The Fifth Annual AUWCL National Health Law Writing Competition is Now Closed
Thank you for participating in the Fifth Annual AUWCL National Health Law Writing Competition. This year's winners are noted below. Please check back in September 2020 for information about our Sixth Annual National Health Law Writing Competition.
America's Oldest Drug Cartel: Civil RICO Action in re Insulin Pricing Litigation and the Case for Overruling the Indirect Purchaser Rule
Jessa Boubker Boston University School of Law
When Medical Devices Have a Mind of Their Own: The Challenges of Regulating AI
Jessica Kolanowski Indiana University Robert H. McKinney School of Law
Why So Trusting?: Informed Consent in the Context of Genetic Research
Meet Our Judges
Sonali Gunawardhana is Counsel at the law firm of Shook, Hardy & Bacon L.L.P. in Washington, DC. She draws on her nearly 10 years’ experience as an attorney at FDA to offer clients detailed and practical guidance on how to avoid and resolve FDA regulatory challenges. Ms. Gunawardhana’s practice focuses on the rapidly changing FDA regulatory requirements for bringing pharmaceuticals and medical devices to market; the complex emerging rules applicable to domestic and foreign food manufacturers, suppliers, and importers; clinical trial compliance requirements for drug and medical device studies; and the defense of FDA enforcement actions against drug, device, food and dietary supplement companies, Clinical Research Organizations (CROs), academic medical research institutions and individual researchers. 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 LL.M. from Washington College of Law, American University.
Jake Harper is an attorney with Morgan Lewis. A frequent speaker on issues involving healthcare fraud, compliance, and reimbursement, Mr. Harper's practice focuses on advising hospitals, healthcare professionals, and other industry stakeholders on compliance with Medicare, Medicaid, and state licensure requirements. Mr. Harper represents providers before the Provider Reimbursement Review Board (PRRB) and the Office of Medicare Hearing and Appeals (OMHA) and assists clients with filing voluntary self-disclosures with the Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS). In addition, Mr. Harper also represents healthcare providers in internal investigations and qui tam False Claims Act matters. Jake is a 2013 graduate of American University Washington College of Law, where he was the Editor-in-Chief of the Health Law & Policy Brief.
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 Shareholder in Polsinelli PC’s Washington, DC office, where she provides federal government relations and regulatory counsel. Specializing in healthcare law and policy, she works to obtain appropriate coverage and reimbursement for innovative healthcare technologies and services such as digital health, value-based care models, and precision medicine. Ms. Roehrenbeck 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 is also a published author on health law and policy matters, including biennial contributions to BNA/Bloomberg’s treatise entitled, “E-Health, Privacy, and Security Law, Second Edition.” 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.
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.