Standardized R&D Data Exchange is Here. Let’s Embrace It.

Commentary Contributed by Aparna Seksaria, SAP Life Sciences 

August 16, 2024 | Life sciences companies have spent much time and treasure working to streamline and improve product development. The drivers have been many, but two have stood out. The first is a desire to improve efficiency and optimize cost, because it’s good for business and the pocketbooks of patients we ultimately serve. The second is to boost material traceability, because product quality depends on it—and regulators demand it. Their demands are well justified: patient lives depend on the product quality that traceability helps ensure. 

Pharmaceutical giants have made progress on both fronts, to no small degree because ERP (enterprise resource planning) and other tools that help track and manage product development have improved and moved to the cloud. But these efforts have had their limits. That’s because life sciences R&D sponsors rely on contract manufacturing organizations (CMOs) for much of their product-development work—from manufacturing to packaging and labeling—and sponsors’ key systems don’t easily extend past corporate boundaries.  

R&D sponsors have addressed this limitation by developing custom APIs and establishing eclectic communications (e.g. spreadsheets, XML drops, emails) with individual CMOs. There are problems with this approach, not least being information gaps and lags that hamper efficiency and impact traceability.  

Further, sponsors work with multiple CMOs and vice versa. The efficiency and traceability of the R&D enterprises of some of the world’s largest and most respected companies therefore depend on ad-hoc assemblages of inconsistent, inefficient, one-to-one API and other connections that must be established with each new sponsor-CMO relationship. That costs more time and money. 

You’d think there would be a better way. Now there is. 

The Benefits of Standardizing Sponsor-CMO Interactions 

The concept is simple: Standardize the R&D-related communications between R&D sponsors and CMOs. Doing so brings many benefits. It increases transparency and traceability in production, inventory, and material flow. It improves sponsor-CMO collaboration by sharing order and inventory information, with the added benefit of lower inventory carrying cost. It lowers the integration and maintenance costs associated with building and maintaining all those one-to-one sponsor-CMO interfaces. It makes onboarding of new CMOs easier, cuts training expenses, and makes employees' lives easier. 

It all adds up to faster, more efficient clinical trials and an acceleration of medical innovation and go-to-market timelines. 

Given the wins to be had through such standardization, it’s reasonable to ask why it wasn’t done years ago. It wasn’t done because R&D sponsors and their CMOs all have had their own approaches to information sharing. Considering the n-to-n relationships among them, the barriers to collaborating on common standards have been higher than the perceived benefits of forging on with good-enough systems.  

Such systems are no longer good enough for the life sciences industry or its regulators. The industry needs comprehensive B2B collaboration to more tightly link the R&D supply chain, one that ideally integrates with sponsors’ existing clinical supply chain management systems to harmonize their processes across clinical and commercial supply chains. It isn’t about changing what information is exchanged between sponsors and CMOs, but rather rationalizing how that information is formatted and packaged.  

R&D-Related Supply Chain Data Standardization as a Vital First Step 

Such standardization is now coming to be. That’s thanks to major pharmaceutical firms working together with the ERP vendors whose ubiquity in the industry has put them in a position to help codevelop agreeable standards and then proliferate them across both sponsors and the CMOs they work with. The effort involved developing ways of sharing a huge breadth of data: regulatory submissions, compliance documents, production and demand forecasts, QA data on batch records and tests, CMC information on the composition and manufacturing processes of investigational products, logistics data related to storage conditions and delivery timing, and much more.  

The hard work of developing standards is largely complete. Now it’s a matter of the industry embracing them and committing to roughly six-month implementation projects to convert data and establish sponsor-CMO portals. It’s an easier sell for sponsors than CMOs, mainly because sponsors gain from unifying their clinical and commercial supply chain data and from using the same framework to communicate with many CMOs. But CMOs also gain by not having to change data formats for different sponsors (and, by extension, having to get employees trained on different formats on a sponsor-by-sponsor basis), as well as through immediate, reliable access to orders, inventory, and a range of other sponsor-supplied information. 

With standardization comes disintermediation and automation, and that’s also poised to happen here. Take traceability as an example. For scientific and regulatory reasons, traceability is paramount during drug-development clinical trials. Do subtle differences in the sourcing or composition of an investigational therapeutic affect its safety or efficacy? Regulators want to know, and, if they ask, you want answers quickly. Rather than waiting for someone on a dedicated team to round up and extract traceability data, the sponsor’s compliance team can tap into the latest data from the CMO through the portal and eliminate the middleman, so to speak.  

There’s much more to come. The ultimate goal in life sciences is to enable total, real-time traceability across the value chain. Standardizing sponsor-CMO data exchange is an impactful way for the industry to take an important step toward that goal. 

Aparna Seksaria is Global Practice Lead for R&D in SAP’s Life Sciences business unit. She can be reached at aparna.seksaria@sap.com.