We Published Guide for European Biotechs Entering the U.S. RNA Market - Part1

Link: https://www.advancingrna.com/doc/bridging-the-atlantic-a-european-executive-s-guide-to-entering-the-u-s-rna-market-pt-0001

Ahmet C. Berkyurek, Ph.D., Cofounder and CEO of CamMed Therapeutics, has published the first installment of a two-part series with Advancing RNA, offering European biotech leaders a practical roadmap for expanding into the U.S. market.

Part 1, "Bridging the Atlantic: A European Executive's Guide to Entering the U.S. RNA Market," draws on Dr. Berkyurek's experience to compare regulatory pathways across the FDA, EMA, and MHRA, and outlines how differences in designation programs, CMC expectations, and clinical trial authorization processes shape strategy for companies pursuing dual-jurisdiction development. The article also breaks down the main models European companies use to establish a U.S. footprint, from full incorporation to lighter-touch partnership structures and addresses the timing decisions that can make or break a market entry effort.

The piece includes additional contributions from CamMed's Chief Scientific Officer Virginia Castilla Llorente, Ph.D., and board members Kenny Simmen, Ph.D., and Natalie Pankova, Ph.D.

Part 2, covering fundraising, manufacturing, partnerships, and long-term growth, will follow.