Speakers

Larry Bauer

Larry Bauer provides counsel to drug manufacturers on a wide range of regulatory topics including Rare Pediatric Disease Designation requests, Orphan Drug Designation requests, Fast Track and Breakthrough Therapy Designation requests, drug development regulatory strategy, preparing regulatory submissions, and drafting regulatory policies and procedures. Mr. Bauer has extensive experience in patient advocacy and has expertise in the planning and execution of Patient Focused Drug Development meetings.

Prior to his current position, Mr. Bauer worked at the NIH for 17 years, part of which time was devoted to working on research for Gaucher disease. This time was followed by a position at the FDA as a Regulatory Scientist in CDER’s Rare Diseases Program working on policy, education, and science related to rare disease drug development. He was part of the committees that developed numerous guidances related to expedited programs, rare diseases, Pre-IND Meetings, and natural history studies. He participated in numerous internal and sponsor meetings related to the development and review of novel rare disease drugs. He also serves on the National Organization for Rare Disorders (NORD) Advocacy Committee.

Michaeleen Crowell, S-3 Group

Michaeleen’s legal training, decades of work on Democratic political campaigns, and extensive government service in the House, the Senate, and Democratic Leadership in both bodies gives her a unique perspective on policymaking, communications, compromise, and strategy. Michaeleen served as Chief of Staff to US Senator Bernard Sanders from Vermont, for 5 years after serving for four months as his Legislative Director. Most recently, she served as Senior Advisor to the Bernie 2016 presidential campaign. Michaeleen was his principal advisor on all policy, political, communications, administrative and strategic initiatives and focused on economic equality and fairness, strong safety nets, democracy preservation, solutions for global warming and renewable energy, expanded care for our Veterans, and health care for all Americans. She has led the development of a full-scale media center that has set the standard for Congressional member use of social media and video to educate the American people. Senator Sanders’ social media communications reach over 25 million people each week and the large-scale, town-hall-style webcast productions of the office have reached as many as 1.7 million live viewers at one time.

She also served as legal counsel for a successful mayoral and a successful congressional campaign in Georgia before returning to Washington as Legislative Director for Congresswoman Denise Majette (GA-4) for two years, and then as Legislative Director for civil rights leader and Congressman John Lewis (GA-5) for 8 years. During her time with Congressman Lewis, she worked on civil rights and voting rights legislation, and on health policy with a primary focus on the Affordable Care Act, Medicare, Medicaid, health disparities, kidney disease and community health centers.

Crowell is a graduate of Boston University with a BA in Political Science and received her J.D. from Boston University School of Law in 1999. She lives in Washington, DC with her husband James and two children.

Tala H. Fakhouri, PhD, MPH, Associate Director for Data Science and Artificial Intelligence Policy, Officer of Medical Policy, Center for Drug Evaluation and Research , U.S. Food and Drug Administration

Tala H. Fakhouri PhD MPH is the Associate Director for Data Science and Artificial Intelligence in the Office of Medical Policy, Center for Drug Evaluation and Research at Food and Drug Administration. Dr. Fakhouri manages a team tasked with developing, coordinating, and implementing medical policy with a focus on data science and the use of Artificial Intelligence (AI) in drug development. These efforts include overseeing an AI policy group, as well as engaging external stakeholders and advancing the development of regulatory science around the use of AI in drug development. She also contributes to the development of medical policy related to real-world evidence and the use of digital health technologies for medical product development. In 2023, Dr. Fakhouri was selected by the Office of Management and Budget (OMB) to serve on the Federal Committee for Statistical Methodology for her expertise in statistical methods. Prior to joining FDA, Dr. Fakhouri served as a Senior Health Scientist and Chief Statistician for the CDC’s flagship population survey, the National Health and Nutrition Examination Survey (NHANES).

The NHANES program, which is conducted by the CDC’s National Center for Health Statistics (NCHS), is recognized as the premier source of nationally representative data on the health of the nation. In her role at NHANES, Dr. Fakhouri advised and provided guidance on all epidemiologic, statistical, and methodological issues related to NHANES within CDC and with external stakeholders, with special emphasis on issues related to selection bias, data linkage, and data quality. She was also responsible for designing strategies to increase survey cooperation rates including changes to recruitment protocol and procedures, changes to survey sampling and design, and developing targeted outreach materials to increase survey representativeness. In addition, Dr. Fakhouri served on the NCHS Disclosure Review Board, the Cancer Moonshot Data Science Workgroup, and co-led the FCSM Nonresponse Bias Subcommittee, which was tasked with identifying gaps in issues related to survey nonresponse and selection bias, and with providing recommendations to OMB on Federal survey standards and guidelines. Prior to joining NHANES, she served as an Epidemic Intelligence Service Officer with the CDC, and deputy lead for health surveys at ICF-Macro International. Dr. Fakhouri published over 30 government reports, peer-reviewed papers, and book chapters on chronic disease epidemiology and on methodological issues related to nonresponse bias and data quality.

Dr. Fakhouri earned a Ph.D. in Oncological Sciences from The Huntsman Cancer Institute at the University of Utah, an MPH in Epidemiologic and Biostatistical Methods from the Johns Hopkins University School of Public Health, and a postdoctoral fellowship in molecular biology and genetics from Harvard University and holds a BSc Medical Technology form the Jordan University of Science and Technology.

Martin Reiser, S-3 Group

Marty Reiser most recently served as Policy Director for House Minority Whip Steve Scalise. He has had a long career in government focused on health care, tax, trade and pension policy and financial services. He was the lead policy staff for the House Republican Whip operation on all major legislation since 2014, including Trade Promotion Authority (TPA), Tax Cut and Jobs Act, USMCA, CARES Act and all COVID-related legislation, the American Health Care Act, Budget Reconciliation, tax extenders, multi-employer pension plan reform, 21st Century Cures and Opioid bills. Marty also directs all coalition efforts for the House Republican conference – including outreach to business community, trade associations, issue advocacy groups and state and local governments. Since May 2020, Marty has had an additional role as chief health policy advisor for the minority on the Select Subcommittee on the Corona Virus Crisis. In that role he has worked on daily basis with CDC, FDA, HHS, the White House, Treasury, the Federal Reserve and the small business community on oversight issues related to the federal government’s response to COVID.

Prior to joining the Whip office in 2014, Marty Reiser served as professional staff for the House Ways and Means Committee Health Subcommittee (Majority). In this role, he was responsible for health care issues impacting private insurance, employers, taxes and the economic impact of health policy, legal issues, and Medicare Secondary payer policies. Worked directly with Leadership, other Committees of jurisdiction in the House and Senate, Congressional Budget Office, Joint Committee on Taxation, Office of Legislative Counsel, Administration officials, outside experts to advance legislation and conduct oversight. Principal staffer for 12 bills that passed the House of Representatives and or were signed into law, including: the Expatriate Health Coverage Clarification Act, the Save our Workers Act, the repeal of the CLASS Act, Health Savings Accounts Improvement Act, the repeal of the medical device tax, and the Hire More Heroes Act. Organized 15 hearings.

Previously, he served as a manager of government policy for Xerox Corporation, and specialized in health, pension benefit and economic issues. In this role he chaired the National Coalition on Benefits, a leading coalition of 200 companies and trade associations formed to advocate for employer interests in health care reform.

He has also served as a Chief of Staff for Rep. Dan Miller (R-FL) and as Rep. Miller’s associate to the Budget Committee. He served as a staff member of the Minority leader’s task Force on Health during the legislative debate over the Health Security Act (HillaryCare) and as lead staff for the Medicare Communications Group during the debate over the the Balanced Budget Act of 1997.

From 1999-2003, he served as Vice President of Public Policy for Citizens for a Sound Economy, a free-market think tank that focused on public policy issues impacting the economy.

Mr. Reiser began his career at the U.S. Department of Commerce. He holds a law degree from George Mason University and a master’s in International Affairs from George Washington University. He earned a BA from Holy Cross.

David Wasserman, Senior Election Analyst, The Cook Political Report with Amy Walter and NBC Contributor

David Wasserman is the Senior Election Analyst for the non-partisan newsletter, The Cook Political Report with Amy Walter, and a contributor to NBC News. Founded in 1984, The Cook Political Report with Amy Walter provides analyses of U.S. presidential, Senate, House, and gubernatorial races. The New York Times called The Cook Political Report with Amy Walter “a newsletter that both parties regard as authoritative.”

Wasserman analyzes the current political environment in lively and entertaining presentations that he can tailor to his audiences’ specific interests or locales. His data-driven forecasting looks at both national and local trends (if requested, he can even do a district-by-district outlook), the relationship between consumer brand loyalty and voting, and what the future holds for American elections.

In 2016, Wasserman drew wide praise for his accurate pre-election analysis, including his uncanny September piece entitled, “How Trump Could Win the White

House While Losing the Popular Vote.” Leading Republican pollster Kristen Soltis Anderson concluded, “Nobody of my generation knows American politics as well as Dave Wasserman.”

Wasserman has served as an analyst for the NBC News Election Night Decision Desk since 2008 and has also appeared on Fox News, CNN, and NPR. His commentary has been cited in numerous publications including the Wall Street Journal, the Economist, POLITICO, and the Washington Post. In 2018, his groundbreaking interactive collaboration with FiveThirtyEight, the “Atlas of Redistricting,” took top prize for News Data App of the Year.

An enthusiast for data and maps, Wasserman serves as a contributing writer to the Almanac of American Politics. A frequent speaker and guest lecturer, he has shared insights into the latest political trends with audiences at Harvard’s Institute of Politics, the Dole Institute of Politics, and the University of Chicago Institute of Politics – where he was named a resident Pritzker Fellow in 2019.

Prior to joining The Cook Political Report with Amy Walter in 2007, Wasserman served for three years as House editor of Sabato’s Crystal Ball, a widely respected political analysis newsletter and website founded by renowned University of Virginia professor Larry Sabato. A native of New Jersey, Wasserman is a graduate of the University of Virginia, where he was awarded the 2006 Emmerich-Wright Outstanding Thesis Prize.