Newsletter | September 14, 2021

09.14.21 -- Best Practices For Raw Material Supplier Change Notifications

Featured Editorial
Industry Insights
Is A Multitherapeutic Contract Research Partner The Best Fit For Your Clinical Trial?

You wouldn’t hire a house painter to retouch fine artwork, so why would you contract a jack-of-all-trades research organization to pilot a clinical trial with critical endpoints that require specific, in-depth expertise?

Analytical Considerations For Biopharmaceuticals During Commercialization

As a project approaches its process performance qualification phase, it is crucial to understand the expectations of regulatory agencies and identify the most efficient ways to validate the analytical methods.

Best Practices Guide To Data Privacy In Clinical Trials

As life sciences companies grow, the regulatory compliance requirements, and the risks expand as well. These responsibilities extend beyond conventional health-related frameworks (e.g. GxP, HIPAA, etc.) but into the realm of data privacy as well. For high-growth institutions with limited resources and bandwidth, the question arises: What should you do?

Cell Therapy Manufacturing Under GMP: How And When To Get Started

Emerging cellular therapies aim to manufacture cell populations for clinical indications, such as cancer, autoimmune, and cardiovascular diseases. As hospitals and translational facilities explore implementation of this technology, they concurrently evaluate whether or not to manufacture the therapies on site. Here is a guideline of how and when to get started.

Uniquely Powerful T Cells And How To Find Them

T-cell-based immunotherapy is proving promising as a treatment for multiple types of cancer but current techniques limit our ability to measure T-cell characteristics of interest and select the most efficacious cells for a therapy. New technologies are needed to allow us to identify the drivers of desired phenotypes such as polyfunctionality, serial killing, and proliferation.

How To Prepare For Future Viral Vector Manufacturing Technologies And Platforms

The challenges and shortage of vector production reflects the fact that these materials and products are having such strong clinical success. Let’s celebrate the reason for this demand. To meet it, we need to industrialize and rethink how we transition from what has historically been carried out in translational clinical centers at smaller scale, using flasks and open systems, toward commercial production and methodologies.

Continuing The Conversation: The Future Of Reimbursement For Cell And Gene Therapies

Cell and gene therapies were expected to pose significant payer challenges; however, several high-cost cell and gene therapies have achieved rapid and broad reimbursement to date across major payer bodies.

Full-Service Support For A Gene Therapy Trial

A clinical-stage biotechnology start-up asked Veristat to run complex U.S. and EU trials of their unique gene therapy. Veristat brought invaluable global capabilities and expertise to a small client team tackling their first clinical-stage program without the large infrastructure or resources to conduct studies in this space themselves. Our end-to-end support started at Phase I and will continue into post-marketing and regulatory follow-up.

Which Ingredient Are You Missing In Your Gene Therapy Success Recipe?

In this podcast, Ratish Krishnan, associate director for cell and gene therapy, talks about the tremendous promise gene therapies have for changing the healthcare paradigm and providing solutions to some of the biggest challenges in gene therapy manufacturing.

Risk Mitigation For Single-Use Cold Chain Distribution

Study data show the utility of low-temperature suitable materials and packaging, sensors for monitoring shipments, and qualification and evaluation through simulated standards and real-world transit.

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