Advancing Revolutionary Therapies

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. 

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.  

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.

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.  

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.

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.

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”.   

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. 

FDA’s Orphan Drug Designation provides incentives to encourage the development of treatments for rare diseases. Listen as Mara Holinger, SVP of Regulatory Affairs at Veristat and members of the regulatory team shed light on ODD classification and the strategic use of subsets in study design. 

Our Regulatory experts kick off Season 3 of the ART Podcast series in just a few weeks! Listen to the trailer to learn more about some of the topics we’ll be covering.