The annual meeting of the Bio Supply Management Alliance was held on October 8th, 2013, and was well-attended by key supply chain executives from the life sciences industry. The morning keynote was given by Virginia Herold, Executive Officer of the California Board of Pharmacy. She spoke about the state of the pharmaceutical supply chain and the looming requirements for serialization and ePedigree. After sharing some disturbing examples of supply chain integrity failures – ones that her team has uncovered which have directly threatened and harmed patients – she reassured the group that the implementation date would not be postponed any further. She also confirmed that if the federal law passed, it would preempt the California ePedigree Law. Despite the challenges we’ve witnessed in Washington on other fronts, the passage of a federal law actually seems more and more likely with each passing day.
There was great discussion from the SCM Executive Panel, which consisted of professionals from Bayer, Bio-Rad, and Genentech, as well as a professor from Golden Gate University. Across the board, the major worries for future bio supply chain success were regulation, information, talent, and change management. There was a talk on big data & analytics, which emphasized the importance of blending the two, and reminded the audience that the business should determine what data and analytics are needed rather than IT; the role of IT, instead, is to collaborate with the business to find a solution. The morning wrapped up with a session on supply & distribution risks, which examined risk analysis solutions for small to mid-sized companies.
The day was then broken into three tracks: Serialization, Strategic Sourcing & Clinical Supply Chain, and Molecular Diagnostics.
The serialization breakout further discussed the implications of the California law and the pending federal legislation. There is continued concern that companies are not adequately prepared, particularly if the federal law passes and requires a more stringent timeline. Two of our experts recently discussed the differences between the California law and the proposed federal legislation in, “At the Serialization Crossroads: Deciding Which Path to Take.”
Strategic Sourcing & Clinical Supply Chain
This breakout had some very interesting discussions on supplier relationship management, change notification, and nearshore vs. offshore options. There was a bit of debate around instilling more control over the clinical supply chain, and improving alignment with the commercial supply chain, along with what tools can be used to do so. While companies must find a suitable balance between applying rigorous planning and maintaining flexibility, the general consensus is that clinical supply chain planning and processes need more control and discipline.
This was the first time diagnostics was broken out at the BSMA. This breakout investigated the growing, fragmented diagnostics market, and the benefits that can be realized through supply chain management best practices. On the topic of how supply chain leaders can prepare to comply with regulatory guidelines, the recent Unique Device Identification (UDI) legislation was a main focus. Additional exchanges included tips for managing third-party logistics (3PL) partners, the potential to design novel shipping solutions that meet the unique needs of diagnostics (cold chain, for example), and optimizing sample kits for clients.
Many of these discussions are ongoing, particularly as regulatory and margin pressures force life science companies to increase their supply chain focus. The struggle for many supply chain executives, however, is communicating supply chain nuances to industry executives who come from more research-driven backgrounds. While there are many challenges ahead, we are seeing progress every day, and encourage business leaders to continue these conversations.