Studying multiple versions of a cellular or gene therapy product in an early-phase clinical trial

The FDA released a draft guidance that outlines regulatory considerations for INDs that study multiple versions of a cellular or gene therapy (CGT) product in a single trial. There are some...

Regulatory considerations from former FDA regulators

In this infographic, we’ve compiled some common questions our ex-FDA experts get asked when helping customers build their cell and gene therapy strategy.

The Parexel Podcast | Episode 12: ASCO20 Debrief: The latest in cell and gene therapy

In 2020, ASCO went virtual for the first time. While the format was different, one thing was clear: despite all that is happening in the world, there are still many patients in need. Todd Shuster,...

COVID-19 and the effect on cellular therapy trials

In clinical trials for cellular and gene therapies, the COVID-19 pandemic has created enormous complexities. Parexel experts Matthew M. Cooney, MD and Roberta L. Steere offer a brief overview.

CMC Considerations for Gene Therapy and Regenerative Medicine Studies

The unforeseen challenges with clinical trial execution in gene therapy and regenerative medicine studies, such as unchanging FDA regulations, discussed

Former FDA expert provides valuable advice on INTERACT programs for CBER products

Many sponsors of CBER-regulated products are familiar with pre-IND meetings, but there’s a new program called INTERACT, which stands for Initial Targeted Engagement for Regulatory Advice on CBER...

Manufacturing Considerations for Cell and Gene Therapy Products to Mitigate the Risk of COVID-19 Disease Transmission

Cell and gene therapies embrace a wide variety of products including: 1) autologous and allogeneic off-the-shelf cellular products; 2) gene modified autologous and allogeneic off-the-shelf...

Establishing Manufacturing Controls: A Hurdle for the Cell and Gene Therapy Industry

Bioprocessing and Biologics risk from Coronavirus

Coronavirus COVID-19 has been all over the news recently.  This virus is part of a larger family called Coronaviridae, which includes viruses that can infect only animals, cause mild colds...

CAR-T: How far have we come and where are we going?

In this episode, Doug Olson, one of the first CAR-T patients treated on a clinical trial for CLL almost 10 years ago, details his experiences with this therapy in its earliest days....

How the UK's HTA Agency Uses Real-World Evidence to Develop Guidance

The UK national health technology assessment (HTA) body, the National Institute for Health and Clinical Excellence (NICE), made a long-awaited announcement last week: NICE has expanded the...

Beware of Regional Donor Eligibility Requirements: They're Not Really the Same Everywhere!

Donor Eligibility (DE) determination is a central aspect of how FDA and other regulatory authorities ensure that a product from a single allogeneic donor has acceptable very low risk of...

Demystifying FDA’s KASA Initiative… and how it aims to improve drug product, facility, and corporate quality monitoring

What is KASA and why does FDA need it? Due to issues stemming from the large volume of generic drug applications submitted to the agency and the fact that some of the submissions are have...

Commercializing Gene and Cellular Therapy

Gene and cellular therapy manufacturing requires strict control in current Good Manufacturing Practice (cGMP) facilities.  Designing a facility or finding a contract manufacturer to meet the...

Criticality of Institutional Biosafety Committee for Clinical Studies of Cell and Gene Therapy Products

Conducting clinical trials for innovative gene therapy products that include viral vector-based products and gene-modified cells is not entirely straightforward.  Operationally, there are...