clinical trials

Featured on the cover of Nature Machine Intelligence, one of Iambic Therapeutics‘ AI platforms, known as NeuralPLexer, can accurately predict protein-ligand complex structures. The platform excels at predicting the complex 3D structures formed when proteins bind with drug-like molecules. In a benchmark study featured in the publication, NeuralPLexer outperformed other systems, including AlphaFold2, in its…

Imagine tripling or quadrupling the speed at which eligible patients are matched to potentially life-saving cancer trials. That’s the promise of ConcertAI’s AI-powered screening technology, which demonstrated a 3 to 4 times efficiency gain over traditional EMR-based methods in a recent study presented at the American Society of Clinical Oncology (ASCO) conference. Focusing on relapsed…

What’s the difference between a multimodal generative AI system to plan a vacation itinerary versus guiding cancer treatment? For the former, data quality is a definite plus, but for the latter, it’s indispensable. “If I ask ChatGPT to plan a vacation for me and it spits out something, I might sit there and second guess…

It’s something of a truism that about nine out of ten drug candidates in clinical trials fail to reach the market. While some amount of guess-work is unavoidable in drug development, Dr. Ali Pashazadeh, co-founder and CEO of Treehill Partners sees faulty decision-making and poor communication as chief factors contributing to high failure rate. While…

 Over the past year, North American biotech firms continued to lear the world in funding by a significant margin in an analysis that included a various equity fundraising types drawn from Crunchbase. Argenx, a publicly traded Dutch biotech, raised $1.1 billion from investors in July 2023 through a global offering. Next in line was…

The FDA’s Center for Drug Evaluation and Research (CDER) recently unveiled the launch of the CDER Center for Clinical Trial Innovation (C3TI), which aims to drive clinical trial innovation. When asked to assess the potential impact of the center, Charles Fisher, founder and CEO of Unlearn, said: “The truth is, I don’t know. I’m sort…

On March 6, 2024, the U.S. Securities and Exchange Commission approved a rule to require some companies to report some of their carbon emissions (Scope 1 and 2, but not Scope 3)1. While some feel this rule doesn’t go far enough, it certainly demonstrates the need to better understand our respective carbon footprints and develop…

Ozempic, Rybelsus and Wegovy have transformed the diabetes and weight loss treatment landscape, but when it comes to the impact of their active ingredient, semaglutide, on fetal development, “the answer is we do not know,” said Dr. Marijane Hynes, clinical professor of medicine at the George Washington University School of Medicine and Health Sciences. Hynes…

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…

Digital pathology is disrupting the drug development process, replacing traditional microscopy rooted in Victorian Era approaches with high-resolution images and AI-powered analysis tools. In a recent editorial webinar, industry experts Nathan Buchbinder (chief strategy officer at Proscia), Dr. John Cochran (chief medical officer and chief pathologist at Q² Solutions, an IQVIA subsidiary), and Dr. Monika…

While diversity in clinical trials has won attention in recent years, uneven representation of diverse populations in clinical trials remains a core barrier to global healthcare equity. Real-world data (RWD) paired with artificial intelligence techniques can almost instantly analyze how well drugs work in diverse subpopulations once they hit the market. RWD can also help…

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…

A recent review of more than 2,000 studies related at least indirectly to obesity on clinicaltrials.gov highlights the pronounced significant shift in research focus toward GLP-1 receptor agonists for a range of indications with at least some involvement of metabolic disorders. The site, which provides a robust but not-exhaustive snapshot of clinical trial activity, cites…

Lantern Pharma’s AI-powered sprint  Lantern Pharma (NASDAQ: LTRN), a publicly traded clinical-stage biotech company with a market cap of around $79 million as of mid-March 2024, is shooting for developing $200 million drugs with a machine learning-based platform. The oncology-focused firm Lantern Pharma, profiled last year, has advanced its new drug (LP-284) to a Phase…

A once-controversial psychedelic substance could potentially be a promising treatment for generalized anxiety disorder (GAD). That’s the view of Dr. Rakesh Jain, a psychiatrist with extensive experience in clinical practice, research, and education, affiliated with Texas Tech University School of Medicine. Jain expressed optimism in LSD-based therapy while acknowledging the challenges inherent in such a…

In a major shift away from decades of stigma, the FDA has granted Breakthrough Therapy Designation to MindMed‘s MM120, an LSD-based treatment for Generalized Anxiety Disorder (GAD). This milestone not only underscores the growing recognition of the therapeutic potential of psychedelics but also could point to a potential turning point for the struggling psychedelic sector…

Debiopharm, an independent Swiss biopharmaceutical company based in Lausanne, seeks to carve a niche in the competitive oncology and infectious disease markets. Its business model focuses on in-licensing promising drug candidates from universities and smaller biotechs, aiming to add value through development. (The company is also partnering with AI-focused firms like VeriSIM Life.) Sandra von…

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…

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…

Rare diseases may seem niche, but their impact is far from small. An estimated 7,000 rare diseases exist, collectively affecting a 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…

In episode 4 of Ai Meets Life Sci, Kayleen Brown, managing editor at DeviceTalks and Brian Buntz, pharma and biotech editor, chat with Helen Merianos, Ph.D., head of R+D portfolio strategy at Sanofi and Michelle Longmire, MD, CEO of Medable. The focus? The two-fold application of AI in their respective companies’ technologies, both for scientific advancement…

Glucagon-like peptide-1 (GLP-1) receptor agonists like semaglutide and tirzepatide have cemented their status as two of the most successful drugs in recent memory. Recent projections have estimated that the drug class could fetch $44 billion by 2030 and $71 billion by 2032. But GLP-1 sales could potentially reach greater heights as these therapies move beyond…

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…

As patients take a more active role in managing their health, they can find navigating the complexities of clinical trial results daunting. Having access to clear, accurate information is crucial for informed decision-making. This is where patient-reported data from clinical trials has real value, offering key insights into the real world experiences of participants, both…

The story of Aduhelm has been rocky now for years. Biogen turned heads when its controversial Alzheimer’s therapy won accelerated approval from the FDA against the advice of its own advisory panel in mid-2021. The company had high hopes for the antibody at that point, pricing it at an average of $56,000 per year. Aduhelm…