Join Foley Hoag LLP for an FDA and Life Sciences Summit, “From Concept to Launch and Thereafter: Key Issues for Pre-Clinical/Clinical/Early-to-Mid Stage Medical Products Companies.” Anchored by a case study, this full-day multisession event will provide a legal, regulatory, and policy introduction to those new to the pharmaceutical, biopharmaceutical, medical device, and medical technology fields (or to those who could use a refresher) - highlighting common issues, considerations, and obstacles surrounding the development, launch, marketing and licensing of medical products. The Summit will offer thought provoking discussions by leading professionals addressing cutting-edge issues and other hot topics. The Summit will include interactive networking breaks, lunch and a post-Summit reception.
Participation in The Summit will be in-person only.
AGENDA
| 8:00 - 9:00 AM |
Continental Breakfast |
| 9:00 - 9:15 AM |
Welcome and Review of Hypothetical Case Study
- Bryant Godfrey - Partner, Foley Hoag
- Jim Bucking - Managing Partner, Foley Hoag
|
| 9:15 - 10:00 AM |
Topic 1: FDA Considerations
- Bryant Godfrey - Partner, Foley Hoag
- Areta Kupchyk - Partner, Foley Hoag
- Tina Papagiannopolous - Counsel, Foley Hoag
- Matthew Piscitelli - Associate, Foley Hoag
|
| 10:00 - 10:45 AM |
Topic 2: Reimbursement and Healthcare Compliance
- Tom Barker - Partner, Foley Hoag
- Colin Zick - Partner, Foley Hoag
|
| 10:45 - 11:00 AM |
Networking Break |
| 11:00 - 12:00 PM |
Topic 3: Government Investigations, Labor and Employment, and Insurance Recovery Considerations
- Christopher Feudo - Partner, Foley Hoag
- Christopher Mosley - Partner, Foley Hoag
- Veronica Renzi - Partner, Foley Hoag
|
| 12:00 - 1:15 PM |
Lunch and In-house Perspectives Panel
- Guled Adam - General Counsel, Sobi
- Stephen Kim - Chief Legal Officer, Avicanna
- Damian Wilmot - Chief Legal Officer, BridgeBio
- Bryant Godfrey - Partner, Foley Hoag (Moderator)
.png "Guled Adam") .png "Stephen Kim") .png "Damian Wilmot") |
| 1:15 - 2:00 PM |
Topic 4: Intellectual Property and Trademark Considerations and Timing
- Jeffrey I. D. Lewis, Partner, Foley Hoag
- Danit Halberstein, Associate, Foley Hoag
- Lucas Watkins, Ph.D, Partner, Foley Hoag
- Don Ware, Partner, Foley Hoag
|
| 2:00 - 2:45 PM |
Topic 5: Hatch-Waxman / Orange Book
- Jeffrey I. D. Lewis - Partner, Foley Hoag
- Matthew Piscitelli - Associate, Foley Hoag
- Lucas Watkins, Ph.D - Partner, Foley Hoag
|
| 2:45 - 3:30 PM |
Topic 6: Licensing
- Sarah Cooleybeck - Partner, Foley Hoag
- Sumi Sedor - Partner, Foley Hoag
|
| 3:30 - 3:45 PM |
Networking Break |
| 3:45 - 4:30 PM |
Topic 7: Antitrust and HSR Considerations
- Austin A.B. Ownbey - Counsel, Foley Hoag
- Tina Papagiannopoulos - Counsel, Foley Hoag
|
| 4:30 - 5:00 PM |
Question and Answer Session and Closing |
| 5:00 - 7:00 PM |
Reception |
CLE credit for this course is available in New York and California. This program is offering 5.0 Areas of Professional Practice CLE credits in NY, and 5.0 General CLE credits in CA. The program is appropriate for both newly admitted attorneys and experienced attorneys. Please note that CLE credit is only valid for live attendance. At this time, we are not able to provide credit for recorded views. Please contact us for details regarding CLE.
For more information about this event, please email
Christina Hawk.
