Alta Sciences

OCTOBER 31, 2023

Altasciences Completes Expansion of New State-Of-The-Art Laboratory in Columbia, Missouri pmjackson Tue, 10/31/2023 - 16:08 Laval, Québec, October 31, 2023 – Altasciences is pleased to announce the completion of its laboratory facilities in Columbia, MO. This is Altasciences’ third purpose-built laboratory.

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Laboratories Clinical Pharmacology Cell Based Assays Drug Development 52

Broad Institute

OCTOBER 23, 2024

What is special about these synthetically designed elements is that they show remarkable specificity to the target cell type they were designed for," said Ryan Tewhey, an associate professor at The Jackson Laboratory and co-senior author of the work with Steven Reilly of Yale, and Pardis Sabeti of the Broad.

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Alta Sciences

DECEMBER 29, 2023

Webinar—Nonclinical AAV Gene Therapy Development–Key Considerations on Study Design, Laboratory Endpoints, and Regulatory Guidance lperez Fri, 12/29/2023 - 18:03 Image Website_Webinar_BioA Gene Therapy.jpg Tags Preclinical Research URL [link] Event End Date Thu, 02/29/2024 - 12:00 Event Start Date Thu, 02/29/2024 - 12:00 Weight 1

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KIF1A

MARCH 2, 2024

Read the Article Rare Roundup The Jackson Laboratory offers “Exploring Rare Disease Through Translational Research” MiniCourse Human health is incredibly complex; developing safe, effective treatments requires knowledge of molecular mechanisms, cell biology, and drug administration. Want to learn more about translational research?

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Laboratories Cell Biology Disease Research 119

Drug Target Review

DECEMBER 5, 2024

Viral vectors have been crucial in transforming the gene therapy landscape due to their natural ability to infect cells. 1 In 2017, the US Food and Drug Administration (FDA) approved the first AAV-based gene replacement therapy (Luxturna), for Leber congenital amaurosis type 2.

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Drug Target Review

JANUARY 2, 2024

Through a series of experiments, they successfully developed a personalised stem cell therapy using a data-driven, single-cell technique based on swift subcellular proteomic imaging. Our recent work proposes the use of an intracellular toolkit to map organelle bio-geography in stem cells that could lead to more precise therapies.”

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Alta Sciences

NOVEMBER 13, 2024

Their three state-of-the-art bioanalytical laboratories feature mirrored operations and uniform protocols to maintain consistency and quality across client projects, ensuring reliable, high-quality data regardless of location. Whether for preclinical or clinical studies, we provide tailored solutions to meet specific research needs.

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Clinical Pharmacology Laboratories Drug Development Pharmaceuticals 40

Drug Target Review

APRIL 17, 2024

His lab applies approaches from computational biology and machine learning to unravel the molecular determinants of response to immune checkpoint blockade therapy, understand the co-evolution of tumour cells and the human immune system during cancer evolution, and learn the complex rules that govern T cell epitope recognition and immune escape.He

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Immune Response Laboratories DNA Virus 106

The Pharma Data

AUGUST 24, 2020

The FDA has approved a request from American Gene Technologies to begin a clinical study into its HIV gene therapy. The treatment is being researched by scientists collaborating from American Gene Technologies, the Laboratory of Immunoregulation and the National Institute of Allergy and Infectious Diseases. Conor Kavanagh.

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Alta Sciences

APRIL 16, 2024

Inside The Altascientist: The Benefits of PCR for Your Gene Therapy Programs pmjackson Tue, 04/16/2024 - 19:04 The gene therapy landscape continues to accelerate in preclinical and clinical research, with programs constantly in development for targeted, personalized medicines. Tags Bioanalysis Weight 15

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Therapies DNA RNA Laboratories 52

Drug Target Review

DECEMBER 11, 2024

Our approach, grounded in Good Laboratory Practice (GLP) and honed through thousands of studies, ensures that even the most subtle toxicological indicators are reliably detected. Such an approach ensures reliable preclinical toxicology data and supports the transition of innovative therapies from the lab to clinical trials.

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International Laboratories Drugs Pharmacokinetics 52

KIF1A

JANUARY 27, 2024

Rare Roundup KRIBB develops new gene therapy candidate for hereditary spastic paraplegia This week we’re flipping the format and starting with our Rare Roundup, after families contacted us with this article about a gene therapy candidate for hereditary spastic paraplegia.

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Elrig

MARCH 25, 2025

In 2016, he was appointed Junior Group Leader with the Swiss National Centre for Competence in Research (NCCR) in RNA & Disease, where he established the laboratory for Genomics Of LncRNAs in Disease (GOLD Lab).

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RNA Bioinformatics Science Pharmacokinetics 59

The Pharma Data

JANUARY 25, 2021

a biotechnology company developing cell and gene therapy treatments for patients suffering from vascular disease, today announced that it raised up to $5.5M that will lead clinical testing of a novel gene therapy for a serious vascular disease in Europe. MIAMI, Jan. 25, 2021 (GLOBE NEWSWIRE) — Ambulero, Inc. , About Ambulero.

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Therapies Disease Licensing Licensing 52

Advarra

AUGUST 8, 2023

Gene therapy research is booming in the clinical setting. In this blog, we summarize the growth, risks, and regulatory requirements for gene therapy research. Defining the Boom in Gene Therapy Research The gene therapy field is experiencing explosive growth in today’s competitive research environment.

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Alta Sciences

OCTOBER 7, 2024

Latest Findings in Gene Therapy Research blussier Mon, 10/07/2024 - 15:16 HTML A Promising Future for Gene Therapy Our experts have been diligently working on groundbreaking research, including a wide range of gene therapy studies, and have compiled a selection of scientific resources featuring the latest advancements.

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The Pharma Data

DECEMBER 22, 2020

In vitro studies have provided compelling evidence supporting the view that Tmod-based cell therapy can distinguish tumor cells from normal cells, across multiple tumor targets,” said Dr. Roger M. Perlmutter, President, Merck Research Laboratories. “We About A2 Biotherapeutics.

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Alta Sciences

MARCH 1, 2024

Norbert Makori and Pierre Jolicoeur: The Benefits of Combining Preclinical and Bioanalytical for Your Gene Therapy Studies pmjackson Fri, 03/01/2024 - 22:20 Recent advances in gene therapy have allowed for diseases to be approached differently. q: How can Altasciences support sponsors’ Gene Therapy Programs?

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Therapies Laboratories Molecular Biology RNA 52

ASPET

MARCH 20, 2024

Our laboratory previously demonstrated reduced levels of TOP2β/180 (and the paralog TOP2α/170) in an acquired etoposide-resistant K562 clonal cell line, K/VP.5 TOP2β/180 can be a target for DNA damage-stabilizing anticancer drugs, whose efficacy is often limited by chemoresistance.

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The Pharma Data

OCTOBER 14, 2020

15, 2020 /PRNewswire/ — Thermo Fisher Scientific announced the launch of its Gibco CTS Rotea Counterflow Centrifugation System, a modular, closed cell therapy processing system that enables scalable, cost-effective cell therapy development and manufacturing. CARLSBAD, Calif. ,

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Therapies Clinical Trials Science Laboratories 52

PPD

MARCH 13, 2024

Within cell therapy clinical trials, apheresis collections contribute to the specific constituents of the given therapy. Whether this is via an allogeneic (healthy donors) or autologous (patient) approach, the material collected is then manufactured and returned to patients for infusion therapy.

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Drug Target Review

DECEMBER 1, 2023

This will enable faster drug production in cell therapy manufacturing and benefits bone marrow donors by facilitating a shorter aspiration process. Cell therapy In the field of cell therapy , cells are used as living drugs to tackle diseases or restore and replaced damaged cells.

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KIF1A

JUNE 17, 2023

This is why direct comparisons of different KIF1A mutations are invaluable; our patient-derived iPSC cells were developed for such comparisons, and projects like the Natural History and EEG studies help us find clinical patterns in KAND, so we can target therapies to the appropriate patients. Want to learn more about NeuCyte’s work?

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Laboratories Therapies Disease Research 98

ASPET

NOVEMBER 30, 2023

To overcome the limitations in conducting direct research on Lewisite-induced ALI in a laboratory setting, an animal model was developed using phenylarsine oxide (PAO) as a surrogate for lewisite.

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Drug Target Review

NOVEMBER 6, 2023

2 It is this complexity that necessitates powerful, targeted combination therapies. 4, 5 More recently, new combination regimens have emerged that incorporate targeted therapies to treat a variety of blood cancers, including multiple myeloma (MM), chronic lymphocytic leukaemia (CLL) and acute myelogenous leukaemia (AML).

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PPD

OCTOBER 31, 2024

Patient recruitment and clinical laboratory and diagnostic services are the top drug development activities likely to be outsourced, similar to previous reports. Furthermore, the development of innovative therapies often necessitates intricate protocols, adding layers of complexity to trial management.

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Drug Development Clinical Trials Trials Drugs 52

Agency IQ

JULY 26, 2024

reference laboratories for high-risk diagnostics The newly available May 2024 meetings of the Medical Device Coordination Group provide insight into the European Commission’s efforts to fully implement the European medical device and diagnostic regulations. Reference Laboratories: E.U. Top IVDR Notified Body concern: Lack of E.U.

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Laboratories Regulations Virus Production 40

Agency IQ

DECEMBER 15, 2023

Key stakeholders weigh in on FDA’s Laboratory Developed Test Rule. The 60-day comment period on the FDA’s proposed rule to revamp the way that laboratory developed tests (LDTs) are regulated ended on December 4th, 2023. This allows us some insight into what the response to the rule is amongst laboratory and diagnostic stakeholders.

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Laboratories Science FDA Regulations 40

Fierce BioTech

AUGUST 22, 2023

This will ensure viral vector analysis accuracy, reproducibility, and comparability across different laboratories and applications. By addressing these analytical challenges, next-generation analytics can accelerate the development and translation of safe and effective viral vector-based gene therapies. Click here to login.

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DrugBaron

JANUARY 8, 2021

Yesterday, Sarpeta (NASDAQ: $SRPT) announced that its gene therapy for Duchenne Muscular Dystrophy failed to improve muscle function in a study of 40 boys, despite achieving impressive expression of micro-dystrophin (at least in the short term). What are the implications of these observations for the future of gene therapy?

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DNA Therapies Disease Production 100

addgene Blog

MAY 30, 2023

These features make AAV ideal for human therapies and in vivo laboratory experiments ranging from transient gene expression in a particular cell type to CRISPR genome editing , optogenetics , and chemogenetics experiments.

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Agency IQ

APRIL 12, 2024

BY RACHEL COE, MSC Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. The regulations also explain that this trait can be demonstrated via appropriate laboratory tests or adequately controlled clinical data.

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Production Laboratories FDA Regulations 59

The Pharma Data

SEPTEMBER 17, 2020

17, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly ‘s potential COVID-19 therapies. Lilly ‘s chief scientific officer and president of Lilly Research Laboratories.

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DrugBank

APRIL 5, 2024

A landmark collaboration between the University of Tennessee Health Science Center (UTHSC), Oak Ridge National Laboratory (ORNL), and the University of Tennessee, Knoxville, secured a $20 million grant from the University of Tennessee-Oak Ridge Innovation Institute (UT-ORII).

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FDA Law Blog: Biosimilars

MARCH 31, 2024

They believe any regulatory oversight for laboratory developed tests (LDTs) should be mandated by Congress, rather than the Executive Branch. The majority of witnesses, along with several of the Congressional members, agreed that legislation is the appropriate path to regulating laboratory developed tests.

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Regulations FDA Laboratories Disease 64

Broad Institute

AUGUST 19, 2024

Jude Children’s Research Hospital have discovered that oleic acid, one of the most abundant fatty acids in the body, restores a healthy balance of vaginal microbes in a laboratory model of BV. A team of researchers at the Broad Institute of MIT and Harvard; the Ragon Institute of Mass General Brigham, MIT, and Harvard; and St.

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Hospitals Treatment Medical Schools Science 121

PPD

OCTOBER 12, 2023

Cell and gene therapies (CGTs) are one of the fastest growing areas in human therapeutics. Since chimeric antigen receptor T cell (CAR-T) therapy was first approved in 2017, there has been a marked increase of cell and gene therapy studies resulting in significant changes in the way diseases are treated as well as patient outcomes.

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