Drug Target Review

OCTOBER 30, 2024

As we continue to evolve our drug characterisation processes at Verseon, we see the extensive use of assembloids as essential enabling technology for the future of all drug development. He has over 20 years’ experience in biomedical research and pharmaceutical drug discovery. Cell Stem Cell. 2013;13(6):734-44.

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Treatment Disease Clinical Trials Molecular Biology 105

Drug Target Review

JANUARY 14, 2025

Nina Truter Nina Truter is a translational scientist with a deep focus on understanding mechanisms of action in drug development and leveraging disparate datasets in biotech.

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Drugs Protein Expression Science Research 69

Drug Target Review

DECEMBER 6, 2024

For more: [link] ; [link] ; [link] ; [link] Nina Truter Nina Truter is a translational scientist with a deep focus on understanding mechanisms of action in drug development and leveraging disparate datasets in biotech.

RNA 52

RNA Drugs Research Science 52

Codon

NOVEMBER 3, 2024

As an undergraduate biology student, I spent some time in a TB lab working on antibiotic resistance — a growing concern for drug developers. These challenges have led to strategies such as directly observed therapy (DOT), in which nurses or physicians monitor patients to ensure they take their medicine every day.

Vaccine 92

Vaccine Trials Therapies Clinical Trials 92

Conversations in Drug Development Trends

APRIL 4, 2024

To help integrate these various regulatory standards, the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use was founded in 2016. The ICH M10 guidelines aim to streamline this process, reducing redundancy in drug development and facilitating faster access to new therapies.

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Small Molecule Clinical Trials Pharmaceuticals Pharmaceutical Companies 80

PPD

MARCH 26, 2024

A large majority of drug developers utilize FSP or hybrid FSP/FSO models, half are “heavy users” Heavy users: Those that use FSP or hybrid FSP/FSO models for most of their clinical development outsourcing. Heavy users leverage these models for nearly three-quarters of their outsourcing.

Clinical Research 98

Clinical Research Pharmaceutical Companies Clinical Development Drug Development 98

FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” It finalized a draft guidance published in 2022.

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Therapies FDA Production Regulations 59

PPD

MARCH 13, 2024

This significance and focus are ever more apparent when the starting cellular material is imperative to drug product success. Within cell therapy clinical trials, apheresis collections contribute to the specific constituents of the given therapy.

Clinical Development 98

Clinical Development Clinical Trials Therapies Trials 98

PPD

JUNE 7, 2023

The number of pediatric patients diagnosed with nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) is on the rise, yet there are currently no approved therapies to treat NAFLD and NASH in adult or pediatric populations. As therapies for the treatment of NASH in adult patients go this year to the U.S.

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Trials Clinical Trials Clinical Research Disease 98

Drug Target Review

NOVEMBER 6, 2023

2 It is this complexity that necessitates powerful, targeted combination therapies. To bring us closer to curing cancer, a combination of effective drugs with non-overlapping mechanisms of action is required. To bring us closer to curing cancer, a combination of effective drugs with non-overlapping mechanisms of action is required.

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Small Molecule Therapies Treatment Disease 111

Vial

DECEMBER 11, 2023

In the decades since its identification in 1989, advances in clinical research for new Hepatitis C therapies and the introduction of direct-acting antiviral agents (DAAs) have led to viral eradication in more than 98% of patients, resulting in HCV crossing from manageable to being the first curable , chronic viral infection.

Clinical Research 52

Clinical Research Therapies Research Vaccine 52

PPD

FEBRUARY 10, 2025

Sponsors find that an FSP solution is often the best choice to help advance their drug development projects, whether they need to fill small gaps in services or support large-scale programs with dedicated teams across functions.

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

Drug Target Review

JULY 7, 2023

There is a clear need for new and approved, safe, effective and innovative targeted therapies to address the underlying causes of autoantibody diseases. The power of precision therapy Targeted — or precision — therapy, a technique that has been honed for many years in cancer treatment, is now being applied in a wider context.

Disease 98

Disease Immune Response Therapies Treatment 98

Codon

SEPTEMBER 29, 2024

It suggested that, in the future, certain classes of drugs, specifically genetic therapies, could be screened entirely virtually via models of life. It wasn’t a silver bullet to the hard problem of drug development, but it wasn’t too far off either. A flurry of new, promising therapeutic targets arose.

Engineering 137

Engineering Virus DNA Therapies 137

DrugBank

MAY 15, 2024

Its structure makes it incredibly difficult for drugs to bind effectively, which has stymied drug development for decades. The binding pockets on KRAS are shallow and polar , not ideal for the kinds of interactions needed for strong, effective drug binding.

Small Molecule 81

Small Molecule Molecular Biology Drugs Disease 81

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. INDIANAPOLIS and THOUSAND OAKS, Calif.

Therapies 52

Therapies Production Government Disease 52

LifeSciVC

JANUARY 16, 2024

These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline. recent announcements from Merck and Sanofi for obesity and broader metabolic disease).

Small Molecule 138

Small Molecule Trials Therapies Disease 138

LifeSciVC

OCTOBER 13, 2022

This summer, approvals on both sides of the Atlantic – for beta thalassemia and cerebral adrenoleukodystrophy in the United States and for severe hemophilia A and aromatic L-amino acid carboxylase deficiency in Europe – show that regulators are likely open to green-lighting a range of emerging gene therapies.

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Therapies Disease Treatment Marketing 40

The Pharma Data

OCTOBER 9, 2021

Neumora leverages proprietary multimodal capabilities and technologies to integrate advanced computational data science with R&D to increase the probability of success of drug development in brain diseases. executive vice president of Research and Development at Amgen. Reese, M.D.,

Disease 40

Disease Therapies Drug Development Science 40

H1 Blog

SEPTEMBER 26, 2023

Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. A recent McKinsey analysis of drugs and vaccines developed since 2000 shows that it takes nearly ten years to go from clinical testing to approval. First let’s look at some challenges and then opportunities.

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Trials Clinical Trials International Regulations 59

The Premier Consulting Blog

JUNE 26, 2023

1 With their poorly understood natural histories, phenotypic heterogeneity, and diverse clinical manifestations, rare cancers pose challenges to drug development and represent a significant unmet need in oncology. Rare cancers account for 25-30 percent of all new cancer diagnoses and 25 percent of cancer deaths.

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FDA Clinical Trials Therapies Trials 52

Drug Target Review

MAY 27, 2024

Caris Discovery, the therapeutic research arm of Caris Life Sciences, was launched to address the paucity of novel oncology drug targets and is uniquely poised to discover first-in-class ADC targets. What role do ADCs play in Caris’ strategy for targeted cancer therapy, particularly in terms of patient-specific treatment plans?

Clinical Trials 59

Clinical Trials Science Molecular Biology Bioinformatics 59

NIH Director's Blog: Drug Development

JUNE 14, 2016

Several years ago, the Food and Drug Administration (FDA) recommended that drug developers take special care to show that potential drugs to treat diabetes don’t adversely affect the cardiovascular system [1]. In fact, the evidence suggests that such drugs might even offer some protection against heart disease.

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Drugs Disease Drug Development Clinical Trials 52

Conversations in Drug Development Trends

APRIL 3, 2024

By: Sue Batchelor, Executive Director, Oncology Project Management Radiopharmaceuticals represent a cutting-edge frontier in oncology treatment, offering the promise of highly targeted therapy with the potential to revolutionize cancer care. Are you aware of the challenges you must address for a successful radiopharmaceutical trial?

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Trials Clinical Trials Compliance Treatment 81

Drug Target Review

OCTOBER 31, 2023

Given there were no other drugs available to them, I cannot even describe the urgency I felt when I entered the project on the drug development side. The drug ended up getting approved, and it extended the lives of children many years where they previously would have had four months at best.

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Cell Biology Pharmaceuticals Science Disease 107

Drug Target Review

JUNE 17, 2024

I am now incredibly privileged to work at the nexus of science and medicine in radiopharmaceutical drug development, and use my built-in scientific lens every day. This therapy is now widely used, but preparing radioactive chemicals to inject into patients many years ago when I was a fresh PhD candidate felt like a very big step.

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Science Therapies International Hospitals 59

Drug Target Review

AUGUST 9, 2024

The science behind drug formulation The formulation of a drug is both an art and a science, requiring a deep understanding of the drug’s chemical and physical properties. 1 Challenges in drug formulation Developing a successful drug formulation is fraught with challenges.

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Science Drugs Compliance Drug Development 59

Alta Sciences

SEPTEMBER 13, 2023

Clinical pain models also serve as useful translational tools for analgesic drugs that progress from preclinical to clinical stages of drug development, and can simulate similar paradigms often used in preclinical evaluations. At Altasciences , we have extensive experience testing various pain models.

Clinical Trials 52

Clinical Trials Treatment Trials Drug Development 52

PPD

JUNE 17, 2024

When outsourcing some or all key functions to an FSP provider, a drug developer gains access to a wider pool of talent, including specialized functional, scientific and technical experts. 3) An entirely new FSP arrangement is needed, and the developer wants to work with an existing FSO partner.

Clinical Trials 52

Clinical Trials Clinical Development Trials International 52

Vial

MARCH 25, 2024

With an international presence in nearly 60 countries, Worldwide is supported by over 3,400 team members. Other therapeutic areas include cell and gene therapy. rather than pharmacologists or clinicians, algorithms managed by data scientists are more likely to drive drug development. According to Hardman et al.,

Clinical Trials 52

Clinical Trials Trials Clinical Development Clinical Research 52

Drug Target Review

SEPTEMBER 26, 2023

Early detection of neurotoxicity induced by potential new therapies is a major challenge, and hiPSC-neuronal cells may provide a solution. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. Trends Neurosci. Pharmacol Rev.

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Drugs FDA Disease Animal Testing 111

Drug Target Review

APRIL 9, 2024

Initial works from the lab concentrated on exploring the role of replicative stress in cancer and ageing, for which the group combined cell biology, mouse models and drug development projects. Among other discoveries, the group developed inhibitors of the ATR kinase and showed their potential for cancer therapy.

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RNA Cell Biology Clinical Development DNA 64

PPD

OCTOBER 2, 2024

To support these functions, PPD™ Functional Service Partnership (FSP) Clinical Operations solutions harness the full range of innovative technologies, applying extensive skill and expertise to empower our customers to bring therapies to market quickly and within budget.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Research Trials 52

PPD

NOVEMBER 14, 2023

As such, success often hinges on getting the right resources in place at the right time — which means having a partner that is an expert at resourcing, recruiting, onboarding and training, not just in the clinical development field, but in the unique world of FSPs.

Clinical Research 52

Clinical Research Clinical Development International Engineering 52

DrugBank

NOVEMBER 4, 2024

   Urgency of Antibiotic Resistance    The escalating threat of antibiotic resistance is an incoming global crisis projected to affect international health and the economy. While the demand for novel antibiotics is undeniable, the industry still struggles with the harsh realities of antibiotic drug development.

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Pharmaceutical Companies Pharmaceuticals Government DNA 71

NIH Director's Blog: Drug Development

DECEMBER 4, 2018

To find out, NIH-funded researchers are loading a few dozen human tissue chips—tiny, 3D devices bioengineered to model different tissues and organs—onto a SpaceX Dragon cargo spacecraft that will ferry supplies to the International Space Station (ISS) U.S. National Laboratory, which is orbiting about 400 kilometers above Earth.

Science 52

Science International Laboratories Research 52

The Pharma Data

JANUARY 27, 2021

A total of 15 patients have been recruited to date in the Phase I dose escalation part of the study, all of whom were late stage and have failed conventional treatments, including several lines of rituximab-containing therapies. (Nasdaq: CASI), a U.S. About BioInvent.

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Pharmaceuticals Clinical Trials Licensing Licensing 52