Pharmacy Policy Symposium Program Booklet

8/19/2019 Pharmacy Policy Symposium Program Booklet

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HOWARD UNIVERSITY COLLEGE OF PHARMACY

PHARMACYPOLICYSYMPOSIUM

March 22, 2016 ● 8:00 AM – 3:00 PM

ARMOUR J. BLACKBURNCENTER

HOWARD UNIVERSITY WASHINGTON, DC

HEALTHPOLICYINSTITUTEM ISSION

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

PHARMACYPOLICYSYMPOSIUM PURPOSE

The purpose of this symposium is to provide a forum for pharmacy students to learn from subjectmatter 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 onthe resource-limited populations.


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PROGRAM

8:00 AM CONTINENTAL BREAKFAST

Pre Test

8:30 AM WELCOME REMARKS & ACKNOWLEDGEMENT OF DISTINGUISHEDGUESTS

ANTHONYK. WUTOH, PHD, RPH PROVOST AND C HIEF ACADEMIC OFFICER , HOWARD UNIVERSITY

DAPHNE B. BERNARD, PHARMD, RPH INTERIM DEAN , HOWARD UNIVERSITY C OLLEGE OF PHARMACY

8:45 AM TOPIC: PRECISION MEDICINE

SUSAN W INCKLER, JD, RPH M ANAGING P ARTNER , LEAVITT P ARTNERS F OOD AND DRUG L AW INSTITUTE , FORMER PRESIDENT & CEOF OOD AND DRUG ADMINISTRATION , FORMER C HIEF OF STAFF

9:15 AM PANELDISCUSSIONRESPONSE:MODERATOR: FRANKL. BROWN , MD

9:45 AM BREAK

10:00 AM TOPIC: DRUG PRICING

LT. EMEKAEGWIM , PHARMD, RPH SENIOR ASSISTANT PHARMACIST , UNITED STATES PUBLIC HEALTH SERVICE C OMMISSIONEDC ORPS , C ENTERS FOR M EDICARE AND M EDICAID SERVICES

10:30 AM PANELDISCUSSIONRESPONSE:MODERATOR: LEONARD EDLOE, PHARMD, FAPHA

11:00 AM BREAK

11:10 AM TOPIC: THE OPIOID CRISIS AND THEFDA ACTION PLAN

JONCA BULL, MD ASSISTANT C OMMISSIONER FOR M INORITY HEALTH , F OOD AND DRUG ADMINISTRATION

11:40 am P ANELDISCUSSION:MODERATOR: SAMUEL STOLPE, PHARMD, RPH


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12:30 PM LUNCH

1:45 PM KEYNOTESPEAKER

ADAEZEENEKWECHI, PHD, MPP

ASSOCIATE DIRECTOR FOR HEALTH PROGRAMS , W HITE HOUSE OFFICE OF M ANAGEMENT ANDBUDGET

2:15 PM PANELDISCUSSION WITH PARTICIPANT Q&AMODERATOR: TAMARA MCCANTS, PHARMD, RPH

EXPERT PANELISTS:

EDWIN CHAPMAN , MDDISTRICT OF C OLUMBIA SUBOXONE T REATMENT PROGRAM

SANDRA M ILLIGAN, MD, JDSENIOR V ICE PRESIDENT AND HEAD , REGULATORY AFFAIRS AND S AFETY M ERCK & C O.

BARBARALOPEZ KUNZ GLOBAL C HIEF E XECUTIVE , DRUG INFORMATION ASSOCIATION

DONALD DOWNING , PHARM.D.C LINICAL PROFESSOR INSTITUTE FOR INNOVATIVE PHARMACY PRACTICEUNIVERSITY OF W ASHINGTON SCHOOL OF PHARMACY

HON. ARTHUR L. BURNETTSR., ESQ (RETIRED)N ATIONAL E XECUTIVE DIRECTOR , N ATIONAL AFRICAN AMERICAN DRUG POLICY C OALITION , INC .

2:45 PM POST/T EST AND PROGRAM EVALUATION

3:00 PM CONCLUSION / WRAP-UP / ACKNOWLEDGEMENTS


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KEYNOTE SPEAKER

ADAEZE ENEKWECHI , PHD, MPP A SSOCIATE D IRECTOR FOR H EALTH P ROGRAMS

W HITE H OUSE O FFICE OF M ANAGEMENT AND B UDGET

Dr. Adaeze Enekwechi is the Associate Director for Health Programsat the White House Office of Management and Budget. As the federalgovernment's chief health care budget official, she provides budget,

policy, management, and regulatory oversight for over $1 trillion inspending 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 ofagencies including Centers for Medicare & Medicaid Services, Officeof the National Coordinator for Health Information Technology,

National Institutes of Health, the Food and Drug Administration, andCenters for Disease Control and Prevention.

She also plays a key role in driving budget, policy, strategy andoperational coordination for a range of complex inter-agency effortsthat require close coordination with agencies across the federalgovernment 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 policyresearch 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 BudgetOffice. She completed a BA at the University of Iowa, an MPP at the American University, and a Ph.D. inHealth Services and Policy from the University of Iowa. She completed her postdoctoral studies at theUniversity of Chicago.


PHARMACY POLICY SYMPOSIUM Tuesday, March 22 nd , 2016 8 a.m.

Armour J. Blackburn Center


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HOT TOPIC SPEAKERS

TOPIC: PRECISION MEDICINE

SUSAN WINCKLER, JD, RPHMANAGING PARTNER, LEAVITT PARTNERSFOOD AND DRUG LAW INSTITUTE, FORMER PRESIDENT & CEOFOOD AND DRUG ADMINISTRATION, FORMER CHIEF OF STAFF

Susan Winckler is the chief risk management officer for LeavittPartners as well as a lead contributor in the firm’s alliancemanagement and regulatory consulting activities. A pharmacist

and attorney by training, Susan is the former chief of the staff forthe U.S. Food and Drug Administration (FDA) within theDepartment of Health and Human Services (HHS) and formerpresident and CEO of the Food and Drug Law Institute, a nonprofitorganization based in Washington, D.C., which provides amarketplace for discussing food and drug law issues throughconferences, publications, and member interaction. Susan is agraduate of the University Of Iowa College Of Pharmacy and theGeorgetown University Law Center, magna cum laude. She is aFellow of the American Pharmacists Association, a Distinguished

Alumna of the University Of Iowa College Of Pharmacy, deliveredthe William A. Zellmer Lecture for the American Society of Health-System Pharmacists and named as Distinguished Young Alumna ofthe University of Iowa Foundation. She was elected a Trustee ofthe United States Pharmacopeial Convention (USP) for the 2015-2020 term, elected a Distinguished Fellow in Public Policy to theNational Academies of Practice, Pharmacy Academy, and named aWoman of Distinction by Alpha Xi Delta Fraternity .





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HOT TOPIC SPEAKER

TOPIC: DRUG PRICING

LT. EMEKA EGWIM, PHARMD, RPHSENIOR ASSISTANT PHARMACIST, UNITED STATES PUBLIC HEALTH SERVICE COMMISIONEDCORPS, CENTERS FOR MEDICARE AND MEDICAID SERVICES

Dr. Emeka Egwim is a Senior Assistant Pharmacist and Lieutenant in theUnited States Public Health Service Commissioned Corps. He is stationedat the Centers for Medicare & Medicaid Services (CMS) in BaltimoreMaryland.

Dr. Egwim studied biology at the University of Maryland BaltimoreCounty. He went on to obtain his Doctor of Pharmacy Degree fromHoward University College of Pharmacy in Washington D.C. He haspublished a number of articles, spoken at multiple seminars on variouspharmacy polices and enjoys engaging pharmacists and pharmacystudents on the role of pharmacists in health policy and governmentalaffairs.

Along with his CMS colleagues, Dr. Egwim analyzes and writes policiesthat implement specific provisions of healthcare laws, which include (butis not limited to) the Patient Protection and Affordable Care Act (PPACA)

and Section 1927 of the Social Security Act. The provisions include theMedicaid Drug Rebate Program (MDRP), the 340B Drug DiscountProgram, 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, stateMedicaid programs, law makers and other stakeholders with clinical and policy expertise as it relates to emergentpharmaceutical treatment regimens, research, care delivery models and standards of care for various diseases orconditions 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.





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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 theDirector of the Office of Minority Health after most recentlyserving as Vice President for US Drug Regulatory Policy at Novartisand, prior to that, as Director of Clinical Regulatory Policy atGenentech. Dr. Bull previously served in FDA in a variety ofpositions 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 amulti-specialty group practice, and she currently serves as anAssistant Clinical Professor at George Washington UniversityMedical Center. Dr. Bull is a graduate of Princeton University andreceived her medical degree from Duke University School ofMedicine. She did her postgraduate training at George WashingtonUniversity, is board certified in Ophthalmology, and is a fellow ofthe American Academy of Ophthalmology.





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EXPERT PANELIST

EDWIN CHAPMAN, MDDISTRICT OF COLUMBIA SUBOXONE TREATMENT PROGRAM

For over 35 years, EDWIN C. CHAPMAN, Sr., M.D. has maintained an activeprivate practice in general Internal Medicine located in NortheastWashington, D.C concentrating on chronic diseases including diabetes,hypertension, and cardiovascular diseases. Additionally, he was themedical director of the United Planning Organization’s (UPO)Comprehensive Treatment Program from its inception in 2000 thruOctober 31, 2012, a multifaceted, non-profit, 500+ slot drug treatmentcenter (methadone replacement therapy) in Washington, DC as acontracted agent of the District of Columbia’s Health Department throughthe Addiction Prevention and Recovery Agency (APRA). Dr. Chapman andthe UPO clinic were featured in the National Alcohol and Drug AddictionMonth 2008 DVD entitled “Medication -Assisted Therapies: Providing aWhole- Patient Approach to Treatment” sponsored and produced by theSubstance Abuse and Mental Health Services Administration (SAMHSA).

Dr. Chapman has kept his hands on the pulse of local and nationalcommunity 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 (501c3 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 tiesbetween medical practitioners and like-minded community partner organizations. Therefore, recognizing a communitycrisis, Dr. Chapman has focused his energies as an active member of the medical committee of the Washington, DC andVicinity Affiliate of The National Black Leadership Commission on AIDS as they advocate for public policies that break thevicious cycle of illicit drugs, crime, and incarceration in exacerbating the HIV/AIDS and Hepatitis C epidemics. To thatend, he was an expert medical panelist on the June 17, 2011 C-SPAN presentation from the National Press Clubsponsored by the Institute of the Black World 21st Century, “Declaring War on the War on Drugs” which also in cludednational experts in social work, criminal justice, law enforcement, public policy, as well as the NAACP. Feature speakersfor the event were the Rev. Jessie Jackson, Sr. and Michigan congressman, the Hon. John Conyers.





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EXPERT PANELIST

SANDRA MILLIGAN, MD, JDSENIOR VICE PRESIDENT AND HEAD OF GLOBAL REGULATORY AFFAIRS AND CLINICAL SAFETY,

MERCK & CO.

Sandra A. Milligan, MD, JD, currently serves as Senior Vice President andHead of Global Regulatory Affairs and Clinical Safety of Merck, consistingof the global Regulatory, Safety and CMC functions of Merck ResearchLaboratories. She previously served as Vice President, Global Regulatory,Immunology, Respiratory, Infectious Diseases and Ophthalmology forGenentech/Roche where she developed and directed global strategicregulatory plans to facilitate and optimize product development,

regulatory approval, and commercialization. Previous toGenentech/Roche she served at Amgen for almost 10 years in variousroles, including Global Regulatory Therapeutic Area Head for the Bonefranchise, as Head of Regulatory Communications Strategy & Operations,and as Senior Counsel for the Development, Regulatory & ComplianceLaw Group, where she provided strategy for development, regulatoryand safety groups. In addition to serving on the DIA Board of Directorsand current President-Elect, Sandra has served as the Program Chair forthe DIA 2013 Annual Meeting in Boston, as well as co-chair of the PublicPolicy/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 UCIrvine for undergraduate studies





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EXPERT PANELIST

BARBARA LOPEZ KUNZGLOBAL CHIEF EXECUTIVE, DIA

Barbara Lopez Kunz is a health care executive with a successful trackrecord in leadership positions for socially responsible organizations. Inher current role as Global Chief Executive of DIA (Drug Information

Association ), she is leading the transformation of the associationthrough a systematic strategy impacting global positioning, thoughtleadership, strategic partnerships, and member and volunteerengagement. In Barbara’s prior role as President of Battelle’s GlobalHealth and Life Science business , she reengineered the business and,through strategic investments, alliance development, and technologycommercialization, delivered the highest rates of growth in Battelle’s

80-year history.Barbara’s leadership experience also includes roles as Senior Vice

President and General Manager for Thermo Fisher Scientific’s Biosciencesbusiness , where she championed the unit’s formation and growththrough 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 DuPontand 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 theboard The Ohio State University Wexner Medical Center; as director and leader of board subcommittees on technology

commercialization and finance for Nationwide Children’s Hospital Research Institute, Children’s National Health SystemResearch Institute, and BioOhio; board director for Levitronix and POCARED, medical device companies; director forAptevo Therapeutics, an immuno-oncology company, and representative director for International Scientific Standards, a

joint venture in South Korea. She is an active supporter of children’s health, serving on the inaugural board of theChildhood 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 INSEAD’sInternational Executive program.





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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 WashingtonSchool of Pharmacy in Seattle where he is the endowed Chair of theInstitute for Innovative Pharmacy Practice. He teaches students andpracticing 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 school’scommunity pharmacy residency program. Several of M r. Downing’sresearch and healthcare access projects have resulted in nationalchanges in pharmacy practice. All pharmacies in the US who providedirect contraception or immunization access have used legislativeefforts and training programs that helped to pioneer. In 2002 hewas awarded the Washington State Pharmacists Association’sPharmacist of the Year Award and also the University of WashingtonSchool of Pharmacy’s Alumni of the Year. In 2005 he was awardedthe American Pharmacists Association’s Academ y of PharmacyPractice and Management Distinguished Achievement Award forhis efforts in innovative public health endeavors. In 2008 he alsoreceived Special Congressional Recognition from Nancy Pelosi forhis community service. In 2009 the Washington State Pharmacy

Association award him the David Almquist Award for his work in gaining state-wide recognition of pharmacistsas healthcare providers. In 2011, the University of Washington School of Pharmacy awarded him the GilbaldiExcellence in Teaching Award.





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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 fromHoward University summa cum laude with a major in political science andminor in economics. Throughout his almost 57-year professional career,he has received numerous awards including the Sustained SuperiorPerformance Award while working with then Attorney General Robert F.Kennedy, the Distinguished Civil Service Award for his work in advisingthe old U.S. Civil Service Commission and the President of the UnitedStates in securing the passage of the Civil Service Reform Act of 1978,recognition by the American Bar Association’s National Conference ofSpecial Court Judges as the Most Outstanding Special Court Judges inAmerica, recognition by the American Bar Association’s NationalConference of State Trial Court Judges as one of the three (3) MostOutstanding General Jurisdiction Judges while serving on the District ofColumbia Superior Court, the Ame rican Bar Association’s Spirit ofExcellence Award and acknowledgement as a WAYMAKER in theAmerican Bar Association Judges’ Journal for his civil rights history and

judicial performance in an extensive interview of his life’s history, andrecognition by Cambridge’s Who’s Who as one of the most knowledgeableexperts in the United States on the drug laws and policies of this Nationand 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 Directorof the National African American Drug Policy Coalition, Inc. and as a citizen volunteer advisor to several offices in the WhiteHouse and to a number of Federal Government Departments and Agencies. In addition, he was recently appointed by theMayor 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 healthconditions, and juvenile and criminal justice issues.




Pharmacy Policy Symposium Program Booklet

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