precision medicine

In statistics and machine learning, there’s a tradeoff between precision and recall: tune a system to be more selective and you inevitably miss more true positives. Cancer clinical trials have stumbled into a similar trap. As oncology has shifted from tumor-type-centered studies to gene-directed approaches, eligibility criteria have grown exquisitely precise. Instead of enrolling patients…

Biomarkers have moved from “nice-to-have” to the backbone of drug development, says Quanterix’s Jorge Marques Signes, who argues they now shape feasibility, timelines and even payer expectations before sponsors commit thousands of patients or years of spend. “Biomarkers are not supplemental anymore,” said Marques Signes, VP of Accelerator & Clinical Services at Quanterix. “They are…

The FDA has granted simultaneous approval for HERNEXEOS (zongertinib tablets), developed and commercialized by Boehringer Ingelheim, for the treatment of adult patients with non-small cell lung cancer (NSCLC). The approval covers tumors with HER2 (ERBB2) activating mutations. It also signed off on Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to…

Only 7.1% of U.S. adults with cancer enroll in treatment trials (JCO, 2024), a bottleneck that slows drug development and limits access to targeted therapies. Proscia, a Philadelphia-based digital pathology company, aims to address that dynamic with its new tool, Aperture, which uses AI to flag potential candidates right at the point of diagnosis by…

Bispecific antibodies (BsAbs) are redefining the landscape of therapeutic design, offering dual-target precision that conventional antibodies can’t match. These specially engineered antibodies bind to either two different antigens or two distinct sites on the same antigen. BsAbs form a powerful new class of therapy which has caused excitement among the drug development community due to…

While diagnostic pathologists can review scanned slides remotely with AI assistance and instant global collaboration, much of the clinical trial pathology world still ships physical glass slides between labs, dealing with FedEx delays and proprietary file formats. “For exploratory assays, yes, it’s exploding. Everyone’s enjoying artificial intelligence and machine learning for various aspects, but there’s…

In 2025, genetic validation is poised to emerge as a high-stakes litmus test in cardiovascular R&D, investors will continue to get better at funneling cash into proven science, and patients will continue their evolution to become more-active partners shaping their healthcare. To hear more about each of these trends, we considered feedback from three industry…

As we edge closer to 2025, advances in long-read sequencing technologies, increasing biobank participation, and a growing emphasis on pharmacogenomics are all set to transform how we diagnose, treat, and prevent diseases. Below, Neil Ward, VP of Pacific Biosciences (PacBio) EMEA, offers insights on what’s happening now—and what’s next—as genomics and precision medicine finally deliver on their promise…

Clinical trials are notoriously expensive, with Phase 3 studies costing upwards of around $55,000 per day and completed trials routinely costing in the tens of millions of dollars. The startup Unlearn aims to chip away at those costs using digital twin technology, a concept pioneered by NASA during the Apollo era to create ‘living models’…

Breast cancer is the most common cancer for women in the nation, with over 300,000 new cases expected to be diagnosed this year. While the narrative for breast cancer early detection centers around mammograms, the gold standard for diagnosis, clinicians have tapped into enhancing radiology and X-ray imaging using artificial intelligence (AI). This AI-enhanced approach…

Redwood City, California–based Earli is, in many ways, a quintessential Silicon Valley startup. As is often the case, there’s not only a Stanford connection but a grand ambition. The company is developing a “synthetic biopsy” platform that aims to detect cancer at its earliest stages by programming cancer cells to reveal themselves and even self-destruct.…

The UK Biobank, with genetic data on half a million individuals, set a benchmark for scale in medical research. It contains whole genome sequencing data for all 500,000 participants, making it the world’s largest genetic project to date. A recent collaboration between the San Diego–headquartered clinico-genomics company Helix and the Salt Lake City–based biotech Recursion…

The potential of Artificial Intelligence (AI) to accelerate medical discovery is immense, particularly within the dynamic and mutable area of biology. Unlike the more predictable fields of chemistry and physics, biology presents unique challenges due to its complexity and constant adaptation, areas where AI can play a transformative role but has been limited to date…

Athos Therapeutics is a clinical-stage biotech focused primarily on developing precision small molecule therapeutics for autoimmune diseases and chronic inflammatory diseases. Like a growing number of biotechs, Athos is giving machine learning a prominent role in its drug discovery approach. Its advanced AI/ML platform integrates patient samples and data from global hospital systems to identify…

Imagine sifting through medical and genetic histories to understand why some patients respond to treatments while others don’t. This is the reality for companies like Merck & Co. A recent pact with Culmination Bio is giving Merck access to more than 40 years of data, including millions of biospecimens to fuel this aim. “We want…

In 2023, the American Society of Anesthesiologists (ASA) issued guidelines advising patients to discontinue GLP-1 receptor agonists (GLP1-RAs) a week before surgery, citing concerns over potential operative complications, leading to delayed or rescheduled surgeries across the U.S. Dr. David Klonoff, a diabetes researcher and Endocrinologist at Mill Peninsula Medical Center, thought it was curious that…

Dandelion Health, the maker of a real-world data and clinical AI platform, has launched the first multimodal real-world clinical dataset focused on uncovering insights and opportunities related to GLP-1 receptor agonist drugs. The company describes the GLP-1 data library as “the first multimodal real-world clinical dataset” related to GLP-1 receptor agonists. The library is sourced…

The top 20 healthcare-focused biotech companies collectively raised $2.9 billion in the first quarter of 2024, according to data sourced from Crunchbase. That represents a 161% increase compared to the $1.1 billion raised by the 20 largest funding rounds involving healthcare-focused biotech companies in Q1 2023, indicating more confident bets on the market viability of…

Over the past decade, the use of deeper sources of real-world data across all stages of the drug development life cycle has become increasingly important to guide disease understanding, trial designs, clinical guidelines, regulatory submissions and post-market studies. The advent of these deeper sources was prompted by the HITECH Act, which had the effect of…

PathAI and Roche Tissue Diagnostics (RTD) have inked an exclusive collaboration to develop AI-enabled companion diagnostics that builds on their initial partnership announced in October 2021. To date, PathAI and Roche have commercially launched four algorithms through the partnership. The new partnership will provide biopharma sponsors with integrated technology for developing companion diagnostics incorporating AI-based…

The University of Pittsburgh’s recent, significant expansion of its high-performance computing capabilities, courtesy of a gift from Dell Technologies, indicates a strategic commitment to using large-scale data analysis for faster translational research. The additional 9.672 gigaFLOPS of computational power – translating to nearly 9.7 trillion additional computations per second – could help Pitt’s Innovation Hub…

A collaboration between the Novo Nordisk Foundation, the Export and Investment Fund of Denmark (EIFO), and NVIDIA will establish a national AI Innovation Centre in Denmark focused on accelerating research and innovation in fields including healthcare, life science, and quantum computing. The initiative is led on the Danish side by the Novo Nordisk Foundation, which…

In 2023, Merck & Co. made a considerable investment in research and development, spending more than $30 billion. This figure represents more than double the company’s R&D spending ($13.5 billion) in 2022. The closest competitor in terms of R&D investment was Roche Pharmaceuticals, with a 2023 R&D expenditure of roughly $14.7 billion. This sum is…

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…

Only 12% of new drug candidates that enter phase 1 clinical development ultimately receive FDA approval. This dismal success rate leaves millions of patients with unmet medical needs and drives up the costs for the small number of drugs that make it to market. More frustratingly, it leaves untold numbers of potentially transformative therapies back-burnered…