Larry J. Bauer Senior Regulatory Drug Expert 202-900-2804
Larry J. Bauer

Overview

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.

Education & Admissions

Education

R.N. Huron Road Hospital School of Nursing
M.A. Counseling Psychology, Bowie State University
B.A. Cleveland State University

 

Experience

Larry Bauer brings more than 27 years of combined service at the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) to his consulting role with a focus on expediting the development of drugs for patients with rare diseases.

 Drug Development

  • Bauer was part of the Regulatory Affairs Team in the Office of New Drugs (OND) Immediate Office where he coordinated the initial years of the Breakthrough Therapy Program and other cross cutting regulatory projects.
  • When CDER’s Rare Diseases Program was initiated in 2010, Mr. Bauer joined the program as a Regulatory Scientist. In this role he helped shape the program, grow the staff, worked on scientific development, engaged with the OND review teams involved in the review of new drugs for rare diseases, responded to congressional inquiries, engaged in policy decision making, and helped develop a comprehensive FDA database for new molecular entities and new biologics products.
  • Bauer was a key figure in the administration of the Rare Pediatric Disease Priority Review Voucher program and oversaw the initial implementation of the program as well as participated in the review of submissions.
  • Bauer was part of the FDA Orphan Council which discussed cross-cutting issues related to rare diseases.
  • He consulted with patient advocacy groups and drug sponsors related to specific programs as well as giving guidance on how to navigate FDA processes and procedures. This consultation included participation in Critical Path Innovation Meetings (CPIM) for rare diseases.
  • Bauer helped develop yearly rare disease educational seminars to train FDA review staff, was on the planning committee for several National Organization for Rare Disorders (NORD) Rare Disease Summits, gave numerous presentations at local and international conferences, and was an invited speaker to numerous rare disease events

Policy

Mr. Bauer was on the planning committees for the following key FDA guidances:

Advocacy

 Mr. Bauer is on the Advocacy Committee of the National Organization for Rare Disorders (NORD) and works with policy makers on Capitol Hill, in the White House, in government agencies, and at the local level to help inform policies that are reflective of the needs of rare disease patients.

Honors & Awards

2018 CDER’s Center Director’s Special Citation
2018 Regulatory Science Excellence Honor Award
2013 CDER Regulatory Science Excellence award
2001 NIH Director’s Award, Teaching/Training
2000 NIH Award for Excellence in Teamwork

Education

R.N. Huron Road Hospital School of Nursing
M.A. Counseling Psychology, Bowie State University
B.A. Cleveland State University