Newsletter | September 20, 2024

09.20.24 -- Have We Got Novel Drug Production And Compliance Timelines All Wrong?

FOCUS ON CLINICAL TRIALS

A New Approach To Genome Engineering With Tessera Therapeutics

Tessera Therapeutics' CEO, Dr. Michael Severino, joins Host Erin Harris to discuss Gene Writing, the biotech's genome engineering technology that writes therapeutic messages into the genome to treat diseases at their source. Severino discusses why delivery has always been a challenge for gene editing technologies and why Gene Writing is different when it comes to efficient delivery.

Better Audits, Faster Through Transparency And Efficiency

Clinical trial audits are evolving. Learn how transparency and efficiency can revolutionize the process, saving time and providing a deeper understanding of operations.

Accelerating Study Start-Up And Patient Recruitment For Clinical Trials

A network of proven and trusted sites means sponsors can progress quickly through the site selection process to study startup and then be assured of reliable patient recruitment and robust data.

How FAIR Data Principles Deliver Clinical Success

Prioritize data management that adheres to FAIR principles — findable, accessible, interoperable, and reusable — to gain operational insights that enable quick decisions and ensure participant well-being.

The Value And Impact Of Decentralizing An Oncology Trial

Incorporating hybrid delivery and remote technologies in oncology clinical trials helps remove a significant amount of the patient burden, enabling them to participate more comfortably.

CLINICAL TRIALS SOLUTIONS

Site Management Organization - Novotech

FOCUS ON SUPPLY CHAIN

Have We Got Novel Drug Production And Compliance Timelines All Wrong?

Drug developers might want to consider longer-term approaches to meeting manufacturing and regulatory requirements.

Navigating The Challenges Of Bringing Cell And Gene Therapies To Market

Cell and gene therapies are witnessing rapid advancements, but significant challenges remain for their commercialization due to regulatory hurdles, manufacturing barriers, high costs, and safety concerns.

Critical Supply Chain And Logistics Considerations For CGT Management

Explore the unique challenges and complexities involved in key CGT logistics areas like donor and patient accessibility, critical raw materials management, and innovative temperature control equipment.

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