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 to Preserve Enterprise Value Amid Shifting Market Dynamics
11:15 am Fireside Chat: Navigating MFN, CMS Action & Enforcement in a Time of Significant Government Intervention
- Interpret evolving CMS priorities, including MFN dynamics, IRA implementation, and PBM reform, to understand impact on pricing, access, and valuation
- Anticipate enforcement, fraud, and compliance risk across pricing and market access to protect the organization in a shifting regulatory environment
- Engage CMS effectively to strengthen submissions, reduce delays, and preserve asset value in an evolving pricing landscape
12:00 pm Roundtable Discussion: Translating Policy Signals into Board-Level Strategy, Risk Framing & Asset Decision-Making
- Reframe pricing reform and policy shifts as strategic drivers of valuation by translating
- evolving signals into clear board-level scenariosEmbed policy awareness into asset strategy by shaping indication sequencing, lifecycle planning, and capital allocation early
- Strengthen enterprise resilience by aligning legal, government affairs, and executive leadership on proactive risk and value protection
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 Expanding Deal Considerations Beyond the M&A Agreement to Maintain Stability & Enable Clearer Decision-Making
- Reduce transaction risk and diligence disruption by embedding legal, governance, and IP readiness into business-as-usual operations before a deal is initiated
- Maintain operational stability and avoid value leakage by proactively managing obligations, disclosures, and stakeholder uncertainty between signing and closing
- Strengthen deal durability beyond signing by addressing ancillary agreements and equipping executives with clear visibility into transaction risks and integration realities
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