Boston, 18th March 2025: The Pistoia Alliance, a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D, is launching the next phase of its project to measure and reduce the carbon footprint of clinical trials. The initiative will assess the environmental impact of digital trial delivery methods (eConsent, decentralized clinical trials (DCT)) and digital health solutions (devices, apps), compared to traditional, paper-based approaches. By closing a critical gap in the understanding of whether digital technologies are more sustainable, the project will establish a standardized methodology for evaluating the use of digital tools in clinical trials. To further support this effort, the Alliance is also launching a new whitepaper that explores the broader sustainability challenges in pharmaceutical R&D and the need for better measurement frameworks to drive meaningful change.
“The life sciences industry is under increasing pressure to reduce its environmental impact, and clinical trials are a significant contributor to its carbon footprint. As CROs and sponsors embrace digital technologies, it is critical to understand whether these innovations are genuinely more sustainable than traditional methods,” explains Thierry Escudier, Portfolio Lead at the Pistoia Alliance. “Right now, data gaps and a lack of standardized methodologies make it difficult to measure the true environmental impact of digital tools in trials. With regulatory bodies, investors, and healthcare stakeholders demanding greater transparency and sustainability, now is the time to establish clear metrics that provide the insights needed to integrate sustainability-by-design into future clinical trials.”
The healthcare sector contributes approximately 5% of global greenhouse gas emissions. Clinical trials are a significant part of this, producing approximately 100 million tonnes of carbon dioxide, equivalent to the annual carbon footprint of Belgium. These emissions stem from all activities performed to run clinical trials at pharmaceutical companies’ facilities and hospital sites. Many of these factors are accounted for by the new industry-standard Clinical Trial Carbon Calculator, which the Alliance also contributed to and was launched in February by the Sustainable Healthcare Coalition and the industry Low Carbon Clinical Trials (iLCCT) community. However, data on the environmental impact of digital tools remains limited.
The Pistoia Alliance’s new initiative will collect real-world data from pharmaceutical companies, CROs, and other stakeholders to develop a standardized methodology for evaluating digital trial technologies, including software and hardware – such as the provisioning of smartphones and tablets for electronic patient-reported outcomes. This environmental impact data will be used to update the database currently powering the Carbon Calculator, so ClinOps teams and others who contribute to clinical trial design will be able to accurately compare digital versus non-digital trial approaches. This will allow clinical leaders to make more informed decisions when designing clinical trials, including reducing emissions while maintaining trial efficiency and quality.
“Collaboration is essential to tackling the sustainability challenges facing pharmaceutical R&D, and the Pistoia Alliance is uniquely positioned to lead this effort. We have a successful and long history of developing frameworks that are multidisciplinary, global, and industry-wide,” comments Dr Becky Upton, President of the Pistoia Alliance. “By working collaboratively, we can establish a standardized approach to comparing the environmental impact of digital technologies in trials against traditional approaches, while ensuring that future innovations support both efficiency and sustainability. To make this initiative a success, we are calling on organizations across the clinical research ecosystem to contribute their expertise, case studies, and funding.”
Press Release March 19, 2025 | Bio-IT World has named the 2025 Innovative Practices Awards winners, choosing to honor four entries. Winners this year include Genmab nominated by Genedata, NHS England nominated by IQVIA, Pistoia Alliance, and Regeneron. The judging panel also highlighted two entries for Honorable Mention: a separate entry from Pistoia Alliance and Quris-AI. All winners will be honored next month at the Bio-IT World Conference & Expo, April 2-4, in Boston.
The Bio-IT World Innovative Practices Awards have for years highlighted outstanding examples of technology innovation in the life sciences. Judged by a panel of expert, peer judges, the Innovative Practices Awards program recognizes partnerships and projects pushing our industry forward, promoting strategies that can be widely shared and implemented across the industry to improve the quality, pace, and reach of our science.
“In another year of tough competition, these four entries stood out as ones cleverly addressing real problems in the space,” said Allison Proffitt, editorial director at Bio-IT World. “These groups worked hard to understand the problems facing teams and solve them strategically; prioritized patients’ needs; and served as standards-bearers, quantifying how well we measure against our own most noble goals.”
This year’s winners stood out for excellence in data standards, analysis, patient service, and industry advancements. Here are the winners with their own project summaries:
Lighthouse Award: Pistoia Alliance for “FAIR Maturity Matrix”
The Pistoia Alliance has achieved an industry first with the creation of its FAIR Maturity Matrix—an easy-to-use self-assessment tool that measures organizational leadership and technical maturity. Over 20 industry experts collaborated to create the tool, successfully simplifying and standardizing the many complex processes involved in FAIR data implementation. The Maturity Matrix is designed to help organizations benchmark and maximize their investment in FAIR, whatever their level of maturity – from those getting started with their FAIR journey to those looking to understand how to move to the next level. It is being adopted by national research and funding organizations, pharmaceutical and life sciences companies of all sizes, consultancies and technology providers. Ultimately, it will help the industry to unlock data siloes, successfully adopt emerging technologies to power data-led decisions, and work together to reduce the time and cost of bringing new therapies to market to meet unmet patient needs.Lighthouse Award: Pistoia Alliance for “FAIR Maturity Matrix”
Knowledge Management Award: Genmab (nominated by Genedata) for “Accelerating chromatography workflows by redesigning and harmonizing data processing and reporting”
Chromatography is the workhorse for analytical assessment and purification of biotherapeutics at biopharma companies worldwide. Data from chromatography workflows are growing exponentially, making it increasingly onerous for biopharma developability groups using different instrumentation to capture and process data, collaborate, assess results, and ensure consistent and reliable outcomes. The results, in part, are error-prone processes, poor scalability, incomparable data, and resources in people, time, and money ill-spent. To address these challenges, Genedata and Genmab developed—Chromatics—a central, integrated software platform for analyzing and managing chromatography data, which enables rapid assessment by project teams globally. The digitalized hardware-agnostic solution eliminates manual processes, automates and harmonizes data processing, provides well-annotated data for AI/ML initiatives, and effectively accelerates the development of biomolecules.
Respect the Patient Award: NHS England (nominated by IQVIA) for “NHS Privacy Enhancing Technology”
Over the next decade, the UK National Health Service (NHS) is moving towards a data-enabled ecosystem with a connected, consistent data architecture. This will put patient data to work to optimize national insights and enable improved healthcare. A key challenge is ensuring compliance, including data auditability and protection, whilst optimizing data usability for crucial insights. The NHS-PET (Privacy Enhancing Technology) is a configurable platform powered by IQVIA Privacy Analytics which provides a secure, scalable solution for the auditing and privacy treatment of patient data within NHS Federated Data Platform (FDP). Benefits realized from PET include cutting waiting times and offering new virtual services. For example, hospital trusts using FDP with integrated PET have treated on average 114 more inpatients in theatres every month since platform introduction. Implementing this vision of shared digital infrastructure across NHSE can benefit care provision across over 500 acute, specialist or community hospitals.
Informatics Award: Regeneron for Unified Namespace for Preclinical Manufacturing and Process Development: an Industry 4.0 digitalization platform for realtime automated decision-making
Regeneron Pharmaceuticals is a science-driven organization committed to discovering and developing new medicines for patients with serious diseases. Like others in the biotechnology space, we face the challenges of orchestrating the systems, applications, and integrations that power our laboratory instrumentation and plant equipment. Historically, harmonizing resources to serve our scientists’ needs has required ongoing manual intervention and expertise across multiple disparate systems. Recently, our scientists and technologists partnered to address these challenges—keeping in mind priorities around compliance, cybersecurity, and scalability—and created a new platform: the Unified Name Space (UNS). The UNS seamlessly connects system integrations, automates interactions, and connects applications to make data available, irrespective of the source. With the UNS in place, we’re able to provide a common platform for organizing a complete view of lab-scale and pilot-scale bioreactors and their related instrumentation to provide operators the information needed for decision-making.
Ones to Watch
The judging panel also chose to highlight two entries with Honorable Mention designations, emphasizing the promise and potential of these projects. These two efforts are ones the judges will be eagerly watching in the year to come and look forward to hearing updates from again in 2026.
In vitro assays are crucial for assessing the safety and efficacy of active substances, metabolites, and impurities in Investigational New Drug (IND) and New Drug Application (NDA) submissions. However, inconsistent data standards for in vitro pharmacology (IVP) have hindered efficient in vitro testing and regulatory review. The Pistoia Alliance has addressed this issue through a public private partnership with regulators at the FDA, working collaboratively with biopharmaceutical industry stakeholders including Abbvie, Novartis, Roche, Pfizer, Amgen, Eurofins, Zifo, Scibite, L’Hasa Limited, and Curl Research. Efforts have standardized the way in which in vitro results are submitted using defined ontology and processes and using FAIR (Findable, Accessible, Interoperable, and Reusable) principles to ensure data is consistent, human and machine-readable, and easily reused for multiple regulatory submissions. Development of a repository of assays, linked to result templates, improves data transparency and enhances analysis capacity, improving efficiency, compliance and safety while accelerating drug development.
Honorable Mention: Quris-AI for “BioAI—De-risking, accelerating, and personalizing drug development”
A leader in AI-driven drug safety, Quris-AI’s patented Bio-AI approach integrates AI, patient-on-chip biology, real-time sensing, and genetically diverse stem-cell-derived tissue. Its automated platform generates and collects data on millions of interactions between known drugs and organs on a chip and then uses this data to train its advanced AI platform. This technology solves the core clinical prediction challenge – predicting, before expensive clinical trials, which drug candidates will work safely and efficaciously in the human body to focus resources, time, and budget on the drugs with the most potential. In a blinded, joint study with top-pharma partners, Quris’ Bio-AI approach outperformed existing safety prediction approaches, while reducing costs by 90%. All six projects will accept their awards during the plenary session at the Bio-IT World Conference & Expo on Friday, April 4 at 8:05am. They will also all each present the details of their winning entries during a dedicated Innovative Practices Awards Session beginning at 10:40am on Friday, April 4, in the Data Management track.
PISTOIA ALLIANCE LAUNCHES 2025 LAB OF THE FUTURE SURVEY
We are pleased to announce that we have launched our Lab of the Future survey, now running for the third consecutive year.
Our annual global survey tracks the adoption of emerging technologies and the skills needed to enable innovation and collaboration in labs of the future across the life sciences ecosystem.
The survey is being conducted in partnership with Open Pharma Research who run the Lab of the Future US and Europe.
Over 200 respondents complete the survey each year, making this research a valuable opportunity for members of the Pistoia Alliance and other industry experts to contribute to this benchmark of investment and technology adoption, providing valuable insights for everyone involved in transforming life sciences R&D in the lab.
To add your views and experiences, please complete this 5 minute survey below
The full survey results will be published and shared across the biopharmaceutical industry in October 2025.
Pistoia Alliance, in collaboration with CCC, finds 85% of life science professionals are concerned about the impact of differing AI regulations on cross-border collaboration
Experts from Chan Zuckerberg Initiative, FDA, AbbVie, Elsevier, Penn Medicine, Takeda and others discuss patient-centricity, data standards, and copyright
London, 10 December 2024:The Pistoia Alliance, a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D, has announced the results of a global survey in conjunction with CCC (Copyright Clearance Center), a leader in advancing copyright, accelerating knowledge, and powering innovation, on the impact of AI and copyright legislation on pharma R&D. While 83% of life science professionals are now using generative AI in their research, there is still widespread concern about the impact of differing AI regulations on cross-border research collaboration (85%). Additionally, 42% of respondents said they don’t think about copyright before sharing or using third-party information with AI tools. The survey was conducted at the Alliance’s annual US conference held this year in Philadelphia, which gathered more than 200 industry experts to collaborate on topics such as AI regulation, harmonization of data standards, and patient-centricity.
“It’s encouraging to see such an uptake in the number of researchers using Generative AI to accelerate R&D, but it’s a concern that copyright is often an afterthought. Less than half (40%) of organizations have a team or person dedicated to understanding copyright issues and AI, even though this is a complex area that requires expertise,” said Babis Marmanis, CCC Executive Vice President & CTO. “The Pistoia Alliance provides an ideal forum to bring copyright to the forefront of discussions around AI adoption and explore how to facilitate the compliant use of AI with published content.”
The event also saw the launch of a new whitepaper from ZS and Pistoia Alliance: ‘Are misaligned incentives preventing better patient outcomes in life sciences R&D?’. The joint paper contains insights from 25 industry leaders to explore how to create a future where near-real-time integration of human health data fuels R&D innovation. Other keynotes at the conference were delivered by Dr Genevieve Haliburton from the Chan Zuckerberg Initiative on its rare disease project, which takes a patient-led approach to driving research priorities, by establishing disease-specific data repositories and collaborating closely with scientific, medical and patient communities. Dr Jennifer Van Camp from AbbVie discussed how organizations can leverage clinical, biomarker, and patient real-world data to identify disease comorbidities and drug repurposing opportunities, enhancing evidence-based drug development.
Collaboration on data standards and ontologies was also widely discussed, underscoring the critical role of a robust data backbone in successful AI adoption. The Alliance launched its new industry benchmark report on the implementation of Identification of Medicinal Products (IDMP) standards, which are due to become mandatory across the EU, with the FDA likely to follow close behind. By standardizing the terminology used to describe substances, the Alliance’s IDMP Ontology will aid compliance, and enable safer cross-border prescriptions. Dr Kevin Snyder, from the FDA, touched on a similar topic, discussing the importance of standardized data in toxicology, with the Standard for Exchange of Nonclinical Data (SEND). He highlighted how collaborations on harmonizing data standards have improved regulatory review practices and enabled predictive models to enhance drug safety.
“AI is fast becoming commonplace in R&D, yet a fifth of researchers are still not using the technology. The best way to overcome any lingering adoption hurdles is together. We must ensure those remaining researchers have the confidence and expertise to use AI safely, so they can accelerate discovery, and enable better outcomes for patients,” commented Dr Becky Upton, President of The Pistoia Alliance. “Whether it’s copyright compliance, broader AI regulation ambiguities, or data standardization, the Alliance is committed to launching projects that will deliver a tangible impact to the life science industry. As 2025 approaches, we are keen for new project suggestions and are looking forward to broadening the Alliance’s reach even further, with more research and projects, and involving more global regulatory agencies in our communities.”
The Pistoia Alliance is now welcoming registrations for its next member conference in London, 25-26 March 2025. To find out more about membership or to suggest project ideas, visit www.pistoiaalliance.org.
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 200 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 CCC
A pioneer in voluntary collective licensing, CCC advances copyright, accelerates knowledge, and powers innovation. With expertise in copyright, data quality, data analytics, and FAIR data implementations, CCC and its subsidiary RightsDirect collaborate with stakeholders on innovative solutions to harness the power of data and AI.
Survey conducted with Open Pharma Research finds cultural barriers to AI are receding, while the need for greater collaboration and knowledge sharing to overcome data challenges persists
Boston, 25th September 2024:The Pistoia Alliance, a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D, has released the results of its annual Lab of the Future survey, conducted in partnership with Open Pharma Research. The survey of 200 experts spanning Europe, the Americas and APAC will be presented at the Lab of the Future Congress in Amsterdam on the 1st/2nd October. The research reveals that 68% of respondents are currently using Artificial Intelligence and Machine Learning (AI/ML) in their work, an increase from 54% in 2023. AI and ML are also cited as the top tech investments planned over the next two years (62%), as companies focus less on infrastructure investments such as Cloud Platforms (37%), ELNs (23%) and LIMs (20%).
Barriers to utilizing experimental data are shifting from behavioral issues towards more content-related challenges. For example, inability to access data (59%) and unstructured data (54%), and lack of metadata standardization (48%) were cited as the biggest barriers. Meanwhile, only 35% cited cultural barriers and institutional resistance to data sharing, down from 48% in 2023. Content-related challenges are also impacting the adoption of AI, with low quality and poorly curated datasets cited as the number one barrier to AI implementation (52%), followed by data that does not adhere to FAIR (Findable, Accessible, Interoperable, Reusable) principles (38%). Privacy and security concerns around data were also raised by 41% of respondents, up from 34% in 2023, as well as the perception that AI is not trustworthy, reliable, or responsible (28%).
“The good news is that cultural barriers to AI adoption are falling as organizations realize the benefits of the technology for accelerating scientific innovation. But the survey shows a sizeable number of respondents are still facing data issues, and fresh concerns are arising around privacy and security, perhaps due to the ambiguities surrounding new legislation including the EU AI Act. The communal recognition of these challenges emphasizes the opportunity for the life sciences industry to work together and overcome these obstacles,” commented Dr Becky Upton, President of the Pistoia Alliance. “The Alliance’s forum and legal framework for pre-competitive collaboration and knowledge sharing is more important than ever for moving the industry forwards. We thank our members for their commitment to creating projects, resources and communities to support safe and effective AI use in the life sciences.”
“There has been an increase in respondents citing financial barriers to AI/ML adoption, from 14% in 2023 to 20% in 2024. Yet we can see that most organizations are still planning to invest in AI, which is a positive sign for R&D overall,” added Zahid Tharia, Pistoia Alliance Consultant and a Director of Open Pharma Research, organizers of the Lab of the Future Congress. “What’s important now is that the life science ecosystem comes together to share the work of developing technology so that everyone benefits. Which is why events such as the Congress and expert resources from the Pistoia Alliance’s Lab of The Future community are so needed.”
To tackle content-related challenges and make data FAIR at scale, respondents called out the need for more data governance frameworks (49%), templates for standardization and metadata (46%), and best practice guides and “how-to’s” (45%). There has been a marked increase in the number of respondents interested in the practical use of ontologies, with 51% identifying more maintenance and management of data standards and ontologies, compared to 42% in 2023, as a key tool to make data FAIR. Training is also seen as more important than previously with 29% of respondents asking for ontologies training (up from 18% in 2023) and 32% looking for education on FAIR data.
“The 14% increase in the use of AI in labs found in this year’s survey clearly shows that AI is being successfully delivered, but not having FAIR data with consistent metadata standards continues to be a challenge according to almost 40% of respondents. On the data sharing front, it’s encouraging to see that cross-lab collaboration is now less restricted by a lack of incentives, but there still seems to be a challenge around company standards or guidelines for data sharing and workflows to actually do it,” commented Christian Baber, Chief Portfolio Officer for the Pistoia Alliance. “The Alliance understands these concerns and is committed to developing projects and tangible resources to overcome the cross-industry hurdles identified by our members and survey respondents. From our network of semantic projects and new ontology training beginning in Autumn, to our FAIR and data governance communities that will help members navigate the intricacies of privacy, security and regulations, our mission is to continue to be the go-to organization where companies collaborate to deliver the benefits of data and technology across the global life science community.”
The full Lab of the Future report is available for free download here
Individuals and organizations interested in joining the Pistoia Alliance’s Lab of the Future community which has a newly formed steering committee including nine major pharmaceutical companies should send an email to membership@pistoiaalliance.org.
The Pistoia Alliance and Open Pharma Research conducted an online survey of 200 participants from the global R&D community across Europe, the Americas and APAC, between May-August 2024. Respondents were from start-ups, pharma, biotech, software and service companies, academia and not-for-profit organizations; including R&D directors, lab managers, digital innovation, informatics and lab automation experts.
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About 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 200 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.
Survey of life sciences experts found 70% recognize potential for AI, but many are struggling to get started or implement it at scale due to challenges including data integrity and interoperability.
London, 8 May 2024:The Pistoia Alliance, a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D, is calling for urgent collaboration to tackle growing challenges around AI regulation and use in life sciences. It comes following a survey, conducted at the Pistoia Alliance’s largest ever European conference, found 70% of life sciences experts recognize the potential of AI but are still struggling to get started or implement it at scale. Almost 300 attendees gathered under the theme ‘Collaborate to Innovate’, with speakers including pioneer of structural bioinformatics Dame Janet Thornton; Lead Scientist for the FDA Global Substance Registration System, Dr Larry Callahan; and experts in R&D from AbbVie, AstraZeneca, GSK, Elsevier, Roche, J&J, and more.
“The impressive attendance at our conference is testament to the willingness of the industry to collaborate and overcome common research and legislative hurdles. As technology develops at pace, the life sciences sector cannot afford to fall behind. Companies must run this race alongside each other, as a unified front, to ensure that everyone benefits equally from AI,” comments Dr Becky Upton, President of the Pistoia Alliance. “Our London conference is evidence of the Alliance’s ability to bring together multiple groups and create a forum for safe and effective collaboration. We look forward to progressing several new projects alongside our existing portfolio as we tackle both long-standing and emerging challenges together.”
The Pistoia Alliance’s survey also revealed worries around the trustworthiness of AI, with 63% of respondents expressing concern that poor data quality could lead to incorrect AI conclusions and potentially harmful clinical decisions. Data quality was also a central theme of the keynote talk given by FDA Lead Scientist, Dr Larry Callahan who discussed the Pistoia Alliance’s influence over the widespread adoption of data standards to make regulatory submissions more efficient. Dr Callahan cited the Alliance’s In Vitro Pharmacology Group and Global Substance Registration System (GSRS) Consortia as successful examples of this.
The Alliance also announced several new projects and initiatives at the event. These include:
Clinical Operations Ontology for clinical trial site feasibility: Clinical trial investigator site selection relies on manually collecting data via questionnaires, which assess whether a site has the right equipment, necessary staff, and diversity of patients to conduct a study. Since much of this information is lost after a trial commences, questionnaires must be repeated for each new trial. The ClinOps project will create a data model to improve the management, analysis, and exchange of clinical operations data, so companies can choose the best investigator site for their study at a lower cost and with reduced manual data collection. The project marks a significant advancement in modelling domain-specific clinical trial design knowledge in a machine-readable format.
Digital accessibility guide: The freely available guide, published by the Alliance’s User Experience Life Sciences Community (UXLS), will inform hardware and software designers how to develop R&D tools that are accessible to all users to encourage technology adoption. For example, having audio descriptions for users with visual impairments, offering transcripts for those with hearing issues, and making websites easy to navigate.
FAIR Maturity Matrix: The concept of FAIR data (Findable, Accessible, Interoperable, Reusable) has been around for nearly a decade, and is an essential step to making R&D data AI-ready. While many pharma companies are well on their way to embedding the FAIR principles, there is no simple, agreed, maturity assessment model for FAIR implementation. The Alliance’s FAIR Implementation Project has designed a matrix to address that gap, with the first draft freely available
Labs2030: This relaunch of the Alliance’s successful Lab of the Future Community will tackle integrating the next wave of disruptive technologies into scientific workflows, including generative AI and virtual lab environments. Labs2030 will bring together scientists and technologists to build the next-generation laboratory environment from a data standards, process, instrument, and knowledge sharing perspective.
“What makes the Alliance stand out is our commitment to launching projects that our members have asked for and that will deliver tangible change to the life science industry,” comments Dr Christian Baber, Chief Portfolio Officer, the Pistoia Alliance. “These new projects, organized under our strategic priorities, will empower companies to navigate change and overcome challenges faster than going it alone. Whether that’s accelerating the adoption of emerging technologies to get new drugs to patients faster, or making headway on their diversity or sustainability goals. As 2024 progresses, we’re also excited to strengthen our ties with global regulatory agencies, involving them further in our projects and communities.”
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 200 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.
Pistoia Alliance Wins 2024 Bio-IT World Innovative Practices Award for Pre-Competitive Collaboration
The Pistoia Alliance has won a prestigious 2024 Bio-IT World Innovative Practices Award for Pre-Competitive Collaboration for its IDMP-O project. Bio-IT World today announced the 2024 Innovative Practices Awards winners. Six projects were honored. Companies driving the winning entries included AstraZeneca, DNAnexus, Pistoia Alliance, Regeneron, Tempus, and UK Biobank.
“The Innovative Practices Awards winners represent the best in the life sciences’ collaborative and innovative accomplishments,” said Allison Proffitt, Bio-IT World Editorial Director. “From groundbreaking projects years in the making, to steady progress in operational excellence, the Innovative Practices Awards reflect where our industry is headed and provide a roadmap to get there.”
The Pistoia Alliance’s Chief Portfolio Officer Christian Baber and Sheila Elz, IDMP-O Project Champion and Master Data Manager at Bayer will be receiving the award at Bio-IT World’s Award Ceremony presentation during the plenary programme on 17 April, at the 2024 Bio-IT World Conference and Expo in Boston. They will also be giving a presentation as part of a dedicated ‘Best Practices in Technology Innovation’ session for award winners on 17 April at 10.30am.
A big thank you to all our sponsors who have helped make our upcoming annual London conference possible: We look forward to seeing all our members from across the life sciences industry for a day of education, networking and collaboration on 24th April at Leonardo Royal London Hotel St Paul’s.
We still have a few sponsorship opportunities available. If you would like to get involved please contact our Marketing team, at comms@pistoiaalliance.org
Sponsorship is a great way to get your brand in front of our senior R&D audience and to support the Pistoia Alliance in providing face-to-face education, networking and collaboration opportunities to its members.
Live Poll Sponsorship – Take the spotlight by sponsoring a live poll during our conference which will be conducted among our audience of around 200 conference delegates using Slido. This is your opportunity to align your company with key topics of the day – AI and real-world data insights – and to feature in a post-event press release where we will promote the key conference discussions and poll findings. As our poll sponsor you will have some input into the 3-5 poll questions which will be developed ahead of the event and you will come up on stage to introduce the poll with us. $4,000 (members) $5,000 (non-members).
Plenary Session Sponsorship – this includes a 15 minute speaking slot in our plenary session and 3 x 2 metre booth and branding opportunities – $12,500 (members) $15,000 (non-members).
Evening drinks receptions sponsorship on 24th April – this includes branding opportunities and acknowledgement at these networking receptions $5,000 (members) $6,000 (non-members) for each event.
We also have a few bespoke packages available for one coffee break sponsorship ($3,125 members / $3750 non members) as well as exhibition booths.
Get in touch and we would be delighted to discuss these opportunities with you in more detail.
I hope you and your colleagues can join us for the conference. If you haven’t registered already, you can see the full agenda and register here.
New Pistoia Alliance Survey Reveals Only 9% Of Life Science Professionals Understand Laws Regulating AI in US and EU Survey exposes knowledge gap surrounding AI legislation, with a fifth of respondents confirming regulations are blocking their research
Boston, 20 February 2024. The Pistoia Alliance, a global, not-for-profit alliance that works to lower barriers to innovation in life sciences and healthcare R&D, today announced the results of a global survey of life science professionals on the impact of emerging AI regulations for pharma R&D. Just 9% of respondents said they know EU and US AI regulations well, with more than a third (35%) having no understanding at all. The survey also revealed the top three challenges preventing life science organizations from keeping up with legislation. Complexity and ambiguity of regulations was the most cited (37%), followed by too many different regulations across regions (23%), and insufficient collaboration between industry and regulatory bodies (20%). The survey was conducted as part of the Alliance’s commitment to overcome the barriers to AI adoption through collaboration, under its 2024 strategic priorities.
“From our Lab of the Future Report we know AI is top of our members’ investment agendas but our new research highlights legislation is a major barrier to adopting AI successfully. We must bridge the gap between life sciences, technology companies, vendors, and legislators to harness AI in a secure and compliant way to accelerate vital health research,” comments Dr Christian Baber, Chief Portfolio Officer of the Pistoia Alliance. “The Pistoia Alliance is perfectly placed to create a forum for discussing the ambiguity and complexity of regulations as they arise. Our Artificial Intelligence and Machine Learning Community of Experts acts as a crossroads between experts in data science, pharma, regulatory bodies and government, and has already made great strides in accelerating AI adoption in life sciences. We now encourage more technology, compliance, and pharma experts to come forwards to join the community, and express interest in our new AI initiatives.”
21% of respondents said existing regulations are blocking their research. Respondents also shared the areas they believe should be prioritized when governments are drafting new AI regulations. The top considerations were patient data privacy and security, and ethical guidelines and bias, cited by 57%. Currently, 31 countries have passed AI legislation and 13 more are debating AI laws. Most recently the EU and the US announced new legislation and an executive order respectively. The EU’s AI Act will be one of the world’s most stringent and will be particularly relevant to pharma due to the bloc’s large market size and tendency to set standards that other regions follow. The EU rules are based on AI’s potential risk and level of impact to consumers. High risk applications such as medical devices, drug manufacturing and diagnostic AI will require conformity assessments, while limited risk applications such as chatbots must be clearly labelled as AI tools.
“AI is new territory for both legislators and pharma companies that we must navigate together. Our members have raised a number of concerns regarding emerging legislation. From ambiguities surrounding risk categories, to challenges around data and AI governance, and the use of synthetic data to train future algorithms,” comments Dr Vladimir Makarov, Project Manager of the Pistoia Alliance AI and ML Community of Experts. “The Pistoia Alliance panel of experts will discuss how legal changes may affect research and allows pharma companies to get involved at the regulatory level. This research gives us a strong baseline to understand members’ current concerns, share back to the regulators, and shape our future discussions and projects.”
The Pistoia Alliance invites representatives from pharma, technology, and regulatory bodies to get involved in its AI and ML Community of Experts to further discuss evolving regulations and their impact on drug discovery and development research. It is also looking to the industry for support in funding this initiative.
This survey was conducted among 125 life science professionals during a February 2024 webinar on EU and US AI regulation and the impact on pharma R&D, run by the Pistoia Alliance.
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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 200 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.
Ontology will improve substance identification, cross-border prescriptions, regulatory process integration with manufacturers, supply-chain analytics, and pharmacovigilance
Boston, US, January 24, 2024. The Pistoia Alliance, a global not-for-profit alliance that advocates for greater collaboration in life sciences R&D, has published its Identification of Medicinal Products (IDMP) Ontology 1.0 under an open-source license. The Pistoia Alliance plans to support the implementation of IDMP-O across the pharmaceutical sector and is calling for pharma, technology companies, health authorities, and regulators to register interest in dedicated training programs on integrating IDMP-O into workflows. The ontology is already in active implementation at several companies, and was co-developed under the Alliance umbrella by 11 organizations: Bayer, Novartis, GSK, Roche, Merck KGaA, Boehringer Ingelheim, Johnson & Johnson, AstraZeneca, Amgen, AbbVie, and Pfizer. Contributing project partners also include the EDM Council, ACCURIDS, OSTHUS and Chemantics.
The common semantic data model created by the Alliance will realize the intended benefits of IDMP standardization, including improved pharmacovigilance, enabling cross-border prescriptions, and preventing medication shortages through interoperability with manufacturers. The ontology will complement existing IDMP standards set by the ISO and ensure all IDMP data is machine-readable from the point of its creation to better support the use of AI technologies across the industry.
“IDMP-O is one of the Pistoia Alliance’s flagship projects with nearly a dozen of our large member companies involved. Our ontology bridges the gap between regulators, pharma, manufacturers, and the clinical space by offering a powerful common language for the description of medicinal product information,” comments Dr Becky Upton, President of the Pistoia Alliance. “With IDMP-O, organizations can more easily comply with standards set by organizations like ISO, reduce duplicated efforts, and ensure patients are prescribed the correct medication for their needs. This project’s success has been made possible by the Alliance’s legal framework for pre-competitive collaboration, and underlines the value of the Alliance to the life sciences sector.”
IDMP standards are critical for giving healthcare providers and manufacturers trusted information about medicinal products regardless of brand names. Standardizing data on substances and drug marketing (Packaged Medicinal Product Identification) ensures medications are made to the correct specification and enables healthcare providers to more easily prescribe safe alternatives if one brand becomes unavailable. For example, a key use case is cross-border prescriptions; IDMP standards make it possible to compare drug information across different countries’ medicinal product dictionaries. This means a patient in Belgium can be sure they’re taking an equivalent drug to one they were prescribed in Germany.
“We’re excited to be supporting the creation of a robust data backbone that will help organizations to automate IDMP data management and ensure their data is FAIR (Findable, Accessible, Interoperable, Reusable),” comments Heiner Oberkampf, CEO and Co-Founder of Accurids. “Implementation of IDMP standards is complex, with a large volume and variety of medicinal data to process held by pharma companies, drug manufacturers, and regulators. But with IDMP-O, organizations can reduce the risk of errors and ensure their data is interoperable and AI-ready to get the most out of it.”
The Alliance’s Open Source IDMP Ontology is now freely available via PA’s ontology governance infrastructure provided by EDM Council and ACCURIDS. Alongside the next phase of the project, governance will be further secured by ISO Technical Specification (TS) 21405, an official methodology and framework for the development and representation of IDMP Ontology. This is co-led by project champions Sheila Elz of Bayer, and Vada Perkins of Boehringer-Ingelheim, with a publication expected in July 2025.
Organizations are invited to get in touch to find more about the opportunities to support the next stage of the project and explore workshops to help implement IDMP-O into their systems.
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About 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 200 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.
In our final newsletter of the year, we’d like to share with you some highlights from 2023 and key initiatives you can look forward to next year. Thank you for your continued support and participation in our best year ever for global events, projects and communities. Best wishes for 2024 from everybody at the Pistoia Alliance. We look forward to another great year of collaborative innovation!
A Year of Success – Collaboration Drives Innovation Take a look at the impact we have made together this year through our collaborative projects and expert communities in our Annual Report.
In 2024 we look forward to working with our new steering committees to build out our portfolio in alignment with our four core strategic priorities.
New Year, New Ideas
From realizing the potential of Digital Twins in Healthcare and developing a Clinical Data Analytics Platform to establishing a Global Substance Registration System Consortium, you can see all the latest member-led ideas and submit and new pre-competitive collaboration ideas to advance innovation by visiting our New Ideas section on our website.
Don’t forget to visit our events page to discover the many different events the Pistoia Alliance and its members are hosting. Notably we are starting our revised Diversity & Inclusion programme again in February 2024, there are still places available for this cohort so please head to our Eventbrite page where members can take advantage of a discounted option.
For more information on the Pistoia Alliance D&I course contact Anca Ciobanu
As we take a look back at all our events in 2023 we would like to send a big thank you for your continued support. As a not-for-profit membership we believe that collaboration is at the heart of everything we do, so if you would like to talk to us about an engagement opportunity or a new project that your have been considering, talk to one of our business development team, either Shaun Tamblin, Cristina Fasca, and Marc Rubenfield (if you are based in the USA)
Press Release: Member-led steering committees composed of global pharma and tech representatives will develop new project ideas to drive industry change
Boston, 14 November 2023: The Pistoia Alliance, a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D, has announced its four new strategic priorities, and has appointed steering committees to lead collaboration in these areas: Harness AI to Expedite R&D, Deliver Data-Driven Value, Sustainability Driven R&D and Accelerate Use of Real-World Data. The priorities were selected in response to the evolving needs of the life science industry amid digital transformation, climate change, and shifts in how research is conducted and healthcare is delivered post-pandemic. The Alliance consulted its members and revisited the challenges raised in its latest Lab of the Future survey. The steering committees are representative of the Pistoia Alliance’s global membership, including experts from top pharma and technology companies, and will help formulate the Alliance’s strategy and project goals.
“The life sciences industry is at an inflexion point in the face of technological innovation, global health challenges, and the emergence of new business models. The pandemic was a similar time of upheaval that proved the value of cross-industry collaboration, and researchers want this change to continue. In our recent survey, 60% of life science experts pointed to a need for collaboration or building industry best practice guides,” comments Dr Hall Gregg, Chief Portfolio Officer at the Pistoia Alliance. “Solving common issues has always been Pistoia’s mission – the time is right to realign our portfolio amid these tectonic shifts, so that we can focus on the issues that matter most to our members and industry. We now invite members to come forward to contribute to this strategy and suggest new project ideas under these four umbrellas.”
The Pistoia Alliance’s pre-competitive legal framework and established history of delivering tangible solutions for common industry barriers means it is well positioned to tackle global challenges. The new committees will build on the work the Alliance has been doing over the past 15 years and give members even more of a chance to steer the Alliance’s strategy. The priorities are:
Harness AI to Accelerate R&D – 54% of life sciences companies already use AI in the lab, and 60% plan further investment in the technology in the next two years. But there are still common barriers to AI adoption, including ethical and privacy concerns, which this group will address through initiatives such as the AI Community of Experts.
Deliver Data-Driven Value – Data is the foundation for emerging technologies like Generative AI, but the industry still struggles to manage, maintain, and share data effectively. This group aims to overcome these common challenges through projects that leverage ontologies, data enrichment, and data integration technologies.
Sustainability driven R&D – ESG has become a priority for pharma, as the industry looks to reduce its carbon footprint and increase the diversity of its workforce. This group will look at the tangible changes the industry can make in these areas, for example the Carbon Footprint for Decentralized Trials project.
Accelerate the use of Real-World Data – The rise of wearables, internet of things (IOT) devices, social media and electronic health records holds huge promise for collecting and sharing patient data and enabling them to be more involved in their care. But harnessing this data in an accurate and ethical way is new territory for the industry and must be explored together.
“External pressures are continually changing and technology is always progressing – so the Pistoia Alliance must evolve too. We designed these priorities to be ‘living and breathing’, so they can flex to the areas that will be most impactful for our members now and in the future,” comments Dr Becky Upton, President of the Pistoia Alliance. “We are confident that the new priorities will fuel even more breakthroughs. We encourage companies to come forward and support collaborative innovation through our new projects, so that we can bring new treatments to patients sooner – who are the most important stakeholders of all.”
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About 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 200 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.
