NextGen Companies Face Resiliency Test During COVID-19 | Deloitte US has been saved
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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:
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.
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.
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.