The topic of AI in drug discovery and development may continue to garner significant attention, but harnessing AI effectively requires a nuanced strategy, and an ability to navigate between details and the bigger picture. Andrew Anderson, vice president of innovation and informatics strategy at ACD/Labs, likens it to boiling water. “On a small scale, it’s…

Global pharma and medical device giant Johnson & Johnson (J&J) has ditched its iconic cursive logo that dates back to the late 19th century, and rebranded its Janssen pharma division as Johnson & Johnson Innovative Medicine. The move underscores the company’s push to prioritize higher-margin prescription drugs. This strategic move comes amidst a backdrop of…

Much of the world is grappling with a mental health crisis — with soaring rates of depression and anxiety. Last year, the startup Gate Neurosciences emerged with a novel approach. While the Carmel, Indiana–based company is focused on synaptic plasticity like many other contemporary CNS companies, it diverges in its strategy. Rather than using a…

Synthetic data in oncology is transforming how researchers and developers approach real-world evidence. They often need this evidence to test hypotheses, predict outcomes and develop algorithms. But privacy constraints and access related to patient data can create delays and lengthen project timelines. Oncology drug researchers and developers have recently begun using synthetic data in oncology…

In the realm of drug discovery, AI is making waves, and 2023 could potentially be a pivotal year for this technology. As the technology enters the popular consciousness, pharma employees are wondering “why they can’t have similar AI-driven tools for their professional tasks,” said Diane Wuest, head of digital R&D at Sanofi, in a recent…

Roughly nine out of ten clinical trials fail as a result of factors such as lack of efficacy and unmanageable toxicity, as the journal Pharma Excipients has noted. After seven years of development, Insilico Medicine has scored a breakthrough with its generative AI tool, inClinico. In particular, the tool demonstrated 79% accuracy in predicting the…

The French pharmaceutical giant Sanofi has unveiled a new AI-powered app called Plai, developed in partnership with AI platform Aily Labs. This move is part of Sanofi’s plan to become the pioneer in fully integrating AI into all operations, according to CEO Paul Hudson. Plai, designed to compile and process Sanofi’s internal data from various…

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…

Generative AI stands to add trillions of dollars of value to the world economy, according to a recent McKinsey report. The consultancy noted that about three-quarters of the value of generative AI spans four areas — customer operations, marketing and sales, software engineering and R&D. The latter could see a 12% annual lift in global…

The fact that the biopharmaceutical industry has a large carbon footprint is well established. A 2022 study from My Green Lab confirmed that biotech and pharma are still among the globe’s top polluters. The research highlights that a mere 4% of the largest publicly-traded biotech and pharmaceutical firms have climate commitments in line with the…

The German multinational pharma and biotech colossus Bayer is taking further steps to ramp up its focus on digital health by launching a new business unit. In 2022, Bayer invested $9.5 million in Woebot Health, an AI-powered behavioral health platform company. In 2020, it launched a venture known as G4A Digital Health Partnership Program to…

From her early days as a research assistant at UCLA, to her work as a postdoctoral fellow at Stanford, Deepcell co-founder and CEO Maddison Mahdokht Masaeli has actively engaged in the field of biomedical engineering. Now, Masaeli and her team at Deepcell, a company she co-founded in 2017, are introducing a new strategy to drug…

“Can we treat chronic inflammation in ulcerative colitis by reversing immune cell activation in colonic mucosa?” That’s an example of a biological question that the AI-enabled drug discovery firm BenevolentAI (AMS:BAI) would ask when exploring a new drug target. Incorporating a disease, sign, mechanism and tissue into a single question provides focal points for the…

Cell and gene therapies are the fastest growing area for drug development. The groundwork for this category was laid with the mapping of the human genome in 2003, and the field has developed rapidly in the intervening decades. These powerful therapies have significant potential for the treatment of cancer and other previously “undruggable” diseases. But…

Drug development involves many rounds of regulatory approval and oversight, including multiple stages of regulatory submissions. In the U.S., these include the Investigational New Drug Application (IND) before clinical trials in humans, the New Drug Application (NDA) or Biologics License Application (BLA), prior to commercial sale and Annual Product Quality Reviews (APQR) to monitor ongoing…

Cambridge, Massachusetts–based Amylyx has dosed the first participant in its phase 2 HELIOS clinical trial of AMX0035 focusing on Wolfram syndrome. The condition is an ultra-rare genetic disorder involving the endocrine system. Symptoms of Wolfram syndrome can include diabetes insipidus, diabetes mellitus, optic atrophy and hearing loss. In September, Amylyx won FDA approval for AMX0035…

Lonza (LON:0QNO) and South Korea-based ABL Bio (KOSDAQ:298380) have joined forces to accelerate bispecific antibody development for immuno-oncology and neurodegenerative diseases. Over email, Basel, Switzerland–headquartered Lonza noted that its experience with novel molecular formats enables the company to handle ABL Bio’s unique challenges. In the partnership, Lonza will provide submission-ready chemistry, manufacturing and controls (CMC) data…

The Estée Lauder family has donated $200 million to the Alzheimer’s Drug Discovery Foundation (ADDF), a nonprofit they founded in 1998 to support Alzheimer’s research. The gift is the largest ADDF has received. “We’ve deployed about $270 million so far for about 700 programs in 19 countries of drug discovery and development over the past…

Pharmaceutical companies face a long list of regulatory challenges ranging from patent expiry to bioequivalence and international harmonization. It’s not uncommon for drug makers to withdraw or discontinue drugs after failing to meet clinical requirements or endpoints, resulting in drug withdrawals. On average, life science companies pull roughly 4,500 drugs and devices from the market,…

Utilizing real-world data (RWD) to generate real-world evidence (RWE) is not new and pharmacoepidemiologists have long-standing experience designing and implementing studies utilizing RWE to satisfy regulatory post-marketing safety commitments and to evaluate the effectiveness of drugs. However, RWD and RWE can be used more largely to support the full life cycle of drug development, during…

One of the ways that the COVID-19 pandemic had a profound impact on the pharma industry was how it highlighted the importance of pharmacovigilance. As personalized medicine gained traction, drug developers had to evolve their strategies to ensure safety and efficacy. In their report, “The Future of Pharmacovigilance,” Dr. Sabine Jeck-Thole and Ben Enejo, partners…

Clinical trials for a new therapy cost a median of $41,117 per patient. Costs like this are no surprise to pharma leaders. But during an age of increasing budgetary pressures, drug developers are under pressure to do more with less money and staff. While there are no “simple” answers to this challenge, there is one strategy that offers…

It’s no secret that the pharma industry is evolving at a rapid pace, with technological advances and new pharmacy options impacting consumer preference every day. And with the industry expected to grow swiftly in the coming years, pharmaceutical companies will need to progress along with that growth to engage key audiences. Big industry players know…

The accepted definition of a biomarker is a “defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions.” This definition was derived from a 2016 partnership between the U.S. FDA and the National Institutes of Health (NIH). Biomarkers are not diagnostic…

Biopharma companies are grasping the key role an integrated product development strategy can play in the drug development process. A recent industry survey found growing uptake of this multidisciplinary approach to improving efficiency and reducing costs and timelines, though the barriers to successful implementation were similar across the board. The potential savings a strong integrated…