Women Leaders in Life Sciences Law

The return of the Trump administration has brought about a wave of regulatory shifts, evolving policies and Executive Orders that are impacting the life sciences industry and legal practitioners in it. Our opening panel will set the stage for the conference with a discussion of how to effectively lead your company and advise your clients in uncertain times, and how to ensure your organization remains resilient and adaptive in an unpredictable environment.

• A breakdown of Executive Order 14151
• Analyzing the latest guidance from the DOJ and EEOC
• Updates on key court cases and legal challenges
• Practical insights for in-house counsel and legal teams navigating shifting regulations

With leadership shifts and policy changes at the FDA and HHS, the life sciences industry faces a period of uncertainty and potential transformation. This panel will explore the latest developments, potential roadblocks, and emerging opportunities under the new administration. Discussion topics include:

• Exploring the implications of RFK, Jr.’s plans to shift NIH focus from infectious disease to chronic disease
• Examining the projected impact of new HHS leadership on vaccine policy, clinical trials, drug approvals, drug pricing, and more
• Status of the “Make America Healthy Again” Commission: how could this initiative reshape federal policies and regulations impacting the life sciences industry?
• CMS and Medicare/Medicaid under new leadership—what are the agency’s new key priorities, and how will they affect the industry?
• Updates on delays, accelerations, and pivots—will pending FDA initiatives stay on track, or is a new regulatory agenda on the horizon?
• The future of rare disease initiatives—will funding and policy support continue or stall?
• AI and the FDA—how will regulatory oversight evolve, and what does it mean for innovation in life sciences?

As women’s health remains at the center of evolving legal and political debates, the life sciences industry must navigate new challenges and opportunities. Recent policy shifts and state laws impacting reproductive health and fertility are reshaping the landscape for companies developing women’s health products. This panel will examine the legal and business implications of these developments and explore how the industry can adapt to the rapidly changing environment. Discussion topics include:

• The status of President Trump’s Executive Order on IVF access and its implications for drug and device manufacturers
• The impact of new state laws defining an embryo and their potential impact on IVF availability
• How the shifting political and regulatory landscape may influence future innovation and investment in women’s health
• Legal and compliance considerations for life sciences companies operating in this evolving space

As global trade policies shift, life sciences companies are facing new challenges in supply chain management, regulatory compliance, and cost mitigation. With evolving tariffs—particularly those involving China and India—companies must adapt quickly to remain competitive while ensuring uninterrupted access to critical materials and products. This panel will explore:

• The impact of new tariffs on life sciences company supply chains and key considerations for compliance
  • Recognizing particular concerns for generic drugs
• Strategies for supply chain diversification to reduce dependency on high-risk markets
• How companies are renegotiating trade agreements and leveraging alternative sourcing solutions
• Risk mitigation tactics to ensure business continuity in an evolving trade landscape

With a new administration and fresh leadership at the USPTO, the life sciences intellectual property landscape is poised for change. This panel will explore key developments in life sciences IP, from pending legislation to evolving policies on patent enforcement and government intervention. Discussion topics include:

• The new USPTO Director’s approach: Will patent protections strengthen or weaken under new leadership?
• What legislative reforms could reshape patent rights and innovation incentives?
• Updates on the PREVAIL Act, RESTORE Act, PERA, and other pending IP reforms
• The future of march-in rights: Will the government expand its ability to override life sciences patents?
• Broader patent law trends and what life sciences companies should anticipate in the coming years

Collaboration is the lifeblood of the life sciences industry, driving innovation through partnerships between biotech startups and pharmaceutical giants, licensing agreements with universities, and other strategic alliances. However, these collaborations come with complex legal and business considerations. This panel will explore key challenges and best practices for structuring and managing successful life sciences partnerships while mitigating risks. Discussion topics include:

• IP Ownership and Inventorship: negotiating rights to innovations and ensuring clear ownership structures
• Data Protection and Confidentiality: safeguarding proprietary research and managing shared data
• Transactional Agreements: Key considerations when entering, structuring, and exiting partnerships
• Risk Mitigation Strategies: Addressing regulatory, financial, and operational risks in collaborative agreements

As regulatory agencies intensify efforts to combat fraud and abuse in the life sciences sector, companies are preparing to weather a new era of enforcement risk. From increased scrutiny on billing practices, financial arrangements and kickbacks, to the expanded use of alternative legal theories, this panel will explore recent fraud and abuse enforcement trends and discuss how life sciences companies should rethink their risk exposure, policies, procedures and internal investigation programs. Topics of Discussion Include:

• What recent cases and policy shifts reveal about emerging fraud and abuse trends and government priorities
• The latest initiatives from the Department of Justice, HHS-OIG, and other regulatory bodies
• How agencies are increasingly using the False Claims Act and Anti-Kickback Statute to target fraudulent misconduct in the life sciences sector
• Proactive Compliance Strategies: steps life sciences companies should take now to strengthen internal controls, mitigate risks, and ensure regulatory alignment

In this session, we will explore new and evolving data privacy regulations, and the cybersecurity risks associated with managing consumer and patient data in the life sciences industry. We’ll also examine proactive legislative efforts across various states aimed at strengthening patient data protection and consent protocols.

• Understanding individuals’ rights over their healthcare data, breach notification requirements, and the crucial role of Data Protection Officers in regulatory compliance
• Navigating data security risks associated with the use of AI in the life sciences sector, as well as how HIPAA’s Privacy and Security Rules align with emerging AI technologies in the life sciences
• Emphasizing the importance of maintaining patient data integrity, implementing strong security measures, and ensuring informed consent
• Reviewing new state legislative advancements that are governing the collection and use of consumer health data

This session will offer a comprehensive look at the challenges of advertising in the life sciences industry. From understanding FDA and FTC guidelines to addressing the complexities of endorsements, testimonials, influencer partnerships and anti-kickback risks, our panelists will share actionable insights and strategies to ensure compliance and minimize legal risks.

Discussion topics include:

• Understanding the latest FDA and FTC advertising and promotional guidelines for life sciences companies
• Best practices for managing endorsements, testimonials and influencer partnerships while maintaining transparency and compliance
• Key considerations surrounding the Anti-Kickback Statute and how it should be impacting life sciences company marketing strategies

As the European Union moves forward with sweeping pharmaceutical reform, U.S. life sciences lawyers must understand the implications for regulatory compliance, market access, and global drug development strategies. This panel will provide a deep dive into key changes in EU pharmaceutical legislation, with discussion points including:

• How these reforms impact U.S.-based companies operating in Europe
• The challenges of navigating evolving compliance requirements and potential legal strategies to mitigate risks
• Revisions to regulatory pathways, intellectual property protections, and drug pricing policies
• Navigating changes in market authorization, exclusivity periods, and patent protection
• Analyzing how these legislative shifts may shape cross-border collaborations, clinical trial regulations, and the future of innovation in the life sciences sector

Everyone encounters bumps in their career journeys, but the most successful professionals know how to turn those challenges into opportunities for growth. This group of panelists will share candid stories of professional missteps, unexpected detours, and the valuable lessons they learned along the way. Join us for an inspiring discussion on resilience, adaptability, and how to reframe setbacks as stepping stones to success. Discussion topics include:

• Lessons from the unexpected: personal stories of career challenges and how they led to new opportunities
• Reframing failure: how to shift your mindset and see setbacks as part of the learning process
• Navigating the tough moments: strategies for overcoming professional obstacles with confidence and grace
• Paying it forward: how to use your experiences to mentor, support, and empower others in their career journeys

In this session, our panelists will analyze high-profile cases and decisions that are currently shaking up the life sciences industry. Walk away with an understanding of how the latest precedents will affect future cases in your life sciences practice.

With over $4 billion in halted NIH grants and defunded university programs, clinical trials and scientific innovation are facing unprecedented disruption. As legal challenges mount, life sciences leaders and legal professionals must navigate the fallout. Topics of discussion include:

• The impacts of halted funding on clinical trials and drug development
• Analyzing ongoing lawsuits against the NIH and updates on the broader legal fight to restore funding
• The consequences of defunding universities and health equity programs on future medical breakthroughs
• How life sciences companies and legal advisors can respond to the disruption, from compliance strategies to managing potential private litigation risks

As Artificial Intelligence continues to revolutionize the life sciences industry, companies must navigate both unprecedented opportunities and evolving regulatory considerations. With President Trump’s Executive Order on AI promoting a more flexible regulatory environment, the landscape is shifting toward industry-driven innovation. This panel will explore the latest advancements, key compliance risks, and how regulatory changes are shaping the future of AI in life sciences.

• Examining the latest ways that AI is being used to accelerate drug discovery, optimize clinical trials, enhance diagnostics, and improve patient outcomes
• Navigating FDA regulations and anticipating future AI-specific guidance for medical technologies
• Legislative efforts to modernize medical device regulations and AI’s role in shaping policy
• Intellectual property challenges and strategies for protecting AI-driven innovations

In life sciences companies, legal teams often engage in a battle of the wills with their R&D, sales and marketing teams, which results in lawyers being viewed as “innovation prevention” or “sales prevention” – rather than “risk prevention.” In this session, our panelists will discuss how to bridge the gap between legal teams and other internal teams. Walk away with an understanding of how to best balance the business’s big-picture goals with sound legal counsel and the tools to be both a proactive business partner and a diligent lawyer. Discussion topics include:

• Strategies for aligning legal counsel with the company’s business objectives without compromising legal integrity
• Approaches for anticipating potential issues and providing solutions that allow for innovation and growth
• Building cross-department collaboration: best practices for fostering communication and collaboration between legal teams and R&D, sales and marketing teams

With a new administration comes renewed debate over drug pricing, reimbursement policies, and market access. As the life sciences industry prepares for potential shifts in Medicare and Medicaid funding, along with the implementation of the Inflation Reduction Act (IRA) provisions, life sciences companies must navigate an evolving regulatory and economic landscape. This panel will examine the latest developments and their implications for pricing strategies, patient access, and industry innovation. Discussion topics include:

• The future of the Inflation Reduction Act (IRA) and potential policy rollbacks
• Analyzing the latest impacts the IRA is having on investment decisions, deal making, competition and innovation
• The impact of the Maximum Fair Price (MFP) for Medicaid drugs, set to take effect in 2026
• Proposed Medicare and Medicaid cuts—how will they impact drug pricing and market access
• Market access challenges and opportunities in light of regulatory uncertainty
• Strategies for legal and compliance teams to adapt to changing drug pricing frameworks

Breaking into the boardroom can be a game-changer for your career, but securing a seat is only the first step. How do you position yourself as a strong candidate, and once you’re there, how do you maximize your influence? In this session, accomplished leaders will share their personal experiences, offer strategic insights, and discuss how to navigate board dynamics to drive meaningful impact.

Discussion topics include:

• Getting on the Radar: How to position yourself for board opportunities and build a compelling board-ready profile
• Navigating the Selection Process: Key considerations for securing a corporate or non-profit board seat
• Making an Impact: Strategies for contributing effectively and asserting your voice in board discussions
• Leveraging Your Role: How to use your board position to expand your influence and create leadership opportunities for yourself and others

Back by popular demand, we will close our event with a panel of esteemed leaders in life sciences law who will share the most influential lesson or piece of advice that they received from a mentor in the course of their career. Our panelists will:

• Pass along meaningful pieces of wisdom that have impacted their own career trajectories
• Share experiences with a mentor or mentee that have helped them in their own job performance, job satisfaction and personal growth
• Impart meaningful advice on the next generation preparing to lead in this space