Daniel Pauletti

Pottstown, PA 19465

dpaulett@mountainbioscience.com

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CAREER SUMMARY

Presently working as an associate at a local CRO creating SAS programs to summarize clinical trial data. These programs are derived from a good working knowledge of our clients protocols, data collection methods, and statistical analysis plans. Previously, over 20 years experience performing complex research experiments in the fields of oncology, immunology, virology, and neurobiology. Able to quickly adapt new technologies to support corporate goals and evolving research targets. Comfort with computers and high tech instrumentation allows rapid integration into projects supporting team goals. Contribution to microbiology section of NDA for Nevirapine (Viramune) was well received by the FDA, which ultimately approved the drug.

EDUCATION

B.S., Natural Sciences, Indiana University of Pennsylvania, Indiana, PA

Minors in Computer Science and Chemistry

SAS Certification for the Pharmaceutical Industry, Philadelphia University, Philadelphia, PA, 2010

SAS Certified Base Programmer for SAS 9, November 15, 2010

SAS Certified Clinical Trials Programmer Using SAS 9, December 21, 2011

SAS Certified Advanced Programmer for SAS 9, June 13, 2012

 

PROFESSIONAL EXPERIENCE

ICON PLC, North Wales, PA                                                                                                                    2012-present

SAS Programmer Analyst II

Write SAS programs to summarize clinical trial data according to company SOPs, CDISC standards, and client specifications.

•    Generate and validate analysis datasets, tables, listings, and figures for clinical trials.

•    Coordinate programming priorities with team members in order to meet delivery milestones.

Octagon Research Solutions, Inc., Wayne, PA                                                                                             2011-2012

Senior Associate

Create statistical analyses for summarizing clinical trial data.

•    Write SAS code for analyzing and creating summary reports.

•    Write data specifications describing the appropriate programming logic for ADaM datasets and variables.

Associate

•    Generate and validate tables and listings for clinical trial data.

•    Programmatically check data for inconsistencies.

United Biosource Corporation, Blue Bell, PA                                                                                                 2011-2011

Intern

Support documentation and programming efforts in clinical trial projects for UBC clients.

•    Review CRF annotations and data definition tables.

•    Perform validation of programmed tables, listings, and figures.

•    Write SAS programs to generate tables, listings, and datasets.

Cephalon, Inc., Frazer, PA                                                                                                                            2001-2009

Research Scientist I

Supported drug discovery in kinase inhibition using molecular biology and protein biochemical techniques.  Also created cell lines expressing targeted surface receptors for screening efforts.

•    Created mammalian cells lines expressing targeted GPCRs and neurotranporters which became targets for drug screening efforts.

•    Screened over 2000 compounds for liver microsome stability using LC/MS, allowing chemists to zero in on development candidates.

•    Set up RT-PCR system to check compound induction of P450 genes resulting in a unique method to predict drug stability in vivo .

•    Cloned, expressed, and purified many kinases so project team could assess specificity of drug candidates.

•    Screened many conditions in co-crystallization efforts for target kinases yielding several solved structures.

Boehringer-Ingelheim, Inc., Ridgefield, CT                                                                                                   1992-2001

Senior Research Associate

Engaged in research efforts for new target validation for autoimmune and inflammatory diseases.

•    Cloned, expressed, and purified antigen presentation proteins for drug discovery leading to several development candidates.

•    Supported new target evaluations for several MAP kinases.  This effort helped establish yeast two-hybrid technology at the company.

Research Associate V

Involved in characterizing drug resistance for nevirapine in clinical trials. Extensive data for HIV clinical isolates were included in technical reports accompanying our new drug application to the FDA.

•    Cloned and sequenced HIV reverse transcriptase isolates from patients undergoing concomitant drug therapy.  The technical reports produced from our group were included in the NDA filing for nevirapine and won the group a Boehringer-Ingelheim Vice President achievement award.

•    Set up and maintained a biosafety level 3 facility in support of HIV research.

•    Implemented cell-based viral replication assay on numerous HIV mutants to discover second generation reverse transcriptase inhibitors.

Bristol-Myers Squibb Company, Wallingford, CT                                                                                           1990-1992

Associate Research Scientist

Set up new biosafety level 3 facility for HIV research.

•    Characterized transduction mechanisms and effects of signaling through cell surface proteins.

•    Designed and implemented cell based assay for anti-viral compound evaluation.  Automated the process so thousands of compounds could be tested.

American Biotech Resources, San Antonio, TX                                                                                             1988-1990

Assistant Scientist

Recruited to establish labs for a startup biotech company.  Main functions were to develop rapid diagnostics for human viruses.

•    Produced human viral diagnostics using hybridoma technology and immunoassay development.

•    Created and ran cell surface markers allowing us to analyze changes in PBL phenotypes of HIV patients undergoing experimental treatments.

Texas Biomedical Research Institute, San Antonio, TX                                                                                 1984-1988

Senior Research Assistant

Team member in the creation of the new Department of Virology and Immunology.

•    Analyzed protein sequences and synthesized peptides for immunologic characterization of viral proteins, which was published in Science for the HIV glycoprotein.

•    Created a software program to predict immunodominant epitopes of proteins.  Published results in Analytical Biochemistry.

The University of Texas Health Science Center, Houston, TX                                                                       1983-1984

Research Assistant

•    Performed experiments to study the biochemical properties of alpha-glucosidase.

•    Researched mechanisms for cystine efflux in rat liver lysosomes.

Publications:

Robert L. Hudkins, Allison L. Zulli, Ted L. Underiner, Thelma S. Angeles, Lisa D. Aimone, Sheryl L. Meyer, Daniel Pauletti, Hong Chang, Elena V. Fedorov, Steven C. Almo, Alexander A. Fedorov, Bruce A. Ruggeri.  8-THP-DHI Analogs as Potent Type I Dual TIE-2/VEGF-R2 Receptor Tyrosine Kinase Inhibitors.  Bioorganic and Medicinal Chemistry Letters, 20:3356-3360, 2010.

Karla K. Kopec, Beth Ann McKenna, and Daniel Pauletti. A Homogeneous Assay to Assess GABA Transporter Activity   Current Protocols in Pharmacology 1.32.1-1.32.13, 2005.

Klunder, J.M., Hoermann, M.A., Cywin, C., David, E., Brickwood, J.R., Schwartz, R., Barringer, K., Pauletti, D., Shih, C-K., Adams, J. and Grob, P.M.  Novel Non-nucleoside Inhibitors of HIV-1 Reverse Transcriptase.  7,8-Arylethyldipyridodiazepinones As Potent Broad-Spectrum inhibitors of Wild-Type and Mutant Enzymes .  Journal of Medicinal Chemistry , 41:2960-2971, 1998.

Cywin, C., Klunder, J.M., Hoermann, M.A.,  Brickwood, J.R., David, E., Grob, P.M., Schwartz, R., Pauletti, D., Barringer, K., Shih, C-K., Sorge, C.L., Erickson, D.A., Joseph, D.P. and Hattox, S.E .  Novel Non-nucleoside Inhibitors of Human Immunodeficiency Virus Type I Reverse Transcriptase.  8-Aryloxymethyl and 8-Arylthiomethyl Dipyridiazepinones .  Journal of Medicinal Chemistry , 41:2972-2984, 1998.

Churchill, L., Graham, A.G., Shih, C-K., Pauletti, D., Farina, P.R. and Grob, P.M.  Selective Inhibition of Human Cyclo-Oxygenase-2 by Meloxicam .  Inflammopharmacology , 4: 125-135, 1996.

Richman, D.D., Havlir, D., Corbeil, J., Looney, D., Ignacio, C., Spector, S.A., Sullivan, J., Cheesman, S., Barringer, K., Pauletti, D., Shih, C-K., Myers, M. and Griffin, J.  Nevirapine Resistance Mutations of Human Immunodeficiency Virus Type 1 Selected During Therapy.   Journal of Virology , 68: 1660-1666, 1994.

Kennedy, R.C., Henkel, R.D., Pauletti, D., Allan, J.S., Lee, T.H., Essex, M. and Dreesman, G.R.  Antiserum to a Synthetic Peptide Recognizes the HTLV-III Envelope Glycoprotein.   Science , 231: 1556-1559, 1986.

Pauletti, D., Simmonds, R., Dreesman, G.R. and Kennedy, R.C.  Application of a Modified Computer Algorithm in Determining Potential Antigenic Determinants Associated with the AIDS Virus Glycoprotein.   Analytical Biochemistry , 151: 540-546, 1985.

Abstracts:

Sheryl L. Meyer, Daniel Pauletti, Jean Husten, Alexander Federov, Torsten Herbertz,  Elena Federov, Ted L. Underiner, Gregory J. Wells, Linda R. Weinberg, Karen L. Milkiewicz, Bruce D. Dorsey, Steven C. Almo, Mark A. Ator.  Use of cMET Crystal Structures to Identify Potential Drug-resistant Mutants.  ASBMB annual meeting 2009.  Abstract #4118.

Cywin, C., Klunder, J.M., Hoermann, M.A., Grob, P.M., Shih, C-K., David, E., Brickwood, J.R., Pauletti, D., Schwartz, R., Barringer, K.  8-Arylalkyl- and 8-Arylheteroalkyl-5,11-Dihydro-6 H -Dipyrido[3,2-b:2’,3’-e]-[1,4]Diazepin-6-ones and Their Use in the Treatment of HIV-1 Infection .  214 ^th National Meeting of the American Chemical Society, Las Vegas, NV, (1997), Abstract MEDI 176.

Pauletti, D., Barringer, K. Grob, P. Shih, C-K.  Nevirapine Suseptibility Phenotypes of HIV-1 Recombinant Viruses with Specific Reverse Transcriptase Genes from Clinical Isolates .  Third Conference on Retroviruses and Opportunistic Infections, (1996) Abstract 330.

Sullivan, J., Brewster, F., Somasundaran, M., Greenough, T., Pauletti, D., Shih, C-K., Griffin, J., Myers, M., Luzuriaga, K.  In Vitro  and In Vivo   Correlates of ZDV/ddI/Nevirapine Therapy of HIV-1 Infection.   The Society for Pediatric Research.

Dreesman, G.R., Pauletti, D., Frenzel, G.D., Lanford, R.L., Kim, J.P., Reyes, G.R., and Burk, K.H.  Characterization of an Immunodominant HCV Peptide. Third Intl. Symposium on HCV, (1991) Strausbourg, France, Abstract V29.