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Experience
Counsel to Internet-based Infectious Disease Medical Clinic*
Served as lead strategic design and regulatory counsel in the formation, development and growth of the highest volume Internet-enabled, multistate-physician medical clinic focused on infectious disease diagnosis and treatment.
Multihospital Internal Investigation Compliance Counsel*
Served as lead compliance counsel in a multihospital internal investigation of clinical research misconduct and improper research billing, resulting in no sanctions from the FDA, OHRP, ORI or CMS.
Private Equity Funded Healthcare Joint Venture*
Acted as lead regulatory and corporate counsel in the formation of a private equity funded joint venture to acquire an existing life insurance company and to repurpose the company into a new Medicare Part D insurance provider serving over 100,000 people.
Development of National Clinical Research Network*
Led strategic counsel for the development of a multihospital, nationwide clinical research network conducting industry-sponsored and NIH-funded clinical studies.
Sale of Physician Group*
Served as lead regulatory and corporate counsel in the sale of a 70-physician anesthesia group to a practice management company funded by private equity.
FDA 510(k) Approval for In Vitro Device*
Led strategic and regulatory counsel in the application to the FDA for 51O(k) approval of an in vitro diagnostic medical device.
Franchise of Medical Management Company*
Served as lead health law counsel in the structuring and implementation of a multi-state franchise operation of a medical practice management company.
Biospecimen Collection and Material Transfer Program*
Served as led regulatory counsel in the development of a nation-wide biospecimen and clinical data collection and material transfer program for one of the largest for-profit health care systems in the country.
Public Health System Clinical Research Program*
Served as special counsel to the office of general counsel to co-architect the formation, development, and implementation of an office of sponsored research in one of the largest public health systems in the country.
* Prior Experience
