pharmaceutical R&D Archives - Medical Design Sourcing

In 2023, Roche and Novartis led the pack in drug pipeline scale

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When reviewing R&D spending trends for 2023, Merck & Co. is a clear outlier given its decision to count its $10.3 billion Prometheus acquisition as an R&D charge. In all, the company committed more than half of its revenue to R&D. But Swiss giants Roche and Novartis remain frontrunners in terms of their pipeline of potential new medications. Both have more than 190 drugs in their pipelines.

Roche’s diversified approach ranges from oncology to ophthalmology

Roche’s focus spans oncology, immunology, neuroscience, and cardiovascular diseases. The company’s oncology portfolio stands out with candidates such as inavolisib and giredestrant that target novel mechanisms in breast cancer. Additionally, Inavolisib, a PI3K inhibitor, targets the PI3Kα isoform, involved in the pathways that drive cell growth and survival. It shows potential not only in breast cancer but also i…

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…

A nurse-turned-pharma-exec strives to advance care for those with an autoimmune liver disease

Intermediate magnification micrograph of primary biliary cirrhosis, from a liver biopsy with H&E stain. Image by Nephron, licensed under CC BY-SA 3.0, via Wikimedia Commons.

Now the vice president and head of medical affairs at CymaBay Therapeutics, Mary Standen‘s passion for healthcare was sparked in her high school years when her mother was diagnosed with breast cancer. Though her mother eventually recovered, Standen was galvanized to help provide both emotional support and practical assistance, such as administering weekly injections. The experience made Standen feel empowered to join her mother’s battle against cancer. “I felt I had it in my power to help with the fight,” Standen said.

The experience proved to be the initial formative experience that propelled Standen into a career dedicated to healthcare and patient advocacy. “After earning her bachelor’s in Psychology from Emory U…

Unlocking generative AI requires reshaping culture, operations, and talent dynamics

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In drug discovery and development, generative AI and natural-language processing (NLP) tools promise more than incremental productivity gains. For companies that can integrate such tools strategically into their workflows, the tools open the door to a fundamental rethinking of operational processes. For instance, generative AI tools can accelerate drafting of research articles, novel target identification, and the creation of SOPs for recipe and formulation. NLP, conversely, can mine unstructured scientific data and complex research papers. Because roughly 80% of healthcare data is unstructured, NLP promises to unlock previously inaccessible insights, transforming raw data into actionable knowledge.

But deploying such tools at scale requires a mix of strategic thinking, curiosity and new approaches to cultivating talent. As we enter 2024, life science organizations must rethink their approach to ad…

MDMA’s potential shift from party drug to PTSD therapy could hinge on strict safety measures

MDMA, the stimulant mood-lifting drug commonly known as ecstasy, could soon transition from party staple to FDA-approved medication — but likely with tight control measures to address its abuse potential and safety risks.

On Tuesday, the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) filed an application seeking FDA approval of MDMA-assisted therapy for post-traumatic stress disorder, based on positive phase 3 results demonstrating significant PTSD reductions for most trial participants. In the studies, a significant number of those receiving MDMA-assisted therapy no longer qualified for a PTSD diagnosis after three treatment sessions, with a large majority seeing clinically meaningful improvements.

Currently, the Drug Enforcement Administration (DEA) categorizes MDMA as a Schedule I controlled substance having no approved medical uses, although it is likely to reclassify the stimulant if it receives FDA approval.

MAPS founder Ric…

How Accenture and AWS are upgrading Merck’s IT and drug discovery R&D engine

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Historically, the pharma sector has exhibited a degree of caution in adopting emerging technologies such as cloud computing and AI, given the sector’s stringent regulatory requirements, data security concerns, and the complexities involved in integrating new systems into legacy processes.

The situation is beginning to shift considerably with the COVID-19 pandemic, in particular, acting as a catalyst, compelling many Big Pharma companies to accelerate their digital initiatives. Pfizer, Sanofi, Novartis, AstraZeneca, and other Big Pharma companies have unveiled ambitious initiatives tapping cloud computing and AI technologies, aiming to streamline various aspects of drug discovery and development.

Inside the Accenture-AWS-Merck pharma alliance

For instance, Merck in 2021 forged an alliance with Accenture and AWS to update its IT infrastructure and facilitate advanced drug discover…

Merck, Amgen back Culmination Bio’s quest to transform healthcare data analytics

In the same week that Merck and Amgen revealed expanded alliances with AWS, the bioinformatics startup Culmination Bio revealed that it has received $10 million in funding from the venture arms of those companies, Merck Global Health Innovation Fund and Amgen Ventures. Culmination Bio, a spinoff from Intermountain Health, has developed a vast data lake of de-identified patient records spanning over 40 years.

Dr. Lincoln Nadauld, CEO of the startup, notes that the funding is evidence that the data it has collected can address pharma’s longstanding quest to boost the efficiency of drug discovery and development. Frequently, pharma companies have “access to vast datasets, but those datasets are often not the right kind of data,” Nadauld said. “It’s fragmented, or it’s unstructured, or it’s deficient in some fashion.”

Culmination Bio readies data lake based on four decades of patient health records

Consequently, Culmination Bio is confident that t…

Anticipating IND submission: Ensuring your drug is ready for preclinical toxicology studies

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Drug development is often a vast and intricate journey. Each phase signifies an advancement in the process, always with an eye toward patient safety and efficacy. But before any therapeutic finds itself on the bedside tables of hopeful patients, it faces a formidable challenge: preclinical toxicology testing. As the gateway to clinical trials, this early testing is more than just a safety assessment. A robust examination establishes a drug’s potential efficacy, possible adverse reactions, and activity within the human body.

Preclinical toxicology is when a drug’s strengths and vulnerabilities are laid bare for all to see. Imagine the invaluable insights drawn from organ-specific tests that reveal hidden adverse reactions or genotoxicity evaluations that shine a light on the risks of cellular mutations.

Such revelations can influence everything from dosing decisi…

Commitment to operational efficiency and partnerships yield dividends for Teva

Teva’s strategy to boost its operational efficiency and tap strategic partnerships seems to be paying off. In its Q3 earnings report, Teva announced that global revenues were up to $3.9 billion, marking a 7% rise from the previous year’s third quarter. Factors fueling the growth include the robust performance of their specialty medications, Austedo and Ajovy, as well as a strong showing from their generics portfolio. However, despite these promising stats, investors appear to be cautious. Teva’s stock is down almost 8% so far this year, currently trading at $8.77.

For Austedo, Sven Dethlefs, the company’s head of North America commercial, noted that the company has seen growth for the extended-release version of the drug. In an earnings call, Dethlefs said the company has seen “a significant number of new prescribers that have never prescribed Austedo before that now start prescribing Austedo XR.” He added that the demand for the …

A-Alpha Bio attracts $51M in total funding to advance machine-learning-driven protein interaction research

3D illustration of an antibody [peterschreiber.media/Adobe Stock]

A central hurdle in computational protein design is the mismatch between proteins designed in silico and their actual behavior after synthesis. “You can design millions of proteins on a computer over the course of a week or a month, but computational approaches are just not good enough,” explained David Younger, co-founder and CEO of A-Alpha Bio, in a recent interview. That is, after synthesis, the proteins often do not behave as desired.

Furthermore, the throughput for manual protein experiments is typically low. “You might be able to design millions of proteins, but you might only be able to test 10,” Younger said. The company thus built a platform designed to mitigate this bottleneck by focusing on protein binding — a crucial aspect of protein function.

Established in 2017 as a spinoff from the Institute for Protein Design at the Univers…

QuantHealth taking a data-driven predictive approach to simulate clinical trials

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In drug discovery, the process of shooting for regulatory approval can feel less like a sprint and more like a marathon, but with no guarantee of crossing the finish line. Despite the hefty investment of time, effort and resources, the success rate for bringing new drugs to market hasn’t improved in recent decades. The American Council on Science and Health estimates an average success rate from 2000 to 2015 of only 13.8%, with costs reaching hundreds of millions per drug. The situation appears more grim with the average cost of developing a drug surpassing $2 billion, according to Deloitte.

“Despite increased understanding of diseases and technologies for drug discovery, developing new medicines remains an unpredictable endeavor filled with many failures,” said David Dornstreich, chief commercial officer and general manager U.S. at QuantHealth.

eClinical Solutions Q&A: The quest to transform raw data into drug discovery gold

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Top pharmaceutical companies sponsor over a hundred clinical trials annually, generating vast amounts of data. Harnessing this deluge is a monumental task. eClinical Solutions, led by CEO Raj Indupuri, tackles this through advanced applications of data analytics and machine learning with a strong emphasis on AI in clinical trials optimization.

Specifically, eClinical Solutions taps AI/ML for automated data mapping, classification, review and mining insights. This enhances efficiency, speeds up cycle times and ensures quality as data complexity grows. The company’s Elluminate platform integrates and structures data, supporting advanced analytics.

Powerful techniques like anomaly detection algorithms can automatically flag potential data issues for human review. ML also classifies and categorizes data to focus reviewer time on the most critical areas. Fostering an innovative cultur…