Women Leaders in Life Sciences Law

In our opening session, an esteemed panel of women leaders in life sciences law will set the stage for the conference with an exploration of the most influential developments impacting life sciences IP, products liability and compliance in 2024, as well as how these latest developments will impact your future practices. At the end of the segment, participate in an interactive Q+A that will allow you to ask your most pressing questions and add to the dialogue.

This panel will take a look at how recent shifts in today’s political landscape are impacting women’s health, and ultimately the life sciences industry. With life sciences companies playing a pivotal role in the development of pharmaceuticals and medical devices used in female reproductive health, this panel will examine:

• Current legislative activity impacting women’s reproductive health care
• The implications that recent restrictions on women’s contraception and abortion care is having on the life sciences industry
• How the recent political landscape may impact future breakthroughs in women’s health
• The role that women in the life sciences industry can play to ensure women’s health remains at the forefront
• Should women’s care be rethought in light of the evolving political landscape?

Life sciences companies are continuing to grapple with the new pricing reform provisions of the IRA, as well as the challenges being ushered in by price negotiations with the government. As drug makers are challenging IRA provisions and trying to thwart Medicare price negotiations through legal efforts, they must also navigate the broader implications of the Act on R&D, innovation and market entry. This panel will explore key topics including:

• Analyzing the impact that the IRA is having on investment decisions, competition, and innovation
• Understanding the elements that are being taken into account in recent ongoing price negotiations with Medicare
• Examining recent lawsuits filed by drug companies to thwart federal government authority to negotiate drug prices
• Considering practical strategies to capitalize on emerging opportunities and mitigate risks associated with pricing reforms and current market dynamics

With recent attacks on DEI initiatives now on the rise, women (and particularly diverse women) are facing a more challenging landscape when trying to climb the corporate ladder. This panel will discuss:

• How did we get here?
• Charting the controversy surrounding existing DEI programs and initiatives
• Understanding why the DEI pendulum is now seemingly swinging in the opposite direction
• How to avoid unintended consequences of your corporate DEI policy
• Considering the unexpected ways that DEI policies can reverberate in an organization and getting ahead of possible negative effects on different employee groups and subgroups
• Exploring the risks associated with dismantling or rolling back of DEI programs
• What women in current leadership roles can do to help promote and maintain female workplace momentum amidst this time of DEI pushback

Following the effects of the pandemic, the global life sciences industry is once again seeing a resurgence of big deal making in 2024. In this session, we will look at the current state of M&A activity in the biopharma space, as well as projections for what dealmaking activity will look like in the year ahead. Topics of discussion include:

• Tracking the recent growth of life sciences M&A
• Identifying areas of the life sciences market that are the biggest targets for investment in 2024
• Analyzing FTC’s new “2023 Merger Guidelines” proposing new rules and reporting guidelines for mergers
• Will the new guidelines impact or hinder life sciences M&A activity?
• Examining the latest developments and trends in antitrust enforcement in the industry
• Understanding the art of life sciences business deals: strategies for success and pitfalls to look out for

This session will explore the evolving legal and business landscape impacting competition, supply chains and trade dynamics on a global scale.

• Analyzing the shifting dynamics of global competition in the life sciences sector, with a focus on emerging markets such as China
• Examine the legal and business ramifications of drug shortages, focusing on recent supply chain disruptions
• Delving into the nuances of global branding and marketing strategies in key markets such as Brazil, China, and beyond
• Gaining an understanding of the legal and business challenges associated with expanding global reach, defending intellectual property rights, and navigating regulatory landscapes in diverse jurisdictions

As funding opportunities for life science companies declined following the pandemic, companies are now innovating and strategizing to raise capital. Given the resilient nature of the life sciences industry, substantial capital investment remains imperative for driving progress and fostering innovation. This panel will examine:

• Strategies for creative funding in a difficult financial environment
• Forging partnerships
• Tapping into government and academic grants
• Seeking angel investments
• Analyzing how companies managed to raise capital despite the scarcity of funds in 2023
• Identifying the most promising avenues for securing capital in 2024
• Assessing the impact of further FTC scrutiny on transactions and whether companies could withstand being challenged in antitrust enforcement

• Amgen v. Sanofi One Year Later: mastering the art of claim balance and disclosure in life sciences patent prosecution
• Understanding the latest on patent validity challenges: key developments and strategies for patent prosecution
• Mastering Subject Matter Eligibility (SME) rejections: innovative strategies for navigating SME jurisprudence in the U.S. and abroad
• Securing IP Rights in AI-Driven Discoveries: overcoming patent challenges from concept to commercialization

This session will provide a high-level overview of the complex landscape of advertising within the life sciences industry. From navigating FDA and FTC guidances, to understanding the intricacies of influencer engagement and kickback statute risks, our panelists will provide valuable insights and practical strategies for compliance and risk mitigation.

• Gain a comprehensive understanding of the latest FDA and FTC guidances governing advertising and promotional activities for life sciences companies
• Review best practices for maintaining transparency in influencer partnerships
• Examine the legal and compliance considerations surrounding the federal Anti-Kickback Statute and its implications for life sciences companies

In this session, we’ll review data privacy laws and regulations, as well as the risk of cybersecurity breaches in handling consumer and patient data. We’ll also look at proactive legislative measures being taken by several states to enhance patient data protection and consent protocols.

Key discussion areas include:

• Exploring the rights of individuals regarding their healthcare data, breach notification requirements, and the pivotal role of Data Protection Officers in ensuring compliance
• Understanding how HIPAA’s Privacy and Security Rules intersect with the evolving landscape of AI technologies in the life sciences sector
• Highlighting the significance of preserving patient data integrity, ensuring robust protection measures, and upholding informed consent practices
• Examining recent legislative developments in states such as Nevada and Washington, which have enacted laws specifically governing the collection and processing of consumer health data

• Embracing Failure: Understanding the role of mistakes in personal and professional growth, and reframing setbacks as learning opportunities
• Exploring techniques and practical strategies for bouncing back from setbacks with grace and resilience
• Understanding how to overcome common pitfalls encountered in the legal profession, such as ethical dilemmas, client conflicts, and career missteps

In this lighting round session, our panelists will walk you through the top 10 court cases impacting the life sciences industry in the last year and their implications for your practice. These cases will span all sectors of the life sciences arena, including IP, product liability, antitrust and more. Cases to be discussed will include:

• Loper Bright Enterprises v. Raimondo; Relentless v. Department of Commerce
• FDA v. Alliance for Hippocratic Medicine
• Gilead Sciences, Inc. v. Superior Court of City & County of San Francisco

Join us for an insightful exploration into the increasing use of artificial intelligence (AI) in various facets of the life sciences industry. Our panel will delve into the various AI applications in medical devices, software products, and drug development, shedding light on the legal and regulatory challenges that accompany these advancements.

• Exploring the innovative ways AI tools are revolutionizing the drug development process, from drug discovery to clinical trials and beyond
• Assessing current FDA guidelines and potential future regulatory frameworks for AI-driven medical technologies
• Reviewing ongoing efforts in Congress to modernize medical device regulations, with a focus on the role of AI in driving legislative change
• Understanding the impact of AI in drug development and surrounding intellectual property protection concerns

• Understanding how life sciences companies and law firms are harnessing the power of generative AI to revolutionize legal research, contract drafting, patent analysis and more
• Reviewing the ethical considerations of generative AI, including issues related to bias, fairness, and accountability
• Analyzing how organizations have successfully integrated generative AI into their legal and business practices

It’s time to revolutionize the dialogue surrounding legal professionals’ career trajectories by redefining legal leadership and exploring career paths beyond traditional roles. Join us for an insightful panel discussion as we delve into the next frontier of legal careers.

• Lawyer 2.0: Unleashing your full potential and leveraging your expertise and skill sets to excel in diverse roles, including the role of CEO and beyond
• Exploring the shifting landscape of legal careers and the increasing trend of lawyers assuming roles and titles beyond traditional legal functions
• Broadening legal horizons by challenging the stigma surrounding legal professionals’ career ambitions and advocate for equal access to diverse career opportunities

Join us for a spotlight session on breakthrough ‘weight loss drugs’ such as Ozempic and Wegovy. As these innovative pharmaceuticals garner attention in the media and medical communities alike, it’s crucial to explore the anticipated compliance and litigation risks accompanying their introduction into the market.

• Gain insights into the latest advancements in weight loss drugs, including the mechanisms of action, clinical efficacy, and regulatory approval processes
• Explore the versatile applications of these drugs beyond weight loss
• Assess the profound and continued impact of these drugs on the life sciences industry
• Review strategies for ensuring compliance with FDA regulations, labeling requirements, and marketing practices
• Examine potential litigation risks associated with these, including allegations of adverse side effects, inadequate warnings, and product liability claims

From breaking through glass ceilings to cultivating diverse talent pipelines, this panel will uncover the transformative impact of women in leadership roles and their contributions to building resilient and forward-thinking legal teams. Our esteemed panelists will discuss topics including:

• Strategies for building and managing a well-rounded and high-performing legal team
• Driving organizational success through gender and racial diversity, mentorship, and effective team-building strategies
• Identifying the needs of your organization and hiring team members who meet specific company needs
• Understanding the different resources needed to develop a legal team in an established company, versus a new and growing company
• Learning how to lead a legal team while also relinquishing control

Building on the positive buzz from our 2023 session on “Joining a Board,” we are reintroducing this important topic with additional insights. Discover your post-appointment responsibilities, learn effective collaboration with fellow board members, and navigate the diverse roles and responsibilities integral to effective board leadership.

• Exploring strategies to distinguish yourself when seeking board positions
• You’re on! Now what? Managing responsibilities and expectations with fellow members
• Gaining insight into board dynamics and the true significance of having a seat at the table

We will close out this year’s conference with a panel of esteemed women 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 golden nuggets of wisdom that have impacted their own career trajectories
• Share examples of targeted initiatives or strategic investments in female talent development that have actually paid off
• Share experiences with a mentor or mentee that have helped them in their own job performance and job satisfaction
• Impart meaningful advice on the next generation of women preparing to lead in the IP legal industry