October 31, 2016
No one can sympathize with the unique challenges of the pharmaceutical supply chain like Academy Award-winning actor Tom Hanks. Heralded for his extremely emotional on-screen portrayals, Hanks’ characters are habitually held up or impeded en route to a destination, be it by storm (“Cast Away”), government red tape (“The Terminal”), pirates (“Captain Phillips”) or a flock of geese (“Sully”).
Nevertheless, Hanks’ characters always find a way to pull through, and in considerably less time than it typically takes for a pharmaceutical company to get its drugs to market.
1. ‘Cast Away’
Did you know that only five in every 5,000 experimental drugs even make it past pre-clinical tests? These odds are slim, but not nearly as slim as Tom Hanks’ chances of being rescued from a deserted island after his FedEx delivery plane crashed into the ocean during a storm. Upon scratching calculations onto a cave’s interior, Hanks realized that the search area was approximately 500,000 square miles, at which point he ruefully consulted Wilson, his volleyball and companion, and said, “they may never find us.”
Nevertheless, Hanks was found four years later adrift in a makeshift raft. That’s eight years fewer than it takes for the average experimental drug to get to market, and at a remarkably modest operational expense (Hanks scraped his vessel together using plant life and detritus).
Like Hanks’ efforts to build a raft to take him home, pharmaceutical companies start with a set of raw materials, which through research, trial and error create something purposeful. The result is the active product ingredient (API) about three and a half years later (Hanks is already at an advantage by now). This API then needs to go through three phases of clinical trials, which takes about six years, followed by a two-year registration cycle with the FDA. From there, if all checks out, manufacturing and distribution can begin, at which point, it’s been about eight years since Hank was found on the open ocean.
2. ‘The Terminal’
Like Tom Hanks, there are countless ways that pharma supply chains can get held up.
“Tell him, in order to export medicines from this country, he needs to have the proper form.”
This was an airport administrator’s order to Hanks in “The Terminal,” (2004) at the time translating for a fellow countryman from Krakozhia, a fictional Eastern European nation that had just devolved into a civil war. As the coup occurred, Hanks was at JFK International Airport, where he soon discovered that his passport was no longer valid. His character spends the next nine months performing good deeds for the hub’s many comers and goers, one of whom is a man trying to travel with medicine for his ill father in Canada.
In the pharmaceutical industry, extended holdups can technically happen at any time. If the FDA “exercises its jurisdictional right to examine, inspect, sample, or review documentation related to an imported product,” it can result in “weeks or months” of shipment delays. This, of course, is completely separate from the two years that it takes the FDA to approve the API. In these situations, drug companies, like Tom Hanks, are left with no choice but to wait. Bear in mind that the FDA is only one regulatory body in a world that’s full of them – ANVISA in Brazil, TGA in Australia, MHRA in the U.K., PMDA in Japan, and so on – and pharma companies need to abide by them if they want to do business with other countries.
Hanks’ character was eventually released from his detention when the war in Krakozhia ended. This took nine months, which still pales in comparison to the two years, plus interest, that drugs may spend tied up in regulatory processes..
And what became of the man who was trying to get medicine onto a flight for his father? Well, Hanks told airport administrators that the medicine was actually for the man’s goat, knowing that this loophole would allow this desperate traveler to board his flight with drugs in tow.
“He love that goat,” Hanks assured the administrator in his broken English, as the man, crying tears of joy, was carried away.
“When something goes wrong, quick adjustments will have to be made to get the supply chain back on course.”
In theory, a supply chain should operate much like a set of mechanical components that comprise an airplane. When the many cogs in that system act predictably (i.e., manufacturing plants, delivery vessels, cargo holdings, inventories, retail distribution networks), things go well. But when something goes wrong, quick adjustments will have to be made to get the supply chain back on course, or at the very least, to mitigate as much chance for potential loss as possible.
Clint Eastwood’s “Sully” chronicles the true story of Captain Chesley “Sully” Sullenberger, the US Airways pilot who successfully landed on the Hudson River after colliding with a flock of geese that killed both of his engines. In the film adaptation, an investigation is launched to make sure that Captain Sully’s actions were in fact necessary, and not the result of rash decision-making. Without giving too much away, the investigators are able to come to a conclusion about the correctness of Sully’s actions using detailed simulations of the event.
While Tom Hanks characters in these peculiar situations seem to reach their destination faster (even when that destination is the Hudson River), the pharma industry, with the fusion of cloud, as well as Big Data and AI, is getting closer to accelerating the time to market with autonomous actions within the supply chain. These new technologies are leading to new opportunities to increase revenue and reduce costs – and possibly beat Tom Hanks to a destination.
If you want to learn more about how pharma companies are utilizing supply chain intelligence to get to solutions (a.k.a. destination) faster, check out this article in CIO Magazine.