National Policy & Advocacy Summit on Biologics

Q&A

AGENDA

9:55 am – Welcoming Remarks: Representative Carol Miller

10:00 am – Opening Remarks

  • David Charles, MD, Co-Founder, Alliance for Patient Access

10:05 am – The Biologics Landscape: Evolving Treatment Options

  • Leah Christl, PhD, Executive Director of Global Regulatory and R&D Policy, Amgen
  • Angus Worthing, MD, Board of Directors, American College of Rheumatology
  • Phil Schneider, Chair of International Advisory Committee, Alliance for Safe Biologic Medicines
  • Moderator: Gavin Clingham, Director of Public Policy, Alliance for Patient Access

10:40 am – Policymaker Engagement: Tackling Barriers to Access

  • Brian Henderson, State Governmental Affairs, Coalition of State Rheumatology Organizations
  • Ashira Vantrees, Staff Attorney, Aimed Alliance
  • Sarah Buchanan, Director of Federal Government Relations & Health Policy, National Psoriasis Foundation
  • Moderator: David Charles, MD, Co-Founder, Alliance for Patient Access

11:35 am – Federal Regulators: Strategies to Support Innovation

  • Michael Ward, Vice President of Public Policy and Government Relations, Alliance for Aging Research
  • Joel White, Founder & President, Horizon Government Affairs
  • Anna Hyde, Vice President of Advocacy & Access, Arthritis Foundation
  • Moderator: Amanda Conschafter, Director of Strategic Communications, Alliance for Patient Access

12:15 pm – Lunch

12:40 pm – Data: A Key Advocacy Tool

  • Rachel Klein, Deputy Executive Director, The AIDS Institute
  • Donna Cryer, Founder & CEO, Global Liver Institute
  • Jared Willis, President, Catalyst Strategies
  • Moderator: Derek Flowers, Grassroots Advocacy Director, Alliance for Patient Access

1:15 pm – Who Decides: Third Party Health Care Players

  • J. Allen Meadows, MD, Executive Director of Advocacy and Governmental Affairs, American College of Allergy, Asthma and Immunology
  • Elizabeth Johnson, LPN, President, National Association of Medication Access & Patient Advocacy
  • Casey McPherson, Manager of Clinician Advocacy, Alliance for Patient Access
  • Moderator: Dennis Cryer, MD, Co-Convener, Biologics Prescribers Collaborative

1:55 pm – Closing Remarks

  • David Charles, MD, Co-Founder, Alliance for Patient Access

SPEAKERS

Representative Carol Miller

Representative Carol Miller

U.S. Representative | West Virginia

Congresswoman Carol Miller represents West Virginia’s First Congressional District. Miller serves on the Committee on Ways and Means. Miller’s focus in Congress is creating jobs, diversifying the economy, innovating, and improving infrastructure, protecting America’s borders, and supporting West Virginia’s energy industries like coal, oil, and gas. Prior to her election to Congress in 2018, Congresswoman Miller served in the West Virginia House of Delegates from 2006 to 2018 where she rose to become the first female Majority Whip. A mother of two and grandmother of seven, Carol Miller is married to her husband Matt, and lives in Huntington, where she owns and operates Swann Ridge Bison Farm and manages real estate. Miller was born in Columbus, Ohio and is the daughter of Congressman Samuel L. Devine and Betty Devine.

Sarah Buchanan

Sarah Buchanan

Director of Federal Government Relations & Health Policy | National Psoriasis Foundation

Sarah Buchanan is responsible for identifying and pursuing federal issues of significance to individuals with psoriatic disease, developing policies and resources to advocate on these issues, and representing the NPF in federally focused coalitions and before federal policymakers. In addition to advocating directly to federal policymakers within Congress and the Federal Agencies, she will also advocate directly with the private insurance sector and other allied stakeholders to improve policies and advance the health and wellness of the psoriatic disease community. She is based out of the Alexandria, VA office.

Buchanan is a 12-year health policy veteran with a passion for collaborating with patients, families, and providers on public policies to improve patient access to care. Prior to joining the NPF, Buchanan established an impactful advocacy program at the Crohn’s & Colitis Foundation, including leadership in state and federal coalitions. She has also served as an appropriations lobbyist with a focus on medical research programs at the Health and Medicine Counsel.

David Charles, MD

David Charles, MD

Founder | Alliance for Patient Access

Dr. David Charles is Chairman of the Alliance for Patient Access and a practicing neurologist in Nashville, Tennessee.  Dr. Charles is a national leader in movement disorders research and is past chairman of the Public Policy Committee for the American Neurological Association and Legislative Affairs committee of the American Academy of Neurology. He is a fellow of the American Academy of Neurology and American Neurological Association and past Board member of the United Council of Neurologic Subspecialties, and Past-President of the Tennessee Academy of Neurology. He is currently leading the only clinical trial approved by the United States Food and Drug Administration to test deep brain stimulation in people with early stage Parkinson’s disease. Dr. Charles took leave from his practice in 1998 and spent a year on the staff of the U.S. Senate Subcommittee for Public Health and Safety, where he served as a health policy advisor. Following this experience in Washington, Dr. Charles conducted Parkinson’s disease research in France as a Fulbright Senior Scholar.

Leah Christl, PhD

Leah Christl, PhD

Executive Director of Global Regulatory and R&D Policy | Amgen

Dr. Christl is Executive Director, Global Biosimilars Regulatory Affairs and Regulatory and R&D Policy at Amgen.  She serves as head of the global regulatory affairs team within GRAAS-Global CMC, Device & Biosimilar Regulatory Affairs, and Business Operations with responsibility for development and execution of global regulatory strategy for Amgen’s biosimilars portfolio.  Dr. Christl also leads the global biosimilars regulatory and R&D policy with responsibility to develop and advance Amgen’s regulatory and R&D policy positions. Prior to joining Amgen, Dr. Christl served as the Associate Director for Therapeutic Biologics in the Office of New Drugs (OND) in the FDA’s Center for Drug Evaluation and Research (CDER). In this role, she developed and led CDER’s approach to implementation of the Biologics Price Competition and Innovation Act (BPCIA) of 2009.  Dr. Christl was also the director of the Therapeutic Biologics and Biosimilars Staff (TBBS) at the US FDA and served as a scientific, regulatory, and policy expert to FDA, HHS, and external stakeholders, on biosimilar products. In addition, Dr. Christl engaged in international activities by serving as a CDER and FDA strategist and lead for international activities related to biosimilars, including serving as FDA lead for the FDA-EMA-Health Canada-PMDA biosimilars cluster and the International Pharmaceutical Regulators Programme – Biosimilars Working Group. Dr. Christl received her PhD in Molecular and Cellular Biology and Pathobiology – Marine Biomedicine and Environmental Science from the Medical University of South Carolina in Charleston.

Gavin Clingham

Gavin Clingham

Director, Public Policy | Alliance for Patient Access

Gavin Clingham is Director of Public Policy for the Alliance for Patient Access, advising on federal and state policies that impact patient access to health care.

With more than two decades of public policy advocacy experience, Gavin brings a comprehensive understanding of the legislative and regulatory process, having served as Legislative Director for a senior Member of the US House Committee on Appropriations. In his role with AfPA, he engages with federal agencies including CMS and FDA, the US Congress and various state legislatures to ensure the health care providers perspective is considered as access policies are developed and implemented.

Gavin received his Juris Doctor degree from the Boston University School of Law, graduated from The Catholic University of America and is a member of the bar of the Commonwealth of Massachusetts. A lifelong Red Sox fan, he lives in Maryland.

Amanda Conschafter

Amanda Conschafter

Senior Vice President, Strategic Communications | Woodberry Associates

Amanda Conschafter brings more than a decade of experience in communications, advocacy education and writing training. Ms. Conschafter has provided writing and editing services on behalf of Fortune 500 companies, industry leaders, government contractors, and nonprofits dedicated to education, veterans employment and health policy. She has led writing tutorials and workshops in both academic and business settings.

Ms. Conschafter also served on the legislative staff of Senator Lindsey Graham, where she communicated the senator’s policy positions on education, the judiciary and entitlement programs. Ms. Conschafter holds a B.A. summa cum laude in English and an M.A.T. in English Education from Converse College.

Dennis R. Cryer, MD

Dennis R. Cryer, MD

Co-Convener | Biologics Prescribers Collaborative

Dr. Dennis R. Cryer is a co-founder and serves as Physician Co-Convener of the Biologics Prescribers Collaborative. An alumnus of Johns Hopkins University and the Medical Scientist Training Program at Albert Einstein College of Medicine, Dr. Cryer has an expansive career: in academia on the research and clinical faculty of the University of Pennsylvania School of Medicine, and 20 years in the pharmaceutical industry at Bristol-Myers Squibb, ultimately as vice president of external medical affairs serving as external liaison for advocacy and quality across therapeutic areas. Dr. Cryer played a leadership role in the clinical research, development and launch of two blockbuster drugs in the cardiometabolic space. Dr. Cryer is a member of numerous scientific organizations including American Association of Clinical Endocrinologists, American Diabetes Association, American Heart Association (former Chair of the Pharmaceutical Roundtable), American Society of Human Genetics, American Society of Hypertension (former Chair, Corporate Affairs Committee), the Endocrine Society, and the National Lipid Association. Dr. Cryer is the Chief Medical Officer of CryerHealth, a Washington, DC based patient-centric healthcare consultancy. In addition, he currently serves as Treasurer on the Board of Directors of the Friends of the National Library of Medicine and is a Founding Member of the Board of Directors of Global Liver Institute.  He is a former member of the Boards of Directors of the Association of Black Cardiologists and the American Academy of Family Physicians Foundation, and officer of the Asthma and Allergy Foundation of America. Dr. Cryer lives with his wife, Donna R. Cryer, JD, in Washington, DC.

Donna Cryer

Donna Cryer

Founder & CEO | Global Liver Institute

Donna R. Cryer, JD, is Founder and Chief Executive Officer of Global Liver Institute (GLI), the premier patient-driven liver health nonprofit operating with offices and partnerships across five continents. Moved by her own experience as a 28-year liver transplant recipient, Mrs. Cryer serves as a fierce advocate for the transformative potential of patient engagement in health policy, research, data, and system design.

Her expertise and effectiveness in advancing the voice of patients in defining and designing equitable healthcare has been recognized by the United States Congress and the White House. In 2021 Mrs. Cryer received both the Global Genes RARE Champions of Hope Founder’s Award and the American Association for the Study of the Liver (AASLD) Distinguished Advocacy Service Award.

Mrs. Cryer serves on the Boards of Directors for the Council of Medical Specialty Societies (CMSS), Sibley Memorial Hospital/Johns Hopkins Medicine, and the Color of Crohns and Chronic Illness (COCCI). She was the first patient to serve on the American Board of Internal Medicine Gastroenterology Specialty Board.

Mrs. Cryer received an undergraduate degree from Harvard and a Juris Doctorate from the Georgetown University Law Center.

Derek Flowers

Derek Flowers

Grassroots Advocacy Director | Alliance for Patient Access

Derek Flowers leads grassroots advocacy at the Alliance for Patient Access, bringing nearly twenty years of experience in political and issue campaign management. With a particular focus on synthesizing all aspects of advocacy, Derek designs and manages campaigns that incorporate grassroots legislative advocacy, strategic and digital communications, event management and government relations.

Derek is a veteran of political campaigns at the state and national level and also served on the staff of the Republican National Committee. A graduate of Iowa State University, Derek lives in Maryland with his wife, Alex, and their twins.

Brian Henderson

Brian Henderson

Director, State Government Affairs | Coalition of State Rheumatology Organizations

Brian Henderson is the Director of State Government Affairs at Hart Health strategies where he works with the Coalition of State Rheumatology Organizations on a variety of issues impacting rheumatologists and the patients they treat.

Anna Hyde

Anna Hyde

Vice President of Advocacy and Access | Arthritis Foundation

Anna Hyde is the Vice President of Advocacy and Access at the Arthritis Foundation. She oversees both the federal and state legislative programs, in addition to grassroots engagement. Her focus is to raise the visibility of arthritis as a public health priority, build support for federal and state legislation that ensures access to affordable, high-quality health care, and enhance patient engagement in the policy-making process. Anna previously served as Senior Director of Advocacy and Access, managing the federal affairs portfolio and overseeing the state advocacy team.

Prior to joining the Arthritis Foundation in 2014, Anna worked as Senior Manager for Federal Affairs at the American Congress of Obstetricians and Gynecologists, where she managed a portfolio of issues including appropriations, physician workforce, and health IT. She began her health policy career as a Congressional Fellow for Energy and Commerce Committee members, where she drafted legislation and staffed Committee activities. Anna received a BA in History from Southern Methodist University, and taught junior high and high school history before moving to Washington D.C. in 2007 to pursue an MA in Political Science from American University.

Elizabeth Johnson, LPN

Elizabeth Johnson, LPN

President | National Association of Medication Access & Patient Advocacy

Elizabeth started her career in allergy and immunology and fell in love with the challenge of specialty medication access. Currently she is the Chief Executive Officer for MedicoCX, a group of independent specialists unified by patient centric access to biologics in a timely and cost effective manner, as well as a co-founder and the immediate past President of NAMAPA, she currently serves as board treasurer. Elizabeth is a Licensed Practical Nurse (LPN) with a rich background in patient care and holds multiple certifications: Certified Professional Coder (CPC), Prior Authorization Certified Specialist (PACS), and Board Certified Patient Advocate (BCPA). These exemplify her knowledge of some of the most integral parts of medication access and the healthcare spectrum.

Combining this knowledge with her love of training, Elizabeth has been able to successfully and consistently educate facilities and physician practices on various methods of acquisition for injectable and infused biologics and biosimilar medications. With a strong focus on understanding medical benefits and buy and bill, she continues to explain how each benefit impacts a patient, clinic/facility, and other key stakeholders. Her efforts have resulted in millions of dollars of unrecognized revenue for medical practices across the US, all while maintaining the patient and their access to treatment as the highest priority.

Rachel Klein

Rachel Klein

Deputy Executive Director | The AIDS Institute

Rachel joined The AIDS Institute, a leading national nonprofit organization that promotes action for social change for people living with HIV and viral hepatitis through public policy, research, advocacy, and education, in 2018. She leads the Institute’s federal policy work, coordinating advocacy efforts to advance policies that increase access to health care and treatment for people living with, or at risk for, HIV and hepatitis C.

In her more than 20 years in Washington, DC, Rachel has worked at several nonprofit health policy organizations focusing on increasing access to health insurance coverage and health care for at-risk populations. She began her career at Families USA, a national non-profit consumer health advocacy organization, where she spent the better part of two decades leading efforts to strengthen and expand Medicaid and the Children’s Health Insurance Program (CHIP). Rachel was also the Founding Executive Director of Enroll America, a nonprofit organization dedicated to maximizing the number of people who enrolled in Affordable Care Act health coverage by advocating for a simple enrollment process, commonsense outreach messaging, and one-on-one help for people enrolling in health insurance coverage.

 

Casey McPherson

Casey McPherson

Manager of Clinician Advocacy | Alliance for Patient Access

Casey McPherson leads clinician advocacy for the Alliance for Patient Access.

Prior to joining the Alliance for Patient Access, Casey worked at the Primary Care Collaborative, a multistakeholder membership organization committed to advancing a health care system built upon a strong foundation of primary care.

Casey graduated from Baylor University with a degree in biology and is currently pursuing a Master of Public Health degree from the Milken Institute of Public Health at the George Washington University. He lives in Arlington, VA.

J. Allen Meadows, MD

J. Allen Meadows, MD

Executive Director of Advocacy and Governmental Affairs | American College of Allergy, Asthma and Immunology

Allen Meadows, MD, is Clinical Instructor of Internal Medicine and Clinical Instructor of Family Practice at the University of Alabama, Birmingham. He is Executive Director of Advocacy and Government Affairs of the ACAAI and past president of the JCAAI.

Dr. Meadows served as President of the Alabama Society of Allergy and Immunology, 1995-96, and as President of the Medical Society of Montgomery County in 1999. He was a member of the Board of Censors of Medical Association State of Alabama, 2002-2004, and on Alabama Board of Medical Examiners, 2002-2004.

Dr. Meadows also serves as Chairman of AfPA’s Respiratory Therapy Access Working Group.

Philip Schneider

Philip Schneider

Chair of International Advisory Committee | Alliance for Safe Biologic Medicines

Philip J. Schneider is founder and principal of MediHealthInsight that provides consultation to the industry and others on matters related to improving the use of medicines including the application of new technologies in healthcare.

He is also Chair of the Alliance for Safe Biologic Medicines (ASBM) International Advisory Board.  ASBM serves as an authoritative resource center of information for the public, and the healthcare and health policy communities on the issues related to biologic medications.

Professor Schneider holds a faculty appointment as Professor – Practice at The Ohio State University College of Pharmacy.

Ashira Vantrees

Ashira Vantrees

Staff Attorney | Aimed Alliance

Ashira has extensive experience in researching a wide variety of issues including public health, health education, human rights, women’s rights, and disability rights. In her role as Counsel, Ashira provides unique legal insight, develops policy, and oversees advocacy and coalition-building efforts of allied organizations focused on advancing common goals. Ashira earned her Juris Doctorate degree from Florida International University College of Law and is licensed to practice law in Florida and the District of Columbia.

Michael Ward

Michael Ward

Vice President of Public Policy and Government Relations| Alliance for Aging Research

Michael leads the Alliance for Aging Research’s regulatory and legislative efforts. In this role, he conducts direct advocacy and strategic planning for engagement with Congressional offices, the White House, and federal agencies, including the FDA, CMS, and the CDC. Michael serves as a convener for multiple coalitions that elevate the patient voice within policy spheres of influence to advance affordability, access, equity, and funding for healthcare research. His work at the Alliance has also focused on advancing patient-centered value assessment, improved methods of quality measurement, and reducing out-of-pocket costs for Medicare beneficiaries.

Previously, Michael worked in leading policy development roles at Premier, Inc., the American Hospital Association, and Avalere. Michael holds a Bachelor of Arts degree in Political Science and Religious Studies from Vanderbilt University and a Master of Science degree in Public Policy and Management from Carnegie Mellon University.

Joel White

Joel White

Founder & President | Horizon Government Affairs

Joel is the Founder and President of Horizon Government Affairs, a health care consultancy that represents several dozen clients and runs four coalitions comprised of 200 organizations dedicated to reforms that improve our health system. Since Horizon’s founding in 2007, his team has helped enact more than 50 laws and helped shape countless regulations governing all aspects of the U.S. health care system.

Previously, Joel spent twelve years on Capitol Hill including as Staff Director of the Ways and Means Health Subcommittee. While on the Hill he helped enact nine laws, including the:

  • 2002 Trade Act, which created health care tax credits for private coverage;
  • 2003 law that established the Medicare prescription drug benefit and created Health Savings Accounts; and
  • 2005 Deficit Reduction Act and the 2006 Tax Reform and Health Care Act, which reformed Medicare payment policies.

Joel is dedicated to community service that helps the poor and those with mental illness. He is on the Boards of Directors of Samaritan Inns, one of the largest private homeless and treatment centers in DC. He runs Arlington Bridge Builders, which develops and operates anti-poverty strategies in VA. He is also on the boards of the Schizophrenia and Psychosis Action Alliance, and Chaddock Behavioral Health.

Joel holds a B.S. in Economics from the American University and is the co-author of the book, Facts and Figures on Government Finance.

Jared Willis

Jared Willis

President | Catalyst Strategies

Jared Willis, a Florida Bar licensed attorney, has a deep background in public policy. From health care to education to real estate and property/casualty insurance issues, Jared’s policy expertise springs from a wealth of experience across the public and private sector throughout multiple industries.

Much of this experience comes from his work within the Senate, under Senate President Kathleen Passidomo, where he helped to guide President Passidomo’s policy initiatives; leading to lasting, strong relationships at all levels of legislative leadership.

Beyond the policy, Jared excels at building teams and coalitions around issue-based advocacy, uniting experts, advocates, and stakeholders to create momentum for his clients.

​This unique mix of policy acumen and collaborative, creative thinking stems from a multi-faceted career, including working within the legislature under Senate President Kathleen Passidomo, directing the Florida Osteopathic Medical Association’s policy shop as part of a collaborative coalition of medical organizations, and a host of experience working with statewide organizations like the Florida Chamber of Commerce to local community advocacy.

Angus Worthing, MD

Angus Worthing, MD

Board of Directors | American College of Rheumatology

Dr. Worthing is a practicing rheumatologist at Arthritis & Rheumatism Associates in DC and is representing the American College of Rheumatology. He recently served on the ACR board of directors and previously was chair of ACR Government Affairs Committee.

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