Building on existing integrations with cloud leaders AWS and Google Cloud and collaborations with Arcadia and TD2, Atropos Health is now partnering with Merck. This new collaboration will tap Atropos Health’s GENEVA OS (Generative Evidence Acceleration Operating System) and related tools with the aim of speeding the generation of real-world evidence. Under the agreement, Merck’s…
Oracle exec maps data integration strategy for modern clinical trials in 2025 and beyond
From FHIR-based APIs to “hybrid data models” and blockchain-enabled audit trails, biopharma companies are exploring a range of strategies in their quest to incorporate Real World Data (RWD) into clinical trials. But technology alone won’t resolve the deeper issues at play. From bridging disparate data sources to safeguarding patient privacy under evolving regulations, sponsors face…
How a ‘rising tide’ of inclusivity is transforming clinical trials
Let’s say there’s a Black female patient with an aggressive form of breast cancer. She meets with her oncologist to discuss a promising targeted therapy that recently won FDA approval. The drug showed strong efficacy in clinical trials, with a 65% response rate. Yet when she asks about efficacy data specific to Black women, she…
TAK-279, an oral small-molecule TYK2 inhibitor offering the convenience of a once-daily pill and biologic-like clinical responses
To the untrained eye, psoriasis might look like a simple skin condition, marked by itching, scaly patches. Yet psoriasis is an immune-mediated disease with systemic consequences. As Dr. Graham Heap, vice president and global program leader at Takeda, explained during a recent interview, “Psoriasis might manifest as plaques on the skin, but it’s an immune…
By 2025, clinical research and patient care converge: Data integration, validation, and evolving markets
A growing chorus of experts agree: 2025 signals a year when AI and its generative variants (genAI) move beyond early experimentation into a period of tangible, large-scale impact — including in the life sciences. While challenges remain as EY recently noted, the future will likely be one where the focus shifts from anticipating breakthrough genAI…
Biotech in 2025: Precision medicine, smarter investments, and more emphasis on RWD in clinical trials
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…
External comparator studies: What researchers need to know to minimize bias
Randomized controlled trials (RCTs) are the gold standard design for studies supporting drug approvals, but they are not always feasible, due to factors such as ethical concerns or very small patient populations. When an RCT is not possible, researchers may opt for a single-arm trial (SAT), which does not include an internal control group, but…
PROTACs in focus: Navigating the complexities of preclinical development
The development of Proteolysis Targeting Chimeras, or “PROTACs*,” has garnered significant attention in the pharmaceutical industry due to their potential to target and degrade disease-causing proteins previously considered undruggable. As a novel therapeutic modality, PROTACs offer a promising alternative to traditional small-molecule inhibitors and biologics. However, despite the excitement around these therapies, preclinical evaluations of…
Why FSP outsourcing of clinical operations roles is surging—and how to optimize your partnership
As the complexity, sophistication, and size of clinical trials have grown exponentially, the need for specialized expertise—often spanning various regions around the globe—has also expanded, along with the demand for flexible staff allocation. Consequently, clinical operations staffing has undergone significant transformations in recent years. The trend has shifted from relying on direct internal hires, to…
Why scientific AI needs clear lines of sight — especially for fields like drug development
Today’s large language models can be as unreliable as they are eloquent. Their tendency to fabricate facts and lose the thread makes them risky tools for scientific research, especially in highly regulated industries like pharmaceuticals and chemistry. They also struggle to provide sources and will fabricate a bogus academic journal without batting an eye. Speaking…
2024: The year AI drug discovery and protein structure prediction took center stage—2025 set to amplify growth
The global AI drug discovery market, valued around $1 to $1.7 billion in 2023, will be worth a multiple of that by the decade’s end. Analysts project the sector could be worth $9 billion or more. 2024 Nobel Prize in Chemistry Recipients: David Baker Demis Hassabis John Jumper Achievement: Computational protein design and structure prediction…
Drug development in 2025: 5 expert predictions cover synthetic data, hybrid trials and more
In 2024, we saw the expanded use of synthetic data and natural language processing transform drug discovery and development. In a batch of predictions published in December of 2023, one expert predicted that synthetic data was set to “take off” in drug research. In 2025, the pendulum could begin swinging back the other way, according…
PathAI launches AI tool for analyzing fibrosis in cancer tissue samples
The digital pathology firm PathAI has released PathExplore Fibrosis, an AI-based tool that analyzes fibrosis and collagen structures from H&E-stained whole-slide tissue images. The software quantifies fibrotic areas and collagen fibers from standard pathology slides, replacing specialized staining techniques and microscopy equipment. The tool processes large datasets of tissue images, designed to work with existing…
3-year study: Tirzepatide prevents diabetes in almost 99% of prediabetic adults
Although Lilly has shared the topline results of the SURMOUNT-1 trial, now, the full data from the three-year study have been published in the New England Journal of Medicine. The company also recently presented the data at ObesityWeek in San Antonio. The biggest conclusion was that 98.7% (752 of 762) of participants who received tirzepatide…
Anima Biotech aims to open the ‘black box’ of disease with large-scale cellular experiments
While many AI companies focus on analyzing existing scientific literature, this approach faces a fundamental challenge: the reliability of the source material itself. “Up to 70% of experiments described in publications cannot be replicated,” notes Yochi Slonim, CEO of Anima Biotech. “You do it once and you publish it. You do it again, it doesn’t…
World AIDS Day Summit & Celebration slated for early December
OraSure Technologies is preparing for the upcoming World AIDS Day Virtual Summit and Celebration of Progress, scheduled for December 5, 2024, from 9:00 to 11:00 a.m. PST (12:00 – 2:00 p.m. EST). This digital event aligns with the 2024 World AIDS Day theme of “Collective Action: Sustain and Accelerate HIV Progress” and will bring together…
Unlearn on shaving millions off clinical trial budgets with digital twins
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’…
GenAI is an ‘always available intern’ but for delicate pharma tasks, human guidance is critical
ChatGPT may be one of the quickest adopted tech platforms in recent memory, but the potential of it and other large language models ability transform the world has also been met with occasional provider outages, hallucinations, and memory problems. “There’s a lot of resentment towards the hype,” notes Christopher M. McSpiritt, head of life sciences…
The return on engagement: How sustained community outreach is improving clinical trial representation
Abstract Despite a wealth of case studies and recent FDA guidance highlighting the advantages of community-level engagement in clinical trials, local clinics and research sites with access, trust, and experience in treating diverse patient populations are frequently overlooked and under-resourced in the drug development process. Lloryn Hubbard and Zoé Felicié, patient diversity experts at the PPD Clinical…
Q&A: Oracle launches new cloud service to analyze global oncology treatment trends
Traditionally, only a small fraction of oncology drugs make it from phase 1 to commercialization. And biopharmaceutical companies continue to face significant challenges in understanding how new oncology drug approvals affect treatment patterns and market share. To deal with such hurdles, Oracle has recently launched CancerMPact Treatment Architecture Trends (PDF overview here), a resource that…
Scorpion’s STX-478 shows promising efficacy and tolerability in early cancer trial
Scorpion Therapeutics’ new oral cancer drug, STX-478, showed promising anti-tumor activity as a monotherapy in a Phase 1/2 trial, achieving an overall response rate (ORR) of 23% in breast cancer and 21% across all tumor types studied. The data were unveiled at the European Society for Medical Oncology (ESMO) Congress 2024, held 13–17 September 2024.…
Kisqali slashes recurrence risk by 28.5% in early breast cancer
Updated results from the Phase 3 NATALEE trial reveal that Kisqali (ribociclib) significantly cut the risk of recurrence in patients with HR+/HER2- early breast cancer. Adding Kisqali to standard endocrine therapy (ET) resulted in a 28.5% reduction in invasive disease-free survival (iDFS) events compared to ET alone (HR=0.715; 95% CI: 0.609–0.840; P<0.0001), Novartis announced in…
Important ERP considerations for biotech manufacturers
Manufacturers in the biotech sector face unique challenges ranging from stringent regulatory requirements to complex production processes. Implementing an ERP (enterprise resource planning) system tailored to their needs is crucial for ensuring compliance, efficiency, and scalability. Whether you are a life sciences CMO (contract manufacturing organization), a pharmaceutical manufacturer with an R&D department, or a…
How Fovus enabled a biotech to accelerate high-throughput screening by up to 96x with cloud HPC
Let’s face it: Cloud-based High-Performance Computing (HPC) offers unprecedented computational power. These systems can perform quadrillions of calculations per second. But that computational horsepower comes at a price – not just financially, but in the form of a steep learning curve and a constant battle against configuration headaches, unpredictable costs, and delays. For researchers working…
From Bayer’s regulatory streamlining to Superluminal’s protein modeling, Google Cloud’s AI gaining biotech momentum
Google Cloud’s Shweta Maniar is on a mission to revamp drug discovery with the power of generative AI, the trendy type of AI that can create new content. The tech is well-suited for a range of applications in drug discovery and across the life sciences. Whether it’s supporting organizations in their drug discovery efforts or…