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.

Media Contacts:

Spark Communications

+44 207 436 0420

pistoiaalliance@sparkcomms.co.uk

Tanya Randall

The Pistoia Alliance

+44 7887 811332

tanya.randall@pistoiaalliance.org

Craig Sender

CCC

+1 917 626 7152

Csender@copyright.com

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 24^th 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 24^th 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.

Sponsors so far…

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.

—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 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.

Media Contacts:

Spark Communications

+44 207 436 0420

pistoiaalliance@sparkcomms.co.uk

Tanya Randall

The Pistoia Alliance

+44 7887 811332

tanya.randall@pistoiaalliance.org

Emerging Regulations of Ai – The Impact of Pharma R&D by Catherine Maskell & Tanya Randall

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.

–ENDS–

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.

Celebrating Collaboration in Life Sciences R&D

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.

Up & Coming Events & Training 

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)

Introducing our 2023 Roundup video…

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.”

–ENDS—

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.

Media Contacts:

Spark Communications

+44 207 436 0420

pistoiaalliance@sparkcomms.co.uk

Tanya Randall

The Pistoia Alliance

+44 7887 811332

tanya.randall@pistoiaalliance.org