Aparna Seksaria, global practice lead, Research & Development Solutions, Life Sciences, SAP, shares insights on the clinical trial process and how SAP helps life sciences companies resiliently manage their supply chains, helping clinical trials run smoothly.
Q: What are some of the industry challenges today that life sciences companies are facing when it comes to the supply chains for clinical trials?
A: Life sciences companies are facing three types of challenges – business, IT, and regulatory.
When it comes to business challenges, life sciences companies today are conducting an increasing number of clinical trials, often hundreds at any given time, and navigating greater complexity. COVID-19 led to an increase in direct-to-patient trials and greater pressure to deliver quick results and put products into the market faster. With the shift to more personalized medicines, clinical trial planning and execution needs to be adapted to account for manufacturing and delivery for batch sizes of one.
In terms of IT challenges, companies use multiple IT systems to manage the clinical trial execution process. As the digital landscape grows and transforms, increased collaboration among a growing number of upstream and downstream supply chain partners is driving companies to develop more integrated, interoperable, and scalable systems.
And lastly, clinicians face mounting regulatory challenges. Countries are developing their own unique regulations, making it challenging to plan, execute, and launch clinical drug products into country-specific markets. Furthermore, depending on unique government regulations, any delays in supplies or quality batch approvals can cause trials to go on hold or delay the availability of critical, lifesaving drugs.
How is SAP helping address these challenges?
SAP recently launched the SAP Intelligent Clinical Supply Management solution, closing a significant process gap in the life sciences industry. Traditionally, companies managed clinical trials via a paper format, tracking trials on lab books, Excel spreadsheets, and custom, siloed applications. With SAP Intelligent Clinical Supply Management, SAP offers customers an integrated solution to help track a clinical trial all the way from study initiation to the shipment of the final drug product. Using SAP standard solutions, together with our extended partner ecosystem, life sciences companies can streamline their clinical trial supply chain processes – readily facilitating forecasting, manufacturing of drug substance and drug products packaging, labeling, and shipping of clinical finished goods.
How have clinical trials evolved over the past decade and how did regulations and technology impact the change?
Until recently, clinical trials were conducted in silos. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together regulatory authorities and the pharmaceutical industry to “achieve greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed, registered, and maintained in the most resource efficient manner whilst meeting high standards.” Furthermore, the adoption of GS1 standards that instill trust and enhance transparency in the clinical supply chain are garnering attention. Finally, organizations like the European Medicines Agency and other standard guidelines are addressing the need for greater diversity and representation in clinical trials, reinforcing the need for technology and resilient supply chains that can support cross-border trials.
With the evolution of direct-to-patient trials, there is an increasing need to integrate the sponsor, contract manufacturing organization, clinical sites, and patient sites across multiple and varied technical landscapes without compromising on quality and delivery of the final drug product.
How can improving batch release processes help with the supply chain for clinical trials and benefit patients at the same time?
For pharmaceutical companies, the smoother the clinical batch execution process, the quicker they can release drugs to the market. Improving the clinical batch release process and gaining greater visibility into drug substances and products with a solution like SAP Intelligent Clinical Supply Management enables clinicians to efficiently track and release clinical batches while considering country-specific, site-specific, and regulatory releases.
During the clinical trial process, delays in the release of a batch can completely derail the execution of a trial. And in treatments like cell and gene therapies, it can cost patient lives. SAP Intelligent Clinical Supply Management optimally integrates with the quality batch release processes, so companies can monitor all the releases in one place with minimal reliance on information transfer from multiple siloed systems. In turn, they can deliver products to market with lesser data hops and quality checks between the systems, thereby improving the lives of the patients who stand to benefit from the drugs.
Why does this matter?
Improving the execution of clinical supply chains matter. Reduced complexity and greater accuracy during clinical trials reduces waste and lowers the cost of execution, ultimately impacting the cost of drugs for the end patient. More effective and efficient clinical trials allow life sciences companies to allocate more resources to solving other challenges in patient health.
Is there anything else you want to add?
The future of clinical supply chains will focus on improving the patient experience, delivering drugs to patient-specific locations, and effectively bringing together dispersed data points as clinical trials become even more decentralized. The efficiency of supply chains will become increasingly dependent on the technology and digital maturity of life sciences companies. At SAP, we are constantly innovating in the clinical space and reimagining the clinical trial supply management processes and its integration into the larger ecosystem of tech-transfer and commercial manufacturing processes.
What excites you about the work you do at SAP?
Every day, I am inspired by the opportunity to make a positive impact on the future of SAP and the life sciences industry. I am surrounded by highly motivated and talented individuals – some of the best brains in technology. Together, we are solving complex challenges facing pharmaceutical companies, advancing progress in clinical trials, and improving patient health.
Explore our infographic showcasing four industry cloud solutions by SAP that digitize routine processes in clinical R&D, so you can bring medicines and medical devices to market faster.
Kelly Cannon is part of Content Creation & Strategy for the Content Lab at SAP.