article thumbnail

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
article thumbnail

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

New whitepaper: Take a deep dive into cell therapy

Drug Discovery World

Download this new white paper ‘Diving deep into cell therapy: An industry perspective’ to find out more. Cell therapy research has never been more exciting with all of the research ongoing.

Therapies 130
article thumbnail

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!

article thumbnail

Considering Master Protocol Use in Your Trial: Evaluating Basket and Umbrella Trial Designs

Conversations in Drug Development Trends

To help determine if a master protocol could be a good fit for your study, check out this white paper for a more comprehensive overview of the appropriateness of master protocols in different contexts. Here are some relevant factors below: What Are the Advantages of a Master Protocol? Contact us.

Trials 78
article thumbnail

Demystifying the ICH M10 Bioanalytical Method Validation Guidelines

Conversations in Drug Development Trends

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.

article thumbnail

Making Informed Decisions in Your Oncology Study: Understanding Biomarkers

Conversations in Drug Development Trends

For a more in-depth look at biomarkers, check out our white paper. The IO biomarker field is rapidly evolving—check out this white paper for the latest details regarding IO biomarkers. Below, we discuss some validated circulating oncology biomarkers, their implementation, and key operational considerations.