Jeffrey Patrick Email & Phone Number

Fishers, In, Us

Develop and implement mass spectrometric methods for the detection and potential quantitation of protein and peptide biomarkers associated with disease states. Systems include clinical samples and biological samples from model systems including in vitro (cell culture), CSF, muscle, bone and serum. Technologies include affinity and immunoaffinity capture, HPLC, capillary and gel electrophoresis, matrix-assisted laser desoprtion ionization mass spectrometry, HPLC/MS and MS/MSValidate methodologies to biological and analytical standards appropriate for their intended use.Transfer technologies and methods to third party labs and oversee protocolsProvide reports for possible submission in NDAs or clinical packages

Implemented targeted proteomic analysis in Biomarker analysis at Eli Lilly for trace level quantitative methods.. Interface with biologists and clinicians to develop and implement mass spectrometric methods for the detection and potential quantitation of protein and peptide biomarkers associated with disease states. Systems include clinical samples and biological samples from model systems. Matrices explored include blood, plasma, serum, CSF, synovial fluids, cell culture media and tissue samples. Methods are biologically and analytically validated and transferred to third party testing facilities.

Co-led a group in responsible for the characterization of peptides, proteins, antibodies and glycoproteins of biotechnology origin. Utilized mass sp[ectrometry, N-terminal sequence analysis, capillary electrophoresis and biochemical methods to achieve these results. Samples were from process, finished dosage forms and reference standards as we wll as process intermediates.

Authored or reviewed technical reports for regulatroy submission for insulin and glucagon process upsets including identification or uknowns and characterization of the nature of the process upsetCreated, validated and provided comparability studies for new in-process, API and dosage form analytical methods for insulins, glucagon and other biomolecule therapeutics including report for submission to regulatory agency. Directed strategy on method and technology strategy including prdving direction to Analytical Development from a manufacturing perspective and interfacing to assure of techinically appropriate supportPresented strategy to upper management in Manufacturing and Technical Services which ultimately led to the formation of Manufacturing Sceince and Technology Division in Lilly.Mentor and develop junior chemists and non-degreed analysts on technical skills and compliance for group of ca. 40Interpretation of method and manufacturing statistical process control dataIdentify improvement opportunities in analytical labs (methods/practices)Refine process for and direct analytical method transfers; Influence analytical development re: method suitability/ruggedness and analytical control strategyDevelop and implement product and analytical control strategies;Investigate and support abberant results from in-process/release/stability testing; Interface w/ manufacturing, tech service, regulatory affairs, QA; make recommendations re: lot release, trend analysis and control chart interpretation Direct evaluation of new technologies including lab advancement projects

Rebuilt group and co-led team of 12 to support characterization of antibodies, proteins and peptides from cell culture and process development through formulation development. Directed, developed and implemented experiments and method for the chemical characterization of peptides, proteins, antibodies and glycoproteins to support fermentation and cell culture development, purification process development, API stability and drug product development and stability. Characterize material for use in and as reference standards. Contributed to several regulatory filings and response letters. Established and directed customer interfaces and produced lab budgets for equipment and other expenses.

Develop and implement experiments and methods for the chemical characterization of peptides, proteins, antibodies and glycoproteins to support fermentation and cell culture development, purification process development, API stability and drug product development and stability. Technologies include N-terminal sequencing, HPLC, capillary and gel electrophoresis, monosaccharide and oligosaccharide analysis, matrix-assisted laser desorption ionization mass spectrometry, HPLC/MS and MS/MS Development and management of the departmental Quality PlanFeasibility studies towards the development of novel protein delivery systemsSupervise and develop 6 associate scientistsDevelop and implement novel techniques for high-throughput quality evaluations of proteins in culture mediaCharacterize and identify process impurities and related substances in culture media and cell isolates, process streams, API and formulated productsProvide information on quality attributes (cellular processing and post-translational modifications) for material from bioprocesses; confirm primary protein structure (glycoproteins, antibodies, peptides; clotting factors) and post-translational modifications towards clonal developmentDevelop experimentation and methods to monitor genetic and metabolic errors related to protein expression using proteomics principlesProvide experimentation and reports to support confirmation of structure for regulatory submissionsProvide mechanisms for capture of proteins from culture/fermentation Develop, validate and transfer analytical methods to support routine testing, including identification of critical process parametersOperate lab in GMP environmentContributed to or authored reports included in submissiosn packages. These included characterization of equivalnce batches or validation batches for peptide, glycoprotein and antibody therapeutics as well as impurity and related substance identification for new products.

Prepared and delivered lectures on protein analysis and chacarerization (mass spectrometry and capillary electrophoresis) to new program in Biotechnology including notes, labs and examsConsulted on program structure and format

Lead team responsible for chemical characterization of drug substance and finished drug (inhalation) product in support of CMC section of regulatory subsissions.Development and validation of analytical methods for drug product and drug substanceIdentify and characterize trace level degradants and impurities in metered dose inhalers and drug substance through collaboration with pharmaceutical chemists, and spectroscopy groups Direct and supervise technical group of up to 8 direct reports (3 PhD, 5 Scientists) Direct the transfer of methods to other internal analytical laboratories (US and international) and outside testing facilitiesInterfacing with QC/QA and production laboratories to evaluate method needs including automation of existing methodologyDue diligence audits of API partner

Leader of the team responsible for chemical characterization of drug substance and finished drug (inhalation) product in support of CMC section of regulatory subsissions. Implemented novel approaches for the identification and detection of impurities and degradants in metered dose inhalers leading to key deliverables for regulatory submissions. Provided reports to support regulatory filings.

Lead an anlytical group in support of formulations and process development. Develop/validate analytical methods for drug product and drug substance; monitor and interpret stability dataSupervise and train technicians and analysts in instrument operation and laboratory techniquesDirect and supervise technical group of up to 13 direct reportsRecommend testing strategies to formulation scientsist/engineers to support formulation and process development, scale-up and refinementTransfer of methods to other internal analytical laboratories (US and international) and outside testing facilities

Develop and validate analytical methods for the analysis and characterization of recombinant proteins and related biomolecules in fermentation, process and reference samples using protein chemistry, enzymology, HPLC, electrophoresis and GC*MS Identify trace level impurities in isolated drug product; supervise and train technicians in instrument operation and laboratory techniques, prioritize and organize daily lab operations; Responsible for performance evaluations and other personnel-related issues; evaluate, purchase and setup HPLC and other instrumentation for use in routine and developmental studies; assist process chemists and engineers with analytical needs.

Analysis of developmental dosage and process samples; develop and validate methods for the quantitative analysis of drugs, excipients and related compounds in dosage forms using HPLC and GC, as well as spectroscopic methods and wet chemistry.

Publications - more than 20 scientific and technical publicationsCommunity Activities

Phd, Analytical Chemistry

Ms, Biochemistry

Bs, Biochemistry

Doctorate, Analytical Chemistry

Advisor: Prof. R.G. Cooks Thesis: Thermochemical properties of biomolecules by MS; on-line analytical MS; Analysis using biomimetic surfaces

Master'S Of Science Degree; S.C, Analytical/Biochemistry

Advisor: Prof. J.W. Baynes Thesis: Identification and Quantitation of protein adducts in diabetic and senesent tissues

Bachelor'S Of Science Degree, Biochemistry