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.
Developing treatments for individuals living with rare diseases is critical, but orphan drugdevelopment is laden with unique obstacles that necessitate innovative, multifaceted approaches. Data from these studies can accelerate research timelines and improve trial planning throughout the product life cycle.
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.
Click to enlarge Six AI and machine learning considerations for effective clinical trial management 1. Accelerate customer speed to market With a modern and integrated user experience, AI solutions put the right data and insights into the right hands in real time.
The substantial value of organoids is becoming increasingly recognised by supportive government initiatives developing novel drugs, with a growth rate of 22 percent between 2023 and 2030 and a market size predicted to reach over US $6.5 5 Organoids are recognised as New Alternative Methods (NAMs) in drugdevelopment.
As the clinical trial landscape evolves, drugdevelopers are faced with novel challenges and changes in study recruitment, trial size and structure, and more. The adoption of new innovations, strategies and technologies offers opportunities to address persistent challenges and develop suitable approaches for the future.
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. Growth of the FSP market is steadily increasing.
Introduction Contract Research Organisation (CRO) outsourcing has become a vital strategy for pharmaceutical and biotechnology companies aiming to optimise clinicalresearch and drugdevelopment.
Acceleration in every step of clinicalresearch is critical to pharmaceutical developers. Yet, today’s clinicalresearch sponsors face significant challenges. These delays financially disrupt the potential of both current and future clinicalresearch. With a median delay of 12.2
We are thrilled to announce that the PPD clinicalresearch business of Thermo Fisher Scientific is getting a brand refresh! Our new visual identity will align more closely with Thermo Fisher’s style, while still retaining elements unique to our PPD clinicalresearch business. What’s changing? Ready to unlock efficiencies?
In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drugdevelopers for phase I trials, second only to navigating regulatory compliance (- 38 percent). Silver Spring (MD): Food and Drug Administration (US); 2016-. 113:9861002.
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.
Distinguishing the Roles of Preclinical vs. Clinical CROs in ClinicalResearch Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drugdevelopment pipeline. What is a Pre-Clinical CRO? over this period. over this period.
For clinicalresearch professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Searching for overlap might allow the investigational product to have a more rapid marketing authorization in multiple regions. Japan, and China.
The PPD clinicalresearch business of Thermo Fisher Scientific has surveyed more than 150 drugdevelopers around the globe to gather annual data on trends in pharmaceutical research and development. Applying artificial intelligence (AI) to drugdevelopment (e.g.,
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.
There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. To find success among the competition, sponsors must have access to the necessary expertise and resources to approach this burgeoning market.
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 drugdevelopment industry. The opportunity to leverage new technologies in drugdevelopment (e.g.,
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.
A recent white paper from the PPD clinicalresearch business of Thermo Fisher Scientific details how these functions have evolved over the years to the point where multiple outsourcing models are now commonly utilized.
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.
How to Facilitate Your Ophthalmic DrugDevelopment tchichekian Thu, 07/06/2023 - 01:11 HTML From Discovery to Market, We’ve Got You Covered. As a leading partner in ophthalmic drugdevelopment , Altasciences has an outstanding track record formulating, testing, and manufacturing ophthalmic products.
These strategies are critical for enhancing the overall success of GLP-1 therapies in clinical practice. GLP-1 Drug Class: Market Overview The market for GLP-1 medications is expanding, with several establishing options and numerous promising therapies on the horizon.
At Worldwide, we understand that every program is different, which means every drugdevelopment path forward will be unique. While large CROs will continue to play an important role in the clinicaldevelopment space, now more than ever, there is a need for companies that place value on personalized collaboration.
Fortunately, advances in clinicalresearch are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
Clinical trials have significantly increased in complexity over the last 20 years, creating new challenges. One of the top reported challenges facing drugdevelopers today is recruiting, enrolling and retaining the right patients for studies. How can virtual support address patient and site challenges?
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. Our mission is a lofty one.
For pharmaceutical innovators and drugdevelopers working to bring oncology therapies to market, patients are the “why” behind it all. For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy.
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.
Contract research organizations (CROs) are an integral partner of the drugdevelopment process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. Understanding the Numbers: How Many Clinical Trials Utilize CROs?
In general, ongoing research in AA is focused on molecules whose mechanism of actions and effectiveness have been proven in psoriasis and atopic dermatitis. CorEvitas will be deploying AA focus groups among physicians and patients to provide insights for pragmatic clinical trial designs.
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.
The recent draft by the FDA introduces additional guidelines for Diversity Action Plans aimed at improving diversity in clinicalresearch. The Impact of Draft Guidance on DrugDevelopment As it stands, drugdevelopment is an expensive endeavor, costing approximately $2.3
Their webinar highlighted key initiatives like Project Optimus, recent study design trends, and the benefit a Bayesian model can have on your drugdevelopment program. Dive deeper into OCE’s inclusivity and accessibility projects and the projects that will most impact drugdevelopment.
However, incorporating the patient experience into your design is one of the best ways to ensure your drugdevelopment program is a commercial success. It plays a significant role in patient recruitment and retention, both of which are vital to maintaining timelines, decreasing program costs, and gaining market approval.
To advance new therapies, pharmaceutical, biotech, and medical device companies engage contract research organizations (CROs) for their know-how in navigating the complex landscape of drugdevelopment and regulatory pathways and to run clinical trials. billion in 2030. As von Itzstein et al.
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. In many cases, higher levels of sponsor oversight are even required by regulation.
As the clinicalresearch landscape continually evolves, the choice of a Contract Research Organization (CRO) partner can significantly impact the success of drugdevelopment programs.
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.
If recruitment moves slowly or individuals with the wrong skills are selected, the clinicalresearch process stalls, costing sponsors valuable time, money and resources. Selecting the Right Partnership Model Clinicalresearch outsourcing models have changed over time to accommodate the industry’s evolving needs.
Breaking the Barriers: How Inaccurate Trial Records Are Delaying DrugDevelopment and Limiting Diverse Patient Populations In an October 2023 report , BMC Medicine completed a follow-up on a 10-year effort to understand, report on and track data sharing challenges with big pharma, specifically for clinical trials.
Non-footprint countries are regions where drugdevelopers lack a physical presence, often in emerging markets or remote areas. These countries offer new opportunities for drugdevelopers to access additional resources, ensure project continuity and rely on localized expertise for recruitment, regulatory insights and more.
In addition, owing to the rarity of these diseases, it can be extremely challenging to gain to patients and perform the clinicalresearch necessary for regulatory approval. In August 2020, new US legislation was passed which promises to have a major influence on the way companies approach pediatric drugdevelopment.
These anecdotal struggles were highlighted in industry research conducted by PPD, the clinicalresearch business of Thermo Fisher Scientific. In a survey of more than 150 global drugdevelopment leaders, more than a quarter (28%) cited lack of R&D funding as the top challenge facing their organization.
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