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Justin Neway

Justin has over 35 post-Ph.D. years of experience in biotechnology and pharmaceutical process development, manufacturing, and quality, and in development, application, marketing, and sales of software solutions to address operational issues and quality compliance in the global biotechnology and pharmaceutical industry.  He has held several executive and management roles with responsibility for large and small teams in research and development labs and production plants, and in software product management, product development, and product marketing and sales.  During the span of his career, he has participated as Principal Scientist in two IPO’s (Genetics Institute in 1986, and Somatogen in 1991), and as Founder in the transaction that resulted in the sale of Aegis Analytical Corporation to Accelrys in 2012 and its subsequent integration into Dassault Système’s BIOVIA brand.

As founder of Aegis Analytical Corporation in 1997, Justin was responsible for conceiving the initial product concept and requirements for the Discoverant software system, and had the leading role in securing $25 million of venture funding, as well as the first product sales, industry partnerships, staffing, management, customers, scientific advisers, product suite names, trademarks and patents. His other roles at Aegis were as the primary conduit for information flow between the FDA, Aegis and the industry to guide the company’s product vision and market strategy; initiating lead development to opportunity stage and supporting sales efforts for closing $75 million of total business with Pharmaceutical and Biotechnology companies; making presentations to bring Aegis and its offerings to the attention of decision-makers and influencers in prospective customer companies, professional groups, industry organizations, and regulatory bodies; and supporting the penetration of Aegis’ offerings into new markets and territories. Aegis was acquired by Accelrys, Inc. in October of 2012 for $30M, and Accelrys was then acquired by Dassault Systèmes for $750M to become the BIOVIA brand in April of 2014.

6 Sessions POC
12 Sessions POC

Industry:
Biotechnology
FDA Compliance
Manufacturing
Pharmaceuticals (also see Cosmetics)
Research & Development
Software
Startup Businesses
Technology (incl Biotechnology & Nanotechnology
Writing & Editing

Education: Graduate of the Business Professionals Course (BPC), 1997. The Aji Network, Ph.D. Biochemistry, 1982. University of Illinois, Urbana, Illinois M.Sc. Biochemistry, 1977. University of Calgary, Alberta, Canada B.Sc. Microbiology (Honors), 1975. University of Calgary, Alberta, Canada

Languages: English and some Afrikaans

Achievements:
REFEREED JOURNAL ARTICLES: 1) Vermylen, V., J-E Fortier, E. Rulier, A. Bernard, C. Jone, and J.O. Neway. 2017. Finding Relationships Between Clinical Batch Quality Data and Patient Outcomes. Pharm. Eng. September-October: 60-66 2) Shashilov, V and J.O. Neway. 2012. Traditional Lot Traceability Approaches are Not Sufficient to Enable Upstream/Downstream Correlation Analysis for QbD. Pharmaceutical Engineering. 32(5): 52-62 3) Blackmore, R.S., J.S. Blome, and J.O. Neway. 1996. A complete computer monitoring and control system using commercially availaibe, configurable software for laboratory and pilot plant Escherichia coli fermentations. J. Ind. Microbiol. 16:383-389. 4) Looker, D., A.J. Mathews, J.O. Neway, and G.L. Stetler. 1994. Expression of Recombinant Human Hemoglobin in Escherichis coli. Meth. Enzymol. 231:364-374. 5) Bauer, K.A., A. Ben Bassat, M. Dawson, V.T. de la Puente, and J.O. Neway. 1990. Improved expression of human Interleukin 2 in high-cell-density fermentor cultures of Escherichia coli K 12 by a phosphotransacetylase mutant. Appl. Environ. Microbiol. 56:1296-1302. 6) MacDonald, H.L., and J.O. Neway. 1990. Effects of medium quality on the expression of human Interleukin 2 at high cell density in fermentor cultures of Escherichia coli. Appl. Environ. Microbiol. 56:640-645. 7) Lam, K.S., J.O. Neway, and G.M. Gaucher. 1988. In vitro stabilization of 6 methylsalicylic acid synthetase from Penicillium urticae. Can. J. Microbiol. 34:30 37. 8) Neway, J.O., and R.L. Switzer. 1983. Degradation of ornithine transcarbamylase in sporulating Bacillus subtilis cells. J. Bacteriol. 155:522 530. 9) Neway, J.O., and R.L. Switzer. 1983. Purification, characterization, and physiological function of Bacillus subtilis ornithine transcarbamylase. J. Bacteriol. 155:512 521. 10) Gaucher, G.M., K.S. Lam, J.W.D. GrootWassink, J.O. Neway, and Y.M. Deo. 1981. The initiation and longevity of patulin biosynthesis. Dev. Ind. Microbiol. 22:219 232. 11) Neway, J.O., and G.M. Gaucher. 1981. Intrinsic limitations on the continued production of the antibiotic patulin by Penicillium urticae. Can. J. Microbiol. 27:206 215. BOOKS: 1) Neway, J.O., (Ed). 1989. Fermentation Process Development of Industrial Organisms. 324 pages. Marcel Dekker Inc. New York. Six Chapters: Actinomycetes by J. P. DeWitt, J. V. Jackson and T. J. Paulus (Abbott Labs, USA), Fermentation of Bacilli by F. G. Priest (Heriot-Watt University, Edinburgh) and R. J. Sharp (Center for Applied Microbiology and Research, Porton Down), Coryneform Bacteria by I. Shiio and S. Nakamori (Ajinomoto Co., Japan), Bioprocess Technology in Industrial Fungi by R. P. Elander (Bristol-Myers Co., USA), Using Mammalian Cells to Produce Products by C. L. Propst (Affiliated Scientific, USA), R. J. von Wedel (Cytoculture International, USA) and A. S. Lubiniecki (Genentech, USA), and Growth of Yeasts by D. R. Berry (University of Strathclyde, Scotland). ISSUED PATENTS: 1) Ruth, J. D., Dorr, S. A., Junak, J. A., Libouban, O., and Neway, J. O. System, Method and Computer Program for Mapping a Hierarchical Display of Process Data of Multi-database Origins. 354018[6,741,998]. 5-25-2004. USA. 1-30-2001. 2) Ruth, J. D., Dorr, S. A., Galemmo, N., Junak, J. A., Libouban, O., and Neway, J. O. System, Method and Computer Program for Assembling Process Data of Multi-database Origins Using a Hierarchical Display. 816547[6,725,230]. 4-20-2004. USA. 3-26-2001. 3) Neway, J. O., Durfee, S. L., and Jahn, G. L. System for Analyzing and Improving Pharmaceutical and Other Capital-intensive Manufacturing Processes. 392928[6,243,615]. 6-5-2001. USA. 9-9-1999. 4) Plomer, J. J., Ryland, J. R., Matthews, M-A. H., Traylor, D. W., Milne, E. E., Durfee, S. L., Mathews, A. J., and Neway, J. O. Purification of Hemoglobin. 438511[5,840,851]. 1998. USA. 5-10-1995.

LinkedIN Profile: https://www.linkedin.com/in/justinneway/

Experience:
Experience Description: Applied Materials, Santa Clara, California - 11/17 to present - Senior Fellow, Technical Advisory Board Dassault Systèmes BIOVIA, Broomfield, Colorado – 10/12 to 2/17 - BIOVIA Vice President and Managing Director, Process Production Operations - Senior Fellow, BIOVIA Science Council Aegis Analytical Corporation, Lafayette, Colorado - 2/97 to 10/12 - Founder, Vice President, Chief Science Officer and Corporate Secretary Baxter Biosciences (aka Somatogen), Boulder, Colorado - 7/90 to 3/97 - Director, Fermentation R&D (11/94 to 2/97) - Director, Process Sciences (4/92 to 11/94) - Director, Process Development (4/91 to 4/92) - Director, Fermentation (7/90 to 4/91) Novartis Vaccines (aka Cetus), Emeryville, California - 11/86 to 7/90 - Director, Fermentation R&D Pfizer BioTherapeutics (aka Genetics Institute), Cambridge, Massachusetts - 12/82 to 11/86 - Principal Scientist, Fermentation Development UNIVERSITY OF ILLINOIS, Urbana, Illinois - 5/79 to 12/82 - Research Biochemist UNIVERSITY OF WESTERN ONTARIO, Ontario, Canada - 9/78 to 5/79 - Senior Demonstrator, Chemistry Department

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If you’re looking for uncommon success in your career as a technical executive, manager or entrepreneur, Justin can help you navigate more effectively based on his many years of experience leading and managing multi-disciplinary teams in pharmaceuticals and biotechnology.  You will benefit from his proven abilities as a scientist, entrepreneur and founder of a successful technical software company for which he provided leadership, creativity, innovation, and venture funding for his team developing, testing, marketing, selling and supporting technical software systems.  Justin also draws from his first-hand experience of the human and technical sides of the change management needed when a small company is acquired and integrated into a much larger corporation.  He knows how to translate complex technical concepts into understandable language, how to make effective presentations to a wide range of large and small technical and non-technical audiences, and how to work effectively with industry analysts and the media.

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