Conversations in Drug Development Trends

APRIL 4, 2024

Global Impact of ICH M10 Validation Guidelines Harmonization of bioanalytical validation methods is crucial in a world where pharmaceuticals are developed and approved across different regions. The ICH M10 guidelines aim to streamline this process, reducing redundancy in drug development and facilitating faster access to new therapies.

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Fierce BioTech

JULY 28, 2023

jsabatino Fri, 07/28/2023 - 11:29 In this white paper, we look at the past, present and future of antibodies as therapies, explaining how the modality became a key pillar of the biopharma industry—and looking forward to the methods and technologies that could unleash its full potential in the years to come. Download here!

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Conversations in Drug Development Trends

MARCH 12, 2024

For a more in-depth look at biomarkers, check out our white paper. Most IO Biomarkers Require Composite Use IO biomarkers can provide valuable data on a patient’s immune response to treatment and specification of which subpopulations would best benefit from immuno-oncology therapy.

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Clinical Trials Immune Response Trials Disease 72

Conversations in Drug Development Trends

AUGUST 14, 2024

Historically, these indications have challenged the one-size-fits-all treatment approach due to patient variability, such as genetic differences in drug metabolism and underlying health conditions. Hematological cancer cells can also develop resistance to therapies over time, reducing treatment effectiveness.

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FDA Law Blog: Drug Discovery

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

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PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy.

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Conversations in Drug Development Trends

DECEMBER 20, 2023

You can learn more about biomarkers and how to use them in oncology studies in this white paper. Single-Arm Trial Design Single-arm trials have also become an increasingly common development strategy to support regulatory approval and allow patients expedited access to novel therapies, particularly in the accelerated access setting.

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