4 Questions and 4 Answers About Innovation in Pharma Manufacturing

The PDA Letter had an opportunity to ask Melissa Seymour, Vice President, Global Quality Control Operations, Biogen and Co-chair of the 2020 PDA Annual Meeting, four questions about innovation in pharmaceutical manufacturing—a major topic at the meeting. Below are her responses.

1) PDA Letter: As we enter the 2020s, what innovations are on the horizon for pharma?

Seymour: We are living in an era of perpetual change and innovation, which is enormously exciting, but also a bit scary. How do we keep up? In pharma, personalized medicine is changing physician/patient interactions focusing on individual response to drugs and treatment regimens. Cell and gene therapy is becoming a reality with many new products in the pipeline. The science linked directly to manufacturing is also moving forward at a rapid pace with advancements in machine learning and artificial intelligence driving huge set of data. Informatics and data science will be critical to future approaches to manufacturing, supply chain and distribution. All of this coupled with increasing global complexity can sometimes leave us feeling overwhelmed!

2) PDA Letter: I’m not a C-Suite leader. How can I encourage innovation within my plant?

Seymour: Innovation is important at all levels of the organization and has an impact at all levels of the organization. Continuous improvement and providing efficiency gains as part of day to day activities is additive and results in overall improvement to processes. Whether you are updating an analytical method, defining process controls, or managing data flow, ideas that are implemented at the floor level are critical to overall operations. Bringing forward new ideas is important across the business from manufacturing to supply chain, to regulatory affairs and quality. Optimization happens at all levels of the business and is impactful and important.

3) PDA Letter: How can regulators, industry, and academia work together to ensure adoption of these innovations, particularly due to the globalized nature of the industry?

Seymour: As much as we are overwhelmed, it is increasingly important that regulators, industry and academia work together to provide harmonization, education, and solutions to today’s challenges. The 2020 PDA Annual Meeting is a great opportunity to do just that. This signature event is an outstanding opportunity for pharmaceutical professionals of all levels to network, learn and innovate. The theme of this year’s meeting is “Enhancing the Future with Innovative Medicines and Manufacturing,” focusing on the future and how innovative approaches can provide opportunities to improve patient access to important medications. There is also ample time for peer-to-peer networking where industry, regulators and academia can converse and share learnings. As employees in the pharma industry, we are privileged to have impactful roles and it is incumbent for each of us to take this seriously and work towards innovative and important solutions for patients.

4) PDA Letter: How will the 2020 PDA Annual Meeting address innovation? Are there particular plenary talks, breakout sessions and interest group meetings I should consider attending?

Seymour: As I mentioned earlier, the theme of this year’s meeting is “Enhancing the Future with Innovative Medicines and Manufacturing.” Our goal is to provide learning and interaction through a comprehensive and informative program aligned with this theme. There will be opportunities to learn and engage on several key topics associated with data management, robotics, human factors, and modular manufacturing. We will have exciting talks around data integrity and managing our digital footprint to ensure data security. As always, we will hear compelling talks from patients, regulators and industry professionals as well as multiple networking opportunities to learn from and engage with peers. Of particular interest this year, we will have some focused activities for young professionals including speakers and networking events. We are really excited to bring forward a program that we feel will benefit all levels of the organization across multiple functions.