Expert Details

Expert in Gene Expression, Genomics, Microarrays, DNA, Drug Discovery, Product Development

Expert ID: 722397 California, USA

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Expert has worked in the biotechnology industry for more than 30 years. He has directed R&D efforts in gene expression technology, genetic engineering technology, DNA microarrays, and high-throughput screening at Sandoz (Novartis), Operon, Agraquest, and GenoSpectra. He has led product development efforts for more than 15 years. His efforts have resulted in the introduction of over 50 products to the market. Expert has worked with nucleic hybridization and DNA techniques for more than 30 years. This includes DNA oligonucleotide synthesis and probe design for oligonucleotide-based DNA microarrays. During his tenure at Operon Technologies he and his research group conceived of and developed oligonucleotide longmers (70 mers) for DNA microarray
use. He and his collaborators in Scotland were one of the first groups to develop quantitative RT/PCR techniques for analyzing RNA splicing. He has publications on in situ, filter-based and DNA chip based nucleic acid hybridizations.

He has been working on developing drugs and discovery tools for twelve years at Operon, and GenoSpectra. This work includes DNA microarrays, high-throughput screening technology and quantitative gene expression technology. He taught a one-day intensive drug discovery and development course at the University of California, Berkeley Extension for several years. He also has taught a one-day course on the power of DNA microarrays. He is currently involved in clinical trials with a cardiovascular protein drug that reduces inflammation and stabilizes vulnerable plaque that is delivered locally.

Expert's group at Sandoz was one of the first groups to effectively genetically engineer corn to be resistant to insects. He holds key patents in corn transformation and a gene expression plasmid construct of Bacillus thuringiensis (Bt) endotoxin. Most of the Sandoz (now Syngenta) insect-resistant transgenic corn lines utilized this technology. Expert and his group also did intensive work on intron-mediated enhanced expression in corn cells. This work is not only key to Bt expression in corn but is routinely used in expressing heterologous genes in mammalian cells. He and his lab also assisted in developing technology to identify these genetically engineered organisms.

He has taught genetics for more than 10 years at the University of Illinois, Santa Clara University and at the University of California, Berkeley Extension. His research has dealt with cytogenetics, developmental genetics, drug development and molecular genetics.

Expert's R&D work and interests have always revolved around eukaryotic genes and their regulation of expression. His work in this area includes heat shock gene expression, developmental regulation of gene expression, intron-mediated enhanced expression in heterologous systems, and codon-optimized gene expression in heterologous systems. He has more than 24 years of experience in these areas. He has also developed protein production systems to produce recombinant protein drugs.

Expert has been performing research and development in the area of genomics and genome biology for the last eight years. As mentioned in his paragraph on DNA technology, he and his lab group developed DNA microarray probe technology at Operon that included the design and manufacture of genomic sets of 70 mer oligonucleotides for expression profiling for the human, mouse, rat, yeast, Mycobacterium, Drosophila, Arabidopsis, C. elegans, Candida and other genomes.

Expert led product development efforts at Operon Technologie Genospectra, Inc. at the Vice President level. He was responsible for putting into place a product development process and the project management oversight to assure on-time introduction of the products. He was involved in product development efforts at the Project Manager/Senior Staff Scientist level at Sandoz. Altogether he was involved with the introduction of over 50 products into the biotechnology market. These products include DNA microarray genomic sets, related products, and transgenic corn plants at Sandoz. The R&D cycles of these products ranged from three to six months to seven years.

Expert is currently serving as the Chief Scientific Officer and Vice President at a company where they are developing a novel cardiovascular protein drug that reduces inflammation and stabilizes and reduces vulnerable plaque in arteries. This project is ready to enter clinical trials. He designed and developed recombinant protein production systems that are capable of producing this bioactive protein is a cost effective manner. He also developed protein purification methods to isolate this protein effectively.

Expert has assisted in recoding and designing genes to be expressed in heterologous systems by codon optimization and avoiding the use of specific inhibiting nucleic acid sequences. Expression levels of the proteins were raised 10- to 100-fold.He made critical suggestions in vector and promoter design that led to stable and ample expression in transgenic organisms expressing heterologous genes.His oligonucleotide design suggestions led to the development of DNA microarrays that yielded consistent and specific expression analysis results. This allowed the development of a platform to be used in clinical research analysis of gene expression in cancer systems.He has advised clients on DNA microarray technology, oligonucleotide design and nucleic acid hybridization as it pertains to intellectual property and basic research and development.

He has also served as an expert witness for a number of patent disputes and has been deposed in number of patent disputes.

Expert may consult nationally and internationally, and is also local to the following cities: Sacramento, California - Stockton, California - Citrus Heights, California - Roseville, California - Davis, California - Lodi, California - Folsom, California - Reno, Nevada - Sparks, Nevada

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Education

Year Degree Subject Institution
Year: 1978 Degree: Ph.D. Subject: Molecular Biology Institution: University of Illinois
Year: 1974 Degree: M.S. Subject: Biological Sciences Institution: University of Illinois
Year: 1970 Degree: B.S. Subject: Biological Sciences Institution: University of Illinois
Year: 1997 Degree: Certificate Subject: Business Management Institution: University of California Berkeley

Work History

Years Employer Title Department Responsibilities
Years: 2009 to 2014 Employer: Cardigant Medical Title: Chief Scientific Officer And Vice President Department: Research and Development Responsibilities: Expert serves as the Chief Scientific Officer for (undisclosed) and is largely responsible for its assay development work, ApoA 1 protein production scale up and vector optimization. He has extensive experience in designing, conducting and supervising complex in vitro and in vivo experimental programs
Years: 2002 to Present Employer: Undisclosed Title: Consultant Department: Responsibilities: Provides consulting in the areas of gene expression, DNA microarrays, product development, associated DNA technology,genomics, drug and clinical R&D, transgenic organisms, protein production optimization, HDL based therapy for cardiovascular disease, genomics, assay development, cancer gene expression, nucleic acid hybridizations, PCR amplification, biosafety and project management.
Years: 2004 to Present Employer: Undisclosed Title: Associate Professor Department: Biology Responsibilities: Taught Biology, Biotechnology and Microbiology. Also served as Director of Biotechnology at Ohlone College. Currently teaching Cell and Molecular Biology at Lake Tahoe Community College.
Years: 1993 to 2005 Employer: University of California, Berkeley Title: Instructor Department: Extension Responsibilities: He teaches molecular biology, drug discovery, and genetics to biotechnology and associated professionals. In addition, at Santa Clara University, he taught general genetics to biology majors for two terms.
Years: 2001 to 2002 Employer: GenoSpectra Title: Vice President Department: Product Development Responsibilities: His responsibilities included: overall project management for R&D; business development issues involving ancillary products; marketing; marketing research; establishing beta sites for new product assessment; technical and customer service; quality assurance; and customer acquisition.
Years: 1995 to 2001 Employer: Operon Technologies Title: Vice President (final position) Department: Scientific Affairs Responsibilities: As Vice President he was responsible for the Microarray Business Unit, the science involved in new product research and development, the technical aspects of business development, and the establishment and maintenance of extramural research projects. He previously served as Director of R&D and Marketing Manager; and before that as product manager for gene synthesis and as the production manager of gene synthesis.
Years: 1994 to 1995 Employer: AgraQuest Title: Vice President Department: R&D Responsibilities: He was one of the founders and Directors of a new business venture that involved high-throughput screening for natural products used as bioactive molecules. As VP of R&D, his responsibilities included the setting up of the research laboratories, the hiring of scientific staff, and providing overall scientific leadership. He also led the initial venture capital fundraising effort.
Years: 1982 to 1994 Employer: Sandoz Title: Associate Director & Senior Staff Scientist Department: R&D Responsibilities: His responsibilities included the direction of a gene expression project (five to eight scientists), the supervision and direction of the transformation project which included 15-20 scientists and to act as deputy research director in the Director’s absence. He served as the Institutional Biosafety Committee (IBC) Chair and as liaison to the California Industrial Biotechnology Association (CIBA).

Career Accomplishments

Licenses / Certifications
He holds a Certificate in Business Administration from the University of California, Berkeley Extension.
Awards / Recognition
Expert was a Damon Runyon-Walter Winchell Cancer Fund Postdoctoral Fellow and an NIH Postdoctoral Fellow. He received the Presidential Award while at Sandoz, Inc.
Publications and Patents Summary
He has more than 65 publications, abstracts, and presentations, and three issued patents.

Additional Experience

Expert Witness Experience
Expert has participated in depositions involving patent disputes as well as composing IPR technical reports.
Training / Seminars
Expert has taught a one-day intensive overview of the drug development process. He has also taught a one-day intensive course about the design, fabrication, and use of DNA microarrays. He taught a two-semester molecular biology course and a genetics course at the University of California, Berkeley Extension. He currently teaches a course on Biotechnology and Society.
Vendor Selection
He has extensive experience and knowledge in synthetic DNA synthesis and knows the strengths and weaknesses of the various vendors who make custom DNA.
Marketing Experience
Expert has been responsible for bringing to market more than 30 biotechnology products that have revenues ranging from $10,000 to more than $100 million. He ran the marketing effort at Operon technologies for two years and supervised the market development thrust at GenoSpectra.

Fields of Expertise

biotechnology, DNA, DNA technology, drug product approval, genetics, genetic engineering, genetically engineered material, plant biotechnology, plant genetic engineering, eukaryotic gene, eukaryotic molecular biology, gene, gene expression, gene expression regulation, molecular biology, plant molecular biology, recombinant DNA technology, genome, genomics, molecular genetics, new consumer product development, drug development, biochemical genetics, cardiopulmonary physiology, medical genetics, high-throughput screening (drug discovery), proteomics, proteome, molecular diversity, DNA fingerprinting, clinical diagnostics, industrial biotechnology, botanical insecticide, plant (botanical), genetic disease, food biotechnology, Food and Drug Administration validation, clinical instrumentation, drug validation, drug clinical trial, locus, Northern blotting, Southern blotting, molecular genetics testing, biochemical genetics testing, pharmaceutical research, molecular medicine, molecular oncology, molecular cytogenetics, molecular biochemistry, human genome, eukaryote, cytogenetics, cardiovascular physiology, applied molecular biology, human genetics, pharmaceutical industry, genetic sequencing, molecular biology translation, plant genetics, genetic mutation process, food engineering, Food and Drug Administration regulation, drug regulation, DNA synthesis, cell (biology), polymerase chain reaction, drug, protein synthesis, plant breeding, animal molecular biology, investigational drug, heredity, genetic manipulation, gene therapy, drug screening, cloning technique, chromosome, breeding, botany

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