LifeSciVC

JULY 17, 2024

It could also encourage more investment in the space and make us better partners to regulators and payors alike. We already have the first-ever clinical-stage NBD1 stabilizer and a second series of highly potent NBD1 stabilizers that are advancing to Phase 1 this summer.

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Conversations in Drug Development Trends

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Ultimately, our goal is to bring safe and effective new therapies to patients.

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Vial

DECEMBER 4, 2023

Clinical research 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 Clinical Research: Perception Over the Years In the U.S.,

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Advarra

SEPTEMBER 14, 2023

In the clinical research space, GxP is a set of quality regulations and guidelines designed to establish the safety, efficacy, and integrity of pharmaceuticals, medical devices, and clinical trials. This blog explores key concepts, regulations, and the importance of GxP in delivering successful clinical trials.

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Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline.

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PPD

DECEMBER 16, 2024

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 clinical research business of Thermo Fisher Scientific.

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PPD

FEBRUARY 10, 2025

In the past, these developers mostly used in-house resources for their clinical monitoring and site management capabilities, whereas today they often prefer functional service provider (FSP) or full-service outsourcing (FSO) models, or a hybrid of the two, to ensure on-time and on-budget delivery of clinical operations.

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Advarra

NOVEMBER 29, 2022

The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.

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Advarra

JUNE 12, 2023

Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring an institutional biosafety committee (IBC) to provide additional oversight and risk assessment. What do the Regulations Say about IBC Review? What Does an IBC Review?

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PPD

AUGUST 5, 2024

Food and Drug Administration (FDA)-approved therapies for treating PAH were primarily vasodilators, designed to overcome the imbalance between vasoactive and vasodilator mediators and to restore endothelial cell function. Complexity: PAH trial sites are complex and require highly experienced clinicians, researchers and support staff.

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The Premier Consulting Blog

APRIL 18, 2024

Development of cell and gene therapies is growing rapidly, given the major advances in genomic technologies and increasing scientific understanding of genetic regulation and immunology. Can you identify a safe AND efficacious clinical dose? Prior to clinical trials, the focus is typically on evaluating safety.

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Conversations in Drug Development Trends

JUNE 21, 2024

The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Check out this webinar on navigating the landscape of oncology clinical trials.

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Olympian Clinical Research

SEPTEMBER 3, 2020

Sleep is especially important in regulating mood. Resources for good sleep hygiene and Cognitive Behavioral Therapy for sleep can be found with a simple online search. The post Battling Depression In A World Of Isolation: Tips For Managing COVID Depression appeared first on Olympian Clinical Research.

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Drug Target Review

JUNE 6, 2023

We are in an era of immuno-oncology (IO) revolution with many approved therapies now available to treat a broad range of cancers. Difficult-to-treat and rare, complicated cancers remain a perplexing challenge for IO researchers. Clinical development of IL-18 therapies has been curtailed, however, by the protein’s lack of efficacy.

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PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers 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. Researchers often employ cell therapy studies for oncology indications, and the U.S.

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Agency IQ

FEBRUARY 12, 2024

BY RACHEL COE, MSC | FEB 7, 2024 10:21 PM CST The Bespoke Gene Therapy Consortium A collaborative effort, the Bespoke Gene Therapy Consortium (BGTC) was launched in October 2021 to “accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease.”

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Advarra

NOVEMBER 10, 2022

This blog highlights some of the major proposed changes and how they may impact the clinical research community. . In addition to the harmonization goal, these additional elements help modernize the regulations with current scientific and participant expectations. . multisite research and trials).

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Crown Bioscience

MAY 4, 2021

Why are cancer treatments for children lagging behind the latest advancements in clinical oncology? Crown Bioscience Director Mike Batey takes a closer look at pediatric cancer and how recent regulatory changes and additional research focus may deliver new therapies for kids.

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Conversations in Drug Development Trends

MAY 23, 2024

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. We recommend early engagement with the EMA Committee for Advanced Therapies (CAT).

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Conversations in Drug Development Trends

APRIL 3, 2024

By: Sue Batchelor, Executive Director, Oncology Project Management Radiopharmaceuticals represent a cutting-edge frontier in oncology treatment, offering the promise of highly targeted therapy with the potential to revolutionize cancer care. Are you aware of the challenges you must address for a successful radiopharmaceutical trial?

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Drug Target Review

APRIL 11, 2024

Can you explain the methodology used to investigate the genetic variants regulating extracellular matrix (ECM) secretion in SMCs, and predict proteins associated with vascular disease? What potential therapeutic targets were identified for accelerating translational research in cardiovascular disease treatment?

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PPD

NOVEMBER 14, 2023

Clinical research 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 clinical development.

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Drug Target Review

SEPTEMBER 26, 2023

Human derived induced pluripotent stem cells (hiPSCs) have revolutionised research and are increasingly used for toxicology screening and disease modelling. Early detection of neurotoxicity induced by potential new therapies is a major challenge, and hiPSC-neuronal cells may provide a solution. Ther Innov Regul Sci. Rockley KL.

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Vial

DECEMBER 5, 2023

In 2017, the Food & Drug Administration (FDA) approved the first gene therapy for cancer and for inherited diseases, the first multiplex NGS panel for companion diagnostics (CDx), and the first drug targeting a genetic signature though not a disease. Fountzilas et al. Satam et al.

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PPD

OCTOBER 2, 2024

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.

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Vial

MAY 15, 2024

Vial | Pros and Cons The unprecedented consequences of the COVID-19 pandemic gave rise to the advent of decentralized clinical trials (DCTs), which are studies that use telemedicine and remote or local healthcare professionals to enable participants to join from different locations. billion and now functions as a subsidiary.

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PPD

OCTOBER 18, 2023

There has been an unprecedented expansion of different types of pharmaceutical therapies, as well as a change in the overall approach to health care. Continued expansion of the biotech industry is occurring in parallel, with an estimated compound annual growth rate of 13.96% from 2023-2030.

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The Pharma Data

MARCH 11, 2021

Retevmo was approved under the FDA’s Accelerated Approval regulations based on the LIBRETTO-001 Phase 1/2 trial’s endpoints of overall response rate (ORR) and duration of response (DoR). Session Title: Targeted Therapy and Ovarian Cancer Trials. Session Type: Clinical Trials Plenary Session. Abstract Number: 442.

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Drug Target Review

OCTOBER 25, 2024

Biomarkers are an essential advancement that will help determine risk for developing Alzheimer’s disease, diagnose the disease before symptoms have progressed significantly, predict how quickly patients may experience cognitive decline and evaluate how well new therapies are working. BioMed Central. link] Lee, A. 2022, May 24).

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NIH Director's Blog: Drug Development

JULY 20, 2017

Years of hard work, supported by the National Institutes of Health and the Cystic Fibrosis Foundation, painstakingly worked out the normal function of the protein that is altered in CF, called the cystic fibrosis transmembrane regulator (CFTR). That combination therapy was designed to help CF patients with two copies of the F508del mutation.

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The Pharma Data

JANUARY 10, 2021

It is a highly-selective Aurora B, CSF1R, VEGFR/PDGFR/c-Kit inhibitor, which exerts a comprehensive anti-tumor effect by simultaneously inhibiting tumor angiogenesis, inhibiting tumor cell mitosis and regulating tumor microenvironment. Chiauranib has shown pharmacological activity superior to that of other similar drugs in animal studies.

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The Pharma Data

DECEMBER 17, 2020

Goater is CEO at Surface Oncology, an immuno-oncology company developing next-generation antibody therapies. Thérin is the president of Advanced Therapies at Siemens Healthineers. Prior to SpringWorks, Smith was the executive vice president of Gene Therapy at Bamboo Therapeutics. Immune Regulation – U.K.-based

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The Pharma Data

JANUARY 24, 2021

This marks the third US clinical site that has obtained both study level and site IRB approval through a central IRB. There are 3 pending US clinical study sites that are expected to receive site IRB approval in 1Q2021. The MU team thrives on pushing the envelope of what’s possible in urological medicine. Dr. Laurence H.

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Advarra

AUGUST 21, 2024

However, some industries like healthcare and clinical research have had a more fragmented experience in the adoption and seamlessness of their digital experience. Nowhere is this more painful than in clinical trials, the backbone of drug development. Everyone may use different software systems to manage these documents.

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The Pharma Data

OCTOBER 14, 2020

Pre-clinical and clinical proof-of-concept data from a first-in-human single dose DSR study demonstrated that single dose DSR therapy was safe and well-tolerated and the positive results were published in the high impact peer-reviewed cardiovascular journal, Circulation. Source link.

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The Pharma Data

NOVEMBER 11, 2020

For more information regarding the POSEIDON clinical study see www.poseidonstudy.com. The DSR therapy is still in development and it should be noted that any statements regarding safety and efficacy arise from ongoing pre-clinical and clinical investigations which have yet to be completed. Source link.

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PPD

DECEMBER 12, 2023

Navigating the Intricacies of the Follow-the-Sun Model in Clinical Research The implementation of a follow-the-sun model, which leverages global resources in different time zones to assure continuous operations, requires a thoughtful approach to cultures, communication and collaboration for effective results. .

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