John J. Koleng, Ph.D., R.Ph.
Vice President of Product Development and Manufacturing
John J. Koleng has co-founded AlphaVektor, LLC and Axxis Innovations, Inc., life sciences development and industrialization consultancies focused on product development, manufacturing, scale up, commercialization, and supply chain management. He has more than 20 years of experience in the pharmaceutical industry, including more than 10 years as a consultant. John has been a founding member of three drug development companies, Oticara, Via Therapeutics, and CloXero Therapeutics, that are actively developing new products under an FDA 505(b)(2) approach.
During his career, John has guided and assisted numerous life-science companies in the development of their technology. His drug development experience ranges from nasal/pulmonary products, injectables, transdermals, and abuse deterrent systems to liquid-filled capsules, hot melt extruded dosage forms, and nano-dose tablets. He has published numerous scientific research articles and is an inventor on 16 issued U.S. patents and numerous pending patent applications. In addition to his other consulting work, John has a historic relationship working with TFF Pharmaceuticals as a consultant and is an inventor on several provisional patent applications filed on behalf of TFF.
Prior to his consulting career, Dr. Koleng was a founding member and served as Vice President of Industrial Operations at PharmaForm, a contract development and manufacturing organization (CDMO). His roles increased from Vice President of Pharmaceutical Research to Chief Operating Officer before the company was sold to Akela Pharma, Inc. in 2007. John has a B.S. degree in Pharmacy (1994), and a Ph.D. in Pharmaceutics (2002), both from the University of Texas at Austin where he currently holds an Adjunct Assistant Professor of Pharmaceutics appointment and serves on the UT College of Pharmacy Dean’s Advisory Council. He is a registered pharmacist.