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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.
They offer patient-specific outcome predictions, generated using machine learning models trained on real historical clinical data. Chief Executive Officer Steve Herne has spent more than 25 years in clinicalresearch, with senior roles at WCG, Bioclinica and Covance. Integration is straightforward,” Herne notes.
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 clinical trial landscape. Why Is There an Increase in Patient-Led Rare Disease Research?
Generative artificial intelligence (AI) has captured global attention for its transformative potential across industries, and nowhere is the promise greater — or more fraught — than in health care and clinicalresearch. This presents three core conflicts: Opaque provenance: The data used to train the model is not transparent.
Susceptibility or risk biomarkers can detect the likelihood of a patient developing a disease or medical condition, which is crucial for treatments that are most effective before the onset of symptoms. Diagnostic biomarkers typically confirm or establish a diagnosis and are often used in selecting patient populations for clinical trials.
Developing treatments for individuals living with rare diseases is critical, but orphan drug development is laden with unique obstacles that necessitate innovative, multifaceted approaches. This limited pool poses significant barriers to conducting statistically significant studies and validating the efficacy and safety of new treatments.
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 drug development. Opportunities in clinicalresearch and drug development were not always easy to come by.
The data, which encompass up to 3 years of follow-up after a single infusion of the treatment, were shared in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025, held from June 13–16 in Glasgow, United Kingdom. President and Chief Executive Officer of Intellia Therapeutics.
Ladders to Cures (L2C) Accelerator By Maria Nemchuk November 25, 2024 Breadcrumb Home Ladders to Cures (L2C) Accelerator The Ladders to Cures (L2C) Accelerator aims to catalyze progress across the research ecosystem and accelerates advances leading to treatments and cures for patients with rare genetic diseases.
The drug development industry faces rising costs and increasingly complex protocols as top challenges, with 49% of developers citing costs as their primary concern and 39% pointing to protocol complexity as a key hurdle, according to a recent survey of 150 drug developers worldwide by the PPD clinicalresearch business of Thermo Fisher Scientific.
1] It’s a privilege to participate in such a prestigious gathering of vision science professionals, and to gain insight into the latest innovations and treatments for complex ocular diseases. AI was the focus of more than 70 poster and paper presentations, highlighting its growing impact in the field.
One of the most important factors to consider during the course of your early-phase clinicalresearch is drug-drug interactions (DDIs), which occurs when one drug alters the effect of another, either by reducing its effectiveness or elevating systemic concentrations to potentially dangerous levelsultimately causing side effects.
The data, presented at the annual European Alliance of Associations for Rheumatology (EULAR 2025) congress in Barcelona, Spain, show that dapirolizumab pegol resulted in significant and clinically meaningful improvements in disease activity while addressing a major symptom that profoundly impacts patients’ daily lives — fatigue.
This milestone marks a potential turning point in the treatment landscape for patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) who are ineligible for stem-cell transplant—a patient population with limited and often suboptimal options. Rates of Grade 3–4 adverse events were comparable between arms (58.5%
It is being investigated as a potential treatment for various herpes infections, including those resistant to traditional antivirals like acyclovir. Research and Development: Pritelivir is being developed by AiCuris Anti-infective Cures, building upon research from Bayer. PAPER By: Carta, Fabrizio ; et al.
In a recent webinar, Challenges of Drug Development in Early Parkinsons Disease , Tom Babic, MD, PhD , our Vice President of Scientific Solutions in Neuroscience, uses his 40+ years of experience to share invaluable insights into the current state and future directions of early Parkinsons disease (PD) research. Robert Hauser a few years ago.
Solid tumors present a significant challenge to clinicalresearch due to their complex and heterogeneous nature. Proactively Address Key Recruitment Challenges in Solid Tumor ClinicalResearch Solid tumor clinicalresearch is challenging, especially because of tumor heterogeneity.
. — Jonathan Gardner Experimental liver disease drug pemvidutide met one of the two main goals of a Phase 2 trial in MASH, resolving the inflammatory disorder and stabilizing fibrosis in significantly more participants than did placebo after 24 weeks of treatment, its developer, Altimmune , said Thursday. milligram shot, the company said.
The event also featured a presentation from Dr. JP Clancy, CFF VP of ClinicalResearch, about the latest medical and scientific advancements to treat cystic fibrosis. Understanding Cystic Fibrosis According to the CFF , cystic fibrosis is a progressive, genetic disease that affects the lungs, pancreas, and other organs.
AI also has the potential to incorporate real-world data (RWD) obtained from electronic health records (EHRs), medical claims or other data sources to inform the design and optimization strategy of clinical trials.
This heterogeneity, present within the same structure or between various organoids, could complicate our understanding of specific mechanisms of action when testing novel drugs in vitro. Stem cell-derived organoids and their application for medical research and patient treatment. Nat Rev Bioeng [Internet]. 95: 729–38
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 clinical development, offering promising advancements in innovative cancer treatments.
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.
Acceleration in every step of clinicalresearch is critical to pharmaceutical developers. Yet, today’s clinicalresearch sponsors face significant challenges. Rather than accepting the persistent delays in clinicalresearch as disruptive, yet unavoidable, we believe they underscore the need for greater efficiency.
Molecular-level biochemical assays like transcriptomics, genomics and proteomics have emerged as valuable tools for identifying potential targets in cancer treatment through deep cyclic inhibition (DCI). How does the DCI mechanism compare to the design of other drugs for cancer treatment?
In China, the high incidence of solid tumors is driving an urgent need for advanced therapies, spurring the push for new treatment approaches. Site selection presents barriers and opportunities As cell therapies expand in Asia-Pacific, areas with large hospitals are often the main hubs for innovation.
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 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.,
In its early stages, HS often presents as a small, pea-sized lump in one place. More research is still needed to understand the causes of HS fully. Receiving an accurate and prompt diagnosis of HS is essential for developing a treatment plan and preventing it from worsening. Treatments for Hidradenitis Suppurativa.
Much of what we discuss I covered in my presentation, “Leveraging Genetics to Support Rare Disease Clinical Trials,” at last year’s World Orphan Drug Congress (WODC) EU. One diagnostic example that I discussed in my presentation is autism.
Eli Lilly and Company (NYSE: LLY) today announced that data from programs across its oncology portfolio and pipeline will be presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, to be held virtually April 10-15, 2021. Portfolio Highlights. Pipeline Highlights.
Though they do positively impact patients’ quality of life and hemodynamic parameters, these treatments — prostacyclin analogs and receptor agonists, phosphodiesterase 5 inhibitors, endothelin-receptor antagonists, and cGMP activators — have shown limited beneficial effects on survival and disease progression.
COHASSET, MA, January 14, 2021 /24-7PressRelease/ — Marquis Who’s Who, the world’s premier publisher of biographical profiles, is proud to present Harvey Leonard Dickstein, MD, with the Albert Nelson Marquis Lifetime Achievement Award. As a seasoned scientist, Dr. Dickstein spent significant time conducting research.
The PPD clinicalresearch business of Thermo Fisher Scientific has surveyed more than 150 drug developers around the globe to gather annual data on trends in pharmaceutical research and development. In Asia , personalized and precision medicine has become the driving force behind transformative clinical trials.
While these conditions cannot be cured, there are treatments available that may lessen the symptoms. In addition, clinicalresearch may provide new information and breakthrough treatments. . Therefore finding treatment options that may help lessen the symptoms is important. . Treatment Options for Pediatric Eczema.
a biopharmaceutical company focused on the development of first-in-class therapeutics for the treatment of cancer, today announced the completion of the Phase 1b clinical trial conducted by the NCI with its lead clinical candidate zotiraciclib (ZTR/TG02), a potent oral cyclin-dependent kinase 9 (CDK9) inhibitor.
SH ) submitted its pivotal phase III clinical trial application (IND) of national class I innovative drug Chiauranib to NMPA, for the treatment of Small Cell Lung Cancer (SCLC) as a single agent for the patients after 2nd-line systemic chemotherapy and recurrence afterwards. (Chipscreen Biosciences, Stock Symbol: 688321.SH
The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinicalresearchers to discuss the latest advancements and challenges in oncology research. Currently, there are 12 approved ADC drugs, and several hundred more are in the development pipeline.
It broadens recruitment strategies, diversifies the patient population, and expands the study population, thus increasing access to potentially life-saving treatments. These trials increase the chances of success by enabling the early detection of effective treatments in defined populations and focusing efforts on the most promising options.
In order to receive the right treatment for your condition, it’s essential to know what type of anxiety you’re experiencing. These symptoms can cause impairment throughout one’s daily life, and GAD is diagnosed when three or more symptoms are present more days than not for at least six months. What is General Anxiety Disorder?
Plaque psoriasis presents itself as patches of red, raised skin covered with silvery scales, along with a red bulbous base. Psoriasis Treatment Options. Once psoriasis is diagnosed, treatment is determined based on the level of severity and if there is a presence of joint involvement, known as psoriatic arthritis.
The type of psoriasis you experience can influence the symptoms and complications associated with your condition as well as the treatment plan that is right for you. Potential treatment options include phototherapy, corticosteroids, and oral medications. Guttate psoriasis usually responds well to topical treatments and phototherapy. .
Explore the unique aspects of mega trials, the challenges they pose to vaccine developers, what the future holds for these large, complex trials, and how a partnership with an experienced provider of clinicalresearch solutions can enable success.
Details of the presentation are as follows: Event: Late Breaking Developments, Part II
Title: One Year and Beyond: Long-term Multiple-dose Study of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate with Extended Durability, in wAMD, DME, and RVO
Presenter: Arshad M Khanani, M.D., Chief Executive Officer.
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