Obtain Regulatory Approval for Gene Therapy
& Gene Editing Therapeutics

Welcome to the Gene Therapy Regulatory Affairs Summit

Overcome Regulatory Hurdles Across Non-Clinical, Clinical & CMC Functions from Pre-IND Through to Approval and Satisfy Regulatory Requirements for Gene Therapies by Demonstrating Safety & Efficacy

With 2023 welcoming newly FDA-approved gene therapies from BioMarin, Krystal Biotech and Sarepta Therapeutics, many more treatments are hot on their heels for approval, investment is pouring into developing gene therapies and the role of regulatory affairs has never been more important.

As the first ever regulatory affairs forum wholly dedicated to gene therapy, this meeting uniquely unites regulatory bodies and the leading regulatory personnel across big pharma and innovative biotech to discuss the hottest topics, identify industry bottlenecks and offer actionable insights.

Don’t miss out on this unrivalled opportunity to inform your trial design, perfect your CMC approach and supercharge your global submission strategy for regulatory success.

Join 80+ industry leaders from 4D Molecular Therapeutics, Advanced Cell & Gene Therapy, Adverum Biotechnologies, Astrazeneca, Bridge Bio, Health Canada, Omega Therapeutics, Opus Genetics, Regeneron Pharmaceuticals, Sangamo Therapeutics, Solid Biosciences, Spark Therapeutics, Ultragenyx Pharmaceutical, and more…

17

EXPERT SPEAKERS FROM INDUSTRY LEADING COMPANIES

5

HOURS OF NETWORKING OPPORTUNITIES

3

DAYS OF CAREFULLY
CURATED CONTENT

1

PRE-CONFERENCE
WORKSHOP DAY

Download the Full Event Guide for more information on:

  • 17+ Expert Speaker Faculty
  • Full access to the 3-day conference agenda
  • Pre-conference workshop day details
  • Audience Breakdown
  • & more
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World-Class Speaker Faculty Includes:

Anastasia Yemelyanova Headshot

Anastasia Yemelyanova

Regulatory Affairs CMC Lead

Spark Therapeutics

Brian Baker Headshot

Brian Baker

Senior Director of IVD Regulatory Affairs

Regeneron Pharmaceuticals

Deirdre Harwood Headshot

Deirdre Harwood

Senior Director of Regulatory Affairs

Ultragenyx Pharmaceutical

Jim Wang Headshot

Jim Wang

Chief Regulatory Officer

Adverum

Omar Tounekti Headshot

Omar Tounekti

Manager

Health Canada

Sarah Tuller Headshot

Sarah Tuller

Chief Regulatory Officer

Opus Genetics

Thomas Powers Headshot

Thomas Powers

Senior Principal Scientist

Pfizer

Yao-Yao Zhu Headshot

Yao-Yao Zhu

Director Global Regulatory Affairs & ex-FDA

AstraZeneca

Exclusive Interviews From the Likes of:

Yao-Yao Zhu

Ex-FDA & Director of Global Regulatory Affairs

AstraZeneca

Join your Gene Therapy Peers from the likes of:

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Previous Gene Therapy Event Series Attendees Have Said:

“I think the diversity of discussions and presentations was extremely useful. Overall, an excellent conference and well organized.”

Takeda Logo
Johnson and Johnson Logo

“Direct feedback from influential Health Authority staff, which added to the overall conference value”

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