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Quality Assurance Development

Location:
Framingham, Massachusetts, United States
Posted:
January 27, 2017

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Gerard P. Palace, Ph.D.

Address: *** ******** ******, **********, ************* 01701

(508) ***-**** acyihf@r.postjobfree.com

Summary

Senior analytical chemist with extensive pharmaceutical experience, focusing on late stage CMC and analytical development, including preparation for IND/NDA filings. Comprehensive process and formulation analytical support within a highly regulated environment for API, solid dosage, and liquid formulations {some injectable studies} for small molecules and polymeric drugs. Familiar with bioanalytical and analytical methods development, validation, transfer, release, stability, expiry dating, performance assessment, and regulatory documentation. Detail-oriented manager with significant experience on complex matrices.

Experience

XYLECO, INC., Woburn MA 2013 -2015

Senior Scientist, Analytical Chemistry

Privately owned chemical company using biotechnological approaches to manufacturing cellulosic-derived products; characterization and control of raw material and media components; HPLC-MS, XRPD, EPR, rheology, KF-titration

GENZYME DRUG&BIOMATERIAL R&D, Waltham, MA (formerly GELTEX PHARMACEUTICALS) 1998-2012

Senior Scientist, Analytical R&D (1998-2000, 2004-2012)

Principal Scientist (2001-2003)

Served as Global Tolevamer Project Team primary analytical member (coordinated analytical work of up to four scientists plus one direct report). Managed tolevamer analytical CMC from discovery to IND up to registration NDA/EMA filing (1200 patients across 18 countries through pivotal Phase III). Work entailed QC, GLC, GMP roles, depending on clinical stage. Supervised one direct report throughout 9 years.

Coordinated analytical work for Eliglustat (small molecule for Gauche’s) during Phase II, including some process development support, focused on drug product analytical development up to NDA filing.

Bioanalysis of cerezyme and myozyme for validation of manufacturing cleaning methods

Performed GMP release-stability of API and DP, including CMC support using compendia methods for clinical comparators/controls (moxifloxacin, vancomycin, and metronidazole).

Methods development, validation, transfer, and analytical support for process and formulation development.

Stress stability, degradation pathways, excipient compatibility, dissolution, specification setting, cleaning validations (including protein drugs), and analytical regulatory documents (small molecules and polymers).

Chemical characterization – trace impurity analysis using HPLC, UPLC, HPLC-MS, GC-MS, SEC, IC, ICP, FTIR, SEM, DSC, TGA, KF, Raman, light scattering, particle sizing, and compendial methods.

ALPHA-BETA TECHNOLOGY, INC., Worcester, MA 1994-1997

Research Scientist II, Analytical Chemistry

Developed analytical HPLC and spectroscopic methods for analytes in Betafectin (an immunomodulatory carbohydrate) through Phase III, focusing on trace protein determination; Pharmacokinetic model-fitting

PROCEPT, INC., Cambridge, MA 1993-1994

Senior Scientist, Rational Drug Design

Developed analytical methods and specifications for PRO2000gel preclinical development through IND.

Managed HPLC lab/analytical and preparative (9 LCs).

ALBANY MEDICAL COLLEGE, Albany, NY 1989-1993

Research Assistant Professor, Pharmacology and Toxicology (1992-1993)

Performed AIDS research focusing on protein and lipid mediators of immune system dysfunction.

Lectured on pharmacokinetics and biotransformation.

STERLING-WINTHROP RESEARCH INSTITUTE, Rensselaer, NY 1979-1986

Research Biologist, Drug Metabolism and Pharmacokinetics, Bioanalytical Section (Grades 13-15)

Developed all ADME methods for Iohexol (radiopaque with peak sales ~$650M/yr).

HPLC/GC bioanalytical methods development – validation, clinical sample analysis for drugs

Postdoctoral Fellow, Immunology, Microbiology and Molecular Genetics (1991-1992)

NRSA Postdoctoral Fellow, Physiology and Cell Biology (1989-1991)

Education

Ph.D., Chemistry, Rensselaer Polytechnic Institute, Troy, NY (1989)

Major Subject: Analytical Chemistry GPA 3.87/4.0

M.S., Chemistry, Rensselaer Polytechnic Institute, Troy, NY (1984)

Major Subject: Analytical Chemistry GPA 3.83/4.0

B.S., Chemistry, with distinction, Clarkson University, Potsdam, NY (1979)

GPA 3.26/4.0

Honors

American Association of Pharmaceutical Sciences, APQ (2002-2012)

American Chemical Society (1991-2012)

Sigma Xi, SUNY at Albany Chapter (1990-1)

NRSA Postdoctoral Fellowship (1989-91)

Biochemistry Fellowship (1986-7, RPI)

Third Annual Quality Assurance Department Commendation (1986, Sterling)

Gamma Sigma Epsilon National Honor Society (1978-9)

Entrepreneur Project Scholarship Award (1978, Clarkson)

Publications

GT160-246, A Toxin Binding Polymer for Treatment of Clostridium Difficile Colitis. Kurtz CB, Cannon EP, Brezzani A, Pitruzzelo M, Dinardo C, Rinard E, Acheson DWK, Fitzpatrick R, Kelly P, Shackett K, Papoulis AT, Goddard PJ, Barker RH, Palace GP, Klinger JD (2001) Antimicrobial Agents and Chemotherapy 45, 2340-2347.

Analysis of the Physiochemical Interactions Between Clostridium Difficile Toxins and Cholestyramine Using Liquid Chromatography With Post-Column Derivatization. Palace GP, Lazari P, Norton K (2001) Biochemica et Biophysica Acta, Protein Structure and Molecular Enzymology 1546, 171-184.

Determination of Amino Acids in Diverse Polymeric Matrices Using HPLC, With Emphasis on Agars and Agaroses. Palace GP, Fitzpatrick R, Tran KV, Phoebe CH, Norton K (1999) Biochemica et Biophysica Acta 1472, 509-518.

Enhanced Clearance of a Multiple Antibiotic Resistant Staphylococcus Aureus in Rats Treated with PGG-Glucan is Associated with Increased Leukocyte Counts and Increased Neutrophil Oxidative Burst Activity. Liang J, Milecan D, Cafro L, Palace G, Fisette L, Armstrong R, Patchen M (1998) Intl. Journal of Immunopharmacology 20, 595-614.

A Novel Carbohydrate-Glycosphingolipid Interaction Between a β-(1-3)-Glucan Immunomodulator, PGG-Glucan, and Lactosylceramide of Human Leukocytes. Zimmerman J, Lindermuth P, Fish P, Palace GP, Stevenson T, Demong D (1998) Journal of Biological Chemistry 273, 22014-22020.

Quantitative Determination of Amino Acid Levels in Neutral and Glucosamine-Containing Carbohydrate Polymers. Palace GP, Phoebe CH (1997) Analytical Biochemistry 244, 393-403.

Neucleotide Changes in Oxidatively Stressed Lymphocytes. Palace GP, Lawrence DA (1995) Journal of Biochemical Toxicology 10, 137-142.

Phospholipid Metabolism of Lymphocytes with Inhibited Glutathione Synthesis Using L-Buthionine-S,R-Sulfoxamine. Palace GP, Lawrence DA (1995) Free Radical Biology & Medicine 18, 709-720.

TNFα Release in Endotoxemia Contributes to Neutrophil-Dependent Pulmonary Edema. Horgan MJ, Palace GP, Everitt JE, Malik AB (1993) American Journal of Physiology 264, H1161-H1165.

Release of Tumor Necrosis Factor After Lung Reperfusion. Palace GP, Del Vecchio PJ, Malik AB, Horgan MJ (1993) American Review of Respiratory Distress 147, 143-147.

Generation of 5-Lipoxygenase Metabolites Following Reperfusion in Isolated Rabbit Lungs. Palace GP, Horgan MJ, Malik AB (1992) Prostaglandins 43, 339-349.

Thrombin-Mediated Release of Lipids from Pulmonary Artery Endothelial Cells Promote Neutrophil Adherence. Fisher MA, Del Vecchio PJ, Palace GP, Denholm EM, Lai L, Malik AB (1991) Circulation Research 68, 930-939.

Is Phylloquinone an Obligate Electron Acceptor in Photosystem I? Palace GP, Franke JE, Warden JT (1987) Federation of European Biochemical Sciences Letters 215, 58-62.

Pharmacokinetics and Excretion of Iohexol After Lumbar Myelography in Man. Shaw DD, Kido DK, Stroshane RM, Palace GP, Sahler L (1985) Investigative Radiology 20, 632-637.

Pharmacokinetics of Iohexol, a New Nonionic Radiocontrast Agent, in Humans. Edelson J, Shaw D, Palace GP (1984) Journal of Pharmaceutical Sciences 73, 993-995.

High-Performance Liquid Chromatographic Determination of Iohexol in Plasma, Urine and Feces. Edelson J, Shaw D, Palace GP (1983) Journal of Chromatography 274, 428-433.

Determination of Sulfinalol Hydrochloride in Plasma and Urine by Liquid Chromatography With Amperometric Detection. Park GB, Koss RF, O’Neil SK, Palace GP, Edelson J (1981) Analytical Chemistry 53, 604-606.

Quantitation of Nitrocellulose by High-Performance Liquid Chromatography and Fourier-Transform Infrared Spectroscopy. Warden JT, Franke JE, Palace GP, Scarton HJ, Wiberley SE (1988) Proceedings of the Joint International Symposium on Compatibility of Plastics and Other Materials with Explosives, Propellants, and Pyrotechnics and Processing Propellants, Explosives, and Ingredients, pp 334-338, April 18-20, New Orleans.

Patents

Patent No. 2478.2035.000, European Patent No. 16159714.1-1452 “Inhibitors of glucosylceramide synthase.”

Patent No .US2010057952; Patent Application No. 10785289.9 2101 PCT, “An amorphous and a crystalline form of Genz 112638 hemitartrate as inhibitor of glucosylceramide synthase.”

US Patent No’s 6,075,050, 5,614,559 and 5,667,343, “Compound for inhibiting HIV infectivity”, Singh SK, Patch RJ, Pallai PV, Neidhardt EA, Palace GP, Willis KJ, Sampo TM, McDonald KW, Shi W.

Abstracts

Verification of Stability-Indicating Method Capability. Palace GP, Cohen J, Kochling J (2011) T2310, AAPS.

Process-Induced Disorder –Could it be the Root Cause of Drug Product Instability? Kochling J, Palace G, Wang D, Yang L, Cohen A (2011) T2342, AAPS.

Cause of Yellow Discoloration of Capsule Contents. Palace GP, Wang Y, Wang W, Willis C, Ganga S, Castaneda J, Cohen A, Kochling J (2010) M1438, AAPS.

Rapid NIR Moisture Analysis Method for In-Process Testing of a Thermal-Labile Formulation. Willis C, Palace GP, Harianawala A, Cohen A, Kochling J (2010) AAPS.

Impact of Sinkers Selection on Dissolution Method Development. Castaneda J, Wu W, Palace G, Willis C, Cohen A, Kochling J (2010) AAPS-NERDG.

Analysis of the Physiochemical Interactions Between Clostridium Difficile Toxins and Cholestyramine Using Liquid Chromatography With Post-Column Derivatization. Palace GP, Lazari P, Norton K (2003) 00286, AAPS.

Amino Acid Analysis in Diverse Polymeric Matrices. Palace GP, Tran KV, Phoebe CH (2000) American Biotechnology Laboratory 18, 65-66 (application note).

GT160-246: A Toxin-Binding Compound effective in the Treatment of Clostridium Difficile Colitis In Vivo, Kurtz CB, Cannon PE, Fitzpatrick R, Goddard PJ, Palace G, Klinger JD (2000) Gastroenterology 118, 2375, No. 4, S2.

Amino Acid Analysis in Diverse Polymeric Matrices. Palace GP, Tran KV, Phoebe CH (1999) 3rd Symposium on Analysis of Well Characterized Biotechnology Pharmaceuticals, P-14, Washington, D.C.

Analysis of Amino Acids in Carbohydrate Polymers. Palace GP, Phoebe CH (1997) American Biotechnology Laboratory 15, 74-76 (application note).

Determination of Amino Acids in Carbohydrate Polymers. Palace GP, Phoebe CH (1996) American Chemical Society, Division of Analytical Chemistry, No. 014, Orlando, FL.

Endotoxin-Induced Release of Tumor Necrosis Factors in Lungs. Horgan MJ, Everitt J, Palace GP, Malik AB (1991) FASEB Journal, 5, A517.

Generation of Arachidonic Acid Metabolites Following Pulmonary Reperfusion. Palace GP, Malik AB, Horgan MJ (1991) FASEB Journal, 5, A1271.

Release of Endothelin-Like Substance From Perfused Guinea Pig Lungs By Platelet-Activating Factor (PAF). Pinheiro JB, Palace GP, Horgan MJ, Malik AB (1990) FASEB Journal, 4, A814.

Thrombin Releases an Endothelin-Like Substance From Pulmonary Microvessel Endothelial Cells. Horgan MJ, Palace GP, Pinheiro JB, Malik AB (1990) FASEB Journal, 4, A838.

Thrombin-Treated Pulmonary Vascular Endothelial Cells Release Factors that Stimulate Neutrophil (PMN) Adherence by CD18-Independent Mechanism and Induce PMN Migration. Fisher MA, Palace GP, Lai LC, Denholm EM, Malik AB, Del Vecchio PJ (1990) FASEB Journal, 4, A348.

Quinone Reconstitution in Photosystem 2 Membranes. Palace GP, Warden JT (1988) Biophysical Journal, 53, A617.



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