Agenda/Scientific Program

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The 2025 CMC Strategy Forum will bring together industry, regulatory, and academic professionals to discuss key emerging CMC issues that affect biotechnology. The Forum will consist of speaker presentations, workshops, and networking opportunities. We look forward to an informative Forum and hope to see you there. Be ready to network, collaborate, and expand your knowledge.

Advances Toward Patient-Centric Quality Standards

Quality standards is a term which encompasses the management of quality from prior to manufacturing through patient dosing. Quality standards are applied in facility design, process design, product release, storage, and dosing. Quality standards are essential to develop and execute appropriate manufacturing process and product control strategies, that ultimately ensure that biopharmaceuticals remain safe, effective, and of consistent quality. A patient-centric quality standard (PCQS) has previously been defined as a set of patient-relevant attributes and their associated acceptance ranges to which a drug product should conform within the expected patient exposure range (see A. Mire-Sluis et al., J. Pharm. Sci. 2024, Vol 113, 837-855).

This Forum will explore the tools available to understand and set patient-centric quality standards including control strategies which ensure safety, efficacy, and product availability for the patient. Advancements, challenges, and case studies in the development and application of patient-centric quality standards will be presented. Regulatory considerations and how to apply them in a fashion which is consistent with regulatory guidance to ensure a robust, safe, and efficacious patient experience will also be explored.

Digital Transformation/AI and Data Analytics to Accelerate Development Timelines

The generation of technical data to support the development and manufacture of pharmaceutical products and associated regulatory submissions is fundamental to the pharmaceutical industry. The recent boom in artificial intelligence (AI) systems and large language models (LLM) has resulted in increased interest in the capability of these systems to support industry activities. By embracing technological advancement, the biopharmaceutical industry can make significant strides in reducing submission timelines and accelerating the delivery of therapeutics. This Forum will include a discussion on current practices with examples of how structured data, digitalization, AI, and generative AI (GenAI) are being leveraged to support pharmaceutical development, manufacturing, and standardized regulatory authoring/submission with dynamic review. The focus will be on opportunities to improve efficiency or accelerate development timelines. The discussion will include considerations for emerging technologies and forward-looking approaches for analytical data modeling. Different aspects of the use of AI or LLMs during CMC development will be discussed including:

• Automated generation of regulatory documents using LLM.
• Bioprocess/cell culture optimization using predictive analysis.
• Leveraging commercial manufacturing data/modeling to optimize process conditions.
• Stability modeling using AI and/or machine learning.
• Use of AI in drug discovery/developability – modeling of protein structure and properties based on sequence.