As of the writing of this column, the 2023 Contract Pharma Conference & Expo is just wrapping up and included some of the top experts in the field. It ranked as the most highly attended events in 22 annual iterations. Themes covered the gamut of high-profile concerns in the industry: Forecasting future moves, supply chain, innovation for drug manufacturing, maximizing contract relationships, industry prospectus, FDA trends, drug supply chain security, CMC data, CGT development, and innumerable side topics.

Supply chain

At the beating heart of the manufacture of drugs is indeed the supply chain. The inputs which get transformed into outputs are selected, procured, and delivered (logistics), as well as received, tested, and transported for this transformation. All these steps represent the backbone of a high-integrity supply chain. If materials don’t get where they need to be, there IS no manufacturing process, which is why my friend and industry colleague, Ray Sison, says “it all comes back to supply chain.” When supply chains break down, things get bad; think stock-outs in the semiconductor and microprocessor market a couple years ago, which also coincided with other part shortages in vehicle manufacture, causing mass-market problems with the delivery of new automobiles. Similarly, FDA has issued a watch list of critical hospital medicines which have limited redundancy buffers in their production, therefore causing them to be at risk of shortages.

No left turns

Companies like UPS, FedEx, and others thrive—and in fact, live and breathe—on logistics. It’s their very business model. When you’re in an organization like that, every logistical detail about Logistics matters, sometimes a lot. Routine and more rare trips are planned by supercomputers, whose algorithms batch certain deliveries for efficiency, and at the end-route driver, seek to minimize seeming trivialities like left-hand turns. Well, it turns out that left-hand turns are bad for business in Logistics—they can increase the probability of accidents as well as cause unnecessary downtime at left-turn signals and stop signs. More efficient flow comes from serializing right-hand turns, even at the expense of additional miles logged. UPS—as but one competitor in this market—has determined that by reducing left turns, they save millions of gallons of fuel each year and the equivalent emissions of over 20,000 passenger vehicles.

The U.S. National Highway Traffic Safety Association (NHTSA) found that left turns are major “critical pre-crash events,” factored in 22.2% of crashes. Contrast this against the prevalence of 1.2% for right-hand turns. 61% of crashes that occur while turning or crossing an intersection via left turns, but just 3.1% with right turns. The city of New York also identified left-turns as 3x more likely to kill pedestrians than right-hand turns. Makes you never want to turn left again, right?

The hive mind

These organizations have also toyed with approaches to arranging Logistics which come to us from the field of Swarm Theory. By rethinking delivery models (plane cargo loads, for example), logistics engineers have been able to reduce some freight transfer rates by up to 80%, with a 20% reduction in workforce handling of the cargo. These principles also apply to the movement of intangibles, like data: Marco Dorigo of the Université Libre de Bruxelles and his academic team have utilized Swarm Theory models to route Internet traffic, demonstrating that the approach outperforms current methods, increasing throughput while decreasing delay latency.

The pharmaceutical supply chain

The pharmaceutical supply chain adds some additional stressors, such as regulatory compliance needs, which essentially act as additional variables to a complex equation. These, however, can be handled similarly to the myriad other factors that are a part of the algorithms, and which are being optimized in other spheres as mentioned above.

The FDA has the Drug Supply Chain Security Act (DSCSA), which provides insight into compliance requirements to protect the safety and security of the pharmaceutical supply chain in the U.S., including 5 Final Guidances published in just the past two months. All of this to say that the industry is evolving very quickly regarding the supply chain of raw materials, finished drugs, and everything in-between. FDA is also providing guidance insight and compliance requirements to ensure that the continued push to a higher-velocity future is met with the same level of quality and security that consumers have come to expect for their medicinal therapies. It’s not often—if ever—that you’ve picked up an OTC or prescription drug and had to wonder what the supply chain was for its components, and whether it was kept under strict compliance standards throughout its processing. And that’s a good thing.