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Author: Catherine Maskell

August 2023 Round-Up

Posted on by Catherine Maskell
Register for our NEW Ontology Training Program
Starting September 13, 2023We are delighted to be launching a training program designed to demystify ontologies for life science leaders. Beginning on September 13th, we will be running five bi-weekly webinars that will draw on use cases and best practices as well as a half-day in-person workshop at our Boston conference on November 14, 2023.Register hereAgenda announced for our Boston conference,
November 14-15, 2023Join us at our annual Boston Conference – “Collaborate. Innovate. Educate.” – where we will be shining the spotlight on how we can collaborate to accelerate the use of AI, Real-World Data and Real-World Evidence, and drive value from data. Our agenda features an exciting program of plenary presentations, panel discussions, themed break-out groups, poster presentations and networking activities.Register hereTo find out more about our last remaining sponsorship opportunities contact Event Lead  zahid.tharia@pistoiaalliance.org.Last change to take part in our Lab of the Future SurveyHave your say on the key technologies and skills that will be needed to develop the lab of the future in our global survey we are conducting with the Lab of the Future Congress. If you can spare 5 minutes, please can you complete our survey here. We will be launching the findings at Lab of the Future Europe, September 26-27, 2023.
Lab Of The Future Survey
Project & Community Developments + New Ideas
Ontology “Request for Proposal” released by the Pistoia AllianceBuilding on the success of the IDMP-Ontology, the Pistoia Alliance plans to initiate additional ontology projects supporting Clinical Operations and Batch Process Chemistry in Pharmaceutical Research and Development.These projects will start with a six-month (approximate duration) minimal viable product phase. Resources required to support these projects include ontology engineers and business process analysts to work with pharmaceutical industry experts to describe business processes and identify use cases that will be used to test the new ontologies and document the value and process improvement achieved through a semantic approach.Interested semantic technology companies are invited to get in touch via: comms@pistoiaalliance.orgExploiting Real-World Data From Social Media in Patient-Focused Drug DevelopmentWith the need to diversify the source of real-world data for regulatory purposes, the Pistoia Alliance and a few of its members set up a Community of Experts to evaluate interest in using social media for patient listening. Having identified that there is a clear need to define guidelines and best practices, the Pistoia Alliance is now launching a project that will evaluate regulators’ expectations, patients’ acceptance, data collection and analysis challenges. If you are interested in joining this new project, please contact thierry.escudier@pistoiaalliance.org.Lab of the Future CommunityWe are looking for speakers for our Lab of the Future Community meetings and webinars. Our community provides a platform to exchange ideas and best practices to develop the lab of the future. If you or your company have an interesting story to share, we would love to hear from you.
Please submit a short synopsis here.
If any of these new initiatives spark your interest or you have a new idea for a pre-competitive collaboration project get in touch.
   
Email New Pre-Competitive Ideas
   
Up & Coming Events
Don’t forget to visit our events page to discover the many different events the Pistoia Alliance and its members are hosting.Japanese edition:  Is your data FAIR(ENOUGH) Benchmark at AstraZeneca – Japanese Edition
August 24, 2023, 0800 BST
RegisterLab of the Future Webinar
September 13, 2023, 13.00 BST
RegisterLab of the Future Europe Congress – September 26 – 27, 2023
As a long-term partner and sponsor we look forward to speaking at the European Congress. You can also join us at the Pistoia Alliance pre-registration drinks on the evening of September 25
Register
UX for Life Sciences Conference 
Join us for our one day conference dedicated to UX in life sciences at GSK in Stevenage, Hertfordshire. Key themes include AI and UX, Accessibility, Augmented or Extended Reality (AR/XR) Design and Designing at Scale.
October 10, 08.30am BST
RegisterLab of the Future Panel Debate
October 18, 13.00 BST:
RegisterPistoia Alliance Members Conference –
Collaborate. Innovate. Educate.
November 14/15, 13.00 BST
Register
*Please note, all events listed on the website are displayed in your local time zone.
Get To Know The Pistoia AllianceThere has never been a more important time to collaborate to innovate as an industry and our projects and communities are a great example of this. If you would like to find out more about the benefits of Pistoia Alliance membership and how you can get involved with all the different projects and communities we run, please register for our open session on September 6th, 2023, 15.00 BST.
Register For – Get To Know The Pistoia Alliance Webinar
   
Membership CornerCatch up on these trending topics and more in our Knowledge Libraries:Enterprise Named Entity Realizing the Promise of Foundation Models in HealthcareRecognition (NER) and Linking with KAZU – A Deep Dive The Application of Large Language Models in Life Science R&D 

July 2023 Round-Up

Posted on by Catherine Maskell
Keynote announced for our Boston Conference,
November 14 & 15 2023We are delighted to announce that Enoch Huang, Vice President, Machine Learning and Computational Sciences, Pfizer will be giving a keynote presentation on Applying AI/ML to Bring Transformative Medicines to Patients. The adoption of AI, Real-World Data and Real-World Evidence will be a key focus of our Boston conference. Our speakers will include Tom Plasterer, Data Strategy Lead, Oncology Translational Medicine, AstraZeneca; Julia Fox, Director, Data & Analytics, Takeda; and John Overington, Chief Data Officer, Exscientia.Register hereThanks go to our sponsors Elucidata, Biovia, Benchling, Elsevier, ChemAxon, Tetrascience, Accenture, CAS and Rancho Biosciences. To find out more about our last remaining sponsorship opportunities contact Event Lead zahid.tharia@pistoiaalliance.org .Take part in our Lab of the Future SurveyCan you spare 5 minutes to help with our Lab of the Future Survey? We are conducting a study into the adoption of emerging technologies and the skills that will be needed to enable innovation and collaboration in the lab of the future and will be launching the findings at Lab of the Future Europe. All participants will receive a copy of the report.
Lab Of The Future Survey
New Ontology Training Program starts September 2023The Pistoia Alliance is a running a new training program to demystify ontologies for life science leaders. Starting on September 13th it comprises of five bi-weekly webinars and a half-day workshop at our Boston conference on November 14th and is focused on use cases and best practices. For further information on how you can attend contact vladimir.makarov@pistoiaalliance.org.
Project & Community Developments + New Ideas
Exploiting Real-World Data From Social Media in Patient-Focused Drug DevelopmentWith the need to diversify the source of real-world data for regulatory purposes, the Pistoia Alliance and a few of its members set up a Community of Experts to evaluate interest in using social media for patient listening. Having identified that there is a clear need to define guidelines and best practices, the Pistoia Alliance is now launching a project that will evaluate regulators’ expectations, patients’ acceptance, data collection and analysis challenges. If you are interested in joining this new project, please contact thierry.escudier@pistoiaalliance.org.SEED ProjectOur SEED project which has brought together a rich set of expertise from industry and academia and a shared ethos that data standardization efforts should be collaborative has now closed having successfully delivered new ontology standards for ADME and drug safety which are available via BAO. The Journal of Biomedical Semantics will be publishing a paper on the project (≈Q4, 2023, “An extension of the BioAssay ontology to include Pharmacokinetic/Pharmacodynamic terminology for the enrichment of scientific workflows”). Our thanks go to project champion Steve Penn from Pfizer and everybody else who has contributed to this three-phased initiative including AstraZeneca, Bristol Myers Squibb, Scibite, Bayer, Biogen, Southampton University, GSK, CDD, Elsevier, Linguamatics, Merck, Sanofi, Takeda, ABBVIE, Chemaxon and Miami University. Steve will continue to advocate for shared data strategies and the consolidation of ontologies as a Pistoia Alliance steering committee member and can be contacted via steven.penn@pfizer.com.D&I in STEM Leadership Program: Join our next cohortDiversity and inclusion are critical to the success of the life sciences industry. Don’t miss the opportunity to take part in our next D&I in STEM Leadership cohort. This 12 week program educates new and experienced leaders on the many different aspects of diversity and helps them to proactively support D&I efforts with their teams and organizations. It also provides an opportunity for participants to build a diverse network of pharma leaders around the world. Find out more here.New ideas for collaboration
If any of these new initiatives spark your interest or you have a new idea for a pre-competitive collaboration project get in touch.
   
Email New Pre-Competitive Ideas
   
Up & Coming Events
Don’t forget to visit our events page to discover the many different events the Pistoia Alliance and its members are hosting.Lab of the Future Webinar
September 13, 2023, 13.00 BST
RegisterLab of the Future Europe Congress – September 26 – 27, 2023
As a long-term partner and sponsor we look forward to speaking at the European Congress. You can also join us at the Pistoia Alliance pre-registration drinks on the evening of September 25
Register*Please note, all events listed on the website are displayed in your local time zone.
lab
Get to know the Pistoia Alliance – September 6, 3pm BSTUX for Life Sciences Conference – October 10, 8.30am BSTLab of the Future Panel Debate – October 18, 13.00 BST:Diversity of Thought – Neurodiversity & Mental Health Event – November 14, 13.00 BSTPistoia Alliance Members Conference – Collaborate. Innovate. Educate. – November 14/15, 13.00 BST
   
Membership CornerCatch up on these trending topics and more in our Knowledge Libraries:Enterprise Named Entity Realizing the Promise of Foundation Models in HealthcareRecognition (NER) and Linking with KAZU – A Deep Dive The Application of Large Language Models in Life Science R&D  To keep up to date with all the news and announcements from the Pistoia Alliance sign up, express your interests and join us in collaboration. 

Pistoia Alliance Partners with Matador in Japan

Posted on by Catherine Maskell

Partnership will boost adoption of new technologies, and unlock Japan’s R&D expertise on areas including targeted immunotherapy, the human microbiome, and neurology

Boston, 14th June 2023: The Pistoia Alliance, a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D, has announced a new partnership with Matador Japan KK, experts in the Japanese pharmaceutical sector, to enable pre-competitive collaboration in the Japanese market. The Alliance and Matador share the vision that bringing together experts from diverse backgrounds and experiences will enable companies to deploy new technologies and solve common R&D challenges faster and more effectively. By joining forces, the Alliance and Matador will help members accelerate research and grant them access to a truly global pharmaceutical ecosystem.

“This partnership marks an exciting stage in the Pistoia Alliance’s evolution. Japan is the second largest pharmaceutical market in the world, and we believe it can benefit from the pre-competitive collaboration the Alliance has long been offering members in regions including Europe and North America,” comments Dr Becky Upton, President of the Pistoia Alliance. “We’ve already had Japanese members including Takeda, QunaSys, Chugai, and National Cancer Hospital East benefit from being part of the Alliance and contribute to advances in exciting areas such as quantum computing. Our work alongside Matador will offer even more Japanese companies the same opportunities.”

The formal partnership builds on a series of Japan-based events held by the Pistoia Alliance last year, where Matador CEO John Bolger discussed specific examples of how the Alliance’s pre-competitive collaboration model of shared-risk and shared-reward delivers value. Together, the Alliance and Matador will create further networking and interest groups in the Japanese language and time-zone that directly benefit member organizations in the region. Japanese pharmaceutical companies have demonstrated R&D excellence in areas such as targeted immunotherapy, the human microbiome, and neurology, and partnering with the Pistoia Alliance will give members access to global expertise in these domains.

“The world-class pre-competitive collaboration happening within the Pistoia Alliance presents great opportunity for the vibrant Japanese life sciences sector,” comments John Bolger, CEO of Matador. “Matador was founded to build a bridge between overseas technology firms and Japanese pharmaceutical companies, and collaboration is critical to this aim. We work to accelerate the implementation of the latest technologies and innovations to support R&D in Japan, and bringing Matador under the Pistoia Alliance umbrella will help us further that mission.”

“Membership of the Pistoia Alliance enables us to collaborate on shared global healthcare challenges with life science organizations here in Japan and all over the world. The Alliance’s educational event program, pre-competitive legal framework, projects and expert communities are dedicated to advancing science and providing better outcomes for patients, both of which are fully aligned with our mission at the National Cancer Center,” commented Dr. Takayuki Yoshino, Deputy Director, National Cancer Center Hospital East.

The Pistoia Alliance invites life science companies and academics interested in pre-competitive collaboration and building their Japanese footprint to come forwards and enquire about upcoming events and interest groups with Matador via email: chazia.abdula@PistoiaAlliance.org

–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.

 About Matador Japan KK

Building upon long-established relationships, Matador Japan has an unmatched track record of partnering with overseas technology providers to bring transformative capabilities to market and successfully deliver value to clients, enabling them to stay at the forefront of advancements in research, optimize business processes, reduce clinical risk, enhance regulatory compliance and much more.

Media Contacts:

Spark Communications

+44 207 436 0420

pistoiaalliance@sparkcomms.co.uk

Tanya Randall

The Pistoia Alliance

+44 7887 811332

tanya.randall@pistoiaalliance.org

With Thanks To Our Spring Conference 2023 Sponsors…

Posted on by Catherine Maskell

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.

Accenture 

Accenture’s purpose is to deliver on the promise of technology and human ingenuity. Learn more: www.accenture.com/lifesciences

BIOVIA

BIOVIA, Dassault Systèmes supports science-based industries by providing a scientific collaborative environment for advanced biological, chemical and materials experiences. BIOVIA solutions including molecular modelling & simulation, data science, scientific and laboratory informatics, formulation design, quality & compliance and manufacturing analytics are used by more than 2,000 companies globally.

CAS

CAS is a leader in scientific information solutions, partnering with global innovators to accelerate breakthroughs by curating, connecting, and analyzing the world’s scientific knowledge. Connect with us at cas.org.

CDD

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 helps scientists register entities, track inventory, manage assay data, capture experiments, calculate Structure-Activity Relationships (SAR), and mine their data for drug candidates. CDD was founded in 2004 and presently serves thousands of researchers doing drug discovery all around the world.  

Learn more at www.collaborativedrug.com

Optibrium

Optibrium develops cutting-edge software for small molecule design, optimisation and data analysis. Their lead product, StarDrop™, is a comprehensive suite of integrated software that enables a seamless flow from the latest data through to predictive modelling and decision-making regarding the next round of synthesis and research. Cerella™, Optibrium’s proven AI software, guides successful drug discovery, generating valuable insights from your compound data.

Optibrium was founded in 2009 in Cambridge, UK, with a US subsidiary, Optibrium Inc., in Cambridge, MA. The company works with over 180 customers and collaborators, including leading global pharma, biotech, agrochemical companies and academic groups.

Seqera Labs

Seqera Labs is the leading provider of workflow orchestration and collaborative data analysis software for the global life sciences community. Thousands of organizations trust Seqera Labs to provision and manage large-scale computational pipelines, boost productivity, reduce cost and complexity, and simplify regulatory compliance. As the creator of open-source Nextflow and Tower, Seqera Labs is on a mission to deliver a seamless user experience and help organizations scale their critical operations. Seqera Lab’s products are used for some of the most important work on the planet, including developing personalized immunogenic vaccines, new diagnostics, ML-based image processing, and pathogenic surveillance. For more information on Seqera Labs, visit http://seqera.io or follow the company at @Seqeralabs.

Strateos

Strateos is a pioneer in the development of remote access laboratories and lab control software for life science discovery. Our mission is to create new knowledge driven by data, computation, automation, and high-throughput robotics with the goal of fundamentally advancing the life sciences. 

The Strateos™ Platform helps scientists more efficiently and reproducibly design, run, and analyze experiments to achieve new and faster scientific discoveries.

Vitality Technet

Our vision is to leverage the power of technology to create a more connected, informed, and sustainable world. As a company, we are committed to responsible and ethical data practices that prioritize data privacy, security, and transparency. We strive to bridge the gap between local vernacular and regulatory compliant semantic standards, creating a unified data landscape that drives value and innovation for our customers. We believe that by putting the needs of our customers and stakeholders first, we can drive positive change and create a world where data is accessible, interoperable, and reusable. Together, we can build a better future for all.

Pistoia Alliance Launches New Community of Experts to Use Social Media Insights to Drive Patient-Centric Drug Development

Posted on by Catherine Maskell

Boston, US, November 17, 2022: The Pistoia Alliance, a global, not-for-profit alliance that advocates for greater collaboration in life sciences R&D, has launched a new Community of Experts (CoE) to harness real-world data from social media. The CoE aims to develop best practices and guidelines to use social media analysis as real-world data (RWD) for patient-focused drug development. The initiative was originally brought to the Alliance by member company Semalytix; the community is supported by representation from companies including AstraZeneca, Bayer, Biogen, Boehringer Ingelheim, Chiesi, Johnson & Johnson, EMD Serono, and Roche. The Pistoia Alliance is now calling for participation and funding from technology and data experts to help unravel the complexity of the social media environment and develop a framework for consistent use.

Social media poses an interesting and promising opportunity to listen to patients’ voices directly and in real-time, capturing unfiltered, first-hand data about the patient experience in large volumes. New guidance from bodies such as the FDA and the EMA acknowledges that online patient experience research is a powerful tool for collecting comprehensive and representative input for patient-focused drug development (PFDD). As such, companies are increasingly using social media to produce Real-World Evidence (RWE). While there is a concise regulatory framework on many sources of RWE for drug approval and Health Technology Assessments (HTA), this guidance is lacking for social media. The Alliance recognizes that uncertainties surrounding regulatory validity and acceptability need to be mitigated for the data to be leveraged successfully.

“The increased presence of patients and their communities on social media represent an opportunity for us to identify relevant knowledge for the drug discovery process with a specific focus on quality-of-life research. Social media listening offers one way to address the limitations of methods used traditionally in quality-of-life research. It complements our insights from these methods and helps us to focus on improvements in disease treatment which are the most relevant to patients,” said Mathias Leddin, Principal Data Scientist for Biomedical Information at Roche.

“State-of-the-art natural language processing has advanced to enable us to conduct retrospective online patient experience studies using social media as a way to inform product development activities. Current methods allow us to carry out such studies in a scalable fashion, capturing the voices of thousands of patients, to identify patients’ unmet needs, concerns and priorities as well as what would be meaningful improvements for them. What we need now is a framework and best practices to integrate such methods into regulatory decision-making,” said Philipp Cimiano, Chief Technology Officer at Semalytix.
Developing a framework will require many different inputs. Patients do not communicate in medical terminology and often use colloquialisms. Additionally, platforms have different governance models for data sharing and access. The Alliance’s CoE proposes to collaborate on strategies to identify and resolve such issues to maximize the benefits of utilizing social media data and help develop better, more patient-centric treatments.

“We are keen to get as much expertise as possible on this complex initiative, particularly RWD experts and technology companies. This data has the potential to be hugely insightful and impactful across the drug development pipeline, and critically, to patients themselves,” commented Thierry Escudier, CoE Lead at Pistoia Alliance. “The cross-disciplinary nature of this issue makes it perfectly placed for the Alliance to tackle. We have the ability to bring together both technology and domain expertise, under a legal framework for pre-collaborative collaboration, that will lead to tangible outcomes.”

The Pistoia Alliance is calling on technology companies, data scientists, and real-world data experts to join its Community of Experts. To get involved, please contact ProjectInquiries@PistoiaAlliance.org. For more information on the Pistoia Alliance, visit https://www.pistoiaalliance.org/.

—END—

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 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/.

—END—

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