|
|
 |
 |
For more than a decade, Aegis Analytical has provided products and services that address the quality, compliance, supply chain predictability and cost of goods issues that confront life science manufacturers.
In recent years, drug manufacturers have faced increased scrutiny from the FDA, and a rising number of drug recalls has suggested quality concerns. The FDA has increased its pressure on the pharmaceutical and biotechnology industry to become more innovative in manufacturing through use of Process Analytical Technologies (PAT) that greatly increase the need for data collection, data access and data analysis systems.
Results of a new study, based in part on FDA data, suggest that pharmaceutical manufacturers could be wasting more than $50 billion a year1 because of inefficiencies. Savings from more efficient manufacturing processes are increasingly seen as essential to achieving target profit margins.
Understanding the sources of process variability is required to achieve these goals, and Aegis enables manufacturers to identify and control exactly what is driving the success or failure of their processes by providing a [real time], comprehensive, user-centric view of [each manufacturing process].
Today, leading life sciences manufacturers such as Baxter, Berlex, Biogen Idec, Bristol-Myers Squibb, Cephalon, Eli Lilly, Genentech, Genzyme, Talecris and Wyeth are using Aegis' Discoverant to improve operational efficiency and quality compliance.
Industry Accolades
According to IDC's “Life Sciences Insights,” data integration is the key to improving pharmaceutical and biotechnology companies' operations. AMR Research analysts have categorized Aegis' Discoverant as an essential tool for process understanding. Silicon Valley Bank/Alliant in its April 2006 report, “The Business Intelligence Landscape,” found that Aegis' software makes unstructured data more useful and valuable for life science manufacturers.
1Jeffrey Macher and Jackson Nickerson. October 2006. Benchmarking Report on Pharmaceutical Manufacturing.
Aegis' technology platform, application set and implementation & support services provide a collaborative root cause analysis and decision-making environment integrated with on-demand data access that spans multiple, disparate data sources and geographic locations to achieve manufacturing efficiency and compliance in data-intensive areas. Discoverant provides users with interactive access to all types of process development and manufacturing data in existing electronic data collection systems and on paper records, integrated with powerful analysis, trending and reporting capabilities to reduce process variability, improve yields and reduce batch failures. Aegis' products are currently focused on the biotechnology and pharmaceutical industries, but can be easily applied to other data-intensive manufacturing environments.
Discoverant specifically enables manufacturers to:
- Maintain process control and identify the root causes of atypical performance quickly and easily to ensure continuous compliance with governing regulations.
- Speed time to value by shortening the technology transfer time and effort involved in the start-up of new product manufacturing.
- Disposition batches quickly. Discoverant provides on-demand access to data from all manufacturing systems (raw materials, in-process and final product), and provides integrated analysis and reporting capabilities, assisting with compliance requirements.
- Set and defend specifications that strike the right balance between business pragmatism and governing regulations.
- Document process control and reverse adverse trends quickly to minimize process problems and failures.
- Streamline FDA reporting and prepare Annual Product Reviews (APRs) in hours instead of weeks .
Executive Team
|
 |
Robert
M. Di Scipio, President and CEO, has 25 years
experience in business development, sales management,
corporate law, and finance, including executive positions
with biotechnology, software and technology companies.
Prior to joining Aegis, Mr. Di Scipio served as Vice
President, Business Development and Associate General
Counsel, and was a member of the Executive Committee,
at Martek Biosciences Corporation (MATK:NASDAQ). He
was Vice President, Corporate Development and General
Counsel and Secretary for OmegaTech, where as a member
of the Executive Committee, he managed legal affairs,
Asia/Pacific sales, the Gold Circle Farms consumer
brand, intellectual property strategy and licensing,
and negotiated the company's sale to Martek. Earlier
in his career, Mr. Di Scipio was in the private practice
of law and worked as a tax attorney with Coopers &
Lybrand. He currently sits on the Board of Directors
of ePals, Inc. (which licenses its safe email technology
and digital literacy curriculum to the K-12 education
market), the advisory board of the First Community
Bank subsidiary of First National Bancorporation (FSNM:NASDAQ)
and the Board of the Deming Center for Entrepreneurship
at the University of Colorado Leeds School of Business.
Mr. Di Scipio is also the founder of Skyland Capital
LLC, a venture capital firm. He received his B.A.
from the University of Michigan and a J.D. from Pace
University. He is a member of the bars of New York
and Connecticut.
Back to top
|
|
 |
Justin
O. Neway, Ph.D., Founder, Executive Vice President
and Chief Science Officer, has 25 years experience
in pharmaceutical and biotechnology process development
and manufacturing, and in the application of software
solutions to quality compliance and operational issues
in pharmaceutical and biotherapeutic manufacturing.
During the 15 years prior to founding Aegis in 1996,
Dr. Neway was with Wyeth Biosciences, Chiron Corporation
and Baxter Hemoglobin Therapeutics, where he held
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. During this time,
Dr. Neway became intimately familiar with the practical
difficulties of accessing process development and
manufacturing data from separate databases and on
paper records, and the significant paybacks achievable
from connecting to that data in real time for investigational
analysis. Dr. Neway received his B.Sc. (Microbiology,
1975) and M.Sc. (Biochemistry, 1977) from the University
of Calgary ( Canada ) and his Ph.D. in Biochemistry
from the University of Illinois ( USA ) in 1982. He
has published refereed papers in scientific journals
as well as other papers, editorials, op-ed pieces
and interviews in trade publications. He has also
presented technical papers and chaired technical conferences
in the field of pharmaceutical manufacturing, quality
compliance and data analysis. Justin's
LinkedIn Profile
Back to top
|
|
 |
Geri L. Studebaker, Executive Vice President, Sales and Marketing , has over 14 years of experience in software marketing and applications. Prior to joining Aegis, Ms. Studebaker was Sr. Director of Worldwide Marketing for Webb Interactive, an e-business software provider for the small to medium-size business. Prior to Webb, Ms. Studebaker held several positions within JD Edwards, the most recent being Sr. Marketing Manager. As project lead for Knowledge Management, Ms. Studebaker developed and managed the entire product lifecycle, from initial product concept and proposal through development efforts, product positioning and global rollout. Ms. Studebaker holds a BS in Corporate Finance from the University of California, San Diego , and an MBA and MS in Marketing from the University of Colorado.
Back to top
|
|
 |
Julian Gallow, Business
Development
Throughout his distinguished career, Mr.
Gallow has spent over 15 years leading, building and
growing organizations. During this time, he has developed
deep expertise in an array of industries including
enterprise software, specialized hardware, finance
and manufacturing. Prior to joining Aegis, Mr. Gallow
served in executive leadership positions at various
companies serving customers such as Reuters, HP/Compaq,
Bristol-Myers Squibb, DaimlerChrysler, Siemens, Tyco,
GE and Dell, as well as various military and other
local and national government bodies. Mr. Gallow has
lived and worked on three continents, including 15
years in Europe. He holds an MS in Management from
Stanford Business School.
Back to top
|
|
 |
Joe Rothman , Vice President of Professional Services. Mr. Rothman has three decades of experience in the computer industry, including product design and development, product management, sales and sales management, project and program management, technology consulting and management consulting. Mr. Rothman worked at Digital Equipment Corporation for 18 years in a number of roles, including development of Digital's management consulting practice. Over the past decade, Mr. Rothman has provided consulting services to FDA regulated companies in the Medical Device and Life Sciences sectors. His work included assisting pharmaceutical manufacturers such as Amgen, Wyeth and Shire with software search and selection for manufacturing data analysis solutions, multi-site implementations of MES systems, development of Knowledge Management strategies, and development of governance capabilities for distributed applications. Mr. Rothman holds BS degrees in Chemistry and Management from M.I.T., and a Masters degree in Management from the Sloan School of Management at M.I.T. He is a member of the adjunct faculty of the University of Denver.
Back to top
|
|
 |
Kevin Hocum , Chief
Financial Officer
Mr. Hocum has over 25 years experience in
Senior Management and Accounting positions in the
construction and manufacturing industries. Previously,
he was the CFO and a director of The Electron Corporation.
He currently serves as a director for two international
real estate and golf course development corporations.
He received a Bachelors degree in Accounting &
Finance from Metropolitan State College in Denver
.
Back to top
|
Board of Directors
|
|
Robert M. Di Scipio,
President, CEO and Chairman of the Board
(See bio above) |
|
Christian
Leikert.
Mr. Leikert is the CEO of Future Capital AG which
is based in Frankfurt. Future Capital AG invests in
companies engaged in the life sciences, chemistry
and information technology. The fund was founded in
March 1999 at the initiative of the Hessen State Government
and Hoechst AG (now Sanofi- Aventis Group) and acts
as an independent venture. Christian serves on the
board of Genomatix Software GmbH, IEP GmbH and Preventor
GmbH. Mr. Leikert received his MBA from Ludwig Maximilians
University in Munich.
Back to top
|
|
|
Wendy
Lea
Wendy Lea has been in the customer relationship
management (CRM) space since 1984 and she has co-authored
two innovative sales methodologies, CHAMP (channel
and alliance management process) and TMP (territory
management and planning), which were widely adopted
as global standards by IBM, Hewlett Packard, Microsoft
and Oracle.
She is currently managing partner
of Chatham Group, an independent consultancy focused
on go-to-market strategies for early/mid-stage startups.
Previously, she led Siebel Systems' eBusiness Consulting
division, joining them in 1999 as a result of its
acquisition of OnTarget, Inc., where she held the
position of vice president of marketing and alliances.
Wendy is chairman of the board
for Newmerix, a provider of enterprise application
lifecycle management software; and is a board member
for Stratify, Metallect and The Forum of Women Entrepreneurs
& Executives. She also sits on the advisory board
of StillSecure and Amazon Consulting. Ms. Lea is also
an active partner for SV2, Silicon Valley Social Venture
Fund, and an advisor for TechStars, a startup fund/incubator
founded by a group of Colorado-based entrepreneurs.
Wendy is a graduate of the
University of Mississippi and lives in Menlo Park,
California.
Back to top
|
|
| |
|
|
 |
 |
