Pharmacy Policy Symposium Program Booklet

HOWARD UNIVERSITY COLLEGE OF PHARMACY
PHARMACY POLICY SYMPOSIUM

March 22, 2016 8:00 AM 3:00 PM
ARMOUR J. BLACKBURN CENTER

HOWARD UNIVERSITY
WASHINGTON, DC
HEALTH POLICY INSTITUTE MISSION

The mission of the Howard University College of Pharmacy Health Policy Institute is to educate future
and current pharmacists and other healthcare professionals on the unique and strategic opportunity to
influence national and global health policy to improve outcomes for underserved populations.
PHARMACY POLICY SYMPOSIUM PURPOSE

The purpose of this symposium is to provide a forum for pharmacy students to learn from subject
matter experts in areas of health policy that are currently of particular interest to pharmacists,
including precision medicine, drug pricing, and mental health and substance abuse and the impact on
the resource-limited populations.
PROGRAM
8:00 AM
CONTINENTAL BREAKFAST
Pre Test
8:30 AM
WELCOME REMARKS & ACKNOWLEDGEMENT OF DISTINGUISHED GUESTS

ANTHONY K. WUTOH, PHD, RPH
PROVOST AND CHIEF ACADEMIC OFFICER, HOWARD UNIVERSITY
DAPHNE B. BERNARD, PHARMD, RPH
INTERIM DEAN, HOWARD UNIVERSITY COLLEGE OF PHARMACY
8:45 AM
TOPIC: PRECISION MEDICINE

SUSAN WINCKLER, JD, RPH
MANAGING PARTNER, LEAVITT PARTNERS
FOOD AND DRUG LAW INSTITUTE, FORMER PRESIDENT & CEO
FOOD AND DRUG ADMINISTRATION, FORMER CHIEF OF STAFF
9:15 AM
PANEL DISCUSSION RESPONSE:

MODERATOR: FRANK L. BROWN, MD
9:45 AM
BREAK
10:00 AM
TOPIC: DRUG PRICING

LT. EMEKA EGWIM, PHARMD, RPH
SENIOR ASSISTANT PHARMACIST, UNITED STATES PUBLIC HEALTH SERVICE COMMISSIONED
CORPS, CENTERS FOR MEDICARE AND MEDICAID SERVICES
10:30 AM
PANEL DISCUSSION RESPONSE:

MODERATOR: LEONARD EDLOE, PHARMD, FAPHA
11:00 AM
BREAK
11:10 AM
TOPIC: THE OPIOID CRISIS AND THE FDA ACTION PLAN

JONCA BULL, MD
ASSISTANT COMMISSIONER FOR MINORITY HEALTH, FOOD AND DRUG ADMINISTRATION
11:40 am
PANEL DISCUSSION:
MODERATOR: SAMUEL STOLPE, PHARMD, RPH
2
12:30 PM
LUNCH
1:45 PM
KEYNOTE SPEAKER
ADAEZE ENEKWECHI, PHD, MPP
ASSOCIATE DIRECTOR FOR HEALTH PROGRAMS, WHITE HOUSE OFFICE OF MANAGEMENT AND
BUDGET
2:15 PM
PANEL DISCUSSION WITH PARTICIPANT Q&A

MODERATOR: TAMARA MCCANTS, PHARMD, RPH
EXPERT PANELISTS:
EDWIN CHAPMAN, MD
DISTRICT OF COLUMBIA SUBOXONE TREATMENT PROGRAM
SANDRA MILLIGAN, MD, JD
SENIOR VICE PRESIDENT AND HEAD, REGULATORY AFFAIRS AND SAFETY
MERCK & CO.
BARBARA LOPEZ KUNZ
GLOBAL CHIEF EXECUTIVE, DRUG INFORMATION ASSOCIATION
DONALD DOWNING, PHARM.D.
CLINICAL PROFESSOR
INSTITUTE FOR INNOVATIVE PHARMACY PRACTICE
UNIVERSITY OF WASHINGTON SCHOOL OF PHARMACY
HON. ARTHUR L. BURNETT SR., ESQ (RETIRED)
NATIONAL EXECUTIVE DIRECTOR, NATIONAL AFRICAN AMERICAN DRUG POLICY COALITION, INC.
2:45 PM
POST/TEST AND PROGRAM EVALUATION
3:00 PM
CONCLUSION / WRAP-UP / ACKNOWLEDGEMENTS

Tuesday, March 22nd, 2016 8 a.m.
Armour J. Blackburn Center
KEYNOTE SPEAKER
ADAEZE ENEKWECHI, PHD, MPP

ASSOCIATE DIRECTOR FOR HEALTH PROGRAMS
WHITE HOUSE OFFICE OF MANAGEMENT AND BUDGET
Dr. Adaeze Enekwechi is the Associate Director for Health Programs

at the White House Office of Management and Budget. As the federal
government's chief health care budget official, she provides budget,
policy, management, and regulatory oversight for over $1 trillion in
spending on a range of federal programs including Medicare,
Medicaid, Insurance Marketplaces, the CMS Innovation Center, the
Federal Employees Health Benefit Program and for a number of
agencies including Centers for Medicare & Medicaid Services, Office
of the National Coordinator for Health Information Technology,
National Institutes of Health, the Food and Drug Administration, and
Centers for Disease Control and Prevention.
She also plays a key role in driving budget, policy, strategy and
operational coordination for a range of complex inter-agency efforts
that require close coordination with agencies across the federal
government including the Department of the Treasury, the Internal
Revenue Service and the Office of Personnel Management.
Most recently, she served as a Managing Consultant at Lewin Group where she specialized in health policy
research and evaluation, Medicare payment policies, health care disparities, and quality measurement.
Prior to that, Adaeze worked at the Medicare Payment Advisory Commission and the Congressional Budget
Office. She completed a BA at the University of Iowa, an MPP at the American University, and a Ph.D. in
Health Services and Policy from the University of Iowa. She completed her postdoctoral studies at the
University of Chicago.
4

HOT TOPIC SPEAKERS

TOPIC: PRECISION MEDICINE
SUSAN WINCKLER, JD, RPH
MANAGING PARTNER, LEAVITT PARTNERS
FOOD AND DRUG LAW INSTITUTE, FORMER PRESIDENT & CEO
FOOD AND DRUG ADMINISTRATION, FORMER CHIEF OF STAFF
Susan Winckler is the chief risk management officer for Leavitt

Partners as well as a lead contributor in the firms alliance
management and regulatory consulting activities. A pharmacist
and attorney by training, Susan is the former chief of the staff for
the U.S. Food and Drug Administration (FDA) within the
Department of Health and Human Services (HHS) and former
president and CEO of the Food and Drug Law Institute, a nonprofit
organization based in Washington, D.C., which provides a
marketplace for discussing food and drug law issues through
conferences, publications, and member interaction. Susan is a
graduate of the University Of Iowa College Of Pharmacy and the
Georgetown University Law Center, magna cum laude. She is a
Fellow of the American Pharmacists Association, a Distinguished
Alumna of the University Of Iowa College Of Pharmacy, delivered
the William A. Zellmer Lecture for the American Society of HealthSystem Pharmacists and named as Distinguished Young Alumna of
the University of Iowa Foundation. She was elected a Trustee of
the United States Pharmacopeial Convention (USP) for the 20152020 term, elected a Distinguished Fellow in Public Policy to the
National Academies of Practice, Pharmacy Academy, and named a
Woman of Distinction by Alpha Xi Delta Fraternity.
5

HOT TOPIC SPEAKER

TOPIC: DRUG PRICING
LT. EMEKA EGWIM, PHARMD, RPH
SENIOR ASSISTANT PHARMACIST, UNITED STATES PUBLIC HEALTH SERVICE COMMISIONED
CORPS, CENTERS FOR MEDICARE AND MEDICAID SERVICES
Dr. Emeka Egwim is a Senior Assistant Pharmacist and Lieutenant in the

United States Public Health Service Commissioned Corps. He is stationed
at the Centers for Medicare & Medicaid Services (CMS) in Baltimore
Maryland.
Dr. Egwim studied biology at the University of Maryland Baltimore
County. He went on to obtain his Doctor of Pharmacy Degree from
Howard University College of Pharmacy in Washington D.C. He has
published a number of articles, spoken at multiple seminars on various
pharmacy polices and enjoys engaging pharmacists and pharmacy
students on the role of pharmacists in health policy and governmental
affairs.
Along with his CMS colleagues, Dr. Egwim analyzes and writes policies
that implement specific provisions of healthcare laws, which include (but
is not limited to) the Patient Protection and Affordable Care Act (PPACA)
and Section 1927 of the Social Security Act. The provisions include the
Medicaid Drug Rebate Program (MDRP), the 340B Drug Discount
Program, the Federal Upper Limits (FUL) for pharmacy reimbursement,
the Medicaid Expansion and Alternative benefit Plans (ABP), State Plan
Amendments (SPAs), the Covered Outpatient Drug Rule amongst others. He also assists in providing the agency, state
Medicaid programs, law makers and other stakeholders with clinical and policy expertise as it relates to emergent
pharmaceutical treatment regimens, research, care delivery models and standards of care for various diseases or
conditions and is instrumental in the development of some CMS Releases including State Release No. 172 titled
Assuring Medicaid Beneficiaries Access to Hepatitis C (HCV) Drugs which was issued by CMS on November 5, 2015.

TOPIC: THE OPIOID CRISIS AND THE FDA ACTION PLAN

JONCA BULL, MD
ASSISTANT COMMISSIONER FOR MINORITY HEALTH, FOOD AND DRUG ADMINISTRATION
Dr. Jonca Bull Dr. Jonca Bull returned to FDA in August 2012 as the
Director of the Office of Minority Health after most recently
serving as Vice President for US Drug Regulatory Policy at Novartis
and, prior to that, as Director of Clinical Regulatory Policy at
Genentech. Dr. Bull previously served in FDA in a variety of
positions in both the Center for Drug Evaluation and Research
(CDER) and the Office of the Commissioner spanning 12 years. Dr.
Bull also previously spent eleven years providing clinical care in a
multi-specialty group practice, and she currently serves as an
Assistant Clinical Professor at George Washington University
Medical Center. Dr. Bull is a graduate of Princeton University and
received her medical degree from Duke University School of
Medicine. She did her postgraduate training at George Washington
University, is board certified in Ophthalmology, and is a fellow of
the American Academy of Ophthalmology.

EXPERT PANELIST
EDWIN CHAPMAN, MD
DISTRICT OF COLUMBIA SUBOXONE TREATMENT PROGRAM
For over 35 years, EDWIN C. CHAPMAN, Sr., M.D. has maintained an active
private practice in general Internal Medicine located in Northeast
Washington, D.C concentrating on chronic diseases including diabetes,
hypertension, and cardiovascular diseases. Additionally, he was the
medical director of the United Planning Organizations (UPO)
Comprehensive Treatment Program from its inception in 2000 thru
October 31, 2012, a multifaceted, non-profit, 500+ slot drug treatment
center (methadone replacement therapy) in Washington, DC as a
contracted agent of the District of Columbias Health Department through
the Addiction Prevention and Recovery Agency (APRA). Dr. Chapman and
the UPO clinic were featured in the National Alcohol and Drug Addiction
Month 2008 DVD entitled Medication-Assisted Therapies: Providing a
Whole-Patient Approach to Treatment sponsored and produced by the
Substance Abuse and Mental Health Services Administration (SAMHSA).
Dr. Chapman has kept his hands on the pulse of local and national
community issues, particularity those that result in preventable health
disparities in the community around his office (Trinidad and Rosedale) and the African American Community in general.
As a founding member and secretary of the board of directors of the Leadership Council on Healthy Communities (501
c3 with 30+ inter faith institutions) chaired by Rev. Frank Tucker, he has been keenly interested in exploring new ways to
collaborate and deliver health care to disadvantaged and underserved communities with a focus on building closer ties
between medical practitioners and like-minded community partner organizations. Therefore, recognizing a community
crisis, Dr. Chapman has focused his energies as an active member of the medical committee of the Washington, DC and
Vicinity Affiliate of The National Black Leadership Commission on AIDS as they advocate for public policies that break the
vicious cycle of illicit drugs, crime, and incarceration in exacerbating the HIV/AIDS and Hepatitis C epidemics. To that
end, he was an expert medical panelist on the June 17, 2011 C-SPAN presentation from the National Press Club
sponsored by the Institute of the Black World 21st Century, Declaring War on the War on Drugs which also included
national experts in social work, criminal justice, law enforcement, public policy, as well as the NAACP. Feature speakers
for the event were the Rev. Jessie Jackson, Sr. and Michigan congressman, the Hon. John Conyers.

EXPERT PANELIST
SANDRA MILLIGAN, MD, JD
SENIOR VICE PRESIDENT AND HEAD OF GLOBAL REGULATORY AFFAIRS AND CLINICAL SAFETY,
MERCK & CO.
Sandra A. Milligan, MD, JD, currently serves as Senior Vice President and
Head of Global Regulatory Affairs and Clinical Safety of Merck, consisting
of the global Regulatory, Safety and CMC functions of Merck Research
Laboratories. She previously served as Vice President, Global Regulatory,
Immunology, Respiratory, Infectious Diseases and Ophthalmology for
Genentech/Roche where she developed and directed global strategic
regulatory plans to facilitate and optimize product development,
regulatory
approval,
and
commercialization.
Previous
to
Genentech/Roche she served at Amgen for almost 10 years in various
roles, including Global Regulatory Therapeutic Area Head for the Bone
franchise, as Head of Regulatory Communications Strategy & Operations,
and as Senior Counsel for the Development, Regulatory & Compliance
Law Group, where she provided strategy for development, regulatory
and safety groups. In addition to serving on the DIA Board of Directors
and current President-Elect, Sandra has served as the Program Chair for
the DIA 2013 Annual Meeting in Boston, as well as co-chair of the Public
Policy/Health Care Compliance/Regulatory Law Annual Meeting track.
Sandra is a graduate of The George Washington University School of
Medicine and the Georgetown University Law Center and attended UC
Irvine for undergraduate studies

EXPERT PANELIST
BARBARA LOPEZ KUNZ
GLOBAL CHIEF EXECUTIVE, DIA
Barbara Lopez Kunz is a health care executive with a successful track
record in leadership positions for socially responsible organizations. In
her current role as Global Chief Executive of DIA (Drug Information
Association), she is leading the transformation of the association
through a systematic strategy impacting global positioning, thought
leadership, strategic partnerships, and member and volunteer
engagement. In Barbaras prior role as President of Battelles Global
Health and Life Science business, she reengineered the business and,
through strategic investments, alliance development, and technology
commercialization, delivered the highest rates of growth in Battelles
80-year history.
Barbaras leadership experience also includes roles as Senior Vice
President and General Manager for Thermo Fisher Scientifics Biosciences
business, where she championed the units formation and growth
through a series of acquisitions, and Vice President, Latin America and
Global Vice President, Enterprise Business Group for the ICI portfolio businesses. She has also held senior roles in DuPont
and PPG Industries, after starting her career as a research scientist. She holds 14 patents.
A leader on numerous corporate and non-profit boards, Barbara has been heavily involved in governance as chair of the
board The Ohio State University Wexner Medical Center; as director and leader of board subcommittees on technology
commercialization and finance for Nationwide Childrens Hospital Research Institute, Childrens National Health System
Research Institute, and BioOhio; board director for Levitronix and POCARED, medical device companies; director for
Aptevo Therapeutics, an immuno-oncology company, and representative director for International Scientific Standards, a
joint venture in South Korea. She is an active supporter of childrens health, serving on the inaugural board of the
Childhood League School, addressing needs of developmentally challenged children.
Barbara holds an MS in Polymer Science from the University of Akron, a BS from Thiel College, and has qualified in INSEADs
International Executive program.
10

EXPERT PANELIST
DONALD DOWNING, PHARM.D.
CLINICAL PROFESSOR
INSTITUTE FOR INNOVATIVE PHARMACY PRACTICE
UNIVERSITY OF WASHINGTON SCHOOL OF PHARMACY
Don Downing is a Clinical Professor at the University of Washington

School of Pharmacy in Seattle where he is the endowed Chair of the
Institute for Innovative Pharmacy Practice. He teaches students and
practicing pharmacists in contraception, leadership and advocacy,
medication management services, law & ethics, medical devices,
community health screening of elders and immigrant populations,
and pharmacy management. Currently he is co-chair of his schools
community pharmacy residency program. Several of Mr. Downings
research and healthcare access projects have resulted in national
changes in pharmacy practice. All pharmacies in the US who provide
direct contraception or immunization access have used legislative
efforts and training programs that helped to pioneer. In 2002 he
was awarded the Washington State Pharmacists Associations
Pharmacist of the Year Award and also the University of Washington
School of Pharmacys Alumni of the Year. In 2005 he was awarded
the American Pharmacists Associations Academy of Pharmacy
Practice and Management Distinguished Achievement Award for
his efforts in innovative public health endeavors. In 2008 he also
received Special Congressional Recognition from Nancy Pelosi for
his community service. In 2009 the Washington State Pharmacy
Association award him the David Almquist Award for his work in gaining state-wide recognition of pharmacists
as healthcare providers. In 2011, the University of Washington School of Pharmacy awarded him the Gilbaldi
Excellence in Teaching Award.
11

EXPERT PANELIST
HON. ARTHUR L. BURNETT SR., ESQ (RETIRED)
NATIONAL EXECUTIVE DIRECTOR, NATIONAL AFRICAN AMERICAN DRUG POLICY COALITION,
INC.
Judge Arthur L. Burnett, Sr. (Retired) is the National Executive Director,
National African American Drug Policy Coalition, Inc. He is a graduate from
Howard University summa cum laude with a major in political science and
minor in economics. Throughout his almost 57-year professional career,
he has received numerous awards including the Sustained Superior
Performance Award while working with then Attorney General Robert F.
Kennedy, the Distinguished Civil Service Award for his work in advising
the old U.S. Civil Service Commission and the President of the United
States in securing the passage of the Civil Service Reform Act of 1978,
recognition by the American Bar Associations National Conference of
Special Court Judges as the Most Outstanding Special Court Judges in
America, recognition by the American Bar Associations National
Conference of State Trial Court Judges as one of the three (3) Most
Outstanding General Jurisdiction Judges while serving on the District of
Columbia Superior Court, the American Bar Associations Spirit of
Excellence Award and acknowledgement as a WAYMAKER in the
American Bar Association Judges Journal for his civil rights history and
judicial performance in an extensive interview of his lifes history, and
recognition by Cambridges Whos Who as one of the most knowledgeable
experts in the United States on the drug laws and policies of this Nation
and the application of the criminal and juvenile justice system and related
healthcare issues involving treatment for substance use disorders and mental health conditions.
He retired completely from the judiciary on February 15, 2013 and continues to serve as the National Executive Director
of the National African American Drug Policy Coalition, Inc. and as a citizen volunteer advisor to several offices in the White
House and to a number of Federal Government Departments and Agencies. In addition, he was recently appointed by the
Mayor of the District of Columbia to a part-time position as a Member of the District of Columbia Commission on Fathers,
Men and Boys. He also serves on a number of other non-profit entities dealing with youth, substance abuse, mental health
conditions, and juvenile and criminal justice issues.
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