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.

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Conversations in Drug Development Trends

AUGUST 10, 2023

With so many exciting developments in the last few years, it’s critical for the psychedelic community to come together to reflect on our progress, share the latest discoveries, and discuss the future of psychedelic research. Check out our full psychedelics offering, and meet the team responsible for planning your clinical trial.

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KIF1A

JULY 22, 2023

2023 Scientific findings need to be validated, replicated, and applied to new systems; this is the reason KIF1A.ORG has invested in our Treatment Accelerator Program. In a clinical trial, treatments are assessed by whether they change endpoints selected before the study. ” Chai et al. Endpoints are measurements of a disease.

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SugarCone Biotech

JUNE 19, 2025

Two large and randomized clinical trials, IMpower-133 and CASPIAN, showing statistically significant improvements in outcomes when chemotherapy was combined with atezolizumab or durvalumab, respectively, in the first-line treatment of ES-SCLC. This Phase 3 trial compared tarlatamab with chemotherapy as second-line treatment.

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Conversations in Drug Development Trends

DECEMBER 5, 2023

Author: Lona Sheeran, SVP, Clinical Operations, Early Phase At this year’s Clinical Trials Nexus, I had the privilege of representing Worldwide Clinical Trials as the sole CRO on a panel discussion: “Reversing the Conversation: What the Clinical Trial Industry Really Wants from its Service Providers.”

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FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3). Meanwhile, Annex 2, which provides guidance on pragmatic and decentralized clinical trials as well as trials incorporating real-world data, is expected to be finalized by ICH later in 2025.

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Conversations in Drug Development Trends

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.

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Conversations in Drug Development Trends

JANUARY 24, 2024

Written By: Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Disease Given that 80% of rare diseases have a genetic etiology, genetic implications should be addressed at the onset of a clinical program to support trial enrollment. One diagnostic example that I discussed in my presentation is autism.

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Alta Sciences

NOVEMBER 9, 2023

Streamlining Clinical Trial Start-up for Accelerated Drug Development mecabana Thu, 11/09/2023 - 16:54 Publication StreamliningClinicalTrialStart-up-ReducedTimelines.pdf Category Case Study Weight 5

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Drug Target Review

JULY 4, 2023

2 However, when dosed at the MTD, ADCs display improved efficacy over small molecules in oncology trials. 3D rendering of Antibody Drug Conjugate Molecules. However, a more detailed look into the clinical data suggests that there is room for further dose optimisation, and this is exemplified by the small molecule drug Sotorasib.

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PPD

NOVEMBER 30, 2023

As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drug development shaped the pharma and biotech industries. These shifts are a prelude to further change and progress in the clinical trial landscape in 2024. Five Predictions for the Drug Development Industry in 2024 1.

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Drug Target Review

JULY 7, 2025

Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. Federal ruling on USDA primate welfare petition, 2023. Food and Drug Administration (FDA). USDA (2020).

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Cytel

OCTOBER 27, 2023

Speakers discussed investigator, regulatory (FDA), industry, and patient perspectives during the special symposium “Challenging the Status Quo of Early Phase Clinical Trial Design: Project Optimus.” Since its launch in 2021, Project Optimus has been reforming the dose optimization and dose selection paradigm in oncology drug development.

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Labcorp Drug Development

FEBRUARY 3, 2023

Welcome to the February 2023 Labcorp Drug Development Decentralized Clinical Trial (DCT) blog. With Rare Disease Day coming soon on February 28, we are going to focus on how patients, sites and investigators can benefit by improving the design and execution of rare disease trials. What is Rare Disease Day?

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Alta Sciences

AUGUST 29, 2024

Engaging at the outset with a fully integrated and experienced drug development partner can ensure safety, with timely data sharing at every step of the drug development plan, and facilitate agile, flexible decision-making and planning. billion USD in 2023 to $166.53 billion USD by 2028.

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Conversations in Drug Development Trends

NOVEMBER 10, 2023

At this year’s annual Pain Therapeutics Summit , which took place in San Diego, CA, October 19 to 20th, I heard brilliant presentations on novel pain medication development, targeted discoveries, pain classifications, the NIH HEAL Initiative , trial designs, biomarkers, and others.

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FDA Law Blog: Drug Discovery

MAY 4, 2023

Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories.

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Drug Patent Watch

DECEMBER 12, 2024

The pharmaceutical industry relies heavily on Contract Development and Manufacturing Organizations (CDMOs) to outsource various stages of drug development and manufacturing. With the increasing complexity of drug development and the need for efficient, cost-effective solutions, selecting the right CDMO is crucial.

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Alta Sciences

AUGUST 29, 2023

Embarking on a Career in Drug Development nbartlett Tue, 08/29/2023 - 14:38 Getting to the Heart of Science with Amber malloy Amber Malloy, Altasciences At the heart of science are stories—stories of courage, challenges, successes, lessons, and people. They remind us of the immense benefits of drug development.

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KIF1A

APRIL 24, 2023

KIF1A.ORG has a lot to share this month including the 2023 KAND Family & Scientific Engagement Conference registration and hotel room links! Community Highlights 2023 KAND Family & Scientific Engagement Conference!! New information from Dr. Chung about the KOALA study and potential future ASO trial! Let’s get started!

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Conversations in Drug Development Trends

OCTOBER 24, 2023

While this is a small number of people in each rare disease patient community, the significant and continued growth of rare disease drug development is unsurprising given that there are over 10,000 rare diseases , with more being discovered every year.

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LifeSciVC

JANUARY 16, 2024

By Aimee Raleigh, Principal at Atlas Venture, as part of the From The Trenches feature of LifeSciVC Just in time for new years’ reflections and resolutions, this year’s JPM felt like a refreshing burst of enthusiasm for a sector that has seen its challenges in 2022 and 2023 but also some green shoots. Additional trials (e.g.,

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Alta Sciences

MAY 30, 2023

Altasciences' Proactive Drug Development Solution: Biologics aasimakopoulos Tue, 05/30/2023 - 17:10 Tags Bioanalysis Clinical Trials Preclinical Research Regulatory Affairs Outsourcing Drug Development URL [link] Category eBook

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Alta Sciences

JUNE 6, 2025

For a contract research organization (CRO), it can play an integral role in increasing the quality and speed of drug development while reducing costs, repetitive manual tasks, and human error. This can result in failed runs and wasted reagents.

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FDA Law Blog: Drug Discovery

JANUARY 2, 2023

Comprehend the structure of FDA and the roles of the three major agency centers: CDER, CBER and CDHR, master the basics of the application and approval processes for drugs and biologics, gain a practical working knowledge of clinical trial process for pharmaceutical products and much more! Clinical trials for drugs and biologics.

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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.

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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. between 2023 and 2032. Understanding the Numbers: How Many Clinical Trials Utilize CROs?

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Alta Sciences

JUNE 9, 2023

Accelerating Global Drug Development Timelines With Ethnobridging rmaloney Mon, 06/12/2023 - 16:07 HTML Safe Strategy to Save Time and Money Avoid repeating Phase I studies for drugs intended for the Asian market. Image Social media_e-bulletin Ethnobridging.jpg Tags Clinical Trials Weight 1

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Alta Sciences

JUNE 5, 2023

Contract Pharma: Regulatory Affairs—Accelerating Drug Development Timelines aasimakopoulos Mon, 06/05/2023 - 13:29 Synopsis Roland Jbeily, Manager of Regulatory Affairs at Altasciences, writes for Contract Pharma about how Health Canada's 30-day regulatory review process could provide an advantage for sponsors.

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PPD

FEBRUARY 22, 2023

In a survey of more than 150 global drug development leaders, more than a quarter (28%) cited lack of R&D funding as the top challenge facing their organization. As we look ahead into 2023, there is still uncertainty in the funding landscape, but forecasts are improving.

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Conversations in Drug Development Trends

JANUARY 17, 2023

Day 2023 appeared first on Worldwide Clinical Trials. Ryan Gladden, our colleague and Black, Indigenous, People of Color (BIPOC) Employee Resource Group (ERG) member, shared his reflections on MLK Day. The post Reflections on Martin Luther King Jr.

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FDA Law Blog: Drug Discovery

SEPTEMBER 28, 2023

Hear about the new requirements under FDORA related to increasing diversity in clinical trials, strategies for increasing the participation of subjects from historically underrepresented groups, and how these new requirements and approaches should be considered in clinical trial and other related agreements.

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Broad Institute

NOVEMBER 2, 2023

Bayer and Broad Institute extend cancer therapy research collaboration By Corie Lok November 2, 2023 Breadcrumb Home Bayer and Broad Institute extend cancer therapy research collaboration Long-standing industry-academia collaboration has already resulted in three clinical oncology candidates.

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Metabolite Tales Blog

APRIL 10, 2024

Where data was publicly available, the routes of human metabolism for each of the drugs in this subset is listed in Table 1. It is proposed that the decreased clearance of the drug observed in patients may be due to depletion of GSH in this population [10]. Drug Metab Dispos. 2023; 51(7):873-883. 2023; 62(12):1765-1779.

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Fierce BioTech

JULY 17, 2023

Best practices for capturing reproducible and accurate in vivo data to reduce failure in clinical trials – the most expensive phase of drug development. png On Demand Start Date Thu, 09/07/2023 - 12:00 Discussion will include: Current in vivo study management practices and processes. How did we get here?

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Vial

DECEMBER 5, 2023

It has become a fundamental tool for researchers to explore the complexities of genetic information and conduct genetic-informed drug development. Sponsors have used NGS to screen patients for clinical trial eligibility and patient stratification , expanded CDx development, and comprehensive genomic profiling (CGP).

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Perficient: Drug Development

SEPTEMBER 22, 2023

Two statistics she shared stood out to me: First, on average, healthcare organizations have 46 systems in place dedicated to operations (Source: Salesforce Research, Healthcare & Life Sciences, April 2023). At Perficient, we have seen this firsthand, many times. What makes it different from Health Cloud?

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