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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.
As the pharmaceutical industry continues to evolve, drugdevelopers encounter new challenges and opportunities in their pursuit of innovation. In response, the PPD clinicalresearch business of Thermo Fisher Scientific conducted its third global survey of 150 drugdevelopers to capture a comprehensive view of these evolving trends.
Stephen Apps discusses how technology can help improve the speed and quality of clinicalresearch and why a dedicated, cross-functional approach is needed to maximize its value for smaller biotechs.
Developing treatments for individuals living with rare diseases is critical, but orphan drugdevelopment is laden with unique obstacles that necessitate innovative, multifaceted approaches. DCEs typically produce population-level estimates and require large samples to be robust.
Clinicalresearch has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management.
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.
ClinicalResearch Organizations (CROs) are companies that provide support to the pharmaceutical and biotech industries by managing various aspects of the drugdevelopment process and conducting clinical trials. appeared first on ProRelix Research.
In today’s data-driven world, AI has become valuable and indispensable, enabling organizations to extract valuable insights from vast amounts of data, make informed decisions and drive innovation across different sectors — including 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.
Organoid technologies are becoming an invaluable solution for preclinical research, with the ability to augment the development of personalised medicine, drug discovery and gene therapies. 5 Organoids are recognised as New Alternative Methods (NAMs) in drugdevelopment. billion by 2030.
Your DrugsDevelopment Stage The stage of your drugdevelopment is a critical factor in selecting a CDMO. Adhering to industry standards, a preference exists for utilizing the same CDMO for both development and commercial manufacturing to enhance communication and timeline management.
As a result, drugdevelopers make better decisions more quickly (removing 50% of study timeline whitespace) to bring new therapies to market faster. 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.
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.
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.
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
It’s essential for maintaining ethical standards, high-quality outcomes and facilitating global standardisation, enabling multi-center and multinational studies, thereby streamlining the development and approval process for new medical treatments, and maintaining public trust in clinicalresearch.
Introduction Contract Research Organisation (CRO) outsourcing has become a vital strategy for pharmaceutical and biotechnology companies aiming to optimise clinicalresearch and drugdevelopment.
Its important for your clinicalresearch organization (CRO) to continually assess and invest in capabilities that help drive the success of your clinical program. There are three core areas we are strategically addressing this year. They include: 1.
How AI Accelerates Clinical & DrugDevelopment Timelines pesurya Fri, 06/14/2024 - 10:59 Wed, 09/11/2024 - 14:00 Resource Type Webinar Viswa Colluru, Ph.D. Optimizing and Accelerating Drug Discovery How can AI be utilized to obtain new biological insights and optimize chemical processes? Tony Cardozo Todd Rudo, M.D.
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. Ready to unlock efficiencies?
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.
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.,
For clinicalresearch professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Food and Drug Administration (FDA) Parallel Scientific Advice procedure, which aims to increase dialogue between the two agencies and sponsor companies.
Dr Pooja Hingorani, Senior Medical Director of Oncology Early Development at AbbVie , shares her journey in STEM, from her early days in New Delhi to her impactful career in oncology research and drugdevelopment. Opportunities in clinicalresearch and drugdevelopment were not always easy to come by.
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.
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.
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.
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 goal is to identify safer, more effective methods of treating illnesses using new drugs or new combinations of existing drugs. A clinical trial 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 clinical trial design is crucial for executing successful clinicalresearch. DEXA (Dual-Energy X-ray Absorptiometry) is the optimal method for accurately measuring body composition in clinicalresearch.
By Ivana Magovčević-Liebisch, CEO of Vigil Neuroscience, as part of the From The Trenches feature of LifeSciVC Patients and their care partners are at the center of our work in the life sciences industry – but at what point during the drugdevelopment process should companies start to engage these key stakeholders?
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.
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.
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.
Animal testing plays a significant role in pre-clinicalresearch and therefore requires the use of millions of animals. 1 Over a quarter of those were for basic research purposes, with most common areas focused on the immune system, the nervous system and oncology. In Britain, 2.88 In Britain, 2.88
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.
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.
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.
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.
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.
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.
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. The Orphan Drug Act creates incentives for developing orphan drugs to treat such diseases.
Food and Drug Administration (FDA) for approval , much work remains for drugdevelopers aiming to advance treatments for pediatric populations. Reflecting Patient Diversity in NASH Trials Data from NASH clinical trials within adult populations may support clinicalresearch into treatment for pediatric populations.
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.
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