The New Normal: Accelerating Scientific Research and Production

Biotech
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“The huge societal cost of every wasted moment in the quest to find treatments for COVID-19 has unleashed an unprecedented wave of data sharing and other collaboration between pharmaceutical companies.”

David Morris, Fortune

Nearly every article about the development of therapies to prevent and treat COVID-19 uses the word “unprecedented.”

And it is not hyperbole.

It typically takes about 10 years to bring a new drug from discovery to the clinic; even repurposing existing drugs for new uses can take years. But just nine months after the world first learned about a unique virus to which no one was immune, thousands of clinical trials are ongoing into therapies; the Food and Drug Administration has granted emergency authorization to numerous treatments; and at least six potential vaccines are in late-stage clinical trials with tens of thousands of participants even as states roll out plans for distribution.

Consider the RECOVERY (Randomised Evaluation of COVID-19 Therapy) trial, run out of the University of Oxford in England: The study is designed to test several possible treatments simultaneously, a unique design that speaks to the seriousness of the disease. Investigators took just nine days to draft the trial protocol and recruit the first patients, an unheard of speed in pharmaceutical research.1

The results have come just as quickly. By mid-October, investigators found that dexamethasone reduced deaths by up to a third in severely ill, hospitalized patients and that the combination of the antivirals lopinavir and ritonavir had no clinical benefit.

They also launched a Phase 3 study on an antibody cocktail (REGN-COV2) and its effects on mortality, hospital stays, and ventilation requirements, and are testing the potential benefits of the antibiotic azithromycin, the anti-inflammatory tocilizumab, and convalescent plasma.2

Just eight months after the genetic code of the virus was discovered, more than 70 vaccines for COVID-19 were in the research pipeline around the world, with six vaccines in human clinical trials.3

“This is an unprecedented feat for the scientific community made possible by decades of progress in vaccine technology and a coordinated, strategic approach across government, industry and academia,” said National Institute of Allergy and Infectious Disease Director Anthony S. Fauci, MD, in a news release.4

One sign of that research world may never return to its pre-pandemic siloed approaches are the numerous partnerships that have sprung up between rival pharmaceutical companies. For instance, pharmaceutical giants Sanofi and GSK joined forces to use proprietary technology each owns to develop an adjuvanted COVID-19 vaccine.5

“I have never seen the level of collaboration that’s going on today,” said Giovanni Caforio, CEO of Bristol Myers Squibb, at a health care conference in July.6

Focus on the Science, not the Politics

The biotech and pharmaceutical industry, however, has had to focus on more than just the research as their work has become increasingly politicized. Politicians have pressured agencies like the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention to change certain recommendations or bypass traditional vetting procedures for treatments with little evidence behind their efficacy or safety, like hydroxychloroquine.7

The pressure has been particularly intense when it comes to the FDA’s oversight of vaccine trials through Operation Warp Speed.

That, in turn, has spread alarm that a vaccine will be approved too soon, before its safety and efficacy are clear.

A survey from STAT and The Harris Poll of 2,050 Americans found support for a vaccine dropping, with just 58 percent of Americans saying they would get a vaccine as soon as one is available compared to 69 percent in August. 8

To reassure the general public, vaccine makers and the FDA have pushed back against any political interference in the scientific process. In September, nine CEOs of pharmaceutical and biotech companies developing vaccines publicly pledged their “on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.”9

And in early October, the FDA published stringent guidelines to biotech and pharmaceutical companies spelling out protocols required for even an emergency use authorization for a vaccine. They include two months of follow-up data to make sure a vaccine is safe and effective. The biotech industry strongly supported the guidelines and, in fact, had lobbied for their release.7

In addition, more than two dozen health policy experts released an open letter October 19 asking the vaccine manufacturers to release more detailed trial design documents, which are not typically shared with the public. As the letter said: “. . . the stakes here are enormous and justify this step.”10

Pfizer Chairman and CEO Albert Bourla took things one step further, releasing an open letter outlining the company’s vaccine timeline and making it clear that the earliest it could expect to submit an application to the FDA was late November.11

In the end, the COVID-19 pandemic will likely be a turning point for scientific research, with new protocols and new cooperation bringing therapies to market much faster than in the “old days” for diseases like cancer.

As the Bristol Myers Squibb CEO said at the Fortune meeting: “We’ve created a virtual table of collaboration that has allowed us to challenge the status quo. It is our job to make sure we don’t go back to our silos and keep the same spirit as we think about other health [problems].”6

  1. Looi M-K, Coombes R. Risky Business: lessons from covid-19. BMJ. 2020;369:m2221. 10.1136/bmj.m2221.
  2. Recovery. News. 2020; https://www.recoverytrial.net/news. Accessed October 20, 2020.
  3. PhRMA. Medicines In Development | 2020 Report: Vaccines. 2020 https://catalyst.phrma.org/new-report-shows-nearly-260-vaccines-in-development-including-dozens-for-covid-19.
  4. National Institutes of Health. Fourth large-scale COVID-19 vaccine trial begins in the United States. September 23, 2020; https://www.nih.gov/news-events/news-releases/fourth-large-scale-covid-19-vaccine-trial-begins-united-states. Accessed October 21, 2020.
  5. Sanofi and GSK to join forces in unprecedented vaccine collaboration to fight COVID-19 [press release] [press release]. April 14, 2020.
  6. Morris DZ. Will the pharmaceutical industry keep collaborating after COVID-19? Novartis and Bristol Myers Squibb CEOs say it has to. Fortune. July 7, 2020. https://fortune.com/2020/07/07/pharmaceutical-industry-collaboration-novartis-bristol-myers-squibb-big-pharma/.
  7. Kaplan S, LaFraniere S, Weiland N, Haberman M. How the F.D.A. Stood Up to the President. New York Times. October 20, 2020. Accessed October 21, 2020https://www.nytimes.com/2020/10/20/health/covid-vaccines-fda-trump.html?utm_campaign=pharmalittle&utm_medium=email&_hsmi=97913474&_hsenc=p2ANqtz-_ui7iAWmCPgT-lemc279RTs6ibpt4CbImRTfSUnlxf5MfhSB0MWaZmoLrTlKr1XgtA2MykmlXLPO5l5Q2jAkndoM3g_w&utm_content=97913474&utm_source=hs_email.
  8. Silverman E. STAT-Harris Poll: The share of Americans interested in getting Covid-19 vaccine as soon as possible is dropping. STAT. October 19, 2020. https://www.statnews.com/pharmalot/2020/10/19/covid19-coronavirus-pandemic-vaccine-racial-disparities/. Accessed October 21, 2020.
  9. COVID-19 Vaccine Maker Pledge. September 7, 2020; https://www.pfizer.com/health/coronavirus/pledge. Accessed October 21, 2020.
  10. Silverman E. Public health experts push vaccine makers, HHS to release Covid-19 trial protocols. STAT. October 20, 2020. https://www.statnews.com/pharmalot/2020/10/20/covid19-coronavirus-pandemic-vaccine-hhs-pfizer-moderna-astrazeneca/?utm_campaign=stat_plus_today&utm_medium=email&_hsmi=97866352&_hsenc=p2ANqtz-_XEKEFGVabRXV5xrRLmvOQueZvPqhkNl0ktL239LTwiWNZxEtyL0iKaZHYX6QPwMiFvsrjuG7Q6soqcvFXittFsWQJpw&utm_content=97866352&utm_source=hs_email. Accessed October 21, 2020.
  11. Pfizer. An Open Letter from Pfizer Chairman and CEO Albert Bourla. October 16, 2020; https://www.pfizer.com/news/hot-topics/an_open_letter_from_pfizer_chairman_and_ceo_albert_bourla. Accessed October 21, 2020.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Debra Gordon, MS

Debra Gordon, MS is a seasoned health care communications professional who specializes in researching and writing content on the U.S. health care system and medical issues for clinicians, businesses, and consumers.

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