BioExec Institute
Module A - Creating Value
Day 1: BioProduct Development & Management
"Understanding the challenges and avoiding the pitfalls is key to successfully bringing bioproducts from research through development." |
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Biopharmaceuticals, medical devices, and other biological products face a plethora of regulatory and safety issues in addition to the major challenges all products face in moving from concept to reality. Understanding the requirements for and the inter-relation between manufacturing, clinical trials, regulatory approvals, and safety testing is essential to success. Industry leaders will join session participants to discuss the trade-offs caused by exploring new R&D models with the goal of creating value for your organizations.
Featured topics:
- Operational challenges of the product development process
- Selection and analysis of new projects and how to optimize their movement through the project pipeline
- Outsourcing for product development
- Key principles in product development that project teams must implement: linking strategy and organizational capabilities
Day 2: Manufacturing & Operations
"Biologics and biopharmaceuticals manufacturing is a linchpin between product development and commercialization." |
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New product development demands technology-specific manufacturing assets and upfront capital investment. Evaluation of innovative designs for manufacturing necessitates an ongoing assessment and alignment with commercial strategy. While manufacturing activities and organizations may be viewed as singular and insular, executives must have an integrated knowledge of the biologics industry environment, pre-clinical through clinical development, economics and science, and stakeholder requirements. Continuous evaluation of product life cycle management, technology, manufacturing options, and infrastructure are critical to optimizing production flexibility and asset utilization. Further, a dynamic regulatory and compliance/quality environment mandates ongoing assessment and implementation of new requirements and systems to minimize business risks.
Featured topics:
- Product development and manufacturing interface creating the foundation for successful technology transfer and clinical trial strategies
- Manufacturing process development and technologies
- Regulatory and compliance/quality considerations in product development and manufacturing
- Comparability assessment considerations while transferring technologies to new and/or multiple manufacturing sites
- Manufacturing Strategies: capacity and facility, supply chain, sourcing decisions and cost of goods
- Manufacturing-marketing interface
