Christopher Riley, Ph.D.
Christopher Riley is the President and Co-founder of Riley and Rabel Consulting Services, Inc. Dr. Riley received his bachelor’s degree in pharmacy (1977) and Ph.D. degree in Pharmaceutical Chemistry (1980) from the University of Bath, England. He was a post-doctoral fellow at the University of Kansas in the Department of Pharmaceutical Chemistry (1981-1982) before joining the faculty of the Department of Pharmaceutics at the University of Florida. He returned to the University of Kansas as a faculty member in 1986 where he remained until 1994.
Dr. Riley’s industrial experience began in 1994 as head of Analytical R&D at Dupont Pharmaceuticals (previously Dupont Merck). In late 2001 he joined ALZA, a subsidiary of Johnson & Johnson, where he had positions of increasing responsibility up to Vice President and West Coast Site Head ChemPharm Development. He left ALZA in May 2007 to form Riley and Rabel Consulting Services. He has co-authored more than 100 book chapters and papers in peer-reviewed journals, as well as two books entitled Pharmaceutical and Biomedical Applications of Liquid Chromatography and Validation of Methods and Systems in Pharmaceutical and Biomedical Analysis. He was elected Fellow of the American Association of Pharmaceutical Scientists (AAPS) and served as the chair of the Analysis and Pharmaceutical Quality Section of AAPS and a Member of the AAPS Executive Committee. Dr. Riley has served as a member and chair of the PhRMA Analytical Technical Committee, as well as a member and chair of the PhRMA Technical Leadership Committee. Dr. Riley represented PhRMA on the ICH Expert Working Group on Impurities in Drug Substances (Q3A) and Drug Products (Q3B) and was Chair of the PhRMA Working Group on Genotoxic Impurities.
Shelley Rabel, Ph.D.
Shelley Rabel is the Vice-President and Co-founder of Riley and Rabel Consulting Services, Inc. Dr. Rabel received a B.S. in Chemistry from Northwest Missouri State University in 1988. She then received a Ph.D. in Pharmaceutical Chemistry from the University of Kansas in 1994, where she was awarded a USP Fellowship and a Training Grant Fellowship with the National Cancer Institute.
Dr. Rabel has over 12 years of experience in the pharmaceutical industry. She started her career at DuPont Pharmaceutical Company (now Bristol-Myers Squibb) in the Basic Pharmaceutics and Biopharmaceutics group providing Preformulation/Formulation support for Discovery and Pharmaceutical Development groups. In 2002, Dr. Rabel joined ALZA Corporation, a subsidiary of Johnson & Johnson, as a Principal Scientist/Manager in Oral Products Development where she was responsible for the development of controlled-release dosage forms. In 2005, she accepted a position with Amgen, Inc. as Associate Director of Small Molecule Pharmaceutics at the San Francisco site. In this role she led the start up and integration of a new Pharmaceutics group, which provided Preformulation support for multiple projects and therapeutic areas. In May of 2007, Dr. Rabel co-founded Riley and Rabel Consulting Services, Inc. Dr. Rabel has nineteen publications, seventeen presentations, and three patents.
M. Andino, D. De Antonis, C. Beels, J. DeGeorge, F. De Knaep, D. Ellison, J. Fagerland, R. Frank, B. Fritschel, E. Harpur, C. Humfrey, G. Mohan, A. Jacks, N. Jagota, J. Mackinnon, R. Mauthe, L. Mueller, D. Ness, M. O’Donovan, C.M. Riley, M. Smith, GlaxoSmithKline; G. Vudathala, L. Yotti, Rationale for Determining, Testing and Controlling Specific Impurities in Pharmaceuticals that Possess Potential for Genotoxicity, Regulatory Toxicology and Pharmacology. 2006, 44: 198-211
Stephen P. Raillard, Joel Bercu, Steven W. Baertschi and C.M. Riley, Prediction of Drug Degradation Pathways Leading to Alerts for Potential Genotoxic Impurities, Organic Process Research and Development, 2010, 14: 1015-1020
Riley, C.M., S.R. Rabel Riley and R.L Phelps,., Assay and Impurities, General Principles and Regulatory Considerations, Specification of Drug Substances and Drug Products: Development and Validation of Analytical Methods, ed. C.M. Riley, T.W. Rosanske and S. R. Rabel Riley, 2014, Elsevier, New York, 109-142
Riley, C.M., T.W. Rosanske and S.R. Rabel Riley, Specification of Drug Substances and Drug Products: Development and Validation of Analytical Methods, ed. C.M. Riley, T.W. Rosanske and S. R. Rabel Riley, 2013, Elsevier, New York, (2nd Edition to be published 4th quarter 2019)
Hanlin Li, David Nadig, Andrew Kuzmission and C.M. Riley, Prediction of the Changes in Drug Dissolution from an Immediate-Release Tablet containing Two Active Ingredients using and Accelerated Stability Assessment Program (ASAPprime®), AAPS Open, 2016, 2(1): 7. Doi:10.1186/s41120-016-0010-5.
N. Buyktimkin, S. Buyktimikin, J. Singh, J.M. Newsam, D. King-Smith, E. Kisak, B.S. Galer, T. Desai, and C.M. Riley, Pharmaceutical Formulations and Methods of Use, US Patent Number 2012/0214874, 2012
H. Chen, G. Winkle and C.M. Riley, Transdermal Composition of Ibuprofen and Methods of Use Thereof. Number 20120214874, 9,849.080, 2017
C.M. Riley and B. Zechinati, Separation of Vancomycin and its Degradation Products. U.S. Provisional Patent Application, Number 62/745,772, October 15, 2018.
P. J. Gilligan, S. R. Rabel Riley, P.A. Meenan. Salt and Crystalline Form Thereof of a Corticotrophin Releasing Factor Receptor Antagonist. U.S. Patent 7153961 B2, Dec. 26, 2006
L. Radesca, James R. Moore, S. R. Rabel Riley, and M. B. Maurin, Crystalline Efavirenz. U.S. Patent 6673372, Jan. 6, 2004.
S.R. Rabel Riley, Rodney Parsons Jr., and Mona Patel. Crystalline (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-3,4-dihydro-2(1H)-quinazolinone. U.S. Patent 6225317, May 1, 2001.