Authored by: SAP and Tenthpin
The transformation of the traditional pharmaceutical supply chain towards the data-driven, patient-centric value chain disrupts the status quo of the Life Sciences industry. Advanced therapy medicinal products (ATMPs) offer new opportunities for personalized treatments, such as cell & gene therapies. With the launch of ATMPs and the introduction of new product and service offerings “beyond the pill”, the lines between pharmaceuticals and medical technology blur, and pharmaceutical companies need to develop a fundamentally different end-to-end capability, towards a truly patient-centric analysis and response across the entire value chain. Both the commercial and the clinical value chain of tomorrow, from the molecule to the patient, or vein-to-vein, will be leaner, faster, more flexible, self-orchestrated and patient-centric.
The impact on clinical trials operations is substantial. The growing number of new product launches impact the way pharmaceutical organizations plan and execute clinical trials: the number of trials is increasing, while at the same time trials are becoming smaller. Trial designs are becoming more complex, due to companion diagnostics, combination products, and longer and more complex manufacturing and resupply processes. Patient enrollment becomes more competitive, due to smaller target population, increased importance of patient and site experience, and patients being better informed. Finally, pharmaceutical organizations are experiencing an overall higher complexity in the end-to-end trials process due to the increase of non-core countries and challenges due to fast changing, global regulations.
How can technology help?
Technology is at the heart of the of the pharmaceutical industry’s transformation. It is changing healthcare, the practice of medicine, how pharma innovations reach patients, and how the industry communicates with their patients. Technology increases the industry’s capacity to innovate. We can predict a significant increase in the efficiency and effectiveness of the next wave of clinical trials thanks to the emergence of improved technologies and access to real-time data. Remote clinical trials, and in the future virtual clinical trials, will quickly transform from a future trend into a real-life standard scenario for the industry. And remote patient monitoring and access to real-time patient data will initiate the next big wave of innovation in the Life Sciences industry.
Overcoming today’s pain points
As pharmaceutical companies are starting to standardize and harmonize their commercial with their clinical supply chain processes, clinical supplies are moving into the center of attention. Clinical supplies are often linked to the same challenges across the whole industry. Silos of information make accurate planning difficult and lead to unnecessary buffers and costs. Companies are experiencing a lack of visibility along the end-to-end clinical supply chain with regards to the actual inventory at clinical sites, inbound and outbound shipments, actual patients and dispensing schedules.
Disjointed, siloed perspectives constantly need to be translated, aggregated and adjusted, leading to a misbalance of demand and supply along the value chain. From a process, data and technology perspective, the industry is experiencing a lack of integration between the different partners in the clinical supply chain. The lack of standardized solutions and interfaces are a detriment to faster and more accurate planning cycles.
Looking towards the future, when clinical studies will change and be more agile and more diverse, and require a variety of different set-ups, the industry will need the flexibility in its IT systems to accommodate such changes. New umbrella, basket or platform trials need to be handled, supplies need to be pooled and more elaborate logistics and shelf life considerations must be included in the clinical planning processes. Alongside new study types, also different collaboration models are required in the future: Different solution vendors on the IRT/RTMS or cold-chain side or clinical supply chain partners (contract manufacturers, logistics service providers and others) need to be onboarded and information needs to be shared on a detailed level.
Industry consortium to drive innovation
Having the knowledge about the transformation the pharmaceutical industry is currently undergoing and the challenges these companies experience in their clinical supply chain triggered a number of questions for SAP and partner Tenthpin Management Consultants (Tenthpin).
”How can we design a Next Generation Clinical Trial Supply Management (CTSM) solution,” was the most important question. How can SAP and Tenthpin build a CTSM solution that allows quick and flexible responses to future trends, while at the same time reducing Total Cost of Ownership (TCO) and overall business risk? How can we improve the clinical trial process for the industry, sponsors, and clinicians, while improving the patient experience and its outcomes? And, how can we rethink the clinical trials process by taking full advantage of emerging technologies?
To make the data-driven, patient-centric value chain a reality, SAP, Tenthpin and several global Life Sciences companies decided to partner, co-innovate, and build an industry solution for CTSM. In order to achieve the objective of building a true industry standard, SAP launched an industry consortium to bring clinical trial sponsors and external clinical supply chain service and solution providers (like CMOs, logistic providers, and IRT/RTMS vendors) together. All members can actively participate in the process design discussions, influence the strategic direction, and proactively shape the future industry best practices for clinical trial supply operations.
Key capabilities that enable the transformation
To have a fundamental impact on the future clinical supplies processes, a clinical trial supply management solution should:
- Accommodate faster planning cycles and novel types of clinical trial protocol set-ups
- Harmonize master data and align processes for an end-to-end information flow
- Standardize interfaces to enable a faster study start-up, but also ease the operational burden of the clinical supplies system landscape during the trial execution
- Be interoperable to allow system flexibility, extensibility and ensure maintenance and upgrades at low TCO
Apart from a facilitated study set-up, accurate planning is instrumental for the optimal supplies provisioning during a clinical trial. Timely visibility into actual supplies consumption is the basis for CTSM-driven replenishment, i.e. anticipating what is needed when and where and accordingly sourcing, manufacturing and shipping needed supplies, without producing overages nor running the risk of supplies shortages.
In order to plan more accurately, a variety of data points need to be brought together:
- planned and actual enrollment data,
- visit and dispensing schedules,
- the overall lifecycle status of a study or sub-studies,
- regulatory approval information for study start or shelf life extensions,
- up-to-date stock information in warehouses/depots,
- in-transit stock,
- in-process orders
- and the real-life quality status of the patient kits, especially in IoT sensor-monitored situations.
Such additional sources of information can be leveraged to apply up-front knowledge whether supply meets demand and can recognize potential future shortages earlier on, helping planners with a recommended course of action to make better decisions and gaining the shop floor and logistics teams valuable lead time to replenish supplies. Combining the protocol-driven consumption logic with supplies network insights and real life data infusion, like cold chain issues, or nowadays during the Corona pandemic enrolment delays or supply chain challenges, like delivery or border crossing delays, helps companies better manage shortages via a fair share distribution model so that ongoing clinical trials can proceed as planned and each patient receives the needed treatment. Awareness of manufacturing and logistics capacity help determine the optimum between production cycles, delivery costs, and supplies buffers on site. Machine learning algorithms and simulation capabilities can further refine the planning process and increase the resulting planning accuracy.
An increase in planning accuracy in-turn reduces the need for high inventory buffers and therefore reduces sourcing, storage and shipping costs. Coupled with a system-supported change management strategy, planning for successor products and optimal management of the grace periods guarantees optimal consumption of existing stock across the various countries participating in clinical trials. Avoidance of hard (static) reservations per trial and pooling of supplies across trials further optimizes the inventory levels. Last but not least, avoiding unnecessarily high stock buffers avoids waste and also impacts the reconciliation effort to recall and destroy the remaining supplies at the end of a trial and supports meeting corporate sustainability KPIs.
A final key requirement to prepare us for the future is the ability to collaborate closely and efficiently with all the stakeholders in the clinical trial space. Outsourcing has been a key trend on the commercial side, so SAP can leverage existing solutions and capabilities also for clinical trials to share information and harmonize workflow processes between the clinical trial sponsor, development partners, contract manufacturers, suppliers, clinical research organizations, labeling and translation service providers or logistics providers. Cloud-based sourcing, collaboration and data exchange capabilities facilitate close cooperation and improve cycle times, technologies like bots help automate and facilitate processes and make the daily life of the investigators and patients easier, while network-based message exchange allow us to move away from high 1:1 connectivity efforts to enable corporations to more quickly and more flexibly do business with each other and start clinical trials.
There is an exciting future ahead of us!
The convergence of new types of medicines and new technologies brings us to a pivotal point in time, how we organize and run clinical trials in future – comparable to what the manufacturing industry has seen with the Industry 4.0 changes. SAP and Tenthpin welcome additional companies to shape this future with us, so we invite you to join the CTSM industry consortium and look forward to your thoughts!