Advancing Revolutionary Therapies

About 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.

Publisher

ART

Category

arts

Language

en

Explicit

No

First episode

12 Oct 2021

Latest episode

8 Feb 2023

Latest episodes

26 episodes in the feed.

1. 

   8 Feb 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.

2. 

   24 Jan 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.

3. 

   15 Dec 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.

Reach and audience

Public platform figures. Ratings count people who left a rating, not total listeners.

Apple Podcasts (US)

5.0 / 5

1 ratings

Contact Advancing Revolutionary Therapies

Guest appearances

Books guests

Based on episode analysis; this does not confirm that the show is currently accepting guests.