Explore the Agenda
Day One
Wednesday, August 5
Day Two
Thursday, August 6
8:15 am Check-in, Coffee & Networking
9:00 am Chair’s Opening Remarks
Deploying Responsible AI to Amplify Legal Capacity & Strengthen Enterprise Oversight
9:15 am Accelerating FDA Submissions Through AI-Assisted Module Drafting to Reduce Risk & Enhance Regulatory Efficiency
- Shortening submission timelines and expanding legal and regulatory capacity by embedding AI into FDA module drafting for a live Phase 2 asset
- Mitigating hallucination, confidentiality, and trade-secret exposure through structured guardrails, validation workflows, and disciplined human oversight
- Demonstrating measurable ROI through a real-world implementation with an external AI partner while preserving defensibility and data integrity
9:45 am Roundtable Discussion: Operationalizing Enterprise AI to Enhance Legal Capacity & Preserve Budget Discipline
- Replacing fragmented individual AI usage with enterprise-wide platforms, structured guardrails, and company-wide training to reduce confidentiality and compliance risk
- Integrating AI into contract management and routine legal workflows to handle more work internally and reduce reliance on outside counsel
- Securing executive alignment by framing AI investment through disciplined budget comparisons and realistic year-one performance expectations
10:15 am Morning Break & Networking
Optimizing IP & Trade Secrets to Strengthen Competitive Positioning, Deal Leverage & LongTerm Defensibility
10:45 am Panel Discussion: Ensuring Cross-Functional Alignment to Safeguard IP Defensibility & Preserve Enterprise Value
- Strengthening collaboration between scientific, regulatory and legal teams to support robust patent scope and resilient trade-secret protection
- Coordinating disclosure timing, data generation, and regulatory positioning to strengthen valuation, diligence readiness, and lifecycle strategy
- Reducing downstream enforcement, inventorship, and documentation risk in an increasingly AI-enabled R&D environment
11:30 am Fireside Chat: Aligning IP Strategy to Protect Assets and Strengthen Deal Leverage
- Build a deal-ready IP position by aligning exclusivity, data generation, and disclosure timing with partner expectations
- Avoid deal blockers by addressing ownership, platform boundaries, and other IP issues that commonly surface during negotiations
- Strengthen leverage with a clear IP narrative that distinguishes asset IP from platform IP and supports confident decision-making
12:00 pm Networking Lunch
Managing Geopolitical & Cross-Border Complexity to Maintain Operational Continuity
1:00 pm Fireside Chat: Structuring Biotech Collaborations for Value, Control and Longevity
- Current negotiation trends in licensing and collaboration deals with big pharma and peer biotechs in competitive global markets
- Strategies for protecting platform IP and downstream inventions in collaborations
- Governance frameworks supporting long-term alliances to maximize control and maintain strategic focus
1:30 pm Panel Discussion: Anticipating Geopolitical & Trade Policy Shifts to Preserve Cross-Border Operational Continuity
- Reduce enterprise disruption by tracking geopolitical shifts affecting trade access, regulatory cooperation, and BIOSECURE-driven supply-chain exposure
- Protect international growth by aligning global footprint and manufacturing strategy with export controls, industrial policy, and supply-continuity risks
- Strengthen board readiness with scenarios that maintain stability amid tariff escalation and policy shocks
2:00 pm Afternoon Networking Break
2:29 pm Elevating GC Leadership to Strengthen Cross-Functional Alignment & Executive Impact
2:30 pm Fireside Chat: Influencing the Board During Volatility to Strengthen Strategic Judgment
- Deliver decision-ready counsel during regulatory, pricing, or capital-market uncertainty
- Shape board-level debate by framing risk trade-offs with clarity and commercial awareness
- Build long-term credibility through disciplined, forward-looking governance leadership
3:00 pm Roundtable Discussions: Embedding Legal Leadership to Accelerate Cross-Functional Execution
3:45 pm Fireside Chat: Developing the Next Generation of GC Leadership to Strengthen Succession & Enterprise Resilience
- Build internal talent pipelines by intentionally developing senior counsel for broader enterprise leadership
- Equip high-performing in-house lawyers with the judgment, cross-functional fluency, and board exposure required for GC readiness
- Strengthen organizational stability through deliberate succession planning and leadership mentoring