March / April 2024

2023 ISPE Pharma 4.0™ and Annex 1: Keynote Presentations

Nada Elsayed
2023 ISPE Pharma 4.0™ and Annex 1: Keynote Presentations

The 2023 ISPE Pharma 4.0™ and Annex 1 Conference was held in Barcelona, Spain, 11–12 December. Topics discussed included transforming operations, quality, and maintenance with Pharma 4.0™ principles and digitalization; strategies for implementing the latest Annex 1 version; the impact of automation on cutting-edge processes; and how rapid microbial monitoring enhances quality control precision and streamlines supply chains.

More than 425 attendees from 30 countries participated in the conference, which included 6 education tracks, networking opportunities and a vibrant exhibition area featuring 34 exhibitors. Participants also heard from industry leaders and regulators who shared their perspectives on the future of pharmaceuticals.

Opening Remarks with ISPE President and CEO

ISPE President and CEO Thomas Hartman kicked off the meeting with a warm welcome to the attendees and shared ISPE’s 2023 accomplishments, including the publication of the highly anticipated ISPE Baseline® Guide: Volume 8 – Pharma 4.0™. After his heartfelt opening speech, keynote speakers from different parts of the industry gave captivating talks. The speakers discussed a wide variety of topics, including innovation during COVID-19, regulatory topics, advancements in the industry, incorporating artificial intelligence (AI), and drug shortages.

Keynote Speakers

Quality Thinking in Lightspeed: People Making a Pandemic Vaccine

In his talk, Prinz gave a compelling presentation on how BioNTech was tasked with having to deliver the COVID-19 vaccine in the middle of the pandemic. Prinz discussed how, when faced with a nearly impossible task, the team had to rapidly find ways to maintain the highest levels of quality while also understanding that typical timelines were not at all feasible. To achieve this monumental task, Prinz had to streamline certain processes, ensure all team members were able to quickly adapt, and trust his team’s ability to deliver.

Prinz described his approach as “quality thinking in light speed.” He focused on the how instead of the why. Specifically, he focused on how to reduce complexity while increasing product quantity without taking any quality shortcuts. Using this approach, while also constantly reiterating the goal with each other, the team found innovative solutions to streamline the process and save precious time.

Some of the solutions they implemented included a single English label across all world regions to cut down on production time. In addition, the team implemented a multidose vial instead of a single-dose vial to reduce the production time. The health authorities also fast-tracked the FDA’s investigational new drug. With all these innovative and streamlined processes, they were able to successfully reach a viable commercial vaccine in an astounding eight months.

Advancing Digitalization in Manufacturing: EU Initiatives

Korakianiti gave a riveting virtual talk on advancing digitalization in manufacturing. She discussed how the use of digitalization and automation is expanding and how it’s important to make them “smart” to ensure that the highest quality levels are delivered. She urged the importance of investing in tech to help reduce or eliminate issues the industry faces: for example, drug shortages as demand increases to unprecedented levels.

Korakianiti noted that regulators have a big burden because they need to adapt quickly to the increasing innovations in digitalization. She explained that the EU is currently reviewing basic pharmaceutical laws to create the framework to promote technological innovation while also increasing patient access and drug availability.

In addition, the agency is also preparing for a future pandemic, should one happen. Regulatory sandbox tools are being implemented to test innovative approaches and the use of AI while safeguarding citizens. As recently announced in a press release, this is done using a risk-based approach. The EMA created a task force to balance guidance and AI use while leveraging current knowledge from other agencies. Korakianiti explained that, ultimately, the goal is to tear down boundaries and provide the best access to patients.

A National Competent Authority Perspective of the Legislative Momentum

Diaz gave a talk that touched on various pharmaceutical industry topics, including undeniable drug shortages experienced across the globe. The EU recognizes growing concerns, especially with drug demand increases coupled with supply chain shortages. The shortages are due to various factors, and some include disruptions related to environmental factors that cannot be solved easily by regulatory initiatives.

A first step to address shortages is to identify ahead of time where issues occur. For instance, the EMA identified a comprehensive list of nearly 500 of the most-used medicines. Over one-third of the active pharmaceutical ingredients (APIs) from that list are manufactured either in China or India. With that in mind, the agency is tracking manufacturing to help get ahead of possible shortages.

Legislators are also implementing incentives to manufacturers of these critical drugs. One incentive involves facilitating AI use in the life cycle management of drugs. Diaz echoed the sentiments of other keynote speakers, stating the importance of AI (if implemented correctly), having new legisla-tions to support supply chain disruptions, implementing regulatory improvements focused on manufacturing, quality controls, and leveraging knowledge from other authorities to facilitate these initiatives and improvements.

ISPE Foundation

Founder & CEO
LifeBee - Digitalizing Life Sciences

Teresa Minero’s energetic presentation about the ISPE Foundation rounded out the keynote session. Minero explained the foundation’s mission to fuel global health equity by fostering access to knowledge and nurturing diverse talent. She discussed the foundation’s philanthropic efforts, which include ISPE Knowledge Without Borders, student scholarships and grants, and supporting expansion of workforce diversity, among others. Before concluding, Minero showed how more than 180 students and Emerging Leaders from more than 30 countries were awarded a grant to attend different ISPE meetings in 2023, thanks to the ISPE Foundation’s support.

The 2024 ISPE Pharma 4.0™ and Annex 1 Conference will be held in Rome, Italy, and virtually 10–11 December. 

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This article contains an abridged, unofficial summary of presentations at an ISPE conference that has not been vetted by any agency or organization. The summaries are an informal and brief synopsis of the speaker views, and do not represent official guidance or policy of any agency or organization.