e-SubmissionsSolutions.com (a California corporation) was founded by Antoinette Azevedo in 2000 to advise all sizes of biotechnology and pharmaceutical companies on the use of technology to manage regulatory documents and publish electronic submissions. Azevedo’s clients range from large, international pharmaceutical companies to small, virtual biotechnology companies—all attempting to be better prepared to manage controlled documents and produce electronic INDs and drug/biologic registrations.

Azevedo was director of West Coast Operations for Liquent from 1997 to 2000. Ms. Azevedo was principal consultant in the CSC Consulting life sciences practice as technical lead for regulatory submission publishing from 1994 to 1997, working with pharmaceutical clients in North American and Western Europe. Her entire career has been devoted to document management and electronic publishing through a several generations of technologies and architectures, in various industries. She dedicated her focus to life sciences beginning in 1994. She is experienced with a number of document management systems, publishing systems and toolsets, and a wide array of options for successfully producing electronic submissions. Her experience ranges from developing strategies for document management and electronic publishing, to implementation of fully-validated systems, and production of paper and electronic submissions accepted for review by regulatory authorities worldwide.

Nicky Bleiel is a Senior Information Developer at ComponentOne. She has been a technical communicator for more than twelve years. Nicky started her career writing books and producing them in hardcopy format, but she has since embraced online help and user assistance, web design, single-sourcing, usability, e-learning, and knowledge management. She has experience writing for products in a variety of industries; including media sales, industrial automation, simulation, and pharmacy.

Nicky has given talks at the Society for Technical Communication (STC) international, local, and regional levels, and has been pleased to share her experience with other STC leaders on Leadership Day at the annual conference. She has presented at WritersUA, LavaCon, and local meetings as well. Topics have included various tools and technologies, user assistance design, single sourcing, and wikis for knowledge management.

Nicky is currently an At-Large Director of STC. Before that, she was on the Board of the Pittsburgh Chapter of STC. During her term as President, the chapter was recognized as a chapter of excellence; during her vice presidency, as a chapter of distinction. She was on the planning committee of the Region 4 Conference “Writers Without Borders: Trends in Technical Communication” held April 2004 in Pittsburgh. She also served as membership chair and was involved with program planning for four years.

She earned a B.A. in Journalism from the Pennsylvania State University. Her Society honors include an Award of Merit for online communication from the Pittsburgh chapter.

As Vice President of Life Sciences and Strategic Initiatives at In.vision Research Corporation, Richard works directly with leading pharmaceutical companies and key life sciences consultants to create regulatory solutions that meet next generation FDA submission requirements. He is an active participant in FDA meetings concerning labeling and other XML requirements, and has served on the technical committees for Structured Product Labeling.

Richard received Bachelor’s and Master’s degrees from Loyola and brings 25 years of experience in business process analysis and system design to his XML sessions and workshops.

Berry Braster is the Director of Tedopres’ North American operations, which is based in Austin, Texas. Tedopres provides translation and technical documentation services to the industry, and is headquartered in the Netherlands. Berry, fluent in 4 languages, holds a BA in International Marketing Management from the University of Amsterdam and has a background in international business and marketing. Before joining Tedopres, Berry was the Marketing Director for an organization specialized in quality assurance and regulatory affairs in Washington, DC. He has been with Tedopres for 6 years, during which he has been involved with the implementation of controlled language with companies in various industries.

Don Bridges manages Life Sciences documentation projects at Data Conversion Laboratory (DCL). He leads DCL’s efforts with both mandated projects (like Structured Product Labeling—DCL has worked with over 125 sponsors and converted over 1500 PIs) and non-mandated projects (like Standard Response Packages, Core Data Sheets, and Technical Documentation for medical equipment). Bridges is a frequent conference speaker and has written several articles on the business aspects of XML implementations. He is a engineering graduate of LSU and calls Albuqerque, NM home.

Tina Wuelfing Cargile, a certified project management professional, is Business Development Manager/Life Sciences Division for McElroy Translation, where she has been employed since 1988. She earlier held the position of Senior Project Manager. She earned her Project Management Professional credential in 2003. Her previous work experience was in publishing and music industries.

Don DePalma is an industry analyst, author, and corporate strategist with expertise in business- and marketing-focused application of technology. He lectures, writes, and is frequently quoted on the topics of online marketing, content management, multicultural marketing, localization, return on investment, and website globalization. His book, Business Without Borders: A Strategic Guide to Global Marketing, is widely used in universities and in business training courses.

Since 2002, he has led research into the best practices, technology, and professional services that support business globalization for Common Sense Advisory.

Jeannette Eichholz works with GE Healthcare in providing transformational medical technologies and services that are shaping a new age of patient care. As Lead Content Management Integrator in Ultrasound, she brings over 30 years experience as a writer and consultant in the fields of medical imaging, manufacturing and information technologies. Jeannette has a Master’s degree in English, with undergraduate degrees in French and German.

David Giordano, founder and President of Technology Services Group (TSG), has over 20 years experience in consulting and systems integration. David started his career in 1986 at Arthur Andersen (now Accenture). An early adopter of image processing technology, David progressed within Andersen to eventually coordinate different image processing projects and software firm relationships. He left Accenture to start Technology Services Group (TSG) in 1996.  Since it’s founding, TSG has focused on the implementation of content management tools combined with Web Technologies for clients in a wide range of industries including many large pharmaceutical companies. TSG is a premier partner with EMC/Documentum and is responsible for coordinating the Midwest Documentum User Group. TSG is also a premier partner with Alfresco.

David has a Bachelors Degree from Northern Illinois University with degrees in Applied Data Sciences and Accountancy. David also successfully passed the CPA in May of 1986.

Joe Gollner is the Vice President e-Publishing Solutions for Stilo International, where he leads an interdisciplinary team in designing, developing and deploying content management and publishing solutions. Gollner came to Stilo through the acquisition, in 2004, of XIA Systems Corporation, a highly-regarded XML solution provider that he had founded in 1998.

Joe has been using and advocating open content standards since 1987 and has successfully implemented over 100 large-scale content management and publishing solutions. He has worked with such industry leaders as Boeing, Samsung, Nokia, Alcatel-Lucent, Xerox, the US Department of Defense, the Russian Academy of Science, Lockheed-Martin, the Canadian Government, InContext Corporation and NATO Headquarters. He was educated in a wide variety of subjects at Queen’s University (BA Literature and Mathematics) and the University of Oxford (Master’s of Philosophy). On the more practical side, he has also completed graduate programs in project management, business analysis and knowledge management.

Sebastian Heycke is a design strategist at Adaptive Path. Sebastian is passionate about collaborating and interacting with people to better understand what it takes to design things that matter. He is equally passionate about skateboarding and architecture, two things he contends that complement each other (talk to him and he’ll explain).

Sebastian’s curiosity around understanding how people tick has been a driving force in his career. Recently, Sebastian has been working in the mobile space to help people find new ways to utilize mobile devices to their full capacity.

Past clients and employers include Suzuki, Telekom, and Adaptive Path’s Charmr.

Sebastian began his education studying linguistics and philosophy at Humboldt University in Berlin until he discovered his passion for design. He holds a diploma in communication design with emphasis on interface design. His motto is that understanding what really matters takes more than a three-minute pop song.

After his doctoral work at UW-Madison, Jeff spent time with Accenture as a Learning Architect helping to direct the development of two web-based training products for the their global workforce. After Accenture, he spent time running his own consulting agency where he worked with clients of all sizes to help them understand how to institutionalize usability at their organizations. Since joining Human Factors International, Jeff has been the Executive Director for the Midwest region, working with numerous international Fortune 500 clients on a series of exciting projects for public sites, intranets, mobile devices, medical devices, and more.

Alan Houser is a distinguished consultant and trainer in the fields of XML, XML technologies, publishing workflows, and authoring and publishing tools. Houser holds an M.A. in Professional Writing and a B.S. in Electrical Engineering from Carnegie Mellon University. Houser is an Associate Fellow of the Society for Technical Communication, a member of the OASIS DITA Technical Committee, and a popular presenter at technical communication conferences.

Inna Kassatkina is co-founder and president of Global Language Solutions (GLS), a professional translation services company headquartered in Newport Beach, California. A full-service agency, GLS specializes in pharmaceutical, biomedical, and medical device translations in more than 100 languages. She provides senior level consulting in international communications to clinical study sponsors, CROs, and IRBs.

Prior to co-founding GLS in 1994, Kassatkina worked for an international firm with strong interests in Russia and offered linguistic consulting to companies doing business in Eastern Europe. She is the author of several articles on the issues of language translation; editor of GLS’ e-publication, Global Communicator; and a frequent speaker at various pharmaceutical, medical devices, and multicultural industry events.

Kassatkina attended Moscow State University and graduated magna cum laude from the University of California, Irvine with a Bachelor’s degree in linguistics. A native of Moscow, Russia, Kassatkina is fluent in several languages.

Pamela Kostur is a partner in Parallax Communications, a full-service communications consulting company in Toronto, Canada. With a focus on content and writing, Parallax specializes in content management strategies, corporate and marketing communications, technical communication and content development.

Pamela has been writing professionally for over 20 years and has extensive experience working with clients around the world in the software, technology, high tech, telecommunications, pharmaceutical, life sciences, and financial services industries. Her expertise lies in aligning content with users’ needs and business requirements. The goal is always consistently structured content, for efficient content management implementation and optimum usability.

Pamela has authored several articles and taught workshops on topics such as miscommunication, usability, content management, information architecture, content modeling, writing for reuse, and structured writing. She is also a co-author of the best-selling Managing Enterprise Content: A Unified Content Strategy (New Riders, 2002).

Like many successful technical communicators, Mark Lewis built his career on an innate ability to simplify complex subjects and discover collaborative ways to leverage his team members’ skills. He now applies that experience to his role as Usability Product Manager for In.vision Research, the leading provider of XML authoring solutions to the pharmaceutical industry. Mark believes that good software thinks like an end-user, rather than like a programmer. Despite a degree in Computer Science from Georgia Tech, Mark maintains a refreshing ability to take technical subjects, strip away the jargon, and describe them in a way that everyone can understand.

Jennifer Linton is the XML and CMS Project Manager at Gambro BCT in Lakewood, Colorado USA. Between 2003 to 2007, Jennifer was a senior consultant at Comtech Services, during which time she authored the Introduction to DITA: A User Guide to the Darwin Information Typing Architecture. She also worked with many companies implementing DITA- and XML-based authoring environment and content management solutions.

In 2006, Jennifer authored an O’Reilly short cut manual titled Beyond Schemas: Planning Your XML Model.

Currently, Jennifer supports Gambro BCT’s move to XML authoring and content management in the technical communications and training departments. She helps to identify processes and procedures, personas, CMS requirements, develop the information model, train the users, and configure the content management system.

Suzanne Mescan is responsible for the overall marketing and public relations effort at Vasont Systems. She has worked for more than 20 years in all aspects of the information management and publishing industry.

Suzanne has authored numerous articles about content management for industry publications and has delivered presentations for the Content Management Strategies conference, Philadelphia XML Users Group, Vasont Users’ Group, and in numerous industry webinars. She earned a BS in Marketing from The Pennsylvania State University.

James Michelson is a principal at JFM Concepts, an honor graduate of the George Washington University and a former Naval Officer with more than 15 years executive marketing and sales experience. Upon leaving active duty he earned a Masters degree in Business Administration from the Jacksonville University. 

James has held key sales positions for both Fortune 15 and small firms in a variety of verticals including technology, industrial, retail, and finance. His extensive experience in developing sales and marketing content for companies both with and without direct sales forces has produced explosive and profitable growth. He specializes in creating programs that improve response rates, serve variable data content, and drive sales. 

James is also an adjunct professor of business, teaching students how to create world class marketing and sales campaigns in both theoretical and practical ways.

Jerome Nadel, is Chief Experience Officer for Human Factors International (HFI). He passionately believes that user experience design and strategy are a fundamental mandate for successful organizations. Jerome’s team collaborates with industry leading clients and cutting-edge startups worldwide. He presents internationally on user-centered and user experience design.

Jerome began his career at the IBM Human Factors Lab, in Charlotte, NC. Following that he held multiple job titles at Unisys, including Program Manager and Co-manager of the Corporate Human Factors group. As Worldwide Vice President of Marketing for a multi-national technology start-up, he supported an acquisition by another international technology leader, Gemplus, where he also served as Vice President of Marketing – driving technology partnerships and promoting usability of mobile data services.

Jerome’s foundations in human factors and usability combined with international experience as a business strategist uniquely position him as a leading expert on strategic usability and user experience.

Alan Pelz-Sharpe is a Principal at CMS Watch, covering Enterprise Content Management technologies and practices. Formerly, Alan was a Strategist at Wipro and VP North America for Industry Analyst firm Ovum. An 18-year veteran of the document technology industry, Alan has written extensively on document, web and records management topics and delivered keynotes at events around the world.

Jennifer Perkins is the Technical Communications Manager at Gambro BCT in Lakewood, Colorado USA. She holds a Bachelor of Arts degree in English Literature from the State University of New York at Plattsburg, and a Master of Business Administration degree from William Woods University.

Jennifer has worked in the technical writing and localization field for 17 years as both a technical writer and a manager of technical communications departments. She began her career as a Technical Writer for Carrier Corporation in Syracuse NY, writing installation and maintenance manuals for commercial air handling systems. At Electrovert, Inc., located in Camdenton, Missouri, Jennifer worked as a Technical Publications Manager responsible for the writing and translation of installation, operation and maintenance manuals for printed circuit board wavesoldering equipment.

In 1998, Jennifer joined Gambro BCT (then COBE Laboratories) as the Technical Communications Project Manager. Currently, Jennifer manages writers and translation project managers to create and translate technical materials, including but not limited to operator’s manuals, training materials, information for use leaflets, and various regulatory materials required by the FDA and other worldwide regulatory agencies.

Neil Perlin has 29 years experience in technical communication, with 23 in training, consulting, and development for online formats and tools like WinHelp, HTML Help, CE Help, RoboHelp, Flare, ScreenCam, Captivate, Mimic, and many now known only in legend. Neil spent six years at Digital Equipment Corp., then became a partner in a documentation consulting firm in the late 1980s, before forming Hyper/Word Services in 1990.

Neil writes columns and articles on online help and documentation and is a popular speaker at IEEE PCS, STC, and other professional groups. He is Adobe Certified for RoboHelp and Captivate and Madcap Certified for Flare and Mimic. He provides training, consulting, and development for online content methodologies like structured authoring and single sourcing, related technologies like XML, and related tools like Flare, RoboHelp, Captivate, and Mimic. Neil can be reached at , http://www.hyperword.com.

Jeff Potts is the Enterprise Content Management Practice Lead at Optaros, Inc., an internet consultancy. Jeff has over 15 years of technology implementation experience in IT departments and professional services organizations. His’ areas of expertise include document management, content management, workflow, collaboration, portals, and search. Past clients include a wide array of Fortune 500 companies. Potts has written and presented for several publications and conferences. You can keep up with Potts by reading his blog.

Courtney Rand holds a bachelor’s degree in International Business from George Washington University, in Washington D.C. He continued his studies at the ESCE (International Business and Management School) and the Institut Catholique in Paris. Prior to joining A2iA in 2001, Courtney worked in various sales positions at Dragon Systems, a pioneer in continuous natural speech recognition. He was instrumental in opening Dragon’s Southern European office in Paris and was responsible for overseeing various international sales channels.

Jon Ritzdorf held a number of technical positions in the localization industry before joining Moravia Worldwide as Solutions Architect in 2006. An Adjunct Professor of localization topics at New York University and Rutgers University, Jon openly shares a decade of combined experience in translation, localization and internationalization. Jon also regularly consults and provides seminars for many of the world’s leading IT and Life Science companies on the subjects of localization best practices, internationalization, and globalization testing. Jon holds an M.A. in Chinese Translation and has basic working knowledge of Indonesian.

Ann Rockley is President of The Rockley Group, Inc, a consultancy that has an international reputation for developing customer-centric enterprise content management strategies and underlying information architecture. Rockley is a frequent contributor to trade and industry publications and a featured speaker at numerous conferences in North America and Europe.

She has been instrumental in establishing the field in online documentation, single sourcing (content reuse), unified content strategies, and content management best practices. Rockley is co-chair of the OASIS DITA Enterprise Business Documents Subcommittee. Rockley led Content Management Professionals to a prestigious eContent 100 award in 2005.

Rockley is a Fellow of the Society for Technical Communication and has a Master of Information Science from the University of Toronto. Rockley is the co-author of the best-selling book, Managing Enterprise Content: A Unified Content Strategy” (New Riders Publishing ISBN 0-7357-1306-5).

Ronald G. Shapiro, Ph.D., a Fellow in the Human Factors and Ergonomics Society (HFES) and the American Psychological Association (APA) and a Certified Human Factors Professional (CHFP), is the Manager of IBM Technical Learning, New Employee Orientation, University Tuition Payment Programs and Career Services. Ron is also on the Executive Council of HFES and has served as the chair of National Ergonomics Month, the HFES Speakers Bureau, HFES Volunteers Committee, and president of the Applied Experimental and Engineering Psychology Division of the APA. He received his B.A. from the University of Rochester and his M.A. and Ph.D. from Ohio State in Experimental Psychology. Ron developed the first version of Games in the 1970s when he taught Introduction to Psychology at Ohio State University. This conference will be his forth appearance at DocTrain.

Richard Sikes has been immersed in localization since 1989. He has held positions as Technical Director for Central Europe for Micrografx, Director of International Development for Delrina Corporation, Director of Development Services for MGI Software, and Director of Globalization for Peregrine Systems where he oversaw localization teams at three company sites and spearheaded company globalization initiatives. Richard also founded the Toronto office of GECAP, which later became part of Bowne Global Solutions.

Richard holds a BA in Fine Arts from the University of California, Diplom-Betriebswirt from the Fachhochschule Heidelberg, and an MBA from the University of Toronto. Richard’s seminars concentrate on a holistic view of the localization process as an integral part of a greater corporate globalization vision, as well as specific tactics for mission determination, process implementation and improvement, budgeting, personnel, infrastructure, career-path planning, and team motivation.

Michael Silverman, founder and chief executive officer of Duo Consulting, has over 20 years experience as an entrepreneur, executive, and innovator.

Michael began his career in 1982 when he founded PinDot Products, a manufacturer of products for people with disabilities. An early and enthusiastic adopter of new technologies, Michael championed computer-aided design and manufacturing in the development of the company’s products. Over the next decade the company secured multiple patents and won numerous awards for its unique products and processes. In 1995 Michael sold PinDot to Invacare Corporation, the leading international manufacturer of medical equipment.

Michael stayed with Invacare until 1997 when he created his first Internet business, and in 1999 founded what would become Duo Consulting. Initially Duo focused on helping entrepreneurs with the creation of new Internet-based businesses. When the market changed in early 2000 Michael successfully transformed the company into the professional consultancy it remains today.

Michael has an MBA from Northwestern University’s Kellogg Graduate School of Management, and a BA in Physiology from Southern Illinois University.

Adam Small has over 12 years experience in the Information Technology (IT) field.  He holds certifications from Cisco, Microsoft, Novell, and Citrix. His career in Information Technology began in the U.S. Marine Corps 12 years ago. After leaving the service he worked as a consultant serving many industries large and small.  From 2000-2007 Adam served as Chief Information Officer for PTS Electronics in Bloomington, IN, a company prominent in the cellular repair industry. It is this experience that led Adam to found TEXTBYREQUEST, where he helps businesses interact with their consumer through the use of text messaging.

Joe Sokohl has more than 15 years of experience in user experience-related fields. He has concentrated on crafting excellent user experiences, using information architecture, interaction design, writing, and user research. At Keane, Joe acts as an advocate for user experience consulting: Information architecture, user research, interaction design, and usability evaluation along with visual design and web design. He manages the careers and education of 35 mostly offshore IAs, visual designers, technical writers, and web developers. Mentoring them in competency skills along with general business consulting practices combines with evangelizing best practices in UX among both internal and external clients.

Previously Joe held UX-oriented positions in Hamburg, Germany; Richmond, VA; Chicago, IL; and Durham, NC. He’s also been a soldier, a cook, a radio DJ, a road manager, a teacher, and a reporter once upon a time.

Angela Starkmann is an independent project manager, translator, and trainer with particular interest in life science. She has worked as linguist and project manager on the customer side (Medtronic) as well as on the service provider side. Together with Angelika Zerfass, she developed the concept of minimal translation management (http://www.m11m.de), a basic translation management workshop for translation customers who have to deal with translation as a side job and sometimes feel overwhelmed by their task.

Angela lives with her family on the country side in Bavaria, and loves the combination of quiet village life and work in the international fast-paced localization industry.

Recovering Pubs director and thirty-year enterprise publishing veteran, experienced in all aspects of information development and delivery, with a strong focus on process, technology, and quality. Early implementer and supporter of structured writing, content management, single sourcing, multi-use/multipurposing, machine translation, and computer assisted information delivery and learning systems. And always seeking the Holy Grail: cost, quality, and timeliness - all at the same time! In multiple languages and multiple media.

It’s been a long, often frustrating journey. I even left the field for a while when the technology and management focus shifted almost exclusively to cost and speed – to the detriment of quality. But times are changing. Decades of research and development in Natural Language Processing and Automated Linguistic Analysis have come to fruition, resulting in Information Quality Management tools and processes that actually work in the real world of enterprise information development. And, I’m back in the hunt.

Andrew Thomas is the Global Information Management Evangelist with SDL Enterprise Technologies. GIM helps corporations driveglobalrevenue and reduce cost by using software and services to deliver global content. Mr. Thomas has worked in the localization industry for more than a decade, managing the translations of a wide variety of content, from computer games to printed manuals to web applications. Before joining SDL, Mr. Thomas was a language intelligence solutions manager for Adobe Systems.

Armin Wahl is responsible for Across Systems’ sales and new business development efforts in the United States. He has worked in high-level positions in the IT, plastic and service industries where he became familiar with the translation requirements and challenges of globally operating corporations. Wahl holds a degree in International Business Management.

Paul helps JustSystems clients compete through content.” With more than 20 years of specialized experience in enterprise content management and knowledge management, he leads and supports engagements that require analysis and improvement of content lifecycles –-- workflows that span the creation, review, localization, publishing, reuse, management, analysis, and visualization of business content.

Prior to JustSystems, Paul spent more than 18 years at Xerox in Rochester, NY, as a Service Line Manager for a content lifecycle consultancy with Xerox Global Services, and in various operations roles in knowledge management, technical publishing, localization, and software engineering.

John Yunker is president of Byte Level Research, a Web globalization research and consulting firm founded in 2000. He is author of “Beyond Borders: Web Globalization Strategies,” which is currently used as a textbook in more than a dozen corporate and university courses. Each year, John analyzes and benchmarks 200 global Web sites in the Web Globalization Report Card.

Ann Zdunczyk currently works at a2z Publishing, Inc, a company she created in 2001 after retiring from Lucent Technologies. Ann has worked as a technical writer, technical trainer and also technical support. She has worked in the translation area ever since the early 90’s doing desktop publishing and technical support for applications. As President of a2z Publishing, Inc. Ann does desktop publishing, data conversion, template creation, translation consulting for translation houses.