IDBS Briefing Note
Axendia was recently briefed by Liz Tyler, VP of Customer Operations, and Jim Brooks, Lead Platform Product Manager – GxP Strategy, at IDBS, a Danaher company. IDBS is an enterprise solutions provider offering SaaS and consulting services for companies engaged in scientific research, discovery, process development and manufacturing. The IDBS data management portfolio is designed to help biopharmaceutical organizations accelerate time to market of next generation therapeutics by overcoming well-recognized inefficiencies and data silos that stem from disconnected workflows and manual and paper-based processes across the product lifecycle.
Rising to the Digital Challenge
Life Sciences companies are famously suffering from the DRIP (Data Rich, Information Poor) scenario. They can only access a fraction of their data to be distilled into actionable insights, and this leaves the true power of data to inform faster and better decision-making unrealized. Inaccessibility to data is the biggest reason for this phenomenon. These data are trapped in flat files, spreadsheets and printouts, disparate systems, data sources, and file formats, and there is a lack of integration between systems. These islands of heterogeneous data make it nearly impossible to search effectively or to apply advanced data analytics, including AI and ML. All these examples serve as barriers to the tremendous insights that reside within the wealth of data a biopharma company generates.
According to Tyler, to realize the transformational value of data, a company needs to move beyond the basics. Implementation of an Electronic Notebook (ELN), capturing files and notes, can serve as a foundation, but today’s expectation is that it also needs to foster internal and external collaboration, allowing people to easily exchange information with one another. “Workflows need to be integrated across different processes, functions and teams, but you also need to have the appropriate approach to how you’re treating that data,” states Tyler. “This is where FAIR [Findability, Accessibility, Interoperability, and Reusability] principles come into play. As a company progresses its digital maturity, their teams can start to really apply enterprise analytics and insight and start to think about applying machine learning. Perhaps use AI to streamline process steps, automate work, or optimize the work that you want to do by designing processes based on predictive models.”
Brooks elaborates that from an advanced analytics standpoint that multiple imbedded tools in the IDBS Polar platform provide higher level insight, however if a customer wants to use their own tools, they can do that too.
Simplifying the Ecosystem
As the industry embarks on a journey towards digital sustainability, there is growing consensus that it needs to move beyond point solutions to the adoption of modern platforms. “The Danaher brand has a solid standing in the life sciences industry, and the IDBS’ flagship solution IDBS Polar, complements this portfolio of brands nicely,” says Tyler. IDBS Polar is comprised of many modules that can pull and share data as well as integrate with instruments and other software systems, making it a hub for scientific data at an enterprise scale.
“Something that’s important to note is that our platform contextualizes the data when it’s captured, which means the data can be used for analytics quite quickly. You don’t have to move it somewhere else to contextualize it, and this is because we also have the analytics embedded in the software.” Tyler calls this concept “a data backbone, which is a combination of the data itself, plus all of this contextualized information.” IDBS provides configurable templates and workflows for data capture, data sharing, analysis and insight reporting. The Global Professional Services team partners with companies to ensure desired outcomes are met.
The ability to query data to produce useful insights continues to be a theme Axendia hears from the industry. Brooks explained their software has evolved accordingly. “We’ve added more structure to the data that is captured, which has improved searchability. Users can search their inventory data and certainly anything that is in the data backbone – the metadata attached to records, users, dates and things like that.”
The goal is to simplify the current digital situation. “The ecosystem for biopharmaceutical companies is complex, and so a path towards an enterprise platform can yield a lot of benefits in terms of simplification. But the intention is not to replace what our customers currently have in place – it is to complement it and enable integrations with their current ecosystems,” says Tyler. With IDBS being dedicated to the life sciences, Brooks also reinforced, “Compliance is part of our legacy, with built-in audit trails, user privileges and the like, which is what our customers expect of us.” Brooks acknowledges that the ease of configurability can add complexity when it comes to qualification, but the aim is to continually provide accelerator templates that minimize the need for bespoke configurations, while supporting their customers’ adherence to regulatory guidelines, including risk-based approaches to validation as put forth by the FDA and GAMP5®.
Answering the Call for the Cloud
Life Science companies have become increasingly “Cloud Comfortable” with many adopting a “Cloud First“ approach. In fact, most organizations will not consider a solution unless it is cloud deployable. Reasons for this shift include lower IT infrastructure burden (especially for smaller companies), improved visibility, data accessibility and collaboration. In line with this industry need, the IDBS platform started as an on-premise solution when first launched, but transitioned to cloud technology close to 10 years ago. IDBS Polar is now SaaS only, and in partnership with Amazon Web Services, any newer offerings will be as well. Given the IDBS legacy install base, however, they continue to fully support their customers who are still using on-premise solutions.
Another relevant offering from IDBS is their Process Information Management System (PIMS), which is cloud-native. IDBS’ PIMS is a cloud-based software solution for process insights and monitoring in manufacturing. PIMS aggregates information from siloed data sources into a single system to help organizations improve product quality and release efficiency.
According to Axendia research, digital tech transfer is one of 10 initiatives pharma must consider to mitigate the impacts of price controls. Biopharma product lifecycle management and digital tech transfer solutions can accelerate and optimize the transfer of manufacturing processes from development to commercial production.
“The goal of PIMS is to create a single source of manufacturing data quickly, especially for tech transfer and scale-up,” states Tyler. Expediting tech transfer and scale-up is of great interest in the Life Sciences industry because significant time is spent achieving these milestones, whether at a single site, across sites or among partners. Says Tyler, “By creating a digital backbone for manufacturing and process data with PIMS, we want to make it so this handover is eliminated altogether. It will just become a continuum. And this is where a cloud-technology platform is a true enabler.”
Image Source: IDBS
In Conclusion
As the Life Sciences industry strives toward bringing medicines to market more quickly and efficiently, we increasingly hear that companies want technology providers to meet them where they are, regardless of their digital maturity or their current digital ecosystem. Biopharmaceutical organizations have no intention of starting from scratch or ripping and replacing, and the expectation is that technology providers will find ways to work together to make this process easier. With over 30 years of experience, IDBS continues to evolve their offerings with the end goal of improving the lives of patients. IDBS is showing a continued commitment to the industry and demonstrating that they are a willing partner with a history of listening to their customers and gaining their insight for future product development.
We will continue to provide updates on IDBS as they become available.
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The opinions and analysis expressed in this post reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this post is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This post is not intended to endorse any company or product and should not be attributed as such.