Global Product Information System (G P I S)

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What is G P I S?

Why do companies need G P I S?

GPIS stands for Global Product Information System and it is a cross funtional and pan-geographic REAL TIME database / system for products in development & products under evaluation.

GPIS is a company specific, customized management process which enables all participants to view / review all pertinent information for decision making before making any decisions. It is a management tool to make timely and accurate decisions based on the most up-to-date available information. GPIS is not a software or IT driven solution. GPIS requires just a web enabled environment which does not require "heavy" IT involvement.

In most pharmaceutical companies, the annual R&D portfolio review for the products in development is a cumbersome, time consuming and resource intensive process. The portfolio review is used to decide which products will be developed for which indications and also to prioritize R&D resources across the portfolio of products / projects. The key information required for decision making is spread throughout the company in various locations and functions. The collection of information and preparation for decision making is time consuming and has the potential errors due to the complexity of the cross functional data set. Companies need a business / management process and a simple tool to effectively managing this complex task to make these critical decisions.

The 3 unique features & functionalities of GPIS are:

1. Data / information integrity
2. Functional and cross-funtional consistency and validation
3. Functional and pan-geographic synchonization of data / information

• Top management
• General managers in countries & regions
• Global Marketing at all levels
• Vice Presidents of Marketing, Marketing Directors
• Vice Presidents New Product Marketing
• Project leaders, project managers, product managers, marketing directors
• For everybody who is actively involved in the development process of a product / project (internal / external)
• For product / marketing managers planning to launch a new product launch in any given country

• GPIS provides REAL TIME up-to-date information about all products / projects in development at all levels of the organization in all countries
• GPIS is THE top management tool for R&D and global commercial strategy
• GPIS is an early warning sytem for all projects encountering a "significant change"
• GPIS provides consistent, cross-functionally validated and updated information for projects in development (scientific & commercial)
• Sales & profit projections for all projects in development (global as well as local forecasts

During the development process of a pharmaceutical product, a company has to successfully complete a series of pre-clinical and clinical studies before it can submit the product for approval to the appropriate health care authorities (FDA etc.). At each stage of development, a decision has to be taken whether to continue the development of a product or to stop. These decisions are normally taken during the R&D portfolio review. In order to make informed decisions about the future development of a product, a company has to review a series of scientific and commercial information.

Eaxmples for scientific information include:

• Animal data (Pharmacology, toxycology, pharmacokinetics wetc.)
• Clinical data, clinical development plan
• Target product profile (TPP)
• Labeling information (Expected package insert)
• Indications
• Contra indications
• Limitations for use (Safety information, precautions etc.)

Examples for commercial / financial information include:

• Healthcare environment and marketing regulations
• Pricing & reimbursement regulations
• Competitive environment (current and future)
• Sales & Profit forecasts
• Cost of goods
• Financial information (Net Present Value etc.)

This information needs to be up-to-date, functionally and cross functionally consistent and pan-geographically validated (sales & profit forecasts). The following slide describes this overall process at a high level.

During the portfolio review a projects should be compared on an "apple to apple' basis, which requires a standardized set of information which will allow to compare the projects an the same set of information. There are various steps involved, which are described at a high level in the next picture.

The scientific and commercial information required for the decision making is complex and one of the difficulties in the process is to ensure that the data is consitent across functions and geographies. The data "cascade" has to be logical and consitent. The following simplified cascade illusterates the concept.

• Development plan for certain indications
  • Target Product Profile (TPP)
    • Approved indications
      • Labeling information (indications, safety, precautions, limitations for use etc.)
        • Maketing claims used as assumptions for sales forecasts
          • Pricing & reimbursement assumptions for sales & profit forecasts
            • Launch dates in various countries etc.
      GPIS is the up-to-date data repository for all the scientific, commercial and financial information required for decsion making.

GPIS is the REAL TIME cross functional and pan-geographic database containing all information required for the portfolio management decision process. GPIS can be accessed by all project team members, countries, senior management and everybody who requested and was granted access to this database.

• Complete transparency in all aspects of data generation & approval
• One data owner
• One approver
• One location
• Transparency for assumtions
• Defined timing
• Date stamped information
• Data are traceable
• Write / change rights for one person only
• "Read only" for non-contributors of data and information

• Pre-clinical results
• Clinical development plan
• Clinical results
• Target product profile
• Regulatory strategy
• Labeling
• Submission & launch dates
• Marketing claims consitent with labeling
• Marketing strategy
• Pricing & reimbursement
• Manufacturing COGs
• sales & profit forecasts
• Risk adjusted NPV

• Regular and timely synchronization on an "as needed" basis (clearly defined triggers)
• Any "significant changes" triggers an automatic synchronization and re-evaluation
• Any change in:
• TPP
• Pricing / Reimbursement
• Unexpected clinical outcome
• Changes in forecasting assumptions