Accelerating Regulatory Development of ATMPs for patients in need

NDAs Dr Paula Salmikangas, Director of Biopharmaceuticals and ATMPs, has been invited to present at the panel session; ‘Accelerating Regulatory Development Of Advanced Therapy Medicinal Products For Patients In Need’ at The Cell & Gene Meeting on the Mesa, October 4-6 in La Jolla, CA.

This panel features distinguished regulators from the U.S., EU and Japan as they share their views on how different expedited programs are supporting innovation and accelerating advanced therapy product developments for patients with significant unmet needs. Panelists will discuss how to improve the regulatory process and lessons learned from recent experience in this rapidly emerging field, including real world evidence generation. Looking to the future, panelists will share ideas on how to bridge the gap with science and the next step in a product life-cycle. Both in terms of process and scientific review and advice, panelists will be asked whether there are things industry could do better, and whether there are tools that could benefit all regions to improve efficiency in the regulatory authority/sponsor dialog.

The Cell & Gene Meeting on the Mesa is a three-day conference combining discussions between key opinion leaders, senior executives and top academic researchers. The program also includes 60+ presentations by the field’s most promising companies and poster abstracts by leading scientists from around the globe.

The annual Partnering Forum at the Cell & Gene Meeting on the Mesa is the largest partnering meeting organized specifically for the advanced therapies industry. If you register you will be able to request a meeting with Dr. Salmikangas.




Dr Paula Salmikangas, Director of Biopharmaceuticals and ATMPs, NDA Advisory Board