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. What Differentiates Mid-Size CROs?

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Drug Discovery Today

JULY 28, 2020

Cancer Research UK, the University of Southampton and Touchlight Genetics, a London based biotechnology company, today (Wednesday) announce a new clinical development partnership to progress a therapeutic DNA vaccine, TGL-100, into an early phase clinical trial targeting head and neck squamous cell carcinoma (HNSCC).

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PPD

JULY 6, 2023

It’s estimated that nearly three out of every four clinical trials are conducted by contract research organizations (CROs), highlighting just how much sponsors value — and rely on — the work that CROs perform. Surveys show that CROs improve trial efficiency and increase productivity.

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Clinical Trials Trials Drug Development Testimonials 98

Broad Institute

OCTOBER 11, 2023

Manguso, who’d recently graduated from college and was conducting research at the University of Copenhagen as a Fulbright scholar, moved back to the Boston area to be with his mother as she underwent treatment. By then, a few cancer immunotherapies had entered clinical trials and only a handful had been approved by the FDA.

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Research Immune Response Clinical Trials Therapies 137

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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Alta Sciences

JUNE 21, 2024

Simpler Clinical Development From Day Dot blussier Fri, 06/21/2024 - 19:10 HTML Connecting the Dots With Comprehensive CRO Solutions When you CONNECT THE DOTS, you open a world of possibilities. At Altasciences, we connect the dots, so you don’t have to. Contact us today.

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Clinical Development Clinical Trials Clinical Research Drug Development 52

PPD

MARCH 11, 2025

While individual rare diseases affect populations that are small in numbers, collectively they impact millions globally, posing significant health and research challenges. Real-world data (RWD) and real-world evidence (RWE) have emerged as transformational tools in addressing these hurdles, advancing rare disease drug development.

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Conversations in Drug Development Trends

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.

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Conversations in Drug Development Trends

JANUARY 21, 2025

Jayaprakash Kotha, MBBS, PhD, ASCP (SH), Vice President, Bioanalytical Laboratory Satish Kumar, MBB, Head of Process Improvement Continuous Innovation is a Cornerstone of Bioanalysis Approximately 80% of drugs that begin the research process fail to reach approval. What is one contributing factor that sets the 20% that do apart from the rest?

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PPD

NOVEMBER 21, 2023

To keep a pulse on this rapidly changing industry, the PPD clinical research business of Thermo Fisher Scientific surveyed 150 leaders in the biopharma and biotech industries for the second consecutive year. Differences in size, resources and agility have led the two groups to take different approaches to clinical development.

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Clinical Development Clinical Trials Trials Clinical Research 52

Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.

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Clinical Development Compliance Clinical Trials Trials 52

Drug Target Review

FEBRUARY 10, 2025

In just two years, CTMC has advanced eight therapies into clinical trials, harnessing genetic engineering to enhance T-cell effectiveness in the fight against cancer. His approach focused on integrating key components of the process: research, clinical, regulatory, and manufacturing into a cohesive, unified system.

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Cytel

FEBRUARY 3, 2023

For clinical development and research and development teams, the Pareto Frontier can perform two functions. Let’s take a closer look:

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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.”

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Conversations in Drug Development Trends

OCTOBER 31, 2023

Last year, we witnessed a significant milestone in oncology clinical development, with almost 50% of all development programs focused on oncology assets. To encourage further expansion and innovation in cancer studies, it’s critical to consider what contributes to success in an oncology trial.

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PPD

NOVEMBER 9, 2023

Creating these continuities yields efficiencies and advantages for the contract research organization (CRO) and the sponsor when it comes to budget and historical knowledge. Our dedicated, global and highly experienced cross-functional early development team is ready to support you through this journey.

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PPD

SEPTEMBER 19, 2023

Whichever route a company takes, deliberate decision-making around the nature and timing of early phase studies is important to manage risks in the clinical development process. Benefits of Early Drug Development Services Early development studies include many elements that set them apart from those in later development.

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Cytel

NOVEMBER 29, 2022

Bayesian methods have continuously played a key role in transforming clinical research in therapeutic areas such as oncology and rare diseases, and in addressing clinical development challenges for COVID-19 drugs, devices, and biologics.

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Clinical Trials Trials Clinical Development Clinical Research 52

Fierce BioTech

DECEMBER 23, 2024

As Phase 1 clinical trials include several different design types with multiple objectives (e.g. png Listing Introduction Join this webinar to receive expert guidance and learn key considerations for successfully planning pharmacy activities in early phase trials. Listing Image DrVince_ListingLogo_250x190.png

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Pharmacy Trials Clinical Trials Clinical Development 52

The Pharma Data

NOVEMBER 30, 2020

Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.

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Alta Sciences

JULY 22, 2024

Insights in FIH studies provide valuable information on potential dosing, efficacy, and safety, and serve as a good guide for the regulatory requirements needed throughout clinical development. jpg Tags Clinical Trials Weight 1

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Trials Clinical Trials Clinical Development Clinical Research 52

H1 Blog

JUNE 7, 2023

Clinical trial success is a key factor for pharma companies when designing and recruiting patients into trials. This data can also provide guidance in terms of diversifying clinical trials to include different types of population demographics such as age, gender, race, ethnicity, or geographic location.

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Trials Clinical Trials Pharma Companies Clinical Development 52

PPD

OCTOBER 21, 2024

Meeting the never-ending challenges of drug development in this active environment — including pressure to identify drug prospects earlier and hire more conservatively — frequently leads biotech companies to outsource some portion of clinical development functions. With FSO, all tasks for a clinical trial are outsourced.

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International Clinical Development Clinical Trials Clinical Research 87

LifeSciVC

JULY 17, 2024

By Mike Cloonan, Chief Executive Officer of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC The drug development process in rare diseases is rife with challenges especially when companies target significant differentiation or first-in-class targets.

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Clinical Research Disease Research Clinical Trials 69

Conversations in Drug Development Trends

JUNE 13, 2024

In the last few decades, oncology research has witnessed countless innovations and breakthroughs, significantly extending the lives of those affected by cancer and improving their quality of life. However, Project Optimus emphasizes the importance of dose-finding studies in early clinical development.

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Trials Clinical Trials Drug Development Clinical Development 52

PPD

OCTOBER 17, 2024

There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. When sponsors are armed with this knowledge, it expedites the ability to expand and scale CGT development.

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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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Clinical Trials Trials Clinical Research Drug Development 98

Alta Sciences

FEBRUARY 8, 2024

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects. In this on-demand webinar, Ingrid Holmes , Vice President of Global Clinical Operations at Altasciences, and Dr. Gary G.

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Clinical Trials Trials Clinical Pharmacology Clinical Development 52

Advarra

JUNE 20, 2023

According to a 10-year oncology research study conducted by the Biotechnology Innovation Organization (BIO), only 5.1% Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54

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Trials Clinical Trials FDA Approval Therapies 52

Advarra

AUGUST 14, 2023

The clinical research industry is only becoming more complex and competitive as organizations are inundated with multiple trials and tight deadlines. The clinical trial process is both expensive and time-consuming, and ends more often in failure than success. Advarra surveyed 1,000 random U.S. In total, 82.8%

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Clinical Trials Trials Clinical Research Research 52

Vial

MARCH 25, 2024

Introduction Worldwide Clinical Trials vs. Vial. Worldwide Clinical Trials is a mid-size, full-service global contract research organization (CRO) that works with biotech and pharma to advance new medications. How do they stack up? Other therapeutic areas include cell and gene therapy.

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Clinical Trials Trials Clinical Development Clinical Research 52

Cytel

MAY 14, 2024

Written by Angela Vinken and Patti Arsenault Key Opinion Leaders (KOLs) — i.e., trusted, well-respected experts — are crucial in clinical research, especially in rare diseases. The challenge, however, is how to use KOLs wisely — they are often clinicians first and researchers second, and their time is in high demand.

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Conversations in Drug Development Trends

MAY 14, 2024

By: Amy Raymond, Derek Ansel, Nathan Chadwick, & Juliane Mills When choosing a CRO for a rare disease study, what truly sets them apart is their methodology: the CRO’s mindset, their approach to each unique study, and their agility in navigating the inherent complexities of rare disease research. Engage stakeholders EARLY.

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Conversations in Drug Development Trends

JULY 29, 2024

Clinical development programs must acknowledge the complexity and variability of obesity as a condition. Partnering with a CRO that emphasizes the complexity of the patient’s voice and harnesses the nuances of clinical trial design is crucial for executing successful clinical research.

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Clinical Research Research Clinical Trials Treatment 52

PPD

OCTOBER 16, 2023

The ability to leverage health care data for real-world research has historically been challenging due to patient privacy and data integration concerns. ” By tokenizing participants in a clinical trial, researchers gain the ability to link RWD from trial participants’ medical data to their clinical trial data.

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Clinical Trials Trials Research Therapies 98

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. That is, how many clinical trials are actually managed by these organizations?

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Clinical Trials Trials Clinical Research Drug Development 52

Labcorp Drug Development

MARCH 7, 2023

The field of nephrology clinical research has been steadily adding new interventional trials over the last five years at an average pace of 176 trials per year. This activity reflects the … The post Enabling better access to kidney disease trials appeared first on Insights From Our Labs to Yours.

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