Welcome/Overview of the NIH SBIR/STTR Programs
Ms. JoAnne Goodnight
NIH SBIR/STTR Program Coordinator

Peer Review of NIH SBIR/STTR Grant Applications
Dr. Anthony Coelho
NIH Review Policy Officer

Compliance Issues – Grants Management and Indirect Costs/Audits
Ms. Teresa Marquette
Senior Grants Management Specialist, NINR
Ms. Ruth Bishop
NIH Division of Financial Advisory Services
Ms. Leanne Robey
NIH Division of Financial Advisory Services

Human Subjects – Do You or Do You Not Have Human Subject Involvement?
Dr. Valery Gordon
Office of Extramural Programs

Animal Welfare Issues
Dr. Axel Wolff
NIH Office of Laboratory Animal Welfare

Intellectual Property & Data Rights – Yours, Mine, and Ours
Mr. Michael Gollin
Venable, LLP

Tales from the Trenches: Anatomy of a Start-up
Dr. Robert Bargatze
LigoCyte Pharmaceuticals

Tales from the Trenches: From Idea to Market
Dr. Geoffrey Hart
Design Continuum

Tales from the Trenches: From Academic Bench to Business
Dr. Mary Pat Moyer
INCELL Corporation

Day 2

Morning

An In-Depth Look at the FDA Process
Part I
Mr. David Arvelo, Small Business Representative, FDA
Dr. Maritza McIntyre, Center for Biologics Evaluation & Research (CBER), FDA
Ms. Mercedes Serabian, Center for Biologics Evaluation & Research (CBER), FDA
Dr. Robert Phillips, Center for Devices and Radiological Health (CDRH), FDA

An In-Depth Look at the FDA Process
Part II
Dr. Haleh Saber-Mahloogi, Center for Drug Evaluation & Research (CDER), FDA
Dr. William Timmer, Center for Drug Evaluation & Research (CDER), FDA
Dr. Robert Kane, Center for Drug Evaluation & Research (CDER), FDA
Dr. Anne Pilaro, Center for Drug Evaluation & Research (CDER), FDA

Tales from the Trenches – Behavioral Research
Ms. Karen Littman
Morphonix, Inc.

State Support Organizations & Resources
Ms. Mildred Holley, Arkansas Small Business Development Center
Dr. Janet Yancey-Wrona, Maine Technology Institute
Mr. Dan Luton, Oklahoma Center for Advancement of Science & Technology

Afternoon

Commercialization Hurdles & Solutions -- Part II
Mr. Dan Luton, Oklahoma Center for Advancement of Science & Technology
Dr. Janet Yancey-Wrona, Maine Technology Institute

Reality Show – Part III

Alliances & Partnerships
Mr. Tim Janke
North Carolina Small Business Technology Development Center

Investment Forum Presentation
Dr. Frederick Holtsberg
Phoenix Pharmacologics, Inc.

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