Guest Column | December 7, 2020

COVID-19 And Beyond: Perspectives From A Regulatory Affairs Professional

By Jiwen Zhang, VP, Regulatory Affairs, Passage Bio

Disclaimer: The views, thoughts, and opinions expressed in the text belong solely to the author, and not necessarily to the author's employer, organization, committee, or other group or individual.

When the bell rang at the New Year’s Eve, the year of 2020, as the number symbolizes, seemed especially exciting and promising. Then COVID 19 hit.

COVID 19 has brought about many disruptions. Delays are happening in research and development, manufacturing, supply chain, almost all the components essential to drug development that ultimately lead to regulatory decisions and patient access to innovative drugs. Interactions with regulatory agencies have become unpredictable with longer wait to hear back from agencies or review teams that are critical to move along the development process. In some way, delays in agency interactions is inevitable since interactions even among our own internal teams have become challenging: no more water cooler catch-up; no more walking to a colleague’s desk for a quick answer or update; no more impromptu huddles to white board a problem and scenarios for solutions.

However, there have been obvious silver linings. Take myself as an example; working from home saves me at least two and half hours of daily commute time, which has become crucial to manage the increasing workload. Getting rid of the commute not only has extended work hours but more importantly has afforded the luxury of thinking through a problem without interruptions. With conferences going digital and some of them being held at off hours, I managed to attend several meetings otherwise unlikely for me to participate, such as the APEC Regulatory Harmonization Strategic Committee (RHSC) meeting that would have been held in Malaysia this year, or the GM1 Family meeting organized by the Cure GM1 Foundation which was so compelling and inspiring.

Along the way, with careful planning and a forge-ahead attitude, we have adapted to the COVID situation. Watercooler catch up is now replaced by using various digital tools. White board sessions are held on Microsoft Teams or through Zoom meetings, which surprisingly have been easier to arrange than before as people have become more available without disruptions of commute or different work schedules. Regulatory agencies have also adapted to offer virtual meetings to foreign sponsors and attempted to accommodate time zone differences. As a result, more meetings with global regulatory agencies can be managed without the need for international travels that are very costly and time consuming.

As COVID-19 likely will linger for some time, new practices and conventions are being developed and established. While a digital conference cannot offer in-person networking opportunities that are as valuable as technical contents to attendees, CASSS for one is considering options such as local hub gathering for their 2021 Cell and Gene Therapy Products Conference to facilitate social connect and technical discussions.

With challenges of conducting clinical trials in COVID-19 environment, using digital tools has become a part of solution. One example is remote assessments in CTs.  Collecting better data in real life situations, which is especially important for neuroscience indications, have been in discussion for some time but without much progress. Now the pandemic has jump started those approaches. The resulting innovations will probably be of a great value to digital health solutions long after the pandemic becomes a distant memory. At the APEC RHSC meeting, several large biopharma companies shared their commitments and plans to advance digital health development, which not too long ago was primarily a focus among medical device companies.

COVID-19 has significantly impacted our daily life, work, and productivity and has manifested social, economic, and cultural issues. But COVID-19 has also brought acceleration in major areas. The fast pace development of vaccines speaks to the innovation of biotechnology, the close collaborations among academia, industry and government agencies and the commitment from all stake holders to overcome this crisis as quickly as possible.

Looking back, when COVID-19 started in early 2020, I for one, had no clue what to expect, how long it will last and what is its impact will be. But over the course of 2020, we have resituated ourselves to the COVID-19 environment, made progresses with amazing strides. We do not want COVID-19, or any another crisis. But when it happens, if we can adapt, embrace the challenges and opportunities, crisis can stimulate innovations, forge alliances, cooperation, and collaborations. In response to crisis, national healthcare policy updates and global regulatory cooperation and convergence are also essential as expressed by high level healthcare officials at the APEC RHSC meeting. For now, accelerating vaccine and antiviral drug development is the focus. But the resulting framework and infrastructure will undoubtedly benefit future healthcare management and delivery to ensure patients’ access to safe and effective treatments.