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
Advanced strategies and tools are being implemented to establish the safety and efficacy of new therapeutic modalities, with the development of new biomarkers becoming one of the most relevant approaches for enhancing the precision and utility of early-stage studies.
Its ability to maneuver persistent drug development challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success. This blog explores the value of functional service provider (FSP) models and how they help biotech companies augment their clinicaldevelopment needs.
“Protocol development can be a complex and meticulous process,” he explains, “as it’s crucial to ensure that trial candidates meet the necessary inclusion criteria.” Prior treatments and patient histories often introduce variables that can affect outcomes, making thoughtful trial design essential for generating reliable data.
In just two years, CTMC has advanced eight therapies into clinicaltrials, harnessing genetic engineering to enhance T-cell effectiveness in the fight against cancer. My focus has always been on advancing novel medicines from research to clinicaldevelopment.
Clinical genomics, powered by NGS, enables more precise target validation, improved patient stratification and optimised trial design, ultimately aiming to increase PoS. Internally, the models learn to associate concepts, find patterns and relate text and images (or other modalities) so that they can be analysed in the same way.
In the trial, participants were directly switched to Mim8 without a washout period. Strong Safety Profile Reinforces Mim8’s Potential Mim8’s safety profile was a central focus of the FRONTIER5 trial. The clinicaldevelopment of Mim8 comes at a time of significant innovation in haemophilia care.
The results from the Phase I/II NXTAGE trial, announced during the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress in Washington, D.C., The trial is evaluating NXT007 in people with hemophilia A without factor VIII inhibitors who have not previously been treated with Hemlibra.
The strategic funding arrangement is designed to support the continued advancement and global commercialization of Revolution Medicines’ RAS(ON) inhibitor portfolio, including its lead candidate daraxonrasib, as the company scales its operations independently across the international oncology market.
Director of Lymphoma Research at Sarah Cannon Research Institute and principal study investigator for the trial. Vice President of Early ClinicalDevelopment and Translational Research at Johnson & Johnson Innovative Medicine. “As formerly Cellular Biomedicine Group, Inc.).
Biopharmaceutical and biotech drug developers have faced increasing challenges in recent years. In the past decade alone, the time needed to complete a clinicaltrial has increased by 20–30%, and the cost to bring a new drug to market has risen to an average of about $2.6
Sanofi Highlights Robust Pipeline of Innovations in Rare Blood Disorders at ISTH 2025 Sanofi is poised to take center stage at the 33rd Congress of the International Society on Thrombosis and Haemostasis (ISTH), set to be held in Washington, D.C., In addition, two poster presentations will offer deeper insights into the LUNA 3 trial.
To date, more than 70 joint research projects have been initiated, and over 10 co-authored publications have appeared in top-tier international academic journals. The company currently operates two global research and development (R&D) centers and four world-class production facilities across China.
Developing a new drug takes an average of 10–15 years and costs upwards of $2 billion, yet the majority of drug candidates fail before reaching regulatory approval. The failure rate in clinicaltrials exceeds 90%, often due to insufficient safety data, efficacy concerns, or regulatory non-compliance.
Predictability of in vitro to in vivo metabolism Predictivity varies but the top line from the responses is that the probability of discovering a major metabolite during later stages of clinicaldevelopment are low, as is complete discordance of in vitro to in vivo metabolism.
Hopes for the Phase IIb trial Donello discusses the key outcomes he hopes to see in the Phase IIb VITALIZE study of zelquistinel for major depressive disorder (MDD). Donello has led numerous international scientific collaborations, acquisition integrations, and the in-licensing and out-licensing of various drug programmes.
Designed to serve a diverse international audience—including patients, healthcare providers, business partners, and investors—the site embodies the company’s twin commitments to scientific rigor and human empathy. Importantly, JCR’s approach to innovation is deeply rooted in collaboration. JCR Pharmaceuticals Co.,
Of course the larger markets would be in non-NRG1 fusion cancers where HER3 is overrexpressed but Partner Therapeutics does not appear to be supporting additional clinicaltrials. This is where the rest of the drug development field comes in. This will lead to near-term approval in NPC.
A final lipophilicity adjustment led to the discovery of CDZ173 (leniolisib), a potent PI3K selective inhibitor with suitable properties and efficacy for clinicaldevelopment as an anti-inflammatory therapeutic. 2] [5] It is a kinase inhibitor [2] [6] that is taken by mouth. [2] mmol) in CH 2 CI 2 (100 mL), was added TFA (41.8
Grifols’ BT524 Fibrinogen Therapy Shows Promise in Phase 3 Trial Published in The Lancet’s eClinicalMedicine Grifols , a globally recognized healthcare company and a leader in the production of plasma-derived therapies, has marked a significant advancement in the treatment of acquired fibrinogen deficiency (AFD).
With a particular focus on biologics, cell, and gene therapies, Galbraiths work is centred on equipping drug developers with the tools, insights, and support needed to advance their therapies from concept to clinic. Almost without exception, CROs are involved in the development of novel therapies. This is where CROs come in.
GSK Licenses Shigella Vaccine Candidate to Bharat Biotech in Push for Global Health Equity GSK today announced a significant step forward in the battle against Shigella a leading cause of diarrhoeal disease and death in children under five by licensing its Shigella vaccine candidate, altSonflex1-2-3 , to Bharat Biotech International Limited (BBIL).
We have seen how quickly vaccines and treatments can be developed when innovation is prioritised and stakeholders work together against the backdrop of imminent societal needs. Converting these challenges into opportunities, we must embrace new clinicaldevelopment strategies that promote agility, efficiency and effectiveness.
It typically begins with the filing of a patent application and extends through various stages: Discovery and initial patent filing Clinicaltrials and regulatory approval Market exclusivity period Patent expiration and generic competition Understanding this lifecycle is crucial for developing a strategy that maximizes protection at every stage.
This support will accelerate the clinicaldevelopment of the company’s pioneering DUO™ System—a minimally invasive transcatheter device designed to treat severe cases of tricuspid regurgitation. These attributes are expected to make the therapy more accessible in routine clinical practice. CroíValve Awarded €12.5M Source link
Food and Drug Administration (FDA) within 30 days, providing a structured timeline for progressing with clinicaltrials. Enhanced Opportunities for Global Market Access The IND process promotes alignment with international standards for sponsors planning to market drugs in multiple jurisdictions.
In every early phase clinicaltrial, the transportation, chain of custody, environmental monitoring and subsequent analysis of biological samples are the cornerstones of a successful, robust and quality outcome. Within cell therapy clinicaltrials, apheresis collections contribute to the specific constituents of the given therapy.
Meeting the never-ending challenges of drug development in this active environment — including pressure to identify drug prospects earlier and hire more conservatively — frequently leads biotech companies to outsource some portion of clinicaldevelopment functions. With FSO, all tasks for a clinicaltrial are outsourced.
Written By: Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Disease Given that 80% of rare diseases have a genetic etiology, genetic implications should be addressed at the onset of a clinical program to support trial enrollment. One diagnostic example that I discussed in my presentation is autism.
This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinicaltrials.
Nasdaq: BIIB) today announced it will share multiple oral and poster presentations from its Alzheimer’s disease clinicaldevelopment portfolio at the Alzheimer’s Association International Conference (AAIC), which will be held in Denver, Colorado and online July 26-30, 2021. Biogen Inc.
Introduction Worldwide ClinicalTrials vs. Vial. Worldwide ClinicalTrials is a mid-size, full-service global contract research organization (CRO) that works with biotech and pharma to advance new medications. With an international presence in nearly 60 countries, Worldwide is supported by over 3,400 team members.
Prior to joining Gannex, Dr. Palmer was Head of Liver Disease ClinicalDevelopment at Takeda Pharmaceuticals. She has also held senior leadership positions at Shire Pharmaceuticals and Kadmon Corporation, where she was in charge of the global development of NASH and other liver disease programs. ” About Ascletis.
A large majority of drug developers utilize FSP or hybrid FSP/FSO models, half are “heavy users” Heavy users: Those that use FSP or hybrid FSP/FSO models for most of their clinicaldevelopment outsourcing. Heavy users leverage these models for nearly three-quarters of their outsourcing.
Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54 Typical clinicaldevelopment timelines for anticancer drugs average an estimated 6.7
The favourable tolerability of eliapixant in this trial is consistent with earlier clinical findings. The selective mechanism of action of eliapixant appears to be translating into improved tolerability in clinicaltrials. These results will guide us to advance our clinicaldevelopment strategy of eliapixant.”.
Clinical research is a key component of developing. A critical component of our medicinal product development is clinical research. This involves conducting clinicaltrials in humans to evaluate the safety and efficacy of new pharmaceutical products. We are committed to Good Clinical Practice.
Approaches to outsourcing clinicaltrials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster. Overseen by an insourced project manager. Contracts are milestone- or unit-based.
The expectation that Pharma will continue buy-ups here is helping to fuel conviction for another strong year ahead for M&A, especially for those acquirers who will rely on inorganic acquisition to build in areas under-represented by internal R&D (e.g., Additional trials (e.g.,
18, 2021 /PRNewswire/ — Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Lonza announced today their agreement in support of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD).
NEW YORK , Jan.
The International Council for Harmonisation (ICH) good clinical practice (GCP) guidelines are critical in ensuring the safety and rights of clinicaltrial participants. The first guidelines published in 1996 and known as ICH GCP E6 provided guidance on the design, conduct, and reporting of clinicaltrials.
There is a continuum of evidence for a given target – at one end are novel targets with some evidence of importance in disease, and at the other end are “de-risked” targets where the biology is precedented with an approved product or late-stage clinical asset(s). Human and mouse genetics can inform not only efficacy but also safety.
To identify strains causing COVID-19 infections within the trial, sequencing of virus variants has so far been performed on 474 COVID-19 cases, of which 124 fulfilled adjudication criteria and were included in the present efficacy analysis. CureVac began development of mRNA-based COVID-19 vaccine candidates in January 2020.
Efficient and effective clinical operations are the backbone of successful clinicaltrials, and today’s biopharmaceutical, biotech and medical device organizations have a range of options to meet their needs in this critical area.
Each model delivers a distinct set of capabilities to the study sponsor: In an FSP arrangement, the contract research organization (CRO) performs a specific function or multiple functions (clinical operations, pharmacovigilance, etc.) across protocols, medicinal products, a portfolio of studies or the entire company.
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