Evolving Operating Models in Regenerative Medicines: A Parallel to COVID-19
By Rachelle Jacques, CEO, Enzyvant
Global healthcare systems are facing the need for urgent evolution as they respond to the new and rapidly growing threat of COVID-19. This is a parallel to the biotechnology sector as we address needed evolution in our operating frameworks to seize the emerging opportunity of regenerative medicines.
Health care systems must quickly adapt to the COVID-19 crisis — scientifically, strategically, and operationally. This need for speed is one important common thread between COVID-19 and regenerative medicines. Regenerative medicines have generated tremendous fervor and attention because of their curative or near-curative potential. These are disruptive innovations and they are doing what disruptors do, requiring the industry to adapt. An opportunity we have never conceived of before has the potential to change everything.
The novel coronavirus response started by understanding the science and epidemiology.
At the earliest stages of the novel coronavirus spread, the rallying cry was “listen to the scientists.” It was and is crucial to hear from the Centers for Disease Control, World Health Organization and other scientific experts in infectious diseases to characterize the new virus and frame the epidemiological problem. To effectively protect communities from the threat of COVID-19, global healthcare systems, policymakers and local governments needed to know more about the cause, models of disease dissemination, impact, and how the spread might be slowed and stopped.
The revolutionary science of cell, gene and tissue-based regenerative medicines is advancing quickly.
At first, the excitement of any emerging biotechnology is focused on the promise of the science. Regenerative medicines are no different and the work to establish the science behind these breakthroughs is advancing quickly. The challenges of proving out the promise of regenerative medicines with compelling evidence of safety, efficacy and even long-term outcomes are being overcome. However, regenerative medicines are unlike anything that has come before. Existing industry frameworks and operating models were built for mass market therapies, not for these uniquely complex and personalized therapies. The obstacles to success for regenerative medicines are understood, and benefits to patients and society at large could be enormous. Yet there is still inertia to the industry changes needed to seize the opportunity of regenerative medicines that will surely save many lives.
The significance and speed of the spread of COVID-19 are better understood. So now what?
The numbers started to show us, as much as the scientists were telling us, that the impact of COVID-19 would not be isolated only to small vulnerable populations of people in a few countries. There was a country-by-country realization that this is a global pandemic impacting most communities and having the potential to overwhelm existing global healthcare systems. Quickly, we became immersed in the very real operational problems of resourcing frontline health care at a massive scale. We have called for creative solutions from public-private partnerships that can speed the provision of testing, equipment, services, vaccines, potential treatments, trained personnel and other resources to communities in desperate, immediate need. The urgency is palpable. The answers to operational challenges are not easy fixes to existing frameworks that were not designed or built for anything of this scale, complexity, urgency, and sweeping consequences to human life.
A threat unlike any other has the potential to change everything. The threat will reshape the underpinnings of the global healthcare system faster than ever before. And, we must evaluate the costs to society of maintaining our traditional approaches compared with costs to society of a long-term COVID-19 solution. After this immediate threat has passed and we look back, lives saved will measure the value created by today's actions. What may seem expensive upfront oftentimes has the benefit of looking astoundingly beneficial and cost effective in the rearview mirror.
New operating models are needed for regenerative medicines.
Regenerative medicines also require new thinking and new approaches across the value chain. Each category of regenerative medicines — cell, gene and tissue-based — are different and each therapy within each category is likely to be unique. Some regenerative medicines are one-patient, one-lot bespoke therapies. When it comes to Chemistry Manufacturing and Controls (CMC) there are no wholesale standards of what good looks like for the production and handling of regenerative medicines.
Even the manufacturing environments themselves are, in some cases, completely new. For example, tissue-based therapies require a perfectly-timed and orchestrated process aligned to work seamlessly for healthcare practitioners, payers, patients and families. All aspects of the supply chain may exist entirely within one center of excellence (COE), a stark contrast with existing industry models.
The CMC and commercial playbooks are relatively new with each regenerative medicine, but also the players may be relatively new at executing the plays. Company sponsors have been at the center of traditional pharmaceutical and biotechnology operating models, working independently with unique partners in each aspect of the value chain. The role of COEs in this operating model have been largely focused on treatment. Now with regenerative medicines, COEs are suddenly involved in, if not at the center of, many aspects of the value chain (see Figure 1). Due to the nature of regenerative medicines, these institutions have been thrust into a key role that they are not organized, incented or governed to perform. From sourcing the raw, fragile biomaterials, to handling of the materials and manufacturing therapies, to managing the intricate-timing of getting therapy at the right time and place to the patient – all this must be led and managed at least in part within the COE’s ecosystem. Any processes, systems and rules related to this were set up for research purposes and are not typically suited for commercialization. This infrastructure to support commercialization of regenerative medicines within the COE ecosystem must be adapted, but at an accelerated pace. The role of the company sponsor is much more as integrator in this operating model to communicate, coordinate, support, and educate. This transition of roles isn’t currently supported by existing approaches, practices, or even certain laws and regulations. Anti-kickback rules that govern relationships between company sponsors and HCPs are one example. These were created to mitigate wrong-doing in the form of financial quid pro quos, but now limit close collaborations needed to effectively bring certain regenerative medicines to patients in desperate need. Clearly changes and updates are needed in several areas to adapt. Change cannot be driven alone by younger biotech companies. This is change at a massive scale that requires all stakeholders, working together.
Figure 1.
There are burning questions to answer as the industry urgently adapts to regenerative medicines.
The first call to action in industry change is to ask the burning questions. How should companies adapt their business models and organizational constructs and how quickly can we get it done? How should COEs evolve and how can we help speed that change? How can other stakeholders, such as payers and regulators, rapidly shift? The second call to action is to collaborate on accelerated real-world solutions to answer these questions, across industry stakeholders.
Speed matters.
Changes to healthcare operating models are happening in response to COVID-19 in days and weeks. These changes are in response to an unprecedented global threat. However, we have to ask ourselves what is standing in our way for more rapid advancement of new operating models for regenerative medicines? It is especially difficult to accept inertia when lives are on the line. Moving fast before the science is solid, with clear safety and efficacy data, is a real risk. But given solid science, moving forward quickly on restructure of the operating model across the value chain has limited risk. We see rapid change playing out in COVID-19. Suddenly, things that were not possible are possible. Rules that were in place are suddenly not as important as they once were. Patients and healthcare systems are waiting in desperate need for the promise of regenerative medicines to be realized. We know the evolution that is needed for regenerative medicines to be successively successful. And, we know what that can mean for patients and the healthcare system as a whole. A decade to change is not acceptable — the clock is ticking down for too many patients around the world.