How to better prepare patients for a cell or gene therapy trial
Parexel spoke with Doug Olson, Cancer survivor and CAR T-cell patient, about how healthcare providers and trial sponsors can better communicate with patients about CGTs.
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Parexel spoke with Doug Olson, Cancer survivor and CAR T-cell patient, about how healthcare providers and trial sponsors can better communicate with patients about CGTs.
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The FDA released a draft guidance that outlines regulatory considerations for INDs that study multiple versions of a cellular or gene therapy (CGT) product in a single trial.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...
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What is different about cell & gene therapy trials, and what does it take to operationalize them effectively? We break it down into five competencies you need for success.
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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.
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Emma Medin, VP, Pricing & Market Access, shares three payer insights to help you price appropriately for your cell or gene therapy.
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In this article, our gene therapy experts at Health Advances, Parexel’s commercial strategy group, outline considerations for competitively positioning your gene therapy.
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Clinical trials of (CAR) T-cell therapies can present unprecedented enrollment challenges. How can we encourage participation in these trials?
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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,...
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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.
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The unforeseen challenges with clinical trial execution in gene therapy and regenerative medicine studies, such as unchanging FDA regulations, discussed
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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...
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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...
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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...
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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....
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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...
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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...
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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...
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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...
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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...
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