Health Law and Policy Program

FIRST PLACE

Julia Thibault
Boston University School of Law

America's Oldest Drug Cartel: Civil RICO Action in re Insulin Pricing Litigation and the Case for Overruling the Indirect Purchaser Rule

SECOND PLACE

Jessa Boubker
Boston University School of Law

When Medical Devices Have a Mind of Their Own: The Challenges of Regulating AI

honorable Mention

Jessica Kolanowski
Indiana University Robert H. McKinney School of Law

Why So Trusting?: Informed Consent in the Context of Genetic Research

Vanessa Burrows

Vanessa Burrows is Counsel at Simpson Thacher & Bartlett LLP.  Ms. Burrows advises biopharmaceutical and medical device manufacturers, healthcare and technology companies, hospitals and other healthcare providers on their regulatory and compliance needs, as well as in connection with M&A and capital-raising transactions.  Her previous experience includes serving as HIPAA Privacy Officer and Attorney for the City of Chicago and its Department of Public Health.  She also advised Members of Congress and their staff on FDA matters as a Legislative Attorney with the Congressional Research Service.  She handled healthcare law, administrative law and constitutional law matters during the creation of the Patient Protection and Affordable Care Act (ACA) and the H1N1 pandemic.  Ms. Burrows is a 2006 graduate of American University Washington College of Law.

Jacob Harper

Jacob Harper is an Associate at Morgan Lewis in Washington, DC. Mr. Harper advises stakeholders across the healthcare industry, including hospitals, health systems, large physician group practices, practice management companies, hospices, chain pharmacies, manufacturers, and private equity clients, on an array of healthcare regulatory, transactional, and litigation matters. His practice focuses on compliance, fraud and abuse, and reimbursement matters, self-disclosures to and negotiations with OIG and CMS, internal investigations, provider mergers and acquisitions, and appeals before the PRRB, OMHA, and the Medicare Appeals Council. Before joining Morgan Lewis, Mr. Harper served as a law clerk at OIG and as a senior litigation paralegal at a national healthcare law firm, where he focused on fraud, abuse, and reimbursement matters. He is also a Certified Medical Reimbursement Specialist through the American Medical Billing Association. He graduated with his JD from American University Washington College of Law in 2013.

Sonali Gunawardhana

Sonali Gunawardhana is Chief Counsel- FDA & Regulatory Law at McKesson Corporation.  In this role, Sonali provides regulatory legal support to McKesson’s businesses, including pharmaceutical private label products, 3PL, REMS programs, clinical research programs, pharmaceutical and medical device distribution.  Previously, Ms. Gunawardhana served as outside counsel to a myriad of pharmaceutical and medical device companies while in private practice at Wiley Rein LLP and Shook, Hardy & Bacon LLP respectively. Prior to her tenure in private practice, she served as Regulatory Counsel at the FDA for close to ten years. There she assisted on a variety of legal and policy issues in the following Centers:  the Center for Devices and Radiological Health; the Center for Drug Evaluation and Research; and the Center for Food Safety and Applied Nutrition. Ms. Gunawardhana received a BA from Syracuse University, a MA from Webster University, a MPH from Boston University, a JD from the University of New Hampshire School of Law and a LLM from Washington College of Law, American University.

Garrett Mannchen

Garrett Mannchen is an attorney at the U.S. Department of Health and Human Services in the Office of the General Counsel. In that role, Mr. Mannchen represents the Centers for Medicare & Medicaid Services (CMS) in federal district court litigation.  His portfolio includes challenges to the Medicaid Drug Rebate Program, reimbursement for prescription drugs under Medicare Part B and Part D, decisions of the Provider Reimbursement Review Board, and Medicaid section 1115 demonstration projects.  Before joining HHS, Mr. Mannchen clerked for Judge Roger Wollman on the U.S. Court of Appeals or the Eighth Circuit. Mr. Mannchen is a 2015 summa cum laude graduate of American University Washington College of Law.

Cybil G. Roehrenbeck

Cybil G. Roehrenbeck is a Partner in the Government Relations and Public Affairs group in Hogan Lovells' Washington, DC office, where she is a leader in the firm's health care lobbying practice. She provides counsel on legislative and regulatory opportunities, often focusing on health care reimbursement and emerging health care sectors such as digital health, artificial intelligence, and value-based care. Prior to coming to Hogan Lovells, Ms. Roehrenbeck was a Shareholder in Polsinelli and previously served as Assistant Director, Federal Affairs and Washington Counsel for the American Medical Association, as well as Legislative Counsel on Capitol Hill. Ms. Roehrenbeck holds several leadership positions with the American Bar Association (ABA) and is a member of the ABA’s Standing Committee on Government Affairs. Ms. Roehrenbeck attended the University of Virginia undergrad and earned her law degree from the University of Georgia, completing her third year at the American University Washington College of Law.  She is a member of the bar in Virginia and the District of Columbia.

Alexis Rose

Alexis Rose is a health care consultant with Strategic Management Services. In that role, she works with health care organizations of all types and sizes to implement and assess their compliance programs. For clients under Corporate Integrity Agreements, she works in conjunction with her colleagues to fulfill the role of compliance expert to Board of Directors and an independent reviewer for both arrangements reviews and claims audits. She also provides regulatory research to clients on a wide variety of Centers for Medicare & Medicaid Services (CMS), Office of Inspector General (OIG), and state regulatory matters. Ms. Rose also provides HIPAA and state privacy expertise such as, the development and implementation of HIPAA privacy and security programs, research related to HIPAA and state privacy laws, and support on breach notification responses. Ms. Rose attended Rutgers University for undergrad, has a Master in Public Policy degree from American University, and graduated with her law degree from American University Washington College of Law in 2018. She is a member of the District of Columbia bar and has a Certification in Healthcare Compliance from the Health Care Compliance Association (HCCA).

Chris Smith

Chris Smith is Senior Counsel in the Health Care & Life Sciences and Litigation & Business Disputes practices, in the Washington, DC, office of Epstein Becker Green. His practice focuses on pharmacy law, drug distribution, and reimbursement issues. Before joining Epstein Becker Green, Mr. Smith worked as a Director of Federal Public Policy at a nonprofit trade association that advocates for pro-patient and pro-pharmacy public policy and as a Director of Policy and Regulatory Affairs at a national trade association representing the pharmacist owners, managers, and employees of independent community pharmacies nationwide. He also has a lobbying certificate from the Association of Government Relations Professionals.  He holds an LLM from American University Washington College of Law's Program on Law and Government, a JD from Vanderbilt Law School, and a BA from the University of Richmond.