Case Study Update on Structured Content Approaches at Genzyme

Transcription

1 Case Study Update on Structured Content Approaches at Genzyme Monica Mehta Director, Regulatory Operations Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. 1

2 Agenda Background Plans for 2009 Business Case Development Plans and next steps Agenda Background Plans for 2009 Business Case Development Plans and next steps 2

3 Background Recognized the value of approaches in submission development and compilation for global submissions Conducted a Proof of Concept in 2008 Content will be: Perceived Benefits Authored once in a manner that is independent of formatting, publishing or viewing considerations and then reused and repurposed for use in a variety of submission documents; Tagged for inclusion/exclusion in submission documents Stored in a content library from where it can be linked Dynamically assembled into global submission documents Delivered to a variety of channels or media Easily searched for reuse and maintenance Reviewed at a granular content level or at a composite document level based on reviewer or organizational preferences Rendered or presented based on the regional agency requirements including different formats and languages (translations) 3

4 Proof of Concept Objective Objective Analyze the potential for utilizing structured content concepts and techniques to the content authoring processes in providing efficiencies in the compilation of global submissions. Focused on the quality related content for submissions in CTD (Proprietary), Redacted (Non-Proprietary) and ASEAN presentations. The Proof of Concept utilized Virtify s Structured Content Management () solution as the technology platform. POC Results Successfully demonstrated the following for a document Editing Structure and Content Map Linking Content Redacting Proprietary Content Tagging/Replacing Content Viewing/Rendering g the same document in different formats ICH or ASEAN CTD Export to Word, PDF or HTML 4

5 Agenda Background Plans for 2009 Business Case Development Plans and next steps Transition to Develop a roadmap Identify Submissions, Geography or Therapeutic area for a pilot Collect metrics Demonstrate the Benefits Identify Best Practices and Lessons Learned Organizational Change Management Process Roles and Responsibilities Supporting Tools and technologies Education, awareness, communication and training Technology choices are critical Solutions should support global, long-term needs Must be open, scalable and extensible 5

6 Build on the success of the POC Plans for 2009 Identify business processes which could benefit from approaches Develop strong business case Qualitative and Quantitative Align with Structured Protocol initiative Develop RFI for vendors Develop Transition Plan Agenda Background Plans for 2009 Business Case Development Communications Process Scope SIPOC Analyses Examples Alignment with Structured Protocol Initiative Quantitative Business Case Model Lessons Learned and Best Practices Plans and next steps 6

7 Communication: Why Now I can find all of the documents ever created! But what I need is to know which documents have the correct information for my purpose! -- and where are the supporting documents and data! Search Search Search Search Search Search Search Research Preclinical Quality Clinical Regulatory Manufacturing Marketing Too Much Rework Communication: Why Companies spend too much time creating new documents, rewriting existing documents, repairing format and applying metadata to documents that provide the same product information for different audiences. Lack of Discoverability In today s business models, content is created in multiple locations, sometimes by multiple authors and frequently moved from one repository to another making it difficult to find and track. Ineffective Automation, Security and Findability Assignment of sufficient and meaningful metadata to enable workflow automation, security, findability and interoperability of documents across systems is labor intensive and time consuming. Stove Pipe Systems Authoring and content search systems are isolated in functional area silos which makes it difficult for authors to avoid re writing and content consumers to discover cross functional information. 7

8 Communication: User Benefits Reuse & Re purpose Content Create documents from reusable content (i.e., building blocks ) of text and data, the system automatically applies formatting and metadata rather than authors. Enhance Transparency Status is tracked at both the topic and document level making it easier to understand what parts of a document, (i.e., topics), are ready for review, and which remain. Improve Workflow, Security and Findability Metadata is at both the topic and document level enabling the system to automatically and selectively notify users of their writing and/or review tasks. With topics, users search and navigate to find content either by subject matter (i.e., the topic ) or document. Communication: User Benefits Write it Once in a manner that is independent of formatting, publishing or viewing considerations and then reuse and repurpose for use in multiple submission documents Apply effective metadata to improve search and dynamically assemble global submission documents Store all content in a single source library from where it can be discovered, linked and reused for multiple purposes Publish documents for internal use as well as regulatory submissions Reduce re review by reusing content at a granular level or at a composite document level based on reviewer or organizational preferences Re publish, don t rewrite content based on regional agency requirements including different formats and languages (translations) 8

9 Communication: and Business Process Maturation On the surface, structured content takes unnecessary re-work out of the business process, i.e., copy & paste Structured content also opens the door to enable maturation of business processes Content is created in more standardized business processes Carried out with predictable results by internal or external resources Based on accepted standards for data, terminology and readability Automatically evolving over time and aligned to business purpose With measurable work effort and tracking of improvements Bottom line, more time is dedicated to quality of the result and achievement of business objectives : Real World Example Content Reused Use of a text fragment, without modification, in multiple documents For example: Reuse in: Clinical Protocol: ICH E6(R1) Clinical Study Report: ICH E3 6.2 Background and Rationale 7. Introduction Protocol Synopsis-Objectives 8. Study Objectives 6.3 Study Objectives and Purpose 8. Study Objectives Content Re-purposed Provision of text to users in multiple roles to provide context and supporting information for multiple business uses For example: Re-purpose information for: Clinical Protocol: ICH E6(R1) Clinical Study Report: ICH E3 6.9 Statistical Methods-Efficacy Analysis Efficacy Evaluation 6.9 Statistical Methods-Safety Analysis Safety Evaluation 6.13 Data Management and Monitoring 9.6 Data Quality Assurance 18 9

10 : Genzyme Process Scope Clinical: Process: Phase III Clinical Trial Process steps to design, conduct, collect data, analyze and report Nonclinical: Process: Repeat Dose Toxicology Study Process steps to design, conduct, collect data, analyze and report CMC Analytical Testing: Process: Stability Testing Process steps to prepare, execute, collect data, analyze and report Labeling: Process: Label Development Develop Target Product Profile Develop Core Data Sheet Develop Package Inserts SPL; PIM etc Comply With Local Regulations Administrative: Process: Implement Global Regulatory Strategy Process steps for submissions to comply with local regulations for drug development and marketing Process steps for submissions and regulatory communications to implement a product s global regulatory strategy 19 Design, Develop and Use a Clinical Protocol Designing the Protocol Writing the Protocol Using the Protocol Source Study Hypothesis Medical Writer selects clinical protocol template based on study design, experience and standards Process Medical Writers & Clinical Scientists write study specific text using MS Word Reusable text is mapped to future clinical documents Output Protocol document is published and delivered to clinical sites Consumer Study configuration information is delivered to clinical systems Clinical Trial Management Systems XML Templates apply previously created reusable text to reduce re-writing Input Text is collaboratively reviewed and updated Process e-data Collection Systems Clinical Data Management Systems XML XML 10

11 Design, Develop and Use a CCDS Target Product Profile Core Data Sheet Labeling Source Research, Development and Marketing provides input to define the target product Process Reusable text is mapped to future pre-clinical and clinical documents Output CCDS document is published and made available from LiveLink Labeling creates and maintains the CCDS Consumer Local markets refer to the CCDS for labeling submissions Templates apply previously created reusable text to reduce re-writing Input Text is collaboratively reviewed and updated, continuously Process Internal decision making bodies refer to the CCDS as a product profile Medical Affairs refers to the CCDS in responding to customer questions Consumer A Document is an information snap-shot but product information continuously evolves Drug R&D Timeline Years C Pre-market Marketed 11

12 Global Development Plan: A Series of Snapshots over time Target Product Profile Drug R&D Timeline Years C Indications and Usage Dosage and Administration Dosage Forms and Strengths Contraindications Warnings and Precautions Adverse Reactions Drug Interactions Use in Specific Populations Drug Abuse and Dependence Overdosage Description Clinical Pharmacology Nonclinical Toxicology Clinical Studies Patient Counseling Information Target Launch Research Preclinical Quality Clinical Regulatory Manufacturing Marketing Linked to Supporting Content and Data Process Scope of Trial Registration & Results Posting Process: Phase III Clinical Trial Posting Trial Results Determination to post results of a trial Where the trial results should be posted When (e.g., post-study, interim, ) After product approval (posting is in context of all studies as submitted) After completion of study (one study at a time) Delay in posting for incomplete study or new indication (file request to delay, requires IND Information) Gather existing trial information Tables, lists and figures (TLFs) CSR (interim, final, errata) Clinical Trial Management information IND/IB/IMPD Registration posting List of publications (peer reviewed if results are presented) Create posting content Author additional topics Character length summaries of: - Patient Disposition (Patient Flow) - Outcome Measures (e.g., PK) - Efficacy or Safety or Both (tabular, no narrative) - Adverse Event Information (SAE, Non-serious AE) Posting trial results to Regulatory Authority Data elements required by Regulatory Authority Maintaining trial results posting Interim to Final Links to new publications with results 24 12

13 Business Case: Clinical Trial Registration and Result Posting Background Authorization to conduct a Phase 3 clinical study usually requires the study be registered and approved in advance for countries where clinical sites are located. Posting of results may also be required Goal Integrate data and content for Phase 3 clinical study trial registration documents to minimize the time required for authoring, review and approval of new content Description The data elements and content components required for trial registration are standardized as elements of the protocol and other documents or data elements required in design of the study Metadata is standardized and templates are defined to enable automatic assembly of trial registration elements by country The data elements and content components required for results posting are standardized as elements of the study report and other documents or data elements provided with the study report Metadata is standardized and templates are defined to enable automatic assembly of trial results elements for posting by country Benefits Elimination of manual transcription errors and time to transfer data and content elements to registration/results package Reduce time and resource required for initial and updated registration or results posting Improve consistency and quality of data and content elements for registration or results posting Opportunity Cost Inability to reduce time for transfer of data or content to registration or results postings Inability to reduce time to review and ensure data and content quality Process Maturity Perform Manage Define Quantify Optimize Objective Current State Clinical Trial Registration and Result Posting Current State SIPOC Business Process Model Start Process End Process Gather Information Summarize and Integrate Draft Registration Package Review Registration Package Submit Registration Package Project Management Update Registration Supplier/Source Input Process Output Consumer [i] Clinical Trial Management System [r] BMRAC Program Dev. & Ops. [r] Biomedical Data Sciences Clinical trial sites List of data elements required for registration Tables lists and figures from Access CTMS to determine location of trial sites Work with Regulatory Affairs Access tables, lists and figures to [r] Clinical Research Protocol Synopsis Access Protocol Synopsis [r] Regulatory Affairs Access IRiS information [r] Regulatory Affairs Access IND information List of countries for trial registration Clinical Trial Registration Package for each country [r] BMRAC Program Dev. & Ops. [i] Regulatory Authority Relies upon labor intensive manual processes to copy and paste information from source to trial registration documents Legend [r] Role involved in conduct of a business process [i] Information source or application 13

14 Clinical Trial Registration and Result Posting Future State SIPOC Business Process Model Start Process End Process Gather Information Summarize and Integrate Draft Registration Package Review Registration Package Submit Registration Package Project Management Update Registration Supplier/Source Input Process Output Consumer [r] Regulatory Affairs List of countries and data elements required for registration Work with Regulatory Affairs Clinical Trial Registration Package [i] Regulatory Authority [r] Biomedical Data Sciences Tables lists and figures from Access tables, lists and figures [r] Clinical Research Protocol Synopsis Access Protocol Synopsis [i] Clinical Trial Management System List of clinical sites and countries Access Clinical Trial Management information [r] Regulatory Affairs Access IRiS [r] Regulatory Affairs Access IND Labor intensive content transfer steps are removed, reducing level of effort and potential for error Legend [r] Role involved in conduct of a business process [i] Information source or application Structured Protocol Template Development Structured Protocol in the scope of the Clinical Data Standards program at Genzyme Process for structuring the global protocol template: Identify content in the protocol which could potentially be structured Identify content as data vs text vs free (ie, unique) Define rules and exceptions for structuring Structured protocol templates will be based on industry standards and variability will be based on Genzymedefined implementation of these standards (ie, preferences) 14

15 Quantitative Business Case: Structured Protocol Develop a quantitative business case model for Structured Protocol Timebox the effort Focus on 2 3 programs selected to best represent the pros & cons Gather only the data needed on cycle times and resources from the selected programs, find the balance of enough data to be credible while not overburdening resources Create a model (based on the data) to project the future state with for each program Candidate Programs A recent program representing Genzyme s evolving business strategy, A legacy program representative of the norm in how Genzyme conducts clinical studies A Phase I focus, one program where we look at a small set of representative Phase I studies A Phase III focus, one program where we look at a pivotal Phase III study Etc. Lessons Learned and Best Practices Focus on the business process and information content involved Do not discuss final document output or format Do not discuss tools and technologies Talk in business terms Clearly articulate business case for the organization Develop models and simulations to articulate the best practices 15

16 Agenda Background Plans for 2009 Business Case Development Plans and next steps Summary 2009 Accomplishments Identified business processes Business case development in progress Identified ways of having conversations with stakeholders 16

17 Plans and Next Steps Complete Business Case Development Decide on Prioritized Initiatives Gather detailed Business Requirements Issue RFI to Vendors RFI Development Vendor Assessment Candidate Future Development Projects Structured Content Management Non Clinical Study Report Stability Testing Results Batch Analyses Clinical Protocol Template(s) Statistical Analysis Plan (SAP) Clinical Study Report (CSR) Drug Product Specifications Informed Consent (IFC) Core Data Sheet Investigator s Brochure (IB) Package Insert Data Management Plan (DMP) Clinical Trial Registration and Results Disclosure Integrations with Systems: IVRS, EDC, CTMS, CDMS, Registries 17

18 Q&A Monica Mehta Director, Regulatory Operations Genzyme Corporation 18