pharma Archives - Medical Design Sourcing

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…

Mapping the more than 1,000 biotech and pharma layoffs in January 2024

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On the heels of a strong year of FDA approvals, there are signs in early 2024 that the biotech sector is recovering. Examples include two recent biotech IPOs, signs of investor optimism and continued M&A momentum. But the biotech sector continues to see a significant number of layoffs. Major layoffs in early 2024 include companies like Cara Therapeutics, Ikena Oncology, Pfizer, and Sana Biotechnology. In early 2024, the rate of layoff events has continued at roughly the same clip over the past several months. Altogether, there were more than 1,300 job cuts in January.

Public companies driving the most layoffs

In terms of the source of the layoffs, public companies such as Pfizer, Intellia Therapeutics, and Thermo Fisher Scientific are letting the most workers go, with more than 600 layoffs in January 2024. Next in line are clinical-stage companies such as the oncology-focused biotec…

Pharma M&A activity primed for another high-flying year in 2024

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Despite challenging interest rates and regulatory environment, pharma M&A activity surged in 2023 with deal volume up more than 30% from the prior year based on a review of more than 200 acquisitions since 2018. The total disclosed deal value in 2023 also more than doubled the prior year’s tally to surpass $100 billion. While the pandemic boosted research into areas such as mRNA, it had something of a chilling effect on M&A. As pharma companies begin to put the pandemic in the rearview mirror, M&A activity has gained momentum.

Analysts upbeat on biopharma M&A activity in 2024

According to PwC, the M&A activity in the pharmaceutical and life sciences sector could continue humming in 2024. Despite a challenging interest rate environment, PwC projects the sector to see deal values ranging from $225 billion to $275 billion. Deal volume in 2023 was in line with pre-pandemic levels. …

Pfizer and AstraZeneca top annual pharma future-readiness rankings

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As 2023 draws to a close, the pharma industry finds itself at an inflection point. On the one hand, stubbornly high inflation rates, a dearth of talent, supply chain hurdles, and a more challenging regulatory climate threaten profitability. But on the other, the rapid advances in areas ranging from cell and gene therapy and IT technology offer new opportunities for efficiency gains and innovation.

Pfizer, AstraZeneca and Lilly come out on top in future-readiness

Against that backdrop, Pfizer, AstraZeneca and Lilly round out the top three rankings in terms of future-readiness, according to an analysis from IMD. In its annual ranking, Pfizer advanced from second to first place, Eli Lilly moved up from seventh to third place, and Novo Nordisk rose from 13th to seventh. While Pfizer has had something of a rough year, missing its revenue projections as demand for Paxlovid and Corminaty slides, …

Harnessing the untapped potential of legacy data in pharma R&D

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Clinical trials for a new therapy cost a median of $41,117 per patient. Costs like this are no surprise to pharma leaders. But during an age of increasing budgetary pressures, drug developers are under pressure to do more with less money and staff. While there are no “simple” answers to this challenge, there is one strategy that offers research and development (R&D) teams a very powerful approach: better leveraging existing legacy data.

Pharmaceutical companies own petabytes of imaging data, generated by in-house research, investigator-initiated studies or clinical trials. This data is valuable and can yield insights that can help researchers better understand disease mechanisms and inform therapeutic approaches. But in many cases, researchers cannot access this important data, as it remains in silos with CROs, investigator labs, or within a specific research group…

How Seer aims to remove technological barriers to studying the proteome

Founded in 2017, the proteomics Seer (Nasdaq:SEER) is building up a growing roster of customers, including pharma and biotech companies, translational and academic labs and CROs. Applications of its technology include biomarker discovery, target identification and multiomics research for cancer or other complex disease detection.

Recently, Weill Cornell Medicine and privately-held SpaceX used Seer’s proteome profiling technology to identify 50 differentially abundant proteins in astronauts postflight. In all, 22 proteins were upregulated, and 28 were downregulated across six time points collected before, during and after the flight. The proteins were “differentially changed as a function of a flight,” said Seer CEO Omid Farokhzad in a recent interview. The research could lead to a better understanding of the impact of space travel on people.

Another Seer customer, Evotec (Nasdaq:EVO), used Seer technology to analyze 105 samples from patients w…

FTC and DOJ staff eyes new ways to enforce antitrust laws in pharma

A two-day virtual workshop from the Federal Trade Commission (FTC) and the U.S. Department of Justice (DOJ) mulled the current state of antitrust law enforcement in the pharmaceutical industry, discussing the role of pharmacy benefit managers (PBMs) in driving up prices for consumers.

“A competitively vibrant market protects access to existing drugs and promotes new innovation, but access to medicine is already in peril by untenable costs,” said Rebecca Kelly Slaughter, an FDA commissioner in the workshop, which was held June 14–15.

M&A plays a role in driving up costs, Slaughter argued. “When mergers diminish competition in pharmaceutical markets, the result is higher prices, which can have a devastating effect for patients,” she said. “Enforcement action is necessary to prevent such harms.”

The workshop was organized by the Multilateral Pharmaceutical Merger Task Force, formed in March 2021 by then-Acting FTC Cha…

How pharma can optimize for right-the-first-time drug manufacturing and sustainability

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The pharmaceutical industry is gradually going green. More pharma companies are embracing sustainability metrics and striving to reduce corporate emissions and their footprint.

More than 25% of major pharma and biopharma companies are committed to reaching net-zero carbon emissions by 2050. Many are also committed to ensuring equal access to medicine for the 2 billion people worldwide that are currently underserved and rely on the United Nations Sustainable Development Goals (UN SDGs). Those initiatives are designed to improve human and planet health while helping achieve sustainable business practices.

Working toward a prosperous and equitable future while building healthy communities can directly support current and future business operations for pharma and biopharma organizations. These companies have concluded there does not need to be a choice between being envi…

Startup vies to get blockchain adoption in pharma off the ground

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Blockchain may be arguably one of the most hyped technologies in recent memory, but the distributed ledger technology better known for its role in cryptocurrency may have significant potential in the pharma supply chain, clinical trials and beyond.

A blockchain-based initiative known as PharmaLedger has won support from prominent companies like Pfizer, Novartis, Merck & Co., Bayer and AstraZeneca.

In 2019, the FDA launched a pilot program supporting the Drug Supply Chain Security Act with the support of IBM, KPMG, Merck & Co. and Walmart.

The pandemic’s disruption of the pharmaceutical supply chain further spurred industry interest in exploring blockchain to improve logistics networks, as the Harvard Business Review observed.

Overall adoption of blockchain in pharma or the enterprise at large, however, remains at a nascent stage.

Blockchain in…

How Target Value Delivery can help keep pharma construction projects on track

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Within the pharmaceutical industry, new plant construction frequently exceeds the allocated budget and runs over the expected time. The problem contributes to the industry’s challenge to bolster drug output over the past decade, according to the consulting firm Turner & Townsend. The firm estimated that some 70% of pharma construction projects miss their original budget by about 15%.

Of course, the pandemic’s negative impact on the supply chain has only exacerbated the problem. But the problem has been common across construction sectors for years. In 2016, McKinsey estimated that large construction projects across industries generally take 20% longer to complete than anticipated and are up to 80% over budget.

Keeping construction projects on track

Clay Seese

One philosophy to help keep projects on tr…

How pharma firms stack up in terms of innovation

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Tthe pharma industry has ramped up its ability to innovate in the past couple of years. Many firms in the sector have retooled operations, rethought clinical trials and accelerated the ability to commercialize new drugs.

Clarivate’s Top 100 Global Innovators 2022 report, however, cited only two pharma companies. Clarivate also projects that the level of innovation of the pharma sector will fall relative to other notable industries from 2020 to 2025.

Part of the reason for that prediction is the trend of increased collaboration in the sector makes it more difficult for individual pharma companies to stand out from the pack, according to Ed White, chief analyst and VP of IP and innovation research at Clarivate.

The pharma research ecosystem is considerably more fragmented now than it was 10 to 20 years ago.

“It’s difficult for us to say …

What’s driving the natural language processing revolution in pharma and life sciences

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Pharmaceutical and life sciences companies are faced with a constant stream of new data flowing into often siloed information systems. About 80% of that information exists in unstructured text that is difficult to extract and use, despite its paramount importance in driving clinical and commercial outcomes.

As a result, these organizations find themselves increasingly overwhelmed with volumes of inaccessible data. At the same time, researchers and data scientists lack effective search tools to find the right information in this “big data” tsunami, causing them to miss opportunities to enhance patient safety, improve clinical trial design, identify previously undetected biomarkers and better understand the voice of the customer.

To overcome the limitations of time-consuming, manual searches through mountains of data, pharma and life sciences companies are looking to artificial…