PRE-CONFERENCE DAY

Synopsis

Explore the crucial role of preclinical animal models in evaluating the therapeutic potential of exosomes across diverse clinical indications. By focusing on the principles of selecting appropriate animal models that closely mimic human conditions, participants will gain insights into translational research methodologies applicable to various therapeutic areas.

Selecting Appropriate Animal Models for Preclinical Studies

• Exploring key considerations in choosing animal models that reflect human disease conditions

• Discussing a comparative analysis of diferent animal models in cancer, cardiovascular disease, and neurological diseases

• Sharing perspectives on the current landscape and future directions of EV research in preclinical models

Sharing Insights from Various Therapeutic Indications

• Understanding the specific considerations in selecting preclinical models for different therapeutic indications, such as Inflammatory based disease, autoimmune disease, oncology, neurological disease and cancer

Translational Considerations and Future Directions

• Bridging the gap between preclinical studies and clinical translation

• Strategies for optimizing preclinical evaluation to enhance translational success

Synopsis

As the demand for exosome-based therapies continues to rise, i’ts crucial to address the challenges associated with scalability, compliance with GMP standards, and process efficiency. In this session, we’ll explore key strategies to overcome these hurdles and maximize the production of exosome therapeutics.

Scalability and GMP Compliance:

• Exploring methods for scaling up exosome production to meet clniical demand while maintaining GMP compliance

• Discussing the importance of integrating GMP-compliant practices into production platforms to uphold exosome purity, consistency, and functionality

• Investigating strategies for automating processes and optimizing manufacturing techniques to enhance scalability and efficiency within GMP guidelines

Batch-to-Batch Consistency:

• Address the complexities of achieving consistent quality and characteristics to maintain batch-to-batch consistency across exosome products, including managing variability in starting materials and manufacturing processes

Regulatory Understanding and Compliance:

• Examining the challenges of navigating regulatory requirements, particularly those set by the FDA, in developing and manufacturing exosome-based therapies

• Discussing effective strategies for addressing regulatory requirements throughout the manufacturing process, including collaboration with GMP firms and alignment with internal processes

Synopsis

Uncover the transformative power of strategic outsourcing in advancing exosome therapeutics development. Explore how outsourcing can streamline processes, accelerate progress, and drive innovation in the field. By leveraging specialized expertise and resources, companies can overcome challenges and maximize opportunities in developing exosome-based therapies.

Delving into Funding & Investor Engagement:

• Addressing the challenge of maintaining investor interest in exosome-based therapeutics by demonstrating clinical benefits and real promise in technologies

• Mitigating risks associated with investor disengagement by ensuring that technologies show genuine clinical potential, sustaining investor confidence and support Exploring Outsourcing Considerations:

• Discussing resource constraints faced by smaller companies developing exosomebased therapeutics, leading them to outsource manufacturing, analytics, safety testing, and preclinical development

• Highlighting the benefits of outsourcing for accessing specialized expertise and facilities required for compliance with GMP standards

Evaluating Challenges Vendor Selection & Collaboration:

• Discussing the importance of selecting vendors with the necessary expertise and capabilities to provide specialized services, such as exosome isolation, characterization, and analysis, for exosome therapeutics development

• Exploring strategies for building collaborative partnerships with vendors through careful evaluation of capabilities, reliability, and alignment with project goals and timelines