XTalks

APRIL 8, 2025

Sponsors must navigate varying approval processes, compliance standards and reporting requirements to ensure that trials meet both local and international guidelines. Specialized facilities such as gene therapy dosing centers or advanced MRI sites can serve as treatment hubs, even if they are far from patients homes.

Clinical Trials 88

Clinical Trials Clinical Trials Trials Gene Therapy 88

BioTech 365

JANUARY 8, 2021

Regains Compliance with Nasdaq Bid Price Rule Ocugen Inc. Regains Compliance with Nasdaq Bid Price Rule MALVERN, Pa., NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene … Continue reading → Ocugen Inc. 08, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc.

Compliance 40

Compliance Gene Development 40

Worldwide Clinical Trials

MARCH 20, 2024

As the study of how an individual’s genes affect their response to drugs, pharmacogenomics is a critical factor in developing effective and safe drugs and dosages in clinical trials. One gene, known as the CYP2C19 enzyme, can convert Clopidogrel, a blood thinner used to prevent stroke and heart attacks.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Genetics 130

Cloudbyz

MARCH 30, 2023

Cell and gene therapies are rapidly becoming an essential component of modern medicine, offering hope to patients with previously untreatable diseases. However, the development and delivery of cell and gene therapies present significant operational challenges that must be navigated carefully to ensure successful clinical trials.

Gene Therapy 52

Gene Therapy Gene Trials Clinical Trials 52

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. Recent Problems in Cell and Gene Therapy Development. Current Regulatory Trends in Cell & Gene Therapy. Trend One: Expected Growth in Cell and Gene Therapy IND filings.

Gene Therapy 52

Gene Therapy Gene Production Clinical Trials 52

XTalks

DECEMBER 16, 2024

With the integration of human intelligence (HI) with AI, the field is discovering new efficiencies and maintaining, or even improving, the rigor required for quality and compliance. Writers act as the ultimate quality controllers to verify the clinical relevance and regulatory compliance of AI outputs.

Compliance 52

Compliance Clinical Research Clinical Trials Clinical Trials 52

The Pharma Data

MARCH 5, 2021

Nasdaq: BIIB) today announced its plans to build a new gene therapy manufacturing facility at its Research Triangle Park (RTP) manufacturing campuses in North Carolina to support its growing gene therapy pipeline across multiple therapeutic areas. Biogen Inc. Source link:[link].

Gene Therapy 52

Gene Therapy Gene Manufacturing Research 52

Advarra

MARCH 20, 2023

The Food and Drug Administration (FDA) recently released new guidance regarding cellular and gene therapy products, one of which may significantly impact early-phase clinical trials of such products. This article explores the implications of this guidance, including new approaches for studies focused on cellular or gene therapies.

Gene Therapy 52

Gene Therapy Gene Production Trials 52

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

BioTech 365

SEPTEMBER 1, 2020

01, 2020 (GLOBE NEWSWIRE) — Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE) (the “Company”), a leader in the development of genetic risk assessment tests, is pleased to announce that it received notification from the Listing Qualifications Department of the Nasdaq … Continue reading →

Genetics 40

Genetics Compliance Gene Development 40

pharmaphorum

DECEMBER 14, 2022

His operational responsibilities will include channel management, compliance services, field deployment solutions, and patient services. Boyds hires cell and gene therapy expert. Ginty is an expert in cell and gene therapies and has previously done regulatory affairs work at AviadoBio and UCB-subsidiary Handl Therapeutics.

Life Science 98

Life Science Gene Therapy Gene Editing Gene 98

Cloudbyz

MARCH 22, 2024

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. In recent years, advancements in artificial intelligence (AI) have offered a promising solution to these challenges.

Clinical Trials 81

Clinical Trials Clinical Trials Trials Compliance 81

XTalks

JUNE 12, 2023

The manufacturing process for cell therapies, like autologous T cell therapy, is complex and labor-intensive, involving numerous procedures that can affect regulatory compliance and consistency. Each batch of engineered T cells is manufactured individually and subsequently infused back into the original patient.

Manufacturing 95

Manufacturing Gene Therapy FDA Approval Gene 95

Cloudbyz

JUNE 21, 2023

Employ CDISC’s validation tools, such as OpenCDISC Validator or Pinnacle 21 Enterprise, to verify compliance with CDISC SDTM rules and guidelines. Ensure compliance with regulatory requirements, such as those specified by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA).

Clinical Trials 93

Clinical Trials Clinical Trials Compliance Trials 93

Pharmaceutical Technology

JUNE 14, 2023

Future waves of approvals for ATMPs (advanced therapy medicinal products, e.g., cell and gene therapies) will heighten demand on the contract packaging industry, further increasing the need for advanced cold chain solutions and specialized packaging designed to withstand cryogenic temperatures.

Contract Packaging 130

Contract Packaging Packaging Packaging Development 130

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. BacTRL Gene Therapy Platform. Related: Red Meat Allergy Test Gets FDA Clearance. “We

Clinical Trials 75

Clinical Trials Clinical Trials Vaccine Vaccination 75

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 Does an IBC Review?

Genetic Engineering 98

Genetic Engineering Gene Therapy Genetics Engineer 98

The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In addition, MasterControl’s ebook looks at how improvements to the management and operationalization of data cannot only be a compliance accelerator, but also a competitive advantage.

Clinical Trials 52

Clinical Trials Clinical Trials Gene Trials 52

The Pharma Data

MAY 26, 2023

Germany, Singapore, Japan and China, and an extended network of over 50 depots, Catalent’s clinical supply services meet a broad range of international compliance and distribution requirements to support global clinical trials. With sites in the U.S.,

Clinical Supply 52

Clinical Supply Gene Therapy Gene Development 52

Camargo

SEPTEMBER 15, 2020

Sponsors can mitigate the risk of such interruptions by ensuring that their API suppliers and CMOs have good compliance records with the FDA. BioMarin received a Complete Response Letter for its BLA for valoctocogene roxaparvovec gene therapy for severe hemophilia A. Senior Director of Regulatory Compliance and Submissions.

Development 130

Development Production Drugs Compliance 130

Cloudbyz

JUNE 11, 2023

DCTs employ digital platforms for remote interaction and consultation, maintaining patient engagement and providing necessary support virtually, which may reduce appointment no-shows and increase protocol compliance. They often come with in-built compliance mechanisms to ensure adherence to regulations and good clinical practice guidelines.

Clinical Trials 95

Clinical Trials Clinical Trials Trials Compliance 95

Cloudbyz

JUNE 13, 2023

Regulatory Compliance: Ensuring compliance with regulatory requirements is essential but can add to the budget. Compliance and Auditing: Ensure adherence to financial regulations, industry standards, and sponsor requirements throughout the trial. This includes transportation costs, lodging, meals, and incidentals.

Clinical Trials 93

Clinical Trials Clinical Trials Trials Marketing 93

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

Cloudbyz

SEPTEMBER 16, 2023

Addressing data privacy and data protection concerns when implementing ChatGPT in clinical trial operations management is crucial to maintain compliance with regulations, safeguard sensitive patient information, and build trust among stakeholders. This may involve conducting regular audits and assessments to maintain compliance.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Compliance 59

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. Individuals with familial cancer syndrome may have inherited mutations that predispose them to cancer development, affecting genes involved in DNA repair and cell cycle regulation.

Hormones 130

Hormones Regulation Clinical Trials Clinical Trials 130

Cloudbyz

FEBRUARY 29, 2024

Rapid Identification of Safety Signals : Timely detection of safety signals is imperative for ensuring patient safety and regulatory compliance in clinical trials. Optimization of Regulatory Reporting : Compliance with regulatory requirements is a cornerstone of pharmacovigilance activities in clinical trials.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Compliance 59

pharmaphorum

JUNE 24, 2022

Meanwhile, side effects are common and unpleasant with current treatment – including skin rash and blisters, vomiting and diarrhoea, and wounds that do not heal – so compliance an be poor. The post Data backs AZ’s Wilson disease drug, but with a question mark appeared first on.

Drugs 100

Drugs Gene Therapy Trials Compliance 100

WCG Clinical

AUGUST 27, 2024

However, newer ones continue to emerge as technologies advance, and IBCs today are tasked with reviewing some of the most complex and debated research taking place, including genome editing and the use of gene drive-modified organisms.

Genetic Engineering 52

Genetic Engineering Engineer Compliance Genetics 52

Drug Channels

JUNE 5, 2023

Two Dedicated Tracks for Your Focus Area : This Summit includes tailored content on specialty network design and patient services to customize the learning experience as well as shared content to maximize collaboration and knowledge-sharing View the detailed online agenda and register today.

Pharmacy 74

Pharmacy Gene Therapy Manufacturing Compliance 74

pharmaphorum

MAY 18, 2022

Also, there is particular emphasis on exploring the potential of gene therapy to develop targeted treatments for these and further neurodegenerative conditions. The promise of gene therapy has the potential, and certainly the ambition to cure certain neurological diseases.

Gene Therapy 92

Gene Therapy Gene Genetics Development 92

Cloudbyz

OCTOBER 19, 2023

Regulatory Compliance: Streamlining processes aids in meeting stringent regulatory requirements and maintaining data integrity. Data Integration: It allows for seamless integration of data from various sources, including electronic health records and wearable devices, ensuring data accuracy and consistency.

Clinical Trials 104

Clinical Trials Clinical Trials Trials Compliance 104

WCG Clinical

NOVEMBER 17, 2023

Although the NIH Guidelines were originally written with non-clinical laboratory research in mind, they also apply to human gene transfer (HGT) research, wherein rsNA or rsNA-containing products are administered to research participants. Since then, however, certain genetic engineering technologies (e.g.,

Genomics 52

Genomics Genome Gene Editing Genetic Engineering 52

Delveinsight

AUGUST 27, 2021

PF-06939926 (Pfizer), SRP-9001 (Sarepta), SGT-001 (Solid Biosciences) After almost 15 years since the first gene therapy trial for Duchenne muscular dystrophy (DMD) began, the dream of a DMD gene therapy might turn into a reality, though with a lot of hurdles. This, in turn, might boost the accessibility of these drugs.

Marketing 92

Marketing Gene Therapy Drugs Gene 92

pharmaphorum

AUGUST 26, 2021

Side effects are common and unpleasant with current treatment – including skin rash and blisters, vomiting and diarrhoea, and wounds that do not heal – so compliance an be poor. Another gene therapy from Ultragenyx – UX701 – is in early development with human testing due to start later this year.

Gene Therapy 52

Gene Therapy Gene Trials Compliance 52

Cloudbyz

AUGUST 9, 2023

Integrated Compliance and Governance With stringent regulations governing clinical trials, compliance is of utmost importance. A unified platform can incorporate compliance guidelines and ensure that all processes align with regulatory standards.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

Pharmaceutical Technology

MAY 23, 2023

In April, the pilot-level Nordic Pharmaceutical Forum (NPF) initiative, representing Finland, Iceland, Norway, Sweden, and Denmark, released an updated strategy document outlining the region’s plans to establish a joint procurement mechanism for medicines, with a declared focus on advanced therapy medicinal products (ATMPs) such as gene therapies.

Medicine 130

Medicine Gene Therapy Marketing Gene 130

XTalks

MARCH 1, 2024

New Treatments for Hearing Loss Gene therapies, stem cell regeneration, next-generation hearing aid technology and cochlear implants are some of the areas of research with significant promise for the development of new treatments for hearing loss. Hearing aids, assistive devices and communication strategies are common treatments.

Gene Therapy 52

Gene Therapy Gene Life Science Genetics 52