The Food and Drug Administration’s Accelerated Approval Pathway has been a lifeline for patients suffering from serious and life-threatening illnesses – like HIV/AIDs, cancer, and sickle cell disease. For more than 30 years, this pathway has expedited access to breakthrough treatments for patients with limited or no options.

But in several unprecedented moves, the Centers for Medicare and Medicaid Services has implemented new restrictions and access barriers to Alzheimer’s disease treatments approved under the accelerated approval pathway.

This briefing will address this new dynamic between CMS and the FDA and its impact on patients.

Special Report: CMS vs FDA: How Medicare and Medicaid Coverage Decisions Limit Access to FDA-Approved Treatments

Agenda

Monday, July 24, 2023

12 Noon: Doors Open / Lunch Available

12:15 PM: Message from Terry Wilcox, CEO & Founder, Patients Rising Now

12:18 PM: Message from Congressional Champions

12:25 PM: Panel Discussion

1:00 PM: Audience Questions

1:10 PM: Closing Remarks from Terry Wilcox

1:15 PM: Adjourn

Speakers

Alka Bhatt, Patient, Pharmacist, Former Biopharma Executive

Joe Hammang, Neuroscientist and Partner at Vital Transformations

Mel Mann, Longest living Gleevec patient

Sue Peschin, President & CEO, Alliance for Aging Research

Robin Strongin, Senior Director, Health Policy, National Consumers League

Congressional Sponsors:

Congresswoman Nanette Barragan

Congressman Dr. John Joyce

Speakers Bios

Alka Bhatt, Patient, Pharmacist, Former Biopharma Executive

Alka Bhatt is a versatile healthcare professional with a background in science and business across both healthcare systems and the pharmaceutical industry. She has spent several years in the biopharmaceutical sector, holding positions in commercialization strategy, brand marketing, business operations and integration, market access, and policy communications. Alka holds a Doctorate of Pharmacy from Rutgers University’s Ernest Mario School of Pharmacy and a Master in Business Administration from Rutgers Business School.

Joe Hammang, Neuroscientist and Partner at Vital Transformations

Joseph P. Hammang, Ph.D. is Partner with Vital Transformation, a healthcare and life sciences industry consultancy based in Washington, DC. Hammang provides strategic consulting services to leading biopharmaceutical firms, start-up biotechnology companies, industry trade organizations as well as non-profit foundations. Joe holds a Ph.D. in the area of Neuroscience from the University of Wisconsin-Madison and is author of 65 scientific articles and invited book chapters and is inventor or co-inventor of over 35 U.S. patents.

Mel Mann, Longest living Gleevec patient

Mel Mann, MBA, M.Ed. was diagnosed 28 years ago with terminal leukemia while serving as a Major in the U.S. Army and given three years to live unless a lifesaving bone marrow donor could be found. Despite conducting numerous marrow donor drives nationwide and adding thousands of people to the marrow registry, Mel was unable to find a donor. Mel entered phase 1 of the Gleevec clinical trial three and a half years after diagnosis and is now the world’s longest living Gleevec survivor. Mel has shared his experiences with many different audiences as a patient advocate.

Sue Peschin, President & CEO, Alliance for Aging Research

Sue Peschin, MHS, is president and CEO at the Alliance for Aging Research, the leading national non-profit organization dedicated to improving healthy aging for all. For more than 35 years, the Alliance has guided efforts to substantially increase funding and focus for aging at the NIH and the FDA; build influential coalitions to guide groundbreaking regulatory improvements for age-related diseases; and created award-winning, high-impact educational materials to improve the health and well-being of older adults and their family caregivers.

Robin Strongin, Senior Director, Health Policy, National Consumers League

Robin Strongin is an accomplished public affairs expert with 40 years experience working in Washington, D.C., Robin has worked with and for federal and state governments, regulatory agencies, the White House, Congress, think tanks, nonprofit organizations, corporations, start-ups, coalitions and trade associations. She ran her own public relations agency for 10 years and created the award winning Disruptive Women in Health Care blog.

The Value of Accelerated Approval for Patient Access & Medical Advances