Senior Vice President National Association Chain Drug Stores
Senior Director, US Pricing & Government Relations AstraZeneca
Odalys has been in the industry for over 25 years, working in the areas of Sales, Commercial Operations, Distribution, Finance, Market Access, and Government Reporting. Currently she is the Sr. Director of Pricing & Government Reporting at AstraZeneca where she is responsible for the Pricing Team overseeing WAC pricing and the Government Reporting Team in charge of CMS, Federal, PHS, and Medicaid. Odalys is a strategic partner and sits on many cross functional governance committees focusing on financial impacts, compliance risks, Government Reporting implications and overall innovation.
Jonathan Connell, JD, MBA
Associate General Counsel Bristol-Myers Squibb
Jonathan Connell is a Senior Counsel within the U.S. Commercial Law and Compliance organization at Bristol-Myers Squibb. Jonathan has been working in the pharmaceutical industry for 15+ years. His current work includes advising clients regarding government price reporting obligations, fraud and abuse compliance, federal and commercial contracting requirements, the federal anti-kickback statute, coverage and reimbursement issues, addressing US market access challenges, and product promotion regulations. In the pricing area, Mr. Connell regularly advises on government price reporting and compliance, as well as commercial contracting with GPOs, IDNs, MCOs, and specialty pharmacies. Prior to joining BMS, Jonathan was in private practice as a member of Arnold & Porter LLP’s FDA and Healthcare practice. Mr. Connell earned both a JD and a MBA from Duke University. Prior to graduate school, Mr. Connell worked for years as a management consultant to the pharmaceutical industry, focusing on drug pricing strategy, compliance with federal pricing programs, and systems integrations. Mr. Connell is also a regular speaker at pharmaceutical industry seminars and conferences.
Alice Valder Curran
Alice Valder Curran
Partner Hogan Lovells
Director Pharmacy Services Delaware Health and Social Services
Cynthia Denemark is the pharmacy director for the Delaware Division of Medicaid & Medical Assistance. She has served as the Pharmacy Director for the state’s fiscal agent and the State of Delaware since the early 1990s. She developed and administered Delaware’s Point of Service prescription system, state-wide Prior Authorization Program, the Delaware Prescription Assistance Program, the Manufacturer Rebate Program, and the Prospective DUR system. She has overseen the federal and state rebate programs, and has a wide range of experience doing quality assurance projects from HEDIS measure analysis, retrospective drug utilization review, and coordination with managed care organizations that are part of the Diamond State Health Plan. She received her pharmacy degree from Purdue University and worked in hospitals, health clinics, and in retail settings.
Associate General Counsel Spark Therapeutics
Amy is Associate General Counsel at Spark Therapeutics, Inc. and advises the company on a variety of complex legal issues, including fraud and abuse compliance, market access and reimbursement. Amy counsels the company on its strategic initiatives, including outcome-based offerings and innovative contracting models for LUXTURNA™, the first gene therapy for a genetic disease.
Prior to joining Spark, Amy was Senior Counsel at a multinational pharmaceutical company where she negotiated business development agreements and advised on commercial and federal contracting and government price reporting compliance. Amy also worked as a transactional attorney at a nationally recognized firm where she focused her practice on advising life science and biotech companies from early stage startups to large public companies. Amy has an undergraduate degree in genetics and developmental biology and 12 years’ experience advising the biotech and pharmaceutical industry on corporate, transactional and regulatory matters.
Chris Hatwig, MS, RPh, FASHP
Chris Hatwig is President of Apexus, the organization responsible for managing the Human Resources and Services Administration’s (HRSA’s) 340B Prime Vendor Program (PVP). He works closely with HRSA’s Office of Pharmacy Affairs in Washington, DC, to educate all stakeholders and to improve the integrity and value of the 340B Drug Pricing Program for the nation’s safety-net providers. Participants in the program include more than 36,000 HRSA grantees and disproportionate share hospitals serving the nation’s low-income and uninsured populations. The PVP provides added value by collectively representing the 340B covered entities’ purchases to secure federal sub-ceiling discounts on pharmaceuticals and discounts on other outpatient pharmacy-related products and services.
Mr. Hatwig is consulted frequently about optimizing the benefits of the 340B Program. He routinely makes national and regional presentations related to the 340B Drug Pricing Program, innovative ambulatory pharmacy services, and drug cost containment strategies.
Before joining Apexus, Mr. Hatwig was the director of ambulatory pharmacy services and value analysis programs at Parkland Health & Hospital System in Dallas, where he practiced for 13 years, managing one of the nation’s largest and most progressive ambulatory pharmacy programs serving low-income and uninsured patients. He was responsible for managing Parkland’s network of ambulatory pharmacies, which processed more than two million prescriptions annually and operated with a drug expense budget of $65 million.
Mr. Hatwig received his bachelor’s degree in pharmacy from the University of Arkansas. He completed residencies in hospital pharmacy and hospital pharmacy administration at the University of Wisconsin, culminating in a master’s degree in hospital pharmacy.
Partner Arnold & Porter Kaye Scholer LLP
Kristin Hicks is a Partner in Arnold & Porter Kaye Scholer's life sciences and healthcare regulatory practice group. Kristin's practice focuses on counseling and litigation for clients in the pharmaceutical industry. Her work includes advising clients regarding all aspects of government price reporting, including counseling on issues under the 340B program, Medicaid, Medicare, the Federal Supply Schedule program, and the TRICARE retail pharmacy program. She often assists clients in preparing drug price reporting policies and reasonable assumptions, and provides guidance on internal audits and price recalculation projects. She also focuses on fraud and abuse compliance, federal contracting requirements, and legislative and public policy issues. In addition, Kristin represents clients in litigation matters regarding government price reporting requirements.
Felicity Homsted, PharmD, BCPS
Chief Pharmacy Officer Penobscot Community Health Care
Felicity Homsted is Chief Pharmacy for Penobscot Community Health Center Inc. (PCHC); Maine’s largest Federally Qualified Health Center serving over 70,000 patients across the state. She is responsible for the administration of four pharmacies, integrated pharmacy services and PCHC’s accredited community pharmacy and health systems pharmacy administration (HSPA) residency programs.
Dr. Homsted’s specific professional interests are quality improvement, advancing the integrations of pharmacists in the primary care setting, and healthcare advocacy. As Chief Pharmacy Officer for PCHC, Felicity has led the movement of pharmacists beyond the traditional dispensing role to develop a model of clinical integration and collaboration within PCHC.
Director, Government Pricing and Reporting AstraZeneca
Brian is the Director Government Pricing and Reporting at AstraZeneca Pharmaceuticals and has over 11 years of experience in government contracting and pricing. He is responsible for all aspects of government pricing compliance ensuring the company meets their required pricing obligations under Government contracts and the Medicaid, Medicare, Federal (VA/DoD) and 340B pricing programs. Brian also provides strategic input and financial assessments on legislative activity. Brian has a degree in Accounting from Villanova University.
President New Hampshire Board of Pharmacy
Member, Board of Directors Ammonoosuc Community Health Services
Member of the NH Board of Pharmacy for 8 years, currently serving as board president. Member of the board of directors for Ammonoosuc Community Health Services, a 340B covered entity.
Recently served as the Administrative Director of the New England Pharmacy Collaborative (NEPC) for several years. NEPC is an organization of 16 hospitals and numerous clinics located across NH and VT that facilitates and coordinates pharmacy related contracting, knowledge sharing, education, and best practice. NEPC has a combined annual drug spend of over $200 million, 1200 beds, and over a thousand providers. NEPC members included several types of 340B covered entities as Critical Access Hospital, Rural Referral Center, DSH, grantees as Hemophilia, Ryan White and Family Planning. NEPC created a ‘shared service’ model that supported many of the 340B program within these covered entities.
Director of Federal Government Affairs & Policy AstraZeneca
Natalie Morris, J.D., M.P.P., is currently a director in AstraZeneca’s Federal Government Affairs & Policy group where she focuses on the 340B, Medicare, and Medicaid programs. After receiving her J.D. from the University of Virginia School of Law, Natalie practiced in the Health Law group at Hogan Lovells prior to joining the Market Access and Reimbursement team at Avalere Health where she helped clients navigate complex drug coverage and reimbursement issues. Prior to attending law school, Natalie received a Master of Public Policy from George Mason University, where she focused on health policy.
David A. Neu
David A. Neu, PharmD, MSHSA
Vice President, Pharmacy Saint Thomas Health
David A. Neu, PharmD., MSHSA is the Vice President of Pharmacy for Saint Thomas Health. He oversees all inpatient pharmacy operations for each of the 8 campuses as well as several outpatient pharmacy services such as the Nuclear Pharmacy, Anticoagulation Monitoring Clinic, four Dispensary of Hope Charity Pharmacies and an outpatient hospital retail pharmacy. Two of the hospitals have 340B status: Saint Thomas Hickman Hospital (340B Critical Access Hospital) and Saint Thomas River Park (DSH Hospital). David is a graduate of the University of Tennessee College of Pharmacy, has completed a Masters in Health Care Administration through the University of Saint Francis and is a 25 year associate of Saint Thomas Health.
Associate General Counsel Eli Lilly
Josh is the federal healthcare programs lawyer for Eli Lilly and Company. He supports government pricing, government strategy, managed healthcare services, and public policy functions at the company. Prior to joining Lilly, Josh was a Senior Associate in the FDA & Life Sciences Practice at King & Spalding.
Health Reporter POLITICO
David Pittman is a health reporter for POLITICO Pro, covering hospitals, doctors, providers and Medicare payment policy.
Pittman joined POLITICO in May 2014 to help launch its Pro eHealth team, covering all things at the intersection of health care and technology policy. Before that, he served as the lone Washington reporter for the health news website MedPage Today, covering nearly all aspects of health policy from Medicare and Medicaid to the Affordable Care Act and Capitol Hill. He has also covered science and regulatory policy for trade newsletter company FDAnews and the weekly newsmagazine Chemical & Engineering News. Pittman got his start in journalism covering healthcare for the daily newspaper in the West Texas town of Amarillo.
Pittman holds bachelor's degrees in journalism and chemistry from the University of Georgia, where he graduated in 2006. While in Athens, Pittman worked as a staff writer of The Red & Black and eventually became editor-in-chief, pestering school administrators. Like any good Southerner, he prefers his tea sweet, chicken fried and fall Saturdays reserved for college football. He is also surviving as an Atlanta Braves fan in a town full of Washington Nationals supporters.
Stephen E. Ruscus
Stephen E. Ruscus
Partner Morgan, Lewis & Bockius LLP
With more than 23 years of experience, Stephen counsels clients in the defense, technology, life
sciences, manufacturing, services and food industries on supplies and service indefinite delivery,
indefinite quantity (IDIQ) task order contracts, fixed-price, and cost reimbursement contracts and
related Federal Acquisition Regulation provisions, subcontract negotiations and compliance,
government contracts disputes, and federal debarment and suspension.
Stephen conducts investigations and prepares reports under the US Department of Veterans
Affairs (VA), the US Department of Defense (DOD), and the US Department of State voluntary
disclosure programs. He appears before the US Court of Federal Claims, US Courts of Appeals, the
Armed Services Board of Contract Appeals, and the Civilian Board of Contract Appeals. He also
represents clients in bid protests before the GAO and the US Court of Federal Claims.
With respect to federal healthcare supplies and services, Stephen counsels clients on VA, DOD,
and US Department of Health and Human Services (HHS) procurements. He also advises on
government pricing laws and regulations governing manufacturer participation in the Medicaid
Drug Rebate, Medicare, 340B, TRICARE, and Veterans Healthcare Act programs; VA FSS
contracts; and public policy affecting these programs.
Additionally, Stephen counsels clients on the implementation and review of complex government
pricing systems, providing strategic advice on the government pricing, fraud, and abuse
implications of commercial pricing and patient benefit programs.
Stephen E. Ruscus represents clients in government contracts procurement, US federal drug
pricing programs, and in litigation before the Boards of Contract Appeals, the US Court of Federal
Claims, and the US Government Accountability Office (GAO). He also advises in protest practice
before the US Small Business Administration and in matters relating to federal procurement of
commercial items and services, including those under Federal Supply Schedule contracts.
Partner Sidley Austin LLP
BILL SARRAILLE is a senior member of the Healthcare Practice group and a nationally-recognized lawyer in healthcare law. Mr. Sarraille concentrates on a variety of healthcare matters, including Medicare and Medicaid reimbursement, coverage and coding, pharmaceutical price reporting, issues related to the marketing and promotion of pharmaceuticals and medical devices, internal investigations, clinical research issues, Stark and Anti-Kickback Law analyses, Medicare and Medicaid audits, healthcare acquisitions and due diligence, compliance program audits, managed care matters, healthcare contracts, administrative litigation, legislative matters, privacy and security, coverage for new devices and services, the Foreign Corrupt Practices Act, international compliance and healthcare contracting, the representation of witnesses and companies before Congressional Committees, and the defense of healthcare criminal and False Claims Act matters. Mr. Sarraille has defended clients in some of the largest healthcare fraud investigations brought by the U.S. Government.
Christopher H. Schott
Christopher H. Schott
Partner Hogan Lovells US LLP
Christopher H. Schott advises clients in the
pharmaceutical industry in connection with drug price
reporting and other compliance obligations. His
practice focuses on the Medicaid, Medicare, and 340B
Drug Pricing programs.
Chris helps pharmaceutical manufacturers apply price
reporting and compliance requirements under these
Department of Health & Human Services (HHS)
programs to their particular business models and
commercial approaches, both in terms of ongoing
compliance through the development of
methodologies and reasonable assumptions, as well as
with respect to evaluating specific commercial pricing
or contracting strategies and initiatives. Chris also
assists pharmaceutical manufacturers that seek to
engage with federal regulators regarding these
programs, whether as to public policy proposals
generally, through comment drafting and in-person
advocacy, or where a manufacturer seeks guidance
regarding specific commercial proposals and how the
regulators may view those proposals under program
standards. He also supports manufacturers in
connection with state price reporting obligations.
Chris translates this regulatory expertise into more
broad commercial support for pharmaceutical
manufacturers. He regularly helps clients evaluate theimpact of HHS program requirements on proposed
M&A transactions and advises on due diligence matters
and the post-closing transition of regulatory
responsibilities under these programs. Chris also
regularly advises pharmaceutical manufacturers
regarding industry-specific price reporting aspects of
their periodic reporting obligations under the U.S.
federal securities laws.
Prior to joining Hogan Lovells, Chris was an associate at
a leading national law firm, where he represented Wall
Street financial institutions and investment banks.
Chris was employed in the telecommunication and
information technology sectors before and while
attending the George Washington University Law
In law school, Chris was a George Washington Scholar
and a member of The George Washington
International Law Review. He is a recipient of the law
school's Richard L. Teberg Award for Excellence in
Partner King & Spalding
John Shakow, Partner, FDA & Life Sciences Practice Group, King & Spalding – John Shakow is a nationally-recognized expert in all aspects of drug pricing and price reporting. He has counseled pharmaceutical and biotechnology clients on their rights and obligations under the Medicaid, Medicare, Federal Supply Schedule, 340B and TRICARE programs for almost twenty years. John regularly advises manufacturers on the spectrum of regulatory, commercial and litigation matters relating to pricing and government payor programs. He has extensive experience helping clients resolve commercial, strategic, organizational and other legal challenges while maintaining the integrity of their government pricing compliance efforts
Edward D Shanshala II
Edward D Shanshala II, MSHSA, MSEd
Chief Executive Officer Ammonoosuc Community Health Services, Inc.
A life-long learner, Ed has had the privilege of mentorship from those who pushed him to pursue excellence personally and professionally. His vision is to redefine health care as an investment with returns; a necessary building block of our economy; by supporting individuals to take accountability for their own health, the wellbeing of the population will improve. Ed is a founding board director of the North Country Accountable Care Organization, the New Hampshire Rural ACO, and the North Country Community Care Organization. In addition he is on the board of directors of Bi-State Primary Care Association, Littleton Regional Healthcare, and the North Country Health Consortium.
Ed served as a co-chair of the Health Recourse Service Administration (HRSA) Patient Safety Pharmacy Collaborative (PSPC), and continues to provide leadership in the promulgation of clinical pharmacy services as a collaborating partner with A3, partnered with the Centers for Medicare and Medicaid (CMS) Quality Improvement Organization (QIO) to integration of Federally Qualified Health Center (FQHC) clinical pharmacy services between in a Critical Access Hospital CAH), and currently collaborating with the CMS QIO on antibiotic stewardship. In addition Ed’s leadership on 340B compliance related to diversion and duplication of discount he has invested time to ensure he and others are able to demonstrate the reinvestment of 340B savings into mission as is the intent of the program.
Regional Inspector General Office of Inspector General (OIG)
Dave Tawes is a Regional Inspector General in the Office of Evaluation and Inspections, a component within the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS). OEI conducts national evaluations that focus on the prevention of fraud, waste, and abuse in programs administered by HHS. Mr. Tawes joined OEI as analyst in 1997, and has since contributed to more than 50 studies involving Medicare and Medicaid prescription drug issues, including AWP reform, the Medicaid drug rebate program, end-stage renal disease drug pricing, and the 340B drug discount program. He also plays a key role in OEI’s work planning efforts for future prescription drug studies.
Senior Government Analyst UCB
Amanda Tucker is currently a Gov’t Pricing Senior Analyst at UCB, and prior to joining UCB she was a Medicaid Analyst at Abbvie. She has extensive knowledge in Medicaid invoice processing including setting up, maintaining, and maximizing the return on dispute resolutions with the states. She has worked with both long established dispute programs, as well as establishing newly implemented programs.
William H. von Oehsen
William H. von Oehsen
Principal Powers Pyles
Sutter & Verville, PC
William von Oehsen is a Principal in Powers, Pyles, Sutter and Verville, P.C., a law firm specializing in health care law and policy. Mr. von Oehsen has more than 20 years experience on pharmaceutical pricing and reimbursement matters, including the 340B drug discount program, the Medicaid drug rebate program, Medicare Part D, Robinson-Patman, and state Medicaid and pharmacy laws. He helped establish and serves as outside counsel to 340B Health, formerly Safety Net Hospitals for Pharmaceutical Access, an advocacy organization of over 1,300 public and private non-profit hospitals participating in the 340B program. Mr. von Oehsen played a key role in helping to enact the 340B program in 1992, as well as to expand the law in 2010 under the Affordable Care Act. In 1997, he helped organize the 340B Coalition, which now represents a dozen national organizations whose members comprise virtually all of the safety net providers participating in the 340B program. Mr. von Oehsen co-founded and served as co-editor of the Drug Discount Monitor, the first publication to focus specifically on the 340B program and other pharmacy access issues.
In addition to representing clients on 340B matters, Mr. von Oehsen provides guidance to pharmacies, pharmacy-related vendors and consultants, states, local governments, and other health care entities in their efforts to improve access to pharmaceutical care and to ensure compliance with drug pricing laws. Mr. von Oehsen has experience in counseling clients on matters involving the federal supply schedule and federal ceiling price programs, state pharmaceutical assistance programs, manufacturer patient assistance programs, the Prescription Drug Marketing Act, Medicare Part B, managed care and related authorities. Mr. von Oehsen has testified before the U.S. Congress and numerous state legislatures and provides technical assistance to federal and state policy makers in both the legislative and executive branches. He has handled litigation matters involving pharmaceutical pricing. He also practices in the area of food and drug law.
Mr. von Oehsen received a Bachelor’s degree from Princeton University, an M.T.S. from Harvard University and a J.D. from Georgetown University.
Charles Washington, CFE, CPP, CICA
Director, America’s Compliance Division Pfizer
Charles is the Director of Fraud Investigations in Pfizer’s Global Compliance and Security Division and leads an inter-departmental team between Global Compliance and Contract Strategy and Management. His role is to integrate Program Integrity in 340B and other government drug pricing programs across the company. He leads the company’s 340B remediation program and has been successful in building cooperative partnerships with covered entities to successfully navigate program integrity in the 340B terrain. Charles holds a Master’s Degree; he is a Certified Fraud Examiner (CFE); a Certified Internal Control Auditor (CICA); and is a frequent speaker on the manufacturer’s perspective of 340B.
Donna Lee Yesner
Donna Lee Yesner
Senior Counsel Morgan Lewis & Bockius LLP
Donna Lee Yesner, a Senior Counsel in Morgan Lewis's FDA Practice focuses her practice on the sale and reimbursement of federal healthcare supplies and services, with an emphasis on pharmaco-economics, government contracts, price reporting, compliance with laws and regulations governing Medicaid, Medicare, Tricare, 340B drug discount programs, debarment, suspension and public policy affecting these programs. Ms. Yesner has experience in all aspects of federal financing and procurement, with particular experience in Federal Supply Schedule contracting, pharmaceutical research and development grants and agreements, claims, and bid protests. She regularly counsels companies regarding compliance with federal healthcare program requirements and the impact of these requirements on their business. Ms. Yesner is Vice-chair of the ABA Public Contracts Section Health Care Contracting Committee and co-chair of the Coalition for Government Procurement Health Care Committee. She has authored numerous articles on procurement, pricing, and reimbursement of medical supplies and lectures frequently on these topics.
Corporate Counsel Pfizer
Michele Zarychta is Corporate Counsel at Pfizer, Inc. Ms. Zarychta provides legal support to the US Payer and Channel Access and Government Contract departments. She provides expertise and counsel related to fraud and abuse, government pricing, managed care and government contracting, and account management. Ms. Zarychta also provides legal support to the company’s 340B remediation program, which works with covered entities to ensure 340B program integrity. Prior to joining Pfizer, Ms. Zarychta was a commercial litigation associate at a law firm, representing clients in a variety of commercial and healthcare matters.