Engineer and Trials - Clinical Research Informer

Samsung Biologics, GreenLight conclude Covid-19 vaccine engineering run

Pharmaceutical Technology

AUGUST 2, 2022

Samsung Biologics and GreenLight Biosciences have completed the initial commercial-scale engineering run for their messenger ribonucleic acid (mRNA) Covid-19 vaccine under their manufacturing collaboration. Following the demonstration at Samsung, the clinical trial of GreenLight’s Covid-19 booster vaccine is anticipated to commence this year.

Engineer

Engineer Vaccine Vaccination Clinical Trials

BlueRock Advances Bemdaneprocel Cell Therapy to Phase III Trial for Parkinson’s Disease

XTalks

JANUARY 16, 2025

BlueRock Therapeutics, a subsidiary of Bayer AG, is making waves in the treatment of Parkinsons disease by advancing its investigational cell therapy, bemdaneprocel, to a Phase III clinical trial. The clinical advancement follows a thorough review of Phase I trial data under the FDAs Regenerative Medicine Advanced Therapy (RMAT) designation.

Trials

Trials Clinical Trials Clinical Trials Gene Therapy

Experimental Alzheimer’s Vaccine Shown to Delay Symptoms in Mice

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.

Vaccine

Vaccine Vaccination Engineer Gene

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Ginkgo buys StrideBio’s AAV discovery and engineering platform assets

Pharmaceutical Technology

APRIL 6, 2023

Ginkgo Bioworks has strengthened its end-to-end R&D capabilities in gene therapy with the purchase of adeno-associated virus (AAV) capsid discovery and engineering assets from StrideBio, for an undisclosed sum. AAV is used in hundreds of active clinical trials, and is described as the preferred viral vector for gene therapy.

Engineer

Engineer Gene Therapy Gene Manufacturing

Providing the Blueprint for Gen AI Adoption in Clinical Trials

ACRP blog

OCTOBER 10, 2024

It’s even being used to review investigator invoices and automate financial reconciliations—a monthly headache every contract research organization, sponsor, and clinical trials operator will be more than happy to resign to machines. A Blueprint for Adoption in Clinical Trials That’s where large integrated site organizations come in.

Clinical Trials

Clinical Trials Clinical Trials Trials Life Science

Health Canada gives approval to Enhertu for breast cancer treatment

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.

HR

HR Trials Engineer Clinical Trials

Not A Placebo: Study Finds Meditation Offers Genuine Pain Relief

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 29, 2024

(Engin Akyurt/Pixabay) If you’re in a lot of pain, being told to take deep breaths and accept the sensations in your body might not feel particularly comforting.

Engineer

Engineer Research Clinical Trials Clinical Trials

Alzheimer’s Could Be Caused by Brain Cells That Age Too Fast

AuroBlog - Aurous Healthcare Clinical Trials blog

MAY 19, 2024

Engineers at the University of California San Diego (UCSD) have used cutting-edge technology to analyze the postmortem brains of 14 donors aged over 59, some of whom died with Alzheimer’s disease and some of whom […]

Engineer

Engineer Development Clinical Trials Clinical Trials

Eneboparatide Advances in Hypoparathyroidism Trial: Key Phase III Update

XTalks

MARCH 19, 2025

Eneboparatide (AZP-3601), an investigational parathyroid hormone 1 receptor (PTH1R) agonist, met its primary endpoint in the CALYPSO Phase III trial, offering new data for adults with chronic hypoparathyroidism. Participants were randomized in a 2:1 ratio to receive eneboparatide or a placebo.

Trials

Trials Hormones Engineer Licensing

Mechanical engineer awarded $2.1 million NIH grant to launch clinical trial for exoskeleton technology

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 […].

Engineer

Engineer Clinical Trials Clinical Trials Trials

Experiment Reveals Human Genes Can Be Controlled With Electricity

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.

Genetic Engineering

Genetic Engineering Gene Engineer Genetics

US Scientist to Live Underwater For 100 Days in Record-Breaking Experiment

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.

Scientist

Scientist Engineer Clinical Trials Clinical Trials

You May Not Need to Lose as Much Weight as You Think, Expert Reveals

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

Engineer Clinical Trials Clinical Trials Clinical Research

Novavax’s Covid-19 vaccine gets Taiwan FDA EUA for use in adults

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. The vaccine showed an encouraging safety and tolerability profile in both trials.

Vaccine

Vaccine Vaccination Clinical Trials Clinical Trials

Merck agrees to acquire Prometheus Biosciences for $10.8bn

Pharmaceutical Technology

APRIL 17, 2023

“This transaction adds diversity to our overall portfolio and is an important building block as we strengthen the sustainable innovation engine that will drive our growth well into the next decade.” The company intends to advance the mAb into Phase III trials for UC and CD in 2023.

Engineer

Engineer Trials Antibody Development

STAT+: Engineered virus shows promise against aggressive form of breast cancer

STAT News

FEBRUARY 9, 2023

But a small new study suggests that help might come from an engineered virus. The subtype is considered particularly dangerous, as it tends to grow and spread more aggressively than other types, and it has fewer effective treatment options.

Engineer

Engineer Medicine Trials Research

CIGB-128 by Center for Genetic Engineering and Biotechnology for Brain Tumor: Likelihood of Approval

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. It is a combination of interferon alfa-2b with interferon gamma.

Genetic Engineering

Genetic Engineering Engineer Genetics Clinical Trials

CIGB-128 by Center for Genetic Engineering and Biotechnology for Brain Tumor: Likelihood of Approval

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. It is a combination of interferon alfa-2b with interferon gamma.

Genetic Engineering

Genetic Engineering Engineer Genetics Clinical Trials

Genetically modified herpes combats advanced cancers

Pharma Times

SEPTEMBER 21, 2022

A new genetically engineered virus has delivered a one-two punch in initial phase 1 trial

Genetics

Genetics Genetic Engineering Engineer Trials

June 27, 2022: Special Edition of Contemporary Clinical Trials Offers New Perspectives on Pragmatic and Virtual Clinical Trials

Rethinking Clinical Trials

JUNE 27, 2022

A special series of articles addressing pragmatic and virtual trials appears this week in the journal Contemporary Clinical Trials and offers practical approaches to the many challenges clinical trials face. The special issue can be found on the Contemporary Clinical Trials website.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

Symvess: Humacyte’s FDA-Approved Bioengineered Solution for Vascular Trauma

XTalks

JANUARY 7, 2025

Symvess is a one-time, single-use, acellular tissue-engineered vessel (ATEV) composed of human extracellular matrix proteins. Secondary endpoints, such as infection rates, amputation and limb salvage, also favored Symvess, with the trial covering traumatic injuries from car accidents, gunshot wounds and industrial accidents.

FDA Approval

FDA Approval Engineer Clinical Trials Clinical Trials

MSD adds rocket fuel to Winrevair's engine in PAH

pharmaphorum

NOVEMBER 26, 2024

ZENITH trial of MSD's Winrevair in PAH could add further momentum to an already impressive launch.

Engineer

Engineer Trials

China NMPA grants approval for CanSinoBIO’s Covid-19 vaccine as booster

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.

Vaccine

Vaccine Vaccination Genetic Engineering Clinical Trials

EC approves Briumvi to treat relapsing forms of multiple sclerosis

Pharmaceutical Technology

JUNE 2, 2023

It has been engineered to remove certain sugar molecules generally expressed on the antibody. The regulatory approval is based on the findings obtained from the ULTIMATE I & II Phase III trials. The therapy targets a unique epitope on CD20-expressing B-cells.

Antibody

Antibody Engineer Clinical Trials Clinical Trials

US FDA approves Daiichi Sankyo-AstraZeneca’s Enhertu for lung cancer

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% In the trial, 1.9% According to the interim efficacy data from a pre-specified patient cohort, a 5.4

FDA Approval

FDA Approval Clinical Trials Clinical Trials Engineer

New lupus partnership with FDA aims to end drug trials’ history of failure

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…

Drug Trials

Drug Trials Trials Drugs Engineer

Synthetic control arms in clinical trials: Making it happen

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?

Clinical Trials

Clinical Trials Clinical Trials Trials Engineer

Synlogic’s SYNB1934 receives orphan drug status from US FDA

Pharmaceutical Technology

MAY 10, 2023

SYNB1934 consumes Phe in the gastrointestinal (GI) tract by leveraging genetic engineering of the drug or drug-carrying capsule, probiotic escherichia coli (E coli) Nissle. This designation also comes at a pivotal time as we prepare to initiate our Phase 3 trial for PKU – Synpheny-3 – in the first half of 2023.”

Genetic Engineering

Genetic Engineering Drugs Engineer Genetics

LSD biotech MindMed buys digital trial firm HealthMode

pharmaphorum

FEBRUARY 19, 2021

With the acquisition MindMed gains access to HealthMode’s intellectual property, platforms for clinical drug trials, and its entire 24-strong digital medicine team. The post LSD biotech MindMed buys digital trial firm HealthMode appeared first on.

Trials

Trials Medicine Engineer Drug Trials

Scientists discover non-invasive approach for cancer therapy

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.

Scientist

Scientist Engineer Clinical Trials Clinical Trials

Umoja and IASO partner to develop therapies for haematological malignancies

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.

Development

Development In-Vivo Engineer Clinical Trials

Capsida Biotherapeutics and Prevail to develop CNS gene therapies

Pharmaceutical Technology

JANUARY 5, 2023

Under the multi-year strategic partnership, Prevail will detect and advance capsids, which are clinically translatable, along with its cargo to develop the transformative genetic medicines by using Capsida’s novel adeno-associated virus (AAV) engineering platform.

Gene Therapy

Gene Therapy Gene Development Engineer

Tech innovations that curb complexity, setting clinical trials up for success

Pharmaceutical Technology

OCTOBER 26, 2022

There is no denying that trial complexity is continuing to increase. Several factors in recent years have contributed to this rise including more complex trial designs, the rapid adoption of decentralisation stemming from the pandemic, and larger global trials. Demand planning drives trial efficiency.

Clinical Trials

Clinical Trials Clinical Trials Trials Production

ARTHEx Biotech raises funds to advance DM1 therapy to clinical trial

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.

Clinical Trials

Clinical Trials Clinical Trials Trials Protein

Opinion: Lack of diversity in clinical trials costs billions of dollars. Incentives can spur innovation

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

Clinical Trials Clinical Trials Trials Engineer

Sanofi and Innate Pharma extend cancer therapeutics partnership

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.

Development

Development Engineer Clinical Trials Clinical Trials

The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering

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

Genetic Engineering Clinical Trials Clinical Trials Engineer

EU approves Daiichi Sankyo-AstraZeneca’s breast cancer therapy

Pharmaceutical Technology

JANUARY 27, 2023

Being co-developed and co-marketed by AstraZeneca and Daiichi Sankyo, Enhertu is a particularly engineered HER2-directed antibody-drug conjugate (ADC). It is also based on the data obtained from the DESTINY-Breast04 Phase III trial, which assessed Enhertu’s safety and efficacy against the physician’s choice of chemotherapy.

HR

HR Engineer Antibody Development

‘A very worrying scenario’: Internal documents on India Covid-19 vaccine raise troubling questions about approval process

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. Read the rest…

Vaccine

Vaccine Vaccination Engineer Clinical Trials

Digital tools driving innovative clinical trials

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. New sensor technology revolutionising data collection.

Clinical Trials

Clinical Trials Clinical Trials Trials Regulation

Biogen’s ambitions in gene therapy hit by another failed pivotal trial

pharmaphorum

JUNE 15, 2021

Just over two years later, both of those candidates have failed late-stage clinical trials, leaving Biogen’s $800 million investment in Nightstar looking like a poor deal. The post Biogen’s ambitions in gene therapy hit by another failed pivotal trial appeared first on.

Gene Therapy

Gene Therapy Gene Trials Genetics

Opinion: Secrecy: A demon of gene therapy’s past bedevils its future

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…

Gene

Gene Gene Therapy Genetic Engineering Engineer

US FDA grants orphan drug status to IN8bio’s INB-400 and INB-410

Pharmaceutical Technology

APRIL 26, 2023

INB-400, an autologous, genetically engineered gamma-delta T cell therapy, is the company’s DeltEx chemotherapy-resistant autologous and allogeneic drug-resistant immunotherapy (DRI) technology. This marks the first-ever designation for genetically modified gamma-delta T cell therapies.

Genetic Engineering

Genetic Engineering Drugs Genetics Engineer

Tessera Cuts Dozens of Jobs Following Positive Preclinical Results

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.

Genetic Engineering

Genetic Engineering Engineer Clinical Trials Clinical Trials

Samsung Biologics, GreenLight conclude Covid-19 vaccine engineering run

BlueRock Advances Bemdaneprocel Cell Therapy to Phase III Trial for Parkinson’s Disease

Webinars

Trending Sources

Experimental Alzheimer’s Vaccine Shown to Delay Symptoms in Mice

Webinars

Ginkgo buys StrideBio’s AAV discovery and engineering platform assets

Providing the Blueprint for Gen AI Adoption in Clinical Trials

Health Canada gives approval to Enhertu for breast cancer treatment

Not A Placebo: Study Finds Meditation Offers Genuine Pain Relief

Alzheimer’s Could Be Caused by Brain Cells That Age Too Fast

Eneboparatide Advances in Hypoparathyroidism Trial: Key Phase III Update

Mechanical engineer awarded $2.1 million NIH grant to launch clinical trial for exoskeleton technology

Experiment Reveals Human Genes Can Be Controlled With Electricity

US Scientist to Live Underwater For 100 Days in Record-Breaking Experiment

You May Not Need to Lose as Much Weight as You Think, Expert Reveals

Novavax’s Covid-19 vaccine gets Taiwan FDA EUA for use in adults

Merck agrees to acquire Prometheus Biosciences for $10.8bn

STAT+: Engineered virus shows promise against aggressive form of breast cancer

CIGB-128 by Center for Genetic Engineering and Biotechnology for Brain Tumor: Likelihood of Approval

CIGB-128 by Center for Genetic Engineering and Biotechnology for Brain Tumor: Likelihood of Approval

Genetically modified herpes combats advanced cancers

June 27, 2022: Special Edition of Contemporary Clinical Trials Offers New Perspectives on Pragmatic and Virtual Clinical Trials

Symvess: Humacyte’s FDA-Approved Bioengineered Solution for Vascular Trauma

MSD adds rocket fuel to Winrevair's engine in PAH

China NMPA grants approval for CanSinoBIO’s Covid-19 vaccine as booster

EC approves Briumvi to treat relapsing forms of multiple sclerosis

US FDA approves Daiichi Sankyo-AstraZeneca’s Enhertu for lung cancer

New lupus partnership with FDA aims to end drug trials’ history of failure

Synthetic control arms in clinical trials: Making it happen

Synlogic’s SYNB1934 receives orphan drug status from US FDA

LSD biotech MindMed buys digital trial firm HealthMode

Scientists discover non-invasive approach for cancer therapy

Umoja and IASO partner to develop therapies for haematological malignancies

Capsida Biotherapeutics and Prevail to develop CNS gene therapies

Tech innovations that curb complexity, setting clinical trials up for success

ARTHEx Biotech raises funds to advance DM1 therapy to clinical trial

Opinion: Lack of diversity in clinical trials costs billions of dollars. Incentives can spur innovation

Sanofi and Innate Pharma extend cancer therapeutics partnership

The Importance of Hazard Communications in Clinical Trials Involving Genetic Engineering

EU approves Daiichi Sankyo-AstraZeneca’s breast cancer therapy

‘A very worrying scenario’: Internal documents on India Covid-19 vaccine raise troubling questions about approval process

Digital tools driving innovative clinical trials

Biogen’s ambitions in gene therapy hit by another failed pivotal trial

Opinion: Secrecy: A demon of gene therapy’s past bedevils its future

US FDA grants orphan drug status to IN8bio’s INB-400 and INB-410

Tessera Cuts Dozens of Jobs Following Positive Preclinical Results

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