Newsletter | April 19, 2024

04.19.24 -- How To Complete Projects On Time

NEW PODCAST EPISODE

Reducing the Disease Burden of AML with Vor Bio's Dr. Robert Ang

In 2021 on Episode 13, Vor Bio’s President and CEO, Dr. Robert Ang shared data about the company’s lead eHSC product candidate. Dr. Ang is back to talk to Cell & Gene: The Podcast about how Vor has treated 8 patients demonstrating clinical proof of concept and is also in the clinic with a CAR-T that could be used in combination with shielded stem cell transplants. Listen now!

FEATURED ARTICLES

Start Fast, Finish Fast: How To Complete Projects On Time

Teams often do a brilliant job executing during the middle of projects. Once a project has been defined and it gains momentum, the project moves along rapidly, until it is time for final deliverables. Ken Ford offers advice for expediting the beginning and the end of projects.

INDUSTRY INSIGHTS

Mass Spectrometry For Biotherapeutics With A Mass Spec Team

The rising demand for vaccines and complex biotherapeutics has led to an increased role for CDMOs in the development process when it comes to characterizing impurities to ensure product quality.

Knowing When To Take Action In A Regulatory Submission Crisis

While a few red flags are common during any submission, several occurring in concert can precipitate a submission crisis. Learn how these can be avoided in this article.

Implementing ICH E6 (R3) In A Risk Averse Culture

Get several pointers on how to facilitate a transition to an agile, multi-faceted, and continuous risk and issue management approach aligned with the Statistical Analysis Plan.

Impact Of Supplier Choice On APAC Clinical Trial Execution

Choosing the right clinical packaging and supply chain partner to support APAC studies can vary significantly based upon which countries are involved and the types of services required.

You Don’t Have To Digitize Everything, You Just Have To Start

Feeling left behind by the sudden digitization of clinical trials? Decentralized clinical trials can be adapted to best serve the patient population, condition, or therapy you’re investigating.

Handling Substantial Modifications Under The CTR

The transition of ongoing clinical trials to meet CTR requirements can be challenging. Examine some key considerations, including substantial modification processes and strategic dossier updates.

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