Steve Arlington is president of the Pistoia Alliance – a global, not-for-profit alliance of life science companies, vendors, publishers, and academic groups
Can you give a quick round-up of your previous career?
My career began in the 1970s, and I’ve worked in the pharmaceutical and diagnostics industry for more than 40 years. I began as a research scientist in the field of immunology, and developed and launched many products in this arena. I am a retired partner from PwC and led the pharmaceutical team in advisory services; I also previously led the IBM life sciences and pharmaceutical global teams. In my career, I have grown two global consultancies into billion-dollar businesses and launched a biotech company; I’ve also served on the advisory boards of major pharma and diagnostic companies, startups, venture capitalists and health providers. I became president of The Pistoia Alliance in 2015.
Please explain what the Pistoia Alliance is about
The Pistoia Alliance is a global, not-for-profit alliance of life-science companies, vendors, publishers, and academic groups. We established the Alliance in 2009. The founding members who came from AstraZeneca, GSK, Novartis and Pfizer, initially met at a conference in Pistoia, Italy. Our mission is to work together to lower barriers to innovation in R&D. We run a series of projects that aim to transform R&D innovation through pre-competitive collaboration.
By bringing together the key constituents, we seek to identify the root causes that lead to R&D inefficiencies. We then develop best practices and technology pilots that help to overcome these common obstacles. Any company that can contribute in some form to life sciences discovery is welcome in The Pistoia Alliance. There are currently more than 80 member companies ranging from global organisations such as Pfizer, Johnson & Johnson and AstraZeneca, to smaller and medium size enterprises, such as Linguamatics, Databiology and Dotmatics.
Why is collaboration so important to the life sciences industry?
Life sciences R&D has changed beyond recognition. We are no longer in an age of blockbuster drugs; the era of personal genomics and Big Data generation is upon us. So whether it’s searching for a cure for cancer, aiming to personalise drugs and treatments for every individual, or integrating R&D into the Internet of Things – life science companies increasingly must look outside of their own four walls to achieve these goals. In essence, life sciences organisations can no longer afford to go it alone. To overcome the problems that society faces – from antibiotic resistance to Zika – sharing, partnering and collaborating will be essential, to accelerate innovation, and to make the lives of patients better.
Modern research generates huge volumes of data, much of which is ‘pre-competitive’; sharing this data could significantly boost innovation in the life sciences industry. Currently, there are no industry-wide standards that make this data discoverable and sharable – whether it comes from regulators, partners, competitors or internally. At the same time, the life sciences industry is being asked to do more to incorporate technologies, such as wearables devices, into their remit. And as mHealth and the Internet of Things gain traction, the complexity of R&D continues to deepen. To address this, life sciences companies could, and do, build solutions themselves, but this is an expensive dead-end, which results in tools that are not interoperable. When data is locked in these systems, it is unusable. This is why collaboration is so important to the industry – to realise the potential of big data in a way that will benefit patients.
What are the biggest barriers to collaboration today?
One of the main barriers lies in the fact that life sciences is a heavily regulated industry. It’s also an industry that typically fiercely protects what it sees as proprietary information. So between worrying about breaking regulatory rules and fear of giving away too much information to competitors, life science companies haven’t historically tended towards collaboration.
There are more practical and technical barriers too. In recent years, there has been much merger and acquisition activity in life sciences. This has left companies with a plethora of research and data tools in use throughout their business, which hampers data sharing. Data formats also vary widely between, and within, companies. Some teams or companies may be using ‘off the shelf’ tools, while others may have invested many millions in building their own in-house systems. On top of this, the growing number and types of data sources is compounding the issue. For instance, data today can originate in varied circumstances – from wearable devices used in clinical trials, to patients’ social media posts.
Another complicating factor is the impact of technology companies, such as Google and Apple, and the shift to personal genomics. It’s possible today to have your entire genome sequenced for under a thousand dollars. Or, send away a swab and receive a genetic analysis for just a hundred dollars. Undoubtedly, we’re about to witness an explosion of genomic data and an increasing awareness among the general public of what interpreting this data could mean.
Together, these barriers are pushing the world of life sciences to a tipping point – collaborate, or fail. The industry must share the costs of building solutions that will have maximum benefit to both their company and the industry as a whole. What this requires is an industry-wide effort to improve cross-domain collaboration, aggregation, access and data dissemination. The potential of this ‘world of data’ in life sciences is unmatched. Think of some of the biggest targets that the industry is charged with; curing cancer, slowing the advance of Alzheimer’s, creating prosthetics that can ‘think’, reversing blindness, personalising drugs. Two things are crucial in all of these fights – data, and collaboration – the Pistoia Alliance provides a forum in which this can happen.
What are the benefits of being a member of the Pistoia Alliance?
Being in the Pistoia Alliance offers companies a way to amplify their R&D budget by pooling resources with like-minded individuals. It is a group where members can share best practice and expertise, and collaborate with peers towards a shared goal. As we have members from global companies with thousands of employees, to a five-person startup, we are able to bring together a variety of expertise and experience. One of the most significant benefits is that members can use the Pistoia Alliance’s legal framework to ratify and guide their collaborative efforts. The framework is proven and acts as a legal ‘safety net’, so that open innovation can take place between all companies. This ensures that members benefit from having access to all of the different links in the R&D chain – from chemistry, to biology, to ‘omics, to IT.
The projects that the Pistoia Alliance runs are also a considerable benefit. Members collaborate as equals on projects that aim to generate significant value for the worldwide life sciences community. From a personal point of view, it is of course also very beneficial to a member’s profile to be part of a successful project that comes to fruition. Many of the Pistoia Alliance’s projects began at a single company, and were further developed under the framework as a result of collaborative efforts.
One example is HELM (Hierarchical Editing Language for Macromolecules); this was initiated by Pfizer when it realised there was no commercial solution available to researchers that allows them to handle complex macromolecules computationally. Pfizer approached the Pistoia Alliance, where a survey found the majority of member organisations had the same issue. A collaborative project ensued, resulting in the creation of an open-source standard for biomolecular language. HELM has now been widely adopted by life sciences companies, scientific publishers and regulatory agencies, including the FDA. HELM is an excellent example of what collaboration can achieve.
What trends do you see most impacting the life sciences industry in the future?
The face of R&D is changing dramatically, new data-types are growing in volume all the time and will continue to do so. This could include everything from wearable devices, to ingestible or implantable chips. And we are now also seeing the emergence of innovations such as viral robots and DNA nanomachines. Robotics and Artificial Intelligence are also set to have a big impact, with industrial-scale robots present in many modern labs that can act as a fully automated ‘lab-in-a-box’. Though an increasing level of automation and technology can significantly reduce the cost of R&D and lower barriers to access, agreeing standards for communications protocols, data use and physical integration is the next important step. The life sciences industry must work together to support the creation of investment, regulatory and academic systems to minimise wasted resources and accelerate progress.
One other trend is the tendency towards large-scale research projects – often instigated by governments or private individuals – with mammoth aims. Recent example include Joe Biden’s Cancer Moonshot, President Obama’s Precision Medicine Initiative, and the Zuckerbergs’ big philanthropic plan ‘to cure, prevent and manage all disease in the next 10 years’. While the aims are laudable, investing money will be only half the battle. These programmes are ambitious and patient-focused, and will undoubtedly generate overwhelming quantities of data. It will therefore be important – if these projects are to deliver – to get all of the relevant stakeholders in the same room and at the same time.