Chief Science Officer, Aegis Analytical: On-demand data access integrated with Process Dev & Manufacturing Analytics
Greater Denver Area
- Current
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- Executive Vice President & Chief Science Officer at Aegis Analytical Corporation
- Past
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- Director, Process Development (Somatogen) at Baxter Hemoglobin Therapeutics
- Director, Fermentation R&D (Cetus) at Chiron
- Principal Scientist, Fermentation Development (Genetics Institute) at Wyeth Biosciences
- Education
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- The Aji Network
- University of Illinois at Urbana-Champaign
- The University of Calgary
- The University of Calgary
- Connections
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463
connections
- Industry
- Biotechnology
- Websites
Justin Neway’s Summary
Over 25 years experience in pharmaceutical and biotechnology process development and manufacturing, and in the application of software solutions to process improvement and quality compliance.
This experience is applied at Aegis Analytical Corporation, maker of Discoverant which provides end users with on-demand data access to data in multiple disparate databases and paper records, integrated with collaborative cause-and-effect analytics and reporting using all the process development and manufacturing data types together - discrete, continuous (on-line), replicate, event and text data. Discoverant is the only fully integrated software system that enables end users to understand and reduce the sources of process variability, improve process yield and quality, to accelerate products from process development to market, and improve manufacturing process predictability.
For 15 years prior to founding Aegis in 1997, was at Wyeth Biosciences (Genetics Institute), Novartis Chiron (Cetus), and Baxter Hemoglobin Therapeutics (Somatogen), with increasingly responsible positions including Technical Manager, Principal Scientist, Project Leader for the CMC section of the IL-2 BLA, Department Director, and Director of Process Sciences.
Along the way, saw the practical difficulties of accessing process dev and mfg data "on-demand" from disparate databases and paper records, and the paybacks achievable from accessing data in real-time for investigational analysis to understand and control the sources of process variability and to prepare and support CMC filings and similar submissions for the FDA and other regulatory bodies.
Published refereed papers in scientific journals as well as other papers, editorials, op-ed pieces and interviews in trade publications. Also enjoyed many opportunities to present technical papers and chair technical conferences in the fields of pharma & biotech process development & manufacturing, quality compliance and data analysis.
Justin Neway’s Specialties:
Strategic planning, several scientific and technical disciplines, and management of multi-disciplinary pharmaceutical and biotechnology manufacturing and process development teams involving operational and regulatory components. Translating complex technical concepts into understandable language, making public presentations to technical and non-technical audiences, working with analysts and the media, and raising investment capital to start a company in a highly technical field.
Justin Neway’s Experience
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Executive Vice President & Chief Science Officer
Aegis Analytical Corporation
(Privately Held; Computer Software industry)
February 1997 — Present (12 years 10 months)
Founder of the company. Responsible for the initial product concepts and requirements for Aegis’ Discoverant software system, along with securing seed and venture funding, as well as first product sales, industry partnerships, staffing, management, customers, scientific advisors, product names, trademarks and patents. Other roles at Aegis are as the primary conduit for information flow between the FDA, Aegis and the industry to guide the company’s product vision and market strategy for Discoverant; to bring Aegis and its offerings to the attention of industry colleagues and decision-makers, professional groups, industry organizations and regulatory bodies; and to move Aegis’ offerings into new markets and territories.
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Director, Process Development (Somatogen)
Baxter Hemoglobin Therapeutics
(Public Company; 201-500 employees; Biotechnology industry)
July 1990 — February 1997 (6 years 8 months)
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Director, Fermentation R&D (Cetus)
Chiron
(Public Company; 501-1000 employees; Biotechnology industry)
November 1986 — July 1990 (3 years 9 months)
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Principal Scientist, Fermentation Development (Genetics Institute)
Wyeth Biosciences
(Public Company; 201-500 employees; Biotechnology industry)
December 1982 — November 1986 (4 years )
Justin Neway’s Education
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The Aji Network
BPC , Business Professionals Course , 1995 — 1997
The Business Professional's Course (BPC) is a two-year business course recognized by GE's Executive Management training program as the equivalent of an Executive MBA degree. The BPC offers participants the opportunity to increase their autonomy and capacity to fulfill uncommon ambitions requiring both uncommon knowledge and uncommon sense. This enables them to design practices and offers that produce income, net worth and business enterprise value in the top 10% of the marketplace.
- Activities and Societies:
- Participated in the LEIP program for one year after graduating from BPC.
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University of Illinois at Urbana-Champaign
Ph.D. , Biochemistry , 1979 — 1982
Thesis Supervisor: Robert L. Switzer, Ph.D.
Thesis title: Bacillus subtilis Ornithine Transcarbamylase.
Thesis research: The physiological role of Ornithine Transcarbamylase and its inactivation by proteolysis during sporulation in Bacillus subtilis were studied using fermentation, protein purification, enzymological, and immunochemical techniques. -
The University of Calgary
M.Sc. , Biochemistry , 1975 — 1977
Thesis Supervisor: C. Maurice Gaucher, Ph.D.
Thesis title: Termination of Patulin Biosynthesis: A Study of the Intrinsic limitations on Continued Antibiotic Production.
Thesis research: The metabolic and physiological reasons for the termination of polyketide antibiotic biosynthesis in Penicillium urticae¬ were studied using fermentation and enzymological techniques. -
The University of Calgary
B.Sc. , Microbiology , 1971 — 1975
Additional Information
Justin Neway’s Websites:
Justin Neway’s Interests:
Gourmet cooking, music composition and production, scuba diving and other outdoor and aerobic activities. Traveled in many countries throughout the world on business and recreationaly, including the United Kingdom, Western and Eastern Europe, Scandinavia, Russia, Ukraine, the Middle East, Africa, North America, Central America, South America, Australia, New Zealand, Pacific Islands, South East Asia, India, Japan and China.
Justin Neway’s Groups:
International Society of Pharmaceutical Engineers
American Chemical Society
Society for Industrial Microbiology
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Aji Collegians -
Pharmaceutical Discussion Group -
ISPE -
Biotech & Pharma Professionals Network -
Quality-by-Design
Justin Neway’s Honors:
Sigma Xi Student Research Prize, 1977
Province of Alberta Graduate Scholarship, 1975
Justin Neway’s Contact Settings
Interested In:
- new ventures
- job inquiries
- expertise requests
- business deals
- reference requests
- getting back in touch
