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. Biobanking will continue to play an integral role in accelerating drug discovery and development, which will necessitate access to a larger array of biological samples.

Research 98

Research Biobanking Drugs Genome 98

Camargo

NOVEMBER 11, 2020

When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.

Development 242

Development Bioequivalency Generic Drugs Production 242

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

Pharmaceutical Technology

APRIL 27, 2023

The successful development and deployment of the mRNA-based COVID-19 vaccines has catalysed the biopharma industry and paved the way to expand this drug modality to new therapeutic areas. This makes the requirement to establish a reliable and robust manufacturing process with clear scalability and compliance goals a priority.

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Manufacturing RNA Contamination Vaccination 130

Cloudbyz

AUGUST 9, 2023

As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. Integrated Compliance and Governance With stringent regulations governing clinical trials, compliance is of utmost importance.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

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

Drug Discovery World

MAY 17, 2024

Challenges in oncology research Time is one of the scarce resources in cancer research yet cancer clinical trials last for about 14-18 months longer than non-oncology clinical trials and the total research cycle for oncology drugs hovers around about 12 years 5. This is where artificial intelligence and machine learning might come handy.

Trials 59

Trials Clinical Trials Clinical Trials Protein 59

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. Drugs such as pembrolizumab (Merck’s Keytruda) and nivolumab (Bristol Myers Squibb’s Opdivo) have revolutionized the treatment options for skin cancer.

Life Science 72

Life Science Dermatology Drug Delivery Systems Medicine 72

Drug Discovery World

DECEMBER 8, 2023

Investments in AI and related technologies are driving this seismic shift where modest improvements in early-stage drug development success rates enabled by AI and machine learning could lead to an additional 50 novel therapies over 10 year s, a more than $50 billion opportunity. appeared first on Drug Discovery World (DDW).

Gene Therapy 64

Gene Therapy Gene In-Vitro Development 64

Drug Discovery World

AUGUST 23, 2023

There’s even a name for the downsides of such under-supported products, poor integrations, and bad user experience: frustrated ELN users call this the “tax on science” That tax has a real cost in terms of drug discovery. This transition improved intellectual property management for early drug discovery.

Laboratory Information Management System 52

Laboratory Information Management System Scientist Compliance Development 52

Cloudbyz

MARCH 6, 2024

Traditionally, pharmaceutical therapies have primarily consisted of small molecule drugs, commonly known as pills. This shift signifies not just a change in the way drugs are manufactured and administered, but also a fundamental transformation in the approach to treating diseases at their root cause.

Gene 73

Gene Immune Response Manufacturing Gene Therapy 73

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

ACRP blog

JUNE 7, 2023

One needs only to look at the industry press to see many recent examples of stakeholders making deals and rearranging assets in order to capitalize on what they hope will be breakthrough technologies and practices in terms of increasing efficiencies in drug and device research and development.

Big Data 59

Big Data Clinical Research Research Clinical Trials 59

XTalks

OCTOBER 19, 2023

An assay development scientist combines deep biological and biochemical expertise with practical laboratory skills to develop tests that can answer specific biological questions or drive the drug discovery process. The assays are designed to detect, quantify or study specific molecules, cells or biological activities.

Scientist 59

Scientist Development Research Compliance 59

Advarra

NOVEMBER 10, 2022

On September 28, 2022, the Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRM). It also proposes adding information about if results will be returned to participants, under what conditions, and whether whole genome sequencing will occur.

Regulation 52

Regulation Research Genome Genomics 52

Drug Discovery World

JUNE 6, 2023

So, I really look forward to the coming year and being in beautiful San Diego next year.” Meet the biotech Sygnature Discovery is an integrated drug discovery and non-clinical solutions provider, offering expertise across a range of therapeutic areas and biological target classes.

Protein 52

Protein DNA RNA Research 52

Advarra

NOVEMBER 29, 2022

There have been recent signals indicating the Food and Drug Administration (FDA) plans to provide greater support for CGT, addressing key issues continuing to impede their development. No Prescription Drug User Fee Act (PDUFA) fee is associated with the INTERACT meetings. Recent Problems in Cell and Gene Therapy Development.

Gene Therapy 52

Gene Therapy Gene Production Clinical Trials 52

The Pharma Data

NOVEMBER 17, 2021

(Nasdaq VIR) moment blazoned US government contracts totalling roughly$ 1 billion (1) (USD) to buy sotrovimab, an investigational monoclonal antibody for the early treatment of COVID-19, which the US Food and Drug Administration (FDA) granted Exigency Use Authorization (EUA) in May 2021.

Antibody 52

Antibody In-Vitro Vaccination Vaccine 52

pharmaphorum

MAY 18, 2022

Both industry and academic researchers aim to deepen the scientific knowledge of the causes of issues such as drug resistance, as well as of rare forms of epilepsy where pathways are better understood, enabling more precise targeting and better individual outcomes.

Gene Therapy 69

Gene Therapy Gene Genetics Development 69

Advarra

SEPTEMBER 29, 2022

The Food and Drug Administration (FDA) website has guidance titled Exculpatory Language in Informed Consent , which includes examples. 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

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. drug development initiative from 2012 to February 2019. Before joining Acorda, Ms.

Clinical Trials 40

Clinical Trials Clinical Trials Production Trials 40

The Pharma Data

MAY 7, 2021

The EMA will assess the medicine’s compliance with the usual standards for efficacy, safety and quality. An Emergency Use Authorization (EUA) application for sotrovimab has been submitted to the US Food and Drug Administration (FDA). About the COMET-ICE Study Design.

Antibody 52

Antibody Trials Vaccination Vaccine 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. 5% have US Food and Drug Administration -approved treatments. Over 7,000 rare diseases are known today, and only c.5%

Development 75

Development Regulation Medicine Containment 75

The Pharma Data

AUGUST 6, 2020

Food and Drug Administration (U.S. 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. Oncology and Hematology. Regulatory. In June, the company announced the U.S. This approval was based on the Phase 3 CheckMate -9LA study.

Production 52

Production Branding Marketing Licensing 52