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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.

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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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog: Drug Discovery

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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Keeping tabs on Covid-19: BetterLife embraces virtual clinical trials and Novan shares positive results from in vitro antiviral technology against SARS-CoV-2

The Pharma Data

This week’s round up features a digital solution for adapting clinical trials to ease the burden on the clinical research industry and an in vitro model that mimics the human airway epithelium using a newly developed technology platform. BetterLife conducts patient centric study via a fully remote clinical trial. Source link.

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Scopus BioPharma Announces Appointment of Additional Directors

The Pharma Data

Scopus is a biopharmaceutical company whose lead drug candidate is a novel, targeted immuno-oncology gene therapy for the treatment of multiple cancers. Dr. Hofstein completed his postdoctoral training and research in the Department of Neurobiology at Harvard Medical School. Hofstein received his B.Sc.

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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. 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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Demystifying the ICH M10 Bioanalytical Method Validation Guidelines

Conversations in Drug Development Trends

The ICH M10 guidelines aim to streamline this process, reducing redundancy in drug development and facilitating faster access to new therapies. Understanding and implementing the ICH M10 guidelines is not just a regulatory requirement; it’s a step towards more efficient and effective pharmaceutical research.