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イベントレポート：EMD Serono社共催、Genedata East Coast Open Forum
Genedata Biologics/Bioprocess、研究開発のデジタル化における業界動向

November 17, 2022
Jana Hersch

On a lovely October day in New England, the Genedata East Coast Open Forum brought together scientists and experts from the local biopharma industry to discuss digitalizing biopharmaceutical R&D. Genedata Open Forums explore different digitalization topics and this event, graciously hosted by EMD Serono in their beautiful Billerica (MA) facility, concentrated on biologics and vaccine workflows. This level of industry collaboration and engagement was an enriching experience, and I’d like to share some of the highlights and lessons from the East Coast Open Forum that may be helpful to others with their digitalization efforts.

EMD Serono

Klaus Urbahns, Global Head of Discovery and Development Technologies at EMD Serono, kicked off the forum with a forward-looking vision of the intersection of medicine and digitalization. He spoke briefly about the short history of biomedicines and the lack of voluminous data in this relatively new field compared to the amount of data already accumulated for older modalities such as small molecules. Klaus stressed that proper organization and sharing of such a limited data resource is essential more than ever and highlighted the importance of excellent data management for any biopharma organization.

Vanita Sood, Global Head of Drug Disposition & Design Discovery & Development Technologies at EMD Serono, discussed the difficulties in predicting biologics’ developability. Early reliable prediction of successful biologics that are safe, efficacious, and have the optimum level of clearance from the body is a tall order for any computational model at the moment. Vanita reported on recent machine learning projects at EMD Serono. She emphasized the need for the community to share and curate more clinical data to incorporate a more vertical understanding of patients and metadata and invited the community to access their data and collaborate on this important topic.

Vera Sellers, Associate Director and leader of the Molecule Group at EMD Serono, presented a remarkable case study featuring developability assessments at different process junctions: hit discovery, hit optimization, and lead optimization. She highlighted how scientific groups across different continents contribute to the workflow and into a standard Genedata system. Vera also mentioned the need for scientists to preserve data for molecules that fail, something they often omit because it is mistakenly considered bad data. However, such bad data are essential for informing the data models and should be maintained in a data management system.

Genedata USA

Jolyon Terragni, Head of Genedata US Operations, gave the inside track on the latest updates to the Genedata Biopharma platform. A market-leading digital solution, the platform supports the discovery of biologics and bioprocess development. Jolyon even presented workflow examples using protein-, cell-, virus-, and RNA-based therapeutics, and vaccines. What followed was a spirited Q&A session that touched on many topics, such as the practicalities of integrating multiple software solutions, validation requirements, and AI, with current users in the audience sharing their experiences.

Novartis

Closing the morning session, Barbara Brannetti, Director of Data Science, Characterization and Formulation at Novartis Institute for Biomedical Research (NIBR), gave a talk about digital transformation in biologics discovery using Genedata Biologics. Genedata Biologics serves as an extendable central data management platform at Novartis. It is integrated into their larger digital ecosystem providing benefits across the scientific, technical, operational, and organizational value chain. Barbara outlined the challenges of the digitalization process and practical approaches to overcoming them, such as internal organization and alignment. Of note was the importance of shared ownership and commitment to digitalizing scientific workflows from Novartis' scientific, informatics, and business teams.

Pfizer

After a delicious lunch and informal discussions among Open Forum attendees, Diana Sapashnik, Scientist in BioMedicine Design at Pfizer, showcased Pfizer's use of Genedata Biologics to manage their gene therapy workflows and analysis of AAV quality control data. She detailed how the software registers viruses and the logic behind Pfizer’s viral production workflows and QC analysis. Genedata Biologics captures the sequence, samples, analytics, and metadata for Pfizer’s expansive AAV workflows.

Merck Healthcare Germany

Uwe Wittenberg, Director of Research Lab Informatics at Merck Healthcare in Germany, continued with a case study and spoke about Merck’s larger data ecosystem and automating aggregation and analysis of complex molecule assay data. EMD Serono has a robust antibody-drug conjugates (ADC) program, which generates both small- and large-molecule information. ADCs have unique digitalization needs and require both large- and small-molecule assay data and the integration of results for both sets of precursors. A central data management platform for large molecules must integrate seamlessly with a small molecule database and exchange information easily.

Genedata Biologics and Genedata Bioprocess

After Uwe’s fascinating talk, Genedata Scientific Consultants Yi-Wei Lee and Christian Tooley, presented a series of short live demos in Genedata Biologics and Genedata Bioprocess. Their demos featured use cases demonstrating both the depth and breadth of the Genedata Biopharma platform. Common challenges experienced by many scientists were demoed and solved in the software, specifically in design protein engineering, protein production, adenovirus vaccine workflows, cell line development, USP, RNA production, and lipid nanoparticle formulation screening.

Takeaways

The Open Forum closed with a lively panel discussion led by Joel Bard from Pfizer, Prashanth Vishwanath from Takeda, Vanita Sood from EMD Serono, and Barbara Brannetti from Novartis. Panelists discussed their digitalization journeys and how R&D digitalization changed their organizations. The audience fired some thought-provoking questions, and the panelists answered with humor and expertise. They shared nuggets on how:

  • Labs can significantly increase throughput and explore more hits at each selection level.
  • Scientists can avoid duplicating experiments on the same protein due to naming discrepancies between international teams.
  • A culture of non-documentation among certain teams was eliminated.
  • Seeing all data stored in a central location and all decisions documented outside of PowerPoint was an “ah-ha” moment and an eye-opening improvement.
  • The East Coast Open Forum provided some valuable industry lessons to all in attendance. For my colleagues and me, the big takeaways on R&D digitalization, regardless of which system you use, included the following:
  • Profound respect for the hard-earned experience and advice that speakers shared on their digitalization journeys.
  • Biologics data is a precious resource, and even data from failed candidates must be recorded and properly stored to build better models and inform machine learning and AI approaches.
  • Automating from the get-go instead of retrofitting later provides a strategic advantage.
  • Securing digitalization buy-in and commitment from all teams (scientific, technical, and business) is essential for successful R&D digitalization projects.
  • Understanding and accepting that digitalization is a never-ending process. Science and technology continuously advance, so people need to stay involved to keep up the pace.

A final thought supported by many in the session was that R&D digitalization has a great impact on changing the data ownership culture in their respective organizations. – Data now belong to all of us and are considered an asset of the organization, not just of specific individuals.

It's not too late to attend the next Open Forum, hosted by Biotalys on December 1 in Ghent, Belgium. Hope to see you there!