Remembering 2021, Anticipating 2022.
The Bracken Group Team Shares a Few Thoughts on the Year Just Finished and the Possibilities That Lie Ahead.
Liz Bloss, DVM
Many new competitors have entered the biopharma field in 2021 as strong investment continues to flow into the sector. Controversial regulatory approvals in 2021 together with new initiatives such as FDA’s Project Optimus will likely lead to increasing scrutiny of the FDA going forward. In 2022, integrating expertise will be more important than ever, leveraging scientific knowledge as well as carefully analyzing data together with up-to-date competitive intelligence and regulatory science. Bracken’s interdisciplinary teams are ideal for partnering with you to face the increasingly challenging questions drug developers will encounter in 2022.
Colin G. Miller, PhD, FIPEM, CSci
This time last year we were predicting the possible end to COVID19 based on the quote from Scott Gottlieb, ex head of the FDA. None of us predicted the amount of mis-information and fear that has been generated and therefore the number of lives that have been lost. Covid19 is here to stay. In my view, humans have weathered many pandemics and in today’s modern era are more equipped to combat the disease if we chose to use the medicines science has provided. If we don’t use the full medical armament available to us, then it is just a matter of accepting a higher sickness and ultimate death rate and stop the fear mongering.
With that said, a friend and colleague Dr Sandy McEwan told me about the strange plague that hit the UK during the reign of Henry VIII called sweating sickness. Henry was apparently terrified of catching the disease as it killed 30% to 50% of those who caught it within 3 to 18 hours of first symptom. We know very little about the exact nature of this mysterious disease because for an inexplicable reason it disappeared. If you wish to read more about this and the doctor who characterized the disease here is the link.
As we try to make the predictions, I am left with the pessimistic fact that more people will die from Covid19 than necessary and the optimistic fact that it could follow the path of sweaty disease!
Jim Gilligan, PhD, MSIB
One of the things we all learned in 2021 is that our predictions were woefully inaccurate. Dealing with the COVID19 pandemic has given us collectively a dose of humility, at least for those brave enough to admit that we don’t really understand everything about this virus nor will we understand everything about future viral pandemics. I do believe the health care industry has made significant historic contributions, ranging from effective and safe vaccines, monoclonal antibody cocktails, to recent oral treatments.
The tools for overcoming COVID19 are available; collectively if we can ignore politics and pursue practical steps, we can overcome what are hopefully the remnants of COVID19 manifested by Omicron. “Lessons learned” as stated in my 2021 predictions should position us to be more adroit in handling future pandemics. We have learned there are no “magic bullets” which will eradicate disease, but collective cooperation goes a long way to overcoming any obstacles placed in our path. This adversity has made us more resourceful in performing our jobs and will lead to innovations that will accelerate medical research and novel drug development in 2022 and the future.
Nick Spring, BSC, DipM
The year ahead will see COVID19 morph into pi, rho, and sigma variants, all more infectious, but less lethal than the variants with which we are now living. Biotech and Pharma will continue to be buoyant sectors throughout the year. Their achievements will include a cure for cancer via CAR-T cell therapy.
Falgun H. Chokshi, MD, MBA
We will see more retail and investor funding at the intersections of blockchain, life sciences, and biotech, especially in the form of Decentralized Autonomous Organizations (DAOs); they drastically democratize and decentralize decision making for capital and resource allocation, compared to traditional corporate structures. Research and development will be the first experiment in this new path. This is cutting edge and very early on any technology adoption curve. Within the next 2-3 years, we will need more education and subject matter expertise to tease out the signal from noise from such emerging and powerful paradigm shifts.
Lisa Cooper, PhD, RAC
For 2022, the oncology sector’s focus is going to ramp up on FDA’s Project Optimus, which will require sponsors to evaluate and re-evaluate their product dosing in new ways. Some may find that they will need to explore more than just one dose, which could result in larger pivotal trials and/or modifications to ongoing studies. We’ll all be keeping a watchful eye out for FDA’s anticipated guidance.
William Reinus, MD, MBA
Medicine continues to advance at a rapid pace. With the human genome decoded, we have moved into the age of genomic medicine and are leaving the age of phenotypic medicine behind. We can expect rapid growth in this area over the next years with more and more targeted gene therapies and diagnostic testing. We predict this will be a major driver of biopharma in the coming years.
Imaging will continue to have an essential and central role in medical endeavors. As imaging becomes more sophisticated, and particularly functional imaging becomes more prevalent, we can expect genomics to become an increasing part of medical imaging. Combine this with the growth of artificial intelligence (AI), and we can expect further sophistication in automated and adjunctive reads. We expect to see growth in studies to verify the value of AI in medical diagnosis.
Nurcan Tosun, MBA, MA
2022 will be the year of defining post pandemic normalcy. New standards set in every industry will give rise to innovative ideas and novel solutions. I expect the smaller companies to advance the normalization process much better and faster. As for us people, high adaptation skills and self-compassion will be our abiding tools to make peace with this normalcy.