April 2, 2020
Advanced therapies in the COVID-19 pandemic: five guidelines for moving forward
The COVID-19 pandemic presents all of us with a dynamic, disruptive challenge unlike anything most of us have experienced in our lifetime. As we publish this post, we very much hope that all of you are safe and healthy.
We also know that few communities are better prepared for a world that requires constant adaptability. Even during normal operations, advanced therapies demand ongoing flexibility and problem-solving. As we all continue our important work on behalf of regenerative medicine — and also pivot to support public health as called — our community already has tools and experience at hand to navigate this challenging time.
The FDA has quickly led the way by issuing new guidance on the conduct of clinical trials during this pandemic. This concise, highly practical guidance reflects the fact that many new obstacles are arising rapidly.
“FDA recognizes that the COVID-19 pandemic may impact the conduct of clinical trials of medical products. Challenges may arise, for example, from quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations if site personnel or trial subjects become infected with COVID-19. These challenges may lead to difficulties in meeting protocol-specified procedures, including administering or using the investigational product or adhering to protocol-mandated visits and laboratory/diagnostic testing.”
The guidance also acknowledges that there is no one-size-fits-all solution at this unprecedented time.
“FDA recognizes that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19 illness and/or COVID-19 control measures.”
Amid this dynamic situation, here are five further experience-based guidelines we’re keeping in mind as we work with our biopharmaceutical clients and ecosystem partners through this evolving pandemic.
COVID-19 Briefing for Advanced Therapies
The COVID-19 pandemic presents all of us with a dynamic, disruptive challenge unlike anything most of us have experienced in our lifetime. In our latest briefing, Heidi Hagen, Co-founder, and Advisor of Vineti and Christophe Suchet, Chief Product Officer of Vineti walk through their suggestions to help advanced therapy developers navigate this challenging time.
Protect patient safety, remember the patient need
Cancer, genetic disorders, and other conditions addressed by advanced therapies don’t stop in the era of COVID-19. There are patients out there who need their product. Now, we need new ways to get those drug products to them safely.
Advanced therapies that require cell collection and/or delivery at academic medical centers face the greatest challenge. All hospitals, especially large academic centers in urban areas, are understandably under greater strain, face new capacity demands, and are requiring tougher safety protocols. Patient safety is also paramount — vulnerable patients with pre-existing conditions shouldn’t be near COVID-19 wards. Some patients may have new questions about participating in a trial at this point, so information that your clinical partners can share with patients will likely prove helpful.
Here, something we call the “80/20” rule can be helpful. It’s common to have about 80 percent of your patients affiliated with 20 percent of the clinical sites you work with. Start by understanding how those “20 percent” sites are proceeding with clinical trials or commercial cell and gene therapies at this moment in time. Do they need additional support? Do other clinical sites that typically see less of your patient volume have the bandwidth to do more right now? Even if operating at a lower volume, a clinical trial or commercial product can still make a life-saving difference for cancer patients.
Patient safety must be paramount, and can be assessed alongside the need for patient treatment. Making this evaluation will probably take place on a site-by-site, and even patient-by-patient, basis. We’ll also be watching this important research endeavor by the American Association of Cancer Researchers to aggregate data on cancer patients with COVID-19.
Protect your people
Alongside patient safety, the safety of the advanced therapy community is also vital. And because cell and gene therapies involve so many different stakeholders across distributed ecosystems, health and safety concerns are complex. Some teams, such as commercial or IT groups, can more easily work remotely. Others, such as certain roles within bench R&D, clinical operations, logistics, supply chain, or manufacturing, require working out of specialized shared facilities with other people.
Fortunately, some such roles requiring co-location already operate with strong sterility and other “clean room” practices in place, and can be further adapted to social distancing. Others, especially roles in logistics and supply chain, require collaborating with courier partners to promote shared safety. Logistics leaders, including QuickSTAT, World Courier, Cryoport, and Marken, have all instituted new safety protocols and are offering regular updates.
The recent FDA guidance and amended clinical protocols allow for further safety enhancements. For example, if post-infusion treatment monitoring is currently handled for patients at a hospital, could it be shifted to an out-patient setting, or even an in-home setting? Improved data exchange through telemedicine could also work. Digital data exchange and telemedicine open up new avenues for conducting compliant protocols and processes safely.
Step up supply chain vigilance and communication
Advanced therapy supply chains always carry risks — and now those are larger than ever before. Widespread disruptions to commercial flight schedules can affect cell collection, drug product delivery, and the overall patient treatment timeline. Patients may have a more difficult time getting to procedures. Hospital logistics teams may have new and competing priorities.
Here, constant monitoring and communication is key. If major airlines are not currently able to meet your drug product timelines, cargo carriers may be available. Specialty couriers, such as those mentioned above, are working around the clock to move products and provide solutions.
Communicate with your collection and infusion centers daily, and remain available to them — they are also juggling a constantly changing situation and working hard to make the most of every opportunity to provide advanced therapy care to a patient.
Monitor manufacturing, wherever it happens
Some advanced therapy developers run their own manufacturing. Some rely on contract manufacturing. Others use a mix of both. One thing is certain — even though biopharmaceutical manufacturing is open as an essential service, it’s “business as usual” for no one right now.
If you operate your own manufacturing facility, a key focus is taking care of your employees, which will in turn help make sure the products you produce are safe. Increased social distancing, increased sterility, and vigilant health monitoring are all key. Some facilities may be going towards more staggered shifts, for example, to allow for greater social distancing among team members.
If you work with a contract manufacturer, increased communication is key. Are their priorities changing? Are their timelines changing? Do you still have the manufacturing slots you planned on, and do you still have visibility into manufacturing timelines? What is the forecast for slots, and do you still have the capacity you’d planned on? All of your capacity — at clinical sites and within manufacturing — is vulnerable to change at this time, and a change on one end ripples across the entire production process.
It’s also important to understand how your manufacturing partners protect their facilities and team. As the sponsor, product safety and quality is ultimately your responsibility.
Strengthen your systems and security
Those of us who can work remotely during this pandemic are fortunate. Cloud-based systems, video conferencing, and other remote tools make collaboration possible in ways that would have been impossible before.
But these advances also carry risks. Many companies, including biopharmaceutical firms, now find themselves in a phase that opens new security weaknesses. Team members working from home and working on their own wifi networks can introduce more security variability. Make sure your SOC (Security Operation Center) has stepped up its monitoring. Have remediation strategies in place.
Remote work also raises new system capacity demands. If you have applications that are behind your network, can your VPN handle the increased load as more team members require remote access? Are all Tier 1 applications up and running in this shifting scenario? Given the shift in work patterns, performance issues should be anticipated and addressed proactively.
Above all, let’s continue to collaborate. We know that some trials have paused for now, and we’ll be here to help when they resume. As always, there will be different agendas at the table in the weeks and months ahead. But the patient is a common agenda. Advanced therapy patients are often very ill, and we all want to get their drug product to them if there’s any way we can.
If you have questions about advanced therapy work in the era of COVID-19, please let us know. You can learn more about Vineti’s response and our ongoing operations here and view our briefing here. If you are healthy at home, we hope you are able to continue your important regenerative medicine work in some way. And if you are facing a health challenge of your own, we send you our team’s best wishes for a strong and speedy recovery.
Heidi Hagen is the Chief Strategy Officer and a Co-founder of Vineti. Over the course of her career, she has overseen the operations and delivery for more than 100,000 doses of cell therapy. Christophe Suchet is the Chief Product and Compliance Officer of Vineti, and previously led IT systems for cell therapy pioneer Kite Pharma. If you’d like to see how Vineti’s Personalized Therapy Management (PTM) platform can help you solve your advanced therapy data challenges, please contact us to schedule a demo.