Conversations in Drug Development Trends

DECEMBER 7, 2023

However, despite their greater service capabilities, large CROs have hit an inflection point in the clinical landscape, leading to unexpected industry dynamics characterized by a rise in CROs that take a more personalized approach.

Clinical Trials

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.

Clinical Development

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.

Therapies

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.

Drug Development

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

Alta Sciences

AUGUST 18, 2023

Don’t miss out: [link] Event End Date Thu, 10/26/2023 - 12:00 Event Start Date Thu, 10/26/2023 - 12:00 Weight 1

Drug Development

Conversations in Drug Development Trends

DECEMBER 5, 2023

Vendors that seamlessly integrate with CROs, delivering services in a timely manner, regardless of which phase the clinical trial is in, can significantly help maintain drug development timelines.

Clinical Trials

Cytel

OCTOBER 27, 2023

Since its launch in 2021, Project Optimus has been reforming the dose optimization and dose selection paradigm in oncology drug development. To address this challenge, the FDA Oncology Center of Excellence initiated Project Optimus. With consensus of multiple stakeholders on “why” the change is needed, the speakers focused on “how.”

Clinical Trials

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. In other cases, well-established biomarker profiles enable patient enrichment strategies in early-stage clinical development.

Therapies

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.

Small Molecule

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.

Clinical Trials

Conversations in Drug Development Trends

FEBRUARY 22, 2023

What will have the greatest impact on rare disease patients in 2023? Katie Nichols, senior project manager at Worldwide Clinical Trials, has been dedicated to rare disease research for seven years, seeing the impact firsthand that the progression of rare disease research has on rare disease communities. So, I decided to pivot.

Disease

Conversations in Drug Development Trends

JANUARY 24, 2024

However, they lack awareness of specific clinical trials that may be relevant to their patients, and they don’t always feel they have the knowledge to explain certain aspects of clinical trials confidently to patients and their family members. Enrolling adequate populations will be required to advance these programs.

Trials

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. So, what are investors looking for? I mean it’s easy, right? Where are investments going in the current market?

Clinical Development

Metabolite Tales Blog

DECEMBER 19, 2023

Metabolite Bioanalysis in Drug Development: Recommendations from the IQ Consortium Metabolite Bioanalysis Working Group A Metabolite Bioanalysis Working Group comprised of experts from 14 different pharma companies have proposed recommendations around best practice in metabolite bioanalysis during drug development.

Pharma Companies

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

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?

Trials

PPD

JUNE 17, 2024

One interesting trend emerging from the 2023 Pulse Report is the rise of hybrid functional service provider (FSP)/full-service outsourcing (FSO) arrangements. Partner with an FSP provider that delivers results across every use case Drug developers count on strategic collaborations for success, and those collaborations come in many forms.

Clinical Trials

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

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

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.

Clinical Research

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. Other Questions.

Therapies

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! Watch the video. Listen here. Read or listen now.

Science

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.

Clinical Trials

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.

Clinical Research

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

Precision for Medicine

JANUARY 23, 2023

QuartzBio’s suite of end-to-end SaaS solutions provides pharmaceutical and biotech clients with a fully connected data ecosystem linking sample, biomarker, and clinical data to improve collaboration, planning and R&D productivity. This convergence of trials, labs and data sciences is driving faster clinical development and approval.

Clinical Research

Drug Target Review

OCTOBER 3, 2024

In 2024 alone, almost 50 antibody drug candidates are anticipated to enter regulatory review, the majority of which are mAbs. Aside from the advent of complex antibody-based drugs, the industry is facing some additional changes which are shaping drug development. Crescioli S, Kaplon H, Chenoweth A, et al. www.science.org.

Molecular Biology

PPD

OCTOBER 31, 2023

Our 2023 industry trends report found that an increasing number of sponsors have begun to gravitate toward the FSP model, with respondents now saying FSP engagements represent 26% of their clinical work on average. Moreover, FSP models allow drug developers to outsource individual functional services to gain efficiency and flexibility.

International

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.

Science

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.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.

Therapies

Vial

MARCH 27, 2024

Increasing Demand for Contract Research Organization (CRO) Support CROs are pivotal to the successful execution of clinical trials, offering a tailored resource of expertise, services, and logistical support that can significantly streamline the process for sponsors. from 2024 to 2030.

Clinical Trials

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.

FDA

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. This means that the voluntary pilot is open for participation requests as of June 20, 2023, with the initial phase set to include up to 9 participants and last for a year.

FDA

Agency IQ

APRIL 12, 2024

In drug development, biochemical assays might be used to determine a product’s binding affinity to a target receptor of interest, along with the strength, stability and duration of the target-ligand complex after the product binds to the receptor. FDA-2023-D-4299: Potency Assurance for Cellular and Gene Therapy Products

Production

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. We owe it to our patients to step firmly on the scientific accelerator.”

Therapies

Agency IQ

DECEMBER 11, 2023

The FDA and oncology: 2023 year in review As we round the corner into the last few weeks of 2023, AgencyIQ has taken a look back at a very busy year for the FDA’s oncology staff, and for sponsors. OCE leadership and staff also kept AgencyIQ staff very busy in 2023 as they attended and presented at countless meetings.

FDA