Removing silos and pooling expertise will change medical research and benefit more patients

Boston, 2^nd November, 2016 – The Pistoia Alliance, a global, not-for-profit alliance that works to lower barriers to innovation in life sciences R&D, is calling on the pharmaceutical industry to support greater collaboration around wearable device initiatives. This theme echoed at The Pistoia Alliance’s annual member conference in Boston earlier this month. Sohini Chowdhury, senior vice president of research partnerships at The Michael J Fox Foundation  (MJFF), the world’s largest non-profit funder of Parkinson’s research, discussed the need for increased cooperation between all links in the life sciences research chain to realise the potential of technology in R&D.

“From patients to physicians, from scientists to trial sponsors – everyone wants more data,” commented Ms Chowdhury. “Wearable devices will be a crucial ‘self-reported’ source of that data, but we know there is still a hill to climb toward field-wide integration. Now, we’re trying to close the loop, and explore the value of wearables for the entire ecosystem. By pooling our resources, we can build consensus and make these reams of data accessible – which will advance our understanding of disease and testing of new therapies.”

During her keynote, Ms Chowdhury also spoke about MJFF’s early wearable device projects. One project includes a wearable sensor in a smartwatch, which transmits data via a smartphone to the cloud. This enables researchers to monitor patients’ movements 24/7, collecting 150 data points per second (over 4 million data points per person per day). With such a large amount of data collected, one of the biggest challenges is in analysing that data. Data scientists need the input of clinical experts to direct their analyses, and scientists and researchers need the help of computational experts to ‘crunch’ the numbers. This kind of collaborative effort will become fundamental to unearthing insights from wearable device data and is a core aim of The Pistoia Alliance.

“The Pistoia Alliance applauds the excellent work that MJFF has been doing, to encourage collaborative efforts that will accelerate research in the field of Parkinson’s. When we take a cross-industry view we can see, however, that many pharmaceutical companies are developing their own wearable devices and applications, in all therapeutic areas – without common industry standards to govern quality and interoperability,” commented Dr Steve Arlington, President of The Pistoia Alliance. “The result is that considerable amounts of time and money are wasted developing unique solutions that cannot interact, and with no facility to share the data gathered. This fragmented approach benefits neither patients nor payers in the slightest. The lack of communication, whether it be between countries or companies, is a significant barrier to the development of new therapies. The Pistoia Alliance was formed to overcome these barriers to innovation, and to offer a unique platform to foster collaboration.”

The Pistoia Alliance creates initiatives to avoid the waste of time and resources resulting from siloed research programmes. Its projects bring together key constituents to identify root causes of R&D inefficiencies; it has also created a proven legal framework for open innovation. One of the Pistoia Alliance’s key successes is its role as a founding partner in not-for-profit foundation, The tranSMART Foundation, an open source platform where interoperable data can be accessed and merged with external proprietary datasets from other parties.

“The tranSMART Foundation was incubated by The Pistoia Alliance, and formed as a result of collaborative effort between scientists all over the world,” commented Keith Elliston, CEO of The tranSMART Foundation. “New data-types – such as that from wearable devices or Internet of Things sensors – are growing in volume all the time. Making sense of all of these data requires a collective endeavour and a platform which improves accessibility. At tranSMART, we are able to provide this environment to support organizations such as the MJFF to achieve its mission.”

For more information about The Pistoia Alliance, please visit: pistoiaalliance.org

For more information about The Michael J Fox Foundation, please visit: michaeljfox.org

For more information about The tranSMART Foundation, please visit: transmartfoundation.org

–ENDS—

About The Pistoia Alliance:

The Pistoia Alliance is a global, not-for-profit members’ organization made up of life science companies, technology and service providers, publishers, and academic groups working to lower barriers to innovation in life science and healthcare R&D. It was conceived in 2007 and incorporated in 2009 by representatives of AstraZeneca, GSK, Novartis and Pfizer who met at a conference in Pistoia, Italy. Its projects transform R&D through pre-competitive collaboration. It overcomes common R&D obstacles by identifying the root causes, developing standards and best practices, sharing pre-competitive data and knowledge, and implementing technology pilots. There are currently over 80 member companies; members collaborate on projects that generate significant value for the worldwide life sciences R&D community, using the Pistoia Alliance’s proven framework for open innovation.

About The Michael J. Fox Foundation for Parkinson’s Research
As the world’s largest nonprofit funder of Parkinson’s research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson’s disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson’s patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $650 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson’s research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson’s disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson’s awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world. For more information, visit us at michaeljfox.org, on Facebook or Twitter.

About The tranSMART Foundation

The tranSMART Foundation is a non-profit organization that provides an open-source, cloud-based, data-sharing and analysis platform that enables scientists at universities, disease foundations, pharmaceutical companies, and government agencies around the world to share pre-competitive data in a way that saves money and time in translating research findings into new therapies and diagnostic tools.  Current Gold Members of the Foundation include: Pfizer, Roche, Sanofi, Takeda, and the University of Michigan.  Founded to steward the tranSMART platform, the Foundation is headquartered in Wakefield, Massachusetts with Centers of Excellence in Ann Arbor, Mich.; London, England; Boston, Mass.; and Amsterdam, Netherlands. The tranSMART Foundation can also be found on the web at www.tranSMARTFoundation.org.

Media Contacts:

Carmen Nitsche, Pistoia Alliance
+001 510-589-3355 / carmen.nitsche@pistoiaalliance.org

Michelle Allison, Spark Communications
+44 207 436 0420 / michelle@sparkcomms.co.uk

Land was the raw material of the agricultural age.

Iron was the raw material of the industrial age.

Data is the raw material of the information age.

Alec Ross, Columbia University

Please also refer to the list of questions and answers related to this strategy update.

Introduction

The world of life sciences R&D is changing rapidly. To ensure the Pistoia Alliance continues to remain relevant, it needs to change with it. While the Pistoia Alliance has been successful in the past, with a strong and growing membership, alongside a series of successful projects, which have improved the efficiency of global life sciences R&D, the Pistoia Alliance faces a number of challenges which must be met in order to ensure its continued relevance.

The Pistoia Alliance has had an impact on life sciences R&D through pre-competitive collaboration. However, it has not been as significant or as wide ranging as hoped. Furthermore, there are some indications its impact may be diminishing. To ensure that the Pistoia Alliance is able to continue to contribute and to influence global R&D strategy at the highest levels, a new strategy is required.

There is a need to restructure the membership of the Pistoia Alliance itself. While we have many excellent members who are unstinting in their contributions, we need to be represented at higher levels in our member organisations if we are to achieve our objectives, and influence life sciences R&D at the strategic level. At the same time, we need to guard against losing our strengths in operational knowledge and skills. The Pistoia Alliance needs to review its membership categories and its governance to ensure we are attractive to the broader health and life sciences communities.

Alongside the change in our membership, we need to review the projects we support. While we have had significant success with a number of these, we have as yet significantly to influence the top levels of life sciences R&D. This new strategy will see the Pistoia Alliance adopt a new approach, becoming involved with new and emerging areas of technology, and influencing the sector on a more strategic level.

We will focus on technologies which support science, technology and digital healthcare at the strategic level. This will see an increase in activities in areas underpinned by e.g. “Omics”, Big Data, Wearables, Robotics and the Internet of Things (IoT).

The Pistoia Alliance has always helped support innovative start-up companies through our many projects. With the growing importance of these companies, increasing our level of support for them will prove beneficial to the Pistoia Alliance. As such, we will be extending the President’s Start-Up Challenge, encouraging more companies to enter, increasing the value of the prizes, and through these efforts increasing our involvement with key stakeholders such as venture capitalists.

Furthermore, we aim to attract the interest of industry investment groups, become one of the most important and well known industry reference point for any start-up looking for validation, and offer high-level, industry support through our members and mentors. This will allow us to utilise the start-up community in helping improve life sciences R&D globally.

All of this will bring about significant change for the Pistoia Alliance, and with that change, a number of risks. However, failure to adapt to these challenges will result in the Pistoia Alliance disappearing, and with it, the many benefits we provide.

While the finances of the Pistoia Alliance have been and continue to be tightly managed, if we do not adopt these changes and increase our revenues, we will run out of money in less than eighteen months.

The life science industry is undergoing massive change across all areas at the moment, making the role of organisations such as the Pistoia Alliance more important than ever. Life sciences R&D would benefit from improved efficiencies and through areas such as pre-competitive collaboration, the Pistoia Alliance can be a powerful force in advocating this and we will look to partner with others to make this happen. Failure to grasp this opportunity will find the Pistoia Alliance declining in relevance.

This new strategy will provide the opportunity for the Pistoia Alliance to enjoy a long and effective future, ensuring we are able to achieve our goal of supporting life sciences R&D globally.

Building a Global Membership

Currently, the Pistoia Alliance has a strong and growing membership across many areas of life sciences and across all levels. However, we need to be represented at higher levels in organisations if we are to achieve our objectives, and influence life sciences R&D at the strategic level.

Since the formation of the Pistoia Alliance, our members have worked tirelessly to support our goals. While this has resulted in a number of successful projects which have improved R&D in life sciences, it has not resulted in the Pistoia Alliance making a large impact.

In order for the Pistoia Alliance to influence the very top levels of life sciences R&D we must broaden our membership. To do this, we must build a reputation within the industry. We must ensure that our projects are seen as being relevant, and providing value. While we have excellent representation at certain levels of the life sciences industry, particularly in the areas of domain expertise and skills, we need to be influencing strategy at the very highest levels and building an industry-leading reputation.

In parallel we need to change the composition of our membership. While pharmaceutical companies may be the single most important part of the network, we need to include others from related and highly influential areas such as regulatory agencies, healthcare providers, service providers and innovators.

To support these changes and to ensure the continued relevance of the Pistoia Alliance, we need radically to restructure how we charge. Membership fees will need to be increased across the organisation or we will run the risk of not having the funds to support our activities.

We will also simplify the current membership structure, removing the existing categories, and charging members according to their size. The current membership division between pharmaceutical/biotech and technical/vendors will also be removed.

The increased funds will enable the Pistoia Alliance to undertake ever more significant projects, which will have a greater impact on global life sciences R&D.

The extension of our membership base will ensure that the Pistoia Alliance is positioned not only to influence life sciences R&D, but also actively to lead in the development of innovative new approaches to tackling the many challenges faced by the sector as a whole.

Supporting Life Sciences R&D Globally

Currently, the life sciences sector is undergoing significant change as it faces a number of challenges. Underpinning many of these challenges are issues around R&D. As many of the so-called ‘easy’ targets have been identified and treatments developed, the industry now needs to focus on more complex and difficult targets. Associated with this is an increased cost in R&D as more complex and expensive methods are required for effective drug discovery. While the objective of the Pistoia Alliance is not to help companies identify novel drug targets or compounds, it is to help with the increasing costs of R&D by reducing the barriers to innovation.

Through pre-competitive collaboration, the Pistoia Alliance can support its members as they strive to improve their R&D. We have had some significant success through our previous projects, such as SESL (Semantically Enriched Scientific Literature) which spawned the IMI Open PHACTs project, Sequence Services which has given rise to several start-up companies, the Vocabulary Standards Initiative which in turn laid foundations for the Ontology Mapping project, HELM (the Hierarchical Editing Language for Macromolecules) which is enjoying increasing adoption globally, and CSCS (Controlled Substance Compliance Services) which is now seen as a useful and successful innovation in the compound management domain.

However, past success is no indication of future success and we must adapt our approach to an ever-changing world. A significant change will be the creation of a budget to support specific projects as agreed by a new sub-committee of the Pistoia Alliance Board called the Portfolio Investment Committee. This will enable the organisation to move quickly to develop new projects as required. This will not replace the traditional funding model with members contributing to projects as they see fit, but will give the Pistoia Alliance the flexibility to exploit rapidly developing opportunities.

We will continue to support our many projects currently underway, which include the Ontology Mapping Service and the Chemical Safety Library, but as ever, we rely on our members to help us identify and develop new projects for the benefit of the sector.

One significant change to our strategy will be in the provision of more active support and for greater engagement with start-up companies. Start-up companies are becoming central to innovation in life sciences, often developing the most innovative technologies and approaches to tackling global problems.

The inaugural President’s Start-Up Challenge has proved successful with a large number of excellent entries from innovative start-up companies, and we want to build on that. The Pistoia Alliance will become one of the significant organisations in fostering innovative start-up companies.

We will use the Start-Up Challenge as the basis for a sustained programme which will see the Pistoia Alliance build strong relationships with life sciences venture capitalists, and their supporting organisations. Through this, and a programme to identify and support the most innovative start-ups, the Pistoia Alliance will become the place for these companies to receive external validation and become the most important and well known industry reference point for any start up looking for validation, and providing high-level industry support. Having successfully launched the inaugural Start-Up Challenge last year, we had an excellent response from the global life sciences R&D community. With the Challenge now established, we need to build on this, increasing awareness in not only the investor and start-up community, but also among large established companies.

The Pistoia Alliance has built a track record in identifying and developing new technologies and techniques, and by combining this with our growing number of start-up members, we can improve life sciences R&D.  By building links with the investment community, we will be able to support our many members and position the Pistoia Alliance as an expert in identifying and fostering innovation.