Why An Integrated Approach Ensures Smooth Entry Into The European Market

Simplify your EU launch and boost returns. Learn how to manage regulatory hurdles, access a huge patient population, and gain end-to-end commercial support.

A CFO's Guide To Driving Growth

Navigate the evolving biotech landscape and secure venture capital with insights on strategic partnerships and investor expectations.

Digital Innovation In Pharmacovigilance

Explore how AI can transform your pharmacovigilance efforts and enhance patient safety by leveraging the insights and decision framework outlined here.

Connecting Manufacturers And Providers To The Services Needed For Full End-To-End Patient And Order Management

Streamline complex cell and gene therapy logistics with an integrated platform that connects manufacturers with vital services, providing full visibility and control for a more efficient and successful patient journey.

Crafting Scalable Solutions For Maximum Reach And Success

Is your supply chain ready for a blockbuster cell and gene therapy launch? Industry leaders discuss selecting partners, managing risk, and scaling operations for maximum reach and success.

Maximizing Impact: Strategies For Building Robust Patient Support Programs

Panelists explore the entire patient journey, from diagnosis to treatment, sharing strategies for creating practical, seamless support systems that ensure access to innovative cell and gene therapies.

Navigating Special Regulatory Pathways For Advanced Therapy Development Success

Don't let regulatory hurdles slow you down. Learn from leading experts about special designations like RMAT and PRIME to accelerate your advanced therapy development and ensure success.

The Power Of Integrated Distribution Strategies

Discover the power of integrated distribution for cell and gene therapies. Learn from expert speakers how adaptable partnerships can successfully bring these innovative treatments to more patients.

Navigating The Digital Era And Beyond For Engaging Key Decision Makers In Specialty Pharmacy

Tune in as experts discuss how biopharma companies can effectively engage healthcare decision-makers in the evolving digital landscape.

An Overview Of Contamination Control Strategy (CCS)

Join experts Londa Ritchey and Patrick Nieuwenhuizen as they explore the key role of a contamination control strategy in Annex 1 for ensuring patient safety and continuous manufacturing improvement.

Early Access Programs: What They Are And How To Plan For Them

Explore how early access programs are tailored to individual sufferers of rare, ultra-rare, or life-threatening conditions, as well as cohort programs, which target groups of patients afflicted with the same disease.

Assessing Gaps And Achieving Compliance With Annex 1

In this podcast episode on Annex 1 compliance and gap assessment, Patrick Nieuwenhuizen shares his insights and expertise gleaned from extensive experience in pharmaceutical regulation and compliance.

Navigating The Process Of Technology Transfer

Olena Chervonenko, Associate Director Quality Management and Compliance at PharmaLex, provides deeper insights into technology transfer and essential factors for achieving success.

Navigating The CGT Landscape: Key Takeaways From The FDA's New FAQ

The FDA's new FAQ on cell and gene therapy offers a roadmap for developers. Review key insights from the document, including the importance of early engagement with the FDA, CMC considerations, and more.

Unraveling The Complexity Of Cell Therapy: Advancements And Challenges

Cell therapy has emerged as a powerful tool for addressing critical medical challenges, but its rapid evolution necessitates a clear regulatory framework and consistent terminology.

Navigating The Cell And Gene Regulatory Landscape

Navigating the complex regulatory landscape is essential for cell and gene therapy success. Explore key considerations, challenges, and best practices for companies operating in this space.