About Tom Layloff

Dr. Thomas Layloff received a BA in Psychology and Chemistry, and MS in Organic Chemistry from Washington University in St. Louis, Missouri. He continued his education at the University of Kansas in Lawrence, Kansas where he received a Ph.D. in Analytical Chemistry with a minor in Mathematics. Upon receipt of the Ph.D. he joined the Chemistry Department of St. Louis University as Professor of Analytical Chemistry. During his tenure there he also served as a Science Advisor (Consultant) to the U.S. Food and Drug Administration’s St. Louis District Laboratory and its successor National Center for Drug Analysis (NCDA). Upon the retirement of the Director and Deputy Director of NCDA he joined the FDA full-time as Director of the laboratory.

During his tenure as Director of NCDA he also served a temporary and subsequent co-lateral assignment as Directory of the FDA Division of Field Science and Technology coordinating the laboratory operations of FDA’s 18 Field Laboratories. During that assignment he directed the establishment of the mission statements, staffing patterns, and recruitment strategies which were used to implement the Commissioners initiative to establish the Field Laboratory Research Centers.

After serving over 20 years as the Director of the St. Louis FDA laboratory he transferred to the Center for Drug Evaluation and Research to serve as Associate Director for Regulatory Standards preparing regulatory concept documents.

He left the FDA to join the United States Pharmacopeia as Vice President and Director of the Pharmaceutical Standards Division. He left the USP to join Management Sciences for Health as Principal Program Associate in the Center for Pharmaceutical Management.

Below is a listing of his Awards and Recognitions and some of his publications.

Awards and Recognitions

Last Updated February 19, 2002.

“American Chemical Society Council Service Award,” For serving as a St. Louis Section Councilor for fifteen years; 2001.

“AOAC International Certificate of Recognition,” “For developing the accreditation criteria while serving as Pharmaceutical Subcommittee Chair of the Analytical Laboratory Accreditation Criteria Committee.” 2001.

“FDA Commissioner’s Distinguished Career Award,” 2000.

“FDA Commendable Service Award,” 1998. “For orchestrating public forums to identify and dialogue on laboratory issues of significance to industrial pharmaceutical laboratories to improve communications and understanding.” Also received a FDA “Hammer Award” for continuing same activity in a different venue.

“Health and Human Services Distinguished Service Award,” 1997. “For outstanding performance in the development of regulations to protect the nation’s children from cigarette smoking.” Also received for this extended effort a letter of thanks from Vice President Al Gore.

"1995 Distinguished Service Award," St. Louis Section ACS, For sustained distinguished service in the St. Louis Section.

United States Pharmacopeia, elected to the Committee of Revision for the 1990-95 term, and re-elected for 1995-2000 term. Elected Chair of the Division of Standards Development Executive Committee, 1992-94 (establishes scientific policies for the USP-NF). Appointed to serve as a member of the USP Reference Standards Committee, 1995-2000 for the adoption of USP Reference Standards.

American Association of Pharmaceutical Scientists (AAPS), elected Fellow, 1990

AOAC International (formerly the Association of Official Analytical Chemists), elected Fellow, 1989

Commissioners Special Citation, "Group Award for Facilities Action Planning Team," 1985

EEO Certificate of Recognition, FDA, Center for Drugs and Biologics, 1984

"St. Louis Section American Chemical Society Award," for outstanding contributions to the chemical profession and demonstrated potential to further its advancement," 1981

FDA Commendable Service Award "In recognition of outstanding leadership and managerial abilities as Acting Director of the Office of Regional Operations' Division of Field Science and Technology during a period in which major new initiatives were instituted," 1980.

Nancy McNair Ring Award. An annual award presented by St. Louis University's graduating Seniors to the outstanding faculty member, 1974.


Last Updated 2008 August 29.

Purchase Requisition System: A Computer-Based, Internally Paperless, Purchasing and Inventory System, S. J. Logan, S. F. Goldsby, L. Jones and T. P. Layloff, Jr., Managing the Modern Laboratory, Volume 1, Number 1, 1985, pages 24-28.

Series of articles originally published in in American Genomic/Proteomic Technology

49. “Rapid Screening of Tuberculosis Pharmaceuticals by Thin Layer Chromatography,” A. S. Kenyon, T Layloff, and J. Sherma, J. Liq. Chromatography, 2001, 24, 1479-1490.

48. “Detection of substandard fixed-dose combination tuberculosis drugs using thin-layer chromatography,” T.A. Kenyon, A.S. Kenyon, B.V. Kgarebe, D. Mothibedi, N.J. Binkin, and T.P. Layloff, Int J Tuberc Lung Dis., 1999, Nov; 3 (11 Suppl 3): S347-50; discussion S351-2.

47. “Algorithms for validating chiral properties of insulins,” N. Purdie, D.W. Province, T.P. Layloff, and M.M. Nasr; Anal Chem., 1999, 71, 3341-6.

46. "A Strategy for Developing Consistent HPLC Data for Assessing Sameness and Difference in Consistency of Pharmaceutical Products," Zielinski, W.L., Brower, J.F., Welsh, W.J., Collantes, E., Layloff, T.P., American Pharmaceutical Reviews, 1998, 1, 44-54.

45. "Photostability Testing of Pharmaceutical Products," Sager, N., Baum, R.G., Wolter, R.J., Layloff, T.; Pharmacopeial Forum, 1998, 24(3), 6331-6333.

44. "The Importance of Analytical Procedures in Regulatory Control," Layloff, T.P., WHO Drug Bulletin, 1997, 11, 128-130.

43. "Retrospective Summary of Twenty Years of Content Uniformity Data for Tablet and Capsule Dosage Forms," Wells, C.E., Layloff, T.P., Pharmacopeial Forum, 1997, 23(4), 4583-4586.

42. “Monitoring recombinant protein drugs: a study of insulin by H/D exchange and electrospray ionization mass spectrometry, Ramanathan R, Gross ML, Zielinski WL, Layloff TP, Anal Chem., 1997, 69, 5142-5.

41. “Pharmaceutical Fingerprinting: Evaluation of Neural Networks and Chemometric Techniques for Distinguishing Among Same-Product Manufacturers,” W.J Welsh, W. Lin, S.H. Tersigni, E. Collantes, R. Duta, M.S. Carey, W.L. Zielinski, J. Brower, T.P. Layloff, Analytical Chemistry, 1996, 68, 3473-3482.

40. “Analyst Training and Certification: Management Responsibilities,” T.P. Layloff, C.M. Kerner and W.B. Furman, Managing the Modern Laboratory, 1996, 2, 23-28.

39. “Weighing on an Analytical Balance,” A.S. Kenyon and T.P. Layloff, Pharmacopeial Forum, 1996, 22, 2686-2689.

38. “Summer of 1995 Mailbox Temperature Excursions in St. Louis,” J.C. Black and T.P. Layloff, Pharamacopeial Forum, 1996, 22, 3305.

37. "On the Choice of a Light Source for the Photostability Testing of Pharmaceuticals," J. P. Riehl, C. L. Maupin and T. P. Layloff, Pharm. Forum, 1995, 21, 1654-1663.

36. "Elimination or Reduction of the Use of Mercury, Mercury Compounds, and Chromic Acid Cleaning Solutions in the USP Procedures," A. S. Kenyon and T. P. Layloff, Pharm. Forum, 1995, 21, 485-489.

35. "Quality Assurance in Weighing," A. S. Kenyon, J. C. Black and T. Layloff, J. AOAC Int., 1995, 78, 1109-1111.

34. "Rapid Screening of Pharmaceuticals by Thin-Layer Chromatography," 1995, WHO PHARM/95.290, 110 pages. A compendium of TLC method for pharmaceutical products.

33. "Purchase Requisition System: A Computer-Based, Internally Paperless, Purchasing and Inventory System," S. J. Logan, S. F. Goldsby, L. Jones and T. Layloff, Managing the Modern Laboratory, 1995, 1, 24-28.

32. "Rapid Screening of Pharmaceuticals by Thin-Layer Chromatography: Analysis of Essential Drugs by Visual Methods," A. S. Kenyon, P. E. Flinn, and T. Layloff, J. AOAC Int., 1995, 78, 41-49.

31. "Analytical Chemical Considerations in Pharmaceutical Regulation,” T. P. Layloff, Pharm. Forum, 1994, 20, 7865-7869; a revision of this publication bearing the same title is in WHO press as PHARM/94.273.

30. "Validation of Computerized Liquid Chromatographic Systems," W. B. Furman, T. Layloff, and R. F. Tetzlaff, J. AOAC Int., 1994, 77, 1314-1318.

29. "Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic Studies," V. P. Shah et al; J. Pharm. Sci., 1992, 81, 309-312.

28. "Training Modules to Develop Analytical Proficiency for Pharmaceutical Chemists," A. S. Kenyon, R. D. Kirchhoefer, and T. Layloff; J. AOAC Int., 1992, 75, 742-746.

27. "A Simplified TLC System for Qualitative and Semi-Quantitative Analysis of Pharmaceuticals," P. E. Flinn, A. S. Kenyon and T. Layloff; J. Liquid Chromatogr., 1992, 15, 1639-1653.

26. "Selection and Validation of Legal Reference Methods of Analysis for Pharmaceutical Products in the United States," T. Layloff and P. Motise; Pharm. Technol., 1992, 16, 122-132.

25. "DECORE, A Relational Database Application for Collection Reports," S. F. Goldsby, S. J. Logan, F. W. Kerner and T. Layloff; FDA Lab. Info. Bull., 1992, 3702.

24. “Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies. Conference report,” Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, Yacobi A, Layloff T, Viswanathan CT, Cook CE, McDowall RD, et al, Eur J Drug Metab Pharmacokinet, 1991 Oct-Dec; 16(4), 249-55.

23. "Scientific Fingerprinting: A Pharmaceutical Regulatory Tool," T. Layloff; Pharm. Technol., 1991, 15, 146-148.

22. "The Future of AOAC: A Prognostication," T. Layloff; J. Assoc. Off. Anal. Chem, 1991, 74, 20-21.

21. "Method Validation: What You Pay for is What You Get," T. Layloff; AOAC Referee, 1991, 15, 10-11.\20. "Analysts: The Unknowns in the Quality Assurance Equation," T. Layloff; AOAC Referee, 1990, 14, 6.

19. "A Simple, Inexpensive Thin Layer Chromatography Method for the Analysis of Theophylline Tablets," P. E. Flinn, Y. H. Juhl and T. Layloff; Bull. WHO, 1989, 67, 555-559.

18. "Studies in the Development of USP Dissolution Test Method Number 2," T. Layloff, Pharmacopeial Forum, 1983, 9, 3752-3757

17. "Quality Assurance Programs for Equipment at NCDA," in "Optimizing Chemical Laboratory Performance Through the Application of Quality Assurance Principles," F. M. Garfield, N. Palmer and G. Schwartzman, Eds, AOAC, l980.

16. “Electrochemical control of redox potential in perfusate for prolonged heart storage,” Jellinek M, Hahn JW, Layloff TP, Kuhls GH, Menz LJ, Jones JS, Willman VL, Trans Am Soc Artif Intern Organs, 1974; 20 B, 533-7

15. "Electrochemical Reductive Acylation of Benzophenone," T. J. Curphey, L. D. Trivedi and T. Layloff, J. Org. Chem., 1974, 39, 383l.

14. "A Crime Lab Advisory Committee," T. Layloff and W. S. Linenweber, Chem. Tech., 1974, 65.

13. "Quantitative Analysis in Revision, "W. R. Bramstedt, W. A. Korfmacher, and T. Layloff, J. Chem. Ed., 1973, 50, 252.

12. "Cyclic Sulfite and Sulfate Esters of Polymethylene Glycols," D. Lipkin and T. Layloff, J. Chem. and Eng. Data, 1970, l5, 450.

11. "Solvation Studies on p-Chloronitrobenzene Anion Radical in Acetonitrile Alkyl Alcohol Solvent Mixtures at 25o," Sr. M. T. Hertrich, O. P., and T. Layloff, J. Am. Chem. Soc., 1969, 9l, 69l0

10. "Electrochemical Preparation of Cyclopropanediol Derivatives," T. J. Curphey, C. W. Amelotti, T. Layloff, R. L. McCartney and J. H. Williams, J. Am. Chem. Soc., 1969, 9l, 28l7

9. "Nickel Complexes with 2-Diethylphosphinoethyl Ethyl Sulfide," J. A. Sieckhaus and T. Layloff, Inorg. Chem., 1967, 6, 2l85

8. "Electron Exchange Reactions of Aromatic Molecules," P. A. Malachesky, T. A. Miller, T. Layloff, and R. N. Adams, Intn'l At. Engy. Comm. Symposium in Electron Exchange, Brookhaven, June, l965.

7. "Electron-Transfer Reactions of Aromatic Radical Ions," J. M. Fritsch, T. P. Layloff and R. N. Adams, J. Am. Chem. Soc., 1965, 87, l724

6. "Homogeneous Electron Exchange Reactions of Aromatic Molecules," T, P. Layloff, T. Miller, R. N. Adams, H. Fah, A. Horsfield, and W. Proctor, Nature, 1965, 205, 382

5. "Solvent Effects on Hyperfine Coupling Constants in Electron Paramagnetic Resonance Spectra," P. Ludwig, T. Layloff and R. N. Adams, J. Am. Chem. Soc., 1964, 86, 4568

4. "The Effect of Lithium Ion on the Mechanism of the Polarographic Reduction of Benzil in Dimethylformamide," R. H. Philip, Jr., T. P. Layloff, and R. N. Adams, J. Electrochem. Soc., 1964, lll, ll89

3. "Effect of Metal Ions on Nuclear Hyperfine Coupling Constants in EPR Spectra," T. Kitagawa, T. Layloff and R. N. Adams, Anal. Chem., 1964, 36, 925

2. "Correlation of Solvent Effects on Electron Paramagnetic Resonance Spectra of the Nitrobenzene Anion Radical," J. Q. Chambers, III, T. P. Layloff and R. N. Adams, J. Phys. Chem., 1964, 68, 66l

1. "Voltammetry and Electron Paramagnetic Resonance Spectra of Halo-nitrobenzene Anion Radicals," T. Kitagawa, T. P. Layloff, and R. N. Adams, Anal. Chem., 1963, 35, l086.

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