KIM C. CAPONE is a Senior Regulatory Analyst with Porzio Life Sciences, LLC. In her role, Ms. Capone assists emerging and established life sciences companies with a wide variety of compliance issues. Ms. Capone is responsible for maintaining the Enforcement Actions Databases of the Porzio Compliance Digest. Through her extensive review of corporate integrity agreements, FDA establishment inspection reports and FDA warning letters, she has developed a thorough knowledge of statutes, regulations, federal health care and FDA requirements, and the codes of conduct that regulate marketing activities.
Ms. Capone is also a member of the team responsible for Porzio AggregateSpendID, the organization's automated tool for the collation and reporting of marketing expenses. In this role, she monitors and analyzes state and federal legislation affecting the sales and marketing practices of the life sciences industry. Additionally, she shares responsibility for customized compliance projects, marketing endeavors, customer support, and training for client product subscriptions. Through her numerous project management responsibilities, she has become familiar with the challenges that life sciences companies face in complying with data collection and state and federal reporting mandates.
Previously, Ms. Capone served on the team responsible for the maintenance and support of the Mid-level Regulations Legend Drugs and Controlled Substances Databases of the Porzio Compliance Digest. While on this team, she has developed a comprehensive understanding of state laws and agency rules that regulate prescriptive and sampling authority of different mid-level practitioners.
For fifteen years prior to joining Porzio Life Sciences, Ms. Capone was employed as a Senior Paralegal by the organization’s parent company, Porzio, Bromberg & Newman P.C. Her work for the law firm involved management and support responsibilities related to mass tort defense litigation for life sciences companies with expertise in database creation and management. Before joining Porzio, Ms. Capone spent eight years performing litigation paralegal work for other law firms.
Ms. Capone co-authored "The Last Two Years: A Summary of 2014 - 2015 Office of Prescription Drug Promotion (OPDP) Enforcement and Relevant FDA Guidance," on March 1, 2016, and "FDA’s Office of Prescription Drug Promotion (OPDP) Enforcement: A Summary of 2013 Warning and Untitled Letters," on February 27, 2014.
Ms. Capone received her B.S. in Business Administration and Management and Paralegal Certification from Montclair State College.