Experts from Chan Zuckerberg Initiative, FDA, AbbVie, Elsevier, Penn Medicine, Takeda and others discuss patient-centricity, data standards, and copyright

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.

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.