Navigating Combination Product Pathways: Industry Experiences and FDA’s Role

Industry experts and regulatory officials will share real-world experiences associated with the intersection of drugs and device topics including: regulatory pathways, interactions with CDER/CDRH, approaches to establish shelf life/stability, risk management, quality management systems, and drug-biologic-device compatibility. Join FDA, FDA Jurisdictional Officers, and industry in this blended panel discussion!

Moderators

• Chin-Wei Soo, Global Regulatory Head – CMC/Devices and Combination Products, Genentech
• Rumi Young, Director, Regulatory Policy, BD

Speakers

• Chelsea O’Connell, Director, Global & Regulatory and R&D Policy at Amgen
• Kristina Lauritsen, Combination Products Regulator, Center for Drug Evaluation and Research (CDER) FDA
• Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA
• Winifred Wu, President and Principal Advisor, Strategic Regulatory Partners, LLC