AGENDA AT A GLANCE
8:00
Registration & Welcome Coffee
8:50
IMAPAC & Chairman's Welcome Address
Novel Formulation Strategies for Complex Biologics - mAbs, Bispecifics, & ADCs
9:00
Advanced Formulation Strategies for Complex Biologics: mAbs, Bispecifics & ADCs
- Overcoming stability and aggregation challenges in mAbs, bispecifics, and ADCs through rational formulation design
- Optimizing excipient selection to enhance protein stability and reduce interfacial stress in high-concentration biologics
- Balancing developability with manufacturability, including viscosity control and drug-product process compatibility
- Addressing unique formulation needs of next-generation biologics to ensure efficacy, safety, and consistent delivery performance
10:00
Next-Generation Delivery Strategies for mAbs, Bispecifics & ADCs
- Tackle viscosity and stability challenges in mAbs and bispecifics for patient-friendly delivery.
- Use excipients and buffer systems to minimize aggregation and degradation across complex modalities.
- For ADCs, tailor formulations to maintain linker–payload stability and control release profiles.
- Explore novel formats (e.g., subcutaneous, sustained-release) to improve efficacy and patient compliance.
11:00
Networking Break
Adjuvants & Immunostimulatory Technologies - Amplifying Vaccine Potency
11:40
Novel Platforms to Boost Immune Response while Enabling Dose Reduction
- Enhance antigen presentation and immune activation to achieve efficacy at lower doses.
- Improve targeting and uptake by immune cells, boosting response efficiency.
- Optimize epitopes and structure to increase immunogenicity while minimizing required dose.
- Prolong antigen exposure to the immune system, reducing the need for higher or repeated dosing.
12:10
Reserved for Solution Provider
13:10
Lunch & Poster Presentation
Formulation Supply Chain – From Clinical to Commercial
14:10
Strengthening Cold Chain and Distribution Strategies for Complex Biologics and Advanced Therapies
- Ensuring end-to-end cold chain integrity for biologics and advanced therapies through robust temperature monitoring and control systems
- Mitigating distribution risks for temperature-sensitive products via real-time tracking, data visibility, and contingency planning
- Optimizing global logistics networks to support timely, compliant, and scalable delivery of complex therapies
- Strengthening collaboration across supply chain stakeholders to maintain product quality from manufacturing to patient delivery
14:40
Reserved for Solution Provider
15:00
The CMC Leader Driving Vaccines from Development to Real-World Supply
- Leading CMC strategy to seamlessly translate vaccine candidates from early development into scalable, compliant commercial supply
- Integrating process development, analytical control, and manufacturing to ensure robust vaccine quality and consistency
- Navigating regulatory expectations to accelerate development timelines while maintaining safety and efficacy standards
- Building resilient supply chains and tech transfer frameworks to enable reliable real-world vaccine distribution
15:30
Networking Break
16:00
Interactive Roundtable Sessions:
- Formulation as a Commercial Differentiator
- From Immunology Discovery to Clinical Translation: Aligning Early Innovation with Formulation and Development Strategy
- From Formulation to Patient: Designing Biologics for Access, Adoption, and Real-World Value
- AI-Driven Biomarker Strategies for Smarter Formulation and Precision Biologics Development
- From Formulation to Delivery: Designing Patient-Centric Therapeutic Platforms for Advanced Modalities
17:00
Cocktail Reception
18:00
END OF DAY 1
8:50
IMAPAC & Chairman's Welcome Address
Outsourcing for Early-Stage vs Late-Stage
9:00
Optimising LNP Formulations for mRNA Therapeutics: Stability, Delivery, and Performance
- Improving lipid nanoparticle (LNP) design to enhance stability and protect mRNA payloads during storage and transport
- Optimizing delivery efficiency and tissue targeting to maximize cellular uptake and therapeutic expression
- Balancing lipid composition and physicochemical properties to improve in vivo performance and reduce toxicity
- Addressing formulation and manufacturing challenges to ensure scalable, reproducible, and clinically viable mRNA therapeutics
9:30
Advancing LNP & RNA Formulation Development and Manufacturing
- Translating LNP design from lab to GMP manufacturing with consistent performance
- Ensuring product quality and reproducibility through robust characterisation and process monitoring
10:00
Scaling RNA Drug Products: From LNP Design to Robust Manufacturing and Tech Transfer
- Translating LNP design principles into scalable RNA drug product manufacturing processes with consistent quality
- Overcoming scale-up challenges in mixing, encapsulation efficiency, and batch-to-batch reproducibility
- Establishing robust tech transfer frameworks to ensure seamless transition from development to GMP manufacturing
- Ensuring product stability, regulatory compliance, and supply chain readiness for clinical and commercial RNA therapeutics
10:30
Networking Break
From Formulation to Device Integration
11:10
Designing the System, Not the Parts: Early CMC and Device Integration in Combination Products
- Integrating CMC and device development early to ensure seamless compatibility between drug product and delivery system
- Designing combination products holistically to optimize performance, usability, and patient-centric administration
- Addressing manufacturability and assembly challenges through aligned drug–device development strategies
- Ensuring regulatory compliance by coordinating CMC, device, and combination product requirements from the outset
11:40
Bridging Formulation, Manufacturing, and Process Development in Advanced Cell Therapies
- Integrating formulation, process development, and manufacturing to ensure consistent quality in advanced cell therapies
- Overcoming scale-up and variability challenges while maintaining cell viability and functional potency
- Developing closed, automated, and scalable processes to enable robust and reproducible cell therapy production
- Aligning cross-functional teams early to streamline tech transfer, regulatory compliance, and clinical-to-commercial transition
13:00
Lunch & Poster Presentation
Smart Aseptic Fill–Finish
14:00
Sarah Pasqualinotto, Head of Fill Finish Global External Quality (Associate Director), Biogen
- Reduce human intervention and enhance consistency using robotics and automated fill–finish systems.
- Enable monitoring, data-driven insights, and predictive maintenance to improve process reliability and efficiency.
- Leverage analytics and AI to detect deviations early, support predictive maintenance, and reduce batch failures
- Combine automation and digital platforms to create connected, efficient, and scalable aseptic production lines.
14:30
Automated Raman detection and advanced process monitoring
- Leveraging automated Raman spectroscopy for real-time, non-destructive monitoring of critical process parameters
- Enhancing process understanding and control through advanced PAT (Process Analytical Technology) integration
- Improving manufacturing consistency and product quality via continuous, data-driven process monitoring
- Enabling faster decision-making and process optimization through automation and advanced analytics integration
15:00
Innovations in Aseptic Fill–Finish: Enhancing Process Control, Contamination Prevention, and Throughput
- Real-time process monitoring and PAT tools improve control over critical aseptic fill–finish parameters.
- Advanced isolator and barrier systems significantly reduce contamination risk and enhance sterility assurance.
- High-speed automation and robotics increase throughput while minimizing human intervention.
- Integrated data systems enable predictive control, faster deviation response, and improved batch consistency.
15:30
Networking Break
Closing Panel Discussion
16:00
CLOSING PANEL
Building Long-Term Value in Oncology and Hematology: Medical Affairs as a Strategic Partner from Development to Real-World Adoption
- Embedding Medical Affairs early in development to shape evidence generation and clinical strategy in oncology and hematology
- Supporting cross-functional alignment to translate clinical data into meaningful real-world treatment value
- Driving stakeholder engagement through scientific communication and education across HCPs, payers, and patients
- Leveraging real-world evidence to optimize treatment pathways and sustain long-term therapeutic value
