Life has certainly changed for all of us over the last few months. Nobody in the world is untouched. I was recently reflecting back on what my personal and professional goals were at the beginning of the year and what I thought my calendar would look like. I knew this was going to be a year of massive change in my professional life but I had no idea it would change as it has. As I write this I am thinking that today I should be sitting at WRIB in one of the training sessions on large molecule applications, sipping coffee and wondering what type of delicious treat they would have for the morning break. I’d be enjoying a week in Arizona with some of my best friends because I consider many of you who share my passion for bioanalysis to be my best friends. I am lucky to work in an industry where I can say this. Unfortunately, this is not where we find ourselves today.
The challenges, issues and adjustments we’ve all made as bioanalytical scientists don’t even register on the same scale as the challenges of those in other industries today. The healthcare workers, grocery store clerks, sanitation workers, public safety officers and many, many others are truly going above and beyond. Putting their lives and those of their families at greater risk with the work of their chosen profession. There are also those millions in other industries (including ours) who’ve sadly lost their jobs and now have health and financial security both to worry about. We all have our personal challenges as well. My son has complained apologetically a few times about having to come home from college early, that he’s being cheated about not thoroughly learning critical parts of biochemistry that he’ll need for his MCAT test in a few months. I don’t think he’s wrong to be concerned. This is his situation and it’s ok for each of us to have our own personal challenges and frustrations even if they wouldn’t even register anywhere on other people’s lists.
There are a number of things I’ve been thinking and talking a lot about lately that specifically relate back to bioanalysis. My professional curiosity has lead me to think about the assay formats and possibilities and which assays different companies would offer. I’ve been in quite a number of discussions with companies running clinical trials that have stopped or are considering whether to stop their trials. From what I’ve heard in the industry the healthy volunteer trials have nearly completely ceased and many other trials are stopping or not recruiting additional subjects. What is it going to take to return our industry to good health? Our society is rightly concerned about the impact of COVID-19 and its economic repercussions but imagine the cost in human lives if 6 months or more of drug development shut down. The FDA cites there were 48 new drugs approved in 2019. What does it mean to us if in 2020 that number is only 24? Does it cost more lives and suffering in the long-term than even coronavirus? It certainly is an impactful number to think about.
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The topic of different assays has been an interesting one. It is astounding that almost overnight so many testing options have emerged even if the kits to collect the samples are hard to come by still in some countries. Based on the research of Dr Corinna Fiorotti, a scientific officer at Bioagilytix Labs (NC, USA), there were over 280 assays available or in development as of April 3 for coronavirus and related applications with many of these providing unreliable results. The FDA has worked with more than 240 test developers who will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. To date, 25 emergency use authorizations have been issued for diagnostic tests. On April 1 Cellex Inc. (NC, USA) received EUA for qSARS-CoV-2 IgG/IgM Rapid Test, which is the first serology test to date to receive authorization to test for the presence of coronavirus antibodies. Very rapidly there were qPCR and other similar assay formats in place for detection of the virus to determine active viral infections. We saw the world’s major consumer testing labs quickly have tests available. Not far behind has been Abbot Labs (IL, USA) with the introduction of a 5 minute point-of-care test. At the same time researchers have also been developing serology tests to look for the antibodies against SARS-COV-2. Serology testing will be critical to longer term determinations of likely immunity for returning to work, restarting clinical trials (or even for enrolment) and for proper patient diagnosis and care. These assays all fall into some version of immunoassay and range from flow-through tests resembling pregnancy tests to highly accurate immune response diagnostic assays. It’s a fascinating area of study and I suspect the bioanalytical field will forever be different because of SARS-COV-2.
The issue of clinical trial disruption that I touched upon is also quite interesting despite being very disheartening. There have been guidances from many of the world’s health agencies providing support for companies trying to continue or start and restart clinical trials depending on their situation. I’ve read a number of these and while they’re very focused on the clinical trials themselves they certainly have implications and considerations for bioanalysts as well. Some of the highlights I identified are simply the regulatory agencies noting clinical trials in a COVID-19 pandemic will have new considerations. Some of the points I noted from the FDA guidance were that modifications to a study may or may not require a clinical protocol amendment. While we may expect an amendment for any clinical trial change under normal circumstances, this may not be the case for COVID-19 adjustments. Sample collection locations and timepoint changes are very possible. This means that a sample, which previously came from one site for a subject, may in the future come from a location more local to the patient. For instance, a patient in a study with a major cancer center in New York City who lives several hours away may have their sample collected locally for some timepoints or even at home if that is deemed safer for the patient. Therefore, a single subject’s samples may come from what seems to be multiple sites. Additionally, we may not get a sample at all if a subject terminates due to COVID-19. This will likely be more common during the pandemic. It would seem that if this is the case, collection and shipping errors will be more common so we should be diligent in reconciliation of samples that we may not receive or that we may receive in error. Studies may also be delayed due to clinical supply shortages. It would be prudent to proactively discuss possible concerns with the CRO/site/sponsor managing the study to understand how the study might be impacted. It is also noted that changes to clinical studies, which occur due to COVID-19 should be outlined in the clinical study report and by inference we can assume that such changes that impact bioanalysis should be discussed in the bioanalysis report as well. The guidance also provides for the possibility that COVID-19 impacts may be described in a separate report specific to the pandemic impact so we should be aware of this as well. Our life as bioanalysts has gotten far more complicated in so many ways.
Another way in which things have changed, hopefully for the short-term, is social distancing and working from home. I’ve always felt that teamwork and close oversight from senior scientists and management were of utmost importance in laboratories doing high complexity testing such as bioanalytical laboratories. In all of the geographies I’ve heard about, laboratories doing pharmaceutical testing have been deemed essential businesses and allowed to stay open. Those working on coronavirus related assays of course need to stay open. Doing so during such times is challenging and a single infection could shut down an entire section or shift for the lab. I’ve seen labs go from one shift to three, separate analysts by at least one seat between everyone, management and senior leadership working mostly from home and QC and QA teams are checking out data to review from home. A practice that would have been taboo just 2 months ago but is necessary now. Many labs are still busy but hiring and training in such an environment is challenging so even where there are jobs, they might go unfilled for a while longer than anyone would like. I certainly have the utmost respect for the challenges currently facing the lab analysts and leaders of the operations teams. As we have heard many times in various COVID-19 updates from our government leaders, lab testing is going to be the one of the keys to getting our world back to work, even before a vaccine is developed. Getting that done is all about these laboratory scientists coming to work every day and doing great work.
The last thought I’d like to leave you with is about our responsibility as scientists to be advocates and teachers of our profession. My friends and family frequently come to me for science questions on everything from pool chemicals to what kind of antibiotic to give their kid. Neither of these questions am I qualified to answer of course. Now more than ever there are questions about SARS-COV-2 that they come to me with. I think it is our responsibility to learn about this virus, learn to educate about it in a simple way and have the nuance to defray the many myths that circulate.
About the author:
Chad received his Bachelor of Science degree in Chemistry from Alma College in Michigan and a Master’s degree in Analytical Chemistry from the University of Michigan with a focus in the use of LC–MS/MS in Protein and Peptide analysis. Chad’s Doctorate of Philosophy at the University of Nebraska was focused on studies of Protein Binding via Affinity LC–MS/MS and computer simulations.
Chad has held senior leadership roles within several major CRO’s over the course of his 24 year career. He has become well known in the bioanalytical community on such diverse issues as implementation of biomarker strategies to facilitate drug development programs, the use of advanced LC–MS/MS technology applied to high-throughput analysis and bioanalytical automation and software validation. He is currently principal consultant at CB Bioanalytical Advising where he supports customers throughout the bioanalytical industry.
The opinions expressed in this feature are those of the author and do not necessarily reflect the views of Bioanalysis Zone or Future Science Group.