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Author: Catherine Maskell

Pistoia Alliance Completes First Phase of Identification of Medicinal Product Ontology Project to Aid Compliance Ahead of EMA’s 2023 Regulation Deadline

Posted on by Catherine Maskell

Boston, US, 2 November 2022: The Pistoia Alliance, a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D, has completed the first phase of its IDMP Ontology project. The project supports companies in complying with the upcoming implementation by the European Medicines Agency (EMA) of the five IDMP standards set by the International Organization for Standardization (ISO) by developing the IDMP Ontology to enable data integration and automate processes. The Alliance – together with experts from Bayer, Novartis, Roche, Merck KGaA, GSK, Johnson & Johnson, and Boehringer Ingelheim – has developed and successfully tested on live proprietary data a minimal viable product (MVP), focused on the substance domain of the IDMP standards. The Alliance is now seeking funding and involvement from more pharma companies, publishers, software companies, and vendors for the next phase to extend the data model to further IDMP domains, including vaccines, gene-technology, and botanical substances.

“Multiple implementation requirements are imminent – the EMA is just the first health agency to mandate compliance with ISO IDMP, and other international domains are likely to follow. Yet, from discussions with our members, we know that many organizations are not yet prepared because of the scale of the data challenge. Companies must invest in their data management now to minimize compliance risks and reduce the costs and time associated with data processing,” commented Dr. Gerhard Noelken, Project Lead, Pistoia Alliance. “We are proud to announce we have delivered this first phase on time and within budget ahead of the EMA deadline and that it’s freely available to all. Our initial data model has proved valuable to our members, who are excited to keep the momentum going and move onto the next phase, expanding the ontologies to new IDMP domains.”

Currently, there is no overarching body for the governance of IDMP standards. This means the terminology to describe substances used in the regulatory, supply chain, pharmacovigilance and clinical sectors is inconsistent. There is a risk that when the new EMA implementation becomes mandatory, companies will suffer increased costs associated with manual tasks to keep up with compliance and interoperability issues. For example, the Alliance estimates it takes three months to set up a CRO collaboration without a harmonized IDMP Ontology and 40 FTE’s to gather and submit IDMP-SPOR (EMA’s Product Management Service) data.

The freely available ontology in development at the Alliance will mean the drug data involved in the R&D processes can be created, stored, and translated to an IDMP-compliant machine-readable format automatically so that researchers can refocus on innovation and the discovery of new medicines.

“The Pistoia Alliance’s legal framework, combined with its global network of life sciences and technology leaders, is perfectly positioned to drive this collaborative initiative. The project has been a huge success at the monthly community of interest meetings, where we demonstrate examples of how the project brings real-world data together,” continued Dr. Noelken. “But ontologies aren’t linear – expanding our data model to the other IDMP domains will require involvement and input from even more experts. That’s why we are calling on companies to get in touch with us so we can continue our successful work and extend the project’s benefits to even more stakeholders across the industry.”

The MVP from the first phase of the IDMP Ontology project is now available under MIT open-source licensing using the following links:

  1. Github repository with ontology files
  2. OntoViewer to browse the ontology
  3. Project wiki with release documentation
  4. Demo instance with IDMP Ontology aligned public data

If you are interested in participating in or helping fund the project’s next phase, please email ProjectInquiries@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.

Media Contact:
Spark Communications
+44 207 436 0420
pistoiaalliance@sparkcomms.co.uk

Tanya Randall
Global Communication & Public Relations Lead, Pistoia Alliance
+44 7887 811332
tanya.randall@pistoiaalliance.org

Pistoia Alliance Launches Global Community of Interest to Assess the Environmental Impact of Clinical Trials

Posted on by Catherine Maskell

Boston, US, 11 October 2022: The Pistoia Alliance, a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D, has announced the launch of the Clinical Trials Environmental Impact Community of Interest (CoI) to measure and compare the carbon footprint of centralized (traditional site-based) and decentralized clinical trials. The initiative was started by Pistoia Alliance member, Syneos Health, which submitted it to the Alliance for further development. The new CoI also works closely with member organization, the Sustainable Health Coalition (SHC) in support of its work with the Sustainable Markets Initiative (SMI). The Pistoia Alliance and the SHC will further align with the SMI as its efforts in this space develop.

In phase one, the Community of Interest is working to collectively agree on the parameters and variables that will be measured. The second phase will see it develop a methodology for calculating the carbon footprint of both trial models. This methodology will be published as a publicly available tool to deliver a cross-industry standard for quantifying the carbon impact of a trial. The CoI currently has 25 members spanning Japan, US, and Europe, including the top 10 pharma companies, CROs, and academic representatives.

“Syneos Health is committed to delivering on our environmental goals and finding ways to make clinical development activities more sustainable,” said Noolie Gregory, Vice President, Decentralized Solutions for Syneos Health. “The Pistoia Alliance offers us a unique, collaborative space to make this happen. Through this initiative, we can drive toward a tangible outcome that will make a material improvement in how we assess the carbon impact of trials and make recommendations for the reduction of this footprint. We are looking forward to working with our peers and colleagues to share our knowledge.”

There is growing pressure from patients, governments, healthcare payers, and providers to reduce the environmental impact of the life sciences. In the future, it can be expected there will be legislation that will necessitate pharma and research companies to adjust their behaviors and develop new ways to measure and report on the environmental impact of their operations. To prepare for this change, the Alliance believes that companies working together on assessing the impact of trials is a key starting point. Clinical trials are complex and have many moving parts – typically spanning multiple geographies, jurisdictions, and hundreds of different sites. To create a robust and accurate methodology that benefits the industry will require a broad mix of experts and opinions from both the life sciences and sustainability fields.

“Shared frameworks have to be created to allow individuals and companies to be efficient and effective in quantifying the impact of their own clinical trials against an industry-wide standard,” commented Dr. Bert Hartog, Senior Director of Clinical Innovation at Janssen. “At Janssen, we are always looking for ways to reduce our impact on the environment whilst continuing to innovate and produce life-changing therapies. We are very keen to get involved in collaborative projects such as the new Pistoia Alliance COI because we recognize that they are the best way to make lasting change happen in our industry.”

“Decentralized trials reduce the burden on the patient and ensure trials are far more patient-centric. Whilst quantifying money and time saved is relatively straightforward, accurately measuring the carbon saving requires a more detailed approach to produce a standard that can be used by all stakeholders – from sponsors to CROs to technology vendors,” commented Thierry Escudier, Strategic Leader for Empowering the Patient at Pistoia Alliance. “There’s lots of great work being done in the industry, and the Alliance hopes to work alongside these other groups. The scale and complexity of the issue make it perfectly placed for the Alliance to tackle – it’s multidisciplinary, global, and industry-wide. We are now calling for all those interested – including research organizations, investigators, pharma companies, and patient groups – to get involved.”
The Pistoia Alliance is seeking experts in sustainability, clinical development, and other relevant fields to join the Community of Interest. Individuals and organizations interested in the initiative should email Thierry Escudier at ProjectInquiries@PistoiaAlliance.org. For more information on the Pistoia Alliance, visit https://www.pistoiaalliance.org/.

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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.

Media Contact:
Spark Communications
+44 207 436 0420
pistoiaalliance@sparkcomms.co.uk

Tanya Randall
Global Communication & Public Relations Lead, Pistoia Alliance
+44 7887 811332
tanya.randall@pistoiaalliance.org

Pistoia Alliance and FDA Collaborate to Establish In Vitro Pharmacology Working Group to Accelerate Regulatory Submissions

Posted on by Catherine Maskell

Boston, US, September 13, 2022: The Pistoia Alliance a global not-for-profit that advocates for greater collaboration in life sciences R&D, has today announced the creation of a new In Vitro Pharmacology Working Group. The group will include liaisons from the US Food and Drug Administration’s Center for Drug Evaluation and Research, as well as representatives from biopharmaceutical companies, contract research organizations (CROs), technology suppliers, and regulatory agencies. The mission of the group is to improve the data structures and standards for in vitro pharmacology (IVP) data in regulatory submissions, to enable faster reviews and interpretations of submissions, and ensure new therapies reach patients as quickly as possible.

The working group will create a shared data structure based on FAIR principles to ensure data consistency in IVP screening across all stakeholders. Companies carry out extensive IVP screening throughout the drug discovery process to support Investigational New Drug Applications (IND) that are submitted to the FDA, which then assesses the drug candidate’s safety before a candidate moves to the next stage of development and into clinical testing. The current lack of consistent standards around data input, reporting, and submission is a common challenge that causes significant inconsistencies in regulatory submissions and limits the accessibility and interoperability of the data.

“The aim of everyone involved in the drug development ecosystem is to get the most safe and efficacious therapies to patients in the shortest possible time. By working collaboratively, biopharmaceutical companies, CROs, technology suppliers, and regulatory agencies can accelerate the timeline by standardizing how IVP data is reported. Working together also reduces the cost and time burden of individually developing solutions to a shared problem,” commented Veronique Francois, Project Manager, Pistoia Alliance. “The Alliance’s experience in bringing together experts to solve common challenges, alongside our formal framework for collaboration, empowers members to cooperate on initiatives that are driving change at the highest levels. We are keen to hear from both members and non-members interested in contributing to this collaborative community of interest and encourage them to get in touch.”

The data template that the IVP working group develops will include detailed and standardized descriptions of in vitro methodologies used for investigational drug safety characterization, alongside a repository of annotated in vitro assay methods. The data structure will utilize new or existing ontologies for the description of common assays to provide greater consistency in regulatory submissions. By employing a common standard, data outputs will also be computer readable. This safeguards the provenance of data and provides a secure audit trail, as well as enabling more effective data analysis to support better decision-making.

The Pistoia Alliance is calling on members and non-members– including biopharmaceutical companies, CROs, technology and solution providers, and electronic laboratory notebook (ELN) developers – who are interested in contributing to help establish new standards to get involved. Any interested party should contact the Pistoia Alliance via: ProjectInquiries@PistoiaAlliance.org.

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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.

Media Contact:
Spark Communications
+44 207 436 0420
pistoiaalliance@sparkcomms.co.uk

Tanya Randall
Communication & Public Relations Lead, Pistoia Alliance
+44 7887 811332
tanya.randall@pistoiaalliance.org

Pistoia Alliance’s SEED Project Takes Root, Seeks Funds in Phase 3

Posted on by Catherine Maskell

The Pistoia Alliance’s Semantic Enrichment of ELN Data (SEED) project is moving forward, to enter an exciting new third phase. The SEED project addresses the challenge facing R&D from the vast volumes of captured experimental data locked in Electronic Lab Notebooks (ELNs). It is still common for scientific research to be recorded in an unstructured text format (non-machine-readable format) with inconsistent context (vocabularies), which vastly reduces the potential for direct intelligent analysis. These unusable and unsearchable data entries have been a significant barrier, resulting in duplicated experiments and vast amounts of time spent tracking down and extracting data.

 

Project Champion Steve Penn, Director, Medicinal Sciences Information Strategy Lead at Pfizer, said the SEED project is important to the pharma and life sciences industries because it helps accelerate digital transformation. When project member companies collaborate on data standards and ontologies together, improvements to the common data infrastructure create richly annotated and structured data. This, subsequently, is a precursor to project member data being unambiguously interpreted and used throughout the drug development lifecycle.

 

The project contributors include Pfizer, AstraZeneca, Bristol Myers Squibb, Scibite, Bayer, Biogen, Southampton University, GSK, CDD, Elsevier, Linguamatics, Merck, Sanofi, and Takeda.

 

Pistoia Alliance member Sanofi is already realizing value from the project and plans to align its ADME assay metadata with the new ontology classes added by the SEED project to BAO. This will make Sanofi’s assay data compliant with the FAIR principles.

 

“Phase 3 will build on the success of phase 2, by agreeing upon a high-level experimental data schema, establishing a consistent top-down framework for building all experiment ontologies,” Penn said. “The goal is to make semantically rich data linked to a backlog of priority domains across industry members.”

 

Phase 2 offered additional data in the form of attributes, mappings, and annotations to create relationships between ontology classes to help to describe and define them. Delivery was centered around the ADME, Pharmacology, and Drug safety Domains, Penn said.

 

The first phase delivered publicly available ADME and Pharmacology assay ontology (industry-standard in BAO). The ontology work for ADME and PD assays mapping incorporated the hierarchical taxonomy in addition to integrating synonyms and mappings to CDISC SEND Study type (SSTYP) and eCTD M4. Following the ontology development was a working prototype of an agnostic solution for semantic enrichment of unstructured data within an eLN using the ontologies developed (thanks to Scilligence and Scibite for this collaborative effort). This solution unlocked the data’s value for future analysis, aligning with the FAIR principles.

 

SEED is an excellent example of the benefits Pistoia Alliance members can gain through collaboration, Penn said. “Before, enhancements on the data standards and ontologies were being developed individually, and eLN companies received numerous overlapping requirements across pharma,” he said. “Now, co-development of data standards, ontologies, and strategies is having significant positive impacts and leaning towards influencing eLN providers roadmaps. The Pistoia Alliance continues to be the fulcrum for this delivery.”

 

Penn is calling on Pistoia Alliance member companies to join this exciting new phase of the SEED project, to bring ideas, funding, and user stories to the table as new participants. “With relatively small investments across industry members we can make huge collaborative strides on the data standards and common data infrastructure to the greater benefit of the drug development lifecycle,” Penn said.

 

To find out more about the SEED project, email Project Manager Gabrielle Whittick via ProjectInquiry@PistoiaAlliance.org.