The supply chain is a critical function in the highly regulated biopharma industry. As such, there was a pre-pandemic tendency to operate conservatively and reactively given the risk associated with the distribution of pharmaceutical therapies. And then seemingly overnight in March 2020, standard operating procedures were no longer sufficient.
 
While downstream supply chains and their business development counterparts faced ramifications from the closing of HCP offices that created lack of access, upstream counterparts were confronted with shortages of key ingredients and APIs. Research and development arms likewise had to pivot and adopt site-less clinical trials which had always shown great promise but lacked traction for widespread adoption.
 
Complicating matters even more was the actual COVID virus itself, an urgent new disease state with a dire public health outlook. Naturally many of the larger biopharmaceutical entities found themselves focused on developing diagnostic tools, vaccine candidates and treatments for COVID.  Once COVID-19 vaccine candidates started to show promise, attention shifted to the necessary logistics to support a global rollout. The extreme temperature control needs of the mRNA-based vaccines garnered media attention around clinic readiness to accept, store and administer these therapies.
 
Though a multitude of supply chain challenges were brought on by COVID, the biopharma industry rose to challenge after challenge, effectively demonstrating an ability to tackle problems while fortifying operations for the next large-scale crisis. 
 
Over-Reliance on Foreign-Produced APIs
One of the earliest supply chain problems to surface as lockdowns were spreading, forcing some manufacturers to temporarily close or scale back, was the recognition that the U.S. is highly dependent on APIs produced in other countries.  According to the FDA’s Center for Drug Evaluation and Research, more than 70% of API manufacturers were operating outside of the U.S. with concentrations across the EU, India and China. In fact, the number of Chinese facilities supplying APIs to the US market had more than doubled since 2010, which is why the FDA expressed concern pre-COVID that approximately 20 of the United States’ most essential drugs used APIs or finished drug products from China.
 
This situation created health security risk in ways that surprised patients and providers alike. Stop gap measures were evaluated including leveraging dormant manufacturing lines from other industries to create APIs domestically. However, in February 2021, President Biden signed E.O. 14017, directing a whole-of-government approach to assessing and strengthening four critical supply chains, including pharmaceuticals and APIs. Since then, the administration has announced plans to increase domestic API production by establishing a public-private consortium for advanced manufacturing and onshoring of essential medicines. This will be buoyed by a $60 million Defense Production Act.
 
Go Time for Digital Enablers
COVID-19 also prompted supply chain suppliers to become better, faster and more transparent around asset tracking. With concerns about counterfeiting, delayed shipments and boats stuck in ports suddenly it was prime time for track and trace technologies and IoT – well ahead of the 2023 deadline for phase II of the Drug Supply Chain Security Act (DSCSA) which mandates complete unit-level traceability in the entire pharma supply. The goal of this fully digital, interoperable system is to find and remove counterfeit therapies from the supply chain. But savvy pharmaceutical leaders and partners see much more value and capacity for these cutting-edge technologies for direct engagement with patient recipients and kickstarting adherence programs. 
 
The Doctor Will (Virtually) See You Now
Clearly the trend towards the digital economy is poised to continue and further accelerate. Not even ten years ago telemedicine was viewed as promising for closing access gaps, but payers were not fully on board with reimbursing for what was then an unproven care model. However, when CMS announced it would pay for telehealth visits for Medicare members, other payers followed suit. Within weeks the platform was rapidly adopted by patients and providers alike who otherwise had no ability to interact.
 
Telehealth as a setting of care created new workflows and opportunities. While patients adapted to same day delivery and curbside pickup of medicines, hospital-at-home programs as an extension of telemedicine were being piloted, and with success based on convenience, satisfaction and cost. Nowadays it us becoming more commonplace to have a “visit in a box” where the practitioner arrives at the patient home with all the materials needed to deliver care.
 
Knowledge is Power
Although today in the U.S. there is a surplus of COVID vaccines, that was certainly not the case in the earliest days of vaccine rollout when the demand vastly outweighed the supply and cases of “vaccine waste” made national headlines. While hesitancy remains a challenge in the US, there are elements of packaging and supply chain processes that may help persuade non-vaccinated individuals to accept the opportunity to be protected from COVID. High quality containers that can keep medicines thermal controlled for hours and days on end, integrated IoT monitors to confirm product condition and status, and trackability all are factors that help ensure the security of our vaccine supply (COVID and otherwise).
 
While it is uncertain if our society will ever fully return to “normal,” we have made significant progress in fortifying many of the biopharma supply chain weaknesses COVID exposed. Today vaccines are available and reaching the ends of the earth while promising new COVID treatments are on the horizon. Additionally, clinical research into other serious disease states has resumed with mRNA showing tremendous potential as new treatments for cancer and chronic conditions. While COVID hit the biopharma supply chain hard, in many ways it has rebounded with more integrity and opportunity than ever.