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.
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. With sites in the U.S.,
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PPD
SEPTEMBER 6, 2023
Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster. Most often done using the vendor’s systems and standard operating procedures (SOP).
The Pharma Data
JUNE 7, 2023
Originally launched in 2019 for early-phase protein therapy development, OneBio Suite offers customers an integrated service to accelerate programs from development to manufacturing, including fill/finish and packaging, and support for clinical supply and commercial launch.
Drug Target Review
SEPTEMBER 10, 2024
However, information would be required on whether the nominated formulation would be sufficiently stable to support the rapid formulation approach and subsequent comparison to the clinical supply. Therefore, there would be almost no appetite for trying to justify a change in formulation between Tox and clinical supplies.
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.
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. The presentation as well as a replay of the webcast will also be available on MorphoSys’ website.
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