Drug Discovery World

JANUARY 23, 2024

The platform was recently updated to support FDA 21 CFR Part 11 compliance and include a full Installation Qualification / Operation Qualification (IQ/OQ) package for pharmaceutical quality assurance, extending the system’s applications into drug manufacturing operations. The consortium has been awarded €3.4

Compliance 52

Compliance Production Development Packaging 52

Roots Analysis

JANUARY 22, 2024

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. Data Handling: Genomic data essential for the implementation of precision medicine is highly sensitive and personal.

Medicine 40

Medicine Genetics Genome Genomics 40

pharmaphorum

JULY 4, 2022

And this is where modern technologies and data-driven medical informatics can really bridge the gaps in rare disease research,” said Dr Joanne Hackett, head of Genomic and Precision Medicine at IQVIA, during a recent pharmaphorum webinar. Navigating rare disease research and treatment.

Genome 103

Genome Genomics Research Medicine 103

pharmaphorum

APRIL 8, 2022

Analysing data spread across many health care facilities and patient registries in compliance with data protection. Joanne Hacket (chair) is the head of genomic and precision medicine at IQVIA and previously was the chief commercial officer at Genomics England. About the panel.

Genome 58

Genome Genomics Research Big Data 58

pharmaphorum

JULY 27, 2021

For example, delivering step-by-step best practice guidance to mobile devices can strengthen confidence, compliance and consistency. They cover up the cracks in the system, using huge amounts of time and energy to smooth over the bumps, repeat lost processes, generate paperwork and backdate signatures to satisfy compliance audits.

Compliance 58

Compliance Manufacturing Genome Genomics 58

Camargo

NOVEMBER 11, 2020

In November 2017, Foundation Medicine received approval for FoundationOne CDx , a genomic profiling test for solid state tumors, which paved the way for partnerships with pharma companies’ therapeutics. Manager of Regulatory Compliance. In 2019, Foundation Medicine and Bayer Healthcare Pharmaceuticals, Inc. Co-Authors: Jenny Fielder.

Development 242

Development Bioequivalency Generic Drugs Production 242

XTalks

FEBRUARY 4, 2021

The power of leveraging clinical data to decipher disease mechanisms and fuel drug discovery has rapidly grown in the era of genomics and personalized medicine. Genuity Science focuses on population genomics as a tool to derive novel biological insights through partnerships with industry-leading pharmaceutical and biotech companies.

Research 98

Research Biobanking Drugs Genome 98

The Pharma Data

DECEMBER 25, 2020

The Public Health Agency of Canada ‘s (PHAC) National Microbiology Laboratory monitors Canadian cases of COVID-19 with the provinces and territories through ongoing analysis of genomic databases in Canada. As the monitoring continues, it is expected that other cases of this variant and other variants of concern may be found in Canada.

Compliance 52

Compliance Genome Genomics Antibody 52

Drug Discovery World

AUGUST 23, 2023

In this metaphor, that’s the regulatory, compliance goals of data management achieved. Moving away from offline processes can take weeks off compliance timelines. The alternative: an integrated biopharma research and development system A new basic ELN may help this lab with compliance and reducing paper waste.

Laboratory Information Management System 52

Laboratory Information Management System Scientist Compliance Development 52

XTalks

MAY 23, 2024

Advances in genomic sequencing and molecular diagnostics are helping healthcare providers to identify specific mutations and biomarkers associated with skin cancer. TDDS are advantageous due to their high bioavailability, low systemic toxicity and improved patient compliance.

Life Science 59

Life Science Dermatology Drug Delivery Systems Medicine 59

ACRP blog

JUNE 7, 2023

Elsewhere in the June issue, Londa Ritchey, MS, MBA, Quality Director with the Quality Management and Compliance group at PharmaLex, writes about how “Putting the Patient First is Integral to Building a Strong Quality Culture.” Undoubtedly, the expectations for precision medicine are high,” Olsen adds.

Big Data 59

Big Data Clinical Research Research Clinical Trials 59

Drug Discovery World

MAY 17, 2024

The need to protect this data isn’t just about compliance with laws like HIPAA or GDPR; it’s about maintaining trust. National Human Genome Research Institute. Cancer datasets are particularly sensitive since they contain confidential health information, necessitating stringent ethical and privacy measures. Anne Trafton.

Trials 59

Trials Clinical Trials Clinical Trials Protein 59

Cloudbyz

MARCH 6, 2024

Longer Lasting Effects: Many biologics have prolonged therapeutic effects, allowing for less frequent dosing regimens and improved patient compliance. As we continue to harness the power of biotechnology, genomics, and digital health, the potential for transformative breakthroughs in healthcare is virtually limitless.

Gene 73

Gene Immune Response Manufacturing Gene Therapy 73

XTalks

OCTOBER 19, 2023

Regulatory and Compliance Knowledge Having knowledge of the regulatory landscape is particularly relevant in clinical diagnostics or pharmaceutical industries where the assays must meet specific regulatory standards. Additionally, advances in technologies in fields like genomics, proteomics and cell biology necessitate specialized assays.

Scientist 59

Scientist Development Research Compliance 59

Drug Discovery World

MARCH 2, 2023

Using AI and ML features, RBM uses predictive analytics, such as compliance, data quality and enrollment throughout the clinical trial to help to determine the performance at different stages. ” The role of AI in rare disease clinical trials might hold the key to helping the UK achieve this vision.

Development 52

Development Drugs Clinical Trials Clinical Trials 52

Drug Discovery World

DECEMBER 8, 2023

This meticulous approach not only facilitates regulatory compliance but also establishes a clear and traceable record of the therapeutic development journey that will help determine which patient will benefit the most.

Gene Therapy 64

Gene Therapy Gene In-Vitro Development 64

The Pharma Data

NOVEMBER 17, 2021

The companies will work GSK’s moxie in functional genomics and combine their capabilities in CRISPR webbing and artificial intelligence to identifyanti-coronavirus composites that target cellular host genes. They will also apply their concerted moxie to probe SARS-CoV-2 and other coronavirus vaccines.

Antibody 52

Antibody In-Vitro Vaccination Vaccine 52

Advarra

NOVEMBER 10, 2022

It also proposes adding information about if results will be returned to participants, under what conditions, and whether whole genome sequencing will occur. In addition to the harmonization goal, these additional elements help modernize the regulations with current scientific and participant expectations. .

Regulation 52

Regulation Research Genome Genomics 52

Advarra

NOVEMBER 29, 2022

The first is titled, Human Gene Therapy Products Incorporating Human Genome Editing , and provides recommendations on the information to include in IND filings for these therapies, including study design, safety, and manufacturing.

Gene Therapy 52

Gene Therapy Gene Production Clinical Trials 52

pharmaphorum

MAY 18, 2022

Genomics has unlocked entirely new insights to what exactly may cause certain neurological conditions. It will lead to better prevention, stronger compliance with prescribed regimes, more disciplined participation in clinical trials, faster recruitment, less attrition, quicker and more reliable results.

Gene Therapy 73

Gene Therapy Gene Genetics Development 73

Advarra

SEPTEMBER 29, 2022

For research regulated by the Common Rule: For research involving biospecimens , whether the research will (if known) or might include whole genome sequencing.

Regulation 52

Regulation Research Genetics Compliance 52

Drug Discovery World

JUNE 6, 2023

I think in the advent of a lot of genomic data for oncology research, people just want to get more data, more answers, and a quicker outcome, whatever that is for them.” The post Reflections from AACR 2023 appeared first on Drug Discovery World (DDW). A single product, quick workflow, getting you the answers as quickly as possible.

Protein 52

Protein DNA RNA Research 52

The Pharma Data

NOVEMBER 15, 2020

a publicly traded biopharmaceutical company, from 2012 to December 2019, managing its international, legal, quality, intellectual property and compliance functions, after serving in other executive roles at Acorda starting in 2004. She currently serves as a non-executive director on the board of Genfit, S.A., Before joining Acorda, Ms.

Clinical Trials 40

Clinical Trials Clinical Trials Production Trials 40

The Pharma Data

NOVEMBER 24, 2020

The Notice of Compliance was granted under priority review and marks the first Health Canada approval of a PARP inhibitor in prostate cancer. “Circulating Tumor DNA Genomics Correlate with Resistance to Abiraterone and Enzalutamide in Prostate Cancer.” MISSISSAUGA, ON , Nov. ” European urology vol.

Gene 52

Gene Hormones DNA Medicine 52

The Pharma Data

DECEMBER 12, 2020

AstraZeneca has developed a broad range of technologies, initially focused on small molecules and biologics and with a growing focus in precision medicine, genomics, oligonucleotides and epigenetics. More recently, AstraZeneca has increased its efforts in immunology research and the development of medicines for immune-mediated diseases.

Development 75

Development Regulation Medicine Containment 75

The Pharma Data

MAY 7, 2021

The EMA will assess the medicine’s compliance with the usual standards for efficacy, safety and quality. The companies will leverage GSK’s expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes.

Antibody 52

Antibody Trials Vaccination Vaccine 52

The Pharma Data

AUGUST 6, 2020

FDA for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. This approval was based on the Phase 3 CheckMate -9LA study. In May, the company announced the U.S. healthcare reform and legislation or regulatory action in the U.S.

Production 52

Production Branding Marketing Licensing 52

Pharmaceutical Technology

JANUARY 13, 2023

Using single-cell genomic sequencing of these cells, the researchers created a cellular atlas of endometriosis that allowed them to identify key molecular differences between the major subtypes of endometriosis, including peritoneal disease and ovarian endometrioma.

Genetics 147

Genetics Drugs Compliance Genome 147

Pharmaceutical Technology

APRIL 27, 2023

Genomic medicine development was ranked as the top industry trend for 2023 in a survey of 198 GlobalData Pharma clients and prospects conducted between October and November 2022. This makes the requirement to establish a reliable and robust manufacturing process with clear scalability and compliance goals a priority. billion by 2028.

Manufacturing 130

Manufacturing RNA Contamination Vaccination 130