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Advancing Revolutionary Therapies

ART

Cell and gene therapies have made impressive clinical progress but continue to face big hurdles. Nothing is standard about study design, study conduct or regulatory process in this specialized area.

PublishesTwice monthlyEpisodes26Founded5 years ago
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Arts

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Artwork for Advancing Revolutionary Therapies

Latest Episodes

MDR’s Article 117 brings improved patient safety measures with implications for manufacturers, as they must fulfill a significant set of additional requirements. Listen as Andrea Larrañaga, Associate Manager, Regulatory Affairs at Veristat and her co... more

Comparability studies are a significant issue for those working in biotherapeutics development, as undetected product changes are considered high risk. Listen as Kevin Hennegan, Lisa Erickson and Sarah Roemer take us through several considerations wh... more

When developing a new therapy for a rare disease, a thoughtful, strategic approach early in the development process supports a well-designed study and agreement to your approach from regulatory authorities. Listen to our podcast as Veristat experts s... more

The development of biosimilar products in the US has been progressing since the regulatory pathway was established as part of the Affordable Care Act. Listen as members of Veristat’s Regulatory team delve into the analytical and clinical science of b... more

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Advancing Revolutionary Therapies launched 5 years ago and published 26 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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