Andy Corts, Chief Information Officer, Sarah Cannon Research Institute

Discover how Sarah Cannon Research Institute (SCRI) leverages business process management (BPM) tools to satisfy diverse requirements and locations in the clinical trial billing process. Spanning 20 locations, multiple sponsors—each with special billing requirements—and two countries, SCRI handles all internal and external billing accurately, securely, and efficiently through a SharePoint interface built on top of OpenText’s BPM solution. Through this process improvement initiative SCRI is able to decrease clinical trial startup times by 25% and increase revenue recognition speed by 60 days.

Attendees will learn firsthand from SCRI’s experience how BPM compliments and extends the native collaboration capabilities of SharePoint to enable the realization of truly collaborative clinical trials.

Learn How To:

• Enable collaborative trials using SharePoint with robust process automation
• Decrease site and study startup time by 25% with BPM automation
• Reduce CRO/Sponsor payment cycle time by 60 days with collaborative trials processes that improve billing

Steve Aylward, General Manager, Healthcare & Life Sciences Group
Microsoft Corporation

During the opening keynote, Mr. Aylward will review Microsoft’s long-term strategy for the health and life sciences space. His presentation will include a wide range of examples of how Microsoft technologies, especially SharePoint, are leading the next generation of life sciences systems to drive innovation in healthcare delivery, regulatory compliance and collaboration. He will also cover current and future initiatives in life sciences and the Microsoft roadmap.

Case Study: Implementing Structured Authoring – Understanding the DITA Model and its Applicability for Content and Metadata Mgmt

Dr. Michael Brennan – Director Informatics, Johnson & Johnson

The DITA (Darwin Information Typing Architecture) Model provides an open XML content standard defining a common structure that promotes the consistent creation, sharing and re-use of information.  This presentation will provide practical insights into the DITA model garnered from the experience of different companies that have implemented structured content authoring. We will introduce the concept of a Structured Authoring maturity model as a means of monitoring progress. A key focus of this session will be the design and application of content maps for clinical and CMC documentation. The implication for ease of re-use and tracking of information across a dossier will also be discussed.

• Translate the concepts of DITA Model/topic-based structured content into high value pharmaceutical applications
• Demonstrate the business value of content
• Understand the role of content design as the foundation of a successful implementation

Rebecca Greenberg – Associate Director at Millennium Pharmaceuticals, Inc

Millennium Pharmaceuticals has implemented an integrated Regulatory Submission Planning and Tracking System using Microsoft SharePoint, Project Server and Master Data Services that incorporates many key elements of Regulatory Information Management.  The system facilitates submission planning in a manner that mirrors best practice techniques used by Submission Managers including capacity planning, resource management and Gantt-based scheduling.  The solution leverages a common data model and robust data dictionaries that eliminate redundant data entry and improve data quality.  It also provides an expandable set of reports that support current and forward looking resource planning and operational metrics collection that address some of the Millennium’s highest priority RIM-related concerns.  An agency commitment tracking feature provides a knowledge base for submission-related Q&R and allows Millennium to respond consistently to agency inquires.

In this session you will learn how to leverage standard project management tools and techniques to plan and execute regulatory submissions.  In addition, you will develop an understanding of how to address common aspects of Regulatory Information Management using the Microsoft SharePoint platform.

Keynote Presentation, Thursday, 8:15 AM

Steve Alyward, General Manager, Healthcare & Life Sciences Group
Microsoft Corporation

During this keynote session, Mr. Alyward will review examples of how Microsoft technologies, including SharePoint, are being used to drive innovation in healthcare delivery, regulatory compliance and collaboration.

Loews Philadelphia Hotel
1200 Market Street
Philadelphia, Pennsylvania 19107
(215) 231-7333 (Reservations)

The first skyscraper ever built in the City of Brotherly Love is home to Loews Philadelphia Hotel. Contemporary décor and gracious hospitality make Loews one of Philadelphia’s most inviting luxury hotels. Enjoy supremely comfortable rooms and personalized service, as well as delicious cuisine from the hip Sole Food restaurant.

• Located in the heart of Philadelphia, steps away from the historic district, shopping, restaurants and sports arenas
• Directly across from the Pennsylvania Convention Center
• Minutes from Philadelphia International Airport and Amtrak’s 30th Street Station

Group Room Rate

A conference Hotel Rate of $169.00 per room is available to conference attendees. Please call the hotel at (215)231-7333 to reserve your room at this special rate by February 8, 2010.

Local Airport

Philadelphia International Airport

Driving Directions

I-95 from the North (Trenton, Betsy Ross Bridge):

• Follow 95 South to exit 22 (Central Philadelphia)
• Follow signs for 676 West
• Continue on 676 to the Broad Street exit
• Make first left onto Vine Street
• Follow Vine to third light (12th Street) and make a right
• Pass the Convention Center
• Cross Market Street
• Entrance and valet parking on right-hand side.

I-95 from the South (Delaware, Maryland, Philadelphia International Airport):

• Follow 95 North to exit 22 (Central Philadelphia)
• Follow signs for 676 West
• Continue on 676 to the Broad Street exit
• Continue onto 15th Street
• Follow 15th Street through seven traffic lights (City Hall on left)
• Continue around City Hall
• Make right onto Market Street
• Drive to 12th Street (Loews Hotel is on the right)
• Make right onto 12th Street
• Entrance and valet parking on right-hand side

From the NJ turnpike (New York) and Ben Franklin Bridge (Cherry Hill, NJ):

• Follow New Jersey turnpike South to exit 4 (Camden/Philadelphia)
• Follow 73 North to 38 West to 30 West
• Follow signs for Ben Franklin Bridge
• Staying in center lane, follow signs for Vine Street/Local Traffic
• Follow Vine Street to 12th Street
• Turn Left onto 12th Street
• Continue approximately four blocks
• Pass Convention Center
• Cross Market Street
• Entrance and valet parking on right-hand side

From 76 East:

• Follow 76 East to exit 344 (676 East)
• Continue on 676 to the Broad Street exit
• Follow signs for Vine Street/Local Traffic
• Continue on Vine to the third light (12th Street)
• Turn right onto 12th Street
• Pass Convention Center
• Cross Market Street
• Entrance and valet parking on right-hand side

  Register For :                                                             Price:
  ShareFEST Conference                                          $795
  April 8-9, 2010

1. Admission to keynote sessions
2. Admission to track conference session
3. Admission to Exhibit Hall and Evening Reception
4. Conference materials – PDF files available for download on this web site
5. Continental breakfast, coffee breaks, and lunch

 HOW TO REGISTER

Register online and use one of the following payment methods:

• Credit Card. You can use the secure online form to pay via credit card and get immediate confirmation of your registration. MasterCard, Visa and American Express are accepted. You’ll receive a REGISTRATION RECORD and RECEIPT. Please print out these pages and bring them with you to the Conference. Present them at the Registration Desk to pick up your badge.
• Check. Fill out the online registration form. Print out the REGISTRATION RECORD and RECEIPT and mail with payment to: NextDocs Corporation,  500 N. Gulph Road Suite 240, King of Prussia, PA 19406. Online registrations mailed without payment will not be confirmed until payment is received.
• Purchase Order. If you register using a P.O., you will be invoiced immediately for the registration amount. Payment must be received before your registration can be confirmed.

CANCELLATION & REFUND POLICY
You can receive a full refund, less a $100 registration fee, for cancellations made by February 8, 2010. Cancellations after this date are non-refundable. Registrations may be transferred to another person.

QUESTIONS
Email us at Registrationinfo@sharefestconference.com.

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.

Antoinette Azevedo, President, e-SubmissionsSolutions.com

Antoinette Azevedo is the founder of e-SubmissionsSolutions, a California company that advises biotechnology and pharmaceutical companies on the use of document management technology to manage regulatory documents and publish electronic submissions. As a widely known industry expert on electronic submissions, Ms. Azevedo has lectured internationally for RAPS, DIA, at vendor user conferences, and for local regulatory affairs professional groups.

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.

Les Jordan, Life Sciences Industry Technology Strategist, Microsoft.

Les provides architectural and technical guidance to internal Microsoft product teams, partners and pharmaceutical companies, essential acting as the CTO of the life sciences team. He also serves as the Director of the BioIT Alliance in 2006. At ShareFEST, Les will be discussing Microsoft’s strategy for the life sciences market and the ecosystem of life sciences vendors that has developed around SharePoint.

Ken Lownie, Vice President of Life Sciences, NextDocs.

Ken is a frequent speaker and writer on content management issues in Life Sciences companies. He recently published an article on the evolution of the use of electronic trial master file technology for clinical trials in the July 2009 issue of Infonomics, and has written on SharePoint adoption patterns in Life Sciences companies for NextGen Pharma and other publications.

David Katzoff, Chief Architect, Valiance Partners.

David has more than twelve years of enterprise-class research, manufacturing, and business and marketing systems for clients in the life sciences, financial services and manufacturing sectors. In addition to overseeing the development of Valiance’s migration products, David plays key consultative roles for large-scale migrations for clients such as Amgen, Pfizer, Wyeth and J&J.

James Averback

Jim has worked in the Life Sciences industry since 1981 with experience ranging from Director of Computing Facilities for 2 major university research centers to being responsible for the Regulatory Informatics functions at 2 major pharmaceutical companies. As an IT owner, project leader and contributor, Jim has implemented new business processes and systems in: Clinical Data Management and Trial Operations, Chemical & Pharmaceutical Development Content Management, Pharmacovigilance AE Reporting, Regulatory Affairs Submission Strategy and Management, and Research Content, Document and Knowledge Management.

Jim’s current focus is in design of content architecture and metadata, collaborative authoring and knowledge management. He is co-chair of the Document and Records Management SIAC of the Drug Information Association and the OASIS DITA Pharmaceutical Content Subcommittee.

Barry Peters Vice President of Corporate Quality and Compliance, TELERX

Barry is responsible for all of the Quality functions at Telerx, a strategic outsource partner providing world class customer care. He brings more than 30 years of pharmaceutical experience in IT, multichannel contact center, customer satisfaction, quality assurance and regulatory compliance from Merck. Peters earned his B.S. in Microbiology from the Pennsylvania State University and completed the Wharton Management Program at the University of Pennsylvania.

About TELERX:

Headquartered in Horsham, Pa., Telerx is a strategic outsource partner that provides world class customer care. By focusing on innovation and insights, Telerx helps leading Fortune 500 companies build brand loyalty and achieve bottom line results. For more information, visit www.telerx.com or call 1-800-2-TELERX. Connect with us on LinkedIn, Twitter, and Facebook.

Carol Smith Director of Clinical Documentation, Cephalon

Carol has 20 years experience in the Pharmaceutical Industry and in her current position implements and manages clinical trial systems along with process re-engineering.

Creation, review and management of essential documents can be a daunting task for Pharmaceutical Companies and Clinical Investigators. This task is time consuming, labor intensive, and at risk of non-compliance. This session will focus on creating efficiencies by implementing SharePoint to collaborate with the Investigator Sites, Pharmaceutical Companies and Outsourced Vendors.

All abstracts must fit into one of the following conference tracks:

Quality Management
This session focuses on the use of SharePoint in the management of GxP documentation and quality processes.

Regulatory Affairs and e-Submissions

This session focuses on the use of SharePoint in the management of regulatory documentation and electronic submissions.

Collaborative Clinical Trials
This session focuses on the use of SharePoint in the management of the Electronic Trial Master File (eTMF) and in optimizing collaboration between sponsor, CRO and site personnel.

Corporate Solutions
This session focuses on the use of SharePoint in the management of corporate documentation such as legal contracts and promotional materials.

Records Management and e-Archiving
This session focuses on how SharePoint Records Center can be used to meet the records management requirements of life sciences companies.

Emerging Technology Themes
This session focuses on connecting sponsors, physicians and patients by leveraging SharePoint’s cloud, mobile and social computing capabilities.

IT Methodologies and Validation
This session focuses on the use of contemporary implementation, verification and validation methodologies in the deployment of SharePoint solutions.

Complimentary Technologies
This session focuses on complimentary technologies such as scanning, faxing, and digital signatures that, when integrated effectively, extend the capabilities of the SharePoint platform.

SharePoint Scalability
This session focuses on the best practices and technical considerations when planning and implementing large scale SharePoint deployments.

Upgrading and Migrating SharePoint Environments
This session focuses on best practices and lessons learned for upgrading/migrating a SharePoint 2007 environment to SharePoint 2010.

Contact Information
For questions on abstract submission and topics, contact Chet Shemanski at cshemanski@nextdocs.com

Exhibit Opportunities
For information on showcasing your company’s products or services, contact Margaret Mottolo at mmottolo@nextdocs.com

The conference sessions are organized into two tracks. Click on the tracks below or on the link to the speakers page for more information about the ShareFEST conference program.

SharePoint in Use: User Case Studies. The Application User Case Studies track includes presentations from individuals who have direct experience implementing SharePoint to address specific business processes in their life sciences companies. You will learn from their first-hand experience how to steer your SharePoint project on a successful course.

SharePoint as an Enterprise Platform. The SharePoint as an Enterprise Platform track includes sessions focused on implementing SharePoint as an enterprise platform in life sciences companies. Topics include architecting and scaling SharePoint environments as well as governance models and validation strategies

ShareFEST Speakers  The Keynotes and track sessions at ShareFEST will be delivered by some of the leading experts on the use of SharePoint in life sciences.  Among the speakers will be executives from both major pharmaceutical and device companies as well as representatives from Microsoft and other leading software vendors.