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
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.
Before any new therapy can be put on the market, it must be tested to ensure its safety and effectiveness, and the research for this process is done through clinicaltrials.
As clinicaltrials become increasingly complex, particularly in decentralized trials and rare disease studies, sponsors experience increased challenges in site selection, forecasting and resourcing, and patient recruitment and enrollment. Discover how AI is used to optimize key aspects of clinicaltrial management.
The number of pediatric patients diagnosed with nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) is on the rise, yet there are currently no approved therapies to treat NAFLD and NASH in adult or pediatric populations. As therapies for the treatment of NASH in adult patients go this year to the U.S.
Food and Drug Administration (FDA)-approved therapies for treating PAH were primarily vasodilators, designed to overcome the imbalance between vasoactive and vasodilator mediators and to restore endothelial cell function. Composite endpoints might include factors such as hospitalization, transplantation and worsening of clinical outcomes.
Yet, four out of five care partners of people with neurodegenerative disorders have never been informed of clinicaltrial opportunities , according to a survey of more than 250 caregivers conducted by PPD, the clinicalresearch business of Thermo Fisher Scientific. There’s little time to lose.
Clinicaltrials are the backbone of medical research, enabling the development of new treatments and therapies that can improve patient outcomes. However, conducting successful clinicaltrials requires efficient communication and coordination among various stakeholders.
By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinicalresearch, particularly in rare disease, represents a significant shift in the clinicaltrial landscape. Why Is There an Increase in Patient-Led Rare Disease Research?
Clinicaltrials have significantly increased in complexity over the last 20 years, creating new challenges. Patients are eager to participate in trials but remain largely unaware of their availability despite growing efforts to recruit. The increase in complexity isn’t just creating challenges for patients.
In the decades since its identification in 1989, advances in clinicalresearch for new Hepatitis C therapies and the introduction of direct-acting antiviral agents (DAAs) have led to viral eradication in more than 98% of patients, resulting in HCV crossing from manageable to being the first curable , chronic viral infection.
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.
The field of clinicalresearch is a dynamic and rapidly evolving one. One way to ensure that you are at the forefront of these developments is by attending clinicalresearch conferences. AACR, founded in 1907, is the world’s oldest and largest professional organization dedicated to advancing cancer research.
With FSO, all clinicaltrial tasks (e.g., study startup, data management, clinical monitoring, pharmacovigilance, regulatory affairs, etc.) are outsourced to a contract research organization (CRO) partner. clinical operations, pharmacovigilance, etc.) Augment your existing services with PPD FSP solutions.
Clinicaltrials are studies involving human volunteers to research ways to prevent, detect, and treat various medical conditions. A clinicaltrial investigating a drug or therapy is typically divided into four phases: Phase I, Phase II, Phase III, and Phase IV.
Partnering with a CRO that emphasizes the complexity of the patient’s voice and harnesses the nuances of clinicaltrial design is crucial for executing successful clinicalresearch. These data emphasize the need for precise and meaningful body composition endpoints in T2D and obesity clinicaltrials.
By: Sue Batchelor, Executive Director, Oncology Project Management Radiopharmaceuticals represent a cutting-edge frontier in oncology treatment, offering the promise of highly targeted therapy with the potential to revolutionize cancer care. Are you aware of the challenges you must address for a successful radiopharmaceutical trial?
Identifying the right targets, de-risking those targets, and then executing trials requires significant capital, strategic focus, and time. We already have the first-ever clinical-stage NBD1 stabilizer and a second series of highly potent NBD1 stabilizers that are advancing to Phase 1 this summer.
For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. For many patients, involvement in oncology clinicaltrials represents a last hope for an effective therapy. Many of these patients’ conditions are disabling.
Distinguishing the Roles of Preclinical vs. Clinical CROs in ClinicalResearch Randomized clinicaltrials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline.
Before any new medical treatment, therapy, or device is approved, it must first be tested through clinicalresearch studies. While some research studies seek participants with illnesses or conditions to be studied in the clinicaltrial, it is not always necessary to have a specific illness or condition to participate.
Clinicalresearch is an integral component of the healthcare ecosystem. It is pivotal in the development of cutting-edge treatments, therapies, and interventions for a wide array of diseases. Patient Payments in ClinicalResearch: Perception Over the Years In the U.S.,
At Olympian ClinicalResearch we’ve gotten a chance to work with countless Schizophrenia patients over the years through our clinicaltrials, and we know just how untrue many of the common assumptions about Schizophrenia really are. . Myth #2: People with Schizophrenia are violent. Learn More.
The enterprise of delivering life-changing medicines to patients involves a complex ecosystem, and in many ways, three key players reside at the core: drug sponsors, the contract research organizations (CROs) that support them and the clinicalresearch sites directly engaging with patients in the trial. We can help.
NCCRED was funded through the Strategy, and commenced in 2018, to build clinicalresearch capacity and work towards establishing evidence-based treatment approaches for both methamphetamines and other emerging drugs of concern. Why do a clinicalresearch priority setting study?
Clinicalresearch is ever-changing and increasing in complexity as a result of novel therapies and technologies. In order to address this challenge and maximise the chances of research success, more innovative and creative trial designs are being developed and researched.
In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinicalresearch and drug discovery. This can be converted to a clinicaltrial simulator, which can model a clinicaltrial before the trial design is finalized and initiated.
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. Accelerate your drug development and clinicaltrial goals and benefit from our 360° CDMO and CRO solutions and expertise.
The discussions at the conference shed light on innovative approaches to enhance long-term outcomes for patients, focusing on combination therapies that not only aid in weight loss but also help preserve muscle mass, an essential component of healthy body composition.
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 therapyclinicaltrials, apheresis collections contribute to the specific constituents of the given therapy.
These shifts are a prelude to further change and progress in the clinicaltrial landscape in 2024. To get a pulse on the changing industry, the PPD clinicalresearch business of Thermo Fisher Scientific surveyed 150 biotech and biopharma leaders for the second year in a row to illuminate industry trends, challenges and sentiments.
The use of engineered genetic materials in clinicaltrials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. The post Risk Assessment for use of Engineered Genetic Materials in ClinicalResearch appeared first on Advarra.
The success of clinicaltrials hinges on increasing access to participation by all eligible patients, including populations that have been underrepresented due to the barriers highlighted below. Specifically, U.S. Patients underlined the need for transparency by pharma and other related companies to build trust and partnership.
Stem cell transplants have saved patients’ lives time and time again, which led us to launch our own Stem Cell Transplant and Cellular Therapy Program. Regarding CAR-T cell therapy, could you highlight the promising findings that have been identified in the early stages of drug discovery, as well as potential challenges?
Gene therapyresearch is booming in the clinical setting. In this blog, we summarize the growth, risks, and regulatory requirements for gene therapyresearch. We also discuss how a centralized biosafety review process can benefit this type of research.
The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.
Considered a rare disease, research in finding better therapies – and possibly even a cure – for SCD may be competing for funding with conditions impacting broader populations. SCD’s significant impact on African Americans also means it predominantly impacts a minority community historically underserved by clinicalresearch.
Development of cell and gene therapies is growing rapidly, given the major advances in genomic technologies and increasing scientific understanding of genetic regulation and immunology. This blog will outline three characteristics of a successful nonclinical program to support entry into clinicaltrials for a cell or gene therapy product.
For more than 40 years, drug developers have been dedicated to advancing HIV clinicalresearch in the quest for treatments and, ultimately, a cure. Approved treatments and therapies have turned what was once a certain death sentence into a manageable condition for those with the disease. million new infections in 2022.
If you’re thinking about joining a clinicaltrial, there are many benefits you could look forward to. But how can you tell if clinicaltrials are right for you? We’ve outlined five reasons why joining a clinicaltrial might be in your best interest. You’ll Get Great Medical Care.
PPD, Thermo Fisher Scientific ’s clinicalresearch business, surveyed more than 150 decision-making leaders at pharmaceutical and biotech companies around the globe to collect key insights on the state of the evolving drug development industry. The opportunity to leverage new technologies in drug development (e.g.,
In an era where clinicaltrials are increasingly global, it’s more imperative than ever to leverage international expertise. Data and safety monitoring boards (DSMBs), also known as data monitoring committees (DMCs), play a critical role in overseeing a clinicaltrial’s safety and efficacy.
With technological innovation and scientific research propelling the development of new therapies, anticipation for the future is high. The goal of this therapy is to replace a disease-causing gene with a healthy one, disable a disease-causing gene, or introduce a new gene to aid in fighting a disease.
The Food and Drug Administration (FDA) recently released new guidance regarding cellular and gene therapy products, one of which may significantly impact early-phase clinicaltrials of such products. The Benefits of the Umbrella Trial There are many potential benefits to the umbrella trial.
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. Other therapeutic areas include cell and gene therapy. How do they stack up?
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