Deadline to
Register: Tuesday, October 24, 2017
Registration begins and lunch will be
provided at 11:45 a.m.
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December of 2016, the 21st Century Cures Act was
signed into law, providing interactive regulatory paths for regenerative
medicine therapies.
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Summer of 2017 marked the first FDA-approved
genetic engineering therapy to turn a patient’s own blood into an autologous
vaccine by changing the way white blood cells function.
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423 North American companies are currently
concentrating entrepreneurial resources on regenerative medicine
therapies.
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In H1 2017, global regenerative medicine
companies raised over $4 BILLION of investor capital to finance research,
development, and commercialization of new therapies!
The exciting science of
Regenerative Medicine develops ways to replace, re-engineer, or regenerate human
cells, tissues, and organs to restore normal function. Many U.S. firms are
pursuing the FDA’s new Regenerative Medicine Advanced Therapy (RMAT) designation
under the 21st Century Cures Act, which facilitates expedited reviews and
approvals of these groundbreaking therapies. Join us for a discussion
about the legal considerations for commercializing a regenerative medicine
innovation. This snapshot will focus on regulatory concerns and litigation
in this emerging space.
Presenters:
Jennell C
Bilek , Ph.D., Pharm.D. | Attorney at Carlson Caspers
Amy Fowler, RAC, JD,
Founder and President | Pathmaker FDA Law
CLE Credits:
1.0 Ethics
CLE Credit Applied for
| Event Code: 249124
Cost:
Food Drug & Device Law Section Member: $15.00
MSBA Member not
in the section: $20.00
Non-Member: $25.00
Law
Student: Free
New Admittees (Attorneys Admitted to the Minnesota Bar
after January 1, 2017): Free
Join the Food Drug & Device Law Section:
MSBA members who are not members of the Food Drug & Device Law
Section can join the section & attend for FREE.
Non-attorneys who are not eligible for membership in the MSBA can join the
Food Drug & Device Law Section. Details are available here.
Remote Participation:
Remote attendance is available. Please indicate that you will attend
remotely when registering. Instructions will be sent via e-mail a day
prior on Wednesday, October 25.
To register with a check, please mail in this
registration form.
Need to cancel? Please see our cancellation policy.
Want more information about the
Food Drug & Device Law Section?
Questions? Contact Geen Mui |
612-278-6346
The MSBA is committed to creating an inclusive environment in which all
members can participate fully. If you need reasonable accommodations to
participate in this event, please notify Geen Mui via phone or email: gmui@mnbar.org. Please
provide notification at least 72 hours prior to the meeting to allow sufficient
time to make arrangements for accommodations. Thank you.