THE CHANGING FACE OF HEALTH CARE INFORMATION MANAGEMENT

Transcription

1 THE CHANGING FACE OF HEALTH CARE INFORMATION MANAGEMENT Graham Shelvey Director Regulatory Operations EU&Int. sanofi aventis Erick Gaussens Chief Scientific Officer ProductLife Group A reality : Information is the pulsing heart of Pharma R&D Finance & Administration Regulatory Affairs Sales I T Business Development Marketing Production Supply Chain & Purchasing 1

2 A Drug = a huge set of information Clinical Pre-Clinical Quality (CMC) Manufacturing Patents Pro Active Safety Product Information Labeling Portfolio management Life Cycle Submissions Dossiers Variations PSUR, DSUR IND, CTA, PIP Authorities External Data (e.g. Agencies ) Discovery Publications External Biblio Clinical Pre-Clinical Quality (CMC) Manufacturing A Drug = heterogeneous information Pro Active Safety Product Information Labeling protocols and data structure/models structured source/computed data structured product data (PIM/SPL) unstructured data assessment and evaluation Portfolio management Life Cycle Submissions Dossiers Variations partially unstructured GxP and patent documents PSUR, DSUR IND, CTA, PIP unstructured reports & publications as yet unstructured regulatory submissions (non-ectd) Authorities partially unstructured t Authorities documents portfolio tracking meta-data External Data external structured or unstructured information (e.g. Agencies ) Patents Discovery Publications External Biblio 2

3 A Drug = Disseminated information, Isolated or Linked? Clinical Pre-Clinical Transverse Quality (CMC) Document Domain Document Manufacturing Comp. Data Patents Source Data Pro Active Safety FDA, EMEA, WHO,.. PV, Portfolio Management Reg. Activities Mngmt. Discovery Regulatory Biblio Product Information Labeling Intranet Portals Search Engine.. Int. Int. Int. Publications Int. Gateway Portfolio To Agencies management Life Cycle Other transversal Int. Int. Submissions Dossiers Variations PSUR, DSUR IND, CTA, PIP Int. Int. External Biblio Authorities Int. External Data (e.g. Agencies ) The different information flows : Before Basic Research Drug Discovery Synthesis Biological Tests Clinical Development Registration Life- Cycle Management Preclinical Development Up to Registration, Production, LCM, Sales: Sales and nearly all information were kept inside the Company, and quite Marketing a lot inside Corporate, or for National Products inside Affiliates information Chemical was and mainly stored in but exchanged Production in paper like format even if stored Pharmaceutical in Development and Distribution Regarding outside Company communication, very few channels: patents prescribing information (depending on country s heterogeneous requirements) registration information (depending on country s heterogeneous requirements) 3

4 The different information flows : Now More and more internal sites and external actors are involved earlier and earlier in the Drug Discovery Lifeexchanges: Basic Synthesis Clinical Cycle patents, publications (before + during development) Research Biological Tests Development Registration Management Throughout development: exchanges with Health Authorities (HA), International Review Boards, Ethics Committee, Data Monitoring Committee, Patient Organization (eg for PIP) Specifically in Phase III : Industrial scale-up/knowledge transfer management to various Preclinical manufacturing sites all over the world During Registration and Development Life Cycle : interactions with potentially all HA around the world with their various demands frequently involving all affiliates/representatives in particular on critical issues like safety not forgetting insurance companies, formularies, lobbys, These exchanges require increasingly detailed requirements on : CTA, IND, PIP, Chemical and On prescribing Pharmaceutical information Development Production and Distribution Sales and Marketing ectd, STF, DMF. CDISC,. and emerging concepts like Risk Management Inspections from the MHRA Resulting in an ever increasing amount of information production/exchange over numerous sites and third parties As a result of these different information flows Information has to be exchanged and shared all along the global life cycle of drugs from the begining g these exchanges take place between numerous actors : sites, third parties, HA, patients, scientific community. wherever its sits information is eventually visible by a lot of people including inspectors. What is new is that the way information is exchanged/transferred is under scrutiny So how do we guarantee information consistency, reliability, traceability, recovery? Process and IT harmonization/validation Information standardization Information exchange standardization 4

5 DRM Reference Model DIA EDM Annual Meeting, Philadelphia 2009 Simplify EDM Save money, time and resources Leverage existing and emerging standards Eliminate duplication of effort, costly mistakes Make EDM systems investment a less expensive DRM Reference Model A Reference Model is a collection of structured content, data and metadata Content vs. Data vs. Metadata Content is narrative prose written by an author Data is information that can be derived by an authoritative i data source Metadata is information that is used to enable business processes 5

6 DRM Reference Model The Reference Model should be able to be implemented on a simple structured fileshare The Reference Model will enable information sharing between companies to support Acquisitions, Collaboration & Divestitures DRM Reference Model Functional Area Content Domains EDM Reference Model organized the content 6 major business domains Labeling Clinical CMC Administrative Nonclinical i l Pharmacovigilance Common data shared across all domains 6

7 DRM Reference Model Economics / Technology Healthcare, government, e-health initiatives Streamlining the data / documentation pathway Standards & Emerging solutions CDISC, HL7 CTD / ectd CRIX EDM must evolve Need for a flexible, open, "free" and sustainable model for the industry from the industry by the industry Once upon a time There was us, the company And them, the agency 7

8 Today s Reality IS More transparency More and more people can see and access the data behind their treatment 8

9 Potential Next Steps Will requires either some significant input from technology or an army of people distributing, reformatting and sharing information However a light at the end of the tunnel The Reference Model could be a major step towards enhancing information interoperability 9

10 Commitment To confirm this approach the DRM SIAC needs more people to expand and further develop the model It will also require that vendors receive requests to install platforms using the model in all areas of health care Conclusion Patients needs must remain paramount Whatever we can do to improve the quality of the information in and around health care should remain our priority 10

11 THANK YOU com 11