Brad Payne (BP), chief operating officer of PCI Pharma Services, talked with Outsourcing-Pharma (OSP) about the factors that shaped the pharmaceutical industry in 2020, and how supply-chain issues likely will continue to be a top priority.
OSP: Could you please share your perspective on some of the key happenings and challenges faced in drug development in 2020?
BP: One of the key challenges for the industry this year was the ability to source raw ingredients for manufacturing and the components needed for packaging from outside of North America and the UK. As a result of the COVID-19 pandemic and border closures, importing and exporting across borders during lockdown became increasingly difficult. As well, uncertainty around Brexit was very much a focus, creating the need for contingency plans.
Another drug development challenge was anticipating the necessary levels of supply. We had to reevaluate how much supply we normally have in our inventory and considered a shift from an eight-week supply to a 10- or 12-week supply. As the pandemic continued, we realized that having more product and raw material in stock and in the supply chain made us better prepared for the following waves of the virus.
BP: At PCI Pharma Services, we were already in the process of a digital transformation, and the COVID-19 pandemic served as an opportunity to accelerate what we had started. We found new and innovative ways to help ensure continuity of business for our clients via technology and learned that many of these solutions were actually more efficient.
A great example is how conducting on-site audits and inspections became challenging under social distancing guidelines as well as travel restrictions. We decided to shift to a virtual model and were impressed with how effective it was.
We have also asked our employees and clients alike to embrace digital transformation. In part, this was necessary during COVID as e-signatures, virtual meetings, and new software became part of the new norm. In the midst of COVID-19, we also launched pci | bridge, an advanced digital platform that gives our clients immediate visibility into their clinical and commercial supply chain and provides instantaneous data and insights to inform decision-making; this has completely changed the way we interface with clients – for the better.
We are continuing to look at the new ways we are doing business – digitally and otherwise – and asking ourselves, what changes should we keep for the long-term? We have proven we can adapt to new ways of working and still deliver the excellent client experiences for which we are known.
The challenges posed by the coronavirus pandemic have allowed us to reassess the effectiveness of the systems we currently have in place. As such, I think there is more willingness to retire old paradigms and policies, that are no longer ideal and try a new approach.
OSP: Please share some of the trends you have observed in drug development, and how these trends are impacting the requests/demands your clients approach you to help address.
BP: One trend that has emerged as a result of the coronavirus pandemic is the rapid shift to both virtual clinical trials and virtual site audits in order to keep life-saving drug launches on track. We have now seen the operations of the clinical trial process digitized through software and services.
At PCI, we fast-tracked our plans to develop Direct-to-Patient (DTP) Clinical Trial capabilities. In a pandemic, you must be clever to see how you can do a study without bringing people together at a trial site.
We have also seen great success with virtual site audits, as I mentioned earlier. These audits allow our clients to gain insight on our processes, review the site metrics, and assess the overall health of the site.
Though all of our sites had the capability to conduct virtual audits and inspections, it wasn’t something we did because there was never a need. But in this unique COVID-19 environment, both sides had to think creatively about how to handle these processes effectively while following the recommended guidelines and restrictions to ensure safety.
Our sites individually assessed the implementation of video footage and photos. Document review through an online portal became the norm. These virtual site audits saved time, travel and resources, so we definitely see using them for the foreseeable future. This is an opportunity to leverage newfound efficiencies for both PCI’s and our clients’ benefit.
We also continue to see advancements in cancer and hormonal therapies, as well as growth in the allergen market, which drives a stronger need in the marketplace for high potent compound suites. We have recently added more of these at our facilities in Rockford, Illinois, and Dublin, Ireland.
We are adding additional high potent tablet and capsule manufacturing capacity at our Tredegar, UK site to support customer clinical and commercial needs in oncology and other indications across global markets. We have also expanded our Biotech Center of Excellence in Philadelphia, Pennsylvania, building out existing cold storage capabilities and leading-edge manufacturing suites as well as continuing to offer innovative design teams to help address the packaging challenges often presented by biologic products.
At PCI, we are making strategic decisions like this that enable us to meet increased demands for bringing complex treatments to market so we can support our clients’ evolving business.
OSP: Supply chain continuity and security are increasingly top of mind for pharma professionals, as well as people outside the industry (see recent proposed legislation, like the Warren-Rubio bill). What kinds of solutions to these concerns do you expect we might see in coming months?
BP: The supply chain over the last 10 years has become more global. During the pandemic, we needed to bring more of this work back to North America to simplify transportation and logistics requirements. Shortening the distance in the supply chain expedites deliveries and lessens room for complicating factors, like customs clearance. We expect more of our clients to shift to localize.
Supply chain security is very important to our clients. At PCI, we have plans to expand manufacturing capabilities at certain sites in the U.S. to meet client demands and ensure that we are a true “one stop shop,” removing any gaps that could contribute to security concerns in the supply chain.
OSP: What advice would you give pharma firms looking to best prepare themselves for the challenges of 2021 and beyond?
BP: As the COVID-19 pandemic continues, pharma and biopharma companies should be prepared to manage an unusual forecast driven by pent up demand. Since people have been quarantined at home, they may be avoiding regular physician visits or medical help unless it is an emergency as to not risk any exposure to coronavirus. As a result, this will likely impact overall volume because patients may not be receiving physician administered drugs or getting new prescriptions written.
Once a vaccine is available and quarantine restrictions are lifted, companies should think about starting to build their supply chains for bulk manufacturing to handle the potential surge in volume, so necessary components can be ordered ahead of time before the demand hits.
Companies should also think about applying for challenging import licenses for hard-to-reach countries as far in advance as possible. As we have seen from the COVID-19 border restrictions, it has become increasingly difficult to get products into certain countries like Eastern Europe, China, Ukraine, etc. Applying for these licenses can be a time-consuming process and companies will want to be as prepared as possible once restrictions are lifted.
Finally, take this time to be proactive and creative. During the past year, when things slowed down at certain points, we had time to look ahead and be more forward-looking and intentional. Brainstorm new processes, models, clinical trial designs, etc.
Consider direct-to-patient initiatives to improve enrollment in 2021 and ultimately save on cost and speed up approvals. Spend more time on the creative aspects, like componentry designs and packaging artwork. Take a step back and discuss what business approaches have proven to be successful and are worth keeping and which ones can be changed.