The pandemic and resilience for the future: AccBio 2021

Abstract

The year 2020 brought the onslaught of a global crisis in the form of the COVID-19 pandemic. While nearly every facet of everyday life and work was impacted by the pandemic, the biopharmaceutical industry found silver linings in innovation, partnership, and resiliency, all of which contributed to unprecedented speed in developing and delivering vaccines and therapies. The 7 th International Conference on Accelerating Biopharmaceutical Development (AccBio 2021) brought together industry leaders to share experiences from the past year and discuss how lessons learned from the pandemic can be carried forward into the future of biopharmaceutical development. Presenters highlighted examples such as introducing biotherapeutics derived from non-clonal cell pools into the clinic, developing modular or platform technologies, and taking novel risks, among others. These strategies for enabling speed to clinic and launch, as well as for sustaining a robust supply chain, are likely to be integrated into future programs to ensure biomanufacturing resiliency and get medicines to patients faster than pre-pandemic times. 1.This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as

Rapidly accelerated development of neutralizing COVID‐19 antibodies by reducing cell line and CMC development timelines

“…Such requirement for speed renders CMC activities, including CLD, on the critical path to fast regulatory approval. In response, the pharmaceutical industry has indeed met the challenge and a number of SARS‐CoV‐2‐neutralizing antibodies have been approved for emergency use in record speed (McGovern et al, 2022 ). Development timelines of CMC activities in both early‐stage and late‐stage development have been significantly reduced to enable the speedy provision of clinical materials.…”

“…For mAb products, a CMC timeline of 10–12 months from DNA to IND application is already considered expedited. However, during the COVID‐19 emergency, combined efforts from sponsors, contract development and manufacturing organizations (CDMO), and regulatory agencies have drastically shortened CMC timelines from DNA to IND to 3–6 months (Figure 1 ), and from DNA to EUA to less than 2 years, for a number of SARS‐CoV‐2 neutralizing antibodies (Agostinetto et al, 2022 ; Kelley, 2020 ; McGovern et al, 2022 ; G. Xu et al, 2022 ; Zhang et al, 2021 ). As CLD serves as the initiation point for the entire CMC program and provides the final clone intended for manufacturing, effective management of CLD timeline and product quality is of utmost importance to ensure the timely delivery of high‐quality clinical materials.…”

Accelerated CMC workflows to enable speed to clinic in the COVID‐19 era: A multi‐company view from the biopharmaceutical industry

“…When considering the overall timelines from DNA transfection to IND/IMPD application (Figure 1a), 30% of COVID programs took less than 6 months, which is in line with previous reports. 8 Nevertheless, most COVID-19 specific development programs took 6-9 months while the majority of non-COVID development programs took 13-18 months. In fact, the "slowest" COVID-19 program took broadly the same time as the "fastest" non-COVID programs (10-12 months).…”

“…3 However, during the pandemic Eli Lilly reported reducing their transfection to first in human (FIH) timeline to less than 2 months for their COVID-19 antibody (bamlanivimab) while AstraZeneca took just 3.5 months from gene to FIH for a therapeutic antibody combination. 8 Interestingly, AstraZeneca leveraged existing platform knowledge to enable this expedited development, their long history and experience with their platform process reassuring health authorities and providing confidence in a novel COVID-19 therapeutic product. 8 Finally, Merck KGaA made clinical trial material available in 4.5 months.…”

Professional Governance in a Time of Crisis

“…Political, policy, social, logistic, and process leadership has dramatically confronted every level of society, pointing out serious challenges in national crisis management and in the effectiveness of our healthcare system. [6][7][8][9] As the pandemic unfolded, many of the issues that arose evidenced the need to address underlying obstacles to effective patient care. It has been truly inspirational that, even in these troubled and tumultuous times, those at the point of service accomplished so much.…”