XTalks

JANUARY 17, 2024

They discussed the top new trends in oncology trial design that sponsors are either incorporating into clinical trials or need to start planning to include. Evolution in Oncology Clinical Trial Design Recent discussions at ESMO highlight a shift in how clinical trials are designed and conducted.

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Clinical Trials Clinical Trials Trials Gene Therapy 124

Worldwide Clinical Trials

MAY 1, 2024

This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinical trials. Maintaining open lines of communication helps address issues as they arise, allowing for real-time clarification and adjustments.

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Clinical Research Trials Research Clinical Trials 173

Pharmaceutical Technology

OCTOBER 25, 2022

Additionally, Astellas will obtain an exclusive option for licencing two clinical-stage programmes of Taysha, namely TSHA-102 and TSHA-120, for Rett syndrome and GAN, respectively. Astellas will also receive specific rights linked to any possible change of Taysha’s control.

Gene Therapy 264

Gene Therapy Gene Development Genetics 264

pharmaphorum

NOVEMBER 11, 2022

The lack of diversity in clinical trials has been a topic of debate for decades, but was thrust into the spotlight as the impact of the pandemic on poorer, less educated and ethnically diverse populations became even more apparent. The post IQVIA’s report card for clinical trial diversity: must do better appeared first on.

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Clinical Trials Clinical Trials Trials Pharma Companies 97

XTalks

MAY 20, 2021

Today is Clinical Trials Day 2021 — a day for recognizing the importance of clinical research in protecting and improving global health. Amid the alarmist headlines posted by other media outlets, Xtalks has remained balanced in its reporting of COVID-19 clinical trial results and safety data.

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Clinical Trials Clinical Trials Trials Vaccine 105

Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases. GlobalData is the parent company of Pharmaceutical Technology.

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Gene Therapy Gene Trials Clinical Trials 264

pharmaphorum

FEBRUARY 11, 2021

Pharma companies face many challenges when involving patients in the design of clinical trials – but doing so can have huge benefits further down the line, improving the sustainability and quality of research. Involving patients in discussions.

Clinical Trials 101

Clinical Trials Clinical Trials Trials Clinical Research 101

Outsourcing Pharma

APRIL 29, 2024

OSP spoke to Berkeley Research Group healthcare managing director, Wendy Cheng for a discussion around developments in AI regulation for pharmaceuticals, clinical trials, and drug development at a global scale.

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Clinical Trials Clinical Trials Regulation Trials 52

pharmaphorum

JULY 19, 2022

Face-to-face discussion educates regulators on what matters most to patients, and guides future decision-making. Regulators are increasingly asking drug developers to include the patient voice in submissions, but the best way to go about this is less clear-cut. Personal approach. About the author.

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Regulation Development Drugs Clinical Trials 105

Worldwide Clinical Trials

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development 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.

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Trials Clinical Trials Clinical Trials Development 242

XTalks

NOVEMBER 19, 2021

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.

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Clinical Trials Clinical Trials Trials In-Vitro 98

XTalks

MAY 6, 2022

In this interview, Xtalks spoke with experts from eClinical Solutions , Katrina Rice, Chief Delivery Officer, Data Services; and Diane Lacroix, Vice President, Clinical Data Management, about clinical data management for modern day digital clinical trials. Data security: The clinical trial data is backed-up and secure.

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Clinical Trials Clinical Trials Trials Life Science 98

XTalks

NOVEMBER 1, 2023

The revolution in clinical research is here, and it’s embodied by a single, powerful word: “patients.” The inclusion of patients during clinical development is not only a moral imperative but a strategic necessity in modern medical research.

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Clinical Trials Clinical Trials Trials Clinical Development 87

XTalks

MAY 11, 2023

Clinical trials are essential for the development of new treatments for rare diseases, but they can be complex and challenging to execute. That mission is really important to me because I think it’s the only way we’re going to accelerate drug development in rare disease.

Clinical Trials 97

Clinical Trials Clinical Trials Trials Development 97

Cloudbyz

NOVEMBER 22, 2024

This prestigious acknowledgment places Cloudbyz among the top-performing companies globally, known for delivering scalable and intuitive CTMS solutions that empower clinical research teams. Our mission is to enable faster, more efficient trials, ultimately supporting the delivery of life-saving therapies.”

Life Science 52

Life Science Clinical Trials Clinical Trials Compliance 52

Outsourcing Pharma

JULY 24, 2023

Phesi, a global provider of patient-centric data analytics, has released the results of its mid-year global analysis of all clinical trials conducted in 2023 to date.

Clinical Development 80

Clinical Development Clinical Trials Clinical Trials Development 80

FDA Law Blog

MARCH 7, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development. The 2006 guidance noted that these would be “rare cases” limited to “specific issues of urgent concern.”

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Clinical Trials Clinical Trials Trials Regulation 105

XTalks

OCTOBER 7, 2020

Not only did this baby survive to do all these things, but he became a poster child for gene therapy with the regulators at the U.S. The Xtalks White Paper, The Intersection of Rare Disease and Advanced Therapies: What it Means for Clinical Development , is available for free download. Partnering with regulators early.

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Development Gene Therapy Clinical Trials Clinical Trials 98

Worldwide Clinical Trials

JULY 8, 2024

With radiopharmaceuticals emerging as a diagnostic and therapeutic (theranostics) procedure, many are in the clinical development pipeline and are expected to play a crucial role in the future of healthcare. The goal is to deliver a precise radiation dose to the diseased tissues while minimizing damage to surrounding healthy tissue.

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Hormones Regulation Clinical Trials Clinical Trials 130

pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine.

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Clinical Trials Clinical Trials Trials Clinical Research 111

BioPharma Reporter

MARCH 3, 2021

The number of advanced therapy medicinal product (ATMP) clinical trials in the UK continues to increase year on year with 154 ongoing trials observed in 2020, demonstrating the appeal of that market for the clinical development of ATMPs, shows a new report.

Clinical Development 52

Clinical Development Development Clinical Trials Clinical Trials 52

pharmaphorum

SEPTEMBER 3, 2020

UK biotech Compass Pathways is planning a $100 million US IPO as it seeks to further develop its depression treatment based on psilocybin – an active ingredient that can be found in magic mushrooms. Another was hospitalised with suicidal ideation. The post Compass plans $100m IPO to fund magic mushroom depression drug appeared first on.

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Drugs Life Science Clinical Development Regulation 116

pharmaphorum

DECEMBER 4, 2020

Results from Pfizer’s clinical trial also took longer than expected to materialise and caused further delays, the spokesperson added. The first shipments of the vaccine are reportedly in the UK following approval by the country’s medicines regulator. million doses.

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Vaccination Vaccine Production Regulation 125

Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. Like any complex and highly regulated industry, the existence of non-conformities and deviations is inevitable. For instance, CAPA in good manufacturing practices (GMP) addresses manufacturing deviations and quality deficiencies.

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Compliance Clinical Development Development Clinical Trials 52

Worldwide Clinical Trials

FEBRUARY 22, 2023

Katie Nichols, senior project manager at Worldwide Clinical Trials, has been dedicated to rare disease research for seven years, seeing the impact firsthand that the progression of rare disease research has on rare disease communities. Rob: When I was diagnosed, my mother was adamantly against a clinical trial.

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Clinical Trials Clinical Trials Trials Research 130

VirTrial

JUNE 17, 2024

Over the past decades, Myasthenia Gravis (MG) clinical trials have made remarkable progress in shining a light on this debilitating disease. Clinical trials in MG – What does history tell us? With a better understanding of the disease mechanisms, new target treatment options emerged in the 20th century.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

VirTrial

JUNE 17, 2024

Over the past decades, Myasthenia Gravis (MG) clinical trials have made remarkable progress in shining a light on this debilitating disease. Clinical trials in MG – What does history tell us? With a better understanding of the disease mechanisms, new target treatment options emerged in the 20th century.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

VirTrial

JUNE 17, 2024

Over the past decades, Myasthenia Gravis (MG) clinical trials have made remarkable progress in shining a light on this debilitating disease. Clinical trials in MG – What does history tell us? With a better understanding of the disease mechanisms, new target treatment options emerged in the 20th century.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

XTalks

FEBRUARY 10, 2023

According to a recent review published in Nature , as of April 2022 almost 1,800 active cell therapy clinical trials were listed in ClinicalTrials.gov, a 33 percent increase from 2021. In a recent webinar, Dr. Vassallo discussed the operational considerations for complex cell therapy clinical trials.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Gene Therapy 52

Pharmaceutical Technology

DECEMBER 6, 2022

The latest development comes after the companies received guidance from a meeting held with the US Food and Drug Administration (FDA) in November. Based on findings from the MIRAGE and TIDAL trials, the company also plans to make a submission seeking marketing authorisation from the health authorities in Japan.

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Development Trials Clinical Trials Clinical Trials 147

pharmaphorum

AUGUST 4, 2020

AstraZeneca has bought an exclusive global licence to develop and market RXC006, a porcupine inhibitor for fibrotic diseases including idiopathic pulmonary fibrosis (IPF). Redx will receive up to $17m in early payments between signing the deal and the successful start of the first clinical trial.

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Drugs Clinical Trials Clinical Trials Pharma Companies 109

Camargo

DECEMBER 20, 2021

The increase is designed to strengthen CBER’s capacity and capabilities for regulating cell and gene therapies. The FDA recognizes that clinical trials in rare disease populations can be especially challenging because the endpoints are not as well understood as in more common diseases. 2024: 48 staffers. 2025: 29 staffers.

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Gene Therapy Gene Development Production 184

The Pharma Data

MARCH 15, 2021

Clinical research is a key component of developing. A critical component of our medicinal product development is clinical research. This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. We are committed to Good Clinical Practice.

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Clinical Trials Clinical Trials Trials Medicine 40

VirTrial

DECEMBER 8, 2023

If you missed Signant’s November 15 webinar about utilizing EDC for modern clinical trials, there is still time. Webinar Takeaways  With increasing decentralization in several aspects of trial , conduct, and management, are EDC systems still relevant? You can watch the  recorded webinar here  and below.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Production 52

VirTrial

DECEMBER 8, 2023

If you missed Signant’s November 15 webinar about utilizing EDC for modern clinical trials, there is still time. Webinar Takeaways  With increasing decentralization in several aspects of trial , conduct, and management, are EDC systems still relevant? You can watch the  recorded webinar here  and below.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Production 52

VirTrial

DECEMBER 8, 2023

If you missed Signant’s November 15 webinar about utilizing EDC for modern clinical trials, there is still time. Webinar Takeaways  With increasing decentralization in several aspects of trial , conduct, and management, are EDC systems still relevant? You can watch the  recorded webinar here  and below.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Production 52

Outsourcing Pharma

MAY 4, 2023

Sam Whittaker is founder, and CEO of multiple clinical trial technology companies, including Greenphire and Mural Health.

Clinical Development 52

Clinical Development Clinical Trials Clinical Trials Development 52