This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
It is hard to ignore some of the most pressing, long-term trends driving the push to accelerate innovation and progress in drugdevelopment. As a result, biopharma and biotech companies working to bring their drug pipelines to the market require deep expertise from trusted partners to help deliver critical therapies for their patients.
Exploring the transformative impact of large language models (LLMs) in molecular biology and drugdevelopment, discussing potential areas of applications and breakthroughs in personalized therapies. While enhancing molecular biology aspects, we also address ethical concerns ensuring responsible application of these models.
Tom Ireland writes about the companies and technologies that are reimagining phage therapy. Soon after its publication, scientists, journalists, and investors were revisiting ‘phage therapy’ as a promising alternative to our failing antibiotics. Nearly three million drug-resistant infections occur annually in the U.S.
Once a patient develops advanced cirrhosis/end-stage liver disease there are no specific therapies to significantly avoid major decompensations and death in the next few years. Could you describe the platform of macrophage biology and cell engineering used by Resolution Therapeutics in developing their cell therapies?
Cell and gene therapy (CGT) studies are rapidly gaining momentum in the Asia-Pacific region, fueled by growing patient demand and a thriving ecosystem of innovation. In China, the high incidence of solid tumors is driving an urgent need for advanced therapies, spurring the push for new treatment approaches.
But commitment to neuroscience drugdevelopment is critically important given the significant unmet medical needs and the ways in which patients, caregivers, and families suffer. Historically, what has limited investor interest in funding neurological and psychiatric therapies in development?
Drugdevelopment is challenging, including not only the complexities of biomolecular drug mechanisms but also the convolutions of regulatory pathways and commercialization strategies. This includes funding large-scale clinical trials and establishing robust manufacturing/distribution networks.
Our primary focus is to design and develop RNA therapies for liver diseases. Our team of chemists then uses this information to develop novel therapies. By doing this, we get a superior understanding of which therapies will and will not work in human biology before a clinical trial.
Could you explain the fundamental distinction between autologous and allogeneic cell therapies and how they differ in terms of cell sourcing and application? Autologous immune cell therapy involves the grafting of a patient’s own immune cells. Then, cells are infused back to that same patient.” There are pros and cons to each.
Bayer and Broad Institute extend cancer therapy research collaboration By Corie Lok November 2, 2023 Breadcrumb Home Bayer and Broad Institute extend cancer therapy research collaboration Long-standing industry-academia collaboration has already resulted in three clinical oncology candidates.
Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drugdevelopment has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). There have been challenges in gene therapydevelopment.
Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
Mixing of service models — a strategy that drugdevelopers are leveraging now more than ever — can bring life-changing therapies to market faster. LEARN HOW The post How to Optimize DrugDevelopment by Combining FSO and FSP Models appeared first on PPD Inc.
2 Unmet needs in lung cancer treatment Recent decades have seen significant advancements in lung cancer treatment, especially with the introduction of targeted therapies and immunotherapies, which have notably improved survival rates. 7 Recent clinical studies highlight promising developments in c-MET-targeting ADCs for NSCLC.
Data science has emerged as an innovative tool in the biopharmaceutical industry, leveraging the power of machine learning and artificial intelligence to drive innovation and efficiency across the entire drugdevelopment lifecycle. This was seen in the case of the BRAF V600E mutation test for melanoma patients receiving vemurafenib.
In the rapidly evolving landscape of oncology drugdevelopment, artificial intelligence (AI) has emerged as a revolutionary force, altering not just the pace but the very methodology of discovery and development.
The deal adds to recent M&A activity as well as signals pharma’s continued interest in pills for inflammatory conditions, which are meant to approach the potency of injectable therapies.
Although effective drugs and therapies have been developed for most breast cancer subtypes, triple negative breast cancer lacks the key receptors that these drugs interact with – in other words, it’s negative for the three receptors for which […]
The full results spotlight cell therapy’s potential to treat lupus and other inflammatory conditions, but also the problems drugdevelopers must solve first.
Moreover, scaffolding inhibitors demonstrated no deleterious effects on effector T cell functions or T-regulatory cell numbers, which we believe enables potential combination with CAR-T or T-cell engagers without any negative effects on those immune therapies.
As the pharmaceutical industry continues to evolve, drugdevelopers encounter new challenges and opportunities in their pursuit of innovation. In response, the PPD clinical research business of Thermo Fisher Scientific conducted its third global survey of 150 drugdevelopers to capture a comprehensive view of these evolving trends.
Why is detecting cancers via liquid biopsy before they become visible on imaging important for drugdevelopment, not just diagnostics? We believe liquid biopsy is very helpful for oncology drugdevelopment because the reduction and clearance of circulating DNA occurs quickly before radiographic imaging is available.
The mission of Lineage Cell Therapeutics is to deliver on some of the early promises of cell therapy. Cell therapy as a concept is a wonderful idea, but many of the early efforts never generated the kind of clinical data that gets people excited and leads to new medicines. In some cases, cell therapy can be curative for the patient.
The Merck KGaA spinout has a tau-regulating medicine it claims could be an “ideal therapy” for Alzheimer’s. The pitch has intrigued both healthcare investors and pharma venture arms.
Overcoming drugdevelopment hurdles with phase-appropriate technology transfers Discover how phase-appropriate technology transfers can help you overcome regulatory challenges, reduce costs, and accelerate your path to commercialization. Learn strategies to maximize efficiency and focus on what you do best—innovating new therapies.
The pharmaceutical industry is undergoing a major shift towards the development of breakthrough medicines and advanced therapies. This continued innovation highlights the complexity of the drugdevelopment process, particularly as the field is highly regulated by health authorities around the world.
To maintain cadence with looming threats in a prolonged field care environment, the broader medical countermeasure (MCM) enterprise must adopt new strategies for CBRN-addressing drugdevelopment. CBRN MCMs).
Five Promising Treatment Areas in Early-Phase DrugDevelopment in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drugdevelopment is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.
Our annual look at the state of the drugdevelopment industry highlights a dual set of challenges complicating progress. Rising costs have become a persistent challenge for drugdevelopers, driven by a combination of internal and external pressures that have intensified in recent years.
s Mark Tobolowsky co-authored the peer-reviewed article “ Microdystrophin Expression as a Surrogate Endpoint for Duchenne Muscular Dystrophy Clinical Trials ” in the recently published edition of Human Gene Therapy. Hyman, Phelps & McNamara, P.C.’s
By Amy Raymond, PhD, PMP, Executive Director, Therapeutic Strategy Lead, Rare Disease Cell and gene therapies (CGTs) include cutting-edge approaches that offer the hope of a healthier, happier, and better tomorrow for a wide range of patient populations. Below, we discuss some of these challenges in cell therapy trials.
Mini-Organs, Major Breakthroughs: How Hub Organoids Are Accelerating Oncology DrugDevelopment dwunderlin Wed, 04/03/2024 - 17:28 Tue, 05/14/2024 - 09:30 Resource Type Webinar Dr. Sylvia F. Boj Duration 60 Minutes Patient-derived organoids are viewed as the gold standard in bridging the gap between the lab and the clinic.
Engaging at the outset with a fully integrated and experienced drugdevelopment partner can ensure safety, with timely data sharing at every step of the drugdevelopment plan, and facilitate agile, flexible decision-making and planning.
proudly announces the return of attorney Sarah Wicks to its drugdevelopment and compliance group. Sarah brings a wealth of experience and a proven track record of advising innovative drug and biologics companies through the intricate landscape of product development and commercialization. Valentine, HPM Director.
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.
Applying CAR T-cell therapy in new clinical settings presents unique challenges. Worldwide Clinical Trials is at the forefront, partnering with drugdevelopment teams to map this new path forward.
Sasinowski — On March 21st, FDA announced the approval of the first nonsteroidal therapy for the treatment of Duchenne Muscular Dystrophy (DMD) (FDA press release available here ). Duvyzat (givinostat), a histone deacetylase (HDAC) inhibitor developed by Italfarmaco, S.p.A., By Charles G. Raver & James E. Valentine & Frank J.
Introduction to Biomarkers in DrugDevelopment Biomarkers have become a cornerstone in the advancement of modern drugdevelopment and precision medicine. The use of biomarkers has transformed the pharmaceutical industry by allowing researchers to developtherapies that target specific pathways in diseases.
Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prepares to launch Operation Warp Speed for Rare Diseases. Peter Marks, head of FDA’s CBER – the organization responsible for regulating gene therapies.
My Attendance at the 2024 Boston Society Cell and Gene Therapy Conference pmjackson Tue, 06/11/2024 - 20:49 , via Wikimedia Commons" data-entity-type="file" data-entity-uuid="c7a7fa8b-b2fe-4d84-a75e-d1ba3a4e2caf" src="[link] width="742" height="249" loading="lazy" /> Ecm85, CC BY-SA 3.0
aimed at identifying and characterizing the challenges in developingtherapies for ultra-rare diseases and conditions that affect exceedingly small populations. By Sarah Wicks — On May 21, 2024, the EveryLife Foundation for Rare Diseases (ELF) will host a Scientific Workshop at the National Press Club in Washington, D.C.
The biotech is working on a preventive therapy for the immune disorder, known as FNAIT for short, while J&J is studying its drug nipocalimab as a treatment.
While these approaches often produce encouraging initial results, the development of drug resistance remains a major obstacle for long-term patient survival. Most targeted cancer therapies used today operate by inhibiting targets along well-known oncogenic signalling cascades.
We organize all of the trending information in your field so you don't have to. Join 15,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content