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However, as we note in that post, the design, timing of initiation, and timely conduct of confirmatory trials are also important considerations in FDAs determination of whether accelerated approval is appropriate. This blog post focuses on interpreting these new authorities with respect to timely conduct of confirmatory trials.
Developing treatments for individuals living with rare diseases is critical, but orphan drugdevelopment is laden with unique obstacles that necessitate innovative, multifaceted approaches. Moreover, in some rare disease trials, it is unethical to design a control group of patients with a placebo.
Applying CAR T-cell therapy in new clinical settings presents unique challenges. Worldwide Clinical Trials is at the forefront, partnering with drugdevelopment teams to map this new path forward.
Our annual look at the state of the drugdevelopment industry highlights a dual set of challenges complicating progress. Pressure and requirements to engage diverse patient populations in trials have become more challenging and expensive, requiring tailored strategies that can stretch both resources and budgets.
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.
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.
Brain disorders are difficult to study and many drug candidates have failed in clinical trials, causing pharmaceutical companies to reduce their investments or even exit the field entirely. The key problem is that there appear to be many different underlying mechanisms that lead to depression. Biomarkers could take many forms.
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.
To understand the significance of this goal, it is important to recognise the current drugdevelopment process. This uncertainty contributes to the high failure rate and enormous costs of drugdevelopment. Currently, understanding these aspects requires extensive animal testing followed by human trials.
Drugdevelopment is challenging, including not only the complexities of biomolecular drug mechanisms but also the convolutions of regulatory pathways and commercialization strategies. This includes funding large-scale clinical trials and establishing robust manufacturing/distribution networks.
Over the past two decades, industry-sponsored clinical trials have targeted treatments for BPD, yielding some promising outcomes; however, broader psychiatric research often excludes BPD patients, a trend that extends to the emerging field of psychedelic studies.
Authors: Rich Worldwide Clinical Trials Exec. This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drugdevelopment strategy and optimal study designs. Director, Therapeutic Area Medical Lead.
This approach has led to the discovery of numerous potential drug candidates. From Lab to Market: The Long Road of DrugDevelopment Once a promising compound is identified, it enters the long and costly process of drugdevelopment. Q: How long does a drug patent last?
As an undergraduate biology student, I spent some time in a TB lab working on antibiotic resistance — a growing concern for drugdevelopers. A 1994 review of 14 prospective trials and 12 case-control studies revealed that the BCG vaccine reduced the risk of TB by 50 percent. Subscribe to Asimov Press. tuberculosis.
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.
Despite their exciting potential, the smooth operation of cell therapy developmenttrials requires extraordinary orchestration, perfectly aligning the product and patient journeys. While clinical supply is essential to any successful trial, autologous cell therapy trials occupy the far end of the spectrum regarding risk tolerance.
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. Many of these patients’ conditions are disabling.
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. Site selection presents barriers and opportunities As cell therapies expand in Asia-Pacific, areas with large hospitals are often the main hubs for innovation.
The pharmaceutical industry is undergoing a major shift towards the development of breakthrough medicines and advanced therapies. This continued innovation highlights the complexity of the drugdevelopment process, particularly as the field is highly regulated by health authorities around the world.
Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.
Yet, four out of five care partners of people with neurodegenerative disorders have never been informed of clinical trial opportunities , according to a survey of more than 250 caregivers conducted by PPD, the clinical research business of Thermo Fisher Scientific. There’s little time to lose.
4 Essential Topics to Cover in Your First CRO Meeting pmjackson Fri, 11/15/2024 - 19:22 Starting a partnership with a contract research organization (CRO) is a sometimes intimidating—yet exciting—first step in your drugdevelopment journey. Let the CRO know any key outcomes from each.
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.
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. In addition to this, I also chaired national trials evaluating an anti-GD2 antibody in pediatric osteosarcoma.
Rare diseases, therefore, present compelling opportunities for DrugDevelopment. Since each disease is present in small groups of patients, this research is also fraught with complex challenges. We're excited to expand our data offering by launching a new Rare Disease add-on to complement our Clinical Trial dataset.
For more than 40 years, drugdevelopers have been dedicated to advancing HIV clinical research in the quest for treatments and, ultimately, a cure. With continued evolution and access to treatment, the HIV drugdevelopment landscape is ripe with opportunity. million new infections in 2022. Since the U.S.
By: Nathan Chadwick, Therapeutic Strategy Lead, Rare Disease Over the last few years in clinical trials, particularly within the rare disease community, a notable shift is underway, where patients and caregivers are taking the lead in reaching out to clinical trial sites rather than the other way around.
Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.” Diversity in Dermatologic Disease Prevalence, Presentation and Outcomes Skin conditions affect all skin types and all racial and ethnic groups.
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?
Five Promising Treatment Areas in Early-Phase DrugDevelopment in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drugdevelopment is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.
But commitment to neuroscience drugdevelopment is critically important given the significant unmet medical needs and the ways in which patients, caregivers, and families suffer. Part of the challenge is that patients present with very different kinds of clinical phenotypes, meaning the populations are heterogeneous.
In an industry survey led by PPD, Thermo Fisher Scientific’s clinical research business, rare diseases emerged as a top therapeutic area in drugdevelopers’ pipelines, with 39% of global biotech and biopharma leaders pursuing therapies in the broad rare disease space.
The FDA Oncology Center of Excellence (OCE) is committed to further enhancing oncology research and as a result, has recently implemented several projects aimed to revolutionize oncology clinical trials. BOIN presents a simpler alternative, particularly advantageous for researchers using a Bayesian methodology for the first time.
Antibody-drugconjugates (ADCs) represent a significant advancement in drug discovery, combining the precision of monoclonal antibodies with the cancer-killing power of cytotoxic drugs. This type of analysis is crucial for drugdevelopers, providing a framework to identify and mitigate toxicity risks early in the design process.
Although several corticosteroid treatments are available as first-line treatments, drugdevelopers continue to seek more effective therapies to improve the wellbeing of those diagnosed with atopic dermatitis. But developing treatments for atopic dermatitis is complex and competitive.
The preclinical findings, together with the early evidence of tolerability and efficacy coming from the MATCH Phase I study, laid the foundations for our characterisation and engineering platform, used to develop Resolution Therapeutics’ lead product, which will be tested in patients starting later this year.
By: Lisle Kingery, PhD, Therapeutic Strategy Lead, Neuroscience With depression rates at an all-time high and limited new treatments available, depression clinical trials are more important than ever. Treatment Treatment can take various forms, including therapy, medication, a combination of both, or a clinical trial.
Eisai and Biogen Present Preliminary Assessment of the Clinical Effects of Lecanemab Following 18 Months of Treatment in the Open-Label Extension of the Phase 2 Proof of Concept Study at 2021 Alzheimer’s Association International Conference (AAIC) . United States and virtually from July 26 to 30, 2021 (Presentation No.:
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Beyer will present psychometric findings from the first-ever, multi-center trial conducted in patients with trichotillomania – an impulse control disorder marked by repetitive hairpulling behaviors. . Promentis’ drugdevelopment efforts are focused on a unique approach to addressing glutamatergic imbalance.
By: Sarah Bly, Regulatory Science and Innovation and Matt Cooper, Executive Director, Therapeutic Strategy Lead, Oncology The European Union (EU) presents a unique set of regulatory challenges and opportunities for clinical trials in oncology. Increased Transparency : Ensures that information on clinical trials is more accessible.
Our integration of curated drug data with clinical trial results and electronic health records ensures that healthcare providers have the information they need to make informed treatment decisions. For example, in oncology, clinical trials often focus on therapies targeting specific genetic mutations.
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