Drug Target Review

FEBRUARY 1, 2024

But commitment to neuroscience drug development is critically important given the significant unmet medical needs and the ways in which patients, caregivers, and families suffer. Part of the challenge is that patients present with very different kinds of clinical phenotypes, meaning the populations are heterogeneous.

Therapies 104

Therapies Drug Development Disease Clinical Development 104

Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues. Asia, and Europe.

Drug Development 52

Drug Development Treatment FDA Approval Drugs 52

The Pharma Data

JULY 29, 2021

Eisai and Biogen Present Preliminary Assessment of the Clinical Effects of Lecanemab Following 18 Months of Treatment in the Open-Label Extension of the Phase 2 Proof of Concept Study at 2021 Alzheimer’s Association International Conference (AAIC) . United States and virtually from July 26 to 30, 2021 (Presentation No.:

Clinical Trials 52

Clinical Trials Treatment Clinical Development Disease 52

Drug Target Review

AUGUST 28, 2024

This is reflected in the MATCH data recently presented at the European Association for the Study of the Liver (EASL), where two patients in the control group had a liver transplant and seven patients died, whereas there were no liver transplants and only two deaths in the treated group.

Therapies 116

Therapies Disease Engineering Medical Schools 116

Drug Target Review

JANUARY 15, 2024

An important limitation of antibodies against tumour antigens is that these agents direct responses to molecular targets present on the surface of the cell. Figure 1: HLA Class I presentation of peptides derived from intracellular antigens. As described below, it also presents challenges and opportunities for TCR-based therapeutics.

Engineering 110

Engineering DNA Virus Immune Response 110

Drug Target Review

JANUARY 8, 2024

We are at the forefront of drug development in an area of research called cellular rejuvenation, which is an approach that has the potential to address many diseases of ageing by restoring aged and injured cells to a more youthful and resilient state. What’s next for Life Bioscience’s preclinical studies?

Science 145

Science Disease FDA Approval Clinical Trials 145

KIF1A

SEPTEMBER 30, 2023

Read the Guide FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies One frustrating aspect of traditional drug development, especially for rare disease communities, is the tempo of regulatory decisions on potential drugs. What’s a pre-print?

Disease 111

Disease FDA Clinical Trials Therapies 111

Conversations in Drug Development Trends

NOVEMBER 21, 2023

As a provider of end-to-end clinical development solutions, we plan to leverage our expertise to refine drug-disease matches identified by Every Cure’s use of AI and data analysis. At Worldwide, we deliver full-service clinical development to support drug approval and commercialization.

Disease 78

Disease Treatment Clinical Trials Clinical Development 78

Conversations in Drug Development Trends

JANUARY 24, 2024

Much of what we discuss I covered in my presentation, “Leveraging Genetics to Support Rare Disease Clinical Trials,” at last year’s World Orphan Drug Congress (WODC) EU. One diagnostic example that I discussed in my presentation is autism. Enrolling adequate populations will be required to advance these programs.

Trials 75

Trials Disease Clinical Trials Clinical Research 75

Fierce BioTech

DECEMBER 23, 2024

First-in-Human, Drug-Drug Interaction, Food Effect, Bioequivalence, etc.), and often require consistent batches of drug product be administered to groups of research participants within a short timeframe, early phase studies present unique challenges for drug developers not typically experienced in later stages of development.

Pharmacy 52

Pharmacy Trials Clinical Trials Clinical Development 52

The Pharma Data

JANUARY 27, 2021

ET ) to discuss the results and next steps in clinical development of BI-1206. Renowned lymphoma expert Mats Jerkeman, MD, Lund University, will give a presentation on the current treatment landscape, and unmet medical need for patients with relapsed or refractory NHL. CET ( 11:30 a.m.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Licensing Licensing 52

Drug Target Review

APRIL 9, 2024

Our approach to investigate the toxicity driven by nucleolar stress was to induce it with certain arginine-rich peptides, present in patients of ALS, which were known to accumulate at nucleoli and cause this type of stress. Among other discoveries, the group developed inhibitors of the ATR kinase and showed their potential for cancer therapy.

RNA 64

RNA Cell Biology Clinical Development DNA 64

Drug Target Review

FEBRUARY 29, 2024

Through further research and work as a principal investigator on clinical studies for several central nervous system indications, I laid the groundwork for a career in gene therapy drug development. The rigors of training as a physician-scientist present their share of obstacles to overcome.

Therapies 111

Therapies Disease Clinical Trials Science 111

LifeSciVC

JULY 11, 2023

Redig, SVP and Head of Clinical Development at HotSpot Therapeutics, as part of the From The Trenches feature of LifeSciVC The American Cancer Society for Oncology (ASCO) annual meeting is among the highlights of the clinical oncology calendar. By Amanda J. His remarks are worth reading in their entirety.

Therapies 66

Therapies Trials Clinical Development Science 66

Drug Target Review

MAY 7, 2024

However, some biomarkers may only be present in a minority of patients, requiring a large patient population to identify such markers. How do AI-enhanced approaches accelerate the drug development process for rare diseases? Not all biomarkers have a limited prevalence.

Disease 59

Disease Clinical Trials Clinical Pharmacology Trials 59

NIH Director's Blog: Drug Development

SEPTEMBER 26, 2019

Meanwhile, tamoxifen alone didn’t affect the drug-resistant vulva cancer cells on the chip, whether or not liver cells were present. This type of cancer cell has previously been shown to pump the drug out through a specific channel. 2] Clinical development success rates for investigational drugs.

Drugs 72

Drugs Science Treatment Clinical Trials 72

Conversations in Drug Development Trends

JUNE 13, 2024

Their webinar highlighted key initiatives like Project Optimus, recent study design trends, and the benefit a Bayesian model can have on your drug development program. However, Project Optimus emphasizes the importance of dose-finding studies in early clinical development.

Trials 52

Trials Clinical Trials Drug Development Clinical Development 52

Conversations in Drug Development Trends

DECEMBER 20, 2023

In November 2023, at Outsourcing Clinical Trials Dach in Zurich, our Executive Director, Oncology Strategy Lead, Matt Cooper , presented “Delivering Oncology Studies – Challenges and Considerations.”

Clinical Trials 83

Clinical Trials Trials Pharmacokinetics FDA 83

Drug Target Review

SEPTEMBER 26, 2023

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. 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.

Drugs 111

Drugs FDA Disease Animal Testing 111

Drug Target Review

DECEMBER 13, 2024

These types differ in their etiology, natural history, and present distinct challenges in disease management. 3,4 However, inter- and intra-tumoural heterogeneity is widespread in lung cancer, leading to multiple mechanisms through which these tumours can and do develop resistance to treatment. percent of total cancer fatalities.

Therapies 98

Therapies Treatment Clinical Trials Drugs 98

The Premier Consulting Blog

JULY 9, 2023

(Degradants are impurities arising from the degradation of the drug substance or a reaction with an excipient and/or the immediate container.) Sometimes a degradant presents unexpectedly after GLP toxicology studies are completed or are underway. ICH Q3A and ICH Q3B outline expectations for reporting, identifying, and qualifying (i.e.,

Small Molecule 52

Small Molecule DNA Drugs Clinical Development 52

The Pharma Data

JANUARY 10, 2021

IDE397 is being developed as a potential best-in-class MAT2A inhibitor for MTAP-deletion, which is prevalent in approximately 15% of all solid tumors. IDE397 program update to be presented at the 39th Annual J.P. IDEAYA’s presentation for the 39 th Annual J.P. SOUTH SAN FRANCISCO, Calif. ,

FDA 52

FDA Clinical Trials Small Molecule Therapies 52

Broad Institute

OCTOBER 11, 2023

His mother had a presentation of the disease that suggested her immune system was already on the job. But immunotherapy was not yet widely used and had not been applied clinically to Merkel cell carcinoma, so she received traditional chemotherapy and radiation therapy, suffering life-threatening complications along the way.

Research 137

Research Immune Response Clinical Trials Therapies 137

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.

Drug Development 64

Drug Development Clinical Supply Production FDA 64

The Pharma Data

NOVEMBER 10, 2020

Michael Yu , the founder, Chairman and CEO, attended and presented on the virtual R&D day via live video webcast. During the introduction presentation, Dr. Michael Yu reviewed the history and achievements in the past nine years since the establishment of Innovent. TYVYT® is the only PD-1 inhibitor included in the NRDL.

Biosimilars 52

Biosimilars Clinical Trials International Clinical Development 52

The Premier Consulting Blog

OCTOBER 11, 2022

However, acceptance of that data depends on a sponsor’s understanding of the FDA criteria for historical control groups, study data standards, and clinical meaningfulness. In this article, we review two case studies involving the successful use of RWD or RWE in advancing the clinical development of treatments for rare diseases.

Disease 52

Disease FDA FDA Approval Treatment 52

The Pharma Data

SEPTEMBER 15, 2020

Sign up today to understand how to implement an affordable supply-forecasting tool into your clinical supply chain. Presenters: Irena Seredina , Executive Director at S-Clinica. During her medical practice, Seredina worked in clinical research as an investigator.

Clinical Supply 52

Clinical Supply Clinical Trials Doctors Clinical Development 52

The Pharma Data

FEBRUARY 21, 2022

At its annual Pharma Media Day 2022, Bayer presented the latest developments in the ongoing transformation of its pharmaceuticals business, which is aimed at delivering long-term, sustainable business growth by bringing forward new options for patients. “We

Clinical Trials 52

Clinical Trials Small Molecule Clinical Development Disease 52

PPD

SEPTEMBER 6, 2023

Under the stresses of the COVID-19 pandemic, drug development organizations faced difficult decisions about keeping staff employed and productive. It’s an effective way to manage capacity and labor uncertainty and provides drug developers the option to retain knowledgeable, proven personnel.

Clinical Research 59

Clinical Research Regulations Packaging Drug Development 59

Alta Sciences

OCTOBER 30, 2023

Podcast : FDA Guidance for Industry Psychedelic Drugs Extensively studied for potential therapeutic efficacy, psychedelic drug development comes with its own set of clinical development requirements. Watch the video. Listen here. The Altascientist : Issue No. Read or listen now. Want to see more?

Science 52

Science Clinical Trials Pharmacokinetics Clinical Pharmacology 52

Conversations in Drug Development Trends

APRIL 5, 2024

Each day throughout the month of February, we heard what was on the minds and hearts of patients and patient advocacy organizations, clinical developers driving treatments, and family members supporting people with rare diseases. We were overwhelmed by how excited the community was to participate! Our Juliane K.

Disease 52

Disease Clinical Trials Trials Treatment 52

The Pharma Data

NOVEMBER 5, 2021

The data were presented at the American Society of Nephrology (ASN) 2021 Annual Meeting. With presently no approved treatments, there’s a major unmet need for curatives that can delay progression to order failure, “ said John Tsai, Head of Global Drug Development and Chief Medical Officer at Novartis.

Disease 52

Disease Treatment Pharmacokinetics FDA 52

PPD

MAY 11, 2023

The global COVID-19 pandemic increased awareness of the importance of vaccine development — both for drug developers and the public. The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developed vaccines, there was variation among who could receive the shots and when.

Vaccine 52

Vaccine Clinical Trials Long-Term Care Facilities Trials 52

FDA Law Blog: Drug Discovery

OCTOBER 2, 2023

Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy. In the December 2019 Guidance, FDA writes that the clinical context for a disease (i.e.,

FDA 64

FDA Drug Development Disease Trials 64

The Pharma Data

NOVEMBER 3, 2020

Senior Vice President, Head of Clinical Development of LogicBio, said, “We are pleased the FDA has granted Fast Track designation to LB-001 in recognition of the importance of our efforts to bring a durable treatment to the children suffering from MMA. Commenting on the announcement, Daniel Gruskin, M.D., About LogicBio Therapeutics.

FDA 40

FDA Treatment Clinical Trials Clinical Development 40

PPD

DECEMBER 14, 2023

In this blog, we’ll explore the benefits associated with employing global resources across time zones for FSP engagements and how PPD ® FSP solutions utilize different regions to drive more efficient clinical development operations.

Clinical Development 52

Clinical Development Clinical Trials International Trials 52

The Pharma Data

DECEMBER 27, 2020

Such forward-looking statements involve substantial risks and uncertainties that could cause Gritstone’s research and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements.

Clinical Trials 52

Clinical Trials Compliance Clinical Development Production 52