Worldwide Clinical Trials

MARCH 20, 2024

For example, Azathioprine, an autoimmune disease and organ transplantation treatment, was linked to severe myelosuppression for patients with specific genetic variants, such as the TPMT and NUDT15 genes. For drugs with a narrow therapeutic index, such as Warfarin, an anticoagulant, dosing is especially important.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Genetics 130

Pharmaceutical Technology

JUNE 29, 2022

We also benefit from having cGMP manufacturing capabilities in compliance with global regulatory requirements, a strong heritage from our mother company’s brand, a proven track record of reliable and secure supply, and a new partner that is probably the best player in the market within enzyme diversity. “We

Drugs 295

Drugs Gene Therapy Production Manufacturing 295

Advarra

FEBRUARY 4, 2025

Advarra convened a panel of experts to discuss practical solutions for balancing compliance with efficiency in clinical trial startups. Many requirements address legitimate concerns like compliance with state laws or unique operational contexts. The key lies in balancing compliance with efficiency.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

XTalks

APRIL 8, 2025

There are over 10,000 rare diseases affecting an estimated 300 million people worldwide where 80% are genetic , 95% lack approved treatments and nearly half begin in childhood. Cross-border enrollment captures a wider range of genetic backgrounds, environmental influences, and cultural perspectives.

Clinical Trials 88

Clinical Trials Clinical Trials Trials Gene Therapy 88

Advarra

JUNE 12, 2023

IBCs, however, seek to protect study personnel, the community, and the environment from exposure to engineered genetic material and other biohazardous agents. The IBC’s review is intended to ensure a thorough risk assessment is performed regarding the risks associated with the genetically modified materials. What Does an IBC Review?

Genetic Engineering 98

Genetic Engineering Gene Therapy Genetics Engineer 98

pharmaphorum

JANUARY 3, 2023

In terms of business transformation of the pharma industry, the areas that can see the most immediate effects are: (1) automated data compliance, (2) data sharing, and (3) data monetisation. Automated compliance. Conclusion.

Compliance 105

Compliance Regulation Pharma Companies Genetics 105

The Pharma Data

DECEMBER 28, 2020

About Fulgent Genetics. Fulgent Genetics’ proprietary technology platform has created a broad, flexible test menu and the ability to continually expand and improve its proprietary genetic reference library while maintaining accessible pricing, high accuracy and competitive turnaround times. TEMPLE CITY, Calif.,

Genetics 52

Genetics Sales Gene Sequencing Marketing 52

Pharmaceutical Technology

MAY 4, 2023

Compliance in the US – HIPAA The Health Insurance Portability and Accountability Act (HIPAA) covers several areas relating to health data, with one of the key requirements being a set of standards – the Privacy Rule and the Security Rule – to protect sensitive PHI from being disclosed without the patient’s consent.

Compliance 130

Compliance Regulation Research Genetics 130

XTalks

DECEMBER 19, 2024

Each patients experience with mental health conditions is influenced by unique genetic, psychological and environmental factors. Once patients join, we must make it easy for them to participate, support their compliance and listen to their experiences to improve future trials.

Clinical Trials 97

Clinical Trials Clinical Trials Trials Research 97

Pharma Marketing Network

JANUARY 29, 2025

AI-driven tools can: Analyze patient insights to tailor drug promotions Enhance HCP-targeted marketing using behavioral data Automate regulatory compliance monitoring Improve sales force effectiveness with AI-generated recommendations Marketers who embrace AI will gain a competitive edge in an industry where precision and speed define success.

Marketing 52

Marketing Compliance Big Data Branding 52

Worldwide Clinical Trials

JULY 8, 2024

Genetic Factors : Certain genetic mutations, such as those in DNA repair genes, can affect how cells respond to radiation. Similar to the FDA, the EMA evaluates radiopharmaceuticals for safety, efficacy, quality, and GMP regulation compliance before granting marketing authorization.

Hormones 130

Hormones Regulation Clinical Trials Clinical Trials 130

BioTech 365

OCTOBER 5, 2020

Diamond Pharma Services has provided EU regulatory, pharmacovigilance, quality and compliance support to GenSight, leading to the Marketing Authorisation Application for LUMEVOQ LUMEVOQ is a gene therapy to treat vision loss due to the rare, mitochondrial genetic disease, Leber Hereditary … Continue reading →

Gene Therapy 40

Gene Therapy Gene Genetic Disease Marketing 40

Drug Patent Watch

DECEMBER 12, 2024

Case Study 1: Orphan Drug for Rare Genetic Disorder A mid-sized pharmaceutical company identified a branded orphan drug treating a rare genetic disorder. Case Study 2: Novel Formulation of Existing Drug A biotech firm discovered a branded drug with a novel formulation that significantly improved patient compliance.

Licensing 96

Licensing Licensing Branding Drugs 96

WCG Clinical

AUGUST 27, 2024

1 This is an important requirement, as the NIH Guidelines were originally created partly in response to public concerns surrounding recombinant DNA and genetic engineering. Many of those original concerns of the 1970s and 1980s surrounding genetic engineering have lessened over time.

Genetic Engineering 52

Genetic Engineering Engineer Compliance Genetics 52

pharmaphorum

OCTOBER 29, 2020

San Diego-based Seqster has developed a portal that gathers together a patient’s data – such as electronic health records (EHR), genetic information, fitness results from wearables etc – and keeps it in a secure format that gives control over its collection, ownership and sharing.

Clinical Trials 97

Clinical Trials Clinical Trials Trials Compliance 97

XTalks

MAY 5, 2022

The Paleo certification program is based on the organization’s principle of encouraging the avoidance of dairy products, genetically modified organisms (GMO’s), grains, highly processed foods and legumes, among other foods.

Packaging 98

Packaging Packaging Licensing Licensing 98

Cloudbyz

JUNE 19, 2023

They can analyze patient profiles, clinical data, and genetic information to identify populations at higher risk for adverse events. Regulatory Compliance and Audit Support: Generative AI and large language models can assist in ensuring regulatory compliance and supporting audit processes in drug and device safety.

Drugs 96

Drugs Compliance Clinical Trials Clinical Trials 96

pharmaphorum

OCTOBER 16, 2020

Over the last five years we have focused on the power of drug repurposing for rare genetic diseases. It is estimated that, worldwide, just 400 treatments are licensed for 7000 known rare conditions, which tend to be determined by a very specific genetic factor.

Trials 105

Trials Clinical Trials Clinical Trials Life Science 105

pharmaphorum

JUNE 24, 2022

Wilson disease is a rare and progressive genetic condition in which the body’s process for removing excess copper is broken, allowing it to build to toxic levels and damage the liver, brain and other vital organs. Now, the data has been revealed – and according to investigators could transform treatment.

Drugs 100

Drugs Gene Therapy Trials Compliance 100

Pharma Marketing Network

JANUARY 9, 2025

Table of Contents Sr# Headings 1 Introduction: Why Staying Updated on Pharma News Matters 2 Emerging Trends in Pharma Marketing 3 The Role of Technology in Modern Pharma Strategies 4 Adapting to Regulatory Changes and Compliance Introduction: Why Staying Updated on Pharma News Matters In the fast-paced pharmaceutical industry, information is power.

Marketing 52

Marketing Compliance Big Data Regulation 52

Advarra

FEBRUARY 4, 2025

Advarra convened a panel of experts to discuss practical solutions for balancing compliance with efficiency in clinical trial startups. Many requirements address legitimate concerns like compliance with state laws or unique operational contexts. The key lies in balancing compliance with efficiency.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Compliance 52

XTalks

NOVEMBER 6, 2020

The Burnaby, BC-based company developed the oral DNA-based vaccine using its proprietary bacTRL Gene Therapy Platform, which uses genetically modified bifidobacteria as carriers of genetic vaccine elements on a DNA plasmid. Related: Red Meat Allergy Test Gets FDA Clearance. “We BacTRL Gene Therapy Platform.

Clinical Trials 75

Clinical Trials Clinical Trials Vaccination Vaccine 75

XTalks

MARCH 1, 2024

At the same time, the EU is also advancing in this domain, poised to ease its genetically modified organisms (GMO) legislation , marking a significant shift in global food regulation perspectives. This landmark guidance aims to demystify the FDA’s risk-based approach towards both genome edited foods and all new plant varieties.

Genome 86

Genome Genomics Production Marketing 86

Cloudbyz

SEPTEMBER 4, 2024

This article explores the critical benefits of real-time data in drug safety management and how it leads to improved patient safety, regulatory compliance, and operational efficiency. Enhanced Regulatory Compliance Maintaining compliance with regulatory requirements is a critical aspect of drug safety management.

Drugs 52

Drugs Compliance Clinical Trials Clinical Trials 52

XTalks

DECEMBER 12, 2023

Moreover, combining biofluid analytes with molecular pathology (genetic biomarkers) allows for the classification and differentiation of neurodegenerative diseases. To accurately identify these genetic factors, genotyping techniques such as Sanger sequencing, next-generation sequencing (NGS) and copy number variant analysis are used.

Trials 111

Trials Clinical Trials Clinical Trials Genetics 111

FDA Law Blog

DECEMBER 6, 2023

For example, one of the primary articles cited by FDA to show poor laboratory performance of LDTs has been the subject of a reanalysis by the College of American Pathologists that found “excellent laboratory performance” of molecular oncology proficiency testing for cancer-associated genetic variants.

Regulation 59

Regulation Genetics Cosmetics In-Vitro 59

WCG Clinical

NOVEMBER 17, 2023

Since then, however, certain genetic engineering technologies (e.g., For example, two trials testing genetically identical genome-edited cell therapies – one engineered with a viral vector, and one without – can differ in their IBC review requirements because of how the cells were modified rather than what they have become.

Genome 52

Genome Genomics Gene Editing Genetic Engineering 52

pharmaphorum

MAY 18, 2022

At UCB, we are trying to understand the whole spectrum of triggers causing epileptic seizures, from genetic factors, brain injury to stroke, cancer or other traumas,” Charl states. Charl believes we are witnessing the ‘decade of the brain’ with significant leaps in scientific understanding of disease pathways and genetic correlations.

Gene Therapy 92

Gene Therapy Gene Genetics Development 92

XTalks

FEBRUARY 4, 2021

Dr. Stephen Sawcer, professor of neurological genetics at the University of Cambridge and an honorary consultant neurologist at Addenbrooke’s Hospital in Cambridge, UK, is focused on the genetics of multiple sclerosis (MS) in his research, including genome-wide approaches to examining the disease. A Biorepository versus a Bioresource.

Research 98

Research Biobanking Drugs Genome 98

ACRP blog

JUNE 7, 2023

However, shifting paradigms to precision medicine will necessitate overcoming many challenges, including those related to technology and data integration; racial bias in genetic population data; privacy, cost, and accessibility concerns; and policy change, oversight, and adoption logistics.”

Big Data 59

Big Data Clinical Research Research Clinical Trials 59

The Pharma Data

MARCH 5, 2021

Gene therapy is an emerging therapeutic modality that may be suitable for a growing list of genetically validated targets in neuroscience. “We The site will be 175,000 square feet and designed in compliance with the most advanced sustainability standards regarding energy use, waste management and water consumption.

Gene Therapy 52

Gene Therapy Gene Manufacturing Research 52

ACRP blog

OCTOBER 10, 2023

We have three cohorts of patients open to accrual: women who have had TNBC, women who are currently receiving adjuvant pembrolizumab following treatment for TNBC, and women who have not had breast cancer, but are at a greater genetic risk with a BRCA1/2 or PALB mutation. trials originating at Cleveland Clinic.

Vaccination 111

Vaccination Vaccine Trials Clinical Research Coordinator 111

Scienmag

OCTOBER 23, 2020

The collaboration serves to improve the authors’ experience and guarantee compliance with their funders’ and institution’s publishing policies, as well as automating the payment and reporting processes. “We are very pleased to collaborate with Bentham […].

Compliance 40

Compliance Genetics Medicine 40

FDA Law Blog

MARCH 3, 2024

Biotechnology equipment includes genetic sequencers, mass spectrometers, polymerase chain reaction machines or any other equipment, components or accessories designed for the research, development, product, or analysis of biological materials as well as any software, firmware, or other digital components.

Genome 102

Genome Genomics Manufacturing Production 102

Cloudbyz

AUGUST 2, 2024

Precision Oncology and Biomarkers The field of precision oncology has evolved, focusing on matching the most accurate and effective treatments based on the genetic profile of the patient and their cancer. Contact us today to learn how Cloudbyz CTMS can help your organization optimize its clinical trial management processes.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

Pharma Marketing Network

FEBRUARY 27, 2025

For example, a LinkedIn article on the future of gene therapy can position a brand as an authority in genetic medicine, attracting biotech investors, researchers, and prescribing physicians. As digital healthcare evolves, pharma marketers must focus on authenticity, compliance, and value-driven storytelling.

Branding 52

Branding Marketing Compliance Pharma Companies 52

XTalks

MARCH 13, 2024

These advancements have not only helped improve the precision of glaucoma management but have also considerably improved patient compliance and quality of life. There are also studies examining gene therapy-based techniques to repair or replace genetic defects contributing to this disease.

Gene Therapy 111

Gene Therapy Gene Life Science DNA 111