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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PPD

NOVEMBER 14, 2023

Clinical research requires vast talent across a variety of roles and specialties, as well as across global locations. 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.

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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.

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PPD

OCTOBER 31, 2023

If recruitment moves slowly or individuals with the wrong skills are selected, the clinical research process stalls, costing sponsors valuable time, money and resources. Selecting the Right Partnership Model Clinical research outsourcing models have changed over time to accommodate the industry’s evolving needs.

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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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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

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.

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Agency IQ

FEBRUARY 12, 2024

The consortium is funded by a public-private partnership called the Accelerating Medicines Partnership (AMP) , through which the Foundation for the NIH (FNIH) administers funds provided by industry, government, and nonprofits to scientists working on applicable basic or clinical research to advance gene therapy development for rare diseases.

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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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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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PPD

NOVEMBER 8, 2022

As 2022 comes to a close, we’re reflecting on the past 12 months as a transformative year for the drug development industry — one that foreshadows both change and opportunity in biopharma and biotech clinical trials in 2023. Six Predictions for the Drug Development Industry in 2023 1.

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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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Advarra

AUGUST 10, 2023

Given the relatively small populations affected by any one rare disease or condition, a pharmaceutical company developing an orphan drug may reasonably expect the final approved drug to generate relatively small sales (when compared with the drug development costs) and consequently incur a financial loss.

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Drug Development Disease Engineering Therapies 52

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.

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Drug Discovery World

AUGUST 7, 2023

In our current environment of political polarization, efforts to encourage diversity are unable to prevail, and more needs to be done to foster the trust that is necessary for broader participation in clinical trial recruitment. RA: How does a lack of patient diversity in trials impact how treatments work in certain populations?

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Conversations in Drug Development Trends

MAY 30, 2024

This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. Initial approval in 2023: FDA, U.S. Then 1 packet to be used twice daily thereafter.

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PPD

JUNE 20, 2023

As some drug development organizations right-size their workforces , a strong CRO partner will rehire your talent — avoiding destabilization of your clinical research — via rebadging through functional service provider (FSP) engagements. The drug development industry is undoubtedly in a season of change.

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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.

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Clinical Trials Clinical Development Trials International 52

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.

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FDA Law Blog: Drug Discovery

JULY 9, 2024

FDA issued its draft guidance titled “ Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies ,” (the “Draft Guidance”) which replaces the previous pre-FDORA April 2022 draft guidance of the same name.

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Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

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Agency IQ

JUNE 28, 2024

See AgencyIQ’s analysis for more detailed history of FDA’s policy and guidance on diversity in research studies ]. In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. at a Friends of Cancer Research event in February 2024. ANNA ESHOO (D-Calif.)

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