Conversations in Drug Development Trends

NOVEMBER 12, 2024

By Amy Raymond, PhD, PMP, Executive Director, Therapeutic Strategy Lead, Rare Disease Cell and gene therapies (CGTs) include cutting-edge approaches that offer the hope of a healthier, happier, and better tomorrow for a wide range of patient populations. Below, we discuss some of these challenges in cell therapy trials.

Therapies 72

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The Pharma Data

MAY 26, 2023

State-of-the-art cryogenic freezers alongside material transfer equipment have been installed that are designed to retain the integrity of investigational advanced therapy products by minimizing their time-out-of-environment. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year.

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Clinical Supply Therapies Clinical Trials Packaging 52

Drug Target Review

SEPTEMBER 10, 2024

For example, tox material from a pool of clones will contain a potentially broader profile of product quality attributes (eg glycan profile, high molecular weight species, etc) in addition to potentially slightly higher relative amounts of process impurities which can resemble the worst-case scenario during the toxicology testing.

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Drug Development Clinical Supply Production FDA 64

The Pharma Data

JANUARY 10, 2021

About MorphoSys MorphoSys is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for patients suffering from cancer and autoimmune diseases. In 2017, Tremfya (R) , developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc.,

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Clinical Trials Clinical Development Clinical Supply Trials 52

LifeSciVC

AUGUST 21, 2024

Keeping ahead of schedule will help to maintain manufacturing efficiencies, ensure adequate supply and product quality, and meet development timelines. I am fortunate to have a great Tech Ops team at Lifordi who is on top of managing all the moving parts across the globe for making tox and clinical supply for us.

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Clinical Trials Trials Disease Treatment 77

The Pharma Data

NOVEMBER 18, 2020

These restrictions and uncertainty around the duration, severity and geographic scope of the COVID-19 outbreak are projected to slow down the enrolment of patients due to re-prioritisation of hospital activities towards COVID-19 patients and away from clinical studies such as PARADIGME. Presentation and live webcast – Q3 2020 results.

Trials 40

Trials Clinical Supply Production Therapies 40

The Pharma Data

NOVEMBER 22, 2020

Preclinical data support MP0420’s potential efficacy as both a prophylactic and as an acute therapy. DARPin® therapeutics have been clinically validated through to the registrational stage. Chief Medical Officer of Molecular Partners. million doses of MP0420, if it is approved in Switzerland. About Molecular Partners AG.

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Trials Clinical Trials Licensing Licensing 40