Advancing Revolutionary Therapies
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.
Podcasting since 2021 • 26 episodes
Advancing Revolutionary Therapies
Latest Episodes
The influence of MDR’s Article 117 in the Marketing of Combination Products
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 ...
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Season 3
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Episode 9
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10:30
Apples to Apples: Playing the Comparability Game in Biotherapeutics Development
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 considerati...
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Season 3
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Episode 8
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16:42
Considerations for Developing Rare Disease Treatments
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 exp...
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Season 3
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Episode 7
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11:03
Regulatory Considerations for Biosimilars Development in the U.S.
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 scienc...
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Season 3
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Episode 6
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15:11
The Importance of Regulatory Project Management
Sponsors are familiar with the role of a Regulatory Strategist on the core team but have less familiarity with the responsibilities of a Project Manager. Listen as members of Veristat’s regulatory team bring to light the invaluable contribution...
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Season 3
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Episode 5
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8:10