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

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 →

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Gene Therapy Gene Genetic Disease Marketing 40

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.

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Gene Therapy Gene Production 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

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

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.

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Hormones Regulation Clinical Trials Clinical Trials 130

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

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

The Pharma Data

AUGUST 7, 2020

As the pharma industry stands firm in its commitment to advance the sector to fight Covid-19, news has emerged from the European Commission who intend to streamline the development of therapies using genetically modified organisms to treat Covid-19. Regenerative medicine and advanced therapies thriving despite Covid-19 disruption.

Clinical Trials 52

Clinical Trials Clinical Trials Gene Trials 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.

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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

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

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.,

Genome 52

Genome Genomics Gene Editing Genetic Engineering 52

XTalks

DECEMBER 12, 2023

In some areas, say Alzheimer’s disease, we have growing collections of imaging, gene, cerebrospinal fluid (CSF) and blood markers to follow and look at target engagement of our drugs,” says James Vornov, MD, PhD, Vice President of the Medical Department at Medpace.

Trials 111

Trials Clinical Trials Clinical Trials Genetics 111

pharmaphorum

AUGUST 26, 2021

The FoCus study of ALXN1840 showed that once-daily oral drug met its primary objective in improving a key biomarker in Wilson disease, a rare and progressive genetic condition in which the body’s pathway for removing excess copper is compromised allowing it to build to toxic levels.

Gene Therapy 52

Gene Therapy Gene Trials Compliance 52

Delveinsight

AUGUST 27, 2021

Duchenne muscular dystrophy (DMD) is a rare genetic disorder usually diagnosed in young boys, gradually weakening muscles across the body until the heart or lungs fail. Sarepta’s gene therapy SRP-9001 is being developed for 4–17 years ambulatory children and non-ambulatory adolescents on stable corticosteroids.

Marketing 92

Marketing Gene Therapy Drugs Gene 92

XTalks

MARCH 1, 2024

Causes can include aging (presbycusis), exposure to loud noise, genetic predisposition, certain medications (ototoxic drugs) and various diseases. Gene Therapies for Hearing Loss Gene therapies to correct genetic mutations that cause hearing loss is an active area of development.

Gene Therapy 52

Gene Therapy Gene Life Science Genetics 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

Roots Analysis

JANUARY 22, 2024

However, these approaches are incompetent for dealing with intrinsic carcinogenic genetic abnormalities. This resulted in the discovery of an individualized concept of treatment known as oncology precision medicine which primarily utilizes the patient’s genomic information to provide gene-targeted diagnostics and therapeutics.

Medicine 40

Medicine Genetics Genomics Genome 40

WCG Clinical

JUNE 24, 2024

Genetic manipulation has an interesting history of self-regulation in the United States (US). In 1953, Watson and Crick formulated the current description of DNA as a double helix 1 and soon thereafter experiments with restriction endonucleases gave scientists the ability to modify and manipulate DNA 2.

DNA 52

DNA Regulation Scientist Research 52

Roots Analysis

SEPTEMBER 20, 2023

Cell therapies are based on the premise that the patient’s own cells ( autologous ), or those from a healthy donor ( allogeneic ), can be genetically re-programmed to combat various diseases. The assays established for traditional biologics are unlikely to be suitable for cell and gene therapies.

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The Pharma Data

DECEMBER 30, 2020

The OvPENS platform team supported our manufacturing partner to scale and meet regulatory compliance such that production for all pre-clinical and clinical requirements ahead are secured. .” “Our platform and corporate development also made great progress in the second half of 2020.

Development 40

Development Trials Manufacturing Compliance 40

The Pharma Data

SEPTEMBER 20, 2020

About KRAS The RAS gene family, which has been the subject of almost four decades of research, contains some of the most frequently mutated oncogenes in human cancers. To learn more about Amgen ‘s innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com. Genes Cancer.

Medicine 52

Medicine Production Sales Clinical Trials 52

Roots Analysis

APRIL 15, 2024

Over the years, these large molecules have demonstrated promising therapeutic outcomes in the treatment of myriad of chronic and challenging disorders, including autoimmune disorders, infectious diseases, genetic disorders, and oncological disorders.

Manufacturing 40

Manufacturing Production Contract Manufacturing Contamination 40

The Pharma Data

NOVEMBER 9, 2020

This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions.

Trials 52

Trials Production Sales Manufacturing 52

Cloudbyz

MARCH 6, 2024

Personalized Medicine: Biologics offer the potential for personalized treatment approaches by taking into account individual variations in genetics, immune responses, and disease characteristics. These novel therapeutics hold promise for addressing previously intractable diseases and expanding the scope of precision medicine.

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Gene Immune Response Manufacturing Gene Therapy 99

Advarra

JUNE 13, 2024

Recombinant DNA technologies and genetically modified biological agents are being adapted for a wide scope of therapeutic applications, and their use is becoming increasingly common in clinical trials. The post The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering appeared first on Advarra.

Genetic Engineering 52

Genetic Engineering Clinical Trials Clinical Trials Engineer 52

Roots Analysis

AUGUST 15, 2024

These diagnostic solutions are essential for detecting and monitoring diseases, identifying genetic predispositions, and guiding personalized treatment plans. Molecular diagnostic solutions are pivotal across various medical fields, including oncological disorders, infectious diseases, genetic testing, and personalized medicine.

Marketing 40

Marketing Genetics Genomics Genome 40

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. A key part of the IBC’s evaluation is assessing the risks posed by the engineered genetic materials.

Engineer 52

Engineer Genetics Clinical Research Research 52

Advarra

JANUARY 11, 2024

Personalized medicine using genetic resequencing techniques, such as cell and gene therapies, enables researchers to create more customized therapies for combatting cancer. And maintaining quality GxP compliance throughout to safeguard both participant wellbeing and product quality is key to creating successful outcomes.

Vaccine 52

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pharmaphorum

JUNE 11, 2021

Leading academic research institutions and pharma/biopharma players exploring therapeutic areas such as immuno-oncology or cell and gene therapy no longer start ‘analogue only’ projects because of time and productivity shortcomings. However, it is vital to understand that compliance is not security.

Clinical Trials 111

Clinical Trials Clinical Trials Trials Compliance 111

Delveinsight

FEBRUARY 12, 2021

Furthermore, GlaxoSmithKline is developing GSK3377794 (NY-ESO-1 T-cells; GSK ‘794), a NY-ESO-1-directed genetically modified autologous T-cell immunotherapy and is an engineered T-cell therapy. Genetic counseling and other symptomatic treatment also help. Argininosuccinic aciduria is a rare disease that is genetically inherited.

Marketing 52

Marketing Clinical Trials Clinical Trials Development 52

Advarra

JULY 6, 2023

When conducting a trial involving engineered genetic materials, incidents involving occupational safety and environmental protection are also reportable to the IBC. The IBC will review the incident in a convened committee meeting to determine if any additional actions are required.

Genetics 52

Genetics Engineer Research Gene Therapy 52

The Pharma Data

JULY 8, 2021

The FDA grants Priority Review to applications for medicines that offer significant advantages over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance.(1) Measures of gene expression in sputum cells can identify TH2-high and TH2-low subtypes of asthma.

Allergies 52

Allergies Trials In-Vivo Medicine 52

Roots Analysis

OCTOBER 19, 2023

In fact, it was bacteriophage research, which led to the modern concept of viruses and formed the grounds of molecular biology and emerging molecular genetics. aeruginosa ) in the soil and minimize the spread of antibiotic resistant genes. Frederick Twort was the first to report the elimination of bacteria using viruses, in 1915.

Bacteria 40

Bacteria Production In-Vivo In-Vitro 40

Pharmaceutical Technology

APRIL 27, 2023

When combined with rapid advancement in delivery technologies, mRNA has the potential to lead to breakthroughs in the development of tailored treatment approaches in a wide range of indications from cancer to rare genetic disorders while enabling rapid responses to emerging threats. billion by 2028.

Manufacturing 130

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Pharmaceutical Technology

FEBRUARY 20, 2023

Free Whitepaper Precision medicine for non-small cell lung cancer (NSCLC): Emerging trends in molecular analysis Lung cancer remains the most deadly of all types of cancer, so molecular testing is a key step to help researchers, pathologists, and oncologists understand the genetic underpinnings of this disease. SZ) and Tigermed (300347.SZ

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