Virtual Online Video Live and Archived


Virtual Pharmaceutical and Medical Device Pricing and Payment Transformation Summit
June 16-19, 2026

Covering Tariffs, Most Favored Nation, TrumpRX, Direct to Consumer, Direct to Employer, Role of CMS & CMMI: GENEROUS, GLOBE, GUARD & BALANCE Models, IRA Medicare Drug Price Negotiations, Price Reporting, FDA Regulation, Medicaid Rebates, Medicare Fair Price, 340B and PBMs



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WATCH CMMI DIRECTOR ABE SUTTON’S INTERVIEW WITH APG’S VALINDA RUTLEDGE REGARDING NEW CMS/CMMI DRUG MODELS


KEYNOTE SPEAKERS

Liz Fowler, PhD, JD

Scholar, Johns Hopkins Bloomberg School of Public Health; Former Director, CMS CMMI (Biden); Former Special Assistant to President Obama, Washington, DC

Mark McClellan, MD, PhD

Director, Robert J Margolis Center for Health Policy, Medicine and Health Policy, Duke University; Former CMS Administrator and FDA Commissioner (GW Bush), Washington, DC

Nicholas Minter, MPP

Acting Director, Seamless Care Models Group, CMS Innovation Center; Former Senior Budget Analyst, HHS; Former Program Examiner, OMB, Silver Springs, MD

Mickey Morgan

Acting Director, Division of Pharmacy, Center for Medicaid & CHIP Services, Center for Medicare and Medicaid Services, Washington, DC

Larisa Strawbridge, MPH

Acting Director, Medicare Drug Rebate and Negotiations Group, Centers for Medicare and Medicaid Services, Washington, DC

FEATURING ROUNDTABLE ON THE IMPLICATIONS OF ACTUAL AND THREATENED US PHARMA TARIFFS BY

Neena Shenai, JD

Partner, WilmerHale; Former Chief Legal Counsel and Head of Compliance for Global Trade, Medtronic; Former Trade Counsel, Ways and Means Committee, US House of Representatives, Washington, DC

Mariana P. Socal, MD, PhD, MPP, MSc

Associate Professor, Bloomberg School of Public Health and Carey Business School, Johns Hopkins University; Co-author, “Comparative Approaches to Drug Pricing” and “Tariffs as a Hidden Tax: Price Pass-Through in Multi-Stage Supply Chains”, Baltimore, MD

Arun Venkataraman, MA, JD

Partner, Covington; Former Assistant Secretary of Commerce, US and Foreign Commercial Service, International Trade Administration; Former Counselor to the Secretary, US Department of Commerce, Washington, DC

Joshua M. Sharfstein, MD

Vice Dean, Johns Hopkins Bloomberg School of Public Health; Former Secretary, Maryland’s Health Department; Former Principal Deputy Commissioner, US FDA, Baltimore, MD (Moderator)

TARIFF COMPLIANCE ISSUES FOR PHARMACEUTICALS AND MEDICAL DEVICE COMPANIES BY

Shani Harmon Alexander, MS, JD

Senior Trade Counsel, Gilead; Former Director, Legal Manufacturing, Organon, Washington, DC

Galina Free, MSc

Head of Trade Compliance, Danaher; Former Global Tax and Customs, Cisco, Bellevue, WA

Roger McCrary, JD

Senior Trade Counsel, Becton Dickinson; Former Vice President of Global Compliance, Momentive; Former Global Trade Compliance Program Leader, Medtronic, Oakland, MI

Neena Shenai, JD

Partner, WilmerHale; Former Chief Legal Counsel and Head of Compliance for Global Trade, Medtronic; Former Trade Counsel, Ways and Means Committee, US House of Representatives, Washington, DC (Moderator)

AN OVERVIEW OF US PHARMA & DEVICE MOST FAVORED
NATIONS/INTERNATIONAL REFERENCE PRICING INITIATIVES BY

Lanhee Chen, PhD

Fellow, Hoover Institution, Stanford; Former Counselor, HHS; Author, “Alternatives to Government-Imposed Price Controls to Lower US Drug Prices”, Stanford, CA

Liz Fowler, PhD, JD

Scholar, Johns Hopkins Bloomberg School of Public Health; Former Director, CMS CMMI (Biden); Former Special Assistant to President Obama, Washington, DC

James Robinson, PhD

Schaeffer Professor of Health Economics & Director, Berkeley Center for Health Technology, University of California, Berkeley; Author, “Most Favored Nation Pricing is an Idea whose Time has Come”, Berkeley, CA

Ian Spatz, MPA, JD

Principal, Rock Creek Policy Group; Former Vice President, Public Policy, Merck, Author, “Most Favored Nation Drug Pricing: Aiming at Pharma’s Achilles Heel”, Washington, DC

Kristi Martin, MA, MPH

Founder, Highway 136 Consulting; Former Chief of Staff for Medicare, CMS; Former Health Care VP, Arnold Ventures, Washington, DC (Moderator)

IMPLEMENTING THE CMS/CMMI BALANCE, GENEROUS, GLOBE AND GUARD MODELS BY

Cindy Cerneka, MBA

Managing Director, Helio Health Group; Former Manager Government Reporting and Commercial Rebates, Mallinckrodt Pharmaceuticals, Durham, NC

Tracy Mumpower

Director Managed Services, Helio Health Group; Former Manager, Commercial Contract Administration, King Pharmaceuticals, Bristol, VA

Joseph Skupen, CPA

Managing Director, Senior Advisor and Technical Leader, Helio Health Group; Former Director FMV Tiering Global Medical Affairs, Sanofi, Berwyn, PA

Stephanie Trunk, JD, CPS

Partner and Life Sciences Industry Group Co-Leader, ArentFox Schiff; Former Legal Counsel, Catalyst Health Solutions, Washington, DC

Chris Cobourn, MS

Managing Director and Government Programs (GP) Practice Lead, Helio Health Group, Placida, FL (Moderator)

NEW BUSINESS MODELS TO MEET PATIENTS WHERE THEY ARE BY

Peter Brensilver, MPH, JD

Senior Vice President, Chief Global Commercial Compliance, and Risk Counsel, Pfizer, New York, NY

David Dopf, JD

Executive Director & Executive Counsel, US Human Pharma Business Law, Boehringer Ingelheim, Ridgefield, CT

Stefanie A. Doebler, JD

Partner and Co-Chair, Health Care Practice Group, Covington & Burling, LLP, Washington, DC

Sarah A. Franklin, JD

Partner and Vice-Chair, Life Sciences Investigations Practice, Covington & Burling, LLP; Former Attorney, US Federal Trade Commission, Washington, DC

AND AN ADVAMED, BIO, AND PhRMA UPDATE BY

John Delacourt, JD

Deputy General Counsel, Vice President Health, Regulatory & Commercial Operations, Biotechnology Innovation Organization; Former Chief Antitrust Counsel, Office of Policy Planning, FTC, Washington, DC

Ida Nassar, JD

Vice President, Assistant General Counsel, Ethics & Compliance, AdvaMed; Former Senior Attorney, Office of Chief Counsel, Drug Enforcement Administration, Washington, DC

Julie Ritchie Wagner, JD

Senior Assistant General Counsel & Head of Global Ethics, Compliance & Enforcement Legal Policy, PhRMA; Former Senior Counsel, Office of Counsel to the Inspector General, US Department of Health and Human Services, Washington, DC

FEATURED FACULTY

Heather Banuelos, JD

Counsel, King & Spalding LLP; Former FDA Counsel, Allergan; Former Associate Chief Counsel, US Food and Drug Administration, Washington, DC

Brian A. Bohnenkamp, MHA, JD

Partner, FDA and Life Sciences, King & Spalding, Washington, DC

Catherine Brandon, JD

Partner, Arnold & Porter; Senior Counsel, Office of the Assistant Secretary for Legislation, US Department of Health and Human Services, Washington, DC

Marijo G. Bustos, MBA

Head of Government Pricing & Reimbursement, UCB; Former Director, Prometic BioProduction & BioTherapeutics & Fresenius-Kabi USA, Smyrna, GA

John Coster, PhD, RPh

Former Director, Division of Pharmacy, & Senior Advisor, Medicare Drug Rebate & Negotiation Program, CMS, Fort Lauderdale, FL

Niels Christian Ersboll, Master at Laws

Partner and Global Co-Chair Antitrust, Arnold & Porter, Brussels, Belgium

Jeffrey Handwerker, JD

Partner, Arnold & Porter; Lead Author, “HHS-OIG Guidance on Manufacturer DTC Platforms and Congressional Pushback”, Washington, DC

Erin Hertzog, JD, MPH

Partner, Manatt, Phelps & Phillips LLP; Former Attorney, Office of the General Counsel, CMS Division, US DHHS; Former Director, Health Law & Policy, Biotechnology Industry Organization, Washington, DC

Mary Kohler, JD

Founder and Principal, Kohler Health Law, PC; Former Expert Counsel, Worldwide Compliance & Business Ethics, Amgen; Former Assistant General Counsel, GSK, Los Angeles, CA

Neal Masia, PhD

Co-founder and CEO, EntityRisk, Inc.; Founder, Health Capital Group, LLC; Former Vice President, Global Economics, Pfizer; Former Analyst, US. Congressional Budget Office, Miami, FL

Rosemary Maxwell, JD

Counsel, Arnold & Porter; Coauthor, “Trump Administration Issues Executive Order to Lower Prescription Drug Costs”, Washington, DC

William Newton

Associate Editor/Senior Writer, 340B Report; Senior Healthcare Reporter, GlobalData Healthcare, Washington, DC

Sayeh Nikpay, MPH, PhD

Associate Professor, School of Public Health, University of Minnesota; Lead Author, “When Safety-Net Programs Compete: Medicaid, 340B, and the Battle Over Drug Discounts”, Minneapolis, MN

Lindsay Pronley

Director Managed Services, Life Science Revenue Management, Government Pricing & Commercial Contacting, Helio Health Group, Milwaukee, WI

Nikki Reeves, JD

Partner and Co-chair, Life Sciences and Healthcare Industry Group, King & Spalding, Washington, DC

Avik S. A. Roy

Co-Founder & Chairman, The Foundation for Research on Equal Opportunity; Chief Strategy Officer, Strive; Former Advisor, Presidential Campaigns of Marco Rubio, Rick Perry, and Mitt Romney, Austin, TX

Gillian M. Russell, JD

Counsel, FDA & Life Sciences Practice, King & Spalding; Former Consultant, Corporate Executive Board, Washington, DC

Valinda Rutledge, MBA

Executive Vice President, Policy and Advocacy, America’s Physician Groups; Former Group Director, Patient Care Model Group and BPCI Lead, CMS, Washington, DC

William Sarraille, JD

Select Counsel, Rare Access Action Project (RAAP); Facioscapulohumeral Muscular Dystrophy (FSHD) Society; and AIDS Drug Assistance Programs (ADAPs); Former Partner, Sidley Austin, Washington, DC

John Shakow, JD

Pharmaceutical Government Price Reporting Expert; Partner, FDA & Life Sciences Practice, King & Spalding LLP, Washington, DC

Nick Shipley

Founder, Cronus Consulting; Former EVP, Biotechnology Innovation Organization (BIO); Former VP, Pharmaceutical Researchers and Manufacturers Association (PhRMA); Former Legislative Director, US House of Representatives, Washington, DC

A HYBRID CONFERENCE AND INTERNET EVENT