Advancing Revolutionary Therapies

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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.

  1. 02/08/2023

    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 her colleagues, Laura Ocaña and Gemma Dorrego, discuss the Article and its influence in the marketing of combination products.

    11 min

  2. 01/24/2023

    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 considerations when Playing the Comparability Game in Biotherapeutics Development.

    17 min

  3. 12/15/2022

    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 experts share important considerations to reduce your regulatory risk along the way.

    11 min

  4. 12/06/2022

    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 science of biosimilars and their regulatory pathway.

    15 min

  5. 11/15/2022

    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 contributions and responsibilities of the Regulatory Project Manager, known for their problem-solving mindset.

    8 min

  6. 10/31/2022

    CMC Pitfalls: From Benchtop to IND

    Listen as members of Veristat’s regulatory team outline the fundamentals— and the pitfalls— as you determine your readiness to file an Investigational New Drug (IND) from a manufacturing perspective.

    13 min

  7. 10/18/2022

    Marketing Application Best Practices for Publishing

    Hear members of Veristat’s Regulatory team guide listeners through several publishing best practices to consider when planning your marketing application. Get a jump start by learning the key steps that go into making documents “submission ready”.

    10 min

  8. 09/22/2022

    Emergency Use Authorizations

    In this ART podcast, Kevin Hennegan, Veristat’s Director of North American Regulatory Affairs, takes us through the many nuances key to the success of an Emergency Use Authorization application.

    9 min
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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.

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