Advancing Revolutionary Therapies | Cell and Gene

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Dec 30, 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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