Women Leaders in Life Sciences Law

The life sciences industry is navigating rapid change – as regulatory shifts, economic pressures, and global policy developments are reshaping pricing, innovation, and supply chains. Our opening panel will set the stage for the conference by providing a high-level look at the most significant forces currently reshaping the life sciences sector and how legal leaders are guiding companies through change and volatility.

Discussion points will include:

• Key regulatory and policy developments currently influencing the life sciences landscape
• Emerging economic and geopolitical factors impacting global life sciences operations
• How companies are recalibrating legal risk, compliance priorities, and business strategy in the face of ongoing volatility
• Practical perspectives on leading legal teams and organizations through periods of change and uncertainty

With the FDA significantly increasing its oversight of the life sciences industry, legal and compliance leaders must stay ahead of shifting policy and enforcement trends and understand where regulators are focusing scrutiny. This session will provide practical insights into current FDA priorities and how companies can adapt compliance programs to mitigate risk.

Discussion topics include:

• An overview of FDA’s latest enforcement activity: examining recent investigations, warning letters, and high-stakes settlements involving life sciences companies
• Keeping pace with recent FDA initiatives impacting vaccine policy, clinical trials, drug approvals, drug pricing, and more
• Taking stock of the recent surge in unannounced FDA inspections and global oversight: what the return of pre-pandemic inspection levels means for compliance readiness
• Exploring FDA’s increased scrutiny of direct-to-consumer (DTC) advertising
• Updates on recent rare disease initiatives, including FDA’s new guidance for accelerating development of individualized therapies for ultra-rare diseases
• Analyzing new and emerging medical device regulations, including FDA’s new QMSR regulation and cybersecurity expectations for connected medical devices

Today’s in-house lawyers are expected to do far more than identify risk—they are increasingly relied upon as strategic partners who help drive business decisions while protecting the organization. The challenge lies in delivering difficult legal advice in ways that build trust, enable progress, and strengthen relationships with business leaders.

This session will explore practical strategies for influencing decision-makers, navigating internal dynamics, and elevating your role from legal advisor to trusted strategic partner. Discussion will explore:

• Delivering difficult or unpopular legal advice in a way that moves the conversation forward
• Communicating legal risk in business terms that resonate with executive leadership
• Navigating internal politics and leadership dynamics within complex organizations
• Building credibility and trust with cross-functional business teams
• Balancing the role of risk manager and business enabler
• Developing the mindset and skills needed to become a go-to strategic advisor for senior leadership

Scientific breakthroughs rarely happen in isolation. Today’s life sciences innovation ecosystem increasingly depends on complex collaborations among pharmaceutical companies, biotech startups, academic research institutions, and patient advocacy organizations. For legal and compliance leaders, structuring these partnerships requires navigating sophisticated deal frameworks, intellectual property considerations, data sharing arrangements, and evolving funding models while preserving alignment among stakeholders with different incentives and goals.

This panel will explore:

• Structuring industry–academia collaborations, including governance models, funding structures, and managing intellectual property ownership
• Legal considerations around data sharing and AI model training within research partnerships
• Key terms and negotiation dynamics in pharma–biotech licensing and co-development agreements
• Managing disputes and decision-making through joint steering committees and collaboration governance frameworks
• The growing role of patient advocacy organizations in funding research, influencing clinical trial design, and shaping development priorities
• M&A and strategic investment trends in biotech, including valuation challenges and dealmaking strategies in uncertain markets
• Practical approaches for legal leaders to structure and manage partnerships that support innovation while mitigating legal and operational risks

As life sciences companies are increasingly integrating AI across the drug and device development lifecycle, legal leaders must navigate evolving regulatory expectations, validation requirements, and governance frameworks to manage risk while enabling innovation.

This panel will delve into key topics, including:

• The growing role of AI-driven tools in drug discovery, biomarker development, and clinical trial design (including patient recruitment and data analysis)
• The latest AI applications used in medical devices, digital health technologies, and software as a medical device (SaMD)
• Comparative perspectives on FDA, EMA, and other global regulatory frameworks governing AI use in life sciences
• Regulatory expectations for validation, transparency, and reliability of AI-enabled tools
• Managing legal and compliance risks when integrating AI into R&D and clinical workflows
• Governance strategies for responsible AI deployment, documentation, and regulatory submissions

As innovation accelerates in mRNA, LNP, and ADC technologies, so too does the complexity–and stakes–of patent disputes surrounding them. Hear from experts as they break down the latest litigation trends and what they mean for protecting and advancing cutting-edge therapies.

• Examining the latest mRNA and LNP litigation trends: Breaking down the core claims, defenses, and outcomes shaping platform IP battles
• ADCs in the spotlight: Why antibody-drug conjugates are becoming a new IP flashpoint and what disputes signal for innovators
• Freedom-to-operate risks: Practical considerations for companies navigating crowded patent spaces and overlapping claims
• Strategic implications: What ongoing disputes mean for licensing, collaborations, and portfolio-building in advanced therapeutics

Even if you are not an IP lawyer, it is important to understand the use of IP as a business strategy and how IP intersects with your work (as a corporate lawyer, regulatory lawyer, litigator, etc.). This panel will delve into key IP pitfalls that non-IP attorneys in the life sciences field should have on their radar:

• Understanding the business strategy of IP: how patents, trade secrets, and exclusivities drive valuation, partnerships, and competitive advantage in the life sciences sector
• Avoiding costly IP missteps in clinical research and regulatory communications
• Cross-functional coordination: practical tips for working effectively with IP counsel early in product development, regulatory submissions, and deal negotiations
• Managing trade secrets in cross-functional teams
• Advertising, promotion, and labeling risks: how marketing claims can impact IP rights and create exposure to competitor challenges

Rising trade tensions, tariffs, and geopolitical uncertainty are reshaping global supply chains for life sciences companies. As organizations reassess where and how products are manufactured, legal leaders are playing a critical role in guiding supply chain strategy while navigating complex regulatory, trade, and operational risks.

This session will explore:

• The impact of tariffs and evolving trade policies targeting life sciences products and components
• Avoiding compliance pitfalls associated with the latest trade, customs and export control laws and enforcement activity
• Assessing the downstream impact of trade restrictions on product availability, pricing, and market access strategies
• Strategies for supply chain diversification and building greater resilience across global operations
• Managing contractual, commercial, and legal challenges arising from supply chain disruption and shifting trade restrictions

• FDA enforcement trends in pharmaceutical marketing
• Key takeaways from the agency’s recent enforcement campaign targeting misleading pharmaceutical marketing
• Navigating the latest compliance pitfalls in Influencer and celebrity product endorsements
• Understanding the biggest compliance risks and “watch outs” in digital marketing and social media promotion of drugs and devices
• Protecting brand reputation and consumer trust

Artificial intelligence is rapidly transforming how legal departments and law firms operate, enabling faster research, smarter contract and patent drafting, and more efficient legal workflows. As organizations integrate AI into both legal and business functions, leaders must balance innovation with careful oversight of ethical considerations, data privacy risks, and governance frameworks.

Key discussion points include:

• How life sciences companies and law firms are leveraging AI tools to streamline legal research, contract drafting, patent drafting, patent analysis, and other core legal workflows
• Ethical and professional responsibility considerations, including concerns around bias, fairness, transparency, and accountability in AI-driven decision-making
• Implementing internal AI governance programs, including policies for responsible use, model oversight, and cross-functional collaboration between legal, compliance, and IT teams
• Managing privacy and regulatory risks when training AI models using healthcare, clinical, or other sensitive data
• Lessons from organizations successfully integrating AI, including strategies for scaling AI-enabled legal operations while maintaining compliance and data security

Fraud and abuse enforcement in the life sciences sector has intensified significantly, with federal and state authorities pursuing record-breaking recoveries and an unprecedented volume of whistleblower litigation. As prosecutors expand enforcement theories—from traditional kickback schemes to cybersecurity certifications and digital health platforms—legal leaders must stay ahead of emerging risks and evolving compliance expectations.

Key discussion points include:

• Examining major enforcement trends and recent settlements in False Claims Act (FCA) litigation, including record-breaking healthcare recoveries and the growing role of whistleblower suits
• Kickbacks and speaker programs under scrutiny, including enforcement actions involving pharmaceutical speaker honoraria and physician engagement programs
• Fraud risks in laboratories, diagnostics, and genetic testing, including allegations involving inducements for testing referrals and improper billing practices
• New enforcement frontiers, including digital health platforms, telehealth prescribing, and DOJ’s Civil Cyber-Fraud Initiative targeting false cybersecurity certifications
• How life sciences companies should be rethinking their risk exposure policies and internal investigation procedures

Competition for talent in the life sciences industry has intensified, creating new legal and business challenges around employee mobility, restrictive covenants, and the protection of confidential information. As regulatory scrutiny of non-compete agreements evolves and jurisdictions adopt different rules governing employee movement, legal leaders must help their organizations balance aggressive talent strategies with compliance and risk management.

Key discussion points include:

• Understanding the evolving legal landscape for non-compete and non-solicitation agreements, including regulatory developments and varying state and global rules
• Best practices for drafting and enforcing restrictive covenants, including common pitfalls that can undermine enforceability
• Protecting confidential information and trade secrets when employees depart for competitors or start new ventures
• Managing talent competition within the life sciences industry, including what companies can—and cannot—do when recruiting from competitors
• Practical guidance for business lawyers advising leadership, including strategies for handling internal talent competition and cross-border workforce issues
• Protecting your organization from claims of discrimination, discriminatory firing and retaliation
  • Understanding best practices regarding reviews and documentation when letting someone go

Many legal professionals are taught to map out a clear five- or ten-year career plan, but real career paths rarely follow a straight line. Hear from women leaders in life sciences law who stepped off the traditional track, embraced unexpected opportunities, and leveraged those experiences to reach senior leadership roles across law firms and industry. Topics of discussion will include:

• Assessing whether it’s time to pivot and identifying what you need to succeed in a new role
• Determining which skills or experiences you may be missing—and how to strategically build them
• Stepping outside your comfort zone
  • Taking on stretch assignments and expanding your skill set to open new doors
  • Leveraging lateral moves, secondments, or cross-functional roles to broaden your expertise
• Positioning yourself for the role you want: how to make your résumé and professional narrative resonate with a different sector (law firm, in-house, government)
• Making intentional decisions about when—and how—to pursue a change
• Leveraging Your Network and Resources
  • Activating mentors, sponsors, and professional connections to support your transition
  • Tools, strategies, and mindsets that help women thrive after making a major career pivot