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
Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
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.
The convergence of real-world data (RWD), technology and artificial intelligence (AI) is playing a vital role in accelerating drugdevelopment. In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinicalresearch and drug discovery.
This significance and focus are ever more apparent when the starting cellular material is imperative to drug product success. Within cell therapy clinical trials, apheresis collections contribute to the specific constituents of the given therapy.
As a result, drugdevelopers make better decisions more quickly (removing 50% of study timeline whitespace) to bring new therapies to market faster. Ready to learn more about how to leverage AI and machine learning to maximize your clinical trial efficiency? Get in touch.
Simpler ClinicalDevelopment From Day Dot blussier Fri, 06/21/2024 - 19:10 HTML Connecting the Dots With Comprehensive CRO Solutions When you CONNECT THE DOTS, you open a world of possibilities. With you in mind, we establish a clear and consistent path from drug discovery to delivery—one solution seamlessly connecting to the next.
Clinicaldevelopment programs must acknowledge the complexity and variability of obesity as a condition. Partnering with a CRO that emphasizes the complexity of the patient’s voice and harnesses the nuances of clinical trial design is crucial for executing successful clinicalresearch.
By Mike Cloonan, Chief Executive Officer of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC The drugdevelopment process in rare diseases is rife with challenges especially when companies target significant differentiation or first-in-class targets.
The PPD clinicalresearch business of Thermo Fisher Scientific conducts an annual survey of more than 150 leaders at pharmaceutical companies around the globe to assess trends in drug discovery and development, including preferences around outsourcing and functional service provider (FSP) utilization.
These survey results also highlight the importance of evaluating a variety of potential CRO partners of different sizes to choose the best match for your clinicaldevelopment goals and corporate culture. At Worldwide, we understand that every program is different, which means every drugdevelopment path forward will be unique.
However, over the past decade, a trend toward incorporating multiple study populations into one protocol has slowly gathered momentum among drugdevelopers. Improved prioritization Promising pipeline candidates with a strong early development protocol may see a positive impact to the net present value of an early-stage asset.
The drugdevelopment industry is constantly adapting and evolving to bring novel therapeutics to market to improve the lives of patients across the globe. While the drugdevelopment industry experienced setbacks during the COVID-19 pandemic, the field is again gaining momentum reminiscent of its pre-pandemic pace.
This exclusive interview with Dr Sharon Benzeno, Chief Commercial Officer, Immune Medicine at Adaptive Biotechnologies, unveils some ground-breaking research on T- cell therapy for cancer , which has seen the first TCR-based therapeutic candidate progress to clinicaldevelopment, offering promising advancements in innovative cancer treatments.
Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drugdevelopers are leveraging now more than ever — can bring life-changing therapies to market faster.
During the drugdevelopment process, companies have a choice of different approaches based on their development plan requirements. Whichever route a company takes, deliberate decision-making around the nature and timing of early phase studies is important to manage risks in the clinicaldevelopment process.
The highly dynamic biotech industry has a core need to remain as flexible and agile as possible across the spectrum of clinicaldevelopment activities. One primary way these companies create a nimble and adaptive environment is by outsourcing some portion of clinicaldevelopment functions.
This expansion represents a significant opportunity for both drugdevelopers and patients, while also presenting a new and diverse set of challenges for drugdevelopers, particularly in clinical trial execution.
Meeting the never-ending challenges of drugdevelopment 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.
These cells demonstrate considerable promise for uncovering drug-induced perturbations to neuronal function such as seizure, and their use extends further to sedation, anti-epileptic drug discovery and modelling of neurological diseases. Another area in need of attention is central nervous system (CNS)-safety testing.
This has aligned with the broader curation of a number of new dose-escalation and efficacy designs for clinicaldevelopment in oncology. A nuanced understanding of these considerations enables sponsors to ask more complex questions like:
Bayesian methods have continuously played a key role in transforming clinicalresearch in therapeutic areas such as oncology and rare diseases, and in addressing clinicaldevelopment challenges for COVID-19 drugs, devices, and biologics.
As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drugdevelopment shaped the pharma and biotech industries. These shifts are a prelude to further change and progress in the clinical trial landscape in 2024. Five Predictions for the DrugDevelopment Industry in 2024 1.
Recently, we have seen increasing numbers of complex FIH studies in CNS-active drugs to gather comprehensive data with a wider range of doses as early as possible. jpg Tags Clinical Trials Weight 1
I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drugdevelopment in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as ClinicalResearch Manager at AstraHässle, a mid-size Swedish pharma company.
7,8 The discovery of these biomarkers provides valuable insights into prognosis and disease progression, while also guiding the clinicaldevelopment of new targeted immunotherapies. Next-generation approaches Antibody Drug Conjugates (ADCs) Lung cancer therapy is enhanced by advancements in ADC technology.
As the clinicalresearch landscape continually evolves, the choice of a Contract Research Organization (CRO) partner can significantly impact the success of drugdevelopment programs. Discover how Worldwide is positioned to meet your needs with agility, expertise, and a truly personalized approach.
Patients are the backbone of clinical trials, playing an essential role in the drugdevelopment process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.
These cytotoxic drugs include DNA base analogs, antimetabolic drugs, tubulin inhibitors, etc. However, most of these chemotherapeutic drugs show a low therapeutic index, and serious side effects are usually attributed to the exposure of non-specific drugs to off-target tissues.
As a result, sponsors must decide whether to leverage a CRO partner even earlier in their drugdevelopment timelines to ensure proper planning for these constraints. How a CRO Accelerates ClinicalDevelopmentClinical trials are becoming increasingly complex as the industry evolves.
This has opened new opportunities in pharmaceutical drugdevelopment, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.
Efficient and effective clinical operations are the backbone of successful clinical trials, and today’s biopharmaceutical, biotech and medical device organizations have a range of options to meet their needs in this critical area.
As Phase 1 clinical trials include several different design types with multiple objectives (e.g. First-in-Human, Drug-Drug Interaction, Food Effect, Bioequivalence, etc.), Logos Attribution 0 Attribution 0 Primary Category Biotech On Demand Off Enable Automatic On Demand On Registration Login Link Already registered?
Under the stresses of the COVID-19 pandemic, drugdevelopment organizations faced difficult decisions about keeping staff employed and productive. Benefits of Rebadging Under an FSP Model in ClinicalResearch A functional service partnership (FSP) model in clinicalresearch can help sponsors navigate unforeseen staffing challenges.
Through further research and work as a principal investigator on clinical studies for several central nervous system indications, I laid the groundwork for a career in gene therapy drugdevelopment. This could bring more viable candidates to the clinic, leading to improved therapies for patients in need.
Their webinar highlighted key initiatives like Project Optimus, recent study design trends, and the benefit a Bayesian model can have on your drugdevelopment program. However, Project Optimus emphasizes the importance of dose-finding studies in early clinicaldevelopment.
Leading Global CROs To advance new therapies, pharma, biotech, and medical device sponsors engage CROs to help navigate the complex landscape of drugdevelopment and regulatory pathways and to manage clinical trials efficiently, ethically, and in compliance with good clinical practice ( GCP ) standards. billion by 2029.
If your company is struggling to hire qualified clinicalresearch associates (CRAs), you’re not alone. A decade-long CRA talent shortage intensified as the COVID-19 pandemic increased strain on the clinicalresearch industry at large. What is causing a shortage of CRAs?
Clinicaldevelopment of IL-18 therapies has been curtailed, however, by the protein’s lack of efficacy. Our deep interest in the interplay between immune cells, cytokines, and the tumour microenvironment has informed our clinicalresearch to date as well as our IO pipeline program.
Clinicalresearch requires vast talent across a variety of roles and specialties, as well as across global locations. In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinicaldevelopment.
The increasing costs associated with in-house drugdevelopment have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. Vial adopts a fixed-fee pricing model devoid of change orders to streamline cost-effectiveness in drugdevelopment.
7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults.
HELLERUP, Denmark , Jan. About orismilast.
With neuroscience experience in Alzheimer’s Disease (AD) and dementia, neurology , pain and addiction, rare and other diseases, and psychiatry, Worldwide has been involved in neuroscience research since the 1970s. Clinical trial designs are expected to become more complex, generating more data volume and diversity.
It’s an exciting process—anticipating development risks, predicting outcomes, and aligning these with the greater vision of medical advancement. The true joy comes from navigating these complexities and asking the right questions early on, because these foundational steps are critical to the success of any clinicaldevelopment process.
Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinicaldevelopment arena.
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.
69 
Let's personalize your content