pharmaphorum

FEBRUARY 1, 2022

Across the industry, pharma companies are turning to AI and real-world data to address many of the challenges of running clinical trials. Can the combined potential of new AI technologies and real-world patient data hold the key to overcoming the challenges in clinical trial design that have historically led to trial failure?

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Clinical Trials Clinical Trials Trials Engineer 104

Scienmag

JANUARY 2, 2022

Mechanical engineer and inventor Zach Lerner, assistant professor in Northern Arizona University’s Department of Mechanical Engineering, has been awarded $2.1 Credit: Northern Arizona University Mechanical engineer and inventor Zach Lerner, assistant professor in Northern Arizona University’s Department […].

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Engineer Clinical Trials Clinical Trials Trials 79

Pharmaceutical Technology

MAY 4, 2023

ARTHEx Biotech will use the funds to advance an antimiR oligonucleotide, ATX-01, to a Phase I/IIa clinical trial in the second half of 2023. New investors Sound Bioventures, Hadean Ventures and the European Innovation Council (EIC) fund have also participated.

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Clinical Trials Clinical Trials Trials Protein 130

Pharmaceutical Technology

SEPTEMBER 5, 2022

In March last year, CanSinoBIO obtained approval for the clinical trial application to analyse Convidecia Air. Administered as a single dose, the genetically engineered vaccine has the replication-defective adenovirus type 5 vector that expresses the spike S protein of the SARS-CoV-2 virus.

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Vaccination Vaccine Genetic Engineering Clinical Trials 264

pharmaphorum

JULY 8, 2022

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Hybrid or decentralised clinical trials (DCTs) have gained traction as technology, infrastructure and knowledge have evolved to support their use. Source: Izmailova et al, 2017.

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Clinical Trials Clinical Trials Trials Regulation 100

Pharmaceutical Technology

JUNE 24, 2022

The protein-based vaccine is engineered from the genetic sequence of the SARS-CoV-2 virus’ initial strain. The totality of preclinical, manufacturing and clinical trial findings that were submitted for analysis formed the basis for the EUA.

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Vaccination Vaccine Clinical Trials Clinical Trials 263

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 7, 2023

New research from ETH Zürich in Switzerland could see future wearable devices (with perhaps a few implants and a touch of genetic engineering) boost our health directly. Fitness trackers help you stay healthy by keeping count of your steps and monitoring your heart rate, driving you on to hit those cardio goals.

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Genetic Engineering Gene Engineer Genetics 246

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 3, 2023

An experimental vaccine that aims to slow down or prevent the progression of Alzheimer’s disease has been trialed in mice with promising early results. Mice engineered with genes that put them at greater risk of an Alzheimer’s-like disease had fewer amyloid plaques following the vaccine.

Vaccination 246

Vaccination Vaccine Engineer Gene 246

AuroBlog - Aurous Healthcare Clinical Trials blog

FEBRUARY 5, 2024

But type “setting a weight loss goal” into any online search engine and you’ll likely be left with more questions than answers. Sure, the many […]

Engineer 246

Engineer Clinical Trials Clinical Trials Clinical Research 246

Pharmaceutical Technology

OCTOBER 26, 2022

According to Tufts Center for the Study of Drug Development (CSDD), in a typical Phase Ill clinical trial, 119 protocol deviations are implemented on average, involving approximately one-third of all patients participating in that trial. IRT standardisation leads to increased consistency and quality.

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Clinical Trials Clinical Trials Trials Production 130

AuroBlog - Aurous Healthcare Clinical Trials blog

APRIL 9, 2023

Joe Dituri, a former US navy diver and expert in biomedical engineering has been living in a 55 square meter (592 square feet) space 30 feet below the […] As nightmares go, being trapped in a small box deep underwater is probably high on many people’s lists. But one US professor is doing this on purpose.

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Scientist Engineer Clinical Trials Clinical Trials 245

Pharmaceutical Technology

JANUARY 13, 2023

Being co-developed and co-marketed by Daiichi Sankyo along with AstraZeneca , Enhertu is a specifically engineered HER2-directed antibody-drug conjugate (ADC). Enhertu’s safety profile was consistent with the previous clinical trials.

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HR Trials Engineer Clinical Trials 321

STAT News

AUGUST 3, 2022

The lack of diversity in clinical trials unfairly skews American medicine and costs billions of dollars a year in early deaths and poor health. The scope of the problem was laid out in a new report that Congress requested from the National Academies of Sciences, Engineering, and Medicine, which we as committee members helped write.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Engineer 98

BioSpace

MAY 25, 2021

Engine is ready to drive its lead program into clinical trials by 2023 while Giiant’s preclinical program will target moderate-to-severe ulcerative colitis.

Engineer 82

Engineer Clinical Trials Clinical Trials Trials 82

Pharmaceutical Technology

AUGUST 12, 2022

The latest approval was based on the findings from the Phase II DESTINY-Lung02 clinical trial, which assessed the safety and efficacy of two doses of Enhertu in HER2 mutant metastatic NSCLC patients. . In the trial, 1.9% According to the interim efficacy data from a pre-specified patient cohort, a 5.4

FDA Approval 264

FDA Approval Clinical Trials Clinical Trials Engineer 264

pharmaphorum

DECEMBER 6, 2022

Clinical trials are the engine for pharmaceutical innovation, but their means of capturing and communicating data are stuck in the past. According to Peleg, one of the biggest inefficiencies is in the process of collecting and streaming data from participants at trial sites to the trial organisers.

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Clinical Trials Clinical Trials Trials Marketing 98

Pharmaceutical Technology

JUNE 10, 2023

CIGB-128 is under clinical development by Center for Genetic Engineering and Biotechnology and currently in Phase I for Brain Tumor. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Genetic Engineering 100

Genetic Engineering Engineer Genetics Clinical Trials 100

Pharmaceutical Technology

JUNE 10, 2023

CIGB-128 is under clinical development by Center for Genetic Engineering and Biotechnology and currently in Phase I for Brain Tumor. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Genetic Engineering 100

Genetic Engineering Engineer Genetics Clinical Trials 100

Pharmaceutical Technology

NOVEMBER 22, 2022

The robust expertise of IASO in monitoring possibly best-in-class CARs leveraging its fully-human antibody discovery platform (IMARS), quickly conducting clinical trials and its in-house GMP facility for producing plasmid, virus vector and CAR-T cells intends to make its new therapies available to larger population across the world.

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Development In-Vivo Engineer Clinical Trials 276

pharmaphorum

APRIL 11, 2022

Dudley Tabakin, CEO of VivoSense, describes how this financing is set to accelerate the development of novel digital biomarkers and improve digital clinical outcome assessments. How can this data be incorporated into clinical trials?”. How can this data be incorporated into clinical trials?”. Tabakin agrees. “In

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Clinical Trials Clinical Trials Trials Development 111

XTalks

JANUARY 7, 2025

Rishi Kundi, a clinical investigator at the University of Maryland Medical System, believes Symvess holds the potential to transform vascular trauma care by overcoming longstanding challenges like infection control and graft failure that have plagued traditional repair methods.

FDA Approval 105

FDA Approval Engineer Clinical Trials Clinical Trials 105

Pharmaceutical Technology

JUNE 2, 2023

Briumvi is an anti-CD20 monoclonal antibody indicated for RMS adult patients with active disease which is defined by clinical or imaging features. It has been engineered to remove certain sugar molecules generally expressed on the antibody. The therapy targets a unique epitope on CD20-expressing B-cells.

Antibody 246

Antibody Engineer Clinical Trials Clinical Trials 246

Pharmaceutical Technology

APRIL 11, 2023

The finding was made as part of a study published in the journal Nature Biomedical Engineering. Kelley added: “Engineering-based tools allow you to do things that open up new areas of biology. CTRL Therapeutics will file an application with the US Food and Drug Administration (FDA) to advance the new platform into clinical trials.

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Scientist Engineer Clinical Trials Clinical Trials 244

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. How can I protect myself from exposure? What should I do if I’m exposed?

Genetic Engineering 52

Genetic Engineering Clinical Trials Clinical Trials Engineer 52

Pharmaceutical Technology

DECEMBER 19, 2022

These two molecules are presently being analysed by the research and development (R&D) team of Sanofi, with one currently being evaluated in clinical trials. Initially, the companies signed a research collaboration and licensing agreement in 2016 to develop and assess up to two bispecific NK cell engagers.

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Development Engineer Clinical Trials Clinical Trials 264

pharmaphorum

MARCH 21, 2022

The integration of a Clinical Metadata Repository (CMDR) and a Clinical Data Repository (CDR) presents the opportunity to maximize automation across the end-to-end clinical trial lifecycle. This functionality offered the perfect synergy with our ryze Clinical Metadata Repository (CMDR) and automation platform.

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Clinical Trials Clinical Trials Trials Compliance 98

XTalks

SEPTEMBER 25, 2024

Patient-centricity isn’t a catchphrase in clinical trials—it’s a guiding principle for improving patient experiences. One of the most critical aspects of this is how patients are compensated for their participation in trials. Meghan Harrington VP, Clinical Trial Financial Management Medidata Alicia C.

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Clinical Trials Clinical Trials Trials Clinical Research 75

STAT News

NOVEMBER 15, 2022

The shot engineered by Bharat Biotech was, in part, an important effort to create a home-grown product that could   bolster the fortunes of the Indian pharmaceutical industry.

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Vaccination Vaccine Engineer Clinical Trials 145

BioSpace

APRIL 25, 2024

The genetic engineering startup, recently honored by BioSpace readers for its work environment, is downsizing as it seeks to launch its first clinical trials.

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Genetic Engineering Engineer Clinical Trials Clinical Trials 92

Antidote

OCTOBER 26, 2022

At Antidote, our mission is to connect patients with clinical trials using a data-driven, technological approach — and one of the ways we do that is through our clinical trial search engine, Antidote Match ™.

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Clinical Trials Clinical Trials Engineer Trials 94

Antidote

SEPTEMBER 7, 2023

Today, Antidote is excited to announce our collaboration with Beyond Type 1 and JDRF to release the first-ever Spanish-language clinical trial search engine for type 1 diabetes (T1D).

Engineer 52

Engineer Clinical Trials Clinical Trials Trials 52

STAT News

JULY 11, 2022

Then it was almost instantly derailed by the death of an 18-year-old clinical trial volunteer named Jesse Gelsinger after he received a genetically engineered virus that had been developed to treat his rare liver condition. Read the rest…

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Gene Gene Therapy Genetic Engineering Engineer 111

STAT News

MARCH 29, 2023

Lupus is a disease long-plagued by failed clinical trials. Together, they created what lupus advocates hope will be an engine for innovation: the Lupus Accelerating Breakthroughs Consortium, or Lupus ABC.   A key partnership is looking to change that.     Read the rest…

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Drug Trials Trials Drugs Engineer 116

Pharmaceutical Technology

NOVEMBER 29, 2022

Focus-X works on developing targeted radiopharmaceuticals based on peptide engineering technology for treating cancer. This takeover will bolster the pipeline of Full-Life, offer a second peptide-based discovery platform and utilise the Radio Technology manufacturing and logistics platforms of Focus-X to progress compounds into clinics.

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Sales Engineer DNA Development 147

Pharmaceutical Technology

JUNE 12, 2023

Quell Therapeutics and AstraZeneca have entered a collaboration, exclusive option and licence deal for the development, manufacturing and commercialisation of engineered T-regulator (Treg) cell therapies for autoimmune diseases. AstraZeneca will take up the further development and commercialisation activities of the clinical candidates.

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Engineer Gene Therapy Clinical Trials Clinical Trials 130

Clinical Trial Podcast

FEBRUARY 3, 2024

To learn more about clinical trials in diabetes, I invited Dr. Stayce Beck, Global Vice President of Clinical Affairs at Dexcom Inc. in Chemical Engineering from the University of Texas at Austin. on the podcast. in Biomedical Science from the University of California San Diego, and her B.S.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Engineer 52

Clinical Trial Podcast

AUGUST 7, 2023

The FDA wants pharmaceutical and medical device manufacturers to enroll diverse patients in clinical trials. One way to achieve the diversity goal is to engage with physicians in the community and provide them with the resources and support to conduct clinical trials. Chris holds a B.S. Chris holds a B.S.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Engineer 52