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Process Development as a Harbinger Arena for Downstream Success in Formulation and Drug Delivery Integrating Process Knowledge Management Across the Enterprise

Abstract
As with traditional Pharma, Biotechnology companies today aggressively prioritize their development efforts on the most promising compounds in the discovery pipeline . Indeed, compounds that appear to be more risk-laden, must be evaluated efficiently for formulation and delivery success. If a less than promising lead needs to be "killed" early in the process, it will allow resources to be focused on other pipeline projects that offer more commercial hope for the company.

Intuitively, companies have traditionally looked to their process development groups to help achieve the efficiencies demanded by the clinic, the marketplace and shareholders alike. However, the solutions typically rely on applying the latest technological and scientific techniques to better characterize the compounds being investigated. And while intrinsic and specific knowledge is indeed gained, it can not be assumed that this new learning will permeate throughout the organization and its third party vendors. Learning and best practices can be applied not only to the current project at hand, but to future ones as well.

This presentation will present two case studies which offer insight into how companies can leverage this knowledge into an overall framework of operational and product development excellence. Doing so, will help companies get more out of their existing systems by removing the "data silos" that have evolved over time. This framework will enable greater accuracy, completeness, and leveragability. Emphasis shall be on the consistency "between" as well as "across" the complete enterprise to yield more insight into the selection and prioritization process for future and ongoing projects in the development pipeline.

Based on case studies in both biotech (lyophilized protein) and small molecule chemistry (phase transitions in the solid state), and relevant market research findings, the presenters will highlight how creating a more effective knowledge management system will help the process development function achieve simultaneous improvements in business operations, scientific outcome and regulatory/quality performance. Deductively, the information presented will provide the strategic roadmap that companies should consider to align with the FDA’s 21st Century GMP Critical Path initiatives.

Speakers:
Sam Venugopal, Business Conformance Manager;
Art Mlodozeniec, Chief Scientific Officer
Conformia Inc., Redwood City, CA