Chronological resume

ANNE B GIORDANI PhD, ELS
● Free lance medical, scientific, and regulatory writer with more than 20 years of
experience in the pharmaceutical industry ● Exceptional analytical skills and
proven ability to prepare clear, accurate, and comprehensive regulatory documents,
scientific papers, and presentations ● Early adopter and champion of process
improvements leading to efficient and high quality document preparation ● Valued
and respected by clinicians, statisticians, and pharmacokineticists alike as a study
reporting team member
PROFESSIONAL EXPERIENCE
ANNE B GIORDANI PhD, LLC, Ann Arbor MI
Principal
PFIZER GLOBAL RESEARCH AND DEVELOPMENT, Ann Arbor, MI
Development Operations
Associate Director, Clinical Communications
Manager, Clinical Communications
Clinical Communications Scientist
Chemistry Department, Parke Davis Pharmaceutical Research
Senior Research Associate
Research Associate
Senior Scientist
Elected member, American Society for Mass Spectrometry Board of
Directors, Member-at-Large for Publications
MOUNT SINAI SCHOOL OF MEDICINE, New York, NY
Research Assistant Professor, Department of Psychiatry
MICHIGAN STATE UNIVERSITY, East Lansing, MI
Research Associate, Visiting Assistant Professor, Department of Chemistry
EDUCATION
Postdoctoral fellow in Mass Spectrometry Michigan State University, E. Lansing, MI
PhD in Analytical Chemistry
University of Virginia, Charlottesville, VA AB magna cum laude in Chemistry
PROFESSIONAL AFFILIATIONS
ATTACHMENT TO RESUME
REGULATORY DOCUMENTS
An 8-Week, Placebo-controlled, Double-blind, Randomized, Fixed-dose Efficacy and Safety Trial of ______ in Adolescent Subjects with Schizophrenia (Protocol No. ______.) April 2010. Introduction on ______. CTD Module 2.2 of sNDA. October 2009. Tabular Listing of Clinical Trials. CTD Module 5.2 of sNDA. October 2009. Evaluation of ______ Phase 2 and Phase 3 Data for the Indian Subpopulation. Supplemental document for Indian Submission. October 2009. FDA Psychopharmacologic Drugs Advisory Committee Meeting, SAPHRIS® (asenapine) Sublingual Tablets (NDA 22-117). Briefing Document (Background Package), Advisory Committee Briefing Materials: Available for Public Release. July 2009. Summary of Clinical Efficacy on ______ (Schizophrenia), CTD Module 2.7.3S of European Sumission. April 2009. A Single-Center, Randomized, Open-Label, Single-Dose Crossover Study to Assess the Relative Bioavailability of ______ Oral Capsule(s) Compared with Oral Solution, to Examine the Effect of Food on the Bioavailability of ______ Capsule(s) in Healthy Male and Female Subjects, and to Evaluate ______ Exposure in Cerebrospinal Fluid. Clinical Trial Report on Protocol ______. May 2009. A Prospective, Randomized, Active-controlled, Rater-blinded Study of the Prevention of Relapse Comparing ______ with Oral Risperidone in Adults with Recently-Diagnosed Schizophrenia Who Are at High Risk of Relapse (Protocol ______; Phase 3b). A Phase I, Single-Center, Double-Blind, Randomized, Placebo Controlled, Single and Multiple Dose, Dose Escalation Study of the Safety and Pharmacokinetics of ______ in Male and Female Subjects and to Explore the Food Effect and Age Effect on ______ Pharmacokinetics. Clinical Trial Report on Protocol ______. March 2009. New Formulation of ______ for the Treatment of Anterior Segment Inflammation, Pain, and Inhibition of Surgically Induced Miosis Following Cataract Extraction with Posterior Chamber Intraocular Lens (IOL) Implantation. Clinical Overview, Module 2.5.5 (Overview of Safety). October 2008. New Formulation of ______ for the Treatment of Anterior Segment Inflammation, Pain, and Inhibition of Surgically Induced Miosis Following Cataract Extraction with Posterior Chamber Intraocular Lens (IOL) Implantation. Summary of Clinical Safety, Module 2.7.4. October 2008. Schiffman R et al. A Multi Center, Double Masked, Randomized Parallel Group Study Evaluating the Safety and Efficacy of a New Formulation of ______ Compared with Vehicle Administered Preoperatively and Twice-Daily Postoperatively for Two Weeks for the Treatment of Anterior Segment Inflammation, Pain, and Inhibition of Surgically Induced Miosis Following Cataract Extraction with Posterior Chamber Intraocular Lens (IOL) Implantation. Clinical Trial Reports on Protocols ______ and ______, Sections 10, 12, and significant contributions to Section 13 (Results—Study Patients, Safety Evaluation, Discussion and Overall Conclusions, respectively). August 2008. REGULATORY DOCUMENTS (continued)
______ Adjunctive Bipolar Maintenance, Briefing Document, Pre-sNDA Meeting. Oct 2007. Chapel S, Cleveland J, Giordani AB, Haig G, Hamid O, Lancaster S. A Double-Blind, Parallel, Multicenter Study to Assess the Effect of ______, Quetiapine (Seroquel®), and Placebo on the QTc Interval in Patients With Schizophrenia (Clinical Trial Report on Protocol ____). June 2005. Brock J, Corrigan B, Feltner DF, Giordani AB, Wastall P. A Dose Escalation Study of the Subjective Effects of ______ and Alprazolam in Healthy, Nondependent Recreational Drug Abusers and Moderate Ethanol Drinkers (Clinical Trial Report on Protocol ____). 29 March 2005. Chakrabarti D, Cleveland J, Corrigan B, Giordani AB, Moton AE, Randinitis EJ. A Randomized, Double-Blind, 14-Day Oral, Repeat Dose, Pharmacodynamic, and Pharmacokinetic Study of the Rebound Effects of ______ Capsule Doses, Zolpidem, and Lorazepam in Healthy Volunteers (Clinical Trial Report on Protocol ____). 02 Mar 2004. Cleveland J, Corrigan B, Feltner DE, Giordani AB, Moton AE. A Multicenter, Randomized, Double-Blind, Active- and Placebo-Controlled 5-Way Crossover Study of the Safety and Efficacy of ______, Zolpidem, and Placebo in Primary Insomnia (Clinical Trial Report on Protocol ____). 21 November 2003. Feltner DF, Giordani AB, Moton AE, Ouellet D, Randinitis E, Werth JL. An Oral, Single-Dose Pharmacokinetic Study of ______ in Subjects With Various Degrees of Renal Function (Clinical Trial Report on Protocol ____). 06 August 2003. Bramson CR, Corrigan B, Feltner D, Giordani AB, Moton AE, Randinitis EJ. A Single-Dose Food Effect and Relative Bioavailability Study of ______ Solution and Capsules in Healthy Volunteers (Clinical Trial Report on Protocol ____). 21 May 2003. Bramson CR, Feltner DE, Giordani AB, Ouellet D, Randinitis EJ, Werth J. A Single-Dose Food Effect and Relative Bioavailability Study of ______ Solution and Capsules in Healthy Volunteers (Clinical Trial Report on Protocol ____). 21 March 2003. Giordani A, Jacquot F, Strub N, Vincent E. A 1-Year Open-Label Safety Extension Study of ______ in Patients With Anxiety Disorders (Clinical Trial Report on Protocol ____): Interim Report for Data In-House as of 31 Dec 2001. 26 September 2002. Brock J, Corbin A, Giordani AB, Kavoussi R. A Sustained Efficacy Study of ______ in Patients With Generalized Anxiety Disorder (Clinical Trial Report on Protocol ____). 01 August 2002. Giordani AB, Holley HP, Robbins JL. 4-Month Safety Update for ______ for Neuropathic Pain. 28 November 2001. Buroker Kilgore M, Giordani AB, Mundel T, Sesti AM, Ventura AY, Yan C. A Long-Term, Open-Label, Multicenter, Safety Study of ______ in Combination With Naproxen Sodium in Patients With Osteoarthritis of the Knee (Clinical Trial Report on Protocol ____). 27 September 2001. Giordani AB, Hotary L, Jaffe M, Nelson D, Sesti AM. A 1-Week, Randomized, Double-Blind, Placebo- and Positive-Controlled, Parallel-Group Study of the Protective Effects of ______ on Naproxen Sodium-Induced Upper Gastrointestinal Mucosal Injury in Volunteers (Clinical Trial Report on Protocol ____). 16 August 2000 REGULATORY DOCUMENTS (continued)
Giordani AB, Buroker Kilgore M, Mundel T, Yan C. A Single-Dose, Double-Blind, Placebo-Controlled, Comparative Efficacy Study of ______ in Combination With Naproxen Sodium in Patients With Postoperative Dental Pain (Clinical Trial Report on Protocol ____). 17 February 2000. Giordani AB, Slomkowski M, Smith F. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of ______ and Fluoxetine in Patients With Major Depressive Disorder (Clinical Trial Report on Protocol ____). 21 December 1999. PRESENTATIONS
Giordani, AB,* Cooke, LW and Davis, MD. Mass Spectrometric Detection and Quantification of 3-5 kDalton-Molecular-Mass-Range Peptide Neurotransmitters/Neuromodulators. Presented at the 46th ASMS Conference, Orlando Florida, June 3, 1998. Giordani AB.* Development of a Micro-Flow-Rate Range Electrospray Interface. Presented at the Parke-Davis Analytical Symposium, Ann Arbor, Michigan, October 1, 1997. Iyer RN,* Giordani AB and Davis MD. Extracellular Brain Levels of the Antipsychotic CI-1007 in the Rat as Assessed by in vivo Microdialysis and LC/MS/MS. Presented at the 45th ASMS Conference, Palm Springs California, June 5, 1997. Iyer RN* and Giordani AB. The Effects of Ion Pairing Agents on Signal Intensities in Electrospray and APCI Mass Spectrometry. Presented at the 44th ASMS Conference, Portland, Oregon, May 13, 1996. Juneau PL,* Giordani AB and Pyne DA. Characterization of m/z Deviates in Electrospray Mass Spectra and Molecular Mass Measurement Uncertainty. Presented at the 43rd ASMS Conference, Atlanta Georgia, May 24, 1995. Giordani AB.* The Effects of Anion Encapsulation by Katapinates on Electrospray Mass Spectra. Presented at the 43rd ASMS Conference, Atlanta Georgia, May 22, 1995. Giordani AB,* Juneau PL and Pyne DA. An Evaluation of the Uncertainty of Protein Molecular Mass Measurement by Electrospray Ionization Mass Spectrometry. Presented at the 42nd ASMS Conference, Chicago Illinois, June 1, 1994. Giordani AB,* Price PC. Development of the ASMS Policy on the Use of High Resolution Mass Spectral Data for Structure Confirmation. Presented at the 42nd ASMS Conference, Chicago Illinois, May 30, 1994. Juneau PL,* Giordani AB and Pyne DA. Statistical Evaluation of the Uncertainty of Molecular Mass Measurement from Single Electrospray Mass Spectra. Presented at the 42nd ASMS Conference, Chicago Illinois, May 30, 1994. Giordani AB.* Use of Crown Ethers to Enhance Electrospray Ionization Mass Spectra of Samples Containing Alkali Metal Salts. Presented at the 41st ASMS Conference on Mass Spectrometry, San Francisco, California, June 3, 1993. Giordani AB,* and Stevenson TI. ES-MS Mr Measurement of a 5kDa Protein with Better than 100PPM Precision and Accuracy on a Finnigan TSQ70. Presented at the Finnigan MAT ASMS User's Forum, San Francisco, California, May 30, 1993. PRESENTATIONS (continued)
Stoehr SJ,* Gordani AB, Naisbitt SR, McIntosh JM, Dooley DJ, Olivera BM, Downs DA. A Polypeptide Fraction Isolated from Conus Magus Venom Exhibits Novel Ca+2 Channel Activity in Neuronal Preparations. Presented at the 22nd Meeting of the Society of Neuroscience, Anaheim, California, October 28, 1992. DeJohn D,* Giordani AB. Automation of Mass Spectrometric Analysis. Presented at the 40th Annual Conference on Mass Spectrometry and Allied Topics, Washington, DC, June 1-5, 1992. Giordani AB.* The Mass Spectrometry Laboratory in Drug Discovery. Presented at Mid West Regional Meeting of the American Association of Pharmaceutical Scientists, Chicago, Illinois, May 4, 1992. Giordani AB.* Electrospray Ionization Mass Spectrometry. Presented at the Parke-Davis Analytical Symposium, Ann Arbor, Michigan, September 19, 1991. Werness S,* Giordani AB, Heath T, Andrews PC. Isolation and Structure of Catfish Insulin. Presented at the Fifth Symposium of the Protein Society, Baltimore, Maryland, June 1991. Giordani AB.* Applications of Mass Spectrometry in Pharmaceutical Research. Presented at the Analytical Seminar, Michigan State University Department of Chemistry, October 12, 1990. Giordani AB,* DeJohn DE. Automation of Mass Spectrometric Analysis in Pharmaceutical Research. Presented at the 38th Annual Conference on Mass Spectrometry and Allied Topics; Tucson, Arizona, June 3-8, 1990. DeJohn DE,* Giordani AB, Reily MD, Colson C, Creger P. Mass Spectrometric Fragmentation of the 1-(2,5-dimethylphenoxy)propyl acetate Moiety. Presented at the 38th Annual Conference on Mass Spectrometry and Allied Topics, Tucson, Arizona, June 3-8, 1990. Giordani AB.* Mass Spectrometry in Psychiatry: Analytical Support of Research in Schizophrenia, Affective Disorders and Alzheimer's Disease. Presented at the Michigan Mass Spectrometry Discussion Group Meeting, Ann Arbor, Michigan, March 17, 1987. Davidson M,* Giordani AB, Mohs RC, Davis KL. Control of Extraneous Factors Affecting pHVA in Clinical Studies. Presented at the Annual Meeting of the Society of Biological Psychiatry; Washington, DC, May 7-10, 1986. Giordani AB,* Gregg HR, Hoffman PA, Cross KP, Beckner CF, Enke CG. Organic Structure Determination by Triple Quadrupole Mass Spectrometry: Progress Report. Presented at the 32nd Annual Conference on Mass Spectrometry and Allied Topics; San Antonio, Texas, May 27-June 1, 1984. Hunt DF, Giordani AB,* Shabanowitz J, Rhodes G. Studies Using Tandem Quadrupole Mass Spectrometry. Presented at the 29th Annual Conference on Mass Spectrometry and Allied Topics; Minneapolis, Minnesota, May 24-29, 1981. Hunt DF, Shabanowitz J, Giordani AB*. Analytical Applications of Triple Stage Quadrupole Mass Spectrometry. Presented at the 28th Annual Conference on Mass Spectrometry and Allied Topics; New York, New York, May 25-30, 1980. PRESENTATIONS (continued)
Hunt DF, Sisak ME,* Buko AM, Ballard JM, Giordani AB, Shabanowitz J. Polypeptide Sequencing using NICI and MS/MS. Presented at the 28th Annual Conference on Mass Spectrometry and Allied Topics: New York, New York, May 25-30, 1980. Hunt DF,* Shabanowitz J, Buko AM, Ballard JM, Giordani AB. Peptide Mixture Analysis on a Triple Quadrupole Mass Spectrometer. Presented at the American Chemical Society Annual Meeting, Washington, DC, September 9-14, 1979. Hunt DF, Giordani AB,* Shabanowitz J. Transition Metal Ions as Reagents for CIMS. Presented at the 26th Annual Conference on Mass Spectrometry and Allied Topics; St. Louis, Missouri, May 28-June 2, 1978. Williamson KL,* Beeman CP, Magyar JG, Burroughs AE, Gertler VL. Conformational Analysis Using 13C NMR and Yb3 Shift Reagents. Presented at the American Chemical Society Annual Meeting, Atlantic City, New Jersey, September 8-13, 1974.
PUBLICATIONS
Iyer RN, Davis MD, Juneau PL and Giordani AB. Brain Extracellular Levels of the Putative Antipsychotic CI-1007 and its Effects on Striatal and Nucleus Accumbens Dopamine Overflow in the Awake Rat. Journal of Pharmacy and Pharmacology, 1998, 50(10): 1147-1153. Juneau PL, Giordani AB and Pyne, DA. Evaluation of the Uncertainty of Molecular Mass Measurement by Electrospray Ionization Mass Spectrometry. Journal of Biopharmaceutical Statistics, 1997; 7(3): 453-565. Boyd RK et al. Mass Spectrometry and Good Laboratory Practices. Journal of the American Society for Mass Spectrometry, 1996; 7(2): 211-218 (contributor). McIntosh JM, Ghomashchi F, Gelb MH, Dooley DJ, Stoer SJ, Giordani AB, Naisbitt SR and Olivera BM. Conodipine-M, a Novel Phospholipase A2 Isolated from the Venom of the Marine Snail Conus magus. J. Biological Chemistry, 1995; 270(8): 3518-26. Senderoff R, Wootton S, Boctor B, Ming Chen T, Giordani A, Julian T and Radebaugh G. Aqueous Stability of Human Epidermal Growth Factor (1-48). Pharmaceutical Research 1994; 11(12): 1712-20. Giordani AB and Price PC. The Use of High Resolution Mass Spectral Data for Structure Confirmation. Journal of the American Society for Mass Spectrometry, 1994; 5(2): 57. Heath TG, Giordani AB. Reverse-Phase Capillary HPLC with On-Line UV, Fluorescence and Electrospray Ionization Mass Spectrometric Detection in the Analysis of Peptides and Proteins. Journal of Chromatography, 1993; 638: 9-19. Loo JA, Giordani AB, Muenster H. Observation of Intact (Heme-bound) Myoglobin by Electrospray Ionization on a Double-Focusing Mass Spectrometer. Rapid Communications in Mass Spectrometry 1993; 7: 186-9. Cody WL, Giordani AB, Werness S, Reily MD, Bristol JA, Zhu G, Dudley DT. Analysis of Rat Amylin Amide from Commercial Sources: Identification of a Mercury Complex. Bioorganic and Medicinal Chemistry Letters 1991; 1(8): 415-20. PUBLICATIONS (continued)
Beylin VG, Colbry NL, Giordani AB, Goel OP, Johnson DR, Leeds RL, Leja B, Lewis EP, Lustgarten DM, Showalter HDH, Sercel AD, Reily MD, Uhlendorf SE, Zisek KA. An Improved Synthesis of Anticancer Benzothiopyranoindazoles. An Efficient Large-Scale ß-Aminoethylation Procedure [1]. Journal of Heterocyclic Chemistry 1991; 28: 517. Davidson M, Giordani AB, Mohs RC, Horvath TB, Davis BM, Powchik P, Davis KL. Short Term Haloperidol Administration Acutely Elevates Human Plasma Homovanillic Acid Concentration. Archives of General Psychiatry 1987; 44(E): 198-90. Davidson M, Giordani AB, Mohs RC, Mykytyn VV, Platt S, Aryan T, Davis KL. Control of Exogenous Factors Affecting Plasma Homovanillic Acid Concentration. Psychiatry Research 1987; 20(4): 307-12. Cross KP, Palmer PT, Beckner CF, Giordani AB, Gregg HG, Hoffman A, Enke CG. Automation of Structure Elucidation from Mass Spectrometry/Mass Spectrometry Data; ACS Symposium Series No. 306, Artificial Intelligence Applications in Chemistry, Thomas H. Pierce and Bruce A. Hohne, eds. American Chemical Society, 1986. Hunt DF, Giordani AB, Rhodes G, Herold DA. Mixture Analysis by Triple Quadrupole Mass Spectroscopy: Metabolic Profiling of Urinary Carboxylic Acids. Clin Chem 1982; 28(12): 2387-92. Hunt DF, Giordani AB, Shabanowitz J, Rhodes G. Retro-Diels-Alder, γ-Hydrogen Rearrangement, and Decarboxylation Reactions. Pathways for Fragmentation in the Collision Activated Dissociation Mass Spectra of Ketones and Carboxylic Acid (M-1)- Ions. J Org Chem 1982; 47: 738-41. Hunt DF, Buko AM, Ballard JM, Shabanowitz J, Giordani AB. Sequence Analysis of Polypeptides by Collision Activated Dissociation on a Triple Quadrupole Mass Spectrometer. Biomed Mass Spectrom 1981; 8: 397-408. Hunt DF, Buko AM, Ballard JM, Shabanowitz J, Giordani AB. Sequence Analysis of Polypeptides by Collision Activated Dissociation on a Triple Quadrupole Mass Spectrometer; in: Soft Ionization Biological Mass Spectrometry; Howard R. Morris, ed, Heyden. London, 1981. Hunt DF, Shabanowitz J, Giordani AB. Collision Induced Decomposition Studies Using a Triple Stage Quadrupole Mass Spectrometer. Anal Chem 1980; 52: 386-90. Pelosi LF, Moran AL, Burroughs AE, Pugh TL. The Volatile Products Evolved from Fluoroelastomer Compounds During Curing. Rubber Chem Tech 1976; 49: 367-74. Burroughs AE. Conformational Analysis by 13CNMR. Shift Reagent Studies on Steroids; Undergraduate Honors Thesis, Mount Holyoke College, South Hadley, MA 01075 (1974). Williamson KL, Clutter DT, Emch R, Alexander M, Burroughs AE, Chua C, Bogel ME. Conformational Analysis by Nuclear Magnetic Resonance. Shift Reagent Studies on Acyclic Alcohols. 1H and 13C Spectra of the Six-Carbon Aliphatic Alcohols. J Am Chem Soc 1974; 96: 1471-79. Allen CW, Burroughs AE, Anstey RG. An NMR Study of Phenyltin Trihalides and their Interactions with Lewis Bases. Inorg Nucl Chem Lett 1973; 9: 1211-17.

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