The FDA gives you a valuable opportunity to get real alignment before you file your IND. If you walk in unprepared, you don’t just waste the meeting. You waste months of your time. While the regulatory information on the FDA website can seem incredibly dense,…  ​ Read More

Thank you, Biocom, for having us! Michael Boyne and Greta Wodarcyk enjoyed being part of the panel alongside speakers Alex Loftis, Farhad Parhami, Ph.D., M.B.A., and Franklin Rice. Clinical planning should drive a company’s entire development strategy from day 1️⃣. Success starts with the end…   ​ Read More

📣 Great opportunity for anyone involved in the drug development process. CatalystBio founders, Greta Wodarcyk and Michael Boyne…Read More

🎉 Congratulations to PolarityBio on their BLA submission! The CatalystBio team is proud to have supported PolarityBio on their BLA submission to the U.S. FDA for SkinTE® – a first-in-class autologous cutaneous multicellular therapy targeting diabetic foot ulcers (DFUs). If approved, this would be the…   ​ Read More

One of our clients is hiring in the Denver-area. This growing start-up working the cell therapy space is looking for: QC Research Scientist: The Quality Control (QC) Scientist supports cGMP manufacturing operations by performing and overseeing analytical testing for release, stability, and in-process control of cell-based…   ​ Read More

We are excited to announce that our Co-Founder and Principal, Greta Wodarcyk, PhD, will be a featured expert at the upcoming  ​ Read More

Michael Boyne, Co-Founder and Principal, will be sharing his deep expertise at the CASSS – Sharing Science Solutions Symposium on the Practical Applications of Mass Spectrometry in the Biotechnology Industry in Costa Mesa, CA. Michael will be sharing his…   ​ Read More

Thank you to everyone who attended this session and joined in on the lively discussion! Special thanks to our host Biocom California, moderator Franklin Rice at The Sights Group, and panelist Mark Kaufmann at Acurex Biosciences.   ​ Read More

Planning your first Pre-IND meeting with the FDA? CatalystBio’s white paper explores when to engage, how to prepare, and key best practices to get the most out of your Pre-IND meeting. Read more here: https://lnkd.in/gXmgbdB2   CatalystBio provides expert guidance to biotech companies at…   ​ Read More

At #BIO2025, Michael Boyne, Co-founder and Principal at CatalystBio, spoke on clinical trial development in the U.S. as part of a panel examining regional approaches to conducting trials and the diverse opportunities available across different countries. The audience also heard valuable insights from Jinhak Kim…   ​ Read More