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An Integrated End-to-End Approach to Antibody Drug Conjugate Development and Manufacturing

Fierce BioTech

An Integrated End-to-End Approach to Antibody Drug Conjugate Development and Manufacturing In this white paper, Lonza experts delve into the common challenges encountered by ADC developers. Read this white paper to learn more. Read this white paper to learn more.

Drugs 52
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Predicting Drug Development in 2023

EG Life Sciences

The year 2022 reflected a transformative path for the drug development industry. Every year, the FDA’s Center for Drug Evaluation and Research (CDER) clarifies to drug developers required study design elements, as well as other data needed on the drug application to support a full and comprehensive assessment.

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New whitepaper: Take a deep dive into cell therapy

Drug Discovery World

Cell therapy research has never been more exciting with all of the research ongoing. Download this new white paper ‘Diving deep into cell therapy: An industry perspective’ to find out more. The post New whitepaper: Take a deep dive into cell therapy appeared first on Drug Discovery World (DDW).

Therapies 130
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Antibodies: The Breakthrough Past, Blockbuster Present and Cutting-Edge Future

Fierce BioTech

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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Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Conversations in Drug Development Trends

Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure. Here are a few of our lessons learned: 1.

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Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?

Conversations in Drug Development Trends

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”.

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How Pharmacogenomics Can Benefit Your Clinical Trial

Conversations in Drug Development Trends

In the increasingly advancing world of medicine, personalized care is a key factor that can progress your drug development efforts. As the study of how an individual’s genes affect their response to drugs, pharmacogenomics is a critical factor in developing effective and safe drugs and dosages in clinical trials.