日本時間のAM2～4時という厳しい時間帯ではありますが、米国特許庁(USPTO)と米国薬事当局(US FDA)のスタートアップのための合同セミナーが開催されるそうです。
Strategies for biotech and medtech startups: Successfully navigating the USPTO and FDA | USPTO
アジェンダは現地時間で下記になるそうです。
Agenda
All times listed are in PT.
| Time | Topic | Speaker/Panelist |
|---|---|---|
|
Master of Ceremony: Laure Clark, Senior Director, Federal Policy & Government Affairs, Biocom California |
||
| 10:00-10:10 a.m. | Opening Remarks |
Stephen Koziol, Regional Director (Acting), USPTO |
| 10:10-11:10 a.m. | Navigating the USPTO application process |
Jonathan Teixeira Moffat, TC 3700 Director, USPTO Brandon Fetterolf, TC 1600 Director (Acting), USPTO |
| Break (5 minutes) | ||
| 11:15 a.m.-12:15 p.m. | Navigating through the FDA approval process |
Kevin Bugin, Deputy Director of Operations, CDER, FDA Barbara Zimmerman, Deputy Director for Regulatory Programs, CDRH, FDA |
| Break (10 minutes) | ||
| 12:25-1:55 p.m. | A guided panel discussion with USPTO, FDA, and industry experts |
Moderator: Laure Clark, Senior Director, Federal Policy & Government Affairs, Biocom California Linda Horner, Administrative Patent Judge, PTAB, USPTO Mary Till, Senior Legal Advisor, OPLA, USPTO Jonathan Teixeira Moffat, TC 3700 Director, USPTO Brandon Fetterolf, TC 1600 Director (Acting), USPTO Kevin Bugin, Deputy Director of Operations, CDER, FDA Barbara Zimmerman, Deputy Director for Regulatory Programs, CDRH, FDA Tom Cowan, Partner, Knobbe Martens Kimberly Miller, Partner, Knobbe Martens |
| 1:55-2:00 p.m. | Closing remarks |
Stephen Koziol, Regional Director (Acting), USPTO |
