Walter King Resume 2015

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WALTER KING, PHD Dover, NH 03820 603-343-4347 [email protected] SEASONED SENIOR R&D EXECUTIVE DELIVERING PROJECTS ON TIME AND ON BUDGET Strong executive leader with proven record in directing development of medical device and laboratory consumable products across diverse customer base for major companies. Possess passion for building high performance teams focused on delivering products on time and on budget. Adept at bringing focus to research and development efforts, across all levels of organization, with major research centers and pharmaceutical and diagnostic partners, within budget and timelines. Successful in leading change management processes in both organizational structure and integration activities. Oversaw key products that were paramount in sale of 2 companies to Abbott and GE Healthcare. Led development of new generation of personalized diagnostic FDA-cleared vitro diagnostic products in breast, as well as molecular IVDs for bladder cancer screening, pre-implantation and prenatal genetic testing, and CE marked products in area of molecular forensics / human ID and instrumentation for diagnostics and infectious disease detection. Directed development and product launch of PathVysion HER-2 DNA probe kit for breast cancer is one of 1 st examples of what is recognized as genomic disease management, or personalized medicine, resulting in 1 st FDA approval FISH test, number 1 global sales, still under US patent protection for FISH technology. Managed development and product launch of key FDA-cleared cancer tests, resulting in Abbott Molecular’s leadership position with UroVysion bladder cancer screening test. Headed development and product launch of Whatman / GE Life Sciences EasiCollect device collection device for forensic DNA analysis, leading to sale to law enforcement agencies throughout world and has been choice for FBI (>$5M / year since 2007). Supervised product development and launch of custom membranes, resulting in incorporation of Whatman / GE Life Science membranes for Cepheid GeneExpert platform for detection of microbial pathogens a key enabling technology, resulting in Cepheid’s 2014 $470.1M revenue. PROFESSIONAL EXPERIENCE GE HEALTHCARE 2008 – 2014 Technology Director, Precision Diagnostics, Life Sciences 2013 – 2014 Westborough, MA and Piscataway, NJ Reported to Chief Marketing Officer, GE Life Sciences. Assessed new and emerging technologies in clinical diagnostics for potential investment, partnerships and / or acquisitions. Developed and supported financial forecasts and ROI that were presented to top senior management in GE Healthcare Life Sciences, which made go-ahead decision. Established key collaborations with diagnostic companies that wanted to adopt GE’s sample collection product. Led technical feasibility plan in collaboration with GE Global Research Center. Spearheaded business re- assessment external collaborative projects with leading diagnostic partners, that resulted in additional funding to support wider market penetration for remote diagnostics. Potential market was in excess of $35M. Chief Technologist, Applied Markets, Life Sciences 2010 – 2013 Set strategy for diagnostic business and developing cross-business opportunities within GE Healthcare business. Developed and administered external R&D collaborations with academic and industrial partners in support of diagnostics. Directed new technology development supporting future diagnostics product pipeline. Supported development of division’s growth playbook with Strategic Marketing. Active member of Business Unit’s senior management team. Identified and developed business and project plans and priorities for each financial year. Helped develop quality metrics for performance and goals that were integral to business unit meeting and exceeding financial performance goals.

Transcript of Walter King Resume 2015

Page 1: Walter King Resume 2015

WALTER KING, PHD Dover, NH 03820

603-343-4347 [email protected]

SEASONED SENIOR R&D EXECUTIVE DELIVERING PROJECTS ON TIME AND ON BUDGET

Strong executive leader with proven record in directing development of medical device and laboratory consumable products across diverse customer base for major companies. Possess passion for building high performance teams focused on delivering products on time and on budget. Adept at bringing focus to research and development efforts, across all levels of organization, with major research centers and pharmaceutical and diagnostic partners, within budget and timelines. Successful in leading change management processes in both organizational structure and integration activities. − Oversaw key products that were paramount in sale of 2 companies to Abbott and GE Healthcare. − Led development of new generation of personalized diagnostic FDA-cleared vitro diagnostic products in breast,

as well as molecular IVDs for bladder cancer screening, pre-implantation and prenatal genetic testing, and CE marked products in area of molecular forensics / human ID and instrumentation for diagnostics and infectious disease detection.

− Directed development and product launch of PathVysion HER-2 DNA probe kit for breast cancer is one of 1st examples of what is recognized as genomic disease management, or personalized medicine, resulting in 1st FDA approval FISH test, number 1 global sales, still under US patent protection for FISH technology.

− Managed development and product launch of key FDA-cleared cancer tests, resulting in Abbott Molecular’s leadership position with UroVysion bladder cancer screening test.

− Headed development and product launch of Whatman / GE Life Sciences EasiCollect device collection device for forensic DNA analysis, leading to sale to law enforcement agencies throughout world and has been choice for FBI (>$5M / year since 2007).

− Supervised product development and launch of custom membranes, resulting in incorporation of Whatman / GE Life Science membranes for Cepheid GeneExpert platform for detection of microbial pathogens a key enabling technology, resulting in Cepheid’s 2014 $470.1M revenue.

PROFESSIONAL EXPERIENCE

GE HEALTHCARE 2008 – 2014

Technology Director, Precision Diagnostics, Life Sciences 2013 – 2014 Westborough, MA and Piscataway, NJ Reported to Chief Marketing Officer, GE Life Sciences. Assessed new and emerging technologies in clinical diagnostics for potential investment, partnerships and / or acquisitions. Developed and supported financial forecasts and ROI that were presented to top senior management in GE Healthcare Life Sciences, which made go-ahead decision. • Established key collaborations with diagnostic companies that wanted to adopt GE’s sample collection product.

Led technical feasibility plan in collaboration with GE Global Research Center. Spearheaded business re-assessment external collaborative projects with leading diagnostic partners, that resulted in additional funding to support wider market penetration for remote diagnostics. Potential market was in excess of $35M.

Chief Technologist, Applied Markets, Life Sciences 2010 – 2013 Set strategy for diagnostic business and developing cross-business opportunities within GE Healthcare business. Developed and administered external R&D collaborations with academic and industrial partners in support of diagnostics. Directed new technology development supporting future diagnostics product pipeline. Supported development of division’s growth playbook with Strategic Marketing. • Active member of Business Unit’s senior management team. Identified and developed business and project

plans and priorities for each financial year. Helped develop quality metrics for performance and goals that were integral to business unit meeting and exceeding financial performance goals.

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WALTER KING PAGE TWO GE HEALTHCARE (Continued)

• Developed and administered external R&D collaborations with academic and industrial partners in support of diagnostics. Provided collaboration and business support for new product configuration; resulted in cardio diagnostic partner gaining access to $25M market. Collaborated with global next-gen sequencing diagnostic partner in China, directing client’s expansion into remote diagnostics for variety of genetic and cancer tests, conservatively estimated to be $10M.

Global Head of Research & Development, Consumables Division 2008 – 2009 Life Sciences The Maynard Centre, Forest Farm Estate, Whitchurch, UK Responsible for the global leadership of Business Unit’s product development portfolio, including intellectual property portfolio management, research activities in support of pipeline products. Managed VCP improvements, product and market support activities. Served as member of Business Units’ senior management team. • Developed and implemented organizational restructuring aligned to changes in GEHC’s business strategy.

Established transition for plant closures, created new R&D groups and Centers of Excellence, and led technology transfer and training between organizations.

• Managed $4M R&D budget, that led to multiple new product launches, that keyed the growth of $350M business with an annual CAGR of 6.4%.

• Worked with Product Management as Global Head of Product Development, improving product registration and development workflows.

• Created Process Engineering functions with Operations, refining process validation and product support activities.

WHATMAN PLC, Sanford, ME 2006 – 2008

Vice President, Global Research and Development Managed all aspects of global research and development activities. Performed intellectual property management and development. Supported marketing, sales, regulatory and manufacturing activities as member of Executive Committee. Participated in merger and acquisition due diligence. • Developed and implemented strategic product portfolio. Authored company-wide product development SOP,

aligning with CFR 820.30. As member of senior management team, successfully negotiated and developed strategic product pipeline, leading to eventual sale of company to GE Healthcare, and product revenues totaled over $10M in 2 years.

• Supported Manufacturing and Quality in addressing customer requirements for CAPA activities and led process development activities for membrane manufacture, resulting in $5M in annual sales.

• Part of limited Senior Executive Team that pitched Whatman to several prospective buyers through Goldman Sachs, which resulted in the sale to GE Life Sciences for $713M.

NANOSPHERE INC., Northbrook, IL 2005 – 2006

Director, Applications Development Group Developed In Vitro Diagnostic (IVD) products for genetic and infectious disease testing, using single nucleotide polymorphism detection technology without amplification direct from patient samples. • Led development of company’s FDA cleared tests for Factor II and V and Cystic Fibrosis genetic tests. Re-wrote

company’s product development SOP to be aligned with CFR 820.30. Organized and built out the product development team. Worked with QA, QC and RA in development of protocols in support of FDA submissions. Efforts led to FDA-clearance and collectively these provided strong commercial visibility of the company’s initial in vitro diagnostic product line after which directly supported their successful IPO.

ABBOTT LABORATORIES, Downers Grove, IL 2001 – 2005

Senior Director, Product Development, Vysis Diagnostic Division, Molecular Oncology Performed as program director of microarray IVD products for molecular cytogenetics and oncology. Led the development of products that were instrumental in company IPO and eventual sale to Abbott for more than $350M.

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WALTER KING PAGE THREE VYSIS, INC. (now Abbott Molecular), Downers Grove, IL 1995 – 2001

Director, Genomic Microarray Platform 1999 – 2001 Acted as Program director of genomic array-based assay products for detection of amplification and deletions in solid tumors, leukemias, lymphomas and prenatal applications. • Coordinated in-house development efforts with major university research centers, such as The University of

California at San Francisco, Institute for Pathology in Basel, and University of Glasgow, University of Chicago, and other institutions worldwide; these efforts were instrumental in development portfolio that met clinical and patient needs using nucleic acid probe technology.

Senior Manager, Assay Development 1995 – 1999 Directed development of IVDs for HER-2 detection in breast cancer (PMA approval), multiplex aneuploidy detection in bladder cancer (510K approval), and pre-implantation testing in blastomeres and polar bodies. Headed development of high throughput, fully automated sample processing station for slide-based specimens for in situ hybridization and routine pathology and cytogenetic staining. • Launched 3 FDA cleared tests for cancer and genetic diagnostics, resulting in Abbott purchasing Vysis as

cornerstone of company’s molecular diagnostics business, now called Abbott Molecular. GENE-TRAK SYSTEMS INC., Framingham, MA 1986 – 1995

Senior Scientist, Assay Development Directed development of assay formats and chemistries for automated clinical analyzer, task included initial feasibility studies, validation of front-end sample processing formats and clinical testing. Led development of highly sensitive amplification chemistry for detection of respiratory, gastro-intestinal and sexually transmitted disease panel. • Supervised development efforts, resulting in successful product release of manual non-isotopic probe based test

for detection of Listeria, Salmonella and E. coli. AMOCO CORP, Naperville, IL 1985 – 1986

Research Scientist, Biotechnology Group, Corporate Research Center Developed nucleic acid probe technology for detection of clinical pathogens.

EDUCATION Postdoctoral Fellow, Departments of Microbiology and Urology, Columbia University Medical Center, New York, NY

Postdoctoral Fellow, Department of Medicine, University of Chicago, Chicago, IL PhD, Committee on Virology, University of Chicago, Chicago, IL

BA, Department of Bacteriology and Immunology, University of California, Berkeley, CA

RESEARCH EXPERIENCE

Identification of Genes Involved in the Differentiation of Embryonal Carcinoma Cells, Columbia University Identification of the Transforming Region in the Epstein-Barr Virus Genome, University of Chicago

PROFESSIONAL MEMBERSHIP

American Association for Cancer Research – Membership #45251

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ISSUED US PATENTS

7,517,645 – Detection of high grade dysplasia in cervical cells 6,376,188 – Method and probe set for detecting cancer 6,174,681 – Method and probe set for detecting cancer

5,750,338 – Target and background capture methods with amplification for affinity assays 5,629,156 – Multiple capture probe sandwich assays

5,376,528 – Probes and methods for the detection of Listeria

PUBLICATIONS • Policht FA, Song M, Sitailo S, O’Hare A, Ashfaq A, Muller CA, Morrison LE, King W, Sokolova IA, Analysis of

genetic copy number changes in cervical disease progression, BMC Cancer 2010, 10:432, 2010. • Sokolova I, Algeciras-Schimnich A, Song M, Sitailo S, Policht F, Kipp BR, Voss JS, Halling KC, Ruth A, King W,

Underwood D, Brainard J, Morrison L., Chromosomal biomarkers for detection of human papillomavirus associated genomic instability in epithelial cells of cervical cytology specimens, J Mol Diagn.,Nov;9(5):604-11, 2007.

• Wong A, Lese Martin C., Heretis K., Ruffalo T., Wilber K., King W., Ledbetter D.L., Detection and Calibration of Microdeletions and Microduplications by Array-Based Comparative Genomic Hybridization, Genet Med. Apr;7(4):264-71, 2005.

• Ritter CA, Bianco R, Dugger T, Forbes J, Qu S, Rinehart C, King W, Arteaga CL, Mechanisms of resistance development against trastuzumab (Herceptin) in an in vivo breast cancer model, Int J Clin Pharmacol Ther. 42(11):642-3, 2004.

• Pestova E., Wilber K., King W., Microarray-based CGH in Cancer, Methods Mol Med., Vol. 97, JE Roulston and JMS Bartlet (eds), Humana Press, pp 355-76, 2004.

• Schraml, P., Schwerdtfeger, G., Burkhalter, F., Raggi, A., Schmidt, D., Ruffalo, T., King, W., Wilber, K., Mihatsch, M. J., Moch, H., Combined array comparative genomic hybridization and tissue microarray analysis suggest PAK1 at 11q13.5-q14 as a critical oncogene target in ovarian carcinoma, Am J Pathol 163(3): 985-992, 2003.

• Van Stedum, S., and King, W., Basic FISH Techniques and Troubleshooting, Molecular Cytogenetics, Protocols and Applications, Methods in Molecular Biology Series Vol. 204, Y-S Fan (ed), Humana Press, pp 51-63, 2002.

• Yakes, F.M., Chinratanalab, W., King, W., Seelig, S., and Arteaga, C.L., Herceptin Induced-Inhibition of Phosphatidylinositol-3 Kinase and Akt Is Required for Antibody-mediated Effects on p27, Cyclin D1, and Antitumor Action, Cancer Res. 62(14):4132-4141, 2002.

• Halling, K.C., King, W., Sokolova, Karnes, R.J., Meyer, R.G., Powell, E.L., Sebo, T.J., Cheville, J.C., Clayton, A.C., Krajnik, K.L., Ebert, T.A., Nelson, R.E., Burkhardt, H.M., Ramakumar, S., Stewart, C.S., Pankratz, V.S., Lieber, M.M., Blute, M.L., Zincke, H., Seelig, S.A., Jenkins, R.B., O’Kane, D.J., A Comparison of BTA Stat, Hemoglobin Dipstick, Telomerase and Vysis UroVysion Assays for the Detection of Urothelial Carcinoma in Urine, J. Urology 167(5):2001-2006, 2002.

• King, W., Proffitt, J., Morrison, L., Piper, J., Lane, D., and Seelig S.A., The Role of Fluorescence in Situ Hybridization Technologies in Molecular Diagnostics and Disease Management, Mol. Diag 5(4):309-319, 2000.

• Halling, K.C., King, W., Sokolova, I.A., Meyer, R.G., Burkhardt, H.M., Halling, A.C., Cheville, J.C., Sebo, T.J., Ramakumar, S., Stewart, C.S., Pankratz, S., O'Kane, D.J., Seeling, S.A., Lieber, M.M., Jenkins, R.B., A Comparison of Cytology and Fluorescence In Situ Hybridization for the Detection of Urothelial Carcinomas, J. Urology 164(5):1768-1775, 2000.

• Jacobson, K., Thompson, A., Browne, G., Shasserre, C., Seelig, S.A., and King, W., Automation of FISH Pretreatment: A Comparative Study of Different Sample Types, Mol. Diag. 5(3):209-220, 2000.

• Sokolova, I.A., Halling, K.C., Jenkins, R.B., Burkhardt, H,, Meyer R.G., Seelig, S.A., and King, W., The Development of a Multitarget,, Multicolor Fluorescence in Situ Hybridization Assay for the Detection of Urothelial Carcinoma in Urine, J. Mol. Diag. 2(3):116-123, 2000.

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PUBLICATIONS (CONTINUED) • Stefano, J.E., Genovese, L., Qi, A., Lu, L., McCarty, J., Du, Y., Stefano, K., Burg, J. L., King, W., and Lane, D.J.,

Rapid and Sensitive Detection of Chlamydia trachomatis using a ligatable binary RNA Probe and QbReplicase, Mol. Cell. Probes 11: 407-426, 1997.

• Shah JS, Liu J, Buxton D, Hendricks A, Robinson L, Radcliffe G, King W, Lane D, Olive DM, Klinger JD. Q-beta replicase-amplified assay for detection of Mycobacterium tuberculosis directly from clinical specimensJ Clin Microbiol. 33(6):1435-41, 1995.

• An Q, Buxton D, Hendricks A, Robinson L, Shah J, Lu L, Vera-Garcia M, King W, Olive DM.Comparison of amplified Q beta replicase and PCR assays for detection of Mycobacterium tuberculosis, J Clin Microbiol. 1995, Apr;33(4):860-7.

• Shah, J.S., Liu, J., Buxton, D., Stone, B. Nietupski, R., Olive, D.M., King, W., J.D. Klinger, Detection of Mycobacterium tuberculosis Directly from Spiked Human Sputum by a Q-Beta Replicase-Amplified Assay, J. Clin. Micro. 33: 322-328, 1995.

• Shah, J.S., Liu, J., Smith, J., Popoff, S., Serpe, G., and W. King, Novel, Ultra Sensitive Q-Beta Replicase Amplified Hybridization Assay for the Detection of Chlamydia trachomatis, J. Clin. Micro. 32: 2718-2724, 1994.

• King, W., Raposa, S., Warshaw, J., Johnson, A., Lane, D., Klinger, J.D., and D. Halbert, A Calorimetric Assay for the Detection of Listeria Using Nucleic Acid Probes, Food borne Listeriosis, A.J. Miller, J.L. Smith and G.A. Somkuti (eds), Elsevier, pp 117.

• King, W., Raposa, S., Warshaw, J., Johnson, A., Halbert, D., and J.D. Klinger, A New Calorimetric Nucleic Acid Hybridization Assay for Listeria in Foods, Int. J. Food Microbiol., 8:225-232, 1989.

• Sawczuck, I.S., Walsh, W., King, W., Olsson, C.A., and C. Nguyen-Huu, Enhanced Expression of Harvey-ras Oncogene in FANFT-Induced Transitional Cell Carcinoma, Urol. Int., 42:321-325, 1987.

• Rubin, M., King, W., Toth, L.E., Sawczuck, I.S., Levine, M.S., D'Eustachio, P., and C. Nguyen-Huu, Murine Hox-1.7 Homeo-box Gene: Cloning, Chromosomal Location and Expression, Mol. Cell. Biol., 7: 3836-3841, 1987.

• Lobel, L., Patel, M., King, W., Nguyen-Huu, and S. Goff., Construction and Recovery of Viable Retroviral Genomes Carrying a Bacterial Suppresser tRNA Gene, Science, 228:329-331, 1985.

• King, W., Patel, M., Lobel, L., Goff, S., and C. Nguyen-Huu, Insertion Mutagenesis of Embryonal Carcinoma Cells by Retroviruses, Science, 228:554-558, 1985.

• Kieff, E., Dambaugh, T., King, W., Heller, M., Cheung, A., van Santen, V., Hummel, M., Beisel, C., and S. Fennewald, Biochemistry of Epstein-Barr Virus, The Herpesviruses, Vol. 1, B. Roizman (ed) Plenum Press, N.Y., pp 105-141, 1982.

• King, W., Dambaugh, T., Heller, M., Dowling, J., and E. Kieff, Epstein-Barr Virus DNA XII, A Variable Region of Epstein-Barr Virus Genome is Included in the P3HR-1 Deletion, J. Virol., 43: 979-986, 1982.

• Kieff, E., Dambaugh, T., Heller, M., King, W., Cheung, A., van Santen, V., Hummel, M., Beisel, C., Fennewald, S., Hennessy, K., and T. Heineman, Biology and Chemistry of Epstein-Barr Virus, J. of Infect. Disease, 146: 506-517, 1982.

• King, W., van Santen, V., and E. Kieff, Epstein-Barr Virus RNA VI: Viral RNA in Restringently and Abortively Infected Raji Cells, J. Virol., 38: 649-660, 1981.

• Dambaugh, T., Beisel, C., Hummel, M., King, W., Fennewald, S., Cheung, A., Heller, M., Raab-Traub, N., and E. Kieff, Epstein-Barr Virus B95-8 DNA VII: Molecular Cloning and Detailed Mapping, Proc. Nat. Acad. Sci., 77: 2999-3003, 1980.

• King, W., Powell, A., Raab-Traub, N., Hawke, M., and E. Kieff, Epstein-Barr Virus RNA V: Viral RNA in a Stringently Infected, Growth Transformed Cell Line, J. Virol. 36: 506-518, 1980.

• Dambaugh, T., Raab-Traub, Heller, M., Beisel, C., Hummel, M., Cheung, A., Fennewald, S., King, W., and E. Kieff, Variations Among Isolates of Epstein-Barr Virus, Annals New York Acad. Sci., 602: 711-719, 1980.

• Dambaugh, T., Heller, M., Raab-Traub, King, W., Cheung, A., Beisel, C., Hummel, M., van Santen, V., Fennewald, S., and E. Kieff, DNAs of Epstein-Barr Virus and Herpes Virus Papio, The Human Herpes Viruses, A. Nahmias (ed), Elsevier, pp 85-90, 1980.

• Kieff, E., Dambaugh, T., Heller, M., King, W., van Santen, V., and A. Cheung, Structure and Function of the Epstein-Barr Virus Genome: A Brief Overview, The Proceedings XIII Symposium on Nasopharyngeal Cancer, Dusseldorf, West Germany, pp 347-376, 1980.

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PUBLICATIONS (CONTINUED) • Powell, A., King, W., and E. Kieff, Epstein-Barr Virus Specific RNA III: Mapping of the DNA Encoding Viral

Specific RNA in Restringently Infected Cells, J. Virol. 39: 261-274 1979. • Kieff, E., Given, D., Raab-Traub, N., Powell, A., King, W. and T. Dambaugh, Nucleic Acid of EBV, Biochem.

Biophys. Acta, 560: 355-373, 1979. • Kieff, E., Raab-Traub, N., Given, D., King, W., Powell A., Pritchett, R., and T. Dambaugh, Mapping of Putative

Transforming Sequences of EBV DNA, Oncogensis and Herpes Viruses, F Rapp and G. de The (eds), I.A.R.C., Lyon, 1978.

• Hayward, D., Pritchett, R., Orellana, T., King, W. and E. Kieff, The DNA of Epstein-Barr Virus Fragments Produced by Restriction Enzymes: Homologous DNA and RNA in Lymphoblastoid Cells. ICN-UCLA Symposia on Molecular and Cellular Biology, Vol. 4 Animal Viruses, D. Baltimore, A. Huang and C.F. Fox (eds), Academic Press, N.Y., pp 619-640, 1976.