New Praise, and Pressure, For the Pharma Industry
ongoing research. But in the legal department, it actually
Amy Fix, partner at Barnes & Thornburg, discusses the
effects of the COVID-19 pandemic on the pharmaceutical industry, including the ways that health and safety protocols have affected the R&D process, the pandemic’s impact on the patent and regulatory landscapes, and what the future of the industry may look like.
CCBJ: Your clients range from large international pharmaceutical corporations to smaller companies producing innovative drugs and drug products. Within the context of the COVID-19 pandemic, what have you
offered some of our in-house colleagues an opportunity to review a great deal of ongoing projects and get caught up on projects that had been placed lower in priority. How do you think the pandemic will influence the future of R&D in the pharmaceutical space? I think there will be some necessary changes in order to accommodate individuals and their particular sensitivities to the virus – like social distancing, appropriate spacing, appropriate partitioning, and other physical measures. The
observed among your clients?
availability of a vaccine will help, but getting it distributed
Amy Fix: At the outset, I think the pandemic caught
nated still remains a challenge. In the meantime, I do think
everybody by surprise. Many of my pharma and life sciences clients are focused on the research and development (R&D) of new medicinal products, and the lab-based business was hit particularly hard, because with social distancing and other required mandates, it was very hard to run research. Additionally, a lot of companies had trouble filling orders for the initial starting materials and required reagents used to perform their research, so there was a backlog associated with getting their R&D
and getting everyone vaccinated who chooses to be vaccithat there’s a longer-term shift that will continue. There will be a change in how a lab-based business can be run. Because, again, people working for long hours in confined spaces just isn’t going to be an appropriate way to work for the foreseeable future. Instead, people will have to work in shifts or in some fashion like that, where one person is in the lab at a time, depending on space constraints. It will make things more difficult in terms of timing, and I think that is the biggest issue. Things that used to be able to be
operations back up and running – even once they were
done rather quickly are going to be on a different timeline,
able to work out some sort of program that allowed for
because the ability for people to be in the lab, in close
social distancing in a lab environment.
confinement, just isn’t available anymore.
The bigger companies fared better than the small com-
In R&D contexts, there’s a timeline associated with every-
panies, and it was often a matter of space. The larger
thing in pharma, and every development program is
organizations, again, had the ability to spread people
given a Gantt chart that says which activity has to happen
out, whereas smaller companies didn’t have the ability to
before the process can advance to the next activity, and if
space people or offer any sort of partition, so they really
everything is shifted because things can’t run in parallel
had to modify their work plans pretty aggressively. As
due to space constraints, then the expectations for these
a result, we had a lot of people slow down some of their
various programs have to be managed for the increased CORPORATE COUNSEL BUSINESS JOURNAL
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