Alta Sciences

FEBRUARY 8, 2024

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects.

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Clinical Trials Trials Clinical Pharmacology Clinical Development 52

Drug Target Review

SEPTEMBER 10, 2024

The current landscape of protein drug development is characterised by accelerated timelines where new drugs are approved in months rather than years. Hence, in many cases an earlier IND may be prevented by the timely provision of representative Drug Substance (DS) to execute such toxicology studies.

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Broad Institute

OCTOBER 11, 2023

“We wanted to see whether there were as yet undiscovered drug targets that would lead to amazing cancer immunotherapies,” Manguso said. Together, Haining, Manguso , and Yates went on to found the Tumor Immunotherapy Discovery Engine ( TIDE ) at the Broad Institute of MIT and Harvard in 2017 with support from Calico as a collaborating partner.

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PPD

NOVEMBER 14, 2023

In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development. This comes as the demand for qualified clinical research associates (CRAs) is expected to increase by more than 36% in the next decade.

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Clinical Research Clinical Development International Engineering 52

Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. Importantly, unlike IQVIA, Vial’s EDC is entirely developed by an internal software engineering team, reducing vendor dependencies.

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Vial

MARCH 25, 2024

Vial is a tech-first CRO reimagining clinical trials to deliver faster, more efficient trial results at dramatically lower costs for biotech sponsors. In the past three years, Worldwide has collaborated on 105 oncology studies supported by a global team of oncology clinical development experts. According to Hardman et al.,

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Clinical Trials Trials Clinical Development Clinical Research 52

Drug Target Review

DECEMBER 13, 2024

7,8 The discovery of these biomarkers provides valuable insights into prognosis and disease progression, while also guiding the clinical development of new targeted immunotherapies. Engineering sites on the antibody to enable specific and consistent attachment of the cytotoxic drug to achieve an optimal drug-to-antibody ratio (DAR).

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The Pharma Data

OCTOBER 27, 2020

28, 2020 /PRNewswire/ — Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, today announces the formation of a new Scientific Advisory Board (SAB). OSLO, Norway , Oct. Fennel cover the key scientific focus areas of Targovax. Dean A.

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Virus Engineering Clinical Development International 40

The Pharma Data

NOVEMBER 10, 2020

Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinical development and commercialization. By joining Innovent, Dr. Liu will be responsible for global R & D, pipeline strategy, business development and international operations.

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Biosimilars Clinical Trials International Clinical Development 52

Drug Target Review

SEPTEMBER 26, 2023

This shift occurred following implementation of the Comprehensive in Vitro Proarrhythmia Assay (CiPA) initiative in 2013 and extensive testing of hiPSC-cardiomyocytes with known proarrhythmic drugs. 1-4 This approach saves time, money, and resources, and ultimately leads to safer medicines going forward to the clinic.

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Drugs FDA Disease Animal Testing 111

Precision for Medicine

JANUARY 23, 2023

SolveBio’s intelligent technologies and enterprise data management platform has integrated into QuartzBio’s suite of SaaS solutions, providing a single, scalable solution supporting clinical sample inventory management and biomarker data management for the biotech and pharmaceutical sectors. Canada, Europe and Australia.

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The Pharma Data

JUNE 2, 2022

The innovative antibodies from A*STAR can potentially enable the development of safer, more efficacious therapies as they selectively bind to antigens that are highly expressed on tumor cells but are absent on normal healthy tissues. . For ongoing news, visit www.a-star.edu.sg. star.edu.sg. Source link: [link].

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Licensing Licensing Therapies Science 52

Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. Understanding the Numbers: How Many Clinical Trials Utilize CROs?

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The Pharma Data

DECEMBER 8, 2020

AbCellera’s AI-powered antibody discovery platform speeds the otherwise lengthy and grueling process by analyzing the database of natural immune systems to find antibodies that can be developed into drugs. Tackle the toughest problems in drug development.” The promise to partners is to “move quickly. Reduce cost.

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RNA Therapies Disease Protein Expression 52

The Pharma Data

JUNE 2, 2022

New multi-program collaboration to develop allogeneic TCR-T/CAR-T programs brings together Immatics’ allogeneic gamma delta T cell therapy platform ACTallo ® with Bristol Myers Squibb’s technologies and oncology drug development expertise.

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The Pharma Data

NOVEMBER 2, 2020

” She pointed to the bigger picture, saying there is “excitement” in the field of obesity drug development: Researchers are studying how various “molecules” in the body regulate metabolism, and trying to turn those molecules into medication. More information. SOURCES: Puneet Arora, M.D., 2, 2020, online.

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The Pharma Data

OCTOBER 19, 2020

Caris Precision Oncology Alliance members also have access to the Caris Pharmatech oncology trial network, which can help reduce the time it takes to identify and connect appropriate patients with novel targeted cancer therapies in clinical development.

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Clinical Trials RNA DNA Science 52

Drug Target Review

JUNE 21, 2023

Strikingly, a strong genetic link between target and disease biology is emerging as a predictor for success in clinical trials. 2,3 This is exemplified by drugs that target disease-specific genes or genetically distinct patient subsets which are more likely to succeed in demonstrating efficacy in clinical development.

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Disease Clinical Trials Therapies Science 111

The Pharma Data

OCTOBER 15, 2020

Additionally, Sarah Haecker Meeks, joined the Company as vice president of Business Development and Steve Nardi joined as vice president of Manufacturing and Engineering Operations. Before joining MaxCyte, Meeks served as vice president of Business Development at Synpromics, which is now part of AskBio. Source link.

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The Premier Consulting Blog

OCTOBER 26, 2022

The MPD is best created and controlled by a sponsor, rather than by a contract development and manufacturing organization (CDMO) assigned to perform the process and assay development.

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The Pharma Data

JANUARY 4, 2021

Barber’s work will give Kiromic a significant acceleration in the clinical development of its therapy platform and an even more significant advantage over its competitors. The pipeline development is leveraged through the Company’s proprietary target discovery engine called “DIAMOND.”

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The Pharma Data

OCTOBER 27, 2020

The collaboration aims to leverage Molecular Partners’ proprietary DARPin® technologies and Novartis’ broad expertise in global drug development, regulatory affairs, manufacturing and commercialization to rapidly advance the program in keeping with the unprecedented global urgency created by the pandemic.

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The Pharma Data

OCTOBER 26, 2020

Based on these promising findings, Transgene intends to continue the clinical development of TG4001 in a larger, controlled confirmatory study as we look to provide a better treatment option for this patient population,” added Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene. Christophe Le Tourneau, M.D., About TG4001.

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The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

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The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

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Agency IQ

APRIL 12, 2024

In drug development, biochemical assays might be used to determine a product’s binding affinity to a target receptor of interest, along with the strength, stability and duration of the target-ligand complex after the product binds to the receptor. The new draft guidance can be broken into three main parts.

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Production FDA Therapies Biochemical Assays 40

Drug Target Review

FEBRUARY 11, 2025

Drug development: addressing complexity and success rates Drug development is a complex and expensive process, requiring multidisciplinary expertise and high-risk financial investments. The financial burden of drug development is substantial, often exceeding $2 billion per drug.

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FDA Law Blog: Drug Discovery

DECEMBER 15, 2024

For tissue-engineered medical products, examples may include biomechanical testing to assess the ability of a vascular graft to tolerate repeat access without leaking, permeability testing to assess the characteristics of a skin graft, or cellular distribution throughout a cell scaffold construct.

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Therapies FDA Clinical Development Production 52

Drug Target Review

FEBRUARY 25, 2025

This is primarily due to the inability of the engineered CAR-T cells to persist long enough to maintain remission. The need for better CAR-T therapies CAR-T therapies have transformed the treatment landscape for cancer, offering the potential for long-lasting remission.

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