11th Annual Summit for Women Leaders in Life Sciences Law - WEB

EARN CLE CREDITS

11 TH ANNUAL SUMMIT FOR

Distinguished Co-Chairs: Veronica M. Lei

Assistant General Counsel Eli Lilly and Company

IN

LIFE SCIENCES LAW

Elena Rossano

Senior Counsel, Global Commercial Operations Amgen

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

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CEO Spotlight Interviews:

Paula Ragan PhD

CEO & President X4 Pharmaceuticals

Miruna Sasu

President & CEO COTA Healthcare

2024 Program Highlights: 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: Amgen

GSK

Meitheal Pharmaceuticals

Sumitomo Pharma America

BeiGene

Johnson & Johnson

Merck

Takeda Pharmaceuticals

EMD Serono

Kymera Therapeutics

Moderna

Vertex Pharmaceuticals

Eisai

Lexeo Therapeuthics

Roche Diagnostics

Xencor

Eli Lilly and Company

Medtronic

Seer Inc.

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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.

Lora Spencer Principal Litigation & Investigations Counsel Medtronic

Honorable Teresa Rea

Gael Tisack Deputy General Counsel, IP Olympus Corporation

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

2 | #WiLS24 #ACIConferences LINKEDIN Pharmaceuticals, Biotech & Life Sciences: Legal, Regulatory, and Compliance Professionals

Robin Walker Chief Legal Officer and Corporate Secretary Areteia Therapeutics

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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 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

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 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 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

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 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

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 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

Jee Lehmann Managing Principal Analysis Group

Jessica Parker-Battle Head of Legal North America Biogen

Lauren M. Lesko Partner Rakoczy Molino Mazzochi Siwik LLP

Tanvi B. Patel Partner Neal, Gerber & Eisenberg LLP

Zoe Philippides SVP, Chief Ethics, Compliance & Privacy Officer & Global Head of Litigation Moderna 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

Karin Simonson VP, General Counsel & Corporate Secretary Envoy Medical 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

Elizabeth Richards Partner Latham & Watkins LLP

Ingrid E. VanderElst, PhD Partner Fasken Martineau DuMoulin LLP

Jenny Robertson Chief Business and Legal Officer Lexeo Therapeutics

Jami Vibbert Partner Arnold & Porter Kaye Scholer LLP

Rita Sanzgiri Board of Directors, Executive Committee Colorado BioScience Association

Anne K. Walsh Director Hyman, Phelps & McNamara

Patti Saris District Judge United States District Court for the District of Massachusetts

Debbie Walters-Francique Vice President, Assistant General Counsel Pfizer

Miruna Sasu President & CEO COTA Healthcare

Ashley Watson General Counsel Medical Devices Johnson & Johnson

Christine Savage Partner King & Spalding LLP

Rachel Yu Partner Sullivan & Cromwell LLP

Christina Schwarz Partner Venable LLP Ellen Scordino Partner DLA Piper LLP

4 | #WiLS24 #ACIConferences LINKEDIN Pharmaceuticals, Biotech & Life Sciences: Legal, Regulatory, and Compliance Professionals

Pre-Conference Workshops Wednesday, July 24th, 2024

9:00 am – 12:30 pm

Advancement Bootcamp: Mastering the Art of Personal A Career 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:

1:30 – 5:00 pm

I Wish Someone Had Told Me: Advice from Inspiring Life B What 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

• Harnessing your unique superpower: Discover what sets you apart and learn to articulate your unique value proposition effectively

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:

• Positioning yourself in a way that differentiates you from your peers

• Shattering the glass ceiling

• 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 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

» 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

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Conference Day One Thursday, July 25 , 2024 th

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

10:00

Morning Coffee Break

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

Coffee & Conversation with Women Leaders in Life Sciences Law: Exploring the Top Legal, Regulatory and Policy Concerns for 2024

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.

microphone-alt Diane Lifton, Senior Vice President, Head of Legal, Regenerative Medicine and Gene Therapy,

This panel will explore key topics including:

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

• 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)

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:

Patti Saris, District Judge, United States District Court for the District of Massachusetts

• Current legislative activity impacting women’s reproductive health care

Denise Cote, Senior United States District Judge, United States District Court for the Southern District of New York

• 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

6 | #WiLS24 #ACIConferences LINKEDIN Pharmaceuticals, Biotech & Life Sciences: Legal, Regulatory, and Compliance Professionals

Linda Horner, Acting Senior Lead Administrative Patent Judge, USPTO

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

AFTERNOON BREAKOUT SESSIONS on KEY LEGAL CHALLENGES IN THE LIFE SCIENCES FIELD TRACK 1

TRACK 2

2:00

2:00

Navigating Today’s Life Sciences M&A Landscape: Charting the Latest Trends and Challenges in Pharma and Biotech Dealmaking

Global Competition and Trade Dynamics in Life Sciences Arena: Navigating Legal and Business Challenges in 2024

microphone-alt Kathleen Gersh, Partner, Loeb & Loeb LLP

microphone-alt Christine Savage, Partner, King & Spalding 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

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

» 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

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AFTERNOON BREAKOUT SESSIONS on KEY LEGAL CHALLENGES IN THE LIFE SCIENCES FIELD TRACK 1

TRACK 2

3:30

3:30

Advertising Challenges in Life Sciences: Understanding FTC/FDA Guidances, Influencer Engagement, and Anti-Kickback Statute Risks

Spotlight on Data Privacy and Cybersecurity in the Life Sciences Arena: Overcoming Challenges and Navigating the Latest Regulatory Frameworks

microphone-alt Pamela Politis, Associate VP, North American Legal, Incyte Corporation

microphone-alt Zoe Philippides, SVP, Chief Ethics, Compliance & Privacy Officer & Global Head of Litigation,

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

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

4:15

Afternoon Break

4:30

Combatting the Emerging DEI Backlash: How Women Leaders in Life Sciences Law Can Maintain Career Advancement in the Face of Recent DEI Disruption microphone-alt 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

8 | #WiLS24 #ACIConferences LINKEDIN Pharmaceuticals, Biotech & Life Sciences: Legal, Regulatory, and Compliance Professionals

5:00

“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

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

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

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

• FDA v. Alliance for Hippocratic Medicine

Kate E. Cassidy, Partner, Wiggin and Dana LLP

• Gilead Sciences, Inc. v. Superior Court of City & County of San Francisco

Selina P. Coleman, Partner, Reed Smith LLP

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

• 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.

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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

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

• Broadening legal horizons by challenging the stigma surrounding legal professionals’ career ambitions and advocate for equal access to diverse career opportunities

• Identifying the needs of your organization and hiring team members who meet specific company needs

1:45

• Understanding the different resources needed to develop a legal team in an established company, versus a new and growing company

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

• 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

10 | #WiLS24 #ACIConferences LINKEDIN Pharmaceuticals, Biotech & Life Sciences: Legal, Regulatory, and Compliance Professionals

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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

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.

REGISTER NOW

AmericanConference.com/LSWomen • 888 224 2480

Continuing Legal Education Credits

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a C5 Group Company Business Information in a Global Context

VENUE INFO

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!

WORRY FREE

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.

Registration

GUARANTEE

All cancellations and changes must be submitted to CustomerService@AmericanConference.com by July 10, 2024.

3 Ways to Register

ONLINE:



 AmericanConference.com/LSWomen

PRICING In-Person Conference Workshop A: Bootcamp Workshop B: What I Wish Someone Had Told Me

EMAIL: CustomerService@AmericanConference.com

SAVE $300

SAVE $200

Register & Pay by May 3, 2024

Register & Pay by June 14, 2024

Register & Pay after June 14, 2024

$1,795

$1,895

$2,095

$450 $450

All program participants will receive an online link to access the conference materials as part of their registration fee.

Additional copies of the Conference Materials available for $199 per copy.

To update your contact information and preferences, please visit https://www.AmericanConference.com/preference-center/.

Terms & conditions and refund/cancellation policies can be found at AmericanConference.com/company/faq/

© American Conference Institute, 2024



PHONE:

1-888-224-2480

REGISTRATION CODE:

B00-684-684L24.WEB Bringing a Team?* 1–3

No Discount

4–8

10% Conference Discount

9–12

15% Conference Discount

12+

Call 888-224-2480

CONFERENCE CODE:

684L24-BOS

Special Discount ACI offers financial scholarships for government employees, judges, law students, non-profit entities and others. For more information, please email or call customer service. *Team/group registrations must be from the same organization/firm and register together in one transaction.