People, science, and information make up the heart of any Life Science organization. And while integral to any pharmaceutical or biotechnology company's success, the manner in which these elements are synchronized, coordinated, and managed represents the key towards moving products through the development process to commercial launch.

However, this key has proven difficult to find as life science companies struggle to identify ways to improve operational efficiencies as a result of shrinking margins, rising development costs, and constrained resources.

Figure 1. Escalation Costs of Drug Developement
(Tufts Center for Drug Development Research Report , 2003)

Over the years, companies have been forced not only to build up their development pipelines but to do so in a way that subscribes to the new mantra surrounding drug development: "quick wins and fast failures." And while intuitively, life sciences organizations have looked to optimize their science to gain these efficiencies, one area that has been largely overlooked revolves around information management - that is the ability to collect, share, and learn from data that is generated at any given point in time throughout history of a drug's development cycle.

Conformia's independent market research has shown that companies today are challenged when handling the wealth of information generated within their development organizations. Whether it is gathering data to present at phase gate reviews, identifying key information gaps and associated development issues, or simply retrieving data with an understanding of why, when, and where it was generated, the business and information processes required to facilitate a seamless transfer of information across the organization has been limited in scope and capability.

Perhaps no other area requires as much assistance in this area as the process development function. As the "middleman" between research/discovery and commercial manufacturing, this functional group represents a huge opportunity in improving development efficiencies via greater knowledge management practices.

The whole of the developmental process, starting with the manufacture of toxicology ("Tox") lots through the production of clinical trial supplies and subsequent, commercial conformance lots, generates significant information and data of all kinds. Today, this "information explosion" is not managed in a way that captures the six (6) dimensions of development - who, what, when, how, where, why. This requires at a minimum, data visibility, retrievability, and traceability - all essential towards reducing product development cycle times as well as improving the success rate of molecules commercialized.

• Visibility - have complete downstream visibility to upstream functions to ensure better design for manufacturability, quality, and scalability; oftentimes, information is not shared with downstream functions early enough in the process to foster an environment that proactively avoids development issues.
• Retrievability - access information generated throughout the complete development process for a specific compound. (See Lifecycle and Composite sections below for more information); data retrieved will be related to materials, processes, equipment, etc. used during the scale-up process as the product moves out of development and into the commercial arena.
• Traceability - create a living development record of information generated; capture data in a manner that allows the history associated with development activities to be identified and understood within the context they were created. For example:
  • "Drill Down" - i.e. understand the materials (BOMs) as well as equipment (BOE) are associated with each step outlined in the process description. Follow the "thread" of information as it goes through the revision process.
  • "Drill Across" - i.e. correlate and understand the impact changes to various elements of a defined process - related to people, material used, rationale, equipment selected, etc. - will affect the final output; link each step outlined in the manufacturing procedures with the associated Bill of Process, BOM, and/or BOE.

Without these characteristics, the ability to perform specific tasks associated with process development activities directly effects the following:

• Inability to capture information systematically and consistently across the lifecycle of drug development reduces "inspection readiness"
• Time spent searching for data within the development arena takes away time that could be better spent at the bench performing various studies
• Limited scope and integration of current information systems and their ability to organize and communicate data contributes to inefficient decision making (information is not available during the relevant phase gate reviews)
• Limited tools available to create a living development history behind product development - one that allows users to understand the complete development history of a compound from bench to commercialization
• Lack of continuous improvement mechanisms; the ability to leverage data from past experiments in a manner that fosters stronger process understanding

Lifecycle vs. Composite Data Capture
To allow these elements to be achieved, it is essential that companies create and maintain the ability to integrate knowledge not only across the lifecycle of development but also, gather information at key ‘composite' points along the way.

Lifecycle View - represent the various inputs going into the development process (from candidate selection to commercialization); whether related to the development of Chemical and/or Bio-related Drug Substance and Product along with Analytical Methods, the following "information elements" should be captured to ensure the rationale behind certain decisions are captured related to the following:

• Process Descriptions: Process Flows, Manufacturing Procedures, Unit Operations, Batch Records, Lab Methods, Method Development
• Materials: Bill of Materials, Specs, Analytical Results, Samples, Usage (traceability)
• Equipment: Bill of Equipment, Cleaning, Calibration, Operating Conditions
• Standards: ICH Q8, CMC Sections, Procedures, Protocols, SOPs, Reference Standards
• Environmental: MSDS, Regulatory Compliance, EH&S, SARA
• People: Qualifications, Certifications, Roles, Training

Composite View - represent key points along the development process where information related to any of the lifecycle components can be captured. Providing this capability to organizations provides real-time visibility related to the development status of projects currently in the pipeline. Having this type of information readily available increases the likelihood that information is available when needed. Some key composite points ubiquitous to life science organizations might include:

• Phase Gate Management: Go/No-Go Decisions, Portfolio Management, "Park" / Revive projects
• Tech Transfers: Drug Substance - Drug Product, CROs/CMOs, Manufacturing, etc.
• Functional Reviews: Technical, Project, Commercialization / Manufacturing
• Regulatory Submissions & Audits: IND/BLA, PLIs
• Summaries: Campaigns, Batch Records, EH&S Reviews
• Knowledge Management: Electronic Record of complete Development Lifecycle
• Quality: Audits, Root Cause Investigations, Prospective - Quality by Design
• IP Management: Patent Filings

Conclusion
Through use of Conformia's solutions, companies producing either large or small molecule drug substance and drug product will gain the first comprehensive solution to simultaneously manage scientific innovation, business performance and compliance. Information integration across the entire development organization will create a new future state of corporate knowledge and infrastructure for tech transfer to Manufacturing which will be leveraged from the initial data entry.


If you have any questions about Conformia's solutions and how we can help your organization, please contact:

marketing@conformia.com