AGENDA AT A GLANCE
8:50
IMAPAC’s Opening Address
8:55
Chairman’s Opening Address
Leadership Panel:
Indian Biologics Market: Trends & Future
9:00
Leadership Panel: India for the World: Biologics Potential and Global Strategy
- India’s competitive edge in biosimilars and large-scale manufacturing
- Strategic collaborations with global pharma for co-development
- Fostering a value-based ecosystem through affordable therapies, patient access, and clinical outcomes
- Future trajectory in the next 5 years
Panelists:
9:50
Reserved for Service/Solution Provider
Keynote Address:
India’s Strengths for Affordable Therapies
10:05
India’s Strategic Advantage in Delivering Affordable Biologics and Advanced Therapies (TBC)
- Leveraging India's cost-effective R&D and manufacturing ecosystem
- Public-private partnerships driving access and innovation in biologics
- India's global role in supplying affordable therapies to emerging and developed markets
10:30
Morning Tea Break, Exhibition Viewing, Poster Presentations & 1-1 Attendee Networking
Advancing from Research & Formulation to Clinical Trials
11:50
Integrated CMC Planning: De-Risking the Path to Clinical Trials
- Coordinating analytical, formulation, and manufacturing readiness
- Regulatory expectations for CMC in early-phase biologics submissions
- Case examples of CMC delays and how early integration prevents them
12:15
Lunch Break, Exhibition Viewing, Poster Presentations & 1-1 Attendee Networking
Regulatory and Advances in Upstream & Downstream Processing
2:00
Continuous Bioprocessing: Real-World Implementation and Lessons Learned
- Key technologies enabling continuous upstream and downstream integration
- Real-world case studies from pilot to commercial scale
- Regulatory perspectives and validation challenges
2:25
Reserved for Service/Solution Provider
2:50
Regulatory Expectations for Process Validation and Comparability
- Guidelines for demonstrating process consistency and product quality
- Managing process changes across clinical and commercial phases
- Key documentation for regulatory filing and audit readiness
3:15
Afternoon Tea Break, Exhibition Viewing, Poster Presentations & 1-1 Attendee Networking
Manufacturing & Quality Assurance
4:00
Role of Digital Systems in Enhancing Quality Oversight and Traceability
- Implementing QMS, eBMR, and MES to ensure real-time quality control
- Data integrity and audit readiness through digital records
- Integrating quality systems across production and QA/QC functions
4:25
Reserved for Service/Solution Provider
4:50
Managing Product Quality Across the Lifecycle: From Lot Release to Post-Approval Changes
- In-process controls and release testing for biologics
- Risk-based approaches to managing quality during scale-up
- Handling comparability and change control in regulatory submissions
5:15
Chairman’s Closing Remarks
5:20
End of Conference Day 1
6:00
Biopharma Excellence Awards 2025
8:50
IMAPAC’s Opening Address
8:55
Chairman’s Opening Address
Manufacturing Automation & Process Scale-up
9:00
Scaling Up Biologics Manufacturing: From Lab to Commercial Scale
- Key considerations in scaling unit operations (bioreactors, filtration, chromatography)
- Maintaining process consistency and product quality during scale-up
- Tech transfer strategies between R&D and manufacturing sites
9:25
Reserved for Service/Solution Provider
9:50
Single-Use Systems in Large-Scale Biologics Manufacturing
- Advantages in flexibility, contamination control, and turnaround time
- Scale-up challenges with SU bioreactors, mixers, and connectors
- Regulatory and validation considerations for SU technologies
10:15
Morning Tea Break, Exhibition Viewing, Poster Presentations & 1-1 Attendee Networking
Advancements in Cell & Gene Therapy
11:00
Utilizing Induced Pluripotent Stem Cells (iPSCs) for Advanced 3D Screening Model and Therapeutic Advancements
- Development of 3D organoid and tissue models using iPSCs for drug screening
- Applications in disease modeling, target validation, and toxicity testing
- Challenges and future directions in integrating iPSCs into biologics pipelines
11:25
Reserved for Service/Solution Provider
11:50
Manufacturing Processes and Analytical Considerations for Allogeneic Cell Therapy
- Upstream and downstream process optimization for consistent cell yields
- Key analytical assays to ensure potency, identity, and purity
- Regulatory expectations for GMP compliance and release testing
12:15
Lunch Break, Exhibition Viewing, Poster Presentations & 1-1 Attendee Networking
Operational Excellence & Supply Chain Solutions
2:00
Driving Operational Excellence in Biologics Manufacturing: Lean, Agile, and Digital
- Implementing lean methodologies to reduce waste and improve efficiency
- Agile manufacturing practices for rapid tech transfer and change management
- Leveraging digital tools for real-time performance monitoring and optimization
2:25
Reserved for Service/Solution Provider
2:50
Risk Management and Contingency Planning in Biologics Supply Chains
- Identifying and mitigating supply chain vulnerabilities
- Dual sourcing, inventory buffers, and regional supply hubs
- Case studies on responding to disruptions (e.g., pandemic, geopolitical)
3:15
Afternoon Tea Break, Exhibition Viewing, Poster Presentations & 1-1 Attendee Networking
The Evolving Antibody-Drug Conjugates ADCs in Oncology
4:00
Next-Gen ADCs: Optimizing Payloads, Linkers, and Targeting Strategies
- Innovations in linker-payload chemistry for improved therapeutic index
- Enhancing tumor selectivity and minimizing off-target effects
- Case studies of next-gen ADCs in solid and hematologic tumors
4:25
Reserved for Service/Solution Provider
4:50
Tackling Toxicity in ADC Development: From Design to Patient Safety
- Understanding off-target and bystander effects: mechanisms and mitigation strategies
- Innovations in linker stability and payload selection to reduce systemic toxicity
- Clinical trial insights on managing adverse events and improving therapeutic index
Closing Panel: Forging India's Vaccine & Biologics Future
5:15
Leadership Panel: Shaping the Future of Novel Vaccines & Biologics – Innovations, Strategies, and Global Collaboration
- Explore recent innovations and technologies transforming the vaccines and biologics industry
- Discuss strategies for advancing affordable biologics and vaccines, especially in the Global South
- Identify opportunities for international collaboration to enhance vaccine and biologics development
- Address clinical trial challenges in developing countries for novel vaccines and biologics
Moderator:
Panelists:
5:55
Chairman’s Closing Remarks
5:00
End of Conference
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