Cloudbyz

JUNE 21, 2023

In the world of clinical research, Electronic Data Capture (EDC) systems play a pivotal role in efficiently collecting, managing, and analyzing clinical trial data. The Study Data Tabulation Model (SDTM) is a widely accepted format that ensures consistency and interoperability of clinical trial data.

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Camargo

OCTOBER 15, 2020

As a sponsor designs clinical studies, the respective comparison control groups become a critical factor to consider. Further, the CFR states that the clinical trial needs to use a design that permits a valid comparison with a control to provide a quantitative assessment of drug effect.

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Cloudbyz

AUGUST 9, 2023

Let’s delve into why this method is paramount for the transformation of clinical research management. Unified Data Management Clinical trials generate vast amounts of data, from patient records to lab results and monitoring findings. Flexibility and Customization Not all clinical trials are the same.

Clinical Research 52

Clinical Research Research Clinical Trials Clinical Trials 52

XTalks

FEBRUARY 10, 2023

According to a recent review published in Nature , as of April 2022 almost 1,800 active cell therapy clinical trials were listed in ClinicalTrials.gov, a 33 percent increase from 2021. In a recent webinar, Dr. Vassallo discussed the operational considerations for complex cell therapy clinical trials.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Gene Therapy 52

The Pharma Data

JUNE 7, 2023

Originally launched in 2019 for early-phase protein therapy development, OneBio Suite offers customers an integrated service to accelerate programs from development to manufacturing, including fill/finish and packaging, and support for clinical supply and commercial launch. At the BIO International Convention, Carey Connolly, Ph.D.,

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pharmaphorum

MARCH 3, 2022

The investment package includes £200 million ($268 million) to enable researchers to better access NHS data through what the government calls Trusted Research Environments and digital clinical trial services.

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Manufacturing Life Science Clinical Trials Clinical Trials 52

Camargo

AUGUST 11, 2021

In addition, the sponsor seeks an agency’s agreement on its proposed plans, including clinical and nonclinical studies. Pre-submission meetings are usually associated with milestone submissions , such as applications to initiate clinical trials or marketing applications. Meeting Package Due. Meeting Type. Meeting Purpose.

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Camargo

JULY 30, 2021

They immediately stood up and said, “No, we’re doing six clinical trials in pediatrics now, specifically in the infant population, for something called pulmonary hypertension in these kids.” But now it’s a warning in their package insert. There were six Pfizer people in the audience.

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BioSpace

NOVEMBER 23, 2022

BioMarin Pharmaceutical announced the FDA no longer plans to hold an advisory committee meeting to review its BLA for Roctavian an AAV gene therapy for adults with severe hemophilia A.

Gene Therapy 40

Gene Therapy Gene Packaging Packaging 40

pharmaphorum

NOVEMBER 22, 2022

Ut comes just as FogPharma is preparing to start clinical trials of alpha-helical polypeptide candidate FOG-001. The Helicons are taken into cells using endocytic trafficking, a process which sees the compounds packaged into folds in the plasma membrane, forming vesicles that are then internalised.

Gene Expression 52

Gene Expression Packaging Packaging Clinical Trials 52

pharmaphorum

JUNE 11, 2021

The Philadelphia-based company said it had taken the decision to go down the biologics license application (BLA) route for Covaxin based on FDA feedback to the EUA data package it had submitted to the agency. — FDA Biologics (@FDACBER) May 25, 2021. million doses.”

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Vaccination Vaccine Clinical Trials Clinical Trials 62

Drug Discovery World

MARCH 29, 2023

Moreover, an extra six months of RDP for drugs with full comparator clinical trials (rather than showing only that a drug is no worse than the standard of care). For rare disease drugs, a variable RDP period of five, nine, or ten years, depending on the novelty of the drug.

Clinical Trials 52

Clinical Trials Clinical Trials Production Medicine 52

pharmaphorum

APRIL 11, 2022

Innovative ‘next-generation’ medicines are met with a series of hurdles such as increased cost of development, regulatory challenges and delays, and longer and more complex clinical trials. And it all fuels the debate: are medicines a cost or an investment? The answer to this question comes back to our definition of value.

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Medicine Clinical Trials Clinical Trials Development 112

pharmaphorum

NOVEMBER 16, 2020

Under Rasi, the EMA implemented a suite of reforms including a drive towards transparency – for example making clinical study reports (CSRs) publicly available – and the implementation of sweeping EU directives on pharmacovigilance, clinical trials and falsified medicines.

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Drug Discovery World

MARCH 13, 2023

The cell and gene therapy (CGT) landscape has grown significantly in the past year. Between the 24 therapies already approved by the FDA 1 and a marked increase in clinical trials, widespread accessibility to precision medicine feels within reach.

Gene Therapy 52

Gene Therapy Gene Manufacturing Development 52

Pharmaceutical Technology

SEPTEMBER 8, 2022

The list includes providers of development services, biologics management supply chain solutions, clinical trial services, commercial and logistics services, as well as packaging, labelling and distributing services for biologics.

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The Pharma Data

JANUARY 17, 2021

It received FDA guidance January 5 th and is in the midst of preparing the first package of investigational new drug (IND) applications – usually with an n-of-1, for individual patients. Safety is critical in all clinical trials, but with ultra-rare diseases, even greater care is taken. they can help many patients.”.

Genetics 52

Genetics Clinical Trials Clinical Trials Drugs 52

The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) has determined that OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA) patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019. SVP, Chief Medical Officer, Novartis Gene Therapies. “We

Clinical Trials 52

Clinical Trials Clinical Trials Gene Therapy Trials 52

Drug Discovery World

FEBRUARY 10, 2023

Magnus Persson is a physician and scientist with a background in both academia and industry, working for the likes of Sanofi on clinical trials activities and across venture capital firms in the US. He is now a founding partner of EIR Ventures, a venture capital firm investing in innovative companies across the Nordics.

Life Science 52

Life Science Drugs Gene Therapy Manufacturing 52

STAT News

NOVEMBER 4, 2022

A man with muscular dystrophy who was first in line to receive an experimental gene editing therapy tailor made to treat the cause of his rare form of the disease has died. Terry had long been too old to participate in clinical trials of experimental therapies for the disease, which are often geared towards young boys.

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Gene Editing Gene Gene Therapy Clinical Trials 105

Drug Discovery World

DECEMBER 15, 2022

As gene editing technologies like CRISPR progress toward clinical study, researchers must continue to advance new approaches and address inherent challenges, explains Jon Chesnut, PhD, Senior Director, Cell Biology R&D, Thermo Fisher Scientific. Early phase clinical trials for gene editing therapies.

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Gene Editing Gene In-Vivo Genome 52

Drug Discovery World

FEBRUARY 6, 2023

Typically, the data obtained from such studies is large and high dimensional with thousands of molecules being measured for each individual sample requiring special statistical, data science, and bioinformatics skills to integrate the information and correlate it with the clinical outcome of interest.

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Big Data RNA Bioinformatics Vaccination 52

Drug Discovery World

OCTOBER 25, 2023

I started my career in a molecular genetics diagnostics laboratory in the NHS and I remember NGS just starting to be evaluated for routine use for every sample that came into the lab, rather than us having to examine single mutations in single genes. discoveries!) This disease has not seen treatment or survival improvement since the 1970s.

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Bioinformatics Genetics RNA Drugs 115

Drug Discovery World

JULY 18, 2023

Since its discovery in 2012, CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) technology has revolutionised the biomedicine and cell and gene therapy fields, providing a versatile tool for precise and efficient genome editing.

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DNA Genome Genomics RNA 98

Drug Discovery World

AUGUST 5, 2022

In drug development, the originator company or sponsor is the primary stakeholder in the development of their drug, be it a small or large molecule, a cell or gene therapy. Why sponsors use external consultants.

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Development Drugs Production Gene Therapy 52

Drug Discovery World

MARCH 27, 2023

The UK government endorses TREs, having recently announced an investment package of up to £200 million in TREs and digitally enabled clinical trials 4. TREs are already paving the way to greater collaboration in drug development, improvements to existing treatment approaches, and driving better patient outcomes.

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XTalks

AUGUST 2, 2023

2) Paxlovid (nirmatrelvir/ritonavir) Paxlovid is a dual-packaged oral medication for the treatment of COVID-19. Meanwhile, BioMarin’s gene therapy Roctavian is approved by the FDA for the treatment of hemophilia A. a month for either 150 mg or 300 mg dose strength packages, and $3,462.13 But all three drugs have new competitors.

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The Pharma Data

OCTOBER 14, 2020

This work may also guide the selection of appropriate participants for clinical trials of COVID-19 vaccines, including future human trials using Tonix’s TNX-1800, a live replicating, attenuated COVID-19 vaccine candidate designed to confer durable T cell immunity.”. President and Chief Executive Officer of Tonix Pharmaceuticals.

Vaccination 40

Vaccination Vaccine Development Medicine 40

pharmaphorum

JANUARY 4, 2023

The cell and gene therapy (CGT) industry is poised to achieved a significant milestone at the end of 2022: the first approval of an allogeneic T-cell therapy in the world. . Over the last two years, the company has doubled its cryogenic storage capacity across its global network of clinical and commercial depots.

Gene Therapy 96

Gene Therapy Manufacturing Gene Production 96

XTalks

SEPTEMBER 14, 2020

By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. Sinovac Biotech is already in Phase III clinical trials testing its CoronaVac vaccine which it plans to evaluate in approximately 11,000 volunteers. The price of that prize is incalculable.

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