Explore the Agenda
Day One
Wednesday, August 5
Day Two
Thursday, August 6
8:00 am Check-in, Coffee & Networking
8:45 am Chair’s Opening Remarks
Deploying Responsible AI to Amplify Legal Capacity & Strengthen Enterprise Oversight
9:00 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
9:30 am Generative AI for Maintaining Contract Compliance & Negotiation Power in BioPharma
- Increase legal team capacity without adding headcount by automating contract drafting, review, and information retrieval through generative AI
- Improve compliance and governance by standardizing contract language and embedding approved playbooks directly into contracting workflows
- Create a centralized contract intelligence hub that enables faster decision-making, stronger negotiations, and greater visibility across the contract lifecycle
9:40 am Panel Discussion: Establishing AI Governance Frameworks to Enable Safe, Scalable Adoption
- Reduce legal and ethical exposure through validated guardrails and approval processes
- Empower teams to adopt AI confidently without breaching policy or regulatory expectations
- Prevent misuse with monitoring, access controls, and cross-functional oversight, while accounting for emerging differences between federal guidance and state‑level AI regulations
10:25 am Morning Break & Networking
Optimizing IP & Trade Secrets to Strengthen Competitive Positioning, Deal Leverage & LongTerm Defensibility
10:55 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 risks in downstream enforcement, inventorship, and documentation risk in an increasingly AI-enabled R&D environment
11:40 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
12:10 pm Panel Discussion: Read Between the Filings: The Story Your Data Won’t Say Out Loud
- Spot the coverage gaps forming in your own portfolio, using filing data showing a 56% drop in average jurisdictions per chem/bio PCT application in just two years (4.3 in 2023 to 1.9 in 2025)
- Identify which jurisdictions carry the most risk today, as filing rules shift fastest and competitive filings surge in the same markets biopharma companies are exiting
- Leave with three concrete moves to rebalance filing strategy before narrower coverage becomes a liability in FTO, deal, or litigation decisions
12:40 pm Networking Lunch
Structuring Strategic Collaborations & Navigating Geopolitical Complexity to Maintain Operational Continuity
1:40 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
2:10 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
2:40 pm Afternoon Networking Break
3:09 pm Elevating GC Leadership to Strengthen Cross-Functional Alignment & Executive Impact
3:10 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
3:40 pm Roundtable Discussions: Embedding Legal Leadership to Accelerate Cross-Functional Execution
4:25 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