Mastering Gene Therapy and Companion Diagnostics Trials: The EU Regulatory Playbook

Discover an informative webinar that will deliver essential insights for biotech and specialty pharma companies planning gene therapy (GMO) trials with companion diagnostics (CDx) in the European Union (EU), as well as strategies for successful trial implementation.

In an era where precision medicine is revolutionizing rare disease treatment, one critical challenge remains: many patients still lack access to the CDx tests needed to guide targeted therapies.

While genetic biomarker testing has become a cornerstone of personalized medicine, significant barriers persist—particularly for those with rare and neurological conditions—limiting their ability to receive the most effective treatments.

This gap in real-world diagnostic accessibility, combined with the increasing sophistication of GMO trials, presents unprecedented challenges for trial sponsors navigating the complex intersection of GMO regulations and CDx requirements within the EU. As these requirements become increasingly stringent, understanding the nuanced European regulatory landscape has become crucial for ensuring successful trial planning and execution.

Through practical case studies and real-world examples, the expert speakers will explore the intricate regulatory pathways and operational considerations that impact trial readiness and timeline management, with a focus on rare diseases and the unique challenges faced in neurological indications. The key areas of focus include:

• A clear understanding of the latest EU regulatory requirements for conducting GMO trials with CDx
• Strategic approaches to navigate complex European submission processes and ensure regulatory compliance
• Key operational readiness factors that can impact trial execution from site selection to logistics
• Essential insights for US-based sponsors looking to successfully conduct GMO trials in Europe

This webinar is designed for regulatory and clinical leaders who need to confidently navigate the evolving European regulatory landscape while ensuring smooth and efficient trial execution. Attendees will examine actionable strategies to streamline submissions, maintain compliance and tackle operational hurdles in GMO trials with CDx—empowering them to drive successful outcomes in their gene therapy programs.

Register for this webinar today to unlock pivotal insights for biotech and specialty pharma companies embarking on gene therapy trials with companion diagnostics in the EU.

Speakers

Mesfin James, Vice President, Head of Regulatory Affairs, TFS HealthScience

Mesfin James is a seasoned regulatory affairs professional with an extensive career spanning over 17 years in the clinical research sector. His invaluable expertise has facilitated multinational, global clinical trials throughout all phases of development and across diverse therapeutic domains.

His profound knowledge is particularly notable in oncology and rare diseases, and he has played a pivotal role in advancing regulatory activities across various regions, including the EU, the Americas, Asia Pacific, North Africa and the Middle East.

His rich experience encompasses a broad spectrum ranging from pharmaceuticals to small and large molecules, GMO-based vaccines and gene therapy products. He is well-versed in the meticulous compilation, review and collation of regulatory dossiers and adept at forging meaningful connections with regulatory authorities and external vendors. Mesfin’s collaborative spirit and keen insight extend to his pivotal role in supporting clinical development activities, providing invaluable regulatory strategy and guidance to cross-functional teams and sponsors across various product types and therapeutic areas.

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Lakshmi Guduri, Senior Director, Project Management, TFS HealthScience

Lakshmi Guduri is a seasoned professional with 16 years of expertise in the pharmaceutical, biotech and CRO industries. With over a decade of global project management experience, she excels in leading cross-functional teams and navigating the complexities of balancing operational needs with financial considerations to successfully deliver programs from start to finish.

Lakshmi’s strategic insight and critical thinking abilities allow her to anticipate challenges and develop innovative solutions that drive project success. Her comprehensive knowledge spans all phases of clinical trials, with experience in diverse global markets, including APAC, Europe and North America. Her expertise covers a broad range of therapeutic areas, such as gene & cell therapy, rare diseases, neuroscience, respiratory, chronic inflammation, immunology, oncology, dermatology, CVM and endocrinology.

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