From Concept to Capacity: Navigating the Intersection of Innovation, Investment, and Sustainable Growth — The GPN Story

• Targeted innovation for unmet needs: How GPN uses innovation to address market gaps beyond existing vaccine platforms
• Strategic capital & partnerships: Using focused investments and partnerships to drive an agile development pipeline
• Early quality integration: Embedding quality, regulatory, and project management early to support scale and long-term growth

Challenges and Opportunities for Data & AI based Drug Discovery and Development

• Opportunities for switching from mechanistic mathematical and computational models to analytical, generative and agentic AI
• Connecting discovery and development by integrating multi-modal data (genetic, omics, literature, clinical, real-world) to reduce silos and create an end-to-end R&D data continuum.
• Creating silo-less R&D, manufacturing, and commercial environments with seamless data flows
• Shifting decisions from retrospective to proactive with modern data & AI frameworks

Tissue Engineered Strategies For Women's Health

• Why women’s health biologics need smarter manufacturing
• Manufacturing challenges in tissue-engineered biologics
• AI assisted decision-making in biologics production
• Impact on translational timelines and patient access

Advances in AI Across The Drug Development Lifecycle: Implications for manufacturing

• GMP is a tightly regulated environment, how is the TGA and international regulators approaching the use of AI in biologics manufacturing?
• For small-to-mid Australian biologics manufacturers, what pragmatic first steps would you recommend to start on an AI implementation journey?
• From your perspective, how is AI changing the way we think about drug development and manufacturing overall? Is this a gradual evolution or a disruptive shift?

‘Off-the-shelf’ cancer cell therapies: manufacturing from research to the clinic

• "off-the-shelf" cell therapy manufacturing process development
• Scale-up from bench-top to patient bedside
• Technology transfer to GMP cleanroom operations

End of Conference Day 1

Pathway To Proof of Concept of a Novel Serotype- Independent Pneumococcal Vaccine

• Advantages of exploratory clinical development in Australia
• The challenges of developing a novel pneumococall vaccine
• Development of a novel surrogate endpoint for a novel approach to pneumococcal vaccination

Development Status of a Biosimilar to Stelara

• NeuLara biosimilar preclinical and clinical results indicating biosimilarity to the originator molecule
• Assessment of glycan structure differences and their impact on binding and half-life
• Next steps and future development of the biosimilar

Bench-To-Bedside Translation of the First Eyedrop Treatment for Keratoconus

• Unmet Clinical Need in Keratoconus – Limitations of current non-pharmaceutical management strategies and the lack of disease-modifying therapies
• First-in-Class Pharmacological Approach – A novel patented combination of growth factors and glucocorticoids driving stromal keratocyte phenotypic reprogramming and collagen II upregulation
• Mechanism-Driven Restoration of Corneal Biomechanics – Strengthening corneal rigidity through extracellular matrix regeneration without observed adverse effects
• From Academic Discovery to First-in-Human Trials – Translational journey from university lab research through scalable manufacturing to clinical development and patient impact

From First-In-Human To Value Creation: Radiopharmaceuticals as a Faster, Lower-risk Development Platform

• Why do radiopharmaceuticals offer a faster and lower-risk path in oncology drug development?
• How do first-in-human biodistribution studies create earlier and clearer value inflections points?
• Why is Australia an ideal location for these early phase studies?

• Overcoming the Tumor Microenvironment (TME): Engineering CAR-T cells to resist immunosuppression and physical barriers in solid tumors.
• Improving Trafficking & Infiltration: Chemokine receptor engineering, regional delivery, and stromal modulation to enhance tumor homing.
• Enhancing Persistence & Survival: Optimizing CAR constructs, co-stimulatory domains, and metabolic fitness for long-term activity.
• Next-Gen Combinations & Platforms: Combining CAR-T with cytokines, checkpoint inhibitors, or armored/multi-specific CAR designs to sustain efficacy.

• Overcoming scientific and translational hurdles unique to rare disease programs
• Adaptive, decentralized, and patient-centric strategies for small and diverse populations
• Leveraging global frameworks, orphan designations, and collaborations to accelerate progress
• Addressing scalability and evidence generation to support commercialization and access

IVX037: Promising RNA Oncolytic Immunotherapy for Common Solid Tumours

• Immune checkpoint inhibitors help only a small group of advanced solid tumour patients; IVX037 aims to boost their effectiveness in hard-to-treat cancers like colorectal, gastric, liver and ovarian
• Intratumoural IVX037 shows early biological and clinical activity in MSS-CRC (mono/with sintilimab), especially in KRAS/BRAF-mutant cases, and delivered a durable PR with strong CA-125 drop in a BRCA2-mutated ovarian cancer patient
• IVX037 is a self-amplifying, positive-strand RNA virus designed to selectively kill cancer cells and trigger a strong systemic anti-tumour immune response

The First-in-Human Journey: Lessons from Early Clinical Development of Antisense Oligonucleotides

• Designing first-in-human trials for antisense oligonucleotides
• Translational challenges in ASO development
• Navigating the evolving regulatory landscape

Advancing RNA Therapeutics: Clinical Development Pathways and Regulatory Considerations

• Bridging preclinical promise and clinical outcomes in RNA therapeutics
• Navigating regulatory pathways for RNA-based therapies in ANZ and globally
• Case studies on safety, efficacy, and clinical trial design for next-generation RNA platforms