06Jun

The COVID pandemic has changed the biotech industry in a positive way, demonstrating it can act quickly and decisively to develop vaccines against the SARS-CoV-2 virus.

“We have seen the transformative power of science,” said Dr. Michelle McMurry-Heath, PhD, president and CEO of the Biotechnology Innovation Organization (BIO).

She, and other speakers presenting in advance of last week’s virtual Biotech Showcase, predicted the impact of the pandemic on the industry will be long-lasting.

An account of the presentation on The Science Advisory Board website pointed to the “massive pivot of biotechnology companies to pursue infectious disease research.” Though not all the companies will achieve funding or success, McMurry-Heath said the pandemic created opportunities to pursue new classes of therapeutics and novel areas of research.

“If companies are innovative and are willing to reinvent their science, there is hope for even more transformative solutions in the future,” the article says.

However, sustaining the transformation and the speed of biotech innovation is challenged by efforts to control healthcare costs, said speakers at a second advance session of the Biotech Showcase.

“Prescription drug prices in the U.S. continually rank among the highest in the world, and it’s no secret that the biotech industry relies heavily on the U.S. market to fund research and development,” the article about the session reports.

The panel of speakers agreed the goal of the federal government and the pharmaceutical industry should be to make innovative, but affordable drugs. Complicating that is the business model. “With high R&D costs, companies (and investors) must have a way to recoup costs, years after the product goes to market,” the article explains.

There are some alternatives, said Dr. Julie Gerberding, Merck EVP and chief patient officer and former head of the CDC. She cited the Department of Defense model, which is built on a public-private partnership incentivizing productivity and innovation. Another is the way the Department of Health and Human Services partnered with the private sector to combat COVID-19.

“With future pandemics a near certainty,” the article reported, “it seems critical that the government should invest more innovation to help avoid or mitigate anticipated crises, [Gerberding] believes.”

“We are all part of the problem and the solution,” Gerberding said. “We have to apply ourselves to find contemporary solutions. We’ve got a lot of work to do.”

Photo by National Cancer Institute

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Green Key
Jun 6, 2023

Study Shows Minorities Underrepresented In Vaccine Trials

Vaccine trials underrepresent large segments of the population, while women are overrepresented, says a study published recently on the JAMA Network Open.

“In this cross-sectional study of 230 US-based clinical trials with 219,555 participants, Black or African American, American Indian or Alaska Native, Hispanic or Latino, and older adults were underrepresented and women were overrepresented compared with the US population,” the research study authors wrote.

Equally significant was the lack of ethnic and racial data reported by trial managers.

“One of the most important findings,” the report says, “Was that despite FDA recommendations, many studies were not complying with reporting guidance regarding demographic characteristics of the study population.”

The researchers found only 34% of the trials reported ethnicity; 58% reported race. All included age and sex data.

“This is a massive gap in information, and if we want to improve enrollment in clinical trials and we want to see diversity in clinical trials, we need the data,” Steven Pergam, an author on the paper told StatNews. “It’s amazing that we don’t have the data.”

Of the trials that did report race, that reported race, Black adults accounted for 11% of the trial participants, 6% were Asian less than one-half of 1% were American Indians, Alaska Natives, Hawaiian or Pacific Islanders.

Whites were 78% of all participants.

In the 79 trials that reported ethnicity, Hispanics and Latinos accounted for 12%.

The imbalance was even more striking in phase 3 trials. There, only 7% of the participants were Black or African American.

“Similarly,” the report says, “Native Hawaiian and Pacific Islander, American Indian and Alaska Native, and Hispanic or Latino participants were underrepresented in phase 3 trials compared with their representation in the US population.”

“Despite advancements, equity in clinical trial enrollment remains an issue,” the report observes.

representation in vaccine trial chart blog.jpg

The underrepresentation of minorities became an issue during the COVID vaccine trials, as pharmaceutical firms struggled to recruit volunteers. Early into the pandemic, a group of US senators wrote to the pharmaceutical companies involved in the Warp Speed vaccine development program saying trials “must include participants that racially, socioeconomically, and otherwise demographically represent the United States.”

It was that difficulty that prompted the writers of the recent paper to study the demographic make-up of vaccine trials over the last decade. Though the differences between the trial participants and the general population were not great, the disparities are enough to be troubling, the researchers said.

“Small inequities are still important inequities,” Laura Flores, lead author on the study told StatNews. “We’re doing a genuine disservice to these populations by not reaching out and not keeping records or not including them in trials that might benefit them.”

Photo by CDC on Unsplash

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Green Key

Director of Green Key Pharma Receives RAPS’ Community Leadership Award

Director of Green Key Pharma, Lindsey Summers, is a co-recipient of the Regulatory Affairs Professional Society (RAPS) 2021 Community Leadership Award!