Posted: 21 May. 2020 12 min. read

NextGen companies face resiliency test during COVID-19

By Hussain Mooraj, principal, NextGen Therapy practice lead, Deloitte Consulting LLP, and Omkar Kawalekar, Ph.D., manager, value chain lead for NextGen Therapies, Deloitte Consulting LLP

In the early days of the COVID-19 pandemic, some biopharmaceutical companies shifted gears and began developing treatments for patients who contracted the disease—and vaccines to keep others from acquiring it. Along with the Deloitte Center for Health Solutions, we interviewed 20 senior executives from global cell and gene therapies (CGT) companies, partners, treatment sites, and academic institutions, to learn about their ongoing operational challenges. Many of them are involved in ongoing trials and several of them had commercialized products. On May 7, Deloitte’s NextGen Therapies practice facilitated an Industry Working Group (IWG) session where 35 executives from 20 institutions (including manufacturers, standards bodies, and providers) shared some of the strategies they implemented early to combat and minimize the impact of the pandemic.

Strategies employed to minimize disruptions

The COVID-19 pandemic affected three key areas in this ecosystem:

  1. The value chain: The COVID-19 pandemic has significantly disrupted the value chain for CGT manufacturers. We define value chain as a series of business operations in which utility is added to the goods and services offered by an organization to enhance customer value. It refers to the process of sourcing, procurement, conversion, and logistics, which becomes a complex network in the CGT world. Some of the executives we interviewed said they were trying to keep their heads above water and keep the value chain from breaking. Even in the best of times, it can be difficult to maintain tight coordination of the CGT supply chain, which is highly time-sensitive. Travel bans, import/export restrictions in various countries, and access to raw materials and samples has created major bottlenecks. Despite these challenges, companies such as Autolus Therapeutics told us their early and corrective measures allowed them to maintain both product supply and development activities, including the filing and acceptance of an investigational new drug application (IND). Autolus, along with others, established a crisis-management team representing cross-functional leadership to manage impacts due to the outbreak. They were able to quickly transition into a distributed network. With the aid of a cloud-first strategy, they enabled remote-working options to access business-critical systems while building robust dashboards, which gave them a control-tower view of all their CGT operations. Novartis typically uses passenger aircrafts to transport its CAR-T therapy (Kymriah) between Europe and the US. In response to international travel bans, the company secured alternate shipment options to avoid delays that could affect treatment.1 Being prepared and acting early helped these organizations stay resilient and determined along their CGT journey.
  2. Ensuring clinical program pipeline continuity: CGT clinical operations are typically restricted to a few specialized (and certified) medical centers, which tend to be located in large metropolitan areas. This requires patients, caregivers, and other relevant stakeholders to commute to such sites. This can pose a major pain-point and increase the health risk to all. Shortly after COVID-19 was declared a pandemic, the US Food and Drug Administration (FDA) issued guidance to temporarily allow researchers to use virtual visits, telephone interviews, and remote monitoring to collect data for clinical trials where possible.2 During our IWG meeting, various strategies to mitigate the impact on ongoing clinical investigations of CGTs were discussed. Representatives from one biopharma company said they instituted an “all hands on deck” theme where daily R&D operations were tracked to assess risk to patient schedules. Taking inputs from their supply chain, accounting for patient logistics, assessing availability of hospital resources, and providing remote access to site managers helped them assess the risks, benefits, and alternative options for each patient on a case-by-case basis. This facilitated business continuity and efficient patient management, thereby minimizing process deviations and patient-safety concerns.
  3. Reducing the impact on ecosystem stakeholders: Safety risks tied to the COVID-19 pandemic, hospital staff shortages, ICU-bed capacity limitations, and stay-at-home orders in most states have significantly disrupted daily operations for nurses, physicians, and other health care providers at medical institutions. Patients often travel long distances—sometimes internationally—to donate starting material (apheresis, as in the case of cell therapies) and receive treatment. This has been made nearly impossible by travel bans. Given the restrictions imposed for traveling across borders/cities and local housing closures, patients and donors have faced difficulty getting to the apheresis sites, diagnostic-test sites, or therapy-infusion sites. Moreover, CGT patients are typically administered an immune-suppressive chemotherapy a few days prior to delivery of the actual therapy. This leaves the patient severely compromised to opportunistic infections, including COVID-19. To help minimize such repercussions, CGT institutions have been assessing the impact of the shutdown on a country-level/regional basis. Allowing couriers to travel to countries for apheresis collection, for example, is being negotiated with local authorities to understand and adhere to additional approval requirements. Be The Match BioTherapies and the National Marrow Donor Program have been working with the US Centers for Disease Control and Prevention (CDC) to make special provisions and secure waivers for foreign nationals (non-US passport holders) to travel between the European Union and the US to transport cells.3

Can COVID-19 ignite an era of change in the CGT industry?

Last fall, the CGT market was projected to grow to $6.6 billion by 2024—up nearly 25 percent.4 Another projection estimates approximately 350,000 patients will be treated with 30 to 60 CGT products by 2030.5 It’s too soon to know how this unprecedented pandemic might impact those projections. However, it is fair to assume that the impact will be significant. That begs the question—how can the CGT industry evolve to get past this situation?

In some sectors, the pandemic has accelerated changes in care delivery that were already underway. For example, fears about seeking in-person care at a hospital or doctor’s office generated renewed interest in virtual health among patients and providers. In the case of CGT, however, the impact has been quite the opposite: progress has stalled, and we don’t know when the wheels will start turning again or what CGT might look like in the future. The pandemic could push company leaders to resolve some of the challenges we outlined in our paper so CGT can thrive.

Consider this: In the post-pandemic era, early stage manufacturing, which is based on completely automated manufacturing technologies, should be tested. Erbi Biosystems, Invetech, and MultiplyLabs are examples of companies that are testing robotic systems for CGT manufacturing. We could also see manufacturers broaden the network of donors (in the case of allogenic therapies) and raw material sources (e.g., viral-vector manufacturers) to be more resilient in times of such supply chain disruptions.

The concept of “bedside manufacturing,” or bringing the manufacturing closer to the patient (perhaps in the hospital itself), might be put to test. This could obviate any logistical complexities and significantly reduce the vein-to-vein timelines in getting the products to the patients.

As for disruptions to clinical trials, the CGT industry could learn and implement a few ideas that are being evaluated by traditional pharma companies, as outlined by our colleague Dawn Anderson in her recent blog. Some examples could be considering relocating trials from COVID-19-hotspots to other regions which have not been hit as hard or determining alternate ways to account for missing data or deviations from planned-study protocols.

To ease the burden of travel on patients deemed eligible for autologous cell therapies, could the industry execute in-house apheresis? Simply put, if you cannot get the patient to the apheresis site, could you get the apheresis (equipment) to the patient, similar to the Red Cross Bloodmobile and Community Blood Center’s LAB on Wheels?

We believe the CGT industry as a whole will continue to assess new constraints and evolve as it responds to these challenges. We, along with the IWG, are pushing for standardization and development of an industry utility, which we believe will help increase resiliency in the value chain, thereby allowing CGT manufacturers and providers to manage disruptions like we’re seeing during the current COVID-19 crisis. We could take advantage of these unprecedented times by creating an opportunity to change existing processes and move this fledgling sector further into the future.

Endnotes

1. Novartis sidesteps Europe travel ban to provide CAR-T drug Kymriah to patients, FiercePharma, March 13, 2020

2. Coronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials, FDA, March 18, 2020

3. COVID-19 FAQs for Patients before Transplant, Be The Match, April 6, 2020

4. The Cell and Gene Therapy Market to Reach Revenues of Over $6.6 billion by 2024, Arizton market research, November 13, 2019

5.  Estimating the clinical pipeline of cell and gene therapies and their potential economic impact on the US healthcare system, Value in Health 22, no. 6 (2019): pp. 621–6.

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Hussain Mooraj

Hussain Mooraj

Principal | Deloitte Consulting LLP

Hussain brings more than 25 years of experience in manufacturing, supply chain, enterprise technology, sales and marketing, and strategy consulting to his role. Hussain works closely with senior executives from global life sciences firms helping them transform their end-to-end businesses and build start-up organizations to be able to launch life-saving new therapies, especially on the CAR-T and gene therapy side. Hussain leads the Next Gen Therapy practice and is the New England regional lead for life sciences.