XTalks

JANUARY 17, 2024

Changes in what clinical performance data is used to inform the trial design and site selection, new approaches to patient recruitment and the rise of advanced treatments such as cell and gene therapy are rewriting the script. Vidal shared their insights from the 2023 ESMO conference which occurred in Madrid.

Clinical Trials 124

Clinical Trials Clinical Trials Trials Gene Therapy 124

Worldwide Clinical Trials

NOVEMBER 27, 2023

Casgevy, the commercial product formerly known as exa-cel, is administered by taking stem cells out of a patient’s bone marrow and editing a gene in the cells in a laboratory, with the modified cells then infused back into the patient after conditioning treatment to prepare the bone marrow.

Gene Editing 184

Gene Editing Gene Gene Therapy In-Vivo 184

BioPharma Reporter

DECEMBER 8, 2022

Emmes has announced the creation of a dedicated center for cell and gene therapy research: which will focus on supporting clinical trials for the Clinical Research Organizationâs (CRO) clients.

Gene Therapy 119

Gene Therapy Gene Clinical Trials Clinical Trials 119

Worldwide Clinical Trials

JANUARY 24, 2024

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. In my capstone, I focused on how, if, and when genetic counselors discuss clinical trials with their patients in the context of a counseling session.

Genetics 184

Genetics Trials Clinical Trials Clinical Trials 184

Cloudbyz

MARCH 22, 2024

In the realm of clinical research, the efficient management of data is paramount. However, traditional methods of data entry, particularly from diverse and unstructured documents, have long posed challenges for researchers, leading to inefficiencies, errors, and compliance risks. Scalability: Cloudbyz’s ClinExtract.AI

Clinical Trials 72

Clinical Trials Clinical Trials Trials Compliance 72

Cloudbyz

FEBRUARY 29, 2024

AI-enabled data extraction holds immense promise in expediting case processing within clinical trials, offering a transformative approach to streamline workflows and enhance efficiency. In this blog, we delve into the potential of AI in pharmacovigilance and its implications for clinical trial safety monitoring.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Compliance 59

Velocity Clinical Research

OCTOBER 4, 2023

Velocity Clinical Research, the leading multi-specialty clinical sites business, announced it is opening greenfield clinical research sites in Bristol, Leicester, and Romford, demonstrating the company’s commitment to the U.K. The sites launch at a time when clinical trial activity in the U.K.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

XTalks

DECEMBER 20, 2022

While clinical trials are becoming more complex, oncology trials have generally had a greater level of complexity than trials in many other disease spaces. Despite this, the number of oncology trials worldwide has increased dramatically over the past two decades. Site Challenges in Oncology Clinical Trials.

Clinical Trials 97

Clinical Trials Clinical Trials Trials Regulation 97

Camargo

JULY 30, 2021

Barry Mangum talks the importance of pediatric research, its evolution over the years, and the obstacles and opportunities that the industry faces as it moves forward. How long have you been in pediatric clinical research, and how did you enter the field? So I’ve been working in that space about 43 years.

Clinical Research 226

Clinical Research Research Gene Therapy Gene 226

XTalks

DECEMBER 14, 2023

In an insightful interview with Xtalks , Cassadie Moravek, the Senior Director of Clinical Trial Portfolio and Program Management at the Pancreatic Cancer Action Network (PanCAN) , shares her perspective on the organization’s efforts in advancing pancreatic cancer research and patient care. Read on to learn more from Moravek.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Doctors 52

XTalks

JUNE 8, 2023

Over the past few years, there has been a significant expansion in the cell and gene therapy landscape, with an increasing number of therapies entering clinical trials and receiving regulatory approvals. “I think if we all go into these relationships with this mindset, we’ll achieve great things together.”

Gene Therapy 98

Gene Therapy Gene Production Development 98

Cloudbyz

JUNE 11, 2023

This transformation has permeated the domain of clinical trials, which is now embracing the concept of decentralized clinical trials (DCTs). This paper delves deep into the universe of DCTs, their distinctiveness from conventional trials, their inherent benefits, existing hurdles, and measures to bolster their adoption.

Clinical Trials 70

Clinical Trials Clinical Trials Trials Compliance 70

XTalks

APRIL 24, 2023

Awareness of rare diseases is growing, and with a better understanding of the pathophysiology of many rare diseases, innovative treatment options are emerging, like gene therapies that can treat the root cause of rare genetic diseases and potentially provide long-term symptom relief, or even a definitive cure.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

Cloudbyz

AUGUST 9, 2023

The clinical research landscape is rapidly evolving. As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. This is where the platform approach comes into play.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

Drug Discovery World

DECEMBER 18, 2023

Digital biomarkers promise to transform preventive medicine and clinical trials, but also raise issues of security, regulation and potential disparities in access. Deepika Khedekar, Clinical Trial Lead at IQVIA, provides an overview of the pros and cons, and suggests a possible solution.

Clinical Research 59

Clinical Research Research Clinical Trials Clinical Trials 59

BioPharma Reporter

FEBRUARY 7, 2022

Planning for Institutional Biosafety Committee (IBC) oversight is a critical and often neglected initiation step for human gene transfer (HGT) clinical research, says an expert.

Clinical Trials 98

Clinical Trials Clinical Trials Gene Clinical Research 98

AuroBlog - Aurous Healthcare Clinical Trials blog

MARCH 17, 2024

US researchers examined gene expression in more than a million brain cells collected post-mortem from 191 donors. Those with schizophrenia and older adults were found to have a comparitively reduced expression of specific genes in both […]

Gene Expression 181

Gene Expression Gene Genetics Research 181

ACRP blog

SEPTEMBER 27, 2023

Food and Drug Administration’s (FDA’s) Rare Disease Endpoint Advancement (RDEA) Pilot Program , the clinical research enterprise gains new support for efforts aimed at efficacy endpoint (or clinical outcome) development and the timely approval of drugs and biological products that treat rare diseases, including rare diseases in children.

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Clinical Trials Clinical Trials Trials Gene Therapy 64

Drug Discovery World

DECEMBER 13, 2022

Clinical research organisation (CRO) Emmes has unveiled a dedicated centre to expand its cell and gene therapy research. . The new centre will offer research services in clinical trial operations, study leadership, statistical services, data management, and pharmacovigilance. .

Gene Therapy 52

Gene Therapy Gene Clinical Trials Clinical Trials 52

Cloudbyz

JUNE 26, 2023

Generative artificial intelligence (AI) techniques are increasingly being applied in clinical research to enhance various aspects of medical data analysis, diagnosis, treatment planning, and drug discovery. Clinical Trial Design and Optimization: Generative AI can aid in the design and optimization of clinical trials.

Clinical Research 76

Clinical Research Research Clinical Trials Clinical Trials 76

XTalks

OCTOBER 18, 2022

A clinical research organization (CRO) is a company that delivers outsourced services to plan, manage and execute clinical trials for biotechnology, pharmaceutical, and medical device companies. Read on to learn why life science and clinical research professionals are choosing a career with Medpace.

Clinical Research 111

Clinical Research Research Clinical Trials Clinical Trials 111

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.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Vaccination 105

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 7, 2023

New research from ETH Zürich in Switzerland could see future wearable devices (with perhaps a few implants and a touch of genetic engineering) boost our health directly. Fitness trackers help you stay healthy by keeping count of your steps and monitoring your heart rate, driving you on to hit those cardio goals.

Genetic Engineering 199

Genetic Engineering Gene Engineer Genetics 199

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 8, 2024

Turning off a gene early in mouse development led researchers to end up with an accidental six-legged embryonic mammal. This strange result took the spinal cord research of developmental biologists Anastasiia Lozovska and Moisés Mallo and their colleagues at Portugal’s Gulbenkian Science Institute in a new direction.

Scientist 198

Scientist Gene Research Development 198

Cloudbyz

JUNE 10, 2023

21 CFR Part 11 is a crucial component of regulatory compliance in clinical trials and, more broadly, any industry subject to the regulations of the U.S. This blog post will serve as a comprehensive guide to understanding and implementing 21 CFR Part 11 compliance in your clinical trials. Let’s explore.

Compliance 88

Compliance Clinical Trials Clinical Trials Trials 88

Advarra

MARCH 31, 2023

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. Gene Delivery Systems Genetic material, in the form of DNA or RNA, does not easily enter cells without the aid of a delivery system.

Engineer 52

Engineer Genetics Clinical Research Research 52

Drug Discovery World

DECEMBER 8, 2023

Andrew Busey , Co-Founder, Form Bio discusses why vertical AI is set to reshape the cell and gene therapy sector. The cell and gene therapy industry is no exception to this digital transformation. General AI tools such as ChatGPT have acted as a catalyst, igniting a wave of AI innovation akin to the early days of the internet era.

Gene Therapy 64

Gene Therapy Gene In-Vitro Development 64

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. Patient input is a crucial component of rare disease clinical trials, as it can provide valuable insights into the patient experience and inform decisions about study design and implementation.

Clinical Trials 97

Clinical Trials Clinical Trials Trials Development 97

XTalks

NOVEMBER 7, 2022

Such information can reveal details about tumor staging, tumor progression, heterogeneity, gene mutations and clonal evolution. Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. percent show less reliability).

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

WCG Clinical

JULY 11, 2023

As countries across the globe reeled from the impact of COVID-19, the clinical research industry found itself in a new era working to understand and navigate the impact and to quickly find a treatment. We can apply this level of rigor and collaboration to your current or upcoming trial.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Gene Therapy 52

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 3, 2023

An experimental vaccine that aims to slow down or prevent the progression of Alzheimer’s disease has been trialed in mice with promising early results. Mice engineered with genes that put them at greater risk of an Alzheimer’s-like disease had fewer amyloid plaques following the vaccine.

Vaccination 230

Vaccination Vaccine Engineer Gene 230

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.

Gene Therapy 52

Gene Therapy Gene Production Clinical Trials 52

AuroBlog - Aurous Healthcare Clinical Trials blog

JULY 19, 2023

Genetic inheritance is a physical link that tethers our birth parents; one-half of two sets of chromosomes meshing together to form our own unique set of molecular instructions for life.

Gene 140

Gene Genetics Clinical Trials Clinical Trials 140

Imperical Blog

MAY 20, 2020

Professionally, especially in the world of clinical research, the opposite is happening. We no longer have any option than to embrace technology and other unconditional approaches to decentralize clinical research away from the study site. Gene counselors and genetic testing. and Europe.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Genetics 52

AuroBlog - Aurous Healthcare Clinical Trials blog

DECEMBER 15, 2022

The authors of the study say their research is the first to link COVID-19 to molecular signatures of brain aging. “We observed that gene expression in the brain tissue of patients who died […].

Gene Expression 221

Gene Expression Gene Research Clinical Trials 221

Drug Discovery World

MARCH 10, 2023

Perhaps most interestingly this week, after previous caution over in vivo gene therapy trials, the FDA has given the go ahead to Intellia Therapeutics to study NTLA-2002 in hereditary angioedema (HAE). News round-up for 6-10 March by DDW Digital Content Editor Diana Spencer.

In-Vivo 52

In-Vivo Clinical Trials Clinical Trials Drugs 52

Cloudbyz

MAY 19, 2021

Introduction Cell and gene therapy is an upcoming wave of therapeutic innovation in the healthcare and life sciences industry and is being pragmatically accepted worldwide. The gene therapy market reported its first market approvals back in 2017 and the evolution has been extensive ever since.

Gene Therapy 52

Gene Therapy Gene Manufacturing Production 52