MSBA Food, Drug & Device Law Section

Annual Report

2019-2020

Section Membership
As of July 1, 2020, the FDD Law Section has 173 members.

Financial Status
The Section had an account balance of $8,926.45 as of May 31, 2020.

CLEs & Events
The Section hosted/co-hosted 7 CLE programs and events in fiscal year 2019-2020.   

Program/Event Title

Date

Event Code

CLE Credits

Number of Attendees

Regulatory and Legal Challenges Presented by COVID-19 plus Annual Elections

06/22/20

311879

1.25 Standard

33

Navigating FDA’s Emergency Use Program During the COVID-19 Pandemic

05/07/20

304827

1.0 Standard

84

Annual FDA Forum - Keynote Speaker Dr Susan Alpert PhD, MD

03/04/20

295824

3.0 Standard

89

Digital Health Software, Does FDA Intend to Regulate It or Not? (co-sponsored with the Health Law Section)

12/20/19

282900

1.0 Standard

54

GDPR and CCPA - The New Data Privacy Regime

11/13/19

281387

1.0 Standard

15

How to avoid “going viral” with the FDA

10/29/19

280655

1.0 Standard

37

The 2019 Fall FDD Law Kick-off

10/24/19

NA

NA

21


Annual Meeting and Election Results

The Section’s Annual Meeting was held on June 22, 2020 and 33 people attended via webinar.

Council Officers:
The following officers were elected to serve on the Section’s Governing Council from July 1, 2020 through June 30, 2021:

Chair:  Aaron Hage, DuVal & Associates, PA
Vice Chair:  Ranelle Leier, Fox Rothschild LLP
Treasurer:  Elie Biel, Faegre Drinker Biddle & Reath LLP
Secretary:  Andrew G. Jackson, Faegre Drinker Biddle & Reath LLP

Council Members:
The following members were re-elected and/or will continue to serve their term on the Section’s Governing Council starting July 1, 2020:

• Jennell Bilek, Carlson Caspers Vandenburgh Lindquist & Schuman PA
• Patricia Kaufman, Stinson LLP (Past Chair)
• Kelly Laudon, Jones Day®
• Amanda Johnston, Gardner Law
• Josh Kim, Stinson LLP
• Allison Lange-Garrison, Norton Rose Fulbright US LLP
• Elizabeth Luoma, Cardiovascular Systems, Inc.
• Heather Potter, Gardner Law 
• Michelle Tessier, Faegre Drinker Biddle & Reath LLP
• Melissa Weiner, Pearson, Simon & Warshaw, LLP

The following candidates were newly-elected to serve a two-year term on the Section’s Governing Council beginning July 1, 2020 and ending June 30, 2022:

• James Babbitt, Legal & Compliance Manager | MMCAP Infuse - MN Dept. of Administration
• Emily Bodtke Zambrana, Associate Attorney | Faegre Drinker Biddle & Reath LLP

Given the current Section Bylaws, the following Council members have completed their third term and may continue to participate optionally as non-voting consultants: 

• Thomas Beimers, Hogan Lovells
• Amy Fowler, Pathmaker FDA Law 
• David Graham, Dykema Gossett PLLC
• Ranelle Leier, Fox Rothschild LLP

Diversity and Inclusion 

• Created a Diversity & Inclusion Subcommittee within the Council; 
• Strategic about engaging new lawyers and law students – prioritized involvement in the bar events at the local law schools;
• Arranged a Diverse Women GCs in Life Sciences Panel presentation in May, which had to be postponed due to COVID-19.

Other Section Accomplishments 

  • This year’s Annual half-day FDA forum had national keynote speaker Dr Susan Alpert PhD, MD – bringing in the largest attendance to date for the forum - and providing relevant updates on legal topics in the Food, Drug & Device industries;
  • Increased outreach to industry and non-legal professionals through the Society of Regulatory Affairs Professionals and through publication of events on the Medical Alley community event page - obtained a new relationship with the Medical Alley Association, a health innovation network of professionals, with the opportunity to outreach to prospective section members;
  • Continued partnering with the MSBA Health Law Section and the Mitchell Hamline School of Law: Health Law Institute with programming; 
  • Recruited a law student liaison for each local law school this term: University of Minnesota Law School, Mitchell Hamline School of Law, and University of St. Thomas Minnesota School of Law;
  • Established a Membership subcommittee along with a Diversity & Inclusion subcommittee within the Council to focus on the relevant needs within these scopes.

Submitted By: 

Tricia Kaufman, 2019-2020 Section Chair | Date: 7/15/20