Ms. Kulkarni provides counsel to pharmaceutical, biotechnology, and medical device companies. She offers insight on federal and state legal, legislative, regulatory, and enforcement matters. In this capacity, she has analyzed existing and proposed legislation, regulation, and policies; drafted legislative and regulatory language, testimony, and white papers; and educated state and federal legislators and policy makers.
Ms. Kulkarni has more than 10 years of experience in the health care industry, including working for pharmaceutical companies in government affairs and sales positions. Immediately prior to joining the firm, she completed a legal internship at the U.S. Food and Drug Administration’s Office of Policy in the Office of the Commissioner where she provided input on First Amendment-related matters; and worked on Food Safety Modernization Act’s Proposed Rule for Produce Safety.
Ms. Kulkarni obtained her Juris Doctor degree from George Mason University School of Law, where she served as a Writing Fellow, teaching first year law students legal research, writing, and analysis. She also served on the school’s Moot Court Board and represented the school on the Moot Court Board’s National Team. She received her bachelor’s degree magna cum laude from Saint Joseph’s University.
- Shruti R. Kulkarni, et al., What’s in a Number? Recommending Practicality in the DATA 2000 Patient Limits, 12 J. Opioid Manag. 243 (2016).
- National Sheriffs’ Association
June 16, 2019
Louisville, KY
“Innovative Law-Enforcement Led Programs to Reduce the Overdose Epidemic”
Presenter
- International Conference on Opioids
June 9 – 11, 2019
Boston, MA
“Finding Your Footing in an Ever Changing Landscape: A Legal, Regulatory, and Public Health Update”
Presenter
- ACI Controlled Substances Summit
May 29 – 30, 2019
Washington, DC
“Understanding the Implications of the National Policy Response to the Opioid Overdose Crisis”
Presenter
- Rx Drug Abuse & Heroin Summit
April 22 – 25, 2019
Atlanta, GA
“Opioid Use Disorder Interventions and Treatment in Jails: Policy and Practice”
Presenter
- National Foundation for Women Legislators Annual Conference
November 14, 2018
Washington, DC
“Doctors in Distress: Avoiding Health Care Provider Shortages”
Presenter
- National Association of State Controlled Substances Authorities Annual Conference
October 31, 2018
“Gender Differences and Substance Abuse: Eliminate Discrimination, Improve Treatment and Save Lives”
Presenter
- 5th Annual Human Abuse and Liability Summit
November 6, 2018
Correct for Gender-Based Disparities in Drug R&D and Law Enforcement
Presenter
- International Conference on Opioids
June 10, 2018
Boston, MA
“Warm Handoff: Bridging the Gap Between Overdose and Treatment”
Presenter
- Rx Drug Abuse and Heroin Summit
April 22-25, 2018
Atlanta, GA
“Gender Differences and Substance Abuse: Eliminate Discrimination, Improve Treatment and Save Lives”
Presenter
- National Sheriffs’ Association
February 11, 2018
Washington, D.C.
“Warm Handoff: Bringing the Gap Between Overdose and Treatment”
Presenter
- ACI’s Legal, Regulatory, & Compliance Forum on Controlled Substances
January 29, 2018
Washington, D.C.
“Politics and Policy of Controlled Substances in View of the Opioid Overdose Crisis”
Presenter
- Abuse Deterrent Formulations Critical Update
December 7, 2017
Philadelphia, PA
“Legislative Initiatives Addressing the Opioid Epidemic”
Presenter
- National Criminal Justice Association
July 30, 2017
Long Beach, California
“Innovative Law Enforcement-Led Programs Save Lives”
Presenter
- Metropolitan Washington Council of Governments
May 9, 2017
Washington, D.C.
“Gender Differences and Substance Use Disorders: Eliminate Discrimination, Improve Treatment, and Save Lives”
Presenter
- National Rx Drug Abuse and Heroin Summit
April 18-19, 2017
Atlanta, GA
“Wielding Women’s Influence To Eliminate Stigma, Improve Health Care, and Save Lives”
Presenter
“Save Lives, Save Costs: Help Law Enforcement Reduce the Opioid Overdose Epidemic”
Presenter
- Abuse-Deterrent Formulations Summit
March 7, 2017
Alexandria, Virginia
“Aligning Market Objectives and Policy for National Public Health”
Presenter
- National Sheriffs’ Association
February 5, 2017
Washington, D.C.
“Shift in Community Policing: Sheriffs’ Innovative Substance Use Programs to Save Lives and Dollars”
Presenter