PhD scientist with over 37 years experience in the FDA-regulated Molecular Diagnostics industry. Expert in Next Generation Sequencing and platform development as well as intellectual property (including work as an expert witness for multiple cases). Proven track record in innovation and core technology conception, reduction to practice and implementation (co-invented and played a key role in commercialization of multiple technologies, many of which are core to Hologic (formerly Gen-Probe) products that generate >$500MM annual revenue) and broad expertise and experience in intellectual property protection (62 issued U.S. patents; >200 issued or pending patents worldwide). Effective leader; directed small to large teams, including matrix management and leading by influence. Proactively built strong relationships with multiple departments across the organization, customers, key opinion leaders and external collaborators to help conceive and drive superior performance, user-friendly, compliant products to market. Known for innovation, successful implementation, leadership, long-term strategic thinking, work ethic and integrity.Goals:• Provide expert consulting services worldwide across a variety of applications• Provide expert witness services for intellectual property casesExpertise (selected):• Next Generation Sequencing and platform development• Cutting-edge research / Technology innovation and reduction to practice / IP protection• Design and development of clinical sample to answer DNA and RNA assays, including sample prep, amplification, detection, quantitation, multiplexing, mutational analysis, platform integration and data analysis• Identification and evaluation of external technology solutions that can bring strategic value• Genomics, Oncology, Infectious disease (bacterial and viral), Blood Screening, HLA typing• Leadership, matrix management, relationship-building, collaboration, vision and strategic thinking for long-term success
Ncn Enterprises
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Sr. ConsultantNcn Enterprises Aug 2012 - PresentGreater San Diego AreaProvide worldwide consulting services in the areas of molecular diagnostics, next generation sequencing, platform development, intellectual property protection (including serving as an expert witness), genomics, companion diagnostics and technology analysis across a variety of applications.
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Sr. Director Of Discovery ResearchGen-Probe Incorporated Apr 2009 - Aug 2012Greater San Diego AreaNEXT GENERATION SEQUENCING TEAM (I was a senior member of the team)• Helped drive the acceptance of next gen sequencing into the organization as a mainstream project• Developed novel, streamlined sample to answer workflows for potential commercial applications• Evaluated (in-house) Pacific Biosciences RS (full collaboration), Ion Torrent PGM and Illumina MiSeq platforms• Worked towards development of commercialization and product strategies; feasibility explored for multiple assays, including high resolution HLA typing, HCV rare variant analysis, prostate cancer biomarker detection, genomic “hotspot” cancer panels and whole bacterial genome sequencing• Explored outside, new technologies as creative solutions to overcome process and assay limitations• Directed scientists and research associates; worked collaboratively with outside entitiesHLA PRODUCT IMPROVEMENT (collaboration with Gen-Probe’s Lifecodes division) – Improved sensitivity and specificity of on-market HLA assays (PCR/Luminex bead-based); required multiple customer visits and collaborative efforts; improvements were incorporated into productREAL-TIME TMA TECHNOLOGY IMPROVEMENT – Co-invented and developed a new format that significantly improved the limit of quantitation of real-time TMA assays; technology implemented and currently in product developmentPRODUCT LIFE CYCLE (PLC) PROCESS IMPROVEMENT TEAM (central focus on the Product Development Process) – Leader of the PLC team with 7 interdepartmental core team members and 235 volunteer members; built strong working relationships across multiple functional areas of the company; initiated over 90 short-term improvement projects, over 50 of which were completed in 2011, saving the company many thousands of dollars while increasing efficiency and decreasing lead and processing time; multiple long-term projects were initiated and carried forward into 2012. -
Director Of BiochemistryGen-Probe Incorporated Jul 2005 - Mar 2009Greater San Diego AreaMULTIPLEX TASK FORCE – Led a multidisciplinary team (matrix management) in the development of a number of novel multiplexing technologies (patents pending), with top candidates incorporated into product development projectsINSTRUMENT DEVELOPMENT/SYSTEM INTEGRATION – Led a multidisciplinary team (matrix management) in the initial development of a new Closed Unit Dose Assay (CUDA) platform (collaboration with Qualigen Inc.) and integration of Gen-Probe’s Real-Time assay chemistries thereonBLEACH ENHANCER FOR CLEANING – Led a multidisciplinary team to create an alternative to an on-market amplicon decontamination product in response to complaints coming from the field; we developed a new product and brought it to market; complaints satisfiedMULTIPLEX QUANTITATIVE PROSTATE ONCOLOGY ASSAY – In collaboration with the Oncology group, developed a quantitative quadruplex (PCA3, PSA, T2:ERG and internal control) Real-Time TMA assay; moved into product developmentCORE REAL-TIME TMA TECHNOLOGY – Played a key role in the implementation of Real-Time TMA technology into mainstream product feasibility and development -
Research Scientist - Sr. Principal ScientistGen-Probe Incorporated Jun 1985 - Jun 2005Greater San Diego AreaPositions held:1997-2005 Principal Scientist/Sr. Principal Scientist1991-1996 Scientific Investigator1989-1990 Staff Scientist1985-1988 Research Scientist/Sr. Research ScientistAccomplishments (selected):CORE TECHNOLOGY CREATION AND ASSAY DEVELOPMENT• Co-invented, protected (IP) and participated in the development and implementation of key Gen-Probe core technologies and assays. Many of these technologies, including HPA, DKA, mismatch discrimination and AE-labeling and purification, are core to Gen-Probe products that generate >$500MM annual revenue.• Co-invented, protected (IP), developed and/or transferred a wide variety of other technologies and assays, including sample processing & target capture, branched nucleic acids, rapid assay formats, modified oligonucleotides, novel amplification and detection strategies, extended dynamic range and adduct protection, many of which were incorporated into product (or are currently in development)• Drove the early technology development and feasibility of real-time TMA; ultimately the technology was incorporated into front-line assays and is currently in developmentANTISENSE THERAPEUTICS – Leader of the antisense therapeutics technical team during the start-up phase of the internal program (ultimately spun out as Chugai Biopharmaceuticals Incorporated)OTHER ACTIVITIES • Led or participated in multiple external collaborations• Authored or co-authored over 20 publications and over 35 posters• Delivered podium presentations at multiple conferences• Chaired sessions, served on organizing committees or chaired organizing committees at multiple conferences -
Research Scientist/Sr Research ScientistWestbridge Research Group Jan 1983 - Apr 1985Greater San Diego AreaR&D and commercial support of novel plant growth regulator formulations to stimulate crop growth and increase yield. Key accomplishments include,• Development and implementation of bioassays to study the effects of plant growth regulators• Development and implementation a Quality Control Program for on-market and under development products• Reformulation of multiple products, resulting in improved consistency, homogeneity and stability; revised manufacturing protocols accordingly• Designed and supervised the building of a new R&D laboratory
Norm Nelson Skills
Norm Nelson Education Details
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Chemistry (Biochemistry Focus) -
Chemistry
Frequently Asked Questions about Norm Nelson
What company does Norm Nelson work for?
Norm Nelson works for Ncn Enterprises
What is Norm Nelson's role at the current company?
Norm Nelson's current role is Expert in Molecular Diagnostics, Next Generation Sequencing and Platform Development.
What schools did Norm Nelson attend?
Norm Nelson attended University Of California, San Diego, California Institute Of Technology.
What skills is Norm Nelson known for?
Norm Nelson has skills like Molecular Diagnostics, Next Generation Sequencing, Patents, Genomics, Biotechnology, Oncology, Cross Functional Team Leadership, Assay Development, Amplification/detection, Sample Processing, Target Capture, Multiplexing.
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