Deadline to Register: Tuesday, June 16, 2015
Join three speakers
for 1.5 hours of the information you need to stay
current.
Christine Kain of Faegre Baker Daniels just published her
article on personalized medicine (Genomic Profiling Is Double-Edged Sword In
Drug Litigation, http://www.law360.com/articles/655100/genomic-profiling-is-double-edged-sword-in-drug-litigation).
Since completion of the Human Genome Project, genomic profiling and the related advent of personalized medicine have
become a hot topic. Many predicted this new genomic
information would lead to targeted drug treatments that work
better with less risk. Along with this optimism came
concern about new litigation, as plaintiffs and defendants seek
and find novel liability theories and defenses. What have we
seen? Translating scientific knowledge into clinical practice has presented difficulties,
some expected and some surprising, but there have been exciting advances, too. And
while plaintiffs have found ways to
use genomic data in products liability cases, defendants also
have found ways to respond to the novel allegations with causation
defenses supported by genomic evidence.
Jennell Bilek of Carlson Caspers will cover
REMS (Risk Evaluation and Mitigation Strategies). REMS are required if FDA
determines that additional safety measures are needed to ensure that the
benefits of the drug outweigh its risks. FDA approved REMS protocols may
limit drug access, and consequently, result in accessibility issues for
companies hoping to perform bioequivalence testing in anticipation of filing an
Abbreviated New Drug Application. The discussion will include a brief
background and the remedies some companies have utilized to gain access.
Amy Fowler of DuVal & Associates will
discuss the proposed rule on Abbreviated New Drug Applications and 505(b)(2)
Applications. The rule is positioned to address two key concerns from an
FTC report on anticompetitive strategies that may delay access to generic drugs
by 1) limiting the availability of 30-month stays of approval on 505(b)(2)
applications and ANDAs that are otherwise ready to be approved and (2)
establishing condition under which a first applicant would forfeit the 180-day
exclusivity period such that approval of subsequent ANDAs would no longer be
blocked.
A continental breakfast will be served
starting at 8:15 a.m. followed by the CLE program at 8:30 a.m. Special
meal requests need to be received no later than Monday, June
15.
Presenters:
Christine Kain, Faegre Baker
Daniels
Jennell Bilek of Carlson
Caspers
Amy Fowler of DuVal &
Associates
CLE Credits:
1.5 Standard CLE Credits
applied for | Event Code: 206470
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, 2015): 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 this event for FREE.
Click here to add the section to your membership and then contact Sue Bores to register for this meeting
at no charge.
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
on Wednesday, June 17.
To register with a check, please mail in this registration form.
Need to cancel? Please see our cancellation policy.
Questions? Contact Sue Bores | 612-278-6325