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Checking the Vital Signs of Pharmaceutical Law – Hot Topics for Today and the Future

Date: Thursday, June 18, 2015 8:30 AM to 10:00 AM
Venue: Honors Room / Minnesota State Bar Association  Minneapolis, MN United States  Get Directions
Total Price: $25.00

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, 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.


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 


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

No sessions have been associated with this event.