2022 ISPE Facilities of the Future Conference

The opening session will take a high-level look ahead at global pharmaceutical manufacturing and related regulatory systems. We will discuss how COVID has impacted our business and the applications of future manufacturing operations and the facilities required to adequately produce product that is safe, cost effective and meets the needs of the patients we serve. Key industry leaders will share their perspectives and their insights into how they see the industry changing as we move forward from COVID.

Historically, industrial manufacturing has advanced from mechanization to mass production and then to automation/computerization. The next phase of manufacturing (referred to as Industry 4.0) involves integration of equipment and communication systems. The pharmaceutical industry is undergoing these same transformations (with the most recent phase referred to as Pharma 4.0). This session will explore aspects of Pharma 4.0 including IoT based technology and analytics, robotics in pharma manufacturing, a data mindset. This will include: The vision to integrate data and to easily visualize and analyze data providing insights across sites The future of pharmaceutical manufacturing with robots and cobots. The fundamental mindset shift to achieve a data driven decision.

Bio Manufacturing of the Future requires cost effective, scalable solutions that can be implemented quicker than the traditional stainless steel facilities of yesterday. This session explores aspects of bio manufacturing that challenge the status quo and push the boundaries of bio manufacturing as we know it. From continuous methodologies to disposable technologies, we explore the industries response to the bio manufacturing capacity challenge.

New facilities for the GMP manufacture of cell and gene therapies are starting to come online. This session includes presentations on two recently constructed facilities that represent the latest industry best practices in design, construction, and flexible, sustainable operation. Speed of construction is a common thread, along with innovative facility designs intended to accommodate future conditions. Join us for an informative session and the opportunity to interact with industry leaders in this segment.

It can be argued that the pharmaceutical industry is changing at its fastest rate in decades, driven in part by the requirement to manufacture new process modalities, as well as the need to deliver new facilities in a quicker and more cost effective manner. Speed to market and accelerating first-in-human has never been as important. Companies are having to respond to challenges such as increased development complexity, demand volatility, and CoG challenges as a result of increasing competition, pricing pressures and profitability.  Furthermore, growing demand for more flexible and sustainable facilities, together with the advancement of new processing and Pharma 4.0 technologies, such as digitization and robotics, requires that Site Master Planning needs to advance accordingly. This session will hear about how two major pharma companies have responded to the above challenging industrial landscape. Merck KGaA will explain how they have introduced a fully continuous bioprocessing platform into a new dedicated bioprocessing centre that facilitates end-to-end convergence of Discovery, CMC Innovation, Development, and Clinical and Commercial supply. Additionally, Bayer will explain how they have adopted a Site Master Planning of the Future approach to accommodate new process modalities, delivery methods, and Pharma 4.0 technologies.

The pandemic has had significant impact to industries around the world and the Pharma Industry has been no exception.  Early on, the Pharma Industry responded with unprecedented speed to bring treatments to patients through collaborations, leveraging expertise and creative solutions.  Today, we continue to navigate the pandemic with resilience and continued partnership.  This session covers a few of these collaborations and extraordinary responses COVID-19 Pandemic.

Hear from government authorities and industry experts on the lessons learned through the pandemic and the innovative development opportunities as a result.  The panel will discuss these topics and more with questions from attendees in this town hall style session.

Biotech is adapting and evolving to have more automation, digitalization, and we need to be ready for the new challenges while continuing to break barriers in our industry. How can we use innovative technology for both personal and professional growth? What types of technologies are smart facilities using for learning? How has virtual reality transformed how we learn?

Join this think tank during the Women in Pharma® breakfast and be part of innovative group discussions to transfer new and emerging knowledge to everyone. Facilitators will encourage creative and innovative design thinking (No prior knowledge required, just creative flow) and participants will be able to contribute and share ideas on different ways, types, and areas to use innovative technology for both personal and professional growth. Ideas from each group will be submitted and shared with the Women in Pharma® community of practice. Top Ideas will be selected as part of the Think Tank pilot and participants can support idea development teams.

This session provides insights from industry experts in meeting the extraordinary challenges of pharmaceutical production and development in the COVID age.  Hear about their experiences implementing new and emerging technologies and how these lessons learned can benefit future opportunities.

This session will explore novel ways to reduce project time lines and demonstrate how PODular manufacturing will increase facility flexibility to meet potential future changing business needs. The presentation is directly applicable to flexible manufacturing facilities and responsiveness of drug supply.  It will address key lead time challenges in traditional manufacturing and offer an option for manufacturing closer to the customer.

The second of the Emerging Technology sessions focuses on concepts promoting rapidly advancing manufacturing technologies enabling improvement in quality and process robustness, supply chain agility, and reduced costs. The session will address emerging practices for applying and taking advantage of the rapidly accumulating data, and illustrate examples of beneficial uses of that data.  Digitization is a key to enabling our industry to capitalize on many of the emerging technologies as they become available.   While these few examples are the “tip of the iceberg” of potential operational enhancements, hopefully they will ultimately lead to improved patient outcomes by mining and applying the right useful data.  Examples are great ways to help us better understand and recognize what further improvements might be most impactful and what data is pertinent to enabling those advances to be realized.

A generation ago, the market for vaccines worked well in wealthy countries – if you wanted to be immunized against a whole range of diseases, you could – but the system did not work that well for developing nations as they do not have the resources to make immunization available to everyone.  With the COVID 19 pandemic the developed world has seen firsthand, the impact and disruption a virus, without a vaccine, can have on the economy, supply chain and day to day life.  In developing countries, COVID is one more deadly virus add to the list of viruses they can’t afford to treat. Without low cost vaccines the impact to developing countries can be more devastating. Some of the leading causes of death in developing countries are HIV/AIDS, Malaria and Tuberculosis all can be solved thru affordable low cost immunization.  The battle to lift the world’s poorest populations out of hunger, extreme poverty and disease is ongoing.  In developed countries, low cost vaccines can help to ensure that all people, especially those people with the fewest resources, have access to the immunizations they need to survive. Speakers from the Bill and Melinda Gates Foundation, IPS-Integrated Project Services, LLC and Rommalag will discuss various programs, challenges and technologies to deploy low cost, distributed vaccine manufacturing capabilities in developing countries.

The world has experienced a dramatic year and the pharmaceutical industry and regulators have been at the forefront of improving the lives of people impacted by the pandemic. The response to the pandemic by the industry and its regulators has been tremendous. Helping solve the world’s problems together has changed the role of the industry and has driven value for the world. In our closing plenary session, we will hear from Joydeep Ganguly, SVP of Gilead, regarding how 2020 redefined the role and the value drivers of their efforts. We will also have Rick Friedman, Deputy Director, Science & Regulatory Policy, Office of Manufacturing Quality, CDER/FDA speak about the advantages of modern manufacturing. The session will conclude with a panel discussion including industry and regulatory leaders.