OR WAIT null SECS
Amid high expectations for a vaccine, bio/pharma readies capacity, weighs pressures.
Bio/pharmaceutical companies have demonstrated the potential of innovation in response to the COVID-19 pandemic, initiating an estimated 175 vaccine programs—including more than 30 in clinical trials—and more than 500 therapy studies with half at clinical stage (1).
While these efforts largely have been commended, the work of scientists and researchers also has been subject to heavy scrutiny, often by people and institutions that are not familiar with the complexities of the drug development process.
In non-pandemic times, drug companies, industry suppliers, and contract service organizations discuss how they are employing processes, products, or services to shorten the time it takes to get a drug to market. The typical wait time, often counted in years, takes longer than most patients and medical professionals would prefer.
The progress made in COVID-19 vaccine and treatment development during the past six months is remarkable. A formidable amount of work stands in the road ahead to continue the research and development; assemble the materials, resources, and capacity to produce the vaccines and therapies; and determine an equitable distribution system.
In this issue, the editors take a look at the efforts of bio/pharma companies, contract development and manufacturing organizations, and materials and equipment to address pandemic-related response, as well as maintain ongoing drug development and manufacturing activities amid travel, communication, and business disruptions.
In “Preparing Pandemic Vaccine Capacity,” Manufacturing Editor Jennifer Markarian reports on multi-pronged efforts to build out capacity for billions of doses of potential COVID-19 vaccines. The article explores how the urgent need for effective treatments and vaccines has spurred investment by drug companies, non-government organizations, and the federal government, triggering frequent announcements of new manufacturing agreements, facility expansions, and commitments to supply raw materials, drug components, and drug substances. The industry’s use of different vaccine platforms including—mRNA, DNA, viral vector, cell-based, and inactivated virus approaches—adds complexity to the coordination efforts. Read the article.
The quality and availability of APIs and other drug components, especially those sourced from offshore, were debated prior to the onset of the pandemic. Criticism of US reliance on foreign manufacturing ratcheted up as the pandemic’s impact on supply chains emerged, prompting government investment in a newly formed API manufacturer (Phlow) and a since-delayed investment in Kodak Pharmaceuticals, as well as an August 2020 Presidential Executive Order requiring the federal government to buy essential drugs from domestic manufacturers.
While the “made in USA” debate plays out, API suppliers have implemented new technologies, risk-based decision making, and increased customer communications to maintain a global supply chain. Efforts are described in “Tracking API Quality During a Pandemic”.
Despite the great progress and investments made to date, science-driven studies still need to play out; that will take time. Bio/pharma professionals—trained to carefully assess risk when making decisions—are treading on dangerous ground when they allow outside factors to influence decisions that are not supported by data.
Previously, FDA was criticized for issuing an emergency use authorization (EUA) for hydroxychloroquine (later withdrawn). More recently, FDA issued an EUA for convalescent plasma—despite reservations from medical experts about the effectiveness of the treatment—following comments from the President that approval delays were politically motivated (2).
Honest assessments of the potential pitfalls associated with developing new treatments and vaccines can be bitter pills for those demanding immediate answers to swallow. However, patience and science will provide the best medicine to guide effective decisions about a return to normal life.
1. BIO, BIO COVID-19 Therapeutic Development Tracker, www.bio.org, accessed Aug. 26, 2020.
2. J. Wechsler, “FDA Caught in Political Crossfire,” www.pharmtech.com, Aug. 24, 2020.
Rita Peters is the editorial director of Pharmaceutical Technology.
Vol. 44, No. 9
When referring to this article, please cite it as R. Peters, “Biopharma Gears Up Pandemic Response,” Pharmaceutical Technology 44 (9) 2020.