Microsoft’s Role in Today’s Life Sciences Ecosystem

Keynote Presentation: Thursday,  8:30 – 9:15 AM

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.

Quality beyond Compliance

Keynote Presentation: Thursday, 9:15 – 10:00 AM

Matt Walz, Chief Technology Officer, NextDocs Corporation

During his keynote, Matt Walz will discuss how the industry is in the midst of a transformative state led by a new breed of business applications on Microsoft SharePoint.  Enterprise software for today’s life sciences companies is increasing playing a larger role in helping companies connect with one another to deliver quality products to market faster and with greater scale.  SharePoint’s open collaboration platforms is delivering greater usability, scalability, flexibility and mobile scenarios which have become key tenets today’s business applications are building upon to enable quality beyond compliance.

 

Manage and Share PreClinical and Clinical Data Using The SharePoint Platform

Thursday, 10:45 -11:20

Dr. Jenny Wei – Head of R&D Informatics and IS/IT China, AstraZeneca

At AstraZeneca, documents from discovery and preclinical studies are managed within the windows file system with access control. Although these documents do not need to be GxP compliant, they are still required to meet Astra Zeneca’s Good Laboratory Standards (GLS). GLS documents require an audit trail to track which individuals made changes to over the life of the asset.  In addition, all the research data are subject to the FDA 24-hour challenge where any data related to a trial compound in must be located and presented within 24 hours.

Astra Zeneca selected SharePoint 2010 as the platform to manage GLS compliant documentation.  New features in SharePoint 2010, including audit trail, records retention policies, document tagging and contents search make it a perfect solution for GLS document management.  As well, SharePoint’s collaboration

features facilitate robust information sharing and promote social networking within the R&D organization.

You Will Learn:

• Which SharePoint 2010 features can be leveraged to support Good Laboratory Standards
• How SharePoint is enabling collaboration within Astra Zeneca’s R&D organization
• How to integrate data analytics with SharePoint 2010

 

Validation Change Control

Thursday, 10:45 -11:20

Jennifer Willhide, Supervisor, Documentation and Operational Compliance Systems, DVC

The FDA recognizes change control as a vital element in ensuring computer systems remain in a validated state.  A good change control system starts with a strong initial validation and should include a comprehensive set of OQ scripts to test all features within the software’s capability.  At Dynport, we added a CAPA tracking functionality to our SharePoint implementation using features which were operationally tested during the initial validation of the system – saving significant time by limiting our validation to performance testing.  Dynport developed a robust IT Change Control System which captures the scope and justification for proposed changes. Using our IT Change Control, a report of completed changes can be used to update configuration guides for future re-validation. This serves as a version history to track the changes and modifications to our environment.

Attendees will learn:

• 21 CFR Part 11 requirements for change control
• Benefits of a robust change control system
• Change control and validation – Review case study of DVC’s system using NextDocs software and SharePoint feature

 

An Overview – How to Implement a GxP-Compliant Document Management System Considering Local Training Requirements

Thursday, 11:30 – 12:05

Dr. Ingo Florian – Head of Quality Assurance, Mundipharma

Case study: An overview of how to implement a GxP-compliant Document Management System considering local training requirements / Training of SOPs between authorization and becoming effective.

Effective training on Standard Operating Procedures (SOPs) is one of the most important requirements for the pharmaceutical industry and one that is regularly monitored by authority inspections. Document Management Systems (DMS) provide the ability to define the time between the authorization (by the Quality department) and the effective (new version is valid) date.  The challenge however, is in cases where urgent revisions are required and the standard authorization phase is too long. This case study will show Mundipharma’s approach to SOP training within the project and the go-live phase.

Best Practice: Combining Waterfall and SCRUM when Building SharePoint Applications in a Regulated World

Thursday, 11:30 – 12:05

Erik Ostergaard – Manager, ProActive A/S

Using a validated/controlled SharePoint set up for LEO Pharma as a backdrop, this session will present best practices for combining the waterfall approach from the V-model with the iterative adjustments from Agile/Scrum while complying with the quality standards required by the Life Science industry.  The process will be described in detail – from establishing the Quality Plan (QP), to developing the URS/specification, use stories and use cases.  The use of Microsoft Team Foundation Server (TFS), defining the test cases and traceability, the code review and testing, the IQ/OQ/PQ approach and the use of HP TestCenter will also be discussed.  Rounding out the session is the RFC (Request for Change) process, deployment governance, release management and finalizing the Quality Report (QR).

• Learn how to combine the waterfall approach from the V-model with the iterative adjustments from SCRUM
• Learn how the components defined in the Quality Plan enable compliance with Life Sciences quality standards
• Learn how the Request for Change (RFC) process is integrated into an Agile/Scrum environment

 

K2: No Code Solutions for Building Workflow Applications in SharePoint

Greg Sanderson, Technical Specialist at K2

Thursday, 1:10-1:45

See how K2 offers an easier way to build and automate process-driven solutions in SharePoint, plus provides the tools necessary to support the entire life cycle of your business processes, including workflow design and modeling, business data and enterprise system integration, reporting and analysis, and process administration.  All without code!

• Learn about key concepts and best practices of Business Process Management
• See how the K2 platform can be used to reduce time and costs through rapid workflow creation and deployment
• Learn how K2 can leverage and enhance your existing Microsoft investments

 

Why Submission Management and Document Management Systems (DMS) Belong Together

Paul Ireland, Global Director, Solution Consulting, Liquent

Thursday, 1:10-1:45

Submission Management as a part of the ECM Process

• DMS & eSubmission Requirements.
• Document and Dossier Lifecycles.
• Live Product Demonstration of InSight Working Together with NextDocs.

This session will highlight some of the benefits and efficiencies gained by using Liquent’s Regulatory Information Management solutions in conjunction with a NextDocs eDMS. Drawing on client experiences, you will see how InSight is able to leverage content and associated information from NextDocs when managing submission lifecycles and your regulatory information.”

How to Transfer a Paper Based Deviation Management to a GxP-Compliant Quality Management System

Thursday, 1:55 – 2:30

Dr. Jorg Kohler – Chief Organization Officer, IDT Biologika GmbH

An effective deviation management process is one of the most important requirements for the pharmaceutical industry and is subject to regular examination during authority inspections. Modern Electronic Quality Management Systems (eQMS) provide the ability to define lean, workflow-based processes that support quality programs. However the real challenge is finding the right balance between CMO process efficiency and the customer’s quality management requirements. This case study will show how IDT Biologika has coped with this challenge within their eQMS implementation project and subsequent go-live phase.

• Transferring a paper-based deviation management process to a GXP-compliant eQMS
• Balancing a CMO’s lean, workflow-based processes with customer quality management requirements
• Lessons learned while implementing a SharePoint-based eQMS

 

Record Center Configuration Strategies

Thursday 1:55-2:30

John Holliday – President, SharePoint Architects

Like it or not, manually setting up a SharePoint Records Center site to process incoming documents requires a lot of steps. In addition, there are lots of ways to slice and dice your file plan to get the configuration just right. In this session, we’ll explore the ins and outs of Records Center configuration, using a variety of tools (including PowerShell, Microsoft Excel and InfoPath) to setup your content types, retention formulas and routing rules correctly.

• Understand the steps needed to properly configure a Records Center site
• Learn how to create a well-structured file plan that supports SharePoint configuration
• Learn different configuration strategies based on information in the plan

 

Case Study AstraZeneca: An Electronic Trial Master File (eTMF)

Thursday, 2:40 – 3:15

Joanne Ritchie, Study Process and Tools Leader, Clinical Operations, AstraZeneca

Michael Agard, Senior Consultant, Life Sciences Practice, Paragon Solutions, Inc.

Key technical and process challenges will be described in establishing an electronic trial master file using the NextDocs SharePoint 2010 platform at AstraZeneca. The speakers will discuss use of the DIA TMF Reference Model in an electronic system and the establishment of Required Document Tracking.  System integration challenges will be presented for: SharePoint 2007/2010, CTMS, regulatory submission documents and a scanning system. Changes required for processes and SOP templates in a global environment will be discussed.  Also, the speakers will provide examples of document and study lifecycles with regards to records management, archiving, and system governance.

• Learn how to use of the DIA TMF Reference Model in an electronic TMF
• Understand integration with adjunct systems required for a eTMF
• Hear about the changes required for the Essential Document SOP, templates and processes control in a validated system
• Learn about records management, archiving and system governance

Achieving The Right Balance to Automation as You Move from Manual to Electronic

Thursday, 2:40 – 3:15

Raoul Lorenz, CEO, LORENZ Life Sciences Group

Raoul Lorenz will be discussing how moving from a disconnected manual process to an electronic process will make the journey from authoring to publishing less chaotic, more collaborative and unmistakably desirable.  He will also explain why too much integration, however, can also have the opposite effect in a world of changing regulatory requirements and constant corporate organizational change.

Attendees will get exposure to the various disparate activities within a document/submission management process and hear where integration and automation makes sense and where it might not – ultimately, making their lives easier in day-to-day operations, but still allowing for change to happen.

This presentation will draw upon Raoul’s real life experiences working with global agencies, industry customers, and regulatory organizations to make practical propositions delivering direct business impact.

Case Study: Millennium’s Solution for Integrated Submission Planning and Tracking and Regulatory Information Mgmt: GOPATS System

Thursday, 3:40-4:15

Rebecca Greenberg – Associate Director, Millenium Pharmaceuticals

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.

 

SharePoint and Office – The Platform for the Next Generation life Sciences Solutions

Thursday, 3:40-4:15

Gabor Fari – Director Life Sciences Solutions, Microsoft Corporation

This presentation focuses on the benefits and unparalleled power of Office 2010 and SharePoint 2010 as a platform for regulatory compliance.  It will explain Microsoft’s strategy of uniting the functionality of Desktop productivity software with the back-end Content Management capabilities of SharePoint, and why Microsoft views Collaboration and Content Management as two essential and indivisible elements of any company’s ECM strategy.  The presentation highlights the benefits of SharePoint as a foundational platform for content-centric applications, and the paradigm of building best-of-breed solutions on an integrated platform.  Pending Microsoft’s product disclosure timeline, the presentation will also provide attendees with a preview of what to expect from the next generation of Office and SharePoint technologies.

• Combining Microsoft Office and SharePoint to form an integrated platform for regulatory compliance
• SharePoint and ECM: All about the Content, Collaboration and Compliance
• Preview Microsoft’s vision for the next generation of productivity solutions

 

Implementing Structured Authoring – Understanding the DITA Model and its Applicability for Content and Metadata Management

Thursday, 4:25-5:00

Dr. Michael Brennan, Ph.D. – Director Informatics, Informatics Center of Excellence, 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

 

Roche Diagnostics Integrates PDF Rendering with SharePoint for Regulatory Compliance

Thursday, 4:25-5:00

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

Roche Diagnostics has implemented a single, hybrid, globally integrated DMS (Document Management System) that combines the strengths of Microsoft SharePoint, SAP Product Lifecycle Management (PLM) application and PDF Rendering from Adlib.  The new DMS supports Roche’s entire product lifecycle from research, idea creation and patent application, to product development, proof-of-concept and user acceptance testing, and finally to the supply chain, production and ongoing quality assurance. Roche has six thousand users on the new DMS which houses 250,000 documents and requires the generation of 40,000 PDF renditions monthly. The speed of the PDF rendering, which takes only seconds, is helping Roche meet aggressive target turnaround times for various document workflows. The integrated system facilitates the submission process to deliver high quality PDFs to meet FDA (21 CFR Part 11) regulatory standards while reducing document QA times, cutting costs, speeding up submission preparation and reducing the potential for rejection due to formatting errors.

You Will Learn:

• How to integrate PDF Rendering with SharePoint
• How SharePoint is enabling high quality PDFs within Roche Diagnostics
• How to meet regulatory standards while reducing document QA times, speeding up submission preparation & reduce rejections

 

What’s Next: A Glimpse into Microsoft’s Health & Wellness Research

Friday, 8:45 – 9:30

Dennis Schmuland, MD FAAFP, Chief Health Strategy Officer, Microsoft Corporation

With more than 850 scientists and researchers working in labs around the world, Microsoft Research (MSR) is focused on advancing the state of the art in computing through a combination of basic and applied research. MSR researchers look over the horizon and beyond today’s products to imagine what might come next as they seek to solve some of the most significant technical challenges we face.

 

Deliver SharePoint Success: Achieving Organization Buy-in to Transform Your Enterprise

Friday, 9:30 – 10:15

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

SharePoint has shifted the paradigm in enterprise collaboration. By empowering knowledge workers, SharePoint can increase worker productivity, improve efficiency and streamline business processes. To achieve this goal, focusing on technology alone is not enough. Effectively identifying business value, gaining stakeholders’ support and efficiently managing SharePoint initiatives is paramount to success. Join SharePoint thought leader Dux Raymond Sy as he shares best practices and proven techniques on how to maximize the business benefits of SharePoint and achieve organizational buy-in that can transform your enterprise

• Gain executive buy-in for SharePoint initiatives
• Identify and prioritize business solutions that SharePoint provides
• Properly plan and appropriately manage expectations
• Engage the business for better adoption
• Define organizational SharePoint

 

A CRO’s Journey to Making Collaborative Trials a Reality with SharePoint and BPM

Friday, 10:45 – 11:20

 

Don’t Learn The Hard Way: 6 Common Pitfalls That Can Derail Your Successful SharePoint Migration

Friday, 10:45 – 11:20

Evan Callender – Director, West Monroe Partners

The decision to migrate to the latest version of SharePoint, either from a previous version or another enterprise platform, is often made because a “newer, better, faster” option is available.  Even when making the right decision to upgrade, organizations should take steps to plan, prepare and manage the expectations of a successful SharePoint migration.
As a leading expert in Enterprise Content Management strategy and implementation, with deep experience in SharePoint migrations, West Monroe Partners has first-hand experience in what can “make or break” a SharePoint Migration.  Session attendees will learn the factors that must be considered, the elements that must be planned and the time that must be budgeted in order to have a seamless and successful SharePoint migration.

Attendees Will Hear:

• Valuable lessons learned after 30+ migrations from 3rd party apps, prior SharePoint versions & other places we can’t discuss!
• How to:
  • Identify & plan for critical issues
  • Test effectively & efficiently
  • Minimize downtime & ensure continuous access

 

Transforming a Paper-Based Trial Master File to a Streamlined Electronic Document Management Solution Using SharePoint

Friday, 11:30 – 12:05

Patricia Brady, Sr. International Clinical Trial Manager, sanofi-aventis

Denis Cardinal, Clinical Information and Collaboration Domain Manager, Sanofi R&D

Sanofi has an extensive portfolio of prescription drugs, vaccines, generics, and consumer healthcare products targeting traditional markets and emerging countries. Sanofi addresses fundamental health issues and makes major therapeutic solutions available in its areas of expertise: oncology, diabetes, thrombotic and cardiovascular diseases, and central nervous system disorders.

At sanofi, managing clinical drug trials was primarily a paper-based process. The logistics of managing this paper-based process for dozens of concurrent trials was daunting, expensive and time consuming.

Sanofi wanted to optimize this current manual process with a streamlined digital signature–compliant document management solution operating in a global, web-based collaborative framework.  The company implemented their Clinical Trial Portal, which is based on Microsoft SharePoint portal and collaboration technologies.

In this session attendees will learn:

• The business benefits that sanofi expects to realize from their clinical trial portal
• The advantages of the SharePoint platform in implementing the solution
• The challenges faced and lessons learned

 

Best Practices for a Successful SharePoint Upgrade/Migration in Life Sciences

Friday, 11:30 – 12:05

Mathew Roberts – National Competency Lead, Portals and Collaboration, EMC

Upgrades and migrations of any type introduce risk to your environment. Avoiding disruption and unforeseen delays requires an understanding of your organization’s IT infrastructure and business objectives and the development of a clear strategy and migration plan. A proven methodology and experienced people are also needed to make this transition successful.

This session will address successful strategies and approaches for migration and/or upgrading to SharePoint 2010 within Life Sciences. We will illustrate the potential pitfalls for SharePoint upgrades and migrations and how to avoid them. Ensuring business continuity throughout the upgrade process – maintaining a successful coexistence of the old and the new environments until the project is complete is critical to life sciences organizations.

Attendees will learn the importance of:

• Understanding the current environment and the level of effort and complexity involved in the migration
• Reducing the risk associated with this technology change• Reducing migration costs with an offshore factory approach
• Leveraging the SharePoint platform more effectively and take advantage of its new capabilities
• Maximizing your investment in SharePoint along the way

 

Deploying and Governing SharePoint Across the Enterprise

Friday, 1:10 – 1:45

Janet Buck, Director, Enterprise Systems, Otsuka Pharmaceuticals
David Gwyn, Vice President R&D and Collaboration, HighPoint Solutions

In this session, you will learn practical approaches for planning and implementing a successful, enterprise-wise SharePoint deployment. Based on first-hand experience, we will address the common challenges around information lifecycle management, architecture, record management, information security, and business process integration. The presentation will also cover the requirements for governing the SharePoint 2007 and 2010 platforms and the tools to achieve GxP compliance within your environment.

Benefits:

• Learn tips for planning and executing an enterprise-wide SharePoint deployment
• Find out how to address common challenges during implementation
• Discover methods and tools for governance and compliance

 

Site Monitoring Made Easy

Friday, 1:10 – 1:45

Jeramiah Rehm, eClinical Solutions Specialist, BioClinica

A large pain point for frontline, traveling clinical research associates who must provide data into a CTMS is the completion of monitoring reports. Due to the nature of their site engagements, there is a large unmet need to support online and offline completion of monitoring reports.  Utilizing SharePoint automation and supportive integration technology, BioClinica has developed an approach for submission of monitoring reports which provides seamless experience to the end user for either online or offline working. This approach provides a robust stream of monitoring data to the CTMS, allowing efficient working practices for CRAs and up to date metrics for the entire study team.

 

Global Hub Based Medical Information Management

Friday, 1:55 – 2:30

Dr. Scott Metker, Chief Architect, RWD

As pharma companies continue to expand through mergers, acquisitions and partnerships, the challenges in managing and providing medical content and information across global regions have increased as well.  Coupled with ongoing pressures to decrease reliance on call centers and improve the accessibility and consistency of medical content, these challenges have triggered the emergence of a new approach: Global Hub Based Medical Information.

This concept is based on the transition of global medical communications from a traditional transactional, phone-based model to one that is centered on providing a direct, localized expert response capacity based on tiered global content hubs.  Content in this model can be standardized around region or product and can utilize a “master record” content to provide greater efficiency in the re-use of content across the organization.

You Will:

• Learn how to realize the success pharma organizations have had in deploying and managing medical information and content across global regions
• Understand how SharePoint can be utilized as the common platform for all of those regional users

How Microsoft SharePoint Functions as the Foundation of Peregrine Pharmaceutical’s Business Process Automation Initiatives

Friday, 1:55 – 2:30

Nick Ferguson, Associate Director of Information Technology, Peregrine Pharmaceuticals

Peregrine Pharmaceuticals selected Microsoft SharePoint and NextDocs to manage key aspects of their quality and compliance program – specifically Deviations, CAPAs, Standard Operating Procedures, Training Records and Regulatory Submissions.

Before implementing SharePoint, Peregrine’s quality program was comprised of manual, paper-based processes while submissions and other regulatory information were managed using open file share directories.  These manual processes were slow and cumbersome and many of the key processes such as document routing for review and approvals could take days.  With SharePoint at the heart of their quality and compliance program, these processes can now literally be accomplished within minutes across the enterprise.

Peregrine is also leveraging SharePoint in combination with other third-party technologies to automate some of their other corporate processes outside of the quality domain – resulting in still more process efficiency and cost savings.

You Will Learn

• The key features of Microsoft SharePoint that make it the ideal platform for automating critical business processes.
• The benefits of implementing a COTS solution to manage key aspects of a quality and compliance program.
• How other complimentary third-party technologies can be leveraged to achieve additional process efficiencies and cost savings.

 

Maximize Efficiency and Collaboration for Improved Product Information – Integrated SharePoint 2010 Knowledge Management Portal Links Explicit and Tacit Knowledge

Friday, 2:40 – 3:15

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

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

Grünenthal’s SharePoint-based “WiseNet” collaboration portal is at the heart of a new integrated knowledge management system that links explicit knowledge – e.g. information captured in regulatory documents – with previously undocumented tacit knowledge which is now captured using a variety of online collaboration tools.

By offering completely new options for information exchange, the system improves the medical community’s ability to profit from experiences made during previous and current product launches. Using a template-based approach, the solution is ready to be scaled out to support future product launches and other new global company initiatives.

In an attractively branded environment, end users across departments and affiliates can now follow product lifecycle developments, collaborate on the creation of product information, and find and connect to expert colleagues. Global virtual team collaboration is supported through the means of on-line calendars, meeting workspaces, discussion groups, people search, and other collaborative technologies.

In this session attendees will learn

• How Grünenthal is leveraging SharePoint to support Knowledge Management within their medical information organization
• Which SharePoint 2010 collaboration features are being used to support information exchange for improved business results
• How highly controlled documents and uncontrolled collaborative content can be segregated yet integrated

 

Assured Compliance Using SharePoint 2010: A Case for Unified Records Management

Friday 2:40 – 3:15

Art Bellis, VP, Sales & Alliances, GimmalSoft

Dean Van Dyke, Group Manager, Microsoft

Kurt Thies , VP of Unified Records Management at Iron Mountain

Low user adoption rates for traditional records management systems are making organizations struggle to demonstrate enterprise-wide compliance with legal and regulatory requirements. In many cases companies have some control over physical records, but are struggling to manage electronic records and email and to apply consistent policy over both physical and electronic records. Join Gold Certified Microsoft Partners GimmalSoft and Iron Mountain along with Microsoft to see how they are producing a new standard for unified records management built on SharePoint 2010.

Attendees will learn about a solution that will benefit their organizations in several key areas:

• Learn how to cohesively manage electronic records alongside physical records inventory, both on premises and offsite, from a common SharePoint™ interface to achieve real unification across physical and digital records.
• Learn how to consistently manage all records, both physical and electronic, through their entire lifecycle, and apply legal holds and policy for retention, holds and disposal to simplify records management processes on a unified platform.
• Learn how a new solution will let companies classify and manage physical and electronic files more consistently, a key requirement for accessing information fast, meeting compliance regulations and being prepared for litigation.
• Learn how SharePoint™ can be a compliant environment not only for electronic records but also physical records.