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As most people are aware, small molecules were the first and predominant drug modality, with natural biologics such as proteins and antibodies entering the market next. Today, according to the Boston Consulting Group, 17 distinct drug modalities exist—some single modal and others multimodal (e.g., antibody-drug conjugates (ADCs), chemically modified biologics, and CAR-T cells). Multimodal approaches potentially offer synergistic benefits to tackle otherwise undruggable targets, as well as to increase efficacy and specificity, reduce side effects, and/or improve stability compared to more traditional modalities.

But multimodal research requires interdisciplinary development from the discovery phase onwards. Avoiding fragmented data silos at this critical phase is crucial. For example, a conundrum presents if a chemistry team is developing part of a multimodal drug (e.g., linker and payload of an ADC) and a molecular biology team another (e.g., the antibody of the same ADC) and the two departments have different entity registration software underlying their respective ELN and LIMS.

When drugs were either small molecules or natural biologics, entity registration was logically tied to the department undertaking the research endeavor. No reason existed for multimodal research software. However, drug development advances bring to the forefront the necessity for common registration software, at a minimum, for companies operating disparate ELN and LIMS in different scientific disciplines. The underlying data object(s) representing the therapeutic must be kept up to date and trackable by everyone involved in the process company-wide irrespective of which application they create, modify, or consume.

Registering versions of the same multimodal entity in different software applications can result in errors or mismatches in the drug lineage and make it difficult to determine where the single source of truth lies for intellectual property development. Common multimodal entity registration software ensures an accurate unified representation of the drug under development by interdisciplinary teams.

Multimodal entity registration software

Sapio Sciences’ new multimodal entity registration solution is a single registration system that can handle natural and non-natural biologics, all forms of conjugates, peptides, and small molecules. The system comes embedded in the company’s customizable lab informatics platform that includes an electronic lab notebook (ELN) and a LIMS. The software is also offered through the company’s Jarvis scientific data cloud as a standalone solution that can be added to an organization’s existing informatics ecosystem to provide multimodal entity registration functionality to solutions that do not themselves have the unified capabilities.

“Part of our heritage is material management, and we built on this approach for our multimodal entity registration software,” said Rob Brown, PhD, senior director, product marketing, Sapio Sciences. “All modalities of therapeutics under development are fundamentally materials with samples that get made and tested. It is just that each modality may have special properties that relate to chemical structure, sequence, cell or other characteristics and those we then layer on top of any material type.”

This bottom-up approach that uses materials, which have samples as a first-class object, made it feasible to combine all modalities into a unified registration system that automatically tracks the complete lineage of every entity and its component parts. Data can then be received from or fed into the plethora of informatics systems across an organization allowing each scientist to visualize the entity in a way that makes sense to them.

The data model also allows expansion for yet to be imagined modalities. They just become new material data types with their own special characteristics. “We bring order to the chaos while fitting seamlessly into the existing landscape of the scientist’s informatics workflows,” Brown noted.

A unified source of registration information that links knowledge about all studied entities is also imperative to build valuable AI/ML predictive models to inform future drug discovery. Multimodal lab informatics systems future proof a company’s core entity information during development of even more advanced therapies as science continues to evolve to tackle more challenging diseases.

 

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To learn more about Sapio Science’s lab informatics platform and multimodal entity registration capabilities, visit: www.sapiosciences.com.

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