Moving the needle on diversity in clinical trials: Where do we go from here?

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Enhancing patient diversity in clinical trials has become a key priority in drug development. The main concern is that critical data that includes underrepresented patient populations is being left out as many clinical trials do not reflect all populations that may eventually take a therapy. These underrepresented groups consist of women, including those who are pregnant and lactating, pediatric and elderly patients, people with disabilities, LGBTQ+ individuals, and racial/ethnic groups specifically, Black/African American, American Indian/Alaska Natives, Hispanics/Latinos, Asians, Native Hawaiian, and other Pacific Islanders.

As a result, the U.S. government has taken increased measures with the passage of the Food and Drug Omnibus Report Act of 2022 (FDORA), which will require sponsors to submit diversity plans to the U.S. Food and Drug Administration (FDA) for all late-stage st…

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GLP-1s, ADCs, AI and the future of pharma

Pharma’s potential breakthroughs in AI, ADCs, and GLP-1 receptor agonists raise a critical question: can innovation outpace the relentless rise of chronic disease?

The IQVIA Institute for Human Data Science sheds light on this theme, among many others, in its 80-page Global Trends in R&D 2024 report.

Pillar 1: GLP-1 receptor agonists targeting metabolic disease

Speaking of next-gen metabolic therapies in particular, Murray Aitken, the executive director of the IQVIA Institute for Human Data Science, sees significant potential. Market projections for GLP-1 drugs are bullish, with some analysts projecting sales potentially hitting $100 billion by 2030. “It’s exciting because if the market for these drugs becomes as big as anticipated, it means they are truly being disruptive in a positive way to human health for hundreds of millions of people worldwide,” said Aitken

New metabolic therapies are sorely needed as the obesity epidem…

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From gatekeeper to strategist: The evolution of the CISO role in drug development

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There’s an old joke about chief information security officers (CISOs) being gatekeepers of new technologies and initiatives – the infamous “Department of No.” Imagine a bouncer who, strangely, doesn’t let anyone in, saying the club is already too full, even when it’s clearly empty.

But that image is outdated — especially in risk-focused industries like financial services where CISOs are integral to digital transformation projects and the broader risk management considerations. 

From CIS-‘no’ to risk maestro

“Drug development is a risk-focused industry as well,” said Daniel Ayala, chief security and trust officer for Dotmatics. “There is a huge amount of risk.” Consequently, CISOs working in pharma contexts are increasingly expanding their roles from technical experts to risk-aware business leaders who happen to have deep technical expert…

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Microsoft and 1910 Genetics: AI-powered partnership targets billion-dollar savings and growth in drug discovery

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The pharmaceutical industry is at a critical juncture: AI and other technological advances offer unprecedented potential, yet the cost of developing new drugs has ballooned for decades, surpassing $2 billion in recent years with the projected return on investment (ROI) falling to a mere 1.2% in 2022, according to Deloitte. Another dimension of the problem is the high failure rate — many potential drugs fall short in the expensive clinical trials.

Microsoft and 1910 Genetics have announced a partnership that aims to reverse the troubling trend.

Accelerating discovery with AI and quantum-inspired computing

Microsoft’s Azure Quantum Elements is at the core of this alliance. The platform integrates high-performance computing, AI, and quantum techniques for faster scientific discovery in chemistry and materials science. The goal is to democratize technologies like AI, high-performa…

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Rare diseases, immense needs: J&J’s mission to change the landscape

Rare diseases may seem niche, but their impact is far from small. An estimated 7,000 rare diseases exist, collectively affecting a staggering 300 million people worldwide.  This immense burden of disease, coupled with a profound lack of treatment options, underscores the urgent need for innovation. “Actually, the total burden of disease and unmet medical need [for rare disease] is really high,” emphasizes Dr. Katie Abouzahr, vice president, autoantibody portfolio and maternal fetal disease area leader at Johnson and Johnson Innovative Medicine. In recognition of Rare Disease Day on February 29 in 2024, we spoke with Abouzahr to explore how Johnson & Johnson Innovative Medicine aims to tackle these challenges.

The profound scarcity of treatments for the thousands of known rare diseases drives Johnson & Johnson’s commitment to this area. Abouzahr highlights that many of these diseases still lack advanced therapies, emphasizing the “incred…

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Big Pharma shakeup: This chart reveals the new top dog of 2023

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In the Aesopian fable, the tortoise’s steady focus and persistence overcomes the hare’s bursts of speed. 2023 saw a similar shift in the pharma sector. While Pfizer, thanks to blockbuster COVID vaccine sales, rocketed to unprecedented heights in 2022 surpassing $100 billion in revenue, its fortunes reversed in 2023. As COVID product demand plummeted, Pfizer’s revenue nosedived to $58.5 billion, even resulting in a quarterly loss in Q3. Conversely, Merck’s consistent, diversified approach propelled it past Pfizer to become the Big Pharma leader in 2023, with a revenue climb to $60.115 billion, making it the top Big Pharma of 2023 — by a hair. While Merck’s revenue was $60.1 billion, Pfizer’s was only $1.6 billion behind.

This article will analyze the current top five Big Pharma firms, analyzing their successes and…

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Beyond the neon: Las Vegas emerging as a surprise biotech hub

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While San Francisco, Boston, and San Diego may reign as biotech royalty, a new contender is carving its niche in the desert. Las Vegas, a city synonymous with entertainment and extravagance, is proving it has the brains and the business acumen to compete on the global biopharmaceutical stage.  This transformation is backed by hard numbers: the Nevada bioscience sector boasts 9,413 jobs. 

The city is helping drive Nevada’s bioscience sector growth, which experienced a 22% growth surge from 2018 to 2021, far exceeding the national average. Its recent Super Bowl spotlight illuminated more than just football; it revealed a city where world-class researchers, visionary investors, and ambitious startups are fueling a bioscience boom.

Tina Quigley, president and CEO of the Las Vegas Global Economic Alliance (LGVEA), emphasized the strategic positioning of Las Vegas in the bi…

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Amidst empty labs, signs of biotech’s resurgence emerge

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In 2023, a year of accelerated regulatory success, a significant number of biotech labs sat empty in major hubs like San Francisco and Boston. The FDA approved 55 groundbreaking therapies in 2023, including Leqembi for early Alzheimer’s and Zurzuvae for postpartum depression. The approval number marked the second highest count in three decades. Amidst this contradiction, the seeds of biotech’s next boom are taking root.

In 2024, 72 late-stage therapies are poised for FDA approval, hinting at the potential for resurgence within the life sciences. While post-pandemic lab construction meets a wave of approvals, a slowdown in venture funding and job growth casts a temporary shadow. Additionally, the biotech lab space real estate picture is not as simple as it seems, with a marked shift in the scale and nature of drug development driving evolving space needs.

Even amidst this p…

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Pushing the frontier of drug discovery with the world’s most powerful supercomputer

Oak Ridge National Laboratory’s Frontier supercomputer. [Credit: ORNL]

Oak Ridge National Laboratory’s Frontier, the world’s first exascale supercomputer with its dizzying 1.1 exaflop speed, is a game-changer for scientific domains ranging from drug discovery to material science and oceanography. The computer holds the top spot on the TOP500 list, an independent ranking of the world’s most powerful supercomputers. “It’s like having a million laptops going into one core,” says Niven R. Narain, Ph.D., CEO of the biopharmaceutical company BPGbio. The company has forged an exclusive partnership with Oak Ridge that enables them to harness the staggering power of Frontier for drug discovery. “Things that historically would have taken us six to nine months to process, it’s like nine hours,” Narain said.

Access to Frontier “changed our company overnight,” Narain said. With…

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2024: AI and scientists take turns at the wheel of drug discovery

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In drug discovery, interest in harnessing the power of AI ramped up significantly with breakthroughs like AlphaFold, where AI predicted protein structures with astounding accuracy. AI’s initial focus was analyzing existing data, with machine learning systems excelling at tasks like predicting new drug interactions, molecular behaviors, and even biological pathways, based on troves of experimental data. ML can also aid in identifying promising drug targets by using natural language processing to analyze scientific literature. 

But AI’s role is rapidly evolving. In 2024, AI is poised to transition from analyzing existing data to a more proactive drug discovery role as a predictor and collaborator. Shifts fueling the trend include the rise of generative AI, which can create novel molecular structures and predict their properties. An…

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Survey: Wielding AI magic in clinical trials requires a master’s touch

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eClinical’s Industry Outlook 2024 report highlights a significant acceleration in AI/ML adoption for clinical trials. Over half of professionals (53%) in functions like clinical operations, data management, and biometrics now see these technologies as central to streamlining trials by 2024, surpassing the emphasis on automation that dominated last year. Despite this hype cycle, a core lesson emerges: progress will be uneven as we learn to harness this new form of “magic.”

The sorcerer’s apprentice: Enthusiasm and the need for mastery

Much like the eager apprentice in Disney’s animated film “Fantasia,” which itself is inspired by Goethe’s “Der Zauberlehrling”(“Sorcerer’s Apprentice“), many in the clinical research field seem eager to unleash the power of AI even before fully grasping the strategic investment required for mastery…

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Big Pharma clicks soared, but new cell therapies made you buzz: What drove biopharma interest in 2023?

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The big Big Pharma names you couldn’t ignore

Despite biopharma’s 2023 layoffs and challenges, innovation won your clicks last year with over 130,000 of them on our Pharma 50 report alone. But while giants dominated, your clicks showed disruptive tech wasn’t far behind. The next-most popular article was a roundup of 100 trailblazing cell and gene therapy companies with more than 80,000 views. Other hits included companies putting AI in drug discovery and development, and the ever-popular biotech startup watch – proof that solutions, not just statistics, attract attention. Rounding out the top five was a roundup of biotech job cuts and openings.

2023 biopharma innovation in the spotlight on Linkedin

But over on LinkedIn, innovation was also a driver of interest. Topics on women’s health, such as Organon doubling down on women’s health, novel approaches to mental illness at…

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