06Jun

The publicity around the current COVID vaccine clinical trials has done much to make the public aware of the difficulties researchers face to ensure the safety and effectiveness of the therapy being tested.

Besides the now well-known need to recruit participants representing all age groups, races, and other demographics, clinical trial managers also have to be on the lookout to avoid what the pharma community has come to call “professional study subjects.”

These individuals are so eager to participate in a clinical study they lie about their medical condition, misrepresent their lifestyle, fail to disclose medications they take and may participate in more than one, even several studies simultaneously.

Eric Devine, PhD, assistant professor of psychiatry at Boston University School of Medicine, says, “I was doing clinical trials and I was running into people who were just lying to me. It was blatant when I looked at their medical records.”

Money is what motivates most professional study subjects, according to a Medscape report. Many trials pay participants, enabling some to earn thousands of dollars. One man who entered an Alzheimer’s trial legitimately earned $31,000.

Others may be driven to participate because of free medical treatment. The Medscape report mentions one woman who lied to get into a trial involving botulinum toxin. “I wanted to get into the study. I wanted free Botox, so I participated. And I got paid — so why wouldn’t I?”

study of the problem published in 2013 found 75% of the subjects who had participated in at least two trials in the previous year admitted concealing some important medical information:

  • 32% hid health problems
  • 28% concealed their use of prescribed medications
  • 20% failed to disclose their recreational drug use
  • 14% reported pretending to have a health condition in order to qualify.

Even when these professional study subjects have more altruistic motives, their deception can skew trial results. If enough of these types of study subjects manage to enroll – and the estimate is that as many as 25% of volunteers apply in a way that violates trial criteria – the results can be skewed.

Medscape says misrepresentation can be serious enough to “invalidate outcomes and even halt further research.”

Subject registries exist to attempt to catch the professional subjects. When detected, these individuals can be entered in a registry. Recently, these registries have begun to incorporate biometric data to foil the professional subjects who have used fake identification.

“That can sound very ‘Big Brother-ish’,” Devine says. “But think about the quality of our information — it can either be lifesaving or not. Do we really want to take a chance with medicine as a science, and leave it up to ‘Well, I hope we didn’t have too many professional subjects in this trial?’ “

Photo by Mehmet Turgut Kirkgoz on Unsplash

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Green Key
Jun 6, 2023

As Pharma Transforms, Drug Stocks Poised for Comeback

Big Pharma is poised for a financial comeback this year, even as both industry leaders and ambitious upstarts will navigate through choppy waters.

J.P. Morgan analyst Chris Schott wrote in mid-December that 2020 will be a recovery year for the stocks of major pharmaceutical companies. After a year in which the S&P 500 was up 25%, the S&P 500 Pharmaceuticals grew not even half that.

Schott basis his forecast on several new drug launches and significant growth for the category of cancer drugs known as PD-1 inhibitors. He also discounts the possibility of drug pricing legislation, suggesting “there appears to be more headline risk than fundamental risk.”

Meanwhile, a CPHi outlook article discusses 10 trends pharma leaders expect the industry to confront during the year. Artificial intelligence and its application in developing, not drugs or clinical outcomes surprisingly, but in predicting timelines and in compliance and regulatory matters.

Cell and gene therapies (CGT) will likely continue to be one of the focus areas in 2020, while the importance of biologicals will continue to grow. Pharma will increasingly turn to CDMOs to take their research from clinical development through regulatory approval.

Peter Bigelow, president of xCel Strategic Consulting, sees more “transformational partnerships between CDMOs and big pharma” in 2020, as the major companies refocus their traditional methods of operation.

“Whereas in the past Big Pharma has been very transactional and has put driving product costs down as a priority, they are instead looking now at partnerships on baskets of products. This means the CDMOs must operate differently, be longer-term in the way they envision these relationships and they must commit to very high degrees of operational and quality improvement.”

Another prediction, this from Jim Miller, founder and former president of Pharmsource, is that CDMOs will continue to be the targets of acquisition. He expects some of the bigger private equity firms to be attracted to the mid-size CDMOs as will larger, public firms.

Morgan analyst Schott agrees. Rather than more mega-mergers, “We see biz dev pivoting towards bolt-on deals in 2020 with focus on building out existing therapeutic verticals and adding potential mid-2020s launch opportunities.”

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Green Key
Jun 6, 2023

Seattle’s Biotech Is Desperate For Workers

One of the nation’s premier biotech centers is finding it so hard to fill jobs the state’s trade association has launched an ambitious marketing campaign to lure workers to Washington state.

“Our industry has jobs. We have jobs at all levels,” said Leslie Alexandre, CEO of the trade group Life Science Washington. “We eagerly welcome people to come and join our ecosystem or to be trained from our schools and colleges.”

The organization hopes to entice workers with a flashy campaign designed to sell the Seattle lifestyle and promote the industry. Life Science Jobs in Washington State, launched last week, with the tag line: “Do your best work. Live your best life.”

In photos, videos and text, the site showcases the Seattle area’s environment and its life sciences industry. The videos have biotech workers telling their stories, extolling the significance of the work they do and the livability of the state. The idea is to introduce the rest of the country to what the state and especially the Puget Sound area has to offer.

Outside the Northwest, said Alexandre, people “simply do not know what Washington is about it.”

The site’s FAQ reinforces the sell. Discussing the cost of living, the site says it’s lower than in “many other life science clusters.,” Industry pay is competitive. The site pitches strongly to families, declaring, “high-ranked schools, abundant parks and excellent healthcare make it one of the best states in the country to raise happy, healthy children.”

Among the initial 217 jobs, the majority are at a senior level, requiring an advanced degree and several years of experience in life sciences. There are, however, several jobs for IT professionals and others, including some mid-level opportunities.

Meg O’Conor Bannecker, public affairs consultant working with Life Science Washington, told the Puget Sound Business Journal the area has a “a growing need for these middle-skill workers.”

She said entry-level jobs in biomanufacturing pay about $42,000, rising to as much as double after only a few years.    

Photo by National Cancer Institute on Unsplash

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