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 aims to take drug to phase 3 for $100-200 million with AI-powered approach
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…
Could LSD change the game in anxiety treatment?
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…
FDA grants breakthrough status to LSD-based anxiety treatment
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’s multilink technology and partnerships drive oncology pipeline strategy
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…
Moving the needle on diversity in clinical trials: Where do we go from here?
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…
From gatekeeper to strategist: The evolution of the CISO role in drug development
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, immense needs: J&J’s mission to change the landscape
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…
When will drug development have its ChatGPT moment? Inside ambitious AI initiatives at Sanofi and Medable
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…
Beyond diabetes and obesity: Can GLP-1 therapies also transform chronic disease treatment?
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…
Off with the training wheels: AI-based patient characterization can improve clinical trial performance without large data sets
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…
Bridging the gap: How resource sheets translate complex clinical trial data into patient empowerment
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…
A timeline of Aduhelm’s rise and fall
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…
Inside Amgen’s ATOMIC strategy to use ML to accelerate clinical trials
Amgen has developed a machine learning platform to slash clinical trial times through smarter site selection. Known as ATOMIC, short for Analytical Trial Optimization Module, the system crunches disparate datasets to predict optimal trial locations, expedite enrollment and trial processes. Early results indicate more than a two times increase in enrollment speed at ATOMIC sites.…
Rice Biotech Launch Pad plans to make Houston a top-tier biotech hub
Houston boasts many world-class assets that have made it a formidable player on the global stage. From the world’s largest medical complex to mission control for the cosmos, few other cities can compete with its diverse strengths. Houston is also home to the prestigious Rice University, renowned for its leading science and engineering programs. Houston,…
Medable: AI-powered platform can halve trial build times
Decentralized clinical trial pioneer Medable unveiled an intelligent automation technology at the JP Morgan Health Care Conference, claiming it can slash standard trial build timelines by at least 50%. This development hinges around electronic clinical outcomes assessment (eCOA) — a common bottleneck in trial startups. “We’ve used AI to essentially take a protocol and translate…
Using AI to unlock new uses for existing cancer medicines
Repurposing is a drug development strategy that has been widely applied in cancer. This strategy, sometimes called label expansion, involves obtaining FDA approval to market a drug for the treatment of new indications, alone or in combination with other drugs. Not only can this approach extend the window of patent protection for a commercialized drug,…
Insilico Medicine’s latest AI-engineered drug ISM5411 could provide a novel approach for treating IBD
Capping off a busy 2023, Insilico Medicine has announced a potentially first-in-class oral PHD inhibitor for the treatment of inflammatory bowel disease (IBD). ISM5411 is the fifth AI-backed drug candidate from Insilico Medicine to reach clinical stages. ISM5411 targets prolyl hydroxylase domain (PHD) enzymes via modulation of the hypoxia-inducible factor (HIF) pathway, which is involved…
At AWS re:Invent, Pfizer exec frames digital as a core business strategy
In the midst of a global pandemic, Pfizer, under the leadership of its chief digital and technology officer Lidia Fonseca, achieved what was once thought impossible. The company, with the partnership of BioNTech, developed a COVID-19 vaccine in only 269 days, a process that traditionally would have taken 8 to 10 years. While prior research…
Genmab’s data-driven strategies speed up drug commercialization
Genmab’s senior vice president, global head of data science and AI, Hisham Hamadeh, describes the company’s journey to becoming “a data-driven decision-making company.” In one sense, there is little choice but to do so. “We’re swimming in data like never before. We’ve seen the volumes of data, the ability to compute on that data, and…
Nipocalimab shows promise in RA subgroups in phase 2a IRIS-RA study
Johnson & Johnson’s nipocalimab, which works by targeting the neonatal Fc receptor (FcRn), has the potential to treat an array of autoimmune conditions. But the antibody recently hit a snag in the first-ever clinical study of an FcRn inhibitor in rheumatoid arthritis (RA), missing its primary endpoint. The development has sparked debate within the rheumatology…
Cybin sees near future for psychedelic therapy after promising interim phase 2 data
With promising interim phase 2 data in hand, Cybin believes psychedelic therapy will become a reality in the “not too distant future,” according to CEO Doug Drysdale. As recently as the 1990s, it would be difficult to imagine that a psychedelic drug would potentially be a clinical option for a mood disorder like depression. But…
The future of MDD treatment: A comparative table highlighting the emergence of fast-acting therapies
The treatment landscape for major depressive disorder (MDD) continues to diversify, and in the coming years, psychedelic options may be available, including COMPASS Pathways COMP360 and the deuterated psilocybin analog CYB003 from Cybin. CYB003 demonstrated a significant -14.08 point reduction in MADRS score, a 53.3% response rate, and a 20% remission rate at a 12mg…
How a data lakehouse can give you a panoramic view of your AI-enabled clinical trials
In recent years, the term “data lakehouse” has entered the lexicon of data professionals. For AI-enabled clinical trials, the lakehouse architecture promises seamless integration of diverse data streams, spanning patient health records to real-time sensor data, all processed efficiently and queried in structured formats. The lakehouse architecture aims to provide a comprehensive overview of data,…
NLP in drug discovery and the quest for the ‘right’ research elements
In drug discovery and development, data sources are as diverse as they are plentiful. There are comprehensive databases brimming with molecular targets, cellular processes, genomic sequences, proteomic profiles, and metabolite patterns that shed light on disease pathways. Data possibilities in the patient care realm are similarly vast, spanning electronic medical records, imaging datasets, and even…