Efficient Process Development Management

There are three underlying factors leading to successful implementation and commercialization of industrial processes or products: 1) dedicated and well-aligned innovative research and development efforts, 2) process safety, and 3) tech-transfer. To ensure successful, safe and profitable transition to commercialization, efficient process development management is key to tying all the pieces together. This session will provide examples to answer the question: How can new processes be implemented rapidly and successfully through innovative solutions in a highly collaborative setting to minimize the time and effort invested in product development stage.

Session Chairs:

• Deboleena Chakraborty, Dow
• Kil Ho Lee, Dow

Schedule:

Abstracts:

Pending finalization - Please check back soon for updates

Translating Innovation to Solve Real-World Problems : Commercialization Process

Bindu Krishnan, Dow

Innovation and Technology drives the commercialization process that results in product leadership and market competitiveness. At the same time, product commercialization is essential for the growth and sustainability of any industry. As a result, industries are adapting to a fast paced approach to product development followed by an effective and streamlined commercialization process. These processes involve developments and activities connecting different business functions. This talk provides insight into the processes involved, the challenges, the partnerships, and other related activities pertaining to the progression from Idea to a product to commercialization.

Quantitative Framework to Guide Process Development in the Pharmaceutical Industry

Amanda Rogers, Bristol Myers Squibb

The nature of the pharmaceutical industry presents unique challenges in managing process development. The pharmaceutical industry is highly regulated. As such, quality risk management drives many aspects of decision-making. Other process development objectives, such as sustainability and cost, must be evaluated in this context. In addition, new drug candidates are often complex molecules requiring innovative synthetic approaches. Therefore, process development can be resource intensive. At the same time, many new drug candidates do not progress beyond clinical development. For this reason, it is important to invest resources judiciously.

This presentation will describe a framework for managing the development of pharmaceutical manufacturing processes efficiently. The proposed approach relies on quantitative process analysis to evaluate performance with respect to quality, sustainability and cost objectives. The resulting information from both modeling and metrics inform decision-making with respect to resource investment for process design throughout clinical development. Case studies are presented to demonstrate the application of this framework to small molecule drug substance process development.