Biological Products Development from Regulatory and CMC Perspective
What regulators look for in a biologics program — regulatory strategy and CMC, read from the other side of the desk by a former FDA reviewer.
The fourth episode of NAPPA Healthcare & Biopharma Insights turns to the part of biologics development that decides whether good science ever reaches a patient: the regulatory path and the chemistry, manufacturing, and controls work that has to hold it up. CMC questions that look procedural early on tend to become the binding constraint later, and regulatory strategy is largely the discipline of anticipating them.
Dr. Audrey Jia, Chief Executive Officer of Wonderfulland and a former FDA reviewer, has assessed biologics submissions from inside the agency and now builds programs that have to satisfy them. This hour covers how she thinks about regulatory strategy for biological products, which CMC considerations matter at which stage, and what a reviewer is reading for when a submission arrives.
The session is open to NAPPA members, partners, and qualified industry guests. Register below to receive Zoom join details.
Key topics.
- ✓ Regulatory strategy for biological products
- ✓ CMC considerations through the development lifecycle
- ✓ How a biologics submission reads from the reviewer's side
- ✓ Practical perspective from former FDA review experience
See how a biologics regulatory path is built, and where sequencing decisions matter most.
Understand which chemistry, manufacturing, and controls questions surface at each development stage.
Learn what an FDA reviewer is actually looking for when a biologics submission lands.
Hear from someone who has worked both sides — FDA review and company leadership.
Reserve your seat.
Registration is free for NAPPA members and qualified industry guests. Join details will be sent to your email immediately after registering.