AGENDA AT A GLANCE
8:50
IMAPAC’s Opening Address
Plenary Leadership Panel:
India’s Biologics & Vaccine Landscape - Market Trends, Public Health Priorities & Global Opportunities
9:00
Leadership Panel: Positioning India as a Global Biologics & Vaccine Innovation Hub
- Evolving market dynamics across biosimilars, vaccines and next-generation biologics.
- Advancing innovation through R&D, strategic partnerships, and translational science.
- Strengthening regulatory, clinical, and commercial readiness for global markets.
- Expanding equitable access while addressing national and global public health priorities.
Moderator:
Panelists:
10:05
Advancing India’s Biologics Pipeline: Innovation for Global Success
- Strengthening biologics pipelines through scientific innovation.
- Leveraging platform technologies for faster development.
- Balancing innovation with commercial viability.
- Expanding strategic collaborations and licensing opportunities.
- Building globally competitive biologics portfolios.
10:30
Morning Tea Break, Exhibition Viewing, Poster Presentations & 1-1 Attendee Networking
Manufacturing Automation, Digitalization, and Bioprocessing 4.0:
AI and Digital Twins
11:00
Building the Digital Bioprocessing Facility of Tomorrow: AI, Digital Twins and Smart Manufacturing
- AI-driven models enabling predictive process control and real-time optimisation
- Digital twins simulating scale-up scenarios before committing capital expenditure
- Real-time monitoring through connected sensors across the full production line
- Smart, autonomous facilities reducing manual intervention in biologics manufacturing
11:25
Automation and Digital Twin Technologies for Biomanufacturing
- Automation platforms reducing manual intervention across production lines
- Digital twin and simulation tools de-risking scale-up decisions
- Data integration connecting shop-floor systems to enterprise platforms
- Practical starting points for facilities beginning their automation journey
11:40
Advancing Bioprocessing 4.0: Automation Strategies for Future-Ready Biomanufacturing
- Retrofitting legacy production lines with robotics and automated systems
- Measuring tangible returns from automation investments made during modernisation
- Managing workforce transition and upskilling through digital transformation rollout
- Key lessons learned from a live, in-progress facility upgrade
- Building cybersecurity safeguards into newly connected manufacturing systems
12:05
Data and Analytics: Quick Takes on the Future of Bioprocessing Decisions
- Machine learning accelerating upstream process optimisation and decision-making
- Multivariate data analysis explained for process characterisation teams
- Predictive models catching potential batch failures before they occur
- Soft sensors enabling faster, real-time release testing decisions
12:30
Lunch Break, Exhibition Viewing, Poster Presentations & 1-1 Attendee Networking
Advancing from Research & Formulation to Clinical Trials
2:00
Panel Discussion: IND Readiness: How Much Data Is Enough Before First-in-Human Studies?
- Weighing analytical characterisation depth against the pressure of speed to clinic
- Defining CMC expectations appropriate for early-phase clinical development
- Managing comparability strategies after process or formulation changes occur
- Balancing clinical supply constraints against evolving quality risk management
- Where global regulators are drawing the line today
Moderator:
Panelists:
2:30
Bioinformatics and Computational Biology Accelerating Biologics Discovery
- In-silico modelling accelerating target identification and candidate screening
- Computational tools predicting developability and reducing late-stage failures
- AI-driven sequence and structure analysis speeding biologics design
- Cloud-based platforms enabling faster, more collaborative research
2:45
Formulating for Complexity: A Conversation on Advanced Biologic Therapeutics
- Designing robust formulations for high-concentration, injectable biologic products
- Choosing excipients carefully to limit aggregation and long-term instability risk
- Exploring drug-device combinations built around patient-centric delivery systems
- Freeze-thaw and lyophilisation strategies protecting long-term product stability
- Accelerated stability studies supporting faster clinical development timelines
3:10
From Discovery to Development: Translational Science Powering Next-Generation Biologics
- AI-enabled target identification accelerating early-stage biologics discovery
- Assessing developability early to guide sound candidate selection strategy
- Platform technologies advancing monoclonal antibodies, CAR-T and gene therapies
- Bridging discovery research with early CMC and manufacturing planning
3:35
Afternoon Tea Break, Exhibition Viewing, Poster Presentations & 1-1 Attendee Networking
Tech Transfer, Scale-Up & CMC Excellence:
Bridging Development and Commercialization
4:05
Scaling-Up Biologics Manufacturing: Optimizing Process Robustness and Commercial Readiness
- Scale-up considerations spanning upstream and downstream bioprocess stages
- Process intensification strategies without compromising batch-to-batch consistency
- Managing process comparability across manufacturing sites and technology transfers
- Analytical technology flagging deviations before they escalate into failures
- Robust checking required ahead of commercial product launch
4:30
Achieving Successful Technology Transfer: From Process Development to Commercial Manufacturing
- Transfer strategies spanning internal manufacturing sites and CDMO partnerships
- Knowledge management practices supporting a smooth, lower-risk handover
- Defining critical process parameters and critical quality attributes early
- Applying Quality by Design principles to reduce overall transfer risk
- Digital documentation and knowledge transfer minimising delays during handover
4:45
Driving CMC Excellence: Perspectives Across the Product Lifecycle
- CMC strategies supporting global regulatory filings and approvals
- Lifecycle management practices following process or manufacturing site changes
- Process validation and continued process verification in day-to-day practice
- Navigating post-approval changes amid shifting global regulatory expectations
5:10
Chairman’s Closing Remarks
5:15
End of Conference Day 1
6:00
8:50
IMAPAC’s Opening Address
8:55
Chairman’s Opening Address
What's Next for India Biologics Landscape?
Emerging Technologies and Industry Transformation
9:00
Visionary Panel: Shaping the Next Era of India's Biologics Industry
- Emerging technologies transforming biologics development pipelines
- Advanced therapeutic platforms reaching commercial scale
- AI and digitalisation reshaping bioprocessing decisions
- Building a stronger domestic innovation ecosystem
- India’s path toward global biologics leadership
Moderator:
Panelists:
9:40
Technologies Powering India’s Biologics Transformation
- Emerging platforms supporting faster, more efficient biologics development
- Digital solutions strengthening data-driven decision-making across the value chain
- Scalable technologies designed for India’s growing manufacturing base
- Global innovation adapted to local regulatory and market needs
9:55
An Industry Perspective: Where India’s Biologics Sector Is Headed
- Key drivers shaping India's biologics growth trajectory
- Balancing innovation investment with commercial realities
- Building talent and capability to sustain long-term growth
- What the next five years could look like for Indian biologics
Aseptic Fill Finish and Packaging:
Sterility Assurance & Product Integrity
10:20
Innovations Reshaping Fill-Finish Technologies for Sterility Assurance and Product Integrity
- Annex 1 compliance and evolving contamination control strategies
- Isolators, RABS and robotic systems reshaping aseptic processing
- Single-use systems enabling more flexible fill-finish operations
- Media fill simulations validating aseptic process performance
10:45
Morning Tea Break, Exhibition Viewing, Poster Presentations & 1-1 Attendee Networking
11:15
Future-Proofing Fill-Finish Operations for Next-Generation Biologics
- High-concentration biologics and challenging fill-finish processes
- Automated visual inspection and defect detection
- Lyophilisation strategies for product stability
- Digitalisation and real-time monitoring in fill-finish operations
- Scaling fill-finish capacity for commercial and global supply
11:40
Advancing Aseptic Fill-Finish Technologies
- Equipment innovations improving sterility assurance and contamination control
- Flexible fill-finish platforms supporting multiple product formats
- Automated inspection technologies catching defects earlier in the process
- Technologies designed to support scale-up from clinical to commercial volumes
11.55
Ensuring Product Integrity Through Advanced Container Closure & Packaging Systems
- Container closure integrity testing (CCIT) technologies in practice
- Selecting between vials, prefilled syringes and cartridge systems
- Extractables and leachables risk assessment for sensitive products
- Packaging compatibility for biologics and advanced cell and gene therapies
- Cold chain packaging and transportation qualification across global routes
12:20
Lunch Break, Exhibition Viewing, Poster Presentations & 1-1 Attendee Networking
Regulatory, Scientific, and Commercial Frameworks
2:00
Panel Discussion: From Regulatory Approval to Commercial Value: Unlocking Global Opportunities for Indian Biologics
- Moving beyond regulatory approval to successful market adoption
- Scientific differentiation supporting commercial competitiveness
- Regulatory agility across multiple global jurisdictions
- Commercial partnerships accelerating international expansion
- Lifecycle strategies maximising long-term product value
Moderator:
Panelists:
2:30
Strengthening Scientific Evidence Across the Product Lifecycle
- Analytical comparability and biosimilarity assessment under next-generation methods
- Weighing clinical trial data against Real-World Evidence (RWE)
- Risk-based CMC approaches replacing traditional lifecycle management rules
- Pharmacovigilance and post-marketing surveillance demands intensifying after launch
- Data integrity and scientific documentation under growing regulatory scrutiny
2:45
Commercialising Biologics: Market Access, Pricing & Global Expansion
- GLP-1 and biosimilar patent expiries reshaping India’s pricing landscape
- Market access strategies tailored to new and emerging regions
- Value-based pricing and reimbursement models gaining wider momentum
- Licensing deals and commercial partnerships accelerating market expansion
- Sustaining long-term success through disciplined lifecycle management practices
3:10
Navigating a Shifting Global Regulatory Landscape for Biologics and Biosimilars
- CDSCO’s 2025 revised biosimilar guidelines easing global regulatory convergence
- Reduced reliance on animal studies through stronger analytical characterisation
- Conditional waivers for confirmatory efficacy trials under defined criteria
- Digital submissions and regulatory intelligence tools gaining wider adoption
- Staying inspection-ready across an increasingly connected global marketplace
3:35
Afternoon Tea Break, Exhibition Viewing, Poster Presentations & 1-1 Attendee Networking
Plenary Closing Panel: Building India's Next-Generation Biologics Ecosystem
Accelerating Collaboration, Innovation & Commercial Success
4:05
Strategic Outlook Panel: Enabling a Collaborative Biologics Ecosystem for Sustainable Growth and Global Impact
- Cross-sector collaboration driving the next wave of biologics innovation
- CDMO, biotech and pharma partnerships deepening across the ecosystem
- Talent development building the industry’s future leadership pipeline
- Digital culture accelerating innovation and collaboration across teams
4:55
Chairman’s Closing Remarks
5:00
End of Conference
CONTACT
Melina Dass, Senior Conference Producer
melina.dass@imapac.com
+65 6230 3594
