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Artificial intelligence (AI) has revolutionised many industries, yet its adoption in pharmaceutical drugdevelopment has been notably slower. For years, AI and machine learning (ML) were often dismissed as little more than advanced statistics with little practical value in drugdevelopment.
Given macro healthcare influences (eg, economic uncertainty, environmental changes) and the numerous available treatments for major diseases, drugdevelopers may need to reassess their therapeutic strategies. This has led drugdevelopers to unintentionally limit their potential within chosen therapeutic spaces.
Showcasing Breakthroughs in Ocular Safety and Translational Models We were especially honored to have Dr. Makori and Dr. Iwabe present a symposium titled Ocular Toxicology Studies of New Drug Modalities: An Approach to Reduce Animal Use. 1] [link] ; This blog was originally published in June 2025. conference locations.
Altasciences At CPHI Americas 2025 pmjackson Thu, 07/03/2025 - 13:41 In the ever-changing drugdevelopment world, staying agile is essential to enabling more informed decisions, faster. It’s a challenge that affects a large percentage of new drug candidates—one we’re passionate about helping to solve.
Leveraging Machine Learning to Accelerate DrugDevelopment Discover how CDMOs are using machine learning to speed up drugdevelopment, cut costs, and improve quality. mcottam Mon, 06/23/2025 - 14:54 Discover how CDMOs are using machine learning to speed up drugdevelopment, cut costs, and improve quality.
Regulatory Guidance for Oligonucleotide Bioanalysis in DrugDevelopment pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.
Unlocking new levels of value with expanded offerings We are launching more dynamic and integrated service offerings that leverage the very latest automation and integrations to accelerate your unique drugdevelopment journey in new and different ways. Contact your business development representative to learn more.
The China-based cancer drugdeveloper’s offering will fund testing of medicines for several blood malignancies — one of which is part of an alliance with Takeda.
Drugdevelopment is plagued by complex challenges, but multimodal AI is unlocking new opportunities. By integrating diverse data sources – from genomics to clinical insights – this approach is accelerating drug discovery, improving patient stratification and boosting success rates.
OGDP is one of several offices in OGD, and it was composed of three divisions: the Division of Legal and Regulatory Support, the Division of Orange Book Publication and Regulatory Assessment, and the Division of Policy Development (DPD). Leading FDAs implementationof the Drug Competition Action Plan (DCAP). 314.150(c).
In preparation for World Orphan Drug Congress Europe, we interviewed Nathan Chadwick, Senior Director, Therapeutic Strategy Lead, Rare Disease, and Derek Ansel, MS, LCGC, Vice President, Therapeutic Strategy Lead, Rare Disease, to hear their insights into the current progress in rare disease research and their hopes for 2025.
As a result of reforms enacted by the Food and Drug Omnibus Reform Act of 2022 (FDORA), FDAs authority to approve as well as withdraw an accelerated approval was given new regulatory teeth to ensure that confirmatory trials are conducted expeditiously.
Unfortunately, this years event, scheduled for February 27-28, 2025, in Washington, DC, was abruptly postponed less than one week before it began. Thats why Worldwide Clinical Trials was committed to ensuring the rare disease community still had a space to share knowledge, resources, and support on Rare Disease Day 2025.
Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drugdevelopment due to their close genetic, anatomical and physiological resemblance to humans. This scarcity disrupts research timelines and limits the ability to replicate results across studies.
On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drugdevelopment, starting with monoclonal antibodies (mAbs).[ One great example is the FDAs 505(b)(2) New Drug Application (NDA) pathway. 7] This was a landmark change in philosophy.
Unlike traditional pharmacokinetic (PK) studies that rely on plasma measurements alone, MSI, when combined with traditional histology, enables spatial mapping of drug distribution, metabolism and target engagement. Toxicological investigations play a key role in assessing drug safety and, importantly, inform development decisions.
My message was that AI-enabled drug discovery was comingsomeday. Fast forward to 2025, and that someday is now. … The post AI Unleashed: Transforming Drug Discovery from Theory to Practice appeared first on Plenge Gen @rplenge. Weve seen an explosion in the availability and capability of AI tools.
Originally developed in the 1970s to treat diabetes, these drugs—such as Ozempic, Wegovy, and Mounjaro—have become headline-makers for their ability to induce significant weight loss. Understanding GLP-1 drugs GLP-1, or glucagon-like peptide-1 receptor modulators, mimic natural hormones that regulate insulin and appetite.
Located in Jiangsu Province, China, the Nantong site serves as a critical component of WuXi AppTec’s expansive Contract Research, Development, and Manufacturing Organization (CRDMO) platform. By integrating operational excellence with architectural brilliance, the site has become a blueprint for the future of industrial science campuses.
That is a decent hypothesis to explore and their early clinical data at ASCO 2025 looked interesting. Now to antibody-drug conjugates (ADC) where we saw some early programs with difficult toxicities. The Next Wave: Targeting B7H3 – a drugdevelopment tsunami in the making? An awesome space to watch. Stay tuned.
1] [2] It was developed by Vertex Pharmaceuticals , [5] and was approved for medical use in the United States in January 2025. [2] 2] [6] Suzetrigine is the first medication to be approved by the US Food and Drug Administration (FDA) in this new class of pain management medicines. [2] Suzetrigine is taken by mouth. [1]
See how combining structured and unstructured data advances drugdevelopment. dfarris Wed, 06/11/2025 - 12:49 Learn how natural language processing (NLP) unlocks critical insights from unstructured EHR data—like physician notes and patient narratives—to give researchers a complete view of the patient journey. Download now.
A post-ASCO update on tumor targets DLL3, B7H3 and Her3 June 2025 Paul D Rennert, SugarCone Biotech LLC Introduction: DLL3, B7H3 and Her3 are compelling tumor antigens to target with cancer therapeutics. As we’ll see, ASCO 2025 was a breakout conference for B7-H3-targeted therapies. That trial is in second-line NSCLC.
As Vice President of Oncology Early Development (OED) at AbbVie , she leads the charge on translating bold scientific ideas into real-world impact – and she’s doing it with a focus on some of the most tenacious cancers out there. Her team sits right at the edge of innovation, where discovery science meets clinical execution. she said.
Forging a Path Forward for Substance Abuse Potential Studies With the Cross-Company Abuse Liability Council By Beatrice Setnik, PhD pmjackson Tue, 03/04/2025 - 20:10 Many of my colleagues and I are members of the Cross-Company Abuse Liability Council (CCALC), where I have been a co-chair for the past seven years, and a member for 15.
How large volume subcutaneous delivery unlocks value and drives sales growth Learn how subcutaneous delivery helps drugdevelopers stand out, improve patient experience, and drive growth. dfarris Thu, 04/17/2025 - 16:04 Learn how subcutaneous delivery helps drugdevelopers stand out, improve patient experience, and drive growth.
The application of AI in the life sciences sector has the potential to revolutionize many aspects of research, development, and patient care. By 2025, we can anticipate pretty significant shifts as AI continues to advance and integrate into various processes within the healthcare ecosystem.
Drug Pricing, Global Diversity Strategies, & Emerging AI Applications Each year, we compile our predictions to provide life sciences, pharmaceutical, and healthcare organizations with a comprehensive look at emerging industry trends and dynamics to help them prepare for the year ahead.
Case Study: Two Examples of Successful Automation Integration at Altasciences for Pharmacokinetic Studies pmjackson Fri, 06/06/2025 - 09:01 By Martin Rougée, Optimization Scientist, Bioanalytical Operations Automation offers several advantages to any industry. This can result in failed runs and wasted reagents.
DARPin therapeutics were a prominent theme at AACR 2025 , with Molecular Partners presenting a trio of preclinical programmes spanning radiopharmaceuticals and immune cell engagers. “My passion for science drew me to DARPin technology, and I was eager to contribute to the development of new DARPin therapies.”
Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3).
CSOs allow pharmaceutical firms to scale sales operations rapidly , particularly during drug launches , geographic expansions , product lifecycle extensions , and co-promotion agreements. These developments demand a highly skilled, therapeutically trained, and compliance-conscious salesforce —precisely what leading CSOs offer.
Pushkal Garg to Lead Unified Research and Development Organization, Signaling Strategic Expansion into Next Phase of RNAi Therapeutics Innovation Alnylam Pharmaceuticals , a global leader in RNA interference (RNAi) therapeutics, has announced the promotion of Pushkal Garg, M.D.,
Built to maximize modern , cloud-based architecture powered by Databricks, this robust interface equips clinical operations teams to rapidly review, analyze, and discuss all the data for clinical trials, driving faster drugdevelopment through heightened collaboration and decision-making.
We are at the forefront of drugdevelopment in an area of research called cellular rejuvenation, which is an approach that has the potential to address many diseases of ageing by restoring aged and injured cells to a more youthful and resilient state. What evidence is there that we can reverse aging with drugs?
2025 holds to be a transformative year for us, with the potential for multiple milestones to come to fruition, with the biggest value inflection being the interim clinical data from our lead asset KRRO-110, a potential best in class compound for patients with Alpha-1 antitrypsin deficiency (AATD). Over the last 4.5
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