ART: Advancing Revolutionary Therapies Podcast

Bringing a novel therapeutic to market is an ART. Hear Veristat thought leaders as they draw on their specialized expertise to offer insight on timely, relevant topics that impact clinical development, the regulatory landscape, and patient access to these novel therapies. 

Our focus on novel drug development has led to success when handling the unknowns that arise across complicated therapeutic areas, such as rare/ultra-rare disease, advanced therapies, oncology, and infectious disease trials. Whether you’re just starting out— or have deep clinical development expertise— there is always something new to learn. 

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Feb 10, 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 ...

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Dec 30, 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 ...

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Dec 14, 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 ...

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Nov 30, 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 ...

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Nov 10, 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 ...

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Oct 28, 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 ...

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Sep 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 ...

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Sep 6, 2022

Orphan Drug Designations and Orphan Subsets

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 ...

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Jun 1, 2022

Reasons for Setting Up Natural History Studies & Their Challenges

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 ...

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May 11, 2022

The Current Landscape of Cell and Gene Therapies and Where We are Headed

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 ...

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Apr 26, 2022

Use of PRO In Cell and Gene Therapy Studies

Patient reported outcomes provide an important dimension to assessing the overall patient impact from a novel treatment. Listen as Robin Bliss describes the ...

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Apr 12, 2022

Real-world Considerations When Administering Advanced Therapy Products

Administering advanced therapy products during a clinical trial can bring about many unique circumstances. Listen as Rachel Smith discusses Convection Enhanced Delivery ...

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Mar 29, 2022

Planning the Way Forward in Neurodegenerative Disease Studies

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, ...

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Mar 16, 2022

Opportunities for Virtual and Central Site Models in Cell and Gene Therapy Trials

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 ...

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Mar 2, 2022

An Introduction to Natural History Studies

If you are wondering how natural history studies are relevant to cell and gene therapy development, listen as Chris Kenwood, Principal Statistician with Veristat, ...

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Feb 16, 2022

Common pitfalls to avoid when planning a marketing application for cell and gene therapies

Developing a successful marketing application involves several strategic steps, as described by Kevin Hennegan, Senior Regulatory Strategist for Veristat. Listen as ...

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Dec 16, 2021

Are Autologous Therapies Here to Stay? Are Allogeneic Therapies the Future?

The pros, cons and future of allogeneic versus autologous therapies are explored as Rachel Smith, Portfolio Director for ...

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Nov 17, 2021

EU Post Marketing Requirements for Cell and Gene Therapy Studies

Post-marketing requirements within the European submission process offer conditional approval more flexible than FDA. Rachel Smith, Portfolio Director for Veristat, ...

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Nov 6, 2021

Selecting Endpoints for an Early Phase Cell or Gene Study

The selection of endpoints for a clinical trial relies on clinical relevance combined with statistical reasoning. Robin Bliss, VP of Strategic Consulting for ...

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Oct 21, 2021

Common Pitfalls in Cell Therapy Studies

Listen as Kevin Hennegan, Senior Regulatory Strategist for Veristat, shares some of the common hurdles drug developers face when bringing cell therapies to market ...

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Aug 12, 2021

The Logistics of a Clinical Study Scale up

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 ...

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Jul 15, 2021

Long-Term Follow-Up Studies in Gene Therapy

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 ...

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Jul 1, 2021

Common Pitfalls in Gene Therapy Studies

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 ...

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