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Resume of TRM, Ph.D.
President

EXPERTISE AND SERVICES

Scientist, Pharmaceutical, Life Sciences, Biotechnology Industries Consultant, Specialist, Forensic Analysis Investigation Expert, Patent Infringement, Expert Witness Testimony, Consulting, Services
Expertise in product and process development, biopharmaceutical products, nucleic acids assay development and validation, biotechnology, research, biochemical genetics, DNA and RNA analysis.

This KKAI Associate also specializes in DNA-based pharmaceutical products, FDA guidelines, IND package analytical parts, HIV DNA vaccine, IND filing and clinical trial, quality control, regulatory submissions, proposal preparation, planning, reporting, budgeting, staffing, regulatory IND and DMF filing, and molecular biology lab setup.

This associate is an expert in areas including DNA genotyping, plasmid DNA forms, plasmid DNA identity, plasmid or gene copy number, residual RNA, residual host chromosomal DNA, molecular genotyping, PCR, RFLP, SSCP, allele-specific PCR, allele-specific hybridization, and recombinant DNA.

Additional experience and specialization includes ligation, transformation, electroporation, clone screening, microbial genetics, mutagenesis, mating and mapping, genotype construction, transformation and maintenance, clone screening, yeast two-hybrid system, yeast tetrad analysis, protein expression, yeast and bacterial vector construction, recombinant proteins in yeast, Northerns, Westerns, recombinant protein purification, protein chemistry, size fractionation, ion exchange chromatography, affinity chromatography, enzymatic assays, spectrofluorimetry, protein expression in yeast saccharomyces, human XPA and XRCC1 DNA repair proteins, virology.

Extensive knowledge regarding genetic predisposition to diabetes mellitus, multiple sclerosis and rheumatoid arthritis, DNA diagnostics of human inherited diseases, yeast mitosis, phosphoribozylaminoimidazole carboxylase, mutants in certain genes of yeast Saccharomyces cerevisiae, yeast in biotechnology, microorganic activity and physico-mechanical properties of solid grounds, spontaneous mitotic recombination in yeast saccharomyces, DNA polymorphisms of yeast saccharomyces, purine biosynthesis in microorganisms, birds, mammalia and man.

Has conducted numerous studies in areas including high coconversion in yeast chromosome XV, a DNA fingerprinting method, a mutant allele and Parkinson disease, human XPA protein, CYP2D6A mutation identification, the etiology and pathogenesis of Parkinsonís diseases, arthritis and TAP2 alleles, the diphtheria toxin gene CRM197 allele, bacterial plasmid copy numbers, supercoiled plasmid DNA and antibody production, bio-organic content in geological samples, teaching and training

PRINCIPAL INDUSTRIES SERVED
Biochemical, Chemical, Medical, Pharmaceutical Life Sciences

EDUCATION
Ph.D., Genetics, St. Petersburg State University, Russia

PROFESSIONAL EXPERIENCE
President, Kevin Kennedy & Associates, Inc.

Project Manager, Kevin Kennedy & Associates, Inc.
Providing project management and consulting services to the Pharmaceutical, Life Sciences, and Biotechnology Industries

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Case Studies

Scientist I, Scientist II, Specialist II, Chiron Corporation, CA

Head of the Nucleic Acids Assay Development group. Analytical project management in biotechnology GMP environment. Designed and developed a variety of novel DNA and RNA analysis methods, validated assays according to ICH guidelines. Prepared SOP (standard operating procedure) protocols, transferred assays to QC. Established a solid and unique analytical platform for characterization of DNA-based pharmaceutical products according to FDA guidelines. Coordinated and oversaw all analytical activities required for product characterization and release. Designed certificates of analysis for the nucleic acid-based products. Composed analytical parts of the IND package for FDA filing. Prepared NIH grant proposals for HIV DNA Vaccine. Supervised and trained staff members in the execution of DNA and RNA analysis procedures.

Post-Doctoral Staff Member, Biology/Biotechnology Research Program, Lawrence Livermore National Laboratory, CA

Designed and constructed novel vectors for protein expression in yeast Saccharomyces. Expressed and characterized human XPA and XRCC1 DNA repair proteins

Visiting Scientist/Consultant, Department of Virology, University of Turku, Finland

Established a PCR-based DNA genotyping platform for determining genetic predisposition to insulin-dependent diabetes mellitus, multiple sclerosis and rheumatoid arthritis

Assistant Professor, Department of Medical Genetics, St. Petersburg Pediatric Medical Institute, Russia

Delivered series of lectures, instructed and trained medical students in theoretical and practical approaches to DNA diagnostics of human inherited diseases. Trained and supervised research group to investigate genetic nature of predispositions to human diseases, and to develop methods for DNA diagnostics.

Ph.D. Candidate, Laboratory of Genetics of Eucaryota, Petersburg Institute of Nuclear Physics, Russia

Discovered that spontaneous conversion events in yeast mitosis involve extended regions of yeast chromosomal DNA

Research Associate, Laboratory of Biochemical Genetics, St. Petersburg State University, Russia

Purified and characterized phosphoribozylaminoimidazole carboxylase from yeast Saccharomyces cerevisiae

HONORS AND AWARDS
Fellowship from European Society of Human Genetics to attend the 25th Annual ESHG Meeting, Barcelona, Spain
Cytochrome P4502D6 Gene Mutations In Predisposition To Parkinson Disease, Research grant from US Department of Energy
Co-Investigator, HIV Vaccine Development Resources - GMP DNA Manufacturing,
RFP-NIH-NIAID-DAIDS-02-07

PUBLICATIONS
Numerous publications on topics related to phosphoribosylaminoimidasole carboxylase, mutants in certain genes of yeast Saccharomyces cerevisiae, yeast in biotechnology, microorganic activity and physico-mechanical properties of solid grounds, spontaneous mitotic recombination in yeast saccharomyces, DNA polymorphisms of yeast saccharomyces, purine biosynthesis in microorganisms, birds, mammalia and man, high coconversion in yeast chromosome XV, a DNA fingerprinting method, a mutant allele and Parkinson disease, human XPA protein, CYP2D6A mutation identification, the etiology and pathogenesis of Parkinson’s diseases, arthritis and TAP2 alleles, the diphtheria toxin gene CRM197 allele, bacterial plasmid copy numbers, supercoiled plasmid DNA and antibody production, and more

Holder of one patent related to the bio-organic content in geological samples

Please note that this is an abbreviated CV. A fully detailed unabridged CV is available under special circumstances.

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Kevin Kennedy & Associates, Inc.
Rapid Response Engineering® Solutions
3905 Vincennes Road, Suite 320
Indianapolis, Indiana 46268
(317) 536-7000 voice
(317) 536-7220 fax

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