Manager Development

POSITIONS HELD

Director of CMC Jan **** – present

XBiotech USA Inc.,

Austin, TX

Manager of Outsource Mfg Feb 2003 – Aug 2006

MannKind Corporation/CTL

Valencia, CA

Director of Clinical Mfg Mar 2000 – Jan 2003

CTL ImmunoTherapies,

Chatsworth, CA

Director of Chemistry and Mfg Nov 1999 – Feb 2000

CTL ImmunoTherapies,

Chatsworth, CA

Peptide Formulation Chemist Oct 1998 – Oct 1999

Minimed Technologies/CTL

Sylmar, CA

Biotechnology Lab Manager Jun 1993 – Sep 1998

Ontario Cancer Institute,

Toronto, ON

EMPLOYMENT DETAILS

Director of CMC – XBiotech USA Inc. Duties included antibody formulation development; process development and troubleshooting; guidance for assay development and validation; oversight of stability program; design of clinical manufacturing facility; sourcing and purchase of raw materials, QC and Manufacturing equipment. Create batch records, procedures, specifications, protocols and stability reports. Initiate investigations, laboratory studies and remediation efforts in a response to process failures or OOS/OOT data. Authored study protocols, reports, and CMC information amendments for comparability and viral clearance studies. Authored CMC Sections for Phase 1-3 clinical trials.

Manager of Outsource Manufacturing / Chemist – MannKind Corporation. Establish peptide synthesis laboratory. Devise alternative synthetic routes to diketopiperazine compounds. Invented novel suspension-forming lyophilizate formulation for extremely hydrophobic peptides. Select and evaluate potential plasmid and peptide CMOs; audit CMO facilities; determine process requirements and identify raw material vendors; coordinate process development and tech transfer activities; author batch records and specifications. Orchestrated the manufacture of injectable plasmid and peptide drug products for a Phase 1 oncology trial.

Director of Clinical Manufacturing – CTL ImmunoTherapies. Inception and design of 2500 sq ft clinical manufacturing facility for plasmid-based cancer vaccines. Hiring and supervision of production, process development, and mechanical staff (12 reports). Sourced and purchased production equipment, set up contracts with CMO’s for components, buffers and raw materials. Authored or co-authored most of procedures, batch records, specifications and validation protocols. Authored CMC sections for IND applications. Worked with design-build firm during programming and conceptual design of pilot plant.

Director of Chemistry and Manufacturing – CTL ImmunoTherapies. Supervised peptide synthesis and formulation development lab and QC assay development activities. Design and set-up of a 500 sq ft clean-room suite for manufacture of drug product for Phase I clinical use. Supervised the production of materials for formulation and stability studies; toxicology and clinical use.

Manager of Formulation Chemistry – Minimed Technologies. Spent one year developing and performing stability studies on synthetic peptide formulations for use in clinical studies in Switzerland. Included peptide synthesis purification, analytical method development, formulation development and stability studies. Also included early start-up activities for CTL ImmunoTherapies' facility in Chatsworth, CA.

Biotechnology Laboratory Manager – Ontario Cancer Institute. Manager and Operator of Peptide and DNA synthesis and analysis core facility; providing services and support to senior scientists, graduate students and post-docs. Manual and automated tBOC and Fmoc peptide synthesis, HF cleavage, synthesis of novel metal chelating peptides, drug targeting vehicles, multiple antigenic peptides. Oligonucleotide synthesis. Analysis and purification of organic chemicals, synthetic peptides and DNA by HPLC, ion-exchange, flash and thin layer chromatography. Synthesis, purification and characterization of various other organic compounds. Maintenance, troubleshooting and repairs to synthesizers, HPLC, etc. Sourcing and ordering all equipment and reagents, budgeting, and other administrative functions.

OTHER SKILLS, CERTIFICATES, TRAINING, ASSOCIATIONS

Expert user Microsoft Word and ExceL. Aslo PowerPoint, Visio, Photoshop.

Member of Parenteral Drug Association, American Peptide Society, and American Chemical Society

Pharmacist Exemptee Certificate for 5 years, California FDB

Certificate in GMP-Conforming Pilot Plants and Production Facilities.

GMP and GLP Training: CTL ImmunoTherapies, MannKind Corporation, XBiotech USA Inc.

EDUCATION

Bachelor of Science, Biochemistry Specialist Program, University of Toronto

OTHER QUALITIES

Can become proficient at most anything, quickly and without instruction. High level of mechanical aptitude. Excellent technical problem-solving skills. Strengths in formulation development, process development and troubleshooting. Good understanding of clean-room design, architectural design, building construction methods, mechanical and plumbing systems. Can troubleshoot and make professional-quality electromechanical repairs to lab instruments (synthesizers, HPLC, etc). Excellent creative and technical writing skills. Self starter, strong work ethic, excellent judgment, generous, honest, ethical, forthright and humorous.

PUBLICATIONS

Jim Ferguson and Liping Liu. 2011. Injectable Formulations for Parenteral Administration [of hydrophobic peptides]. International Publication Number WO 2011/082369 A2 (International patent application PCT/US2010/062612, European patent application EP2521539; US patent application 201********).

Mazen T. Saleh, Jim Ferguson, Joan M. Boggs, and Jean Gariépy. 1996. Insertion and Orientation of a Synthetic Peptide Representing the C-Terminus of the A1 Domain of Shiga Toxin into Phospholipid Membranes. Biochemistry 35(29):9325.

Kate Sheldon, Deming Liu, James Ferguson, and Jean Gariépy. 1995. Loligomers: Design of de novo peptide-based intracellular vehicles. Proc. Natl. Acad. Sci. USA 92(6):2056.

Deming Liu, Kate Sheldon, James Ferguson, and Jean Gariépy. 1994. Abstract: Cellular localization of novel nuclear targeting peptides, American Association for Cancer Research annual meeting, San Francisco, CA, April 9-14.

Kate Sheldon, James Ferguson, and Jean Gariépy. 1993. Abstract: Design of cytotoxic nuclear targeting peptides. Thirteenth American Peptide Symposium, Edmonton, Alberta, June 20-25.

Douglas B. Williams, Jim Ferguson, Jean Gariépy, Don McKay, Yen-Tung Teng, Shinji Iwasaki, and Nobumichi Hozumi. 1993. Characterization of the Insulin A-Chain Major Immunogenic Determinant Presented by MHC Class II I-A(d) Molecules. J. Immunol. 151:3627.

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