterize these barriers. Are they primarily to do with process and technology? Or is it institutionalized bureaucracy? Perhaps a combination of factors? We hope we can get a lively conversation going in the comments. Please invite your colleagues and peers to participate in the dialogue.
Well now, Nick, this is a topic in which I am personally compelled to participate. As the CEO of GenomeQuest, a supplier of massive-scale genomic analysis capability with a focus on next-generation sequencing data to nine of the top ten pharmaceutical companies, I have a unique view of how pharma operates across organizational boundaries. Allow me to provide some examples on the ways in which pharma creates its own obstacles to innovation.
On a Monday, I can have a conversation with a VP of Research in pharma who says, “I want to outsource the elements of our research pipeline that are pre-competitive.” On Tuesday, I speak to Director of Bioinformatics for the same company who says, “we’ve decided to build our own internal pipeline for managing sequence data.”
On a Wednesday I have a short conversation with the CEO of another pharmaceutical company who tells me, “we need to be innovative straight across the company.” On Thursday, the VP of Translational Medicine from the same company tells me that, “collaborations to rescue drugs using genomics are a key strategy for us this year.” And on Friday, the Director of Bioinformatics tells me, “we don’t have a genomics strategy.”
Every pharmaceutical company we work with has a core group of brilliant informaticists who are struggling valiantly to address the problems relating to genomics data management and analysis. This is hard work – the data volumes are enormous, with a single genome producing as much data as 30 human genome projects on a next-generation sequencing machine. And yet, every single one of these groups is doing exactly the same thing; bringing in open source tools and writing PERL scripts to tie things together. There is perfectly sound commercial software to do this janitorial work, that costs as little as one FTE. And yet you put 5 FTEs on the problem and have a 50% chance of building a solution in a year.
But don’t worry about this waste, because at least You Are Doing The Same Things As All Of Your Competitors.
And it would almost be funny, except for the sad fact that the promise of a highly innovative pharmaceutical company is indeed the betterment of the lives of individuals with terrible diseases. And like many, I have a personal story about a horrible degenerative disease for which there is truly no good therapeutic. For this reason, the emotion I find myself experiencing is less a ridiculing laughter and more a deep sense of urgency to help you so that sick people can have gain access to new therapeutics that can change their lives and the lives of their families.
But can pharma be helped?
We recently delighted a group of researchers and informaticians on a pilot assessment of our software technology for their needs in high-throughput transcriptome analysis (RNA-Seq). In the final hour, just as the group was ready to adopt our platform, they received word from above that the company was entering into a genomics strategy and planning activity and that for the next six months, all activity relating to genomics and next-generation sequence would be put on hold.
Now here is a group with data, more coming, heavily invested for a six-month period, software in place, and all plans are scrapped. A company at the forefront of RNA-Seq research, and they will now wait for a broader strategy before moving forward with anything. Yet their researchers want to look at the transcriptomes of the diseases they study. Their informaticists want to innovate on better methods for discovery. Instead, the researchers will wait four months to get their data. Instead, their informaticists will go back to writing PERL scripts to transform data in Excel sheets from one format to another. I can tell a hundred stories like this.
And the beat goes on.
So here are the obstacles to innovation in pharma, broadly:
- a top down corporate strategy that fails to recognize the innovation happening at the lower levels of the company
- a systemic desire of informaticists to build pre-competitive tools on their own, when they should only be developing unfair COMPETITIVE advantages
- an enterprise-wide culture of letting perfect get in the way of good enough
- an inability to understand the fully-loaded costs of doing research, from FTEs to power to wetware to computers
- therefore an inability to measure the ROI of partnerships and customer-vendor relationships
- a lack of empowerment of innovative departments with sufficient budget to be nimble, even if it means duplication of effort across the enterprise
Innovation happens among small teams who are empowered to take risks and who are allowed to fail. For those of you who are doing this, you know who you are, and congratulations. Call me, let’s toast a glass of Bordeaux to your success. And if we aren’t already, let’s partner to develop new therapies for oncology, cardiology, neurology, and infectious disease through the promise of genomics.
For the rest of you: hurry up. Not only will your company be left behind, but the patients who depend upon your innovation will continue their marches toward morbidity and untimely death.
Richard J. Resnick
CEO
GenomeQuest, Inc.
resnick@genomequest.com
Rick, i have a name for it (in my book) – Serendipity Induced Chronic-disconnectedness, accompanied by Change Intertia (SICCI = SICKY).
My hobby horse is the fragile, underperforming supply chains in the industry, but it is equally applicable across the board, such as the issues you describe. Fundamentally, the senior management boards still believe drug discovery & development is about a ‘lucky strike’ then a race to the clinic to get an approval; anything else is off their radar screen. Does that ring a bell for you?
This may not be quite what you are looking for since I parachuted in here from some random tweet about “What’s Strangling Pharma Innovation”
Seems to me the biggest barrier isn’t technical, but economic/political. Its BIG Pharma itself. The large Drug Companies have no financial interest in curing people of diseases. All their economic alignment is to create ever more expensive drugs that people have to use on a daily basis for the rest of their lives.
Until that changes and the economic incentives are aligned so that cures are rewarded (or non-cures are penalized) we are pretty much doomed.
Of course if some genius outsider comes along and produces real cures, based on cell / tissue regeneration or other SENS like techniques they will get fabulously rewarded. But they have to run the 9 figure gauntlets of FDA approval which only major players can afford…
Obstacles to Innovation…
Compare IT in High Energy Physics to IT in pharma. HEP management always recognised that computers were needed to get at the physics and so invested substantially in high performance IT and IT management. There has never been that same visceral understanding in senior pharma management – that computers were needed to get at the biology and the chemistry and they were and are increasingly critical to deliver the novel drugs urgently required for unmet medical needs.
Consider the general case of IT organisations in pharma. IT reports into the CIO who in turn reports into the CFO and CFOs tend to regard IT as an expense rather than an urgently needed opportunity. And that brings us to the question of why pharma CIOs seem to understand little of the end-to-end information flows in the companies they serve? Rather they focus on attempting to drive out cost, running internet auctions for several thousand desktop computers or struggling with implementing SAP. None of which contributes in any way to innovation.
I was at a conference the other day and one of the delegates – an informatician at a top 20 pharma – reported that his legal department would not allow him to use the ‘cloud’!
Then there are the QA departments who regarded themselves – not the business owners – to be the arbiters as to whether or not a validated system could be released into production – and the QA departments who agonise over Computer Systems Validation templates or demanding thousands of pages of documentation to be produced (that no-one will ever read again) when validating a common, best-of-breed, off-the-shelf-commercial product. And then the QA departments – who still struggle to implement a risk-based validation methodology to include the opportunity of pharma using cloud-based services (even if the legal department were to allow it!)
So to the way forward; Senior Management in Pharma R&D should get engaged much more in some of the detail of R&D operations: find out how the CIO thinks he is supporting R&D, ask legal how they can help pharma to use the cloud, and get to grips with QA. Pharma in general and Pharma R&D in particular is a high-risk business in dire need of innovation; IT, Legal and QA need to understand that and become partners of R&D in cutting through red tape and creating a true innovation culture.
It’s complicated. I should say up front I’m an academic, and aside from a internship when I was a nipper, have not worked in pharma. However it seems as though there are a number of factors. Economics is the main problem – with less money one must cut back on more speculative research. The diseases are becoming less tractable – less low-hanging fruit, more complex combinations of targets, etc.
I think the duplication of research in pre-competitive areas sounds like a serious waste of money, if one is able to define what “pre-competitive” even means. There is a great deal spoken about “open innovation”. This too is nebulous, but essentially relies on companies encouraging the suggestions of others, and buying the ideas they like. I think the incentive structure here is weak – there is every chance that by submitting a good idea, a small number of people will deem it to be a bad idea, in secret. Or, even worse, your idea is bought and you are then shut out of the development of the project. In other words, the merest promise of valuable intellectual property will tend to make a promising project go private prematurely, and one then loses the advantage of openness. While there have been no examples (?) and this is speculation, I don’t see open innovation leveraging the real advantages of openness for this reason. Though I think these approaches have to be a step in the right direction, and I’ve been very interested to read about what Pistoia are doing. Even though there is precious little information. Because you’re not open enough.
We’re hoping to provide a disruptive kick pretty soon – open source drug discovery. No patents. A challenge to the traditional way of doing things has to be healthy. Perhaps we can in the process bring more clarity to what terms like open innovation in pharma really mean and whether they can be useful. The world needs an innovative pharmaceutical industry.
Mat, Thanks for your input
As you state we are entering a new era in Life Science research where the pressures to succeed are making us look at options for driving new innovation, bringing in external partners and collaborations plus also reducing cost of the operational activities.
I think its worth differentiating Open Innovation from Open Collaboration. The purpose of Open Collaboration is to share requirements openly amongst a group of customers and suppliers (representing the full value chain) so that we can look at new business models for delivery and also collaborate on the standards and signposting of existing approaches. Open Collaboration works well in pre competitive spaces where all parties are looking to improve the efficiency of the activities.
In Open Source Drug Discovery, you will also have need for collaboration environments and information standards to support the partnering. What issues do you see with enabling these collaborations?
Thanks
As a member of an IT and Automation service department for research in a Pharma company I do see indeed some obstacles for innovation. Innovation happens in research labs and is heavily dependent on the availability of appropriate IT support (accessibility of information/data and related/supporting IT applications) as well as a flexible use of equipment in the lab (rearrangement, replacement, and utilize new instruments, also in automated systems). On top of this, the available budget is always limited even in larger companies.
Legacy data architecture and IT structures are major obstacles in providing required information across the company. The biggest effort is needed to align different data silos to a company-wide data repository. Additionally, the ‘automated’ gathering and storing of data for further analysis and subsequent reporting support the scientists’ decision on following investigation cycles.
On the equipment side the challenge in research labs changed during the past years. There is a growing pressure to use equipment in a very flexible and automated or semi-automated manner and to integrate instruments for new applications in shorter time. Furthermore, scientists need to adopt technological innovations provided by instrument suppliers more easily and rapidly. Exporting captured data from prop¬ri¬e¬ta¬ry software for further analysis can be impracticable or frustrating.
This situation leads to a waste of resources in the widest sense: Available equipment needs to be re-pla¬ced for compatibility reasons, software drivers have to be purchased or developed and data conversion is done on a case by case basis. In consequence, either additional money has to be spent or software development time is needed which hinders a reduced innovation cycle in drug discovery and de¬ve¬lopment.
It is the aim of SiLA (Standardization in Lab Automation, http://www.sila.coop) to remedy this situation by establishing globally provider in¬dependent, open standards for device integration. In addition, SiLA actively sup¬ports the introduction of an open data interface standard and distributes labware description files based on its universal labware specification standard.
SiLA enables pharma and biotech R&D to focus on its main business by reducing equipment connectivity effort to a minimum. This is achieved by using proven, tested and maintained documentation and code. Standardizing the interconnectivity will dramatically increase the flexibility, accelerate the innovation cycle and reduce the implementation and testing effort.
Niklaus, thanks for some good comments
Given the diversity of the Life Science environment and the pressures we are under on delivery, we see a key role for the Pistoia Alliance to signpost the available standards and best practices that exist to day. We are very keen to work with a range of outside groups such as SILA and others to enable these individual standards to be brought together into a workflow that adds real value to the scientist.
What signposting do you think would be necessary?
Thanks
Nick
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