Looking at what lies ahead for the life sciences, set against a backdrop of increasing digitalisation, climate change and emerging public health challenges

By Becky Upton

The onset of the pandemic resulted in a major transformation in the way research is conducted and healthcare is delivered, with this change particularly driven by rapid adoption of digital technologies. In short, COVID-19 was a case in point that proved the value of global collaboration.

The life sciences are now at another inflection point. Technological innovation continues at pace, concerns over the impact of climate change on human well-being are growing and emerging public health challenges demand cooperative approaches. That’s why the Pistoia Alliance has set out four new strategic priorities to enable the industry to continue collaborating on important projects that will drive tangible change.

Technology once considered futuristic is now an integral part of many modern labs. One such technology at the top of the adoption curve is artificial intelligence (AI). According to our recent survey, 60% of companies intend to invest in AI and machine learning (ML) over the next two years, making it the most popular technology.

It’s no surprise companies are investing, given that we are already seeing AI fuel breakthroughs in key areas of pharmaceutical research – for example, accelerating existing workflows in small molecule discovery and lead optimisation for new drug candidates, shaving months off time-intensive processes.

However, there are common barriers holding back successful adoption of AI in R&D functions. As the industry moves from peak hype to a more realistic view of the capabilities of AI, there is a need to define clear use cases for exactly which areas of R&D AI can add value to – for example, real-life instances where companies have used AI to save time or identify new drug candidates.

There are also questions surrounding the accuracy of data being used to train algorithms and models, in addition to privacy concerns and ongoing perceptions that AI is not trustworthy or responsible. Overcoming these ethical and practical challenges requires the industry to pool its expertise and experiences, and the Pistoia Alliance’s AI Community of Experts provides a safe space for organisations to share ideas under a pre-competitive legal framework.

Underpinning the successful use of any new technology – including AI – is the need to establish a foundational data backbone. This backbone is made up of the behind-the-scenes technologies, systems and data science techniques that are critical to producing high-quality, shareable and reproducible R&D data. For example, more than half of companies are investing in cloud technologies, while 60% expect to be using Laboratory Information Management Systems (LIMS) in the next two years to digitally capture and share experiment methods and results.

Despite investment showing that organisations are committed to foundational data technologies, many still face significant data quality and management challenges. Data silos, unstructured data and lack of metadata standardisation all prevent data from moving freely through research ecosystems, leading to longer, most costly workflows.  Poor quality data also has a knock-on effect on the successful implementation of future technologies, such as generative AI and Large Language Models.

One strategy for tackling these issues is embedding the findable, accessible, interoperable, reusable (FAIR) principles into research environments. Such data standards are increasingly urgent, as many regulatory bodies seek to make it compulsory for data to be high quality and machine readable. The European Medicines Agency (EMA) has become the first agency to mandate data standards for the Identification of Medicinal Products (IDMP). IDMP standards ensure medications are produced to the correct specification, enable the safe prescription of alternative drugs and facilitate cross-border prescriptions.

To support pharma companies in IDMP compliance, the Pistoia Alliance has created a common data model in collaboration with Bayer, Novartis, GSK, Roche, Merck KGaA, Boehringer Ingelheim, Johnson & Johnson, AstraZeneca, Amgen, AbbVie and Pfizer, demonstrating how collaboration can support the automation of data management and ensure data is interoperable and AI-ready from the point of its creation.

Environmental, social and corporate governance (ESG) is becoming a priority for the life sciences industry, with growing pressure from patients, governments and regulators to reduce environmental impact and increase diversity. Legislation mandating that pharma companies modify their operations and report on environmental and social impact is due to be introduced. But knowing where to start is difficult. The industry has many moving parts, with companies spanning multiple geographies, each with their own cultures and legalities. This disparity means there is currently no standard method for measuring social or environmental impact and there is no industry benchmark that companies can aim for.

To make quantifying ESG more achievable, organisations must work together on areas where tangible change can be made. One example is the Pistoia Alliance’s Clinical Trial Environmental Impact Community, in partnership with Syneos Health and the Sustainable Health Coalition. The Community is developing a standard methodology for measuring the carbon footprint of clinical trials, so companies can quantify the impact of their trial programmes against an industry-wide standard. The Alliance is also increasing industry diversity, with its Diversity and Inclusion Leadership programme, which includes participants from Bayer, GSK, Pfizer and Takeda.

The rise of wearable and smart devices, increased use of social media and implementation of electronic health records has the potential to transform the collection and sharing of patient data. Use of these technologies exploded during the pandemic, as researchers and healthcare providers sought to minimise in-person contact. However, harnessing real-world data in an accurate and ethical way is new territory for the industry and regulatory guidance is a work in progress.

‘As the industry develops a more realistic view of AI, there is a need to define exactly which areas of R&D AI can add value to’

The industry must explore together how to leverage real-world data effectively to support patient-centric R&D.

One area of particular interest is social media. Such platforms offer a promising opportunity to listen to patients’ voices directly, capturing unfiltered, first-hand data about the patient experience in large volumes. Yet uncertainties surrounding the regulatory validity of social media data must be mitigated if companies are to unlock value from patients’ insights.

Cross-disciplinary expertise is critical for all real-world data use cases due to the overlap between data science and medical domains. The Pistoia Alliance is bringing together experts from AstraZeneca, Bayer, Biogen, Boehringer Ingelheim, Chiesi, Johnson & Johnson, EMD Serono and Roche to develop guidelines for how social media data can be incorporated into R&D successfully.

The Pistoia Alliance was founded as a not-for-profit more than 15 years ago with a mission to lower the barriers to innovation in the life sciences through pre-competitive collaboration. Core to this mission is proactively aligning with the wider issues impacting the life sciences industry and our more than 150 members, spanning multinational pharma companies, medium and small enterprises. We recognise that by working together and sharing expertise, the industry can overcome common obstacles and de-risk investments, so companies can continue delivering life-changing therapies to patients.

Through our collaborative efforts, the Pistoia Alliance is guiding the life sciences industry towards a future that is innovative, ethical and responsive to the needs of patients and the planet. External pressures are continually changing and technology is always progressing – so we must continue to evolve too. Our four priorities have been designed to be ‘living and breathing’, so that they can flex to the areas that will be the most impactful to the industry now and in the future.

Becky Upton is president of the Pistoia Alliance