Panel Discussion: Navigating Global Regulatory Expectations for Cell & Gene Therapy Development

Time: 9:00 am
day: Conference Day Two

Details:

As cell and gene therapy programs become increasingly global, developers must align with diverse regulatory frameworks across regions. This session explores what’s required to successfully advance programs through non-clinical, CMC, and clinical milestones in markets such as Europe, Asia-Pacific, and Latin America.

• Understanding regional differences in CTA requirements for advanced therapies
• Preparing CMC and comparability packages for international regulatory review
• Leveraging accelerated pathways and early engagement opportunities outside the U.S.
• Opportunities for global harmonization and early agency engagement in advanced therapy programs

Speakers:

Rajesh Thangapazham Dr. Rajesh Thangapazham is an experienced global regulatory affairs strategist specializing in regenerative medicine, cell and gene therapies, ATMPs, mRNA/LNP therapeutics, and emerging technologies such Read more

Brett Howard Brett Howard is a Senior Director of US Regulatory Policy at the US Pharmacopeia, where he manages USP's regulatory efforts concerning pharmaceutical quality, covering both Read more

Domingos Savio Silva Junior Domingos S. S. Júnior is a private equity manager and lead investor at DSJ Capital, an investment firm he founded in 2017 that specialises in Read more