The potential for faster innovation, and the power of collaboration and workplace and operations modernization are emerging into high relief as the assessment of the pandemic experience continues to deepen.
Among recent venues where industry and regulators have come together to explore these themes was the February ISPE Facilities of the Future Conference. Focused on the dialogue that took place there, the IPQ story that follows is divided into three parts:
● PART I: The Evolving Landscape of Pharmaceutical Operations
The first part of the story features insights from three thought leaders who shared their perspectives on where the pharma industry finds itself in the wake of a pandemic and the deeper trends and learnings that are presenting themselves at this stage of pharma’s evolution.
Gilead’s Joydeep Ganguly explored how biopharma operations will be “indelibly informed” by the pandemic experience. He highlighted five prominent developments for which the pandemic has served as a catalyst: ● deeper understanding of the speed at which innovation can move ● the progression from piecemeal digital transformation to digital standards ● the evolution in partnership models ● modernization of the workplace and workforce, and ● greater emphasis on meaning and purpose.
BMS’ Louis Schmukler provided a complementary view of the current developments and future evolution of biopharma. He outlined the major longer-term trends at work and how industry will need to respond to them.
CDER Office of Manufacturing Quality’s Rick Friedman highlighted the advantages of modern manufacturing for patients, industry, and regulators. Also reviewed is the closing panel discussion of: ● the notion of a “golden era” in industry innovation ● a more innovation friendly regulatory paradigm ● pandemic learnings on collaboration, and ● harmonization of regulatory standards.
● PART II: Government-Industry Collaboration in This and Future Pandemics
The ISPE conference also provided a forum for key US government participants in the COVID effort to explore how the government helped develop a plan to address the health crisis and coordinate the complex web of industry participants essential to that effort.
Office of Science and Technology Policy’s Matthew Hepburn spoke about Operation Warp Speed and the government’s vision for working with industry to combat COVID and future pandemics. Two representatives from the Biomedical Advanced Research and Development Authority (BARDA), Arlene Joyner and Tom Warf, provided additional detail on the government’s activities in response to the pandemic.
● PART III: Reducing the Cost of Vaccine Manufacturing for Broader LMIC Access
The third part of the story focuses on a session at the conference on how the Bill and Melinda Gates Foundation (BMFG) is helping pave the way for innovators to explore new technology for improving vaccine access in low and middle income countries (LMICs).
BMFG’s Rachel Lee provided an overview of the foundation’s role in enabling companies to explore developing innovative technology by partnering with them to remove their financial risk.
Rommelag’s Tim Kram explained how Gates funding is supporting his company’s research into the potential for adapting blow-fill-seal packaging to lower vaccine delivery costs in LMICs, and IPS’ Rob Roy described the Gates-funded work IPS is doing in modular technology for aseptic fill-finish applications. Also reviewed is the Q&A that followed the three presentations.