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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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. By 2032, this value is expected to reach US$108 billion.

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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.

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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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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

APRIL 13, 2023

In 2018, the US Food and Drug Administration (FDA) introduced a policy for accepting real-world data (RWD) and real-world evidence (RWE) in addition to traditional clinical trial data in new drug applications. With RWD, fewer patients require direct enrolment in randomised clinical trials.

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Drug Discovery World

MAY 6, 2024

billion on R&D during 2021, with Germany and Switzerland being the biggest contributors, and around one fourth of clinical trials worldwide were performed in Europe 1. Even before this, however, Amsterdam was established as an important centre for drug development. The CDD will sponsor and manage KWF-supported trials.

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Drug Discovery World

MARCH 7, 2023

Powers taught for more than six years at the National Institutes of Health, on medical product development and commercialisation, and at Georgetown Law School as an adjunct professor. Dr Janette Thomas, CEO, Five Alarm Bio Five Alarm Bio is an anti-ageing therapeutics company, which completed a seed investment round in early 2023.

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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. This year, the U.S.

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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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Conversations in Drug Development Trends

FEBRUARY 22, 2023

Panelists will answer questions such as: What are the greatest challenges holding patients back from enrolling in trials? What will have the greatest impact on rare disease patients in 2023? I have participated in many trials and studies. So, I decided to pivot. and other questions that hit upon my emotional experience.

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Disease Clinical Trials Trials Treatment 52

Drug Discovery World

FEBRUARY 12, 2024

Dr Pandora Pound , Fellow Oxford Centre for Animal Ethics explores the hinderances of animal testing in pharma and why new technologies such AI, genomics and synthetic biology c an further drug development. Furthermore, DILIsym predicted that a related drug, ubrogepant, would be relatively safe for the liver. doi:10.1001/jama.2023.14443

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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. The company reported a revenue of $11,116 million for the first nine months of 2023, marking a 4.2%

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Vial

MARCH 1, 2024

Introduction Contract research organizations (CROs) are essential in pharmaceutical research and development (R&D). By geographical region, the global CRO services market in 2023 was dominated by North America. billion in 2023 attributable to its laboratory products and biopharma services segment (53.8% of total revenue).

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Clinical Trials Clinical Research Laboratories Trials 52

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. Many diagnoses are made clinically based on a patient’s symptoms, as opposed to genetic testing or established biomarker profiles.

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Drug Discovery World

NOVEMBER 9, 2023

This MHC-restricted surface presentation of peptides gives access to a new class of attractive intracellular cancer targets for the potent T-cell engagers which we have developed at CDR-Life. RA: In terms of developing antibodies directed against MHC, are there any manufacturing and engineering challenges?

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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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Small Molecule Trials Therapies Disease 139

Alta Sciences

OCTOBER 30, 2023

Top 10 Life Science Resources pmjackson Mon, 10/30/2023 - 16:16 There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below! Read it now. The Altascientist : Issue No.

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Drug Discovery World

OCTOBER 16, 2023

From the Beatson Institute for Cancer Research in Glasgow, to Edinburgh Drug Discovery in the University of Edinburgh’s Institute for Genetics and Cancer (IGC). At ELRIG’s Scottish Research and Drug Development Forum meeting, DDW’s Diana Spencer provided a snapshot of drug discovery in Scotland.

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Drugs Science Therapies Targeted Protein Degradation 189

Drug Discovery World

MARCH 29, 2023

On January 31 2023, an internally circulated version of the European Commission’s overhaul of the EU’s pharma legislation was leaked, and published by Politico 1. Moreover, an extra six months of RDP for drugs with full comparator clinical trials (rather than showing only that a drug is no worse than the standard of care).

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Vial

MARCH 27, 2024

The Costs of Working with a CRO Running clinical trials is an integral part of the pharmaceutical industry, crucial to the development and approval of new drugs and treatments. These services range from clinical study design and data management to statistical analysis and regulatory support. from 2024 to 2030.

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Clinical Trials Trials International Compliance 52

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

PPD

JUNE 22, 2023

Sponsors and clinical research organizations (CROs) alike are facing competitive recruiting from limited talent pools. These challenges were echoed in a 2022 industry survey conducted by the PPD clinical research business of Thermo Fisher Scientific. We are committed to operational excellence across drug development.

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Clinical Research Clinical Trials Trials Drug Development 52

The Pharma Data

MARCH 23, 2023

Head of Global R&D ad interim and Chief Medical Officer at Sanofi “Change cannot come quick enough for people living with uncontrolled COPD but , unfortunately , many investigational treatments have failed to demonstrate significant clinical outcomes leaving these vulnerable patients with limited treatment options.

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Trials Disease Treatment Therapies 40

LifeSciVC

OCTOBER 18, 2023

By Bob Clarke, CEO of Kinaset Therapeutics, as part of the From The Trenches feature of LifeSciVC As we enter the final leg of 2023, navigating the investment market in biotech continues to be fraught with twists and turns. In a market like today, later stage, clinically validated targets are a potentially ‘safer’ place to balance portfolios.

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Marketing Clinical Development Clinical Trials Production 62

PPD

NOVEMBER 21, 2023

The drug development industry is constantly adapting and evolving to bring novel therapeutics to market to improve the lives of patients across the globe. While the drug development industry experienced setbacks during the COVID-19 pandemic, the field  is again gaining momentum reminiscent of its pre-pandemic pace.

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Clinical Development Clinical Trials Trials Clinical Research 52

Drug Discovery World

JANUARY 23, 2023

Dr Julie Warner is Vice President of Regulatory Affairs at global drug development consultancy, Boyds. In addition, a new system – the Clinical Trials Information System (CTIS) – was introduced to enable the implementation of the CTR.

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Clinical Trials FDA Drug Development Compliance 130

PPD

OCTOBER 31, 2023

For each trial, the partner team must rapidly recruit workers in sufficient numbers and with the correct skills to complete each segment of the project with agility and ease. If recruitment moves slowly or individuals with the wrong skills are selected, the clinical research process stalls, costing sponsors valuable time, money and resources.

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International Clinical Research Clinical Development Research 52

Agency IQ

JULY 21, 2023

The paper recommends a risk-based approach that weighs patient safety and integrity of development data. BY KIRSTEN MESSMER, PHD, RAC JUL 18, 2023 11:07 PM CDT Regulatory background In April 2021, the E.U. An earlier report highlighted three key areas for international regulatory consideration when employing AI in drug development.

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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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Agency IQ

FEBRUARY 12, 2024

Furthermore, the Consortium would also work to develop standardized approaches to nonclinical testing as well as a set of standardized analytical methods, which could be used to assess product quality and manufacturing processes and controls.

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FDA Therapies Clinical Trials Virus 40

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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Drug Development Treatment FDA Approval Drugs 52

The Premier Consulting Blog

JUNE 18, 2023

This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.

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Drug Development Disease Clinical Trials Drugs 52

Agency IQ

JUNE 26, 2023

While the pilot has been in development for a while, the move comes as the FDA is looking towards a broader shift in its approach to LDTs. In effect: If a CDx is not readily available at the time that a drug is approved, the FDA expects that one will be approved/cleared/granted at some point in the future.

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Drug Discovery World

JANUARY 17, 2024

Brett Swansiger, Chief Commercial Officer at ANGLE discusses the importance of liquid biopsies in precision medicine trials for cancer. Furthermore, oncology clinical trials are frequently challenged by low enrolment rates, failure to achieve primary endpoints, study design complexity and limited funding 5.

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DNA Clinical Trials RNA Treatment 147

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. Speak with an expert today to discuss your next clinical program. Watch the webinar.

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Drug Development Clinical Trials Biosimilars Pharmacokinetics 40

Drug Discovery World

JANUARY 12, 2023

In January 2022, DDW’s Megan Thomas spoke to decision-makers from the drug discovery industry about their predictions on what 2022 holds for our sector. As we head into 2023, DDW will be publishing a series of reflections on these predictions.

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