Drug Target Review

OCTOBER 6, 2023

This master regulator of the regulatory T cell (Treg) genome has opened new horizons in the fight against cancer, offering a precise and tailored solution to modulate the immune system’s response. Our team has created proprietary techniques to engineer Tregs that specifically remove SRC-3 that is expressed in the nucleus.

Small Molecule 111

Small Molecule Engineering Protein Expression Therapies 111

Advarra

JUNE 12, 2023

Gene therapy research is exciting and full of promise, but because of the risks involved, it’s also highly regulated, requiring an institutional biosafety committee (IBC) to provide additional oversight and risk assessment. What do the Regulations Say about IBC Review? What Does an IBC Review?

Engineering 98

Engineering Therapies Regulations Research 98

Drug Target Review

APRIL 30, 2025

Zylberberg shares a notable success story involving a CAR-T therapy developer – a type of cell therapy that uses genetically engineered T-cells to fight cancer. Building trust in AI – both among regulators and clinicians – will be key to unlocking its full potential in CGT, she explains.

Therapies 90

Therapies Drugs Clinical Trials Trials 90

Alta Sciences

NOVEMBER 4, 2024

Engineering and Administrative Controls: The cornerstone of safe HPAPI manufacturing lies in strict controls and the use of personal protective equipment (PPE). Engineering controls, such as airlocks and pressure-controlled rooms, further minimized the risk of airborne contamination and cross-contamination.

Engineering 52

Engineering Production Compliance Laboratories 52

The Pharma Data

MARCH 18, 2022

Columbia Engineering researchers report that they have developed a “cloaking” system that temporarily hides therapeutic bacteria from immune systems, enabling them to more effectively deliver drugs to tumors and kill cancer cells in mice. Sheng Professor of Biomedical Engineering. ” An Effective On/Off Switch.

Engineering 52

Engineering Drugs Small Molecule Therapies 52

Drug Target Review

JULY 7, 2023

The epigenome (meaning ‘above the genome’) is a system of reversible marks regulating how the DNA is read, translated and used. 2 Additionally, the epigenetic editing toolkit allows for precise temporal regulation. What is epigenetic editing? So, where does epigenetic editing currently stand and how will it transition into the clinic?

DNA 105

DNA Engineering Therapies Regulations 105

Chemical Biology and Drug Design

MARCH 18, 2025

In the context of our previous findings that artesunate (ART) could inhibit the migration and invasion of TC cells through phosphoinositide 3-kinase/protein kinase B (PI3K/Akt), this study was engineered to investigate whether ART regulates the tumor microenvironment in TC.

Protein Expression 100

Protein Expression Engineering Regulations Treatment 100

PerkinElmer

MARCH 4, 2022

Early approaches focused on regulating intracellular aggregate formation by inhibiting tau kinases, tau aggregation, or improving microtubule stabilization. 1 “There is great interest in identifying targets that regulate the expression or degradation of tau,” explained the authors in Communications Biology. “We Communications Biology.

Regulations 52

Regulations Disease Research Engineering 52

Perficient: Drug Development

AUGUST 19, 2024

Banks have silos, these silos have been created due to mergers, regulations, entities, risk types, chinese walls, data protection, land laws or sometimes just technological challenges over time. The team analyzing the data warehouses, the data lakes and aiding the analytics will have to have this one major organizational goal in mind.

Regulations 109

Regulations Marketing Government Compliance 109

ASPET

AUGUST 21, 2024

This review details the onset mechanisms of drug-induced TdP, including I Kr inhibition, pharmacokinetic factors, autonomic regulation and reduced repolarization reserve. It also explores the utility of proarrhythmic surrogate markers (J-T peak , T peak -T end and terminal repolarization period) besides QT interval.

Compliance 100

Compliance Pharmacokinetics Drugs Engineering 100

LifeSciVC

MAY 14, 2025

Microgravity crystallization, in combination with modern innovations in antibody engineering (e.g., Regulators may reasonably ask is a drug crystallized in orbit the same as if made on Earth? Convenience is an increasingly common competitive lever in the biopharma industry, particularly for crowded targets.

Science 89

Science Production Research Drugs 89

Drug Target Review

DECEMBER 13, 2023

The study mentions the overlap in genes associated with Fatigue Dominant long COVID and ME/CFS, including those involved in circadian rhythm regulation and insulin regulation. She is a computational biologist with a background in bioprocess engineering and biotechnology.

Bioinformatics 145

Bioinformatics Disease Regulations Immune Response 145

Advarra

MARCH 6, 2025

The Value of Clinical Research Clinical research is the engine that drives medical innovation, leading to the discovery of new drugs, treatments and medical devices that enhance patients access to treatment options, improve patient care and outcomes, and transform the healthcare landscape.

Clinical Research 52

Clinical Research Research Clinical Trials Bioethics 52

Drug Target Review

JANUARY 2, 2024

In research published in Scientific Reports , 1 investigators focused on mesenchymal stem cells (MSCs), known for their potential in treating cell defects and regulating immune responses.

RNA 128

RNA Immune Response Therapies Disease 128

Codon

OCTOBER 13, 2024

Genetic engineering in the medicine cabinet is one thing; allowing it at the dinner table is another. Through genetic engineering, researchers have developed Golden Rice which can help address the problem of vitamin A deficiency , cotton that produces its own insecticide , virus-resistant papayas , and more. At the dining table.

Engineering 108

Engineering Virus Production DNA 108

Agency IQ

JULY 22, 2024

The 103 regulations the EPA is currently working on On July 5, 2024, the EPA published its Spring 2024 Unified Agenda, which reveals what regulations the agency is planning on releasing by the end of the year and beyond.

Regulations 40

Regulations Production Engineering International 40

FDA Law Blog: Biosimilars

FEBRUARY 19, 2024

Loloei tackled legal matters related to various aspects of the regulation of medical devices, in vitro diagnostics, and combination products including regulatory and compliance issues, dispute resolutions between the FDA and sponsors, and FDA enforcement actions. During her FDA tenure, Ms. Gibbs , HP&M Director.

FDA 59

FDA Engineering Regulations Production 59

SCIENMAG: Medicine & Health

SEPTEMBER 22, 2023

A groundbreaking study conducted by Jun Sun’s research team at the University of Illinois Chicago has revealed a new and critical role of Axin1 in regulating intestinal epithelial development and microbial homeostasis. Credit: Shari Garrett et al. […]

Research 52

Research Engineering Regulations Disease 52

Drug Target Review

APRIL 11, 2024

Can you explain the methodology used to investigate the genetic variants regulating extracellular matrix (ECM) secretion in SMCs, and predict proteins associated with vascular disease? Previous studies support LTBP1’s involvement in ECM organization and TGF-beta activation, crucial for fibrous cap formation and stability.

Disease 59

Disease Engineering Regulations Clinical Research 59

Broad Institute

MARCH 14, 2024

Continuous evolution of compact protein degradation tags regulated by selective cereblon molecular glues. By Leah Eisenstadt March 14, 2024 Credit: Courtesy of the authors. Paper cited Mercer JAM, et al. March 14, 2024. Funding This work was supported in part by the National institutes of Health and the Howard Hughes Medical Institute.

Targeted Protein Degradation 141

Targeted Protein Degradation Small Molecule Medical Schools Science 141

DrugBank

JUNE 13, 2024

These microscopic particles, which are smaller than 100 nanometers, can be engineered to deliver drugs to specific targets with precision. Viral vectors, engineered from modified viruses that have lost their disease-causing potential, have emerged as a powerful tool for this purpose.

Therapies 98

Therapies Drugs DNA Treatment 98

Common Sense for Drug Policy Blog

DECEMBER 20, 2023

By 1972, the Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) had instituted severe regulations that restricted access, said Roberts. These regulations were designed primarily to prevent methadone from being diverted to the street, he said. Washington, DC: The National Academies Press.

Treatment 52

Treatment Regulations Engineering FDA 52

Drug Target Review

AUGUST 17, 2023

These antibodies are negatively regulated by the inhibitory IgG receptor, FcγRIIB (CD32B). Dogma suggests inhibition is mediated through the FcγRIIB immunoreceptor tyrosine-based inhibition motif (ITIM), negatively regulating immunoreceptor tyrosine-based activation motif (ITAM)-mediated signalling from activating FcγRs.

International 98

International Therapies Regulations Clinical Trials 98

Drug Target Review

APRIL 14, 2025

The ability to engineer spirulina in this way offers significant advantages in terms of manufacturing costs and scalability. We genetically engineer spirulina to express therapeutic proteins like antibodies or enzymes right inside the organism, Finrow explains. Its simple in principle.

Therapies 52

Therapies Marketing Drug Development Treatment 52

Common Sense for Drug Policy Blog

OCTOBER 4, 2024

States that regulate cannabis and cannabis-derived products do not have uniform testing procedures or regulatory approaches to ensure product integrity, safety, and labeling (Schauer, 2021)." dwf_admin Fri, 10/04/2024 - 12:00 Source National Academies of Sciences, Engineering, and Medicine.

Production 52

Production Engineering Regulations Science 52

FDA Law Blog: Biosimilars

FEBRUARY 9, 2024

Lenz, Principal Medical Device Regulation Expert & Lisa M. Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. By Adrienne R.

FDA 105

FDA Compliance Regulations Engineering 105

FDA Law Blog: Biosimilars

NOVEMBER 5, 2023

Dr. Won will share his expertise and insights on the intricacies of the United States Food and Drug Administration (FDA) regulations pertaining to medical devices, with a special focus on class II and class III hearing devices. Philip Won , of Hyman, Phelps & McNamara, P.C.

Science 52

Science FDA Approval FDA Regulations 52

DrugBank

JULY 8, 2024

This membrane regulates the diffusion of the drug from the reservoir into the skin. Nanoparticles offer a versatile platform for drug delivery, where their size and surface properties can be engineered to optimize interaction with the skin. Encapsulating drugs within nanoparticles brings several advantages for TDD.

Treatment 98

Treatment Drugs Clinical Trials Engineering 98

Drug Target Review

FEBRUARY 28, 2024

These include engineering the cells to express cytokines that promote their maturation and/or differentiation, and engineering drug-resistant γδ T cells that can be combined with chemotherapies, which stress cancer cells but would otherwise also deplete the T-cell population. Regulation of cutaneous malignancy by gammadelta T cells.

Therapies 105

Therapies Engineering Molecular Biology Science 105

Drug Target Review

JULY 13, 2023

As for regulatory considerations, Klein anticipates engaging in discussions with regulators to address novel aspects such as mechanism, toxicology, and dosing regimens. He believes that condensates regulate numerous cellular processes and are dysregulated in various diseases.

Disease 98

Disease Small Molecule Cell Biology Drugs 98

FDA Law Blog: Biosimilars

DECEMBER 6, 2023

filed comments on behalf of the Coalition to Preserve LDT Access and Innovation in response to FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices. Weighing in at nearly 60 pages, the comments detail extensive flaws in the proposed regulation. Javitt — On Monday, Hyman, Phelps & McNamara, P.C.

Laboratories 59

Laboratories FDA Regulations Compliance 59

Perficient: Drug Development

JANUARY 16, 2024

a healthcare and life sciences software engineering firm based in San Diego, California, with European operations located in Cluj-Napoca, Romania. We’re a full-service software engineering service provider focused on improving the patient experience through innovative software solutions and technologies.

Engineering 64

Engineering Science Compliance Production 64

Perficient: Drug Development

OCTOBER 16, 2023

Each truck is equipped with sensors that continuously monitor engine health, tire pressure, and fuel efficiency. Scenario 1 (Predictive Maintenance): The AI algorithms detect a subtle but consistent increase in engine temperature and decreased fuel efficiency in one truck.

Engineering 52

Engineering Regulations Production 52

Drug Patent Watch

DECEMBER 10, 2024

These agencies set guidelines and regulations that generic drug manufacturers must follow to ensure that their products are bioequivalent to the innovator drug. Regulatory professionals play a crucial role in navigating the regulatory landscape, ensuring compliance with guidelines and regulations, and communicating with regulatory agencies.

Drug Development 52

Drug Development Compliance Drugs Regulations 52

Perficient: Drug Development

SEPTEMBER 5, 2023

Despite many federal and state regulations aimed at improving the safety of utilities workers in the United States, there are several fatalities and many more injuries every year resulting from arc flash incidents on the job. What Does an Arc Flash Electrical Safety Program Involve? How Do I Start? How much will this cost? ”

Regulations 52

Regulations Engineering 52

Drug Target Review

AUGUST 10, 2023

1 The research, supported by the National Institutes of Health, centres on a cellular chaperone protein called GRP78, responsible for regulating protein folding within cells. In the top row, human lung cancer cells were engineered to over-express GRP78 in the nucleus. Previous studies led by Dr Amy S.

Cell Biology 52

Cell Biology Small Molecule Regulations Engineering 52

The Pharma Data

JANUARY 19, 2021

But altering the tracr-L with genetic engineering to make it function more like a guide RNA increased CRISPR-Cas9 cuts. The authors suggest natural tracr-L regulates autoimmunity. In bacteria with unaltered tracr-L, levels of CRISPR-related genes were low. And removing tracr-L altogether greatly increased CRISPR-Cas9 expression.

Research 52

Research RNA Molecular Biology Small Molecule 52