Explore the Agenda
8:15 am Check-in, Coffee & Networking
9:00 am Chair’s Opening Remarks
Navigating Regulatory Shifts to Protect Pipeline Momentum & Strengthen Executive Decision-Making
9:15 am Panel Discussion: Stabilizing Development Momentum to Preserve Market Confidence During Regulatory Volatility
- Maintain investor and partner confidence by aligning regulatory pivots with disciplined communications
- Protect timelines and budgets by responding decisively to CRLs, endpoint shifts, and evolving agency expectations
- Strengthen resilience by leveraging patient advocacy, public affairs, and cross-functional escalation pathways during periods of agency uncertainty
10:00 am Fireside Chat: Interpreting Regulatory & Political Signals to Strengthen GC Engagement Amid FDA Volatility
- Enable Boards to make better decisions and anticipate events by translating apparently inconsistent FDA signals, shifting policies, and congressional initiatives, e.g. user fee timelines, into clear strategic scenarios
- Avoid unnecessary development disruptions by filtering regulatory shifts into those which genuinely threaten timelines versus political noise
- Strengthen enterprise resilience by building a forward-looking view of regulatory risk that spans political and litigation cycles, and enables long development horizons
- Incorporate the global context, and reflect on how US activities do or don’t change market access and commercial value elsewhere
10:30 am Morning Break & Speed Networking
This networking session is your chance to get face-to-face with fellow legal leaders to facilitate rapid yet meaningful exchanges of insights and expertise. Elevate your networking experience during this session designed for impactful connections within the space.
Strengthening Pricing Strategy & AI Governance to Preserve Enterprise Value Amid Shifting Market Dynamics
11:15 am Fireside Chat: Positioning Assets Strategically to Protect Valuation Amid Pricing Reform & Federal Policy Shifts
- Safeguard enterprise value by understanding how IRA, potential MFN expansion, and federal reform influence asset modeling, even pre-approval
- Strengthen board-level conversations by framing pricing reform as a strategic scenario, not a technical reimbursement issue
- Prevent future revenue compression by integrating pricing policy awareness into indication sequencing and lifecycle planning early
11:45 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
12:30 pm Networking Lunch
Advancing Compliance Maturity to Reduce Enforcement Exposure & Support Scalable Operations
1:30 pm Panel Discussion: Building Stage Appropriate Compliance Foundations to Strengthen Development to Commercial Readiness
- Understand the core compliance infrastructure required at each stage of development, allowing you to anticipate obligations and minimize maturity gaps as programs advance
- Compare how Legal versus Compliance build and own early compliance foundations in small companies, clarifying operating models, decision rights, and how different organizations divide responsibilities on the road to commercial readiness.
- Leave with a clear, stage-based roadmap outlining what must be in place early, what should evolve over time and what must rapidly scale ahead of commercial launch
2:15 pm Enhancing Compliance Governance of Functional Roles & Responsibilities to Reduce Enforcement Risk
- Minimize enforcement and promotional risk through well-defined functional roles, decision rights, and compliance program design that clearly assigns activities across medical, commercial, HEOR, payer, research, and field teams
- Clarify high-risk cross-functional interfaces, including medical-commercial boundaries, payer engagement, and research interactions, to prevent blurred ownership and reduce OPDP and regulatory exposure
- Implement stage-appropriate governance structures that scale from development through commercialization, enabling faster decision-making while maintaining compliance integrity and defensibility
2:45 pm Afternoon Networking Break
Driving Deal Readiness to Maximize Growth Opportunity, Valuation Confidence & Board Optionality
3:15 pm Panel Discussion: Strengthening IPO Readiness to Reduce Liability Exposure & Support Defensible Board Decision‑Making
- Build disclosure discipline early by aligning scientific claims, press releases, BD decks, and public statements to withstand S‑1 scrutiny
- Reduce litigation and enforcement risk through structured risk‑factor design and clear escalation controls
- Strengthen Board decision‑making with disciplined go/no‑go criteria, documentation standards, and scenario pathways
- Prepare for life as a public company by aligning IPO readiness with post‑IPO ongoing public company obligations, capital markets strategy, contingency planning, and dual‑track financing scenarios
4:00 pm Preventing Acquisition Disruption to Safeguard Enterprise Stability & Strategic Clarity
- Reduce diligence surprises by strengthening contracts, governance, IP oversight, and cross-border controls before a transaction is live
- Maintain continuity between signing and closing by proactively managing disclosures, employee uncertainty, and TSA complexity
- Enable clearer executive decisions through balanced framing of transaction risk, integration realities, and investor communications
4:30 pm Navigating Market-Aligned Merger Strategy to Preserve Valuation, Deal Certainty & Board Confidence
- Aligning board, executive leadership, and external advisors under compressed timelines and shifting market conditions
- Protecting valuation and negotiation leverage while managing regulatory scrutiny, disclosure complexity, and operational continuity
- Preserving strategic optionality by anticipating antitrust, pricing, and capital-market dynamics and clearly framing risk trade-offs for board decision-making