ABOUT DR. STEVE

Stephen J. Hellebusch, Ph.D. is President of HellRC (Hellebusch Research & Consulting), a company that specializes in the design and analysis of projects for the pharmaceutical industry. He recently helped establish the value of a new pharmaceutical product and assisted it through the FDA approval process at ZS Pharma. Steve’s research was useful in bringing investors to ZS Pharma. The company was acquired by AstraZeneca in 2015. 


Prior to ZS Pharma, Steve consulted with Adams Respiratory Therapeutics, Inc., helping them bring Mucinex, a very successful cold product to market. Steve currently does research in behavioral economics and consults with several pharmaceutical start-ups.


Steve has extensive experience working on FDA-related Rx-to-OTC switch projects. In fact, he has conducted over 50 projects related to switch issues on various products. Many of these studies concerned label comprehension.


Steve’s research was pivotal in the successful Nicorette and NicoDerm CQ switches. He also conducted studies for Rogaine 5%, and served as a consultant on that approval team in 1997. He has conducted label comprehension studies on Tagamet HB and Wartner, a wart removal device. He was a member of the Bayer Primary Prevention team that presented to the Food and Drug Administration (FDA) in December, 2003. He spoke on labeling and label testing at the FDA in September of 1995, and in June of 2000, and spoke at the Consumer Healthcare Products Association (CHPA) meeting in November, 2000. He has published articles on label comprehension in several issues of Focus, the magazine of the Regulatory Affairs Professionals Society.


Steve began his research career at Burke Marketing Research, Inc. From Burke, he went to Mobil Chemical Company. He left Mobil in 1985 to go to Merrell Dow Pharmaceuticals, Inc. where he was in charge of all marketing research on nonprescription products, potential switch products, and several prescription products as well. Steve received his Ph.D. in Experimental Psychology from the University of Notre Dame, concentrating in research design, statistics, perception, and memory. In addition to his current project and consulting work, he periodically teaches a tutorial for the American Marketing Association that emphasizes the importance of setting objectives correctly.


Speaking Engagements:


Arbitrary Coherence and Image Perception in a National Sample. Presented at MBAA International Conference. Chicago, IL. April, 2018

Identifying Marketing Research Objectives, American Marketing Association Tutorial, Fall, 1994; Spring and Fall of 1995, 1996, 1997, 1998, 1999, 2000, 2001, 2002, 2003, 2004, 2006.

Using Marketing Research to Drive Brand Sales Success, Medical Marketing Association via Webcast, February, 2006.

Involving the End User in Label Wording Development, Pharmaceutical Packaging and Labeling Summit, Center for Pharmaceutical Training, October, 2003.

Identifying the Target for Switch Products, Research and Scientific Development Conference, Consumer Healthcare Products Association, November, 2000.

Validity of Consumer Research, FDA Conference on Regulation of Over-The-Counter Drugs, June, 2000.

Views on Label Testing, FDA Conference on Labeling, September, 1995.