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.
10:30
Cracking Long-Acting Injectables Translation: Lessons from Small Molecules, Implications for Biologics
- Early PK and biocompatibility data for small‑molecule LAIs often fail to predict clinical outcomes, creating a persistent predictability gap.
- The injection site acts as a complex, dynamic system, where depot behavior, tissue response, and absorption are tightly linked.
- Traditional approaches (e.g., IVIVC) are insufficiently predictive, requiring a shift to mechanistic, model‑informed translation.
- Success depends on integrated CMC–PK–clinical strategies that reduce uncertainty early through coordinated design.
- These learnings are relevant to high concentration /complex biologics, where greater molecular complexity further tightens the link between formulation, delivery, and clinical performance.
11:00
Networking Break
Adjuvants & Immunostimulatory Technologies - Amplifying Vaccine Potency
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
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
From Formulation to Device Integration
9:00
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,
9:30
Reserved for Service Provider
10:00
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
