The 11^th annual Bio Supply Management Alliance (BSMA) conference brought together leaders from across the life sciences supply chain community to share learnings, network, and collaborate on the challenges and opportunities facing the industry. While life sciences companies are rarely on the forefront of supply chain innovations, many of the same disruptors impacting other industries (e.g., the Amazon effect, next generation tech, etc.) are transforming the supply chain model in the life sciences industry.

The unique demands on the supply chain due to the rapid emergence of CAR-T treatments, cell and gene therapies were front and center at the conference. The mounting pressures on the supply chain are creating opportunities to evolve standard practices and drive new value in traceability, commercialization, and more. In addition to the disruption caused by the latest therapy models, conference speakers and attendees also dove into the role of new and emerging technologies in the supply chain. As innovations in artificial intelligence, IoT, and blockchain transform other industries, supply chain leaders are exploring how these same technologies can be used to create faster, more flexible, more efficient, and more secure supply chains.

Building a “Perfect” Personalized Medicine Supply Chain

Panelists and speakers from cell therapy leaders Novartis, Gilead’s Kite Pharma, Celgene, Gritstone, and  Clarkston’s own Janel Firestein discussed the process of developing a supply chain for groundbreaking new treatments.  Throughout the day, a few key areas emerged as common across the biopharmaceutical and biotech industries.

Traceability, Chain of Custody, and Chain of Identity

In autologous treatments, the traceability requirements for chain of identity (COI) and chain of custody (COC) from apheresis to the treatment of the patient and beyond have presented challenges without a standard solution. With more constituents in the value chain, more data to be captured, and new data streams to incorporate, companies looking to scale up operations are facing new obstacles to growth and development in the supply chain.

What, for each company, started out as manual, people- and paper-driven processes, has given way to an amalgamation of systems to support electronic capture of COC/COI. Each organization has worked with its partners to develop technology solutions and processes that capture the necessary information.  There is still opportunity to enhance and integrate these technologies, particularly as the number of commercialized cell and gene therapies is projected to grow significantly over the next 3 years.

Commercializing the CAR-T Supply Chain

With only 2 CAR-T treatments approved for commercial use, companies are still navigating the murky waters of commercialization in the personalized medicine world. In that transition from clinical to commercial production, challenges have emerged.

The first is how to scale – traditional biotech models scale from small batches of clinical production to large batches for commercial production. Since most CAR-T treatments today are a batch of one, that model switches from a scale up to a scale out model. Identifying the right partners and how to execute that scale out becomes critical to ensuring successful commercialization.

The capabilities of your technological landscape play a critical role in the commercialization readiness of your treatment and organization. In addition to the COC/COI requirements noted above, the additional analytical and manufacturing data captured for CAR-T treatments, and compliance with patient privacy regulations across the globe, requires robust technology solutions to be in place BEFORE commercial launch.

Additionally, as many of these treatments have originated in academic or other research institutions and are being rapidly tested and brought to market, one of the unique challenges associated with scaling manufacturing is building the supply base. In some cases, there may be one or possibly no cGMP compliant suppliers for key starting materials. In other cases, for more common materials, the volumes required are so low that CAR-T manufacturers may not be considered prime customers for suppliers. As companies with interests in commercializing these treatments continue to invest more in the R&D processes, this situation will change. In today’s environment, however, the raw material supply presents many risks for a make-to-order cycle with no room for error.

Development of Emerging Standards

In a rapidly developing industry that defies many paradigms of the traditional biotech supply chain, there is a huge opportunity for industry collaboration to define and implement standards for the mutual benefit of manufacturers, providers, and patients. Two areas with opportunities for new, industry-driven standards are in apheresis center processing and with the FDA and other regulatory bodies on quality standards.

First, on apheresis center processing, with the number of cell and gene therapy treatments growing at a nearly exponential rate, the number of protocols associated with those treatments also runs the risk of growing exponentially. With a finite number of apheresis centers, the myriad of similar but potentially different protocols could become overwhelming quickly. That, coupled with the need for each manufacturer to audit apheresis centers for procedure compliance creates a compliance, quality, and administrative risk. Working together to develop standards for apheresis collection where possible will help drive efficiency and minimize risk in the process – helping ensure the most critical element of supply.

Second, the industry should start now to work with the FDA to craft regulations where current regulations don’t exist or do not fit the new treatments. Areas include, but are not limited to, requirements for chain of identity, rapid sterility testing, or the use of artificial intelligence to support batch record review. With the industry and the FDA working together, new methods and standards can be put in place that ensure quality, safe product that can be turned around even faster – helping with the effectivity of the product – particularly in last-line treatments.

Emerging Technologies in the Life Sciences Supply Chain

Throughout the day, there were many discussions amongst panelists and attendees on the impacts emerging technologies will have (and are having) in the life sciences industry. Every day, it seems there are new processes being deployed using blockchain technology, particularly outside of the pharma and life sciences industries. Based on the discussion among leaders at the conference, that’s about to change – whether it’s to support serialization or enable COC/COI in CAR-T, the promise and appetite for blockchain-driven solutions is imminent.

The internet of things (IoT) is already playing a major role in today’s pharma supply chains. Cold chain solutions such as IoT-enabled cryo-containers currently provide large amounts of real-time data to manufacturers. Manufacturers are leveraging this data to ensure compliant, quality products reach the patient when and where they need them. Smart, IoT-enabled medical devices are allow companies like Illumina to proactively service their devices to ensure they remain in service with as little downtime as possible. These IoT-enabled devices provide large amounts of data that open doors for countless applications in machine learning and artificial intelligence. For example, companies are using predictive data to better plan their supply chain and improving manufacturing and quality testing via transportation data.

Finally, no industry seems to be exempt from the Amazon effect. While the direct impact in biopharma has been minimal so far, the expectation of the patient experience is quickly aligning with the expectations of the consumer experience. Whether it’s providing a CAR-T patient visibility to where his/her treatment is in the process or enabling real-time distribution of drugs directly to patients – driven by Amazon’s acquisition of PillPack, the days of the slow, traditional pharma supply chain are quickly slipping away – to be replaced by a more nimble, patient-centric model.

What’s readily clear from the annual Bio Supply Management Alliance conference is the rapid pace of disruption and change in the industry, leading to as much or more disruption to traditional supply chain strategies and operations. This new normal will the marriage and understanding of high-science industry concepts with functional business process expertise in order to effectively and sustainably transform operating models. To learn more about innovation in supply chain, personalized medicine, or more, subscribe to our insights below or contact us for help.