Survey of life science experts found 43% of companies plan to implement IDMP Ontology this year
The Pistoia Alliance has launched a new industry benchmark report: Accelerating Digital Transformation in Pharma with IDMP. The report examines the status of the implementation of Identification of Medicinal Products (IDMP) standards in global pharma and the role of the IDMP Ontology in accelerating digital transformation.
The European Medicines Agency (EMA) continues to advance the implementation of IDMP standards, a regulatory framework that will become mandatory across the EU, with the FDA likely to follow close behind. Failure to implement IDMP could lead to a number of risks including regulatory penalties, inefficiencies in operations and threats to patient safety.
Key findings from the report:
43% of companies said they plan to implement IDMP Ontology this year
89% of companies recognize the long-term value of IDMP beyond compliance
Pharmacovigilance is no longer seen as key to the success of IDMP even though it was its original purpose
The survey was conducted by the Pistoia Alliance, ACCURIDS and MAIN5 and supported by the award-winning IDMP Ontology project with participants from Abbvie, Amgen, AstraZeneca, Boehringer Ingelheim, Bayer and Novartis.
The Pistoia Alliance continues to run the IDMP Training program, designed to equip organizations with a comprehensive understanding of how the IDMP Ontology addresses complex challenges inherent in the IDMP domain. Attendees will gain insight into the ontology’s structure and how it can be used to streamline processes, enhance data interoperability, and ensure regulatory compliance.
A collaboration from Pistoia Alliance and ZS Associates
Collaborative white paper highlights misaligned incentives in R&D are holding back full human data integration and better patient outcomes
The Pistoia Alliance and ZS have launched a new white paper: “Are misaligned incentives preventing better patient outcomes in life sciences R&D? The hidden barrier to full human data integration.”
This joint research initiative brings together insights from 25 industry leaders including sponsors, regulators, patient advocates, healthcare providers, and health systems. It explores what it would truly take to create a future where near-real-time integration of human health data fuels R&D innovation, and identifies the key opportunities and challenges that currently stand in the way of achieving this vision.
Despite advances in data collection, wearables and mobile apps, analytics, AI and machine learning, as well as an increasing openness to grassroots cross-industry collaboration, interviewees expressed repeatedly that the technical challenges of integrating comprehensive health data are less daunting than the human and organizational ones, namely: misaligned incentives that discourage stakeholders from across the research,development and clinical continuum from making this integration possible.
The white paper highlights how misaligned incentives are hampering data sharing withing life sciences organizations, across different life sciences organizations and across healthcare systems and provides recommendations for fixing the underlying problems that can be solved if the industry works together and takes action now to break down siloes, share data and align around shared goals.
The Pistoia Alliance and ZS are calling for organizations ready to help move the industry forward to get in touch and to bring project ideas or opportunities for collaboration to help solve the challenges surfaced in this paper.
For further information and to get involved please email: timeforchange@pistoiaalliance.org
With the support from our sponsors and members, we have been able to create one of the largest conferences in the Pistoia Alliance’s history. Each sponsor has brought something new to the day, with the view to sharing their latest developments within the wider Pharma community. Amino was established in 2021 in response to the growing need we saw for a specialist data consultancy focused on the foundational aspects of data management. It’s well-known that organisations are increasingly looking to exploit the data they hold to grow their businesses or deliver new products and services to their customers or citizens. These organisations are now recognising that their ability to do this is highly dependent on their underlying data. Amino provides an advisory and delivery consultancy capability to enable organisations to establish the firm data foundations which are essential for exploitation of data at scale in large organisations.
We work with some of the world’s largest organisations that are driving significant change in their markets through their use of data in sectors such as pharmaceuticals, aerospace & defence, and retail.
Our overarching proposition is to “be a clear voice in a world of complex data”; we work in partnership with our clients to give them the clarity to make informed strategic decisions, and to support them in the execution of their data strategies. We support them on their data journey and have a clear focus on enabling them to develop their in-house data capabilities. We aspire to be easy to do business with, trusted for quality of delivery, as well as being recognised as a great place to work.
Amino was formed during the Covid-19 pandemic and was an entirely virtual organisation for the first two years of our existence. In 2023 we opened our first office on Threadneedle Street in London. We have now also opened an office in the GoCo Health Innovation City in Sweden and have a US business that operates from North Carolina.
Conducting a robust scientific knowledge review is a time-consuming endeavour, often stretching over weeks and requiring the concerted effort of multiple experts. The culmination of this process is a carefully triaged collection of articles, each requiring meticulous manual review to extract pertinent data. Consequently, this rigorous selection process tends to focus solely on articles with direct relevance, inadvertently overlooking a vast array of potentially insightful, albeit seemingly unrelated, literature. Such oversight may result in missing key pieces of information crucial for elucidating the signalling pathways and mechanisms of interest.
In response to these challenges, Biorelate has developed an innovative approach that leverages proprietary NLP technologies to automatically identify cause-and-effect relationships among key entities (such as drugs, genes, biological processes, and diseases). By synthesising and summarising directed pathways of cause-and-effect from millions of articles, Biorelate’s method offers a streamlined process for exploring the mechanisms of action. This not only drastically reduces the time required for such searches—from weeks to mere moments—but also provides instantly accessible summaries, complete with precise references. These summaries can be directly incorporated into scientific reports, bolstering ongoing research with robust, evidence-based insights.
Galactic AI™ is the powerhouse behind Biorelate’s suite of products and services, representing the pinnacle of data curation technology in the biopharmaceutical sector. This cloud-based supercomputing platform integrates state-of-the-art technologies, including Natural Language Processing (NLP), Artificial Intelligence (AI), and Large Language Models (LLMs), to deliver unparalleled data curation capabilities.Galactic AI™ revolutionises the way research questions are answered by illuminating the complex cause-and-effect relationships among genes, diseases, drugs, and various biological entities buried within the vast expanse of biomedical literature, alongside other more common research intelligence techniques. By leveraging the power of Galactic AI™, researchers can accelerate the pace of discovery and innovation in the biomedical field, leading to breakthroughs in understanding, preventing, and treating diseases.
CAS Custom Services partners with you to identify and solve your scientific information challenges, delivering unique solutions that help you accelerate informed decision-making, mitigate risk, and uncover insights that drive success. As the leading innovator in scientific data management, search, and retrieval, we are uniquely qualified to help you meet your scientific information needs. We leverage our high-quality content, specialized expertise, and proprietary technologies in new ways to creatively solve your most difficult data problems, delivering solutions that help you navigate today’s complex data landscape and reveal the unseen connections that spark innovation. Learn more at https://www.cas.org/solutions/cas-custom-services.
Collaborative Drug Discovery (CDD) provides an intuitive software suite extensively used by creative biologists and chemists working in academic, biotechnology and pharmaceutical settings. Their flagship product, CDD Vault, enables researchers to intuitively organize and analyze both biological and chemical data, and to collaborate with partners through a straightforward web interface. CDD Vault helps scientists register entities, track inventory, manage bioassay data, capture experiments, calculate Structure-Activity Relationships (SAR), and mine their data for drug candidates. It also functions as an Electronic Laboratory Notebook (ELN) to capture and share experimental results. CDD Vault is differentiated through its intuitive design, superior performance, and workflows for secure, collaborative data sharing capabilities. CDD was founded in 2004 and presently serves thousands of researchers doing drug discovery all around the world. Learn more at www.collaborativedrug.com
At Crown Point Technologies, we are more than just a service provider; we are your strategic partner in navigating the complex intersection of technology, data, and innovation. With a strong focus on Life Sciences, Manufacturing, and Government sectors, our seasoned team of professionals brings decades of experience to the table. We specialize in creating tailored and seamlessly integrated technology solutions that empower organizations to thrive in the digital age.
Our core competencies are foundational to providing cutting-edge digital solutions: Software Engineering and Architecture: Modern data platforms, cloud technologies, and software engineering techniques support robust and scalable solutions. Semantic Technologies: Demonstrated expertise in ontology design, knowledge graph implementation, and semantic data modeling drive data-first principles. Data Science: Leveraging cutting-edge artificial intelligence and machine learning, we drive actionable insights through natural language processing, analytics, and Generative AI.
At Crown Point, we believe in shaping the future. Our commitment extends beyond mere technology implementation; it’s about revolutionizing the life science landscape. Through our partnership with the Pistoia Alliance, we aim to streamline drug discovery and manufacturing, enhance clinical trial operations, and ensure compliance with evolving regulations.
Our vision is clear: to empower organizations with the tools they need to accelerate innovation, improve patient outcomes, and drive sustainable growth within the life sciences sector. Reach out to us at contact@crownpoint.tech to learn more.
Digital Science is a technology company working to make research more efficient. We invest in, nurture and support innovative businesses and technologies that make all parts of the research process more open and effective. We believe that together, we can help researchers make a difference. Visit www.digital-science.com.
Life sciences R&D organizations require access to data and analytics solutions, often curated from a vast information ecosystem, to compete in a rapidly evolving landscape that encompasses advances in scientific research, global regulatory patterns, market trends, and supply chain dynamics.
Elsevier Innovation Intelligence for Pharma offers scientific intelligence solutions that help accelerate informed risk and development decisions, which enable you to shape healthier futures.
The Elsevier Innovation Intelligence for Life Sciences portfolio provides a variety of intelligent R&D solutions, including:
Reliable, authoritative, and relevant data in an array of formats
Semantic technology that enables the integration of heterogenous datasets for superlative digital transformation
Domain experts with experience and a thorough understanding of complex life sciences data
Even today Early R&D, Precision Diagnostics and Translational Biomarker teams spend about 80% of their time wrangling data. Elucidata’s mission is to empower scientists in the life sciences field by reclaiming every valuable hour for their research endeavors.
Elucidata’s data harmonization platform – Polly, helps research teams make multi-modal biomedical data Machine Learning ready. Each dataset on Polly is processed consistently using pipelines of your choice, is custom curated with granular annotations and undergoes robust QA/QC checks to ensure highest data quality standards.Polly transforms multi-modal and multi-source biomedical data (Omics, Assay, Real World Data, Clinical & EHR Data, and CRO data) into a Unified Data Model. With our 10X faster LLM-powered curation and human-in-the-loop model to achieve 99.99% accuracy, we are fast-tracking time to analysis. Today, Polly is facilitating use case like patient stratification, biomarker discovery, target ID & validation, data management, and development of clinical and commercial pipelines across Pfizer, Janssen Pharmaceuticals, NextGen Jane and IMBDx and over 35 premier biopharma companies and research labs.
Head-quarted in San Francisco, we are a 120+ multi-disciplinary team of experts based across the US and India. In September 2022, we raised $16 million in our Series A round led by Eight Roads and F-Prime along with our existing investors Hyperplane and IvyCap.
Odysseus Data Services (Odysseus) is a market leader in enabling standardized Real-World Evidence (RWE) data analytics at scale. Odysseus offers full stack RWE services and solutions, including RWD data harmonization into OMOP, healthcare ontology curation, RWE data analytics and data network platforms (Prometheus), RWE software engineering and BI, and data analytics service. Odysseus is an active OHDSI open science community thought leader and contributor, including in the design and development of the OMOP CDM standard, standard OMOP Vocabularies as well as open-source data analytics tools (ATLAS) and methods.
RockStep Solutions is modernizing in vivo research. We collaborate with leading life science organizations to redefine digital landscapes and equip in vivo scientists with the cutting-edge cloud-based software to accelerate scientific breakthroughs, while positioning them for a data centric future.
Who We Are:Our journey began in Bar Harbor, Maine, over a decade ago. Fueled by grants from the National Institutes of Health (NIH), we set out to transform laboratory workflows. Today, we stand as pioneers in cloud informatics, bringing better technology to scientists to help them accelerate getting new medicines to those in need.
What We Do: At RockStep, we specialize in managing in vivo research operations and data. Our flagship product, Climb™, is a proven, cloud-native software solution that streamlines in vivo workflows, facilitates efficient collaboration across stakeholders from vivarium managers to veterinarians to study directors, and ensures robust, high-quality study data for reuse downstream in drug discovery and development.
Climb: Revolutionizing in vivo Research Workflows
Comprehensive: Climb allows companies to manage studies, animal health, animal colonies, and research data through one comprehensive solution. No more fragmented systems.
Seamless Integration: Climb seamlessly integrates into the lab tech ecosystem, enabling companies to keep up with the fast pace and high throughput requirements of the biopharma industry.
User Centric Design: Developed by scientists, Climb modernizes in vivo research practices. It harnesses the value of preclinical study data while providing a reliable and secure tech framework to enable FAIR data and power AI in vivo models.
Trusted by Industry Leaders: From the largest global biopharma companies to mid-sized firms, emerging startups to global CROs, RockStep Solutions Climb accelerates in vivo research programs regardless of study type or complexity.
TopQuadrant’s TopBraid EDG is the preeminent knowledge graph creation and curation tool, and the only provider that has the functionality needed for enterprise-scale semantics. With EDG you can manage metadata to enhance access to all relevant information and use it more intelligently by Creating flexible knowledge graphs that ensure data consistency and integrity, Validating, ingesting, mapping, cleaning, and normalizing metadata from most sources, Enriching metadata with auto-tagging, auto-classification and more, Governing data collaboratively to improve the quality and consistency of data using a full suite of workflow features, Exploring the knowledge graph with powerful query, visualization and analysis tools and Integrating with SPARQL or GraphQL endpoints, APIs and more to feed downstream systems.
Zifo is a global specialist enterprise scientific and process informatics service and solution provider working across research, development, manufacturing and clinical domains with expertise in over 90 partner technologies and platforms. We serve customers from pharma/biotech/CRO, industrial chemicals and food & beverage, fast-moving consumer goods, and oil and gas. Our “Glocal” approach leverages remote delivery to ensure cost-effective delivery and solutions coupled with dedicated local support to ensure engagement, success and quality.
ZS is a management consulting and technology firm focused on transforming global healthcare and beyond. We leverage our leading-edge analytics, plus the power of data, science and products, to help our clients make more intelligent decisions, deliver innovative solutions and improve outcomes for all. Founded in 1983, ZS has more than 12,000 employees in 35 offices worldwide. To learn more, visit https://www.zs.com/or follow us on Twitter and LinkedIn.
The Digital Accessibility Starter Guide is a succinct one-page compilation of digital accessibility heuristics designed to guide interface reviews. While it is not comprehensive documentation, nor is it a substitute for a thorough audit, it can facilitate the early and consistent integration of digital accessibility considerations into the product and project roadmaps.
WHY IS IT IMPORTANT?
As UX practitioners in the life sciences, we are tasked with evaluating the usability of domain-specific digital platforms, websites, and applications, including those intended for the general public. In addition to reviewing interfaces against usability heuristics, there is a valuable opportunity to assess accessibility. Existing accessibility documentation, often technical and extensive, may blur the line between design and development, making it difficult to integrate accessibility considerations into heuristic reviews seamlessly. Introducing digital accessibility too late in the process can result in increased development costs and resource expenditure. The Digital Accessibility Starter Guide aims to embed a digital accessibility perspective into user interface evaluations early and often, by providing a set of relevant and actionable heuristics.
WHO IS IT FOR?
The Digital Accessibility Starter Guide is designed for a wide range of professionals involved in UX, whether directly or indirectly. This includes UX researchers, UX/UI designers, UX managers, UX strategists, digital product designers, product owners, among others, who design or evaluate interactive interfaces.
HOW WAS IT DEVELOPED?
The author engaged in a structured iterative research and design process, depicted in a high-level journey map.
The process unfolded as follows:
– Research: After defining the scope to target design reviews and common scenarios, the author examined various resources for accessibility checklists, such as A11Y-101, A11Y Project, IBM Equal Access Toolkit, Web.dev, and AstraZeneca’s internal accessibility documentation. This review continued until common concepts began to emerge. These concepts were then distilled according to the predefined scope and organized into eight categories, with synthesized content for each. Relevant references to these concepts in WCAG2.1AA were identified, but not included in this guide for the sake of brevity.
– Design: Design sprints were conducted with digital accessibility colleagues to refine the heuristics, culminating in the creation of the one-page Digital Accessibility Starter Guide.
– Test: The guide was shared with the internal UX team for feedback, applied to multiple projects and intern training. It proved effective in highlighting digital accessibility issues to project stakeholders, in addition to usability issues, and served as an educational resource.
WHAT NOW?
The Digital Accessibility Starter Guide is currently being shared with a broader audience, and we are open to feedback and use-case discussions. If you have insights or experiences to share, please feel free to contact the author.
Special thanks to Yuliya Podlesny and Katherine Wahl for their digital accessibility expertise and the AstraZeneca Global UX team for providing feedback.
Innovative projects will tackle social media “listening,” AI ethics and security, measuring the carbon footprint of clinical trials, and publishing industry-specific ontologies for R&D
Boston, 10th January 2024: The Pistoia Alliance, a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D, has appointed Dr Christian Baber as its new Chief Portfolio Officer. Dr Baber brings 30 years’ industry expertise, including experience of leading both R&D and technology divisions for global pharmaceutical organizations focused on informatics and predictive modelling for drug discovery. Dr Baber has worked with the Pistoia Alliance for more than 15 years, including four years as a board director. His varied background working with startups up to large pharma – including Neurocrine, Shire, Takeda, and Janssen –equips him to effectively represent and support the diverse members of the Pistoia Alliance.
As Chief Portfolio Officer, Dr Baber will oversee the progression of the current portfolio of projects and communities, ensuring they continue to deliver tangible outcomes that drive industry change and better outcomes for patients. He will also support the development of new projects, aligning the Alliance’s portfolio to its recently announced 2024 strategic priorities, which were designed to meet the evolving needs of members and demands from regulatory and Government agencies. The four priorities are: Harnessing AI to Expedite R&D, Delivering Data-Driven Value, Sustainability Driven R&D, and Accelerating Use of Real-World Data.
“There is no other pre-competitive collaboration organization that provides as much value as the Pistoia Alliance. It puts everyone you need to make change in one room together. From pharma and biotech to vendors and regulators – its breadth and reach is unmatched,” comments Dr Baber, Chief Portfolio Officer of the Pistoia Alliance. “My guiding principle as Chief Portfolio Officer will be to work with our members and demonstrate what the Alliance is able to achieve for them based on pressing needs within the community. Whether that’s helping to improve the sustainability of their operations or tackling the ethics of emerging technologies such as AI. I’m also keen to build on our relationships with global regulatory agencies and to collaborate closely with them on these issues as we develop new projects together.”
2024 will see the Pistoia Alliance launch several new projects relevant to members’ and regulators’ focuses, including a domain-specific Large Language Model project and an AI ethics and security framework, both currently in incubation phases. The Alliance is also working on four collaboratively designed ontologies: Clinical Operations, Process Chemistry, IDMP Ontology, and a general pharma ontology, to improve data interoperability and reduce data errors. The Alliance’s Carbon Footprint of Decentralized Clinical Trials project is expected to move into the next phase of data collection, while its Social Media Listening Real-World Evidence project plans to publish a framework outlining standards for data collection. It also has active communities in areas including Data Governance, AI and Machine Learning, User Experience and Lab of the Future.
“We are pleased to have agencies approaching the Alliance to co-develop new regulations and industry guidelines. It underlines the Alliance’s reputation for being a trusted and representative voice for the industry. This year, and in response to members’ needs, we will focus on making regulatory collaboration even more core to the Alliance’s work,” comments Dr Becky Upton, President of the Pistoia Alliance. “We were founded on the principle that breakthroughs in science and technology are not made alone. With our new strategic priorities, and by bringing Dr Baber onboard to lead our strategic priorities and portfolio, our commitment to working together for the industry’s benefit is stronger than ever.” Organizations looking to find out how they can get involved in the Pistoia Alliance, fund projects or provide expertise can join an introductory webinar on January 17th, 2024.
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.
