The spread of COVID-19 disrupted the entire clinical trials industry and exposed the fragility of standard systems and practices, with the unintended benefit of leaving behind a trail of new trends that are shaping the future clinical supply chain and providing new opportunities for the accelerated adoption of patient-centric digital technologies and virtual trials. In addition, we previously witnessed a shift toward the decentralization of storage and distribution and are potentially moving in the direction of a risk-based approach for the sake of cost efficiency.
Despite the fact that we are now entering the next stages of a post-pandemic world order, pharmaceutical and biotech companies are still managing a variety of continued COVID-19 disruptions, including restarting or resuming delayed or halted clinical research. While clinical trial distribution and supply chain efficiency may be at risk during and after this crisis, maintaining an agile global network and being able to quickly respond to challenges will be critical for ensuring drugs and supplies safely and confidently get where they need to go.
Mitigating disruption to the supply chain
Sponsor requirements and legislation are constantly evolving. Unpredictable circumstances can cause challenges at any time, threatening the scheduled delivery and condition of products or supplies. Therefore, using a one-size-fits-all approach to clinical distribution rarely garners success. Tailoring solutions towards each sponsor’s individual needs means being more prepared when the unexpected arises, providing the opportunity to pivot quickly to a solution.
Also, as demonstrated by the recent pandemic, in addition to previous natural disasters and other crises, flexibility and rapid responses to last-minute disruptions are required to ensure products — from cell and gene therapies to ancillary equipment — arrive securely to the patient, manufacturing sites, or point of care. This agility and creative problem-solving, along with making end-to-end tracking and monitoring more transparent, helps to create efficiencies throughout logistical processes, ultimately reducing costs and improving the bottom line.
Storing drugs and supplies closer to patients
Historically, the overall pharma supply chain operated with one global location to achieve the best economies of scale in manufacturing and to reduce the number of local storage facilities. However, since the pandemic, we’ve discovered the limitations of this strategy. Travel bans, restricted areas and social distancing measures have caused disruptions in shipments of deliveries and low investigational product inventory levels at most sites.
In the aftermath of COVID-19, biotech and pharmaceutical companies are reevaluating their approach and taking a more holistic view of the supply chain by streamlining the regional distribution of clinical products. More specifically, sponsors will need to rethink supply storage and labelling strategies, including limiting import/exports where possible. For better access to destinations and timely distribution, sponsors will also need to consider consolidation and decentralization using more local storage, in addition to the larger and longer-term storage of products and equipment.
Bringing the clinical trial to the patient’s home
Due to the pandemic, social distancing measures greatly decreased patient mobility, in addition to site availability. Despite relaxing guidelines as countries reopen, the demand for virtual trials will continue to rise. Home health care and Direct-to-Patient/Direct-from-Patient capabilities will become a requirement in protocols to keep patients in trials and, in many cases, may be the only option to keep a trial viable. Logistics solutions will need to be geared to increasing patient care in the home, which can include shipping from a central depot or pharmacy, regional or local depots, and investigator sites. Other considerations include service delivery interfacing, data security and regional regulatory differences.
The importance of engaging a supply chain solutions partner early
Adopting a supply chain partner with a strategic framework can help sponsors minimize challenges by providing creative solutions to move clinical trials forward. In fact, such a partner can not only ensure patients are enrolled and supplied with their required medications, but also encourage them to take their medication and continue with treatment.
What’s more, a supply chain partner with a global GMP/GDP (good manufacturing/good distribution practice) depot network in strategic locations can assist with risk mitigation in storage and distribution. And finally, integrating a partner early on in a clinical development program can accelerate the time urgently-needed therapies reach patients, the time to ship samples to investigator sites or central and specialty labs and, ultimately, the time a therapy is approved and reaches the marketplace.
By leveraging UPS networks globally, Marken was able to find solutions where and when no one else could, accessing geographies inaccessible to commercial airlines during flight reductions or eliminations. Utilizing a Rapid Response Team, Marken onboarded new clients quickly and efficiently to meet patient needs through these uncertain times, maintaining end-to-end visibility throughout to ensure decisions were made quickly and confidently.
Pharma and biotech companies can’t control what happens next in this new reality, but proactive sponsors with a mitigation strategy will be better prepared for the next disruption.