Remembering 2020, Anticipating 2021.  

 The Bracken Group Team Shares a Few Thoughts on the Year Just Finished and the Possibilities That Lie Ahead. 

Liz Bloss, DVM 

2020 brought with it enormous challenges—and also big wins. Colleagues, clients, and collaborators across the industry learned how to be flexible thinkers and communicate more broadly and globally.  

Because we couldn’t meet in person, we figured out how to converse using technology.  Because we couldn’t travel, we discovered that we could bring together more colleagues across the globe with technology. Because of wider participation, we shared more information and exchanged more knowledge more quickly, leading to faster and better decisions. In some cases, that translated into faster and more honed reviews by the regulators.    

This ability to converse better and faster globally will serve us well in the future. Becoming more adept in our communication methods and styles will become more and more important as we share our knowledge globally in increasingly cross-cultural and cross-functional teams.  Here’s to 2021 and beyond! 

Colin G. Miller, PhD, FIPEM, CSci 

At this same time last year, none of us could have predicted the events that were about to unfold as COVID-19 was just being identified. However, a pandemic such as this was predicted—we just had to watch the movie Contagion 10 years ago or read blogs in 2013. At the start of 2020, the pharma industry was suffering a “bad rap” in the court of public opinion, but by the end of 2021 this will have changed, if the vaccines prove effective (as the results are suggesting at the time of writing).  According to Scott Gottlieb, ex head of the FDA, the pandemic could end in 2021. History books will describe the events of 2020/2021 as the 21st century pandemic in which the pharmaceutical industry re-invented itself and re-invigorated innovation.   

Most generations have lived through a major catastrophe, be it a world war or pandemic. This may be ours; 9/11 was short lived and although horrific, did not cause the number of deaths we are seeing from COVID-19.  However WW2, WW1, The Spanish flu, HIV, Smallpox, the plague, and many others killed more people than COVID-19.  This is not to minimize the challenge and the deaths, but to point out that the biopharma industry became the “white knight.” If the global leadership of this industry continues to step up and ensure that patients’ health and wellbeing are seen as the primary targets, then potentially more lives will be saved—not just from the prevention and treatment of COVID-19, but also other diseases will be conquered in faster timeframes and patients will become more engaged in the clinical trial process. 

 Jim Gilligan, PhD, MSIB 

“Lessons learned” is a phrase that is often bantered about.  As a country, and in particular, those of us in the healthcare sector, we have learned a tremendous amount and we still have a lot to learn about COVID-19.  As an example, healthcare professionals are now much better equipped on how to treat individuals who are COVID-19 positive and presenting with symptoms. The use of anticoagulants is now standard, which was not the case at the onset of the pandemic.  Advances in molecular biology have provided the tools to sequence a unique virus, identify the region responsible for allowing SARS-CoV-2 transmission to humans, and develop PCR, antibody, and antigen tests in record time.  These powerful tools were not available even a short decade ago. The private/public partnership to create a vaccine in record time demonstrates what can be achieved when everyone is working together toward a singular goal.   

Another lesson learned is how vulnerable our society is to a virus that is not exceptionally virulent, but is highly contagious. As the word of COVID-19 spread in March of 2020, few people expected we would still be in the current situation at the end of 2020. As we move into 2021, the availability of vaccines from multiple organizations will help restore normalcy; but lest we forget what a difficult time we endured, let’s hope we stand better prepared in the future thanks to “lessons learned.” 

The healthcare industry is poised to make continuing contributions to society in general in 2021. Our industry and its commitment to medical research and breakthrough therapies are often overlooked in the grand scheme of healthcare. The ability to return to school, work, have family and social gatherings, and not live in fear of a potentially lethal virus are invaluable.   Bottom line: the achievements we have made in 2020 will provide better lives for millions of people in 2021. 

Nick Spring, BSC, DipM 

2020 was a year that started off strangely and got weirder by the day. In Europe, the EU was reeling from Brexit and its impacts and connotations—not only for the economic union, but also the impact on issues such as unified regulatory standards by which pharmaceuticals and medical devices are governed. In the US (and globally) the COVID-19 pandemic wreaked havoc with the healthcare system, the economy, and society. In addition, science in the form of leaders like Dr. Fauci, Dr. Scott Gottlieb, Dr. Rick Bright, Dr. Robert R. Redfield, CDC, and WHO came under blistering and consistent attack from a non-science based political point of view. Finally, the year finished with probably the most divisive and politically charged Presidential election since the Vietnam era of the 1960s. Joe Biden won decisively, which is probably good for the life sciences industry as a whole given his commitment to easier general access to healthcare.  

So, my predictions are as follows: Politically we will see a new building up of both internal and importantly external relationships abroad. This will put the US back on the map as a traditionally trustworthy ally and leader on global initiatives such as the environment, cybernetics, computing, space exploration, knowledge, and life sciences. The US will rejoin the WHO and play a prominent leadership role in its refocusing and restructuring. Economically, with unemployment in the US moving back again toward 10%, things are going to get tough. I think that from January to June we may see the economy slip into a mini recession; however, with the pandemic regressing, matters will pick up positively in the second half of the year.  

On the social front, the pandemic accelerated the concept of working remotely and virtual companies. I think that it is here to stay, so the concept of a traditional office and commuting will evolve, which will be excellent for people’s work/life balance as well as the environment since it will cut down on carbon emissions. Finally, on the technology front, the US will continue to lead the way on key scientific initiatives such as the COVID-19 vaccines, anti-virals, and anti inflammatories.  In addition, we will see a major upswing in the adoption of key disruptive software technologies such as artificial intelligence, machine learning, and blockchain. This will in turn facilitate significant upgrades in personalized medicine, clinical trials, genomics, and cell-based tech such as CAR-T Cell cures for cancer. 

Lisa Cooper, PhD, RAC 

It is anticipated that 2021 will initially be focused on the progress of COVID-19 treatments and vaccinations; however, progress in the areas of oncology and pediatric diseases is also expected. A shift from a primary focus on extending life of oncology patients to one of managing symptoms of disease and treatment, including pain and nausea, is likely to be seen.  Advancements in novel drugs to treat rare pediatric diseases are expected as closely watched ongoing clinical trials complete enrollment. 

Bernie Dardzinski, PhD 

The SARS-CoV-2  pandemic has changed the world in multiple significant ways. With most people working and attending school virtually, the routines of daily living have been drastically shifted, resulting in a resetting of expectations for family, work, school, and the economy. With another divisive and partisan election, we must continue to move forward with understanding and compassion. Vaccines will start to bring the pandemic under control, but it will not be until 4Q2021 or 1Q2022 that life might approach what we had considered as “normal” at the end of 2019. 

The next 3-4 months will tax the health care industry infrastructure because of the increased testing, hospitalizations, and deaths. Pandemic preparedness will become part of the national conversation on healthcare. 

Artificial intelligence (AI), already in place to aid radiologists in reading low-revenue procedures like chest X-rays, will expand to other uses within bioimaging. There will be an increasing emphasis on the use of AI in patient populations—understanding adverse events, predicting response to treatment, or monitoring individual health.  

Unfortunately, meeting with TBG colleagues face-to-face to enjoy each other’s company with sustenance and good cheer will likely have to wait until the 3Q 2021 . 

Monica Luchi, MD, FACR, MBA 

The global community endured a dark period in 2020 like no other we’ve experienced. We have looked to scientists, healthcare workers, and pharmaceutical and biotech companies to bring us an answer to the worldwide COVID-19 crisis. I expect 2021 will deliver on the hope of vaccines and will provide an opportunity to surpass our previous ‘normal state.’ Despite the seismic shift in our daily lives, there have been continuous advances in both science and technology that are opening innovative and exciting areas of medical exploration. Our experience with the pandemic has taught us fresh new ways to conduct clinical research, optimize working as remote teams, enhance collaboration with regulators, and maximize investor engagement. The change in perspective is valuable, and I have great hopes for what is possible in 2021. 

Karen Kopicko 

Precision medicine is revolutionizing the healthcare industry in the hope of providing vastly improved outcomes for patients. A surge in global incidences of cancer and numerous chronic and infectious diseases has shifted the priority of scientists and researchers worldwide to understand the underlying cause of such ailments. 

To date, the essence of practicing medicine has been to obtain as much data about the patient’s health or disease as possible. Physicians have had to rely on their experience, judgement, and problem-solving skills while using rudimentary tools and limited resources. 

The precision medicine industry combines molecular biology with systems biology to find ways to prevent and treat diseases. The Pandemic has pushed organizations to reinvent their “digital roadmap” for 2020 and beyond. This cultural transformation to digital health has been the nexus for disruptive technologies to begin to make advanced methods available not only to medical professionals but also to their patients. As treatments become more precise, pharma companies will need to create more targeted commercial strategies. The clinical trial recruitment process will become more challenging and a new series of stakeholders will emerge.  

FDA has become the driving force behind the movement toward more personalized treatments across all disease areas. The Agency continues to advance the movement toward more personalized medicines, while offering accelerated approvals and collaboration around innovation. The framework for product development and review will set the stage for continued advancement of this cutting-edge field and further enable innovators to safely develop effective therapies for many diseases with unmet medical needs. 

Scientific development in this area is fast-paced, complex, and poses many unique questions during a product review, including how these products work, how to administer them safely, and whether they will continue to achieve a therapeutic effect in the body over a long period of time without causing adverse side effects. FDA approvals of personalized medicines will play a big part in advancing the use of these therapies in routine clinical care. 

In 2021, the transformation of healthcare from one-size-fits-all, trial-and-error medicine to a targeted approach utilizing each patient’s molecular information will continue to accelerate.  We will see the FDA more regularly and rapidly approve diagnostic tools and treatments that expand the frontiers of personalized medicine. We will see approvals that redefine drugs’ intended populations and provide patients with more personalized treatment options. We will see modifications to FDA framework for artificial intelligence/machine learning-based technologies. Payers, providers, and policymakers across the industry increasingly recognizing the potential for gene therapies and precision medicine to transform disease treatments will gain momentum. 

Brad Wyman, PhD, MS 

In 2020, we learned two things. First, we really can work remotely, and it is wonderful! Second, social interactions are critical to helping us to keep our sanity. 2021 will be marked by internal mental conflict as offices reopen, forcing us to reconcile between our love of working remotely and the desire to keep our sanity.