drug development Archives - Page 3 of 4

Sanofi puts AI ‘Plai’ app at the center of drug discovery and clinical trial operations

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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 departments, creates bespoke “what if” scenarios to guide decision-making. Sanofi aims to exploit Plai’s analytical capabilities to enhance strategic planning.

From ChatGPT and Google Maps to Plai

Sanofi’s AI aspirations are longstanding. In 2022, the company launched its inaugural digital accelerator, supporting the adoption of digital, data and AI across operations. That same year, Sanofi acquired Amunix Pharmaceuticals, tapping its AI technology to develop targeted cancer therapies that spare healthy tissue.…

QuantHealth taking a data-driven predictive approach to simulate clinical trials

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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 Council on Science and Health estimates an average success rate from 2000 to 2015 of only 13.8%, with costs reaching hundreds of millions per drug. The situation appears more grim with the average cost of developing a drug surpassing $2 billion, according to Deloitte.

“Despite increased understanding of diseases and technologies for drug discovery, developing new medicines remains an unpredictable endeavor filled with many failures,” said David Dornstreich, chief commercial officer and general manager U.S. at QuantHealth.

Generative AI could boost biopharma R&D productivity by billions, according to McKinsey

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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 functional spending as a result of generative AI, representing an approximately $328 billion windfall annually.

An evolution or revolution: UBS and McKinsey’s take on generative AI in biopharma

The investment bank UBS recently reached more muted conclusions, noting that generative AI would represent more of an evolution than a revolution for biopharma.

Conversely, McKinsey bets the technology could deliver productivity gains that account for 10% to 15% of overall R&D costs. This potential largely stems from the applicatio…

Why a smart approach to AI-driven drug discovery prioritizes sustainability

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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 UN’s Intergovernmental Panel on Climate Change (IPCC) to cap warming at 1.5°C by 2030.

Yet climate change remains the most pressing threat to human health, potentially causing 250,000 additional deaths per year, as the World Economic Forum has noted.

AI as a doubled-edged sword in sustainability

For biopharma, AI-driven drug discovery could serve as a double-edged sword when it comes to sustainability. On the one hand, these technologies promise to enable new discoveries and optimized processes that could slash emissions.

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Decoding Bayer’s digital health leap and its implications on drug discovery and personalized medicine

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 drive digital collaboration in cardiometabolic and renal disease, oncology and women’s health.

This new unit, the Bayer Precision Health group, plans to focus on identifying digital and digital-supported consumer healthcare opportunities. The group seeks to create new precision health products based on real-world evidence and digital technologies.

Bayer’s new digital health unit has a priority mission. It seeks to cultivate pioneering digital technologies. The goal? Empower individuals to make more informed health choices. It aims to accomplish that objective by uncovering novel delivery mechanisms, as our sister…

Deepcell’s REM-I platform marries AI with morphological analysis for drug discovery

Introducing Deepcell’s REM-I, which applies AI to cell morphology analysis.

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 discovery with the launch of REM-I. The platform combines AI and morphological analysis, a technique that studies the form and structure of organisms and their specific structural features.

“The REM-I platform offers several unique capabilities for deep assessment of single cell images and the ability to sort cells without bias,” Masaeli explained in an interview. “It is specifically designed to expose and analyze the heterogeneity within samples, as well as the heterogeneity in respons…

BenevolentAI is pioneering AI-driven drug discovery methods

“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 company’s AI models to explore when generating target hypotheses, said Anne Phelan, chief scientific officer of Benevolent AI in a presentation at the Royal Society earlier this year.

BenevolentAI’s strategy involves a comprehensive understanding of the biological systems underlying various diseases, breaking down silos in clinical areas and tapping diverse multimodal data to discover novel therapeutic targets. For ulcerative colitis, the company’s AI models sift through vast amounts of scientific literature and data to spot promising targets and pathways that could potentially alleviate …

Development challenges and regulatory changes for cell and gene therapies

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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 cell and gene therapies also have unique characteristics that can lead to manufacturing challenges and extended regulatory timelines. As of February 2020, cell and gene therapies account for 12% of the preclinical pipeline and 16% of the clinical pipeline.

Given the scale of investments made to support these development efforts and advancements possible, drug sponsors have looked to the U.S. FDA to consider accelerating gene and cell therapy development. The regulatory body has responded by shifting its departmental structure to st…

Amylyx Pharmaceuticals launches phase 2 trial for AMX0035 Wolfram syndrome therapy

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 (sodium phenylbutyrate and taurursodiol), marketed as Relyvrio, for adults with amyotrophic lateral sclerosis (ALS).

Both sodium phenylbutyrate and taurursodiol are smal molecules demonstrating neuroprotective effects in preclinical studies.

Trial design

The HELIOS is an exploratory open-label proof of biology study. Amylyx anticipates topline results from HELIOS in 2024.

The HELIOS trial is an exploratory open-label, single-group proof of biology study, with Amylyx anticipating topline results in 2024. The trial aims to assess the safety and efficacy of AMX0035 in…

Lonza and ABL Bio partner on bispecific antibody development for immuno-oncology and neurodegenerative diseases

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 for investigational new drugs (INDs), explained Andrew Brown, Lonza’s head of global process development support. “Leveraging more than three decades of expertise and innovative technologies, we provide an integrated drug substance and drug product program,” Brown said. “Thanks to our experience with new molecular formats, we know how to handle [ABL Bio’s] specific challenges.”

In the domain of bispecific antibody development, Lonza supports customers with problem-solving aiming…

Accelerating Alzheimer’s research: ADDF’s chief scientific officer reflects on the Lauder Foundation’s $200M gift

Beta-amyloid plaques and tau in the brain. [Image from National Institute of Aging]

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 25 years,” said Dr. Howard Fillit, co-founder and chief science officer of the nonprofit.

The Lauder gift will sustain ADDF’s philanthropic model for the next 10 or 15 years, Fillit said. “We want to use our donors’ money solely for the advancement of the development of new drugs for Alzheimer’s disease,” he explained. The organization ensures that every cent of each dollar donated goes towards drug research, with no deductions for administrative costs, salaries, rent…

Three strikes in pharma: Exploring recent drug withdrawals and clinical trial challenges

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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, many of which are widely used. In recent years, drug companies, for instance, have pulled a growing number of products for nitrosamine contamination. While the FDA can identify safety concerns, it often falls upon the manufacturer to initiate and execute a recall.

Here, we round up three recent examples of recent drug withdrawals where pharma companies either pulled drugs from the market or gave up on developing a drug for a given indication.

Covis Pharma withdraws Makena

The Zug, Switzerland–base…