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 78

Genome Genomics Research Big Data 78

WCG Clinical

NOVEMBER 17, 2023

This change expanded the definition of HGT research to include research using nucleic acids that are able to replicate, be transcribed, translated into protein, and/or integrate into the host genome. If implemented, these changes would broaden the definition of HGT to include new gene editing and genome-modified products.

Genome 52

Genome Genomics Gene Editing Genetic Engineering 52

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

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

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 66

Compliance Manufacturing Genome Genomics 66

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

Pharma Marketing Network

OCTOBER 24, 2024

Personalized medicine, often driven by genomic data, is revolutionizing how treatments are marketed. However, with the rise of digital marketing, compliance has become more complex. Always be one step ahead by integrating compliance checks into every campaign and staying informed on FDA and EMA guidelines.

Marketing 52

Marketing Branding Pharma Companies Compliance 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

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

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 92

Gene Therapy Gene Genetics Development 92

Roots Analysis

SEPTEMBER 4, 2024

Integration of External Data and Systems: Integration of external data sources, such as patient health records, genomic data, and real-world healthcare results, require advanced data management infrastructure and cybersecurity measures in order to protect patient privacy and ensure data security and compliance.

Marketing 40

Marketing In-Vitro Compliance Development 40

Pharma Marketing Network

OCTOBER 14, 2024

With advancements in genomics and biotechnology, there is a move towards tailoring treatments to individual patients based on their genetic makeup. Pharma executives must navigate these regulatory complexities while maintaining compliance to protect their brand reputation and foster trust with stakeholders.

Marketing 52

Marketing Branding Big Data Drugs 52

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

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

Pharma Marketing Network

OCTOBER 17, 2024

By leveraging data from genomic studies and electronic health records, marketers can identify niche markets and craft messages that speak directly to the needs and concerns of specific patient populations. As we move towards 2025, regulatory bodies are increasingly focusing on transparency, patient privacy, and ethical marketing practices.

Marketing 52

Marketing Pharma Companies Regulation Production 52

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

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

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

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 Genome Genomics 147

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 99

Gene Immune Response Manufacturing Gene Therapy 99

Roots Analysis

AUGUST 15, 2024

Understanding Molecular Diagnostic Solutions Molecular diagnostic solutions are advanced techniques and tools used to analyze biological markers in the genome and proteome. Next Generation Sequencing (NGS): DNA sequencing provides comprehensive genomic insights identifying mutations and variations in the sequence.

Marketing 40

Marketing Genetics Genome Genomics 40

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 72

Life Science Dermatology Drug Delivery Systems Medicine 72

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 40

Compliance Genome Genomics Antibody 40

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

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 Containment 52

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

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

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 40

Antibody Trials Vaccination Vaccine 40