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.
This presentation, from a USG/BARDA perspective, will examine the journey and thought processes as the COVID19 pandemic unfolded on how facility capacity was addressed. With multiple products being developed and manufactured at the same time and the urgent need to get product out to the American people, many “out of the box” and “never done before” strategies had to be implemented. Learning from these, presenters will share some of the plans going forward to prepare for the “next pandemic”.
This presentation will discuss the advantages of a robust automation platform in conjunction with the overall benefits of implementing effective digital technologies. Some key elements of incorporating digital technologies includes not only the value that is added, benefits to overall production, but understanding the impact on the design of a facility as well as the impact on the overall network infrastructure. A case study will be presented by Iovance describing their roadmap for implementation for their path to Pharma 4.0. Iovance is a Cell Therapy Center located in the heart of Cellicon Valley at the Navy Yard in Philadelphia, and is the first centralized, scalable, state-of-the-art manufacturing facility dedicated to producing potentially life-saving tumor cell therapies for patients.
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.
Presenters will provide an overview of the mission, grant program and several programs that the Gates Foundation is doing to reduce the cost of immunization and to give every person a chance at a healthy, productive life. Additionally, they will discuss the factors influencing the cost of vaccine manufacturing, COGS, and Supply Chain complexities in Distributed Vaccine Manufacturing, including the utilization of Aseptic Blow/Fill/Seal technology.
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.
This presentation will discuss the significant potential for improving manufacturing capabilities in the drug industry, and emphasize how modern technologies can be leveraged to improve quality, supply, compliance, and efficiency.
For Engineering & Operations teams, the pandemic posed an unprecedented set of challenges. Without a playbook, groups had to respond to new imperatives with a completely unique set of constraints. Everything had to be reimagined. This also provided an opportunity to redefine business processes, ways of working and engineering constructs that had been in place for a while, by creating a platform for accelerating transformations in spaces that till date were viewed as emerging (e.g., digital, sustainability and ESG, hybrid workspaces). This presentation takes a step back and reflects upon lessons learned from a practitioner viewpoint, focusing on how the Engineering, Facilities, and Operations teams within the industry responded to a crisis. The presentation leverages at-scale examples within Gilead Sciences’ operations efforts to highlight trends that we believe will become future standards, and areas that require our industry to continue innovating.