IN LIFE S CIE NCES LAW
July 25 – 26, 2024 | Seaport Hotel Boston, MA
Increasing the Prominence of Women through Professional Development, Substantive Legal Discussion, and Woman-to-Woman Networking.
Insights from Women Leaders in Government and the Judiciary:
Jacqueline Corrigan-Curay Principal Deputy Center Director
- Center For Drug Evaluation And Research | CDER
U.S Food and Drug Administration (FDA)
Denise Cote
Senior United States District Judge
United States District Court for the Southern District of New York
Patti Saris District Judge
United States District Court for the District of Massachusetts
Linda Horner
Acting Senior Lead Administrative Patent Judge, Patent Trial and Appeal Board
USPTO
Veronica M. Lei
Assistant General Counsel
Eli Lilly and Company
Elena Rossano Senior Counsel, Global Commercial Operations Amgen
CEO Spotlight Interviews: Paula Ragan PhD CEO & President X4 Pharmaceuticals
2024 Program Highlights:
Miruna Sasu
President & CEO
COTA Healthcare
CHEVRON-RIGHT Exploring the Intersection of Life Sciences, Women’s Health, and Politics
CHEVRON-RIGHT Spotlight Sessions on the Inflation Reduction Act, Artificial Intelligence, and Semaglutide and GLP-1s
CHEVRON-RIGHT Collaboratives on Career Laddering, Reframing Professional Setbacks as Growth Opportunities, Shaping Legal Teams and Thriving on Company Boards
CHEVRON-RIGHT New Breakout Sessions on: Advertising, Managing Global Competition and Trade Dynamics, Navigating Today’s Capital Markets and M&A Landscape, and Patent Prosecution
Network and Benchmark with Women Leaders From:
Meitheal Pharmaceuticals
Medtronic
Roche Diagnostics
Seer
Xencor EARN CLE CREDITS Distinguished Co-Chairs:
Sumitomo Pharma America
Takeda Pharmaceuticals
Vertex Pharmaceuticals
Join us at the Beautiful Seaport Hotel in Boston this July for ACI’s 11th Annual Summit for Women Leaders in Life Sciences Law.
The life sciences industry is experiencing a time of unprecedented innovation. Advancements in AI, medical breakthroughs through the evolving use of mRNA and gene therapies, the introduction and still untapped potential of semaglutide and GLP-1s, and the further development of personalized medicine have pushed the industry into an exciting new era.
Against this extraordinary backdrop, American Conference Institute (ACI) invites you to join us at our 11th Annual Summit for Women Leaders in Life Sciences Law to celebrate the achievements of women attorneys and related professionals in the life sciences sector.
This summit has earned its standing as the one and only forum where today’s as well as tomorrow’s women leaders in life sciences law can convene and discuss the latest legal, regulatory, and policy developments impacting the life sciences industry and network with similarly minded women professionals. This is the place where women leaders in the life sciences can network and strategize on professional development, career advancement, and how to increase the prominence and recognition of women within the biopharmaceutical and medical device sectors.
This year, our esteemed faculty will examine the life sciences industry’s role in the evolving political and policy debate impacting women’s health. They will also explore the emerging opportunities and challenges arising at the intersection of Artificial Intelligence and the life sciences. Prepare for fresh insights on navigating the current life sciences M&A landscape as well as managing the continued implications of the Inflation Reduction Act on drug pricing and commercialization.
This year’s event will also examine strategies for forging non-traditional pathways to success in a male-dominated sector, reframing professional setbacks as opportunities for growth, mastering the art of personal branding, and thriving on company boards.
Whether you're a seasoned legal practitioner or just embarking on your professional journey, ACI’s “WILS” conference offers the unique opportunity to network with like-minded women and draw inspiration from the industry's most accomplished women leaders.
Don’t miss the chance to chart your path to professional success among a group of exceptional women leaders in life sciences law.
Last year’s event sold out! Register today to secure your seat. We hope to see you this July!
2024 ADVISORY BOARD
Lori G. Cohen
Vice Chair
Co-Chair, Global Litigation Practice
Co- Chair, Trial Practice Group
Greenberg Traurig LLP
Aileen M. Fair
Senior Corporate Counsel, Litigation & Government Investigations
| Antitrust & Competition Law
Bristol Myers Squibb
Tamara Joseph Chief Legal Officer
Spero Therapeutics
Elona Kogan
General Counsel and Corporate Secretary Seer
Deborah A. Logan
Associate General Counsel
EMD Serono, Inc.
Donna M. Meuth
Associate General Counsel, Intellectual Property Eisai Inc.
Honorable Teresa Rea
Former Acting Under Secretary of Commerce for Intellectual Property and Former Acting Director of the United States Patent and Trademark Office)
Elena Rossano Senior Counsel, Global Commercial Operations Amgen
Lora Spencer Principal Litigation & Investigations Counsel Medtronic
Gael Tisack
Deputy General Counsel, IP Olympus Corporation
Robin Walker
Chief Legal Officer and Corporate Secretary Areteia Therapeutics
2024 FACULTY
CO-CHAIRS
Veronica M. Lei Assistant General Counsel
Eli Lilly and Company
Elena Rossano Senior Counsel, Global Commercial Operations Amgen
DISTINGUISHED FACULTY
Deidre Arnold
VP - Commercial Legal Alnylam Pharmaceuticals
Caryn Borg-Breen, Ph.D. Partner Ballard Spahr LLP
Kate Cassidy Partner Wiggin & Dana LLP
Victoria Wohlfeil Cherry General Counsel & Corporate Secretary Meitheal Pharmaceuticals
Kellie Combs Partner
Ropes & Gray LLP
Rupa Cornell VP President & Head Counsel
Takeda Pharmaceuticals
Jacqueline Corrigan-Curay Principal Deputy Center Director - Center For Drug Evaluation and Research | CDER
Food and Drug Administration (FDA)
Denise Cote
Senior United States
District Judge
United States District Court for the Southern District of New York
Rebecca Clegg Counsel
Axinn, Veltrop & Harkrider LLP
Halli Cohn Partner Troutman Pepper
Lauren Cole
Managing Director Silicon Valley Bank
Selina P. Coleman Partner Reed Smith LLP
Jean Cunningham Principal Consultant Larson Maddox
Jacqueline Tambone deGrandpre Shareholder Greenberg Traurig LLP
Jennifer DiFruscio
Assistant General Counsel
Vertex Pharmaceuticals
Celia Eckert SVP, General Counsel & Corporate Secretary Xencor
Jennean Endres Vice President US Legal GSK
Suneeta Hazra Partner
Arnold & Porter Kaye Scholer LLP
Elizabeth Holland Partner
A&O Shearman
Linda Horner
Acting Senior Lead Administrative Patent Judge USPTO
Thora Johnson Partner
Orrick, Herrington & Sutcliffe LLP
Lisa Jakob
Executive Director, Intellectual Property Merck
Jaelyn Edwards
Judelson Partner
Akin Gump Strauss Hauer & Feld LLP
Annabelle Fowler, PhD Associate Principal Charles River Associates
Megan N. Gates Partner Covington & Burling LLP
Kathleen Gersh Co-Chair, Life Sciences Loeb & Loeb LLP
Nancy Bonifant Halstead Partner
Reed Smith LLP
Diane Lifton
SVP, Head of Legal, Biopharma and R&D Sumitomo Pharma America, Inc.
Deborah A. Logan
Associate General Counsel
EMD Serono
Jeny Maier
Managing Partner Axinn, Veltrop & Harkrider LLP
Nicole Mantini Partner Torys LLP
Lynn Mehler Partner
Hogan Lovells
Donna Meuth
Associate General Counsel Intellectual Property Eisai
Zoe Philippides
SVP, Chief Ethics, Compliance & Privacy Officer & Global Head of Litigation
Moderna
Christine Kain Partner
Faegre Drinker Biddle & Reath LLP
Kristen R. Klesh Partner
Loeb & Loeb LLP
Amanda Klingler Partner
King & Spalding LLP
Elona Kogan
Chief Legal Officer
Seer
Lisa LeCointe-Cephas Partner
DLA Piper LLP
Jee Lehmann
Managing Principal Analysis Group
Lauren M. Lesko Partner
Rakoczy Molino Mazzochi Siwik LLP
Karin Simonson VP, General Counsel & Corporate Secretary Envoy Medical
Pamela Politis Associate VP, North American Legal Incyte Corporation
Paula Ragan PhD CEO & President X4 Pharmaceuticals
Jane E. Remillard Partner
Nelson Mullins Riley & Scarborough LLP
Terra Reynolds Partner
Latham & Watkins LLP
Elizabeth Richards Partner
Latham & Watkins LLP
Lauren Misztal SVP, General Counsel Clario
Mary Murrane Deputy U.S. Attorney U.S. Attorney’s Office, District of Massachusetts
Juliana Neves Partner
Licks Attorneys
Qing Nian Head of Legal - North America & Corporate BeiGene
Kristen O'Shaughnessy Partner
White & Case
Jessica Parker-Battle Head of Legal North America Biogen
Tanvi B. Patel Partner
Neal, Gerber & Eisenberg LLP
Jenny Robertson
Chief Business and Legal Officer
Lexeo Therapeutics
Rita Sanzgiri
Board of Directors, Executive Committee
Colorado BioScience Association
Patti Saris
District Judge
United States District Court for the District of Massachusetts
Miruna Sasu President & CEO
COTA Healthcare
Christine Savage Partner
King & Spalding LLP
Christina Schwarz Partner Venable LLP
Ellen Scordino Partner DLA Piper LLP
Lora Spencer Principal Global Litigation & Investigations Counsel Medtronic
Gargi Talukder Partner
Orrick, Herrington & Sutcliffe LLP
Leticia Padilla De Truman Corporate Counsel AVEO Oncology
Malaika D. Tyson Ph.D. Shareholder McAndrews IP
Ingrid E. VanderElst, PhD Partner
Fasken Martineau DuMoulin LLP
Jami Vibbert Partner
Arnold & Porter Kaye Scholer LLP
Anne K. Walsh Director
Hyman, Phelps & McNamara
Debbie Walters-Francique Vice President, Assistant General Counsel Pfizer
Ashley Watson General Counsel Medical Devices Johnson & Johnson
Rachel Yu Partner
Sullivan & Cromwell LLP
Pre-Conference Workshops
Wednesday, July 24th, 2024
9:00 am – 12:30 pm
ACareer Advancement Bootcamp: Mastering the Art of Personal Branding, Self-Marketing and Being Your Own Best Advocate
microphone-alt Karin Simonson, VP, General Counsel & Corporate Secretary, Envoy Medical
Verna Krishnamurthy, Assistant General Counsel, Specialty Care, Sanofi
As a woman in today’s highly competitive life sciences market, building a strong personal brand is not always enough. Leveraging your brand’s unique value to stand out from the crowd, and developing effective strategies for self-marketing and self-promotion are essential steps to making you a viable candidate for upward mobility within this male-dominated industry.
Join us for an empowering workshop tailored to equip women in the life sciences industry with actionable strategies to elevate and leverage your personal brand and propel your career forward. Our workshop panelists will provide insights on:
• Harnessing your unique superpower: Discover what sets you apart and learn to articulate your unique value proposition effectively
• Positioning yourself in a way that differentiates you from your peers
• Building client-centric branding that showcases your deep understanding of your clients' needs and positions you as a trusted advisor
• Becoming recognized as a thought leader in the life sciences arena, expanding your market presence, and seizing opportunities for growth within the industry
• Overcoming challenges in self-marketing and self-advocacy by:
» Discussing tactics with your mentors
» Engaging in mock interviews
» Developing tactical tools for marketing yourself effectively on social media/LinkedIn
» Navigating common hurdles that arise when seeking raises or internal promotions
5 – 6 pm
Please join us at our Welcome Reception
Sponsored by
1:30 – 5:00 pm
BWhat I Wish Someone Had Told Me: Advice from Inspiring Life Sciences General Counsel and Chief Legal Officers on Cultivating Success, Balancing Professional and Personal Goals and Thriving at the Executive Level
microphone-alt Jenny Robertson, Biotech & Public Company Executive, Chief Legal Officer, Board Member, Lexeo Therapeutics
Victoria Wohlfeil Cherry, General Counsel & Corporate Secretary, Meitheal Pharmaceuticals
Elona Kogan, Chief Legal Officer, Seer
You asked – and we listened! Back again by popular demand, ACI is excited to deliver this intimate mentorship workshop, specifically curated to empower and guide women at all stages in their career on how to advance within the ranks of the life sciences legal arena. Join us for a unique opportunity to sit down with a group of inspiring and influential General Counsel and CLOs who will impart valuable insights and advice on:
• Shattering the glass ceiling
• Developing and honing the skills needed to thrive at the executive level
• Cultivating fruitful relationships with outside counsel and internal legal teams
• Running an efficient legal department
• Overcoming the challenges of managing and mentoring in a hybrid workplace model
• Balancing the responsibilities of executive leadership with a robust personal life
• Battling through burnout and persevering through bumps in your career journey
Conference Day One
Thursday, July 25th, 2024
8:15
Co-Chairs’ Opening Remarks
microphone-alt Veronica M. Lei, Assistant General Counsel, Eli Lilly and Company
Elena Rossano, Senior Counsel, Global Commercial Operations, Amgen
8:30
Coffee & Conversation with Women Leaders in Life Sciences Law: Exploring the Top Legal, Regulatory and Policy Concerns for 2024
microphone-alt Diane Lifton, Senior Vice President, Head of Legal, Regenerative Medicine and Gene Therapy, Sumitomo Pharma America
Rachel Yu, Partner, Sullivan & Cromwell LLP
Ellen Scordino, Partner, DLA Piper LLP
Moderator: Malaika D. Tyson Ph.D., Shareholder, McAndrews IP
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. They will provide insights on how these latest developments are affecting the industry today and what they may mean for the future. 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.
9:15
Where Life Sciences, Women’s Health and Politics Collide: Exploring Where the Life Sciences Industry
Fits Within the Evolving Political Landscape Impacting Women’s Health
microphone-alt Kellie Combs, Partner, Ropes & Gray LLP
Juliana Neves, Partner, Licks Attorneys
Lynn Mehler, Partner, Hogan Lovells
This panel will look at how recent political and policy shifts impacting women’s health are affecting the life sciences industry. With life sciences companies playing a pivotal role in the development of pharmaceuticals and medical devices specifically for women, 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 are having on the life sciences industry
• How the current 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
• How women’s care may be rethought in light of the evolving political landscape
10:00
10:30
Managing the Continued Fallout of the Inflation Reduction Act: Reexamining Drug Pricing, Innovation, and Commercialization Strategies in the Wake of the IRA
microphone-alt Kristen O’Shaughnessy, Partner, White & Case LLP
Rebecca Clegg, Counsel, Axinn, Veltrop & Harkrider LLP
Moderator: Elizabeth Holland, Partner, A&O Shearman
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 law’s broader implications on R&D, 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
11:15
CEO Spotlight Interview
microphone-alt Paula Ragan PhD, CEO & President, X4 Pharmaceuticals
Moderator: Leticia Padilla De Truman, Corporate Counsel, AVEO Oncology
11:45
Women
in Government
and
the Judiciary
Roundtable: Lessons of Power and Progress in the Public Sector
microphone-alt Jacqueline Corrigan-Curay, Principal Deputy Center Director - Center For Drug Evaluation and Research | CDER, U.S Food and Drug Administration (FDA)
Patti Saris, District Judge, United States District Court for the District of Massachusetts
Linda Horner, Acting Senior Lead Administrative Patent Judge, USPTO
Denise Cote, Senior United States District Judge, United States District Court for the Southern District of New York
In this unique session, an esteemed panel of influential women leaders in government as well as the judiciary will discuss their thoughts for the life sciences industry for 2024 and what they anticipate next on the horizon. They will also share personal stories about their roads to government leadership, the challenges they encountered, the barriers they have overcome, and the strategies they employed to ascend to their current positions in the public sector.
1:00
Networking Luncheon
Sponsored by
2:00
Navigating Today’s Life Sciences M&A Landscape: Charting the Latest Trends and Challenges in Pharma and Biotech Dealmaking
microphone-alt Kathleen Gersh, Partner, Loeb & Loeb LLP
Annabelle Fowler, PhD, Associate Principal, Charles River Associates
Jeny Maier, Managing Partner, Axinn, Veltrop & Harkrider LLP
Anne K. Walsh, Director, Hyman, Phelps & McNamara
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 and how this is affecting M&A
• Understanding the art of life sciences business deals: strategies for success and pitfalls to look out for
2:45
Maneuvering Capital Markets: Strategies for Innovative Life Sciences Company Funding in a Challenging Financial Landscape
microphone-alt Megan N. Gates, Partner, Covington & Burling LLP
Lauren Cole, Managing Director, Silicon Valley Bank
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
2:00
Global Competition and Trade Dynamics in Life Sciences Arena: Navigating Legal and Business Challenges in 2024
microphone-alt Christine Savage, Partner, King & Spalding LLP
Ingrid E. VanderElst, PhD, Partner, Fasken Martineau DuMoulin LLP
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 and China
• 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
2:45
Hot Topics in Patent Prosecution: Understanding the Critical Do’s and Don’ts of the Patent Application Process
microphone-alt Donna Meuth, Associate General Counsel Intellectual Property, Eisai
Jane Remillard, Partner, Nelson Mullins Riley & Scarborough LLP
Gargi Talukder, Partner, Orrick, Herrington & Sutcliffe LLP
• 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
3:30
Advertising Challenges in Life Sciences: Understanding FTC/FDA Guidances, Influencer Engagement, and Anti-Kickback Statute Risks
microphone-alt Pamela Politis, Associate VP, North American Legal, Incyte Corporation
Jennifer DiFruscio, Assistant General Counsel, Vertex Pharmaceuticals
Kristen Klesh, Partner, Loeb & Loeb LLP
Moderator: Deborah A. Logan, Associate General Counsel, EMD Serono
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
3:30
Spotlight on Data Privacy and Cybersecurity in the Life Sciences Arena: Overcoming Challenges and Navigating the Latest Regulatory Frameworks
microphone-alt Zoe Philippides, SVP, Chief Ethics, Compliance & Privacy Officer & Global Head of Litigation, Moderna
Jami Vibbert, Partner, Arnold & Porter Kaye Scholer LLP
Nancy Bonifant Halstead, Partner, Reed Smith LLP
Thora Johnson, Partner, Orrick, Herrington & Sutcliffe LLP
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
5:00
Combatting the Emerging DEI Backlash: How Women Leaders in Life Sciences Law Can Maintain Career Advancement in the Face of Recent DEI Disruption
Rita Sanzgiri, Board of Directors, Executive Committee, Colorado BioScience Association
Jessica Parker-Battle, Head of Legal North America, Biogen
With recent attacks on DEI initiatives now on the rise, 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
“Mistakes – I’ve Made a Few”: Overcoming Bumps in Your Career Journey and Reframing Professional Setbacks as Opportunities for Growth
microphone-alt
Rupa Cornell, VP President & Head Counsel, Takeda Pharmaceuticals
Jennean Endres, Vice President US Legal, GSK
Jacqueline (“Jackie”) deGrandpre, Shareholder, Greenberg Traurig LLP
Caryn Borg-Breen, Ph.D., Partner, Ballard Spahr LLP
Join us for a candid and insightful discussion with a panel of senior-level life sciences industry executives, revered as the “deans” of their field, as they reflect on personal mistakes and regrets they’ve experienced in their careers. From missteps in the courtroom, to mismanaging a difficult client relationship, to missing out on an ideal job opportunity - our panelists will share invaluable insights on perceived mistakes they encountered in their career journeys and the lessons they’ve learned along the way.
• 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
5:45
Conference Adjourns for Day 1
Cocktail Reception Sponsored by
Conference Day Two
Friday, July 26th, 2024
8:30
Co-Chairs’ Opening Remarks
microphone-alt Veronica M. Lei, Assistant General Counsel, Eli Lilly and Company
Elena Rossano, Senior Counsel, Global Commercial Operations, Amgen
8:45
Life Sciences Litigation Trendspotting:
A Look at Key Court Decisions
Impacting the Life Sciences Industry in 2024 and Critical Takeaways for Your Practice
microphone-alt Christine Kain, Partner, Faegre Drinker Biddle & Reath LLP
Lauren M. Lesko, Partner, Rakoczy Molino Mazzochi Siwik LLP
Tanvi B. Patel, Partner, Neal, Gerber & Eisenberg LLP
Suneeta Hazra, Partner, Arnold & Porter Kaye Scholer LLP
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
9:30
CEO Spotlight Interview
microphone-alt Miruna Sasu, President & CEO, COTA Healthcare
Moderator: Terra Reynolds, Partner, Latham & Watkins LLP
10:00 Morning Coffee Break
SPOTLIGHT ON ARTIFICIAL INTELLIGENCE
10:30
Leveraging AI in Medical Devices, Drug Development, Diagnostics, and Clinical Trials: Strategic Management of the Legal and Compliance Risks
microphone-alt Lora Spencer, Principal Global Litigation & Investigations Counsel, Medtronic
Elizabeth Richards, Partner, Latham & Watkins LLP
Amanda Klingler, Partner, King & Spalding LLP
Jaelyn Edwards Judelson, Partner, Akin Gump Strauss Hauer & Feld LLP
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, 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
11:15
Harnessing Generative AI in Business Operations and Legal Practice: Optimizing Resources and Navigating Ethical Compliance Pitfalls
microphone-alt Lauren Misztal, SVP, General Counsel, Clario
Kate E. Cassidy, Partner, Wiggin and Dana LLP
Selina P. Coleman, Partner, Reed Smith LLP
• 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 challenges related to bias, fairness, and accountability
• Analyzing how organizations have successfully integrated generative AI into their legal and business practices
12:00 Networking Luncheon
This conference is one of the few events I have attended that is focused on women helping women with real-life, practical tips on how to make a significant impact on your career. Many of the speakers are willing to share stories not just of success, but stories of adversity and how to turn those situations around into successful ones. I block my calendar early, so I can be sure to attend each year.
– Chief Legal Officer, Beam Therapeutics Inc.
1:00
Mastering the Art of Career Laddering in the Life Sciences Arena: Forging and Navigating Non-Traditional Pathways to Success in a Male-Dominated Sector
microphone-alt Ashley Watson, General Counsel Medical Devices, Johnson & Johnson
Lisa Jakob, Managing Counsel, Trademark Group, Merck
Lisa LeCointe-Cephas, Partner, DLA Piper LLP
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
1:45
Life Sciences in the News: Exploring the Anticipated Compliance and Litigation Risks Associated with Semaglutide and GLP-1s
microphone-alt
Jee Lehmann, Managing Principal, Analysis Group
Nicole Mantini, Partner, Torys LLP
Halli Cohn, Partner, Troutman Pepper Hamilton Sanders LLP
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
2:30 Afternoon Break
2:45
Breaking Barriers and Building Teams: Women Shaping Legal Departments in Growing Life Sciences Companies Share Lessons from the Front Lines
microphone-alt Celia Eckert, SVP, General Counsel & Corporate Secretary, Xencor
Qing Nian, Head of Legal - North America & Corporate, BeiGene
Debbie Walters-Francique, Vice President, Assistant General Counsel, Pfizer
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
3:30
“The Best Thing I Ever Learned From a Mentor – 2024 Edition”: Cultivating and Empowering the Next Generation of Women Leaders in Life Sciences Law
microphone-alt Christina Schwarz, Partner, Venable LLP
Deidre Arnold, VP - Commercial Legal, Alnylam Pharmaceuticals
Jean Cunningham, Principal Consultant, Larson Maddox
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
4:15
End of Conference Wrap Up
LIFE SCIENCES GLOBAL SERIES PORTFOLIO
hands-helping BECOME A SPONSOR
With conferences in the United States, Canada, Latin America and Europe, the C5 Group of Companies: American Conference Institute, Canadian Institute, and C5 Group, provides a diverse portfolio of conferences, events and roundtables devoted to providing business intelligence to senior decision makers responding to challenges around the world.
Don’t miss the opportunity to maximize participation or showcase your organization’s services and talent. For more information please contact us at: SponsorInfo@AmericanConference.com
EARN CLE CREDITS
Continuing Legal Education Credits
Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.
ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.
ACI certifies this activity has been approved for CLE credit by the State Bar of California.
ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.
Questions about CLE credits for your state? Visit our online CLE Help Center at www.AmericanConference.com/Accreditation/CLE/
C5 celebrates 40 years of excellence! We are thrilled to have provided exceptional conference experiences globally with our outstanding team, speakers, sponsors, partners, and attendees. To mark this milestone, we're launching a new logo which represents our commitment to innovation, growth, and excellence, represented by the five Cs of C5: Current, Connected, Customer-Centric, Conscientious, and Committed.
Looking back on 40 years, we are grateful for our achievements—hosting global conferences, uniting industry leaders, and supporting business growth. However, we are not done yet! We are committed to pushing boundaries and creating impactful experiences and we're excited for the next 40 years of success.
VIEW EVENTS
Seaport Hotel
1 Seaport Lane, Boston, MA 02210
American Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a negotiated rate. To take advantage of these rates, please contact the hotel directly and quote “ACI’s Women in Life Sciences“.
Please note that the guest room block cut-off date is June 21, 2024. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.
Book with confidence!
Register and pay to lock in your early rate and be eligible for a full refund until July 10, 2024.
If you are unable to attend for any reason, you will have the following options:
y A full credit note for you, or a colleague to attend another event.
y A full refund.
All cancellations and changes must be submitted to CustomerService@AmericanConference.com by July 10, 2024.