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Message From the Chair: Why Attend the 2024 ISPE Biotechnology Conference | Biopharmaceutical Engineering

Phillip R. Smith, PhD
DNA strands-by Thomas

The biotechnology industry continues to evolve, advancing the frontiers of science and engineering in the design, development, and manufacture of a wide variety of therapeutic modalities. Advances in cell and gene therapies continue to offer treatments for diseases that were previously uncurable, with seven approvals in 2023, including treatments for sickle-cell disease, hemophilia, type 1 diabetes, Duchene muscular dystrophy, and others. Additionally, five monoclonal antibodies, five peptides, and four oligonucleotide therapies were approved in 2023. In 2024, many mRNA vaccines, antibody drug conjugates, and bispecific antibodies are in development

Indeed, the array of therapeutic modalities being employed across the industry is truly stunning. These therapies would not be reaching patients without the exceptional skills and hard work of the biopharmaceutical engineers and scientists who build the factories, provide the advanced processing technologies, develop, and validate the manufacturing processes, and manufacture the medicines.

2024 ISPE Biotechnology Conference

However, significant challenges remain. The high costs of drug development continue to rise, expensive therapies remain unavailable for large portions of the world, environmental impact/sustainability concerns are arising in all industries, and manufacturing capacity constraints exist for both new and existing medicines. How will the industry respond, and what solutions might be on the horizon for these challenges? At the 2024 ISPE Biotechnology Conference, industry professionals will hear from leading experts on these and other important topics.

The conference will kick off on Monday, 17 June, in Boston, Massachusetts, USA, with a series of exciting keynote addresses. These include presentations focusing on healthcare equality, mRNA vaccines, digital twins, global supply chains, and artificial intelligence (AI). These keynotes will be delivered by leaders from industry, academia, and the US Food and Drug Administration (US FDA). Piper Trelstad, PhD, with the Bill & Melinda Gates Medical Research Institute, will provide a session entitled “Healthcare Equality – Technology and Innovation Applied in Service of Low- and Middle-Income Countries.” Robert Langer, PhD, with the Massachusetts Institute of Technology, will then present “From Nanotechnology to mRNA Vaccines: How Overcoming Skepticism Led to New Medical Treatments and Ways to Tackle the Global Health Challenge.” Subsequently, Rene-Pascal Fischer, with Fraunhofer IESE, will lead a session “Towards Individualized Medicine: Embracing Digital Twins and Digital Dependability in Pharma 4.0™” before the networking break.

Following the break, Francesco Cicirello, Senior Director, Quality Compliance with BioNTech US Inc., and Richard Denk, Senior Consultant, Aseptic Processing and Containment with SKAN AG, will provide the keynote session, “Global Supply Chain Strategy.” Attendees will learn how to overcome decentralized manufacturing challenges and how this could be supported by the industry in dialogue with regulatory agencies.

This presentation will be followed by a keynote session from Sharmista Chatterjee, PhD, Division Director in the Division of Process Assessment II within the US FDA’s Office of Process and Facilities. Chatterjee serves as an OPF representative on the Center for Drug Evaluation and Research (CDER)’s Emerging Technology Team.

In the second half of the day, two topic tracks will be held covering environmental sustainability and quality culture maturity. Each track session will provide the chance for attendees to ask questions and hear expert responses. The day will end with a networking reception, with opportunities to connect with speakers, exhibitors, and conference attendees.

On Tuesday, 18 June, the conference will resume with four topic tracks throughout the day. These include data science-assisted technology transfer and process characterization, novel technology innovations in advanced manufacturing, lifecycle strategies for acceleration and commercialization, and challenges and trends in biopharmaceutical facility design. Each track session will include an opportunity to pose questions and secure answers. Post-conference trainings will be available on Wednesday, 19 June – Thursday, 20 June, on the topics of Advancing Pharmaceutical Quality (APQ) Quality Management Maturity and GAMP® Basic Principles.

While the pace of change continues to increase in biopharmaceutical development, this brings exciting opportunities to accelerate the delivery of life-changing medicines and therapies to patients worldwide. This conference will bring together key leaders, experienced practitioners, and young professionals from across the industry to discuss and progress solutions to challenges and opportunities facing the biotechnology industry.

Industry professionals are invited to participate in the conference, to discover new ideas, reconnect with colleagues, make new connections, and contribute to the dialog on the key focus topics in the conference agenda. 

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