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 ...

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...

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...

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...

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...

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 read...

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 a...

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.

Listen as Rachel Smith, Portfolio Director at Veristat, reviews considerations for setting up Natural History studies and the value they bring to rare and ultra-rare clinical research, despite the challenges in their design. 

Cell and gene therapy innovations continue to progress despite their clinical trial complexities. Listen as we replay some of Ewan Campbell’s insights from a recent webinar where Ewan provides a historical recap of the approved cell and gene th...

Patient reported outcomes provide an important dimension to assessing the overall patient impact from a novel treatment. Listen as Robin Bliss describes the appropriate execution of PROs using clearly defined endpoints, measurable changes withi...

Administering advanced therapy products during a clinical trial can bring about many unique circumstances. Listen as Rachel Smith discusses Convection Enhanced Delivery (CED) which delivers medicines directly into the brain. Learn how to prepar...

Clinical trials involving advanced therapies for the treatment of Central Nervous System (CNS) do not follow a classic road map to market. Listen as Ewan Campbell, Advanced Therapy and Biotech Director for Veristat outlines some of the unique c...

The roadmap to market for a cell or gene therapy is undoubtedly challenging, but also filled with great promise. Listen as we replay some of Rachel Smith’s insights from our recent webinar where Rachel reviews virtual and central site models in...

If you are wondering how natural history studies are relevant to cell and gene therapy development, listen as Chris Kenwood, Principal Statistician with Veristat, takes us through an introduction. Learn how natural history studies provide evide...

Developing a successful marketing application involves several strategic steps, as described by Kevin Hennegan, Senior Regulatory Strategist for Veristat. Listen as Kevin identifies some of the key components of a cell & gene therapy market...

Our cell and gene experts are back for season two of ART Podcast starting next week! Listen to the trailer to learn more about some of the topics we’ll be covering.

The pros, cons and future of allogeneic versus autologous therapies are explored as Rachel Smith, Portfolio Director for Veristat, shares her observations on the impact of these techniques on advanced cell-based therapies and what the next deca...

Post-marketing requirements within the European submission process offer conditional approval more flexible than FDA. Rachel Smith, Portfolio Director for Veristat, discusses the three types of post-marketing requirements that can be requested ...

The selection of endpoints for a clinical trial relies on clinical relevance combined with statistical reasoning. Robin Bliss, PhD, and VP of Strategic Consulting for Veristat, takes us through the how-to’s of selecting appropriate endpoints fo...

Scaling up from phase 1 to global phase II/III trials to beyond marketing approval has several implications on a sponsor’s commercial strategy. Hear from Rachel Smith, Portfolio Director for Veristat, as she uses our recent work with a biotech ...

Rachel Smith, Portfolio Director for Veristat, takes us through a number of pitfalls to avoid when planning for a gene therapy study. With the stakes high and having conducted trials for the first gene therapy approved in Europe, put Rachel’s l...

Mariana Oviedo, Project Manager for Veristat, provides an overview of the key items that must be taken into consideration when designing and running a long-term follow-up study for a gene therapy product, sharing experiences from both a scienti...