Agenda/Scientific Program

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The 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, panel discussions, 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.

Innovations and Lifecycle Management of Bioconjugate Therapies

Bioconjugates represent a dynamic and rapidly evolving class of biopharmaceuticals. Their molecular structure, tunability, improved targeting specificity, and therapeutic efficacy continues to be leveraged for new therapeutic indications. Examples of bioconjugates include antibody-drug conjugates (ADCs) including those with novel non-cytotoxic payloads (e.g. siRNA, immunostimulatory, PROTAC Mab conjugates), peptide conjugates, pegylated proteins, and vaccine conjugates. The rapid emergence of novel bioconjugation technologies, payloads, and linkers as well as their application to different protein modalities has made bioconjugate development and manufacturing increasingly complex. Additionally, as the field continues to expand, understanding the opportunities and challenges in advancing new bioconjugate technologies, responding to CMC considerations, and managing the post-approval landscape are essential to the continued success of this growing class of therapies.

The Forum will aim to discuss the following elements:

• Analytical and Process Challenges.
• Complexity of Managing Global Supply.
• Considerations for Manufacturability, Control Strategies, Comparability.
• Design Considerations for Bioconjugates.
• Outsourced Manufacturing, Particularly International Contract Management.
• Regulatory Expectations for Bioconjugates, Lessons Learned from Globally Approved Bioconjugates.
• Supply Chain Logistics.
• Utility of DMFs and Global Adoption of DMFs.