Women Leaders in Life Sciences Law

To kick-off the 2^nd annual West Coast Women Leaders in Life Sciences Law, the co-chairs will set the tone for the following two days by speaking to the event theme: Building Community. Empowering Leadership. Advancing Innovation.

The FDA is entering a new phase defined by faster approval pathways, greater regulatory flexibility, and heightened scrutiny. For biopharma legal and compliance leaders, this shift is creating both opportunity and complexity as expectations evolve across clinical development, approvals, and post-market oversight.

This session will examine the implications of a more dynamic and less predictable regulatory environment, where policy direction, political influence, and scientific innovation are increasingly intertwined.

Key Discussion Areas:

• Analysis of the most impactful FDA policy shifts in 2026
• Where is the FDA increasing scrutiny – practical insight into emerging regulatory risks and enforcement trends
• Guidance on integrating regulatory considerations into deal-making and strategy
• Tools to navigate increased uncertainty in the FDA environment

MFN pricing – acting as both industry catalyst and iconoclast – is now making drug pricing policy a central driver of legal risk and deal structuring across biopharma.

With the intensity of MFN pricing discussions and continued impact from the Inflation Reduction Act, pricing pressure is increasingly embedded in licensing, collaboration agreements, and M&A valuation. In-house counsel are now managing pricing and policy risk directly within transaction terms, reshaping royalties, milestones, and valuation frameworks well before commercialization.

This session will examine how legal teams are adapting to this evolving landscape, including the use of change-in-law provisions, royalty rebalancing mechanisms, and valuation adjustments in response to pricing uncertainty, tariffs, and broader healthcare policy shifts.

Key discussion areas:

• Impact of MFN and pricing reforms on licensing and collaboration agreements
• Allocation of pricing and reimbursement risk in deal structures
• Adjustments to royalties, milestones, and valuation terms under policy uncertainty
• Use of change-in-law and risk rebalancing provisions in contracts
• Intersection of tariffs, trade policy, and pharmaceutical supply chain risk
• Implications for biotech exits and transaction certainty

With venture capital tightening and funding pathways becoming more uncertain, biotech companies – particularly pre-commercial players – are rethinking how innovation is financed and advanced. Rising clinical development costs, a challenging IPO environment, and heightened investor expectations are driving new business models, while large pharma increasingly shapes the ecosystem through strategic partnerships, option-based collaborations, venture investments and asset acquisitions.

This session explores how biotech companies are adapting through creative financing strategies, capital-efficient operating models, and collaborative approaches to advancing innovation in a highly selective investment environment.

Key Discussion Areas:

• Examining how the pullback in venture capital has reshaped biotech growth strategies and financing timelines
• Identify where capital is flowing – including AI-enabled drug discovery, precision medicine, obesity and metabolic disease, immunology, cell and gene therapy – and where opportunities may be overlooked
• Strategies to position assets for partnership, investment or acquisition
• Innovative financing structures and evolving operating models

The volume of False Claims Act (FCA) whistleblower filings is on pace for a third-consecutive record-setting year, and the Department of Justice has signaled its intention to use the FCA as a key component of its health care enforcement efforts. This panel will examine how DOJ and HHS are collaborating through the reinvigorated DOJ–HHS False Claims Act Working Group, including its stated focus on drug pricing and kickbacks, and what companies can expect. The panel will address emerging risk areas involving customs compliance and country of origin requirements as DOJ expands its interagency partnerships through its Trade Fraud Task Force and enforcement around DEI programs, which has targeted the pharmaceutical industry. The panel will provide an overview of noteworthy FCA matters affecting the life sciences sector and discuss how recent organizational changes within DOJ may affect enforcement activity in the future.

With government grants becoming less predictable, venture capital remaining selective, and IPO markets still constrained, many companies are being forced to find alternative ways to advance their technology or assets without relying solely on traditional financing.

Partnership structures that allow for the advancement of assets through shared resources – “sweat equity” – rather than cash investments are on the rise. While these arrangements can be highly effective, they create significant legal complexity. This session will share first hand insights and examples of creative partnerships and the legal considerations for long-term success.

Key Discussion Areas:

• Essential contractual provisions for resilience when funding conditions change
• Ways in which university technology transfer offices adapting to funding uncertainty
• Exploring innovative licensing and co-development models gaining traction
• Protecting IP while collaborating with potential competitors
• The role of legal departments in helping companies advance assets while conserving capital

This discussion will provide a clear, accessible look at the forces reshaping life sciences IP – and what they mean for the future of innovation and commercialization.

As strategic partnerships become a cornerstone of life sciences innovation, legal teams are instrumental in establishing the structures and processes that enable partnerships succeed over the long term.

This session explores practical approaches to alliance management throughout the partnership lifecycle – from designing governance structures, managing IP and data rights, dispute prevention and resolution, and shifting strategic priorities.

Key Discussion Areas:

• Designing governance frameworks that promote accountability and collaboration
• Managing IP ownership, data rights, and decision-making throughout the alliance
• Addressing deadlocks, disputes, and changing business objectives before they derail partnerships
• Supporting alliance success amid funding pressures, restructuring, and organizational change
• Evolving from transaction lawyer to strategic advisor and relationship steward

AI is not just a technology shift – it’s a leadership shift. As AI becomes embedded in decision-making and operations, the leaders who stand out will be those who think critically, communicate clearly, and navigate complexity with confidence. For women in life sciences, this presents a strong opportunity, as many existing leadership strengths – collaboration, systems thinking, and empathy – align closely with working effectively alongside AI.

This session focuses on using AI as a thinking partner to enhance insight, decision-making, and overall leadership impact.

Key discussions areas:

• AI adoption as a leadership differentiator, not just a technical one
• Critical skills: questioning, synthesis, communication, and adaptability
• Shifting from using AI as a tool to a strategic thinking partner and examples of use cases
• Practical ways to enhance decisions, insights, and team leadership with AI
• Best practices to drive enthusiasm and adoption

In today’s volatile environment – marked by geopolitical shifts, evolving regulations, economic unpredictability and the omnipresence of AI – the role of legal counsel has expanded beyond risk management, and adversity has become the true test of leadership.

It is in these moments that resilient leaders rise, motivating their teams to stay focused, adapt, and push forward. In this fireside chat, two life sciences legal leaders will share powerful lessons in resilience and how they lead with confidence, clarity and influence.