As MassBio’s first Entrepreneur-in-Residence, I do my best to bring a lifetime of perspective that I have been fortunate to grow alongside the growth of the industry from the late 1980s to today. The global standstill we have been living is being met by the extraordinary efforts by our industry and by our healthcare heroes to combat COVID-19. Now is a time of extreme evolutionary selection pressure that we’re seeing in many forms.
Chapter one of most introductory biology textbooks teaches how evolution shapes living things. Darwin taught us that generations of organisms occasionally mutate such that over time, a new trait may become advantageous to a species’ survival. While dinosaurs flourished for 180 million years in Earth’s warm, stable climate, insignificant warm-blooded mammals bided their time until the impact of a massive asteroid darkened the sky and chilled the planet for years… an example of extreme selection pressure.
Evolutionary selection pressures also apply to governments, companies, and their inventions that likewise must adapt or die. Who would have predicted that Carnival Cruise Line stock would crater by 80% while shares in Zoom soared 250% just since late February?
While the word “unprecedented” accurately describes the all-consuming global impact of COVID-19 on our lives, we must seek parallels to gain any sense of perspective.
Think back to the start of 2020, if you can. The biotech industry was growing the newest branch of its evolutionary tree in the form of gene and cell therapies. Actual cures were now accessible to patients. These one-time treatments challenged healthcare systems built upon predictable annual budgets to pay for modest annual treatment costs of chronic conditions like insulin for diabetes or statins for heart disease. Clinical medicine was beginning to more widely adopt digital means for remote recording of some endpoint measures in clinical trials outside of the hospital or doctor’s office. Meanwhile, the ‘asteroid’ of COVID-19 was just entering our orbit.
Biotech and clinical trials have been profoundly impacted by the COVID-19 asteroid. Most trials were being conducted in conventional hospital settings requiring patient travel along with potential exposure to COVID-infected patients and staff. As of early April, 75% of all clinical trial sites worldwide had been paused and/or suspended enrollment of new subjects. Few biopharma sponsors of clinical trials were already employing remote monitoring, home nursing assessment, and patient reported measures in their clinical trials. Suddenly, all clinical-stage biopharma companies are looking to preserve ongoing trial results by quickly adapting or adding clinical trial tools to current studies, including:
- Direct-to-patient support where even injected or infused drugs can be self-administered in the home by the patient or family caregiver
- In-home and alternative site clinical services where a healthcare worker comes to the patient’s home
- Patient remote monitoring from simple measures like blood pressure or glucose levels) to more advanced endpoints such as behavioral metrics, physical movement, sleep patterns or muscle strength
Where these tools are in place, patients can continue to receive their treatments. The forward-thinking biotech companies and those able to quickly adapt, are continuing to assess trial endpoints. They will be better positioned for their new drugs to be approved. Some trials using only in person assessments will not be able to recover from the protracted standstill caused by COVID-19. The companies using only traditional reporting tools will face delays and risk their new drug approval altogether.
MassBio itself has adapted quickly, moving in early March from convening in-person events and meetings to conducting everything virtually and addressing new needs of our members, starting with the immediate response of the Emergency SupplyHub in identifying and gathering supply and demand for Personal Protective Equipment, to weekly Town Hall dialogs with leaders such as Steve Walsh, head of Massachusetts Health & Hospital Association and Bruce Booth, partner at Atlas Venture. As our members evolve and embrace their new virtual settings, MassBio has evolved right with them, moving all programming from our professional development forums to our ‘TED-style’ Possible Talks online.
While we all look forward to a return of fundamental human connections, remote clinical trials, business travel, remote/teleworking, and even the premise of an entire staff commuting daily to a downtown office or lab will be forever changed by COVID-19. In a hope for a brighter future, paraphrasing Darwin, “It is not the strongest of a species that survive, nor the most intelligent, but the ones most responsive to change.”