Ian Davis

Ian Davis

Work History

Work History

Methods Development Manager

CompuChem Laboratories
  • Directed and participated in method development and validation for gas chromatography/mass spectrometry (GC/MS) analysis from urine samples
  • Developed and implemented quality control standard operating procedures (SOPs) to meet Armed Forces Institute of Pathology (AFIP), College of American Pathologists (CAP), and Clinical Laboratory Improvement Act (CLIA) certification
  • Managed formulation of quality control standards, reagents, and specialized glassware
  • Managed accurate, expedited analytical preparation of 1,500+ samples per week
  • Coordinated assignments for production staff over three shifts
  • Hired, trained, and conducted performance reviews

Forensic drug testing division purchased by http://www.labcorp.com

Aug 2007 - Present

Vice President, Bioanalytical Services

Celerion (formerly MDS Pharma Services)

Accountable for the profit and loss of three global bioanalytical laboratories (Zurich, Montreal, Lincoln)

  • Exceeded P&L objectives in first year of leadership for 3 global bioanalytical operations (Zurich, Montreal, Lincoln) while providing GxP LCMS, immunoassay, and immunogenicity services
  • Accountable for quality processes and deliverables for all sites
  • Collaborate with FP&A partners to forecast revenue and costs, while improving performance relative to budget
  • Global bioanalytical business sponsor of >20 LeanSigma process improvement and cost containment projects
  • Partner with business development and marketing functions to identify new therapeutic area focused opportunities for LCMS and ligand binding businesses
  • Drive on-time performance for lab operations and quality assurance to meet client expectations
  • Establish, maintain and report operational metrics for global laboratory operations
Feb 2002 - Sep 2006

Director, Operations

Pharsight

Directed project management, budgeting, forecasting and revenue recognition function for 25 statistical modeling and simulation consultants

  • Delivered client-facing sales and marketing strategy support through refinement of work plans, sales presentations, use of Salesforce.com and Onyx CRM software
  • Prepared and priced 600+ statistical modeling and simulation work plans for delivery to clients
  • Created high ROI public source meta-database group that relieved consultants from literature search, manual data transfer/entry, and quality control functions
  • Worked extensively with kineticists/statistician “headhunters” to identify, screen, select, interview, and decide on U.S. and EU consultant hiring, including relocation and compensation packages
  • Directed operations for ~25 modeling and simulation statisticians w/ $10M/yr revenue
  • Profit and loss responsibility for achieving consulting group revenue targets
  • Directed SCS revenue forecasting and deliverables recognition on a monthly and quarterly basis, created and managed quarterly/annual consulting budget
  • Created and directed SCS project management and expense reporting functions, including creation of PM processes and performance metrics entire consulting group
Jul 1999 - Jan 2002

Consultant

Articulated Strategies

  • Created business relationships between clients with extraordinary bioanalytical needs and bioanalytical laboratories that could ensure successful delivery of clinical trial sample results
  • Qualified laboratories for Nobex and Pozen for bioanalytical methods development and validation GxP analysis of large and small molecules in patient samples from pharmacokinetic clinical trials
  • Developed standard operating practices and procedures for Pharmacia GxP informed consent-based program to isolate and store patient DNA samples at an academic laboratory in Montreal
Jun 1997 - Jul 1999

Director, Program Management

PPD Inc

  • Provided client-facing strategy support for Phase I clinical/laboratory sales and marketing teams
  • Delivered strategic planning guidance within Phase I/Lab Services
  • Project management for multi-disciplinary Phase I clinical studies in PPD U.S. and U.K. facilities, including creation of PM processes and performance metrics
  • Managed clinical research associate (CRA) to provide contracted Phase I monitoring
  • Integrated post-merger Phase I services (clinical research, lab, pharmacokinetics, biostatistics, data management, medical writing) for improved customer service on five PPD campuses
Nov 1995 - May 1997

Manager, Outsourced Laboratory Services

Alza Corporation

Managed a group that identified appropriate contract laboratories for the regulated analysis of biological samples obtained during the conduct of pharmaceutical trials

  • Directed daily operations for three outsourcing scientists charged with laboratory qualification, analytical methods development, validation, and in-study management of outsourced bioanalytical and analytical methods for formulation, toxicology, and clinical trial support
  • Created and directed GLP outsourcing group to deliver on-time and on-budget pharmacokinetic sample analysis for clinical pharmacology group under Dr. Suneel Gupta
  • Enhanced outsourcing group services in under one year to include provision of outsourced cGMP analytical, cleaning validation, and small batch analytical standard/internal standard syntheses
  • Developed customer service orientation, performance metrics and expectations for management of multi-disciplinary outsourcing services group

Company was purchased by Johnson & Johnson in 2002

Nov 1989 - Oct 1995

Manager, Bioanalytical Contracts

Glaxo

Solely responsible for creation and growth of a world-class bioanalytical outsourcing function within Dr. Bob Powell’s Clinical Pharmacology Department

  • Services included:
    • World-wide laboratory identification, audit, and pre-contract qualification
    • Pricing, terms, conditions, and scientific/regulatory expectation negotiations
    • Technical management of all methods development, validation, and in-study sample analysis campaigns
  • Managed the person responsible for on-time creation and clinical site delivery of all pharmacokinetic specimen labels, shipping supplies and national/international (IATA/USDOT) shipping labels and customs/HAZMAT documentation
  • Directed twice monthly project management meeting for all Phase I/II clinical trial protocols that required participation from all pharmacokineticists and study monitors
  • Personally conducted final in-house bioanalytical data review for all methods development, validation, and study reports from contracted laboratories
  • Six years as contributor to departmental strategic planning team, including:
    • Process definition, “mapping,” and success metrics
    • Departmental mission, vision, and values statement
    • Development of a world-class, fully integrated, all-services clinical pharmacology organization
    • SWOT analyses
    • Clinical pharmacology study management software development
  • Managed $3M+ annual bioanalytical budget

Education

Education
Jun 1981 - Aug 1983

M.S.

University of North Carolina at Chapel Hill

Focus on synthesis of bidentate ligands

Aug 1979 - May 1981

University of South Carolina

Post-baccalaurate courses in chemistry, biology, physics and math required for application to chemistry graduate programs. Study was paired with full-time research position in bioinorganic laboratory supervised by Dr. John Dawson.

Skills

Skills

PC and Macintosh hardware/software

  Skilled in the use of Microsoft, Apple and OpenOffice writing, spreadsheet and presentation applications Highly skilled in recording and mixing music from live and studio sessions Skilled in troubleshooting and repairing common PC hardware and software issues  

Publications and Abstracts

PUBLICATIONS

1."Stereoselective Pharmacokinetics of Chlorpheniramine and the Effect of Ranitidine," K.M. Koch, R.L. O'Connor-Semmes, I.M. Davis, Y. Yin. Journal of Pharmaceutical Sciences, 1998 87:9, 1097-1100.

2."Pharmacokinetics of Bismuth and Ranitidine from Single Doses of Ranitidine Bismuth Citrate," K.M. Koch, I.M. Davis, A.E. Gooding, Y. Yin. British Journal of Clinical Pharmacology, 1996, 42:201-205.

3."Pharmacokinetics of Bismuth and Ranitidine from Multiple Doses of Ranitidine Bismuth Citrate," K.M. Koch, B.M. Kerr, A.E. Gooding, I.M. Davis. Brit J Clin Pharm 1996, 42:207-211.

4."Pharmacokinetics and Pharmacodynamics of Ranitidine in Renal Impairment," K.M. Koch, M.J. Liu, I.M. Davis, S. Shaw, Y. Yin. Submitted to Clinical Pharmacology and Therapeutics.

5."Effect of Antacid on the Absorption of Ranitidine Bismuth Citrate (GR122311X) (Protocol H2B-102)," K.M. Koch, P.E. Warner, P.H. Hsyu, I.M. Davis, Y.Y. Shen, G.E. Pakes. Submitted to J Clin Pharm, October 1994.

6."Sumatriptan Absorption from Different Regions of the Human Gastrointestinal Tract," P.E. Warner, K.L.R. Brouwer, B.K. Hussey, G.E. Dukes, W.D. Heizer, K.H. Donn, I.M. Davis, J.R. Powell. Pharmaceutical Research, 1 (12), 138 (1995).

7."Determination of Remifentanil in Human Blood by Liquid-Liquid Extraction and Capillary GC/HRMS/SIM using a Deuterated Internal Standard," C.M. Grosse, I.M. Davis, R.F. Arrendale, J. Jersey, J. Amin. Journal of Pharmaceutical and Biomedical Analysis, 12 (2), 195 (1994).

8."Quantification of GR90291 in Human Blood by High Resolution Gas Chromatography-Mass Selective Detection (HRGC-MSD)," D. Lessard, B. Comeau, A. Charlebois, L. Letarte, I.M. Davis. Journal of Pharmaceutical Biomedical Analysis, 12 (5), 659 (1994).

9."Pharmacokinetics of Cefuroxime Axetil and Cefaclor: Relationship of Serum Concentrations to MIC's for Common Respiratory Pathogens," N.C. James, K.H. Donn, J.J. Collins, I.M. Davis, T.L. Lloyd, R.W. Hart, J.R. Powell. Antimicrobial Agents and Chemotherapy, 25 (9), 1860 (1991).

10."Gas Chromatography/Mass Spectrometry in Clinical and Forensic Toxicology," I.M. Davis, R.W. Bousquet, P.S. Childs. In-Service Training and Continuing Education, American Association for Clinical Chemistry, June 1989.

11."X-Ray Absorption Spectroscopy of Horseradish Peroxidase and Horseradish Peroxidase Models," J.E. Hahn, T.M. McMurry, M. Renner, L. Latos-Grazynski, K.S. Eble, I.M. Davis, A.L. Balch, J.R. Groves, J.H. Dawson, K.O. Hodgson. Journal of Biological Chemistry, November 1982.

12."Magnetic Circular Dichroism Spectroscopy as a Probe of Ferric Cytochrome P-450 and its Ligand Complexes," J.H. Dawson, L.A. Andersson, M. Sono, S.E. Gadecki, I.M. Davis, J.V. Nardo, E.W. Svastits in The Coordination Chemistry of Metalloenzymes, I. Bertini et al. (eds.), 369-376, 1983, D. Reidel Publishing Co.

13."Spectroscopic Investigations of the Active Site Structure of Cytochrome P450 with X-Ray Absorption Spectroscopy," J.H. Dawson, L.A. Andersson, I.M. Davis, J.E. Hahn in Biochemistry, Biophysics and Regulation of Cytochrome P450, J.A. Gustaffson et al. (eds.), 565-572, 1980, Elsevier/North-Holland Biomedical Press.

ABSTRACTS

1.J.H. Leete, G.Y. Leong, I.M. Davis. "Development and Validation of an ELISA Method for the Determination of Human Anti-Leuprolide IgG and IgM Antibody," 1997 American Association of Pharmaceutical Scientists, Boston, MA, November 2-7.

2.W.J. Harman, R.L. Tacey, G.Y. Leong, I.M. Davis. "Solid Phase Extraction and High Performance Liquid Chromatography Followed by Radioimmunoassay for the Determination of Luteinizing Hormone-Releasing Hormone in Human, Swine and Guinea Pig Plasma," 1997 American Association of Pharmaceutical Scientists, Boston, MA, November 2-7.

3.M. Allen, M. Hamzavi, D. Harvan, H. Warren, I.M. Davis. "Validation of an Analytical Method for Quantitation of Methylphenidate and it's Metabolite, Ritalinic Acid, in Human Plasma and Beagle Plasma Using LC/MS/MS," 1997 American Association of Pharmaceutical Scientists, Boston, MA, November 2-7.

4.D. Harvan, M. Allen, B. Lilley, H. Warren, I.M. Davis. "Validation of a Human Plasma Method for Oxybutynin and Desethyloxybutynin Enantiomers at Low pg/mL Concentrations Using LC/MS/MS," 1997 Western Regional Meeting of the American Association of Pharmaceutical Scientists, South San Francisco, CA, April 24-25.

5.I.M. Davis, H.B. Warren. "Pre-Validation: Criteria to Prove that Validation of a Bioanalytical Method is Indicated," 1997 Western Regional Meeting of the American Association of Pharmaceutical Scientists, South San Francisco, CA, April 24-25.

6.I.M. Davis, H.B. Warren. "Pre-Validation: Criteria to Prove that Validation of a Bioanalytical Method is Indicated," Eighth International Symposium of Pharmaceutical and Biomedical Analysis, Orlando, FL, May 4-6, 1997.

7.D. Lee, J. Amin, J.A. Jersey, D. Morris, I.M. Davis, R.M. LeLacheur. "Quantification of 5-Fluorouracil, Uracil, and 776C85 in Human Plasma Employing Liquid-Liquid Extraction and Isotope Dilution GC/MS/SIM," 1996 American Association of Pharmaceutical Scientists, Seattle, WA, October 27-31.

8.B.E. Lilley, I.M. Davis, J. Amin, J.A. Jersey. "Quantification of Lidocaine in Human Plasma Employing Solid Phase Extraction and GC/MS/SIM," 1996 American Association of Pharmaceutical Scientists, Seattle, WA, October 27-31.

9.D. Minser, Y. Tondeur, I.M. Davis, H. Warren, J.A. Jersey. "Quantification of Oxybutynin Enantiomers in Human Plasma at Low pg/mL Concentrations Using Solid Phase Extraction and Isotope Dilution LC/MS/MS," 1996 American Association of Pharmaceutical Scientists, Seattle, WA, October 27-31.

10.C.J.L Bugge, D.E. Gleinser, K. Stanford, K. Byers, J. Schroeter, D.B. Garcia, L.L. Yee, G.Y. Leong, I.M. Davis. "Determination of the Nonapeptide Leuprolide in the pg/mL Range in Human and Dog Serum by LC-MS-MS," 1996 American Association of Pharmaceutical Scientists, Seattle, WA, October 27-31.

11.B.M. Kerr, I.M. Davis, S.M. Witherspoon, D.L. Emerson, W.S. Dalton, M.B. Mann, P.S. Wissel. "Pharmacokinetics (PK) and Dynamics (PD) of the Multidrug Resistance (MDR) Inhibitor GG918 in Healthy Volunteers (HVTs)," presented at a 1995 Oncology meeting (TBD).

12.M.S. Tan, D.B. Garcia, C.J.L. Bugge, I.M. Davis. "Determination of Ethanol at Low Microgram per Milliliter Concentrations by Headspace Gas Chromatography," 1995 American Association of Pharmaceutical Scientists, Miami Beach, FL, November 5-9.

13.S.A. Testino, Jr., L.F. McCoy, I.M. Davis, J.A. Jersey. "Determination of Ergotamine and Dihydroergotamine in Human Serum Using Solid-Phase Extraction and LC/MS with Selected Ion Monitoring," 1995 American Association of Pharmaceutical Scientists, Miami Beach, FL, November 5-9.

14.R.L. O'Connor-Semmes, K.M. Koch, I.M. Davis, Y. Yin, S. Shaw. "Stereoselective Pharmacokinetics of Chlorpheniramine and the Effect of Ranitidine in Healthy Male Volunteers," ISSX Proceedings, 4th International ISSX Meeting, Seattle, WA, 27-31 August 1995.

15.D.G. Minser, S.A. Guyan, J.V. Steidl, I.M. Davis, J.A. Jersey. "Rapid, Rugged, and Routine Quantification of Chlorpheniramine Enantiomers in Human Serum at Low pg/mL by SPE and GC/MS/SIM," 1995 Sixth International Symposium on Pharmaceutical and Biomedical Analysis, St. Louis, MO, April 1995.

16.K.M. Koch, B.M. Kerr, I.M. Davis. "Bismuth Pharmacokinetics Following Multiple Oral Doses of GR122311X (Ranitidine Bismuth Citrate)," 1994 American Association of Pharmaceutical Scientists, San Diego, CA, November 6-10.

17.K.M. Koch, I.M. Davis. "Bismuth Pharmacokinetics Following Single Oral Doses of GR122311X (Ranitidine Bismuth Citrate)," 1994 American Association of Pharmaceutical Scientists, San Diego, CA, November 6-10.

18.J.A. Jersey, S.A. Guyan, I.M. Davis. "Methyl Esterification of GR90291 to GI87084 During Solid Phase Extraction," 1994 American Association of Pharmaceutical Scientists, San Diego, CA, November 6-10.

19.S.A. Testino, Jr., I.M. Davis, J.A. Jersey. "Determination of Propofol in Human Whole Blood Using Liquid-Liquid Extraction and GC/MS with Selected Ion Monitoring," 1994 American Association of Pharmaceutical Scientists, San Diego, CA, November 6-10.

20.J.A. Jersey, S.A. Guyan, B.E. Lilley, D. Minser, I.M. Davis. "Rugged Quantitative Analysis of GI87084 from Whole Blood Using Solid Phase Extraction and GC/HRMS/SIM," 1994 American Association of Pharmaceutical Scientists, San Diego, CA, November 6-10.

21.P.E. Pivarnik, C. Horton, R. Kim, I.M. Davis, M.N. Dudley. "Performance of a Rapid, Sensitive Fluorescence Polarization Immunoassay (FPIA) for Measurement of Zidovudine (ZDV) and its Glucuronide Metabolite (GZDV) in Serum and Urine," 34th Interscience Conference on Antimicrobial Agents and Chemotherapy, Orlando, FL, October 4-7, 1994.

22.J.A. Jersey, I.M. Davis, J.V. Steidl. "Trace Level Quantification of Chlorpheniramine from Serum Employing Solid Phase Extraction and GC/MS/SIM," Fifth International Symposium on Pharmaceutical and Biomedical Analysis, Stockholm, Sweden, September 21-24, 1994.

23.J.A. Jersey, I.M. Davis, J.V. Steidl. "Determination of Chlorpheniramine in Serum Employing Solid Phase Extraction and GC/MS/SIM," Fifth International Symposium on Pharmaceutical and Biomedical Analysis, Stockholm, Sweden, September 21-24, 1994.

24.J.V. Steidl, I.M. Davis, J.A. Jersey. "Enantiomeric Separation of Chlorpheniramine by Gas Chromatography: Merits and Pitfalls," 1994 American Association of Pharmaceutical Scientists Eastern Regional Meeting, New Brunswick, NJ, April 21-22.

25.J. Amin, J.V. Steidl, I.M. Davis, J.A. Jersey. "Determination of Sufentanil in Human Whole Blood by GC/MS/SIM and Solid Phase Extraction," 1994 American Association of Pharmaceutical Scientists Southeast Regional Meeting, Durham, NC, April 21-22.

26.J.A. Jersey, J. Amin, M. Chu, C.M. Grosse, I.M. Davis. "Gas Chromatography - High Resolution Mass Spectrometry as an Analytical Tool for Pharmacokinetic and Pharmacodynamic Studies," 1993 American Association of Pharmaceutical Scientists, Orlando, FL, November 14-18, 1993.

27.J.A. Jersey, S. Guyan, L. Abbey, C.M. Grosse, I.M. Davis. "Determination of Alfentanil in Whole Blood by GC/MS Using Liquid-Liquid and Solid Phase Extraction," 1993 American Association of Pharmaceutical Scientists, Orlando, FL, November 14-18, 1993.

28.S. Lam, D. Lessard, L. Letarte, J. Prevost, R. Wagner, K. Selinger, I.M. Davis. "High and Low Sensitivity Quantitation for GR90291 in Human Urine by GC/MS/SIM and HPLC," Fourth International Symposium on Pharmaceutical and Biomedical Analysis," Baltimore, MD, April 20, 1993.

29.C.M. Grosse, I.M. Davis, R. Arrendale, J. Jersey, J. Amin. "Determination of GI87084 in Human Blood by Liquid-Liquid Extraction and GC/HRMS/SIM Using a Deuterated Internal Standard," Fourth International Symposium on Pharmaceutical and Biomedical Analysis, Baltimore, MD, April 20, 1993.

30.D. Lessard, A. Charlesbois, K. Selinger, I.M. Davis. "Sample Preparation and Quantitation for GI87084 in Human Urine by GC/MS/SIM," Fourth International Symposium on Pharmaceutical and Biomedical Analysis, Baltimore, MD, April 19, 1993.

31.D.A. Tye, E.H. Evans, D.D. Tye, R. Brown, I.M. Davis. "Highly Sensitive Determination of Bismuth Concentrations in Human Plasma Using Hydride Generation and Inductively Coupled Plasma Mass Spectrometry," The Pittsburgh Conference, Atlanta, GA, March 12, 1993.

32.D.A. Tye, D.D. Tye, R. Brown, I.M. Davis. " Sensitive Determination of Bismuth Concentrations in Human Plasma, Blood and Urine Using Inductively Coupled Plasma Mass Spectrometry," American Association of Pharmaceutical Scientists, San Antonio, TX, November 1992.

33.S.J. Baker, J.V. Karounis, M.V. Watts, F.W. Lee, I.M. Davis. "Comparison of the Percutaneous Absorption of [3H]-Fluticasone 17-propionate from Scalp Solution and Ointment Formulations in the Rat," Third International Society for the Study of Xenobiotics (ISSX) meeting, Amsterdam, The Netherlands, June 24-28, 1991.

34.R.F. Arrendale, J.K. Bolon, A.K. Sinhababu, S. Prakash, I.M. Davis, J.P. Chism, S.E. Unger. "Determination of GI87084, an Ultra-short Acting Opioid, and its Major Metabolite, GI90291, in Whole Human Blood by Capillary GC/MS/SIM and GC/NCI-MS/SIM," 201st National American Chemical Society meeting, Atlanta, GA, April 14-19, 1991.

35.S.R. Prakash, I.D. Correa, S.E. Unger, I.M. Davis, G.T. Miwa, D.R. Thakker. "Study of the Solvolysis of Nitrogen Mustards by 1H-NMR," American Association for Cancer Research meeting, Washington, DC, May 21-25, 1990.

36.J.H. Dawson, L.A. Andersson, I.M. Davis. "Investigations of Heme Proteins and Model Heme Complexes with EXAFS and other Spectroscopic Techniques," Southeast/Southwest Regional Meeting of the American Chemical Society, December 10-13, 1990.