ShareFEST 2012 keynote speaker:

Steve Aylward ,General Manager, US EPG Health Care & Life Sciences, Microsoft Corp.

Steve Aylward currently serves as General Manager of US EPG Healthcare & Life Sciences. In this role, he is responsible for Microsoft’s healthcare strategy as well as marketing, services and partner execution in the health plan, provider and life sciences customer segments.

Steve has more than 20 years of experience and success in healthcare sales, marketing and management, having joined Microsoft after a thirteen-year career at Siemens Medical Solutions and Shared Medical Systems (SMS), where he was most recently responsible for Revenue Cycle Solutions. Through his experience with Siemens’ Healthcare Data Exchange subsidiary (HDX), Steve gained a detailed knowledge of the need for providers, health plans, and other healthcare parties to collaborate and connect for better health outcomes.

Other speakers:

Gabor Fari, Director Life Sciences Solutions, Microsoft Corporation .

In his role as Director of Life Sciences Solutions in the Health & Life Sciences Industry Unit, Gabor Fari plays a key role in defining and executing on Microsoft’s Life Sciences solutions and business strategy. His main areas of focus are Enterprise Content Management, Regulated Document Management and Clinical Trials. Gabor is also the architect and driving force behind the Intelligent Content Framework, with the mission to introduce an entirely new way of managing Enterprise Content in Regulated Industries, based on the latest XML technologies and standards. Gabor serves as the Microsoft representative on several DIA SIAC groups and the OASIS DITA Pharmaceutical Content Subcommittee.

Patricia Brady, Sr. International Clinical Trial Manager, Sanofi U.S.

Patricia has over 15 years of clinical experience starting as a Medical Program Coordinator for Pulmonary Immunology at Merck. In this role she managed Pivotal Phase II –III trials within their Rheumatoid Arthritis Program. During this pilot project, Mrs. Brady pioneered the use of electronic data capture. Currently at Sanofi-Aventis she focuses on the use of collaborative technology to facilitate operational excellence in clinical research specifically on the electronic Trial Master File and Collaboration with external users.

Dr, Michael Brennan, Director Informatics, Johnson & Johnson

Dr, Michael Brennan joined Centocor/Johnson & Johnson in 2003 as the Executive Director, Global Regulatory Operations. Presently, Michael is Director, Informatics, Informatics Center of Excellence. Prior to this role, Michael served as the Business Lead for a major cross company initiative (within Johnson & Johnson. The ERIS program (Electronic Regulatory Information Systems) was targeted to provide a common information management platform to support the creation, collaboration, exchange and life-cycle management of regulatory information across all J&J pharma companies and with external partners as well manage submission to regulatory authorities worldwide.

Michael has over 25 years experience within the pharmaceutical industry. He received his Ph.D. in Experimental Psychology from the State University of New York at Binghamton and did post-doctoral research and was a faculty member in the Department of Neurology, New York University School of Medicine.

He serves as J&J Representative to PhRMA ERS (Electronic Regulatory Submissions Working Group).

Michael has been active within DIA. He is presently serving on the steering committee for the upcoming (March 2012) Computational Science Meeting.

Michael also currently serves on an ICH working group that is exploring transition to XML documentation.

Dux Raymond Sy, Managing Partner, Innovative-e, Inc.

With over 15 years of experience in Information Technology and Project Management, Dux has earned a reputation as among the leading experts in leveraging technology to enhance project management. A certified Project Management Professional (PMP), he is currently a managing partner and the chief evangelist of Innovative-e, Inc., a Microsoft-certified, business technology consulting and services company that employs a business-first approach to successfully implement SharePoint for clients.

As a thought leader in maximizing project team collaboration, he is the author of “SharePoint for Project Management” published by O’Reilly Media. He is focused on empowering organizations on how to leverage the benefits of SharePoint technologies with quantifiable goals such as: Increasing productivity and efficiency, decreasing collaboration redundancies and streamlining electronic communications.

A sought after speaker, Dux has presented in various Microsoft and Project Management Institute (PMI) events. Additionally, he facilitates a “Delivering SharePoint Success” mentoring workshop where he shares proven best practices in managing SharePoint projects.
He regularly blogs on topics related to project management, SharePoint and globalization at MeetDux.com.

Matt Walz, Chief Technology Officer, NextDocs Corporation

Matt Walz founded NextDocs Corporation along with Zikria Syed to provide SharePoint-based document management solutions to the life sciences industry. As the chief designer of NextDocs products, he is an expert on using SharePoint as a compliant platform for regulated content. At ShareFEST he will be reviewing the landscape of SharePoint-based products and tools available to life sciences companies.

John Holliday, CEO of SharePoint Architects

John Holliday is CEO of SharePoint Architects, a SharePoint consultancy focused on enterprise content management, records management and business process automation. John is the author of “Professional SharePoint 2007 Records Management Development”, and has co-authored many popular SharePoint development books, including “Professional SharePoint 2007 Development”. He is the developer of the CAML.NET Framework, which enables developers to create SharePoint queries more easily, and the CAML.NET Intellisense add-in for Visual Studio 2008 and 2010. John is also the founder of the SharePoint Developer Network (www.SharePointDeveloper.org – twitter: @SPDEVNET), which is committed to helping SharePoint developers find jobs and professional support.

David Gwyn, Vice President of Research & Development for HighPoint Solutions

Mr. Gwyn is Vice President of Research & Development as well as Collaboration Practices for HighPoint Solutions. With more than 20 years of experience in the Life Sciences industry, David is a seasoned executive with extensive experience delivering Documentum and SharePoint. He is responsible for solution vision and strategy and is an expert in business development, client management, client solution delivery, and team development.

He is a member of the Project Management Institute (PMI), International Institute of Business Analysis (IIBA), and the Drug Information Association (DIA). David’s academic credentials include an M.B.A from the University of Phoenix and a B.S. in Computer Science from Indiana University of Pennsylvania.

Erik Korsvik Østergaard, Senior Business Consultant and Manager at ProActive

Erik Korsvik Østergaard is a Senior Business Consultant and Manager at ProActive, delivering Microsoft solutions to the key processes in Life Science (GxP/non-GxP). During the past 10 years, Erik has focused on implementing and adopting SharePoint solutions and services on enterprise scale to international Life Science companies, as project/programme manager in the industry (at Novo Nordisk) and as consultant. Focus areas are web/SharePoint/ECM strategy, governance in all aspects, QA/QC and Organizational Change Management.

Jenny Wei, Head of R&D Information China Hub, AstraZeneca global R&D

Dr. Jenny Wei is the Head of R&D Information China Hub, AstraZeneca global R&D. Dr. Wei joined AZ Innovation Centre China as Principal Scientist in Informatics in 2008 and shortly was appointed to Head of IS/IT in charge of information management for AZ translational medicine efforts in China. In July 2011, she was promoted to Head of R&D Informatics China, leading the R&D Information China Hub to deliver informatics solutions for AZ global R&D. Prior to AstraZeneca, she was a Principal Software Developer and Senior Product Architect at Merck Rosetta BioSoftware developing informatics solutions for genomics data management and data analysis. During her more than 12 years informatics/software careers, she also held positions in Merck Research Lab Department of Bioinformatics and AT&T Wireless.

Evan Callender, Director, West Monroe Partners

Evan Callender is a Director in the Customer Experience practice at West Monroe Partners, a full-service business and technology consulting firm focused on guiding organizations through projects that fundamentally transform their business. Evan, who has over 13 years of experience in architecture definition, application design, development, and packaged software implementation, partners with global pharmaceutical firms to help them strategize, plan and implement ECM solutions and execute full scale change management programs to promote the adoption of these systems.

Evan’s primary focus is Microsoft web technologies in data management with portal and content management products using SharePoint 2007/2010. He has served over 40 SharePoint clients over the past 7 years, completing more than 15 migrations from previous versions of SharePoint or other third party applications. His key strength lies in his ability to optimize SharePoint’s features and functionality to meet the needs of his clients while being able to customize SharePoint when necessary to create cost effective, integrated and scalable solutions.

Jennifer L Willhide, Documentation and Operational Compliance Systems Supervisor, DynPort

With 8 years of experience in Quality Assurance at DynPort, Jennifer has managed quality systems including CAPA, Change Control, Deviation/Investigations and Internal Audits. During the validation of the company’s electronic document management system, Jennifer used her knowledge of SharePoint to integrate existing quality systems into the new environment. Jennifer acts as the System Administrator and is responsible for IT Change Control and validation efforts to maintain Part 11 compliance. Currently, she is upgrading DynPort’s EDMS to SharePoint 2010 and is executing the resulting validation activities.

Andy Corts, Chief Information Officer, Sarah Cannon Research

Andy is an accomplished healthcare IT professional with experience in developing and executing IT strategies focused on application management, infrastructure strategies, and governance. In his previous role as director of Collaborative Services at SCRI, he was responsible for the development of SCRI’s electronic health record strategy as well as the clinical trial portal, mySCRI. Prior to joining SCRI, he was a director in HCA’s IT Strategy and Planning group and a senior consultant at Cap Gemini Ernst and Young. Andy received his bachelor’s degree in French and International Business in 1999 from the University of Tennessee in Knoxville.

Dr. Ingo Florian, Head of QA, Mundipharma

Dr. Ingo Florian has been with Mundipharma since 2008. In his current role he serves as the Head of QA Germany & Central Eastern Europe Issues. Prior responsibilities at Mundipharma included installation and maintenance of QA and PhV-Systems in the CEEC and implementation of PAT & Quality Risk Management. He received his Ph.D. at the Humboldt University Berlin.

Matthew Roberts, National Competency Lead, Collaboration & Content Management
EMC Consulting

Matt Roberts leads EMC Consulting’s Portals, Collaboration, & Content Management consulting practice in North America. Responsibilities include technical thought leadership & evangelism, go-to-market strategy, delivery readiness, strategic sales & delivery, community enablement, and solution offering development.

Dennis Schmuland, MD FAAFP Chief Health Strategy Officer US Health & Life Sciences Microsoft Corporation

Dr. Dennis Schmuland serves as Microsoft’s Chief Health Strategy Officer for the US Health and Life Sciences (HLS) division. As Microsoft’s senior health industry executive, his responsibilities include thought leadership with customers and partners, long term vision & strategic plan, consumer engagement, industry solution strategy, and public and analyst relations across the four vertical lines of business within US HLS: Health & Human Services, Health Insurance, Providers, and Life Sciences. In 2009 he received the distinguished Microsoft Circle of Excellence award for exceptional business leadership, thought leadership and strategic innovation.

W. David Debany, Senior Associate in the Regulatory Operations group at Millennium

W. David Debany is a Senior Associate in the Regulatory Operations group at Millennium: The Takeda Oncology Company. Mr. Debany is responsible for assessing technology needs for the Regulatory Affairs department, working with Medical Informatics to develop and implement new technology initiatives. Mr. Debany has over 8 years of experience in Regulatory Operations as a publisher, writer, trainer, and business analyst.

Paul Ireland, Global Director, Solution Consulting at Liquent

Paul Ireland has worked with life sciences organizations to provide, manage and consult on various aspects of their Regulatory Information Management needs for the past 14 years. He has worked both within the industry heading a CRO’s Authoring, eDMS, and Publishing offerings, and for Liquent as a provider of Regulatory Information Management solutions.

Dieter Schlaps, Service Area Lead, Drug Regulatory Affairs for Life Sciences, NNIT

Dieter Schlaps has more than 10 years of experience in Pharmaceutical IT specializing in Medical Statistics, Pattern Recognition, Clinical Data Management and Document Management. He has a deep pharmaceutical business understanding, high regulatory and technical expertise. Dieter Schlaps is Service Area Lead in Regulatory Document Management, Electronic Submissions, Labeling and Validation Processes.

Raoul-A. Lorenz, CEO, LORENZ Life Sciences Group

Raoul-A. Lorenz has been the CEO of the LORENZ Life Sciences Group since 2006. After he completed his studies at the European Business School in the UK, he started with LORENZ in 1996. In 1999, he became CEO of reg123.com Limited, a regulatory affairs information portal. Since 2000, he has taken on successive Directorships at LORENZ, including the UK, US, Canadian, German and finally the Indian divisions of the LORENZ Life Sciences Group. Prior to becoming the CEO, Raoul was appointed VP Sales & Marketing for the Group in 2003. Raoul has also led workshops at numerous events on electronic submissions in Europe, North America and Australia, as well as presented on the topic at DIA, BIRA/TOPRA, and others. He was also the chairman of the Drug Information Association (DIA) Special Interest Area Committee for Communications & Publications in 2001/2002.

Nick Ferguson, Associate Director, Information Technology, Peregrine Pharmaceuticals

Nick Ferguson is Associate Director, Information Technology for Peregrine Pharmaceuticals (and its biomanufacturing subsidiary Avid Bioservices) and has over 13 years of professional experience in developing standards and long term strategies, designing and building scalable infrastructure, and delivering technology solutions to meet corporate objectives. Mr. Ferguson joined Peregrine in 2000 as Manager, Information Technology and was promoted to his current role in 2010. With direct responsibility for planning for and implementing information technology solutions, he leads a team of 5 to support Peregrine, and Avid Bioservices, a cGMP biomanfacturing subsidiary. Previously, Mr. Ferguson served as a Network Engineer at Lockheed Martin. He holds Microsoft and Novell certificates in System Engineering and Administration and is a member of the Network Professional Association.

Jeremiah Rehm, eClinical Solutions Specialist, BioClinica

Mr. Rehm has been an innovator in Life Sciences for over 15 years and spent the last 10 of those designing and maintaining the industry’s fastest growing Clinical Trial Management System (CTMS). Prior to joining BioClinica, Mr. Rehm worked as a technology consultant and led the product management team at TranSenda International. He specializes in the use of Microsoft products to consolidate and analyze operational study information, including the translation of this data into meaningful performance metrics.

Dr. Hans-Jürgen Schwarz, Senior Director, Medical Affairs, Grünenthal GmbH

Hans-Jürgen has over 15 years of experience in the pharmaceutical industry. As Head of Scientific Relations & Knowledge Management he has been responsible for the implementation of a knowledge management solution for Grünenthal Europe & Australia. Prior to this role he held various positions in Medical Affairs, Marketing and Clinical Development. He received his Ph.D in Molecular Genetics at the University of Bonn.

Ralf Zimmermann, Head of Document & Raw Data Management, Roche Diagnostics GmbH

Working since 2002 at Roche Diagnostics in the Document Management area implementing and supporting solutions based on Documentum, EdocCompliance, Sharepoint and SAP DMS. Since 15 years experiences in IT developments in the medical products industry in fields like Business Process Engineering, Content Management, B2B solutions and Document Management.
PhD in Biophysics (Technical University Munich), post Doctoral Fellow at Princeton University, USA. Trainer for European Medical law regulations.

Art Bellis, VP, Sales & Alliances, GimmalSoft

Art Bellis is Vice President of Sales & Alliances for Gimmal. He brings 20 years of experience developing and marketing records management software to his role at Gimmal. Art is recognized as an industry expert and has been regularly called upon by ARMA and AIIM to speak on issues related to technology and information management. Various academic programs including the University of British Columbia, University of Washington and Vancouver Community College call on Art to lecture on records management issues and trends. Art possesses an extensive working knowledge of enterprise content & records management and has a proven track record developing and executing on both direct and channel sales strategies.

Kurt Thies, VP, Unified Records Management at Iron Mountain

With over 20 years of executive leadership in records and information management, Kurt founded Accutrac Software, Inc., which developed and sold the Accutrac records management program. With a strong customer focus, Accutrac has been a leading product among corporate, legal and government customers. After Accutrac was acquired by Iron Mountain, the leading records management service company, Kurt has worked to develop a unified strategy for records management, integrating Accutrac as a platform to manage inventory, policy and process across physical and electronic information.

Janet Buck, Information Technology, Otsuka America Pharmaceutical Inc.

In her current role, Janet leads Otsuka’s Enterprise Business Application Organization in which she defines the strategy and architecture for the company’s use of SharePoint for their Internet, Intranet and Collaboration Portals. Her other key areas of support include Global Content Management, Quality and Compliance, Finance, Human Resources, Legal and Technical Operations. Janet has over twenty years of leadership experience deploying applications within several large Life Sciences companies with the last eight years focused on content management for Quality and Compliance documents. Her current challenge is the development of a governance model for a SharePoint environment that encompasses all aspects of intranet and collaboration portal usage by the enterprise.

Scott Metker, Chief Engineer/Architect, RWD Technologies.

Dr. Metker is a Chief Engineer for RWD’s Technology Implementation and Integration Practice. He develops and supports Content Management Systems (CMS), Customer Relationship Management (CRM) systems, and XML authoring and publishing solutions for a variety of clients and industries. Dr. Metker has significant experience configuring and interfacing CRM and EMC solutions, such as Siebel, Documentum and SharePoint, in regulated, validated environments. He is the architect of RWD’s infoMaestro Integrated Medical Communications Solution which has been deployed to a number of large pharmaceutical organizations globally. Dr. Metker has a bachelor’s degree from Virginia Polytechnic Institute and master’s and doctoral degrees in electrical engineering from the Pennsylvania State University.