Drug Discovery World

MAY 8, 2024

Fiona Maini , Senior Director Global Compliance & Strategy, at Medidata looks at the rise of artificial intelligence (AI) and machine learning (ML) within life sciences and the applications for the technology in clinical trials.

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Drug Discovery World

APRIL 20, 2023

Dr Paula Moran, Dr Kiri Granger, Dr J Mark Treherne , and Dr Jenny Barnett explore the effects of long Covid-19 symptoms and what the opportunities are for drug developers working to treat post-Covid-19 cognitive impairment. These may provide an opportunity for treatment for post-Covid-19 cognitive impairment.

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Drug Discovery World

JULY 25, 2023

Justin Hay , Senior Director, Amy Cheung Senior Director of Integrated Drug Development, and Patrick Loebs Director, at Certara, examine recent changes in paediatric guidelines and how they affect drug development projects. The guidance mentions PBPK four times regarding renal function and DDIs.

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EG Life Sciences

FEBRUARY 15, 2023

The year 2022 reflected a transformative path for the drug development industry. It is without a doubt that 2022 predicted change and opportunity in biopharma and biotech clinical trials in 2023. Approval processes were slow in comparison to 2020 and 2021, where 53 and 50 approvals were achieved respectively.

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DrugBank

AUGUST 15, 2024

Drug development is challenging, including not only the complexities of biomolecular drug mechanisms but also the convolutions of regulatory pathways and commercialization strategies. This includes funding large-scale clinical trials and establishing robust manufacturing/distribution networks.

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Drug Discovery World

OCTOBER 17, 2023

The buzz with week has been around Phase I trials, with new therapies for lung cancer, geographic atrophy, Parkinson’s, sarcopenia and long Covid demonstrating positive early results or entering clinical trials for the first time. The post New podcast: DDW Highlights 17 October 2023 appeared first on Drug Discovery World (DDW).

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Drug Discovery World

OCTOBER 20, 2023

A new free service will offer insights in under ten days to sponsors conducting clinical trials, identifying potential ‘zombie trials’ and providing actionable recommendations for failing trials. The Health Check and Trial Rescue Service is an initiative of data software and services company Phesi.

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Drug Discovery World

JULY 17, 2023

Analysis of 13,490 clinical trials finds almost a third have been cancelled during Phase II amidst an overall decline in clinical development productivity. Data analytics company Phesi has released the results of its mid-year global analysis of all clinical trials conducted in 2023 to date.

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Drug Discovery World

JUNE 29, 2023

Read more: FDA recommendations to inform psychedelic drug development Elevating extracellular serotonin In 2023, Evecxia Therapeutics reported favourable safety, tolerability, pharmacokinetic, and pharmacodynamic data from a Phase I trial of EVX-101 in healthy volunteers treated with escitalopram.

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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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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 Discovery World

JANUARY 23, 2023

Clinical trials have led our news section this week, with positive results announced from several Phase I and II studies. You can listen below, or find The Drug Discovery World Podcast on Spotify , Google Play and Apple Podcasts. The post DDW Highlights podcast: 23 January 2023 appeared first on Drug Discovery World (DDW).

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Drug Discovery World

JULY 10, 2023

It’s been a fascinating week in drug discovery, as AstraZeneca announced that its Phase III trial of datopotamab deruxtecan did not meet its second primary endpoint and saw an 8% drop in its stock market value as a result. You can listen below, or find The Drug Discovery World Podcast on Spotify , Google Play and Apple Podcasts.

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Drug Discovery World

MAY 11, 2023

BioTrinity 2023 marked the 17 th annual edition of BioTrinity and took place in London, UK from Tuesday 25 April to Wednesday 26 April. The RSV candidate is the lead program, and the company is working towards generating the pre-clinical data to support a Phase I clinical trial.

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Drug Discovery World

JANUARY 2, 2024

Cancer Research Horizon’s Innovation Summit 2023 took place on 21 November 2023 at the Royal Society of Medicine, and included talks from researchers translating their research, as well as networking with members of the entrepreneurial ecosystem. As for Infinitopes, the company’s trials will begin in 2024.

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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

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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Drug Discovery World

OCTOBER 6, 2022

protofibril antibody lecanemab met the primary endpoint and all key secondary endpoints in the global Phase III Clarity AD clinical trial. . Eisai has stated its intention to file for regulatory approval in the US, Europe and Japan by March 2023. The challenge of Alzheimer’s. Greater inclusion of ethnic populations.

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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

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

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

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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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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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 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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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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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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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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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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FDA Law Blog: Drug Discovery

MARCH 13, 2023

Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). By Larry J.

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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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LifeSciVC

JULY 11, 2023

The meeting brings together tens of thousands of physicians, scientists, patients, advocates, innovators, and those involved in oncology drug development from around the world in order to explore the latest advances in cancer treatment, clinical trials, and translational and clinical research.

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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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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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Drug Discovery World

JUNE 1, 2023

A market research report published in late June 2018 by HTF market Intelligence Consulting suggested that the ADC market in China would grow exponentially by 2023 4. This appears to be supported by the number of Chinese collaborations, approvals and expansions in 2023 alone.

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Drug Discovery World

FEBRUARY 13, 2024

Often this can be drug approvals, exciting research into hard-to-treat indications, or even regulatory updates that enable players within the sector to utilise the latest technologies and drive therapies to market faster, ultimately benefitting patients. But is AI the answer to the industry’s development challenges?

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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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