Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Rita C. Peters

When I first entered the business-to-business publishing world more than 30 years ago, I never expected to spend a significant portion of my career writing about bio/pharmaceutical development and manufacturing. The subjects I have covered are somewhat obscure to someone not involved in that industry, prompting the comment: “There’s a magazine for that?” As a writer/journalist, I sometimes would question my choice to write about pharmaceutical regulations or bioprocessing equipment versus penning the great American novel.

During the past 18 months, reporting on the pandemic-related news and bio/pharmaceutical development and manufacturing efforts to combat the pandemic served as a reminder of the important role media outlets such as 

The achievements by the bio/pharmaceutical industry to produce billions of doses of new vaccines has been remarkable; however, it is obvious that more work is to be done. For me, it is time to transition to my next chapter; I will be retiring from my position of editorial director of these publications at the end of September 2021.

I leave with the confidence that the magazines, websites, webcasts, newsletters, videos, podcasts, conference sessions, and other multimedia programs are in the great hands of the editorial team of Felicity Thomas, Susan Haigney, Jennifer Markarian, Feliza Mirasol, Meg Rivers, Grant Playter, and new editorial director, Christopher Spivey.

I also know readers and advertisers will be supported by the sales team led by Publisher Mike Tracey and the webcast, design, content marketing, audience development, and other experts who have supported 

 over the years. I am grateful for their expertise, dedication, and friendship during my time with the publications.

Currently, we are witnessing the impact rumors or misinformation about COVID-19 and vaccines can have on society. As essential healthcare providers, bio/pharma companies cannot contribute to such misinformation or prioritize the bottom line over the quality and safety of the products they produce. Likewise, the companies supporting these efforts are obligated to share information supported by science and data, not marketing or sales objectives.

Keeping a “science first” mantra at the forefront will help ensure the bio/pharma industry can meet its primary obligation of serving patients.

Thank you for the opportunity to represent this industry.

When referring to this article, please cite it as R. Peters, “The Next Chapter,” 

Articles

While the players may change, pharma’s patients-first focus should not.

The Next Chapter

As the global COVID-19 pandemic passes the 18-month mark, there are signs that some businesses are resuming pre-pandemic operations. Answers to the “when can I …” questions about returning to the office, school, vacation, indoor activities vary based on region and vaccination status. On the bio/pharmaceutical front lines, drug companies and Congress are asking FDA: When will inspections resume?

In March 2020, travel restrictions prompted FDA to put inspections on hold and conduct only mission-critical inspections and focusing on efforts to prevent drug shortages and bring pandemic-related vaccines treatments to market. From March 2020 to March 2021, application decisions of 48 human drugs—including six deemed “mission critical” and nine animal drugs were delayed because inspections were not conducted. As of March 2021, the agency had a backlog of approximately 1000 inspections for human and animal drug facilities to tackle (1).

In a six-page letter dated July 22, 2021, members of the House Energy and Commerce Committee sought details about foreign inspections; if delayed inspections are slowing the approval of applications for new drugs, generics, and biosimilars; if FDA is using inspection reports from trusted inspectorates; and how will FDA’s data modernization plan impact inspection activities. In addition, the committee asked how the $38.3 million provided to FDA to address the pandemic has been used to resume domestic and foreign inspections (2).

Acting FDA Commissioner Janet Woodcock outlined the Agency’s plans in testimony before the Senate Health, Education, Labor and Pensions Committee on July 20, 2021 (3). FDA has established an Inspectional Affairs Council to coordinate inspection approaches and assessments across product centers and will review the number of COVID-19 cases in different regions to assess risks to personnel. The agency will announce domestic inspections in advance to ensure a facility is available and safe; however, FDA officials say it will take time to resume the foreign drug inspection program.

The House Committee’s letter closed with the question: How long, after a return to standard operations for domestic and foreign inspections, will it take to clear the backlog? As in other aspects of businesses and daily life, the desire to make up for lost time is urgent.

Resiliency Roadmap for FDA Inspectional Oversight

, Report (May 2021). 
2. Committee on Energy and Commerce

FDA Under Pressure to Restore ‘Normal’ Drug Inspections,

When referring to this article, please cite it as R. Peters, “FDA Inspections Back on Track?” 

Congress questions FDA on plans to catch up and move forward with facility inspections.

FDA Inspections Back on Track?

In the first six months of the global COVID-19 vaccination campaign, nearly 2 billion vaccine doses have been administered, with nearly 841 million people partially vaccinated and 430 million fully vaccinated. However, these numbers represent a small fraction of the global population in need of vaccines (1).

Most completed vaccinations are concentrated in developed or wealthy nations that secured doses for their population in advance; in some cases, vaccine supply is outpacing demand. In other global regions where the need for vaccinations is critical, programs are hampered by limited supply and resources.

With governments and global trade organizations suggesting waivers to intellectual property protection, patent pooling, and technology transfers to help low- and middle-income countries produce vaccines, manufacturers are suggesting increased production and other steps to meet global demand (2).

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), which represents leading bio/pharmaceutical companies and bio/pharmaceutical associations, in May 2021 noted in a statement that “Manufacturers, governments, and non-governmental organizations must work together to take urgent steps to further address this inequity. Immediate action must focus on stepping up responsible dose sharing and maximizing production without compromising quality or safety” (3).

Proposed actions include encouraging nations with significant vaccine supplies to share a “meaningful proportion” of doses with low-income countries; expand production partnerships and access to raw materials; urge governments to eliminated trade and regulatory barriers; provide support for vaccine deployment; and prioritize the development of new COVID-19 vaccines.

Manufacturers have pledged to provide more than 1 billion vaccine doses at no- and low-profit rates to lower income countries (2). That’s a good first step on a long journey to vaccinating the world.

1. Our World in Data, “Coronavirus (COVID-19) Vaccinations,” 

, accessed June 1, 2021.
2. J. Wechsler, “Vaccine Makers Ramp Up Production, Donations to Protect IP,” 

, June 1, 2021.
3. IFPMA, “Five Steps to Urgently Advance COVID-19 Vaccine Equity,” Press Release, May 19, 2021.

When referring to this article, please cite it as R. Peters, “A ‘We are the World’ Vaccination Effort?” 

Bio/pharmaceutical manufacturers have made a good first step toward global vaccination through pledging doses at no- to low-profit rates. 

A “We are the World” Vaccination Effort?

With some indicators showing vaccines are helping to ease the number of the COVID-19 infections in some regions, many people are asking when they will be able to resume previously routine activities. The US Centers for Disease Control and Prevention attempted to answer some questions about when it is safe to stop wearing a face mask for typical social situations in an April 27, 2021 guidance for fully vaccinated people (1).

The underlying message: if you are fully vaccinated, you can participate in more normal activities without wearing a mask compared with people who have not been vaccinated.

In the United States, the initial frenzy to secure a COVID-19 vaccine calmed as vaccine production ramped up to meet demand; as of late April 2021, almost 30% of the adult US population was fully vaccinated (2). The next concern is convincing the vaccine-hesitant that the risks of not getting vaccinated far outweigh potential side effects of the injection. One positive sign is that as more people are vaccinated, more people holding a “wait-and-see” approach are lining up to get vaccinated. However, a persistent group of approximately 20% said they would get the vaccine only if required or not at all (3).

Various statistical models suggest that the combined number of vaccinated adults and people with some immunity due to exposure to the virus may mean herd immunity is within reach for the US. There are warnings, also, that the nation can slip back and forth over this crucial threshold if a sufficient number of people are not vaccinated.

With the virus raging in hotspots such as India and Brazil, however, a quick end to the pandemic is not in sight. Evolving variants threaten to set back advances made thus far. Some patients have lingering, and sometimes debilitating, effects from COVID-19. The task of healthcare professionals and pharmaceutical researchers to control the pandemic—and deliver new treatments—is not yet done.

In the 15 months following the initial outbreak of the SARS-CoV-2 virus, bio/pharmaceutical companies launched more than 850 research programs for vaccines and treatments for COVID-19, including 218 vaccines, nearly 250 antivirals, and nearly 400 treatments; approximately 46% were in clinical-phase development. Approximately one-third of the antivirals and 90% of the treatments were redirected or repurposed therapies (4).

Meanwhile, the National Institutes of Health has announced a large Phase III clinical trial to evaluate existing prescription and over-the-counter medicines for people to self-administer at home to treat COVID-19 symptoms. The goal is to determine treatment options for patients with mild-to-moderate symptoms, who are not sick enough to be hospitalized, to take at home. Currently, there are no approved medicines that patients can take at home to address symptoms of the disease. The trial will study up to seven drugs already approved by FDA for other conditions (5).

While the public may be eager to throw away the masks and get back to “normal” life, the reality is that COVID-19 will not magically go away any time soon. Treatments to manage the symptoms will be a big part of the bio/pharma picture for the foreseeable future. For bio/pharma companies, the work goes on.

1. CDC, “When You’ve Been Fully Vaccinated,” 

, accessed April 27, 2021.
2. CDC, “COVID-19 Vaccinations in the United States,” 

, accessed April 27, 2021.
3. L. Hamel and M. Brodie, “KFF COVID-19 Vaccine Monitor: What We’ve Learned,” 

, April 16, 2021.
4. BIO, COVID-19 Therapeutic Development Tracker, 

, accessed April 27, 2021.
5. NIH, “Large Clinical Trial to Study Repurposed Drugs to Treat COVID-19 Symptoms,” Press Release, April 19, 2021.

When referring to this article, please cite it as R. Peters, “Moving Into the Next Phase,” 

As face masks start to come off, bio/pharma’s COVID-19 battle goes on.

Moving Into the Next Phase

A lesson of the COVID-19 pandemic is the need for accurate, unbiased, science-based evidence to support public and personal health decisions. As a society, we sometimes have a difficult time embracing this concept.

Too often, announcements—both good and bad—about diagnostic testing, the spread of the virus, and the development and manufacturing of vaccines were packaged to meet specific messaging agendas by bio/pharma companies, policymakers, and the media.

For years, drug companies routinely released press announcements to industry and investor communities about the status of drug candidates in advance of peer or regulatory review. The intense public interest in the progress of COVID-19 vaccine candidates placed these announcements in the spotlight, with some negative consequences.

Recently, the data and safety monitoring board (DSMB) overseeing Astra-Zeneca’s COVID-19 vaccine candidate raised an alarm that the company’s March 22, 2021 press release (1) reporting initial data from a Phase III clinical trial included outdated efficacy data. The National Institute of Allergy and Infectious Diseases (NIAID) urged the company “to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible” (2). AstraZeneca released updated data on March 25, 2021 in another press statement (3).

In a March 23, 2021 interview with ABC News, Anthony Fauci, NIAID director, noted that the AstraZeneca candidate “is likely a very good vaccine”, but the inaccurate information in the press release was outdated and a bit misleading; Fauci characterized the confusing press statements as “an unforced error” (4).

A science-by-press-release approach with its dangerous and embarrassing implications is unfortunately making its way to the business and scientific press.

 have seen a new, disturbing trend: the influx of press announcements, articles, and commentary from drug companies and industry suppliers that are strictly self-promotional and have little to no objective, scientific, or technical value for readers. We’ve received pitches about obscure products with no application for drug development, quotes from executives that extoll the virtues of their business, and promises for technical articles that turn out to be repurposed marketing literature.

 rely on the industry supplier market for financial support; however, the industry suppliers need independent publications to reach the qualified audience that seeks the technical insight and analysis provided by experts in pharmaceutical sciences. Attempts to substitute marketing or advertising messages for substantive science- and technology-driven information can backfire.

Many forms of messaging are available; using the most appropriate form for the intended purpose will increase the potential for the message to be heard and acknowledged.

Share the story of your company’s capabilities and products in paid advertising and content marketing programs. Contribute to the credibility and independence of advancing bio/pharm science by sharing objective, non-promotional information about drug development, formulation, manufacturing, and quality processes by authoring a technical article to 

The editors welcome objective, informative editorial driven technical articles authored for Pharmaceutical Technology by experts at bio/pharmaceutical companies, regulatory authorities, industry suppliers, and consultants on process and formulation development, manufacturing operations, drug delivery, packaging, labeling, and distribution. View the editorial guidelines at 

1. AstraZeneca, “AZD1222 US Phase III trial Met Primary Efficacy Endpoint in Preventing COVID-19 at Interim Analysis,” Press Release, March 22, 2021.
2. NIH, “Data and Safety Monitoring Board (DSMB),” Press Release, March 23, 2021.
3. AstraZeneca, “AZD1222 US Phase III Primary Analysis Confirms Safety and Efficacy,” Press Release, March 25, 2021.
4. M. Vann, “Fauci Calls ‘Outdated’ Data in AstraZeneca’s US Vaccine Trial ‘Unfortunate,’” 

When referring to this article, please cite it as R. Peters, “Avoiding Unforced Errors,” 

Smart, accurate, science-based messaging is needed to advance bio/pharma science.

Avoiding Unforced Errors in the Bio/Pharma Industry

We are now approaching the one-year mark of the year of living distantly, thanks to the public health measures necessitated by the COVID-19 pandemic. In the past 12 months, people have adapted to working from home, buying everything online, and functioning in a bubble.

Like many others, I relate my pandemic experience to the 1993 film 

. In the movie, weatherman Phil Connors—the main character—is trapped in time, reliving an unpleasant, monotonous day over and over and over and over again. In the role, actor Bill Murray plays out Phil’s depression, frustration, and anger until he finds a path from his self-adsorbed existence to one of compassion, collegiality, and personal redemption.

Before the pandemic, the bio/pharma industry had a reputation problem. While the rest of the world lived out pandemic-induced isolation and repetitive days, the bio/pharma industry made remarkable progress by innovating and collaborating with colleagues, partners, and competitors.

Recent reports released by FDA show that despite restrictions posed by the pandemic, 2020 was a very good year for drug development. The Center for Drug Evaluation and Research (CDER) approved 53 new therapies in 2020, the second highest number of annual approvals in the past 10 years, including 21 classified drugs as first in class and 31 approved to treat rare or orphan diseases. The approval rate was impressive; 92% of the drugs were approved without a complete response letter, up from the 85% average of the previous eight years. And 75% of the drugs were approved in the United States first, before other countries (1). To read more about FDA’s 2020 performance reports, read the 

Regulatory Watch column in the March 2021 issue

FDA had some missteps in 2020, such as the approval, then revocation, of an Emergency Use Authorization (EUA) of chloroquine and hydroxychloroquine, which raised questions of undue political pressure on a scientific process. And progress has been slow on many pandemic-related drugs in development.

Still, the bio/pharma industry had some notable successes, specifically the emergency approval of two novel vaccines in record time—with other vaccine reviews pending—and the rapid approval of remdesivir to treat patients with COVID-19.

When EUAs were issued for the Pfizer-BioNTech and Moderna vaccines in late 2020, it was hailed as the beginning of the end of the pandemic. In reality, it was the beginning of the next phase.

Now, growing concern in public health and medical circles about emerging variants of the SARS-CoV-2 virus and their possible resistance to vaccines and treatments prompted renewed research and regulatory strategies. FDA recently issued a set of guidance documents to address the emergence of variants of SARS-CoV-2, including an update to the October 2020 guidance on EUA for vaccines to prevent COVID-19 and guidance on the impact of the variants on monoclonal antibody (mAb) products and other treatments.

In the cover story for the March 2021 issue

, author Cynthia Challener takes an in-depth look at genetic vaccines, challenges associated with manufacturing and distribution, and the potential for rapid reformulation to tackle virus variants.

As the pandemic enters its second year, the pressure is still on bio/pharma companies and FDA, as demand for vaccine production intensifies and any delays—from manufacturing issues or bad weather—contribute to growing public impatience.

I finally see signs that we are emerging from this long winter. The snow that fell in my backyard before Groundhog Day 2021 is finally melting. Daffodils are pushing up from the ground. The pace of vaccinations is accelerating.

However, the virus, like the weather, can be tricky. We must maintain vigilance of social distancing and good manufacturing practices. Today will soon be tomorrow.

1. FDA, Advancing Health through Innovation: New Drug Approvals 2020, Report (January 2021).

Rita Peters is the editorial director of 

When citing this article, please refer to it as R. Peters, "Fighting Through This Slow Season of Change," 

Bio/pharma works hard today to change the calendar to tomorrow.