10th Annual Summit for Women Leader in Life Sciences Law - WEB

July 26 – 27, 2023 • Omni Parker House, Boston, MA

Distinguished Co-Chairs:

Aileen Fair

ANNUAL

IN LIFE SCIENCES LAW Women Leaders SUMMIT FOR

Increasing the Prominence of Women through Professional Development, Substantive Legal Discussion, and Woman-to-Woman Networking

Keynote Interview:

Julia Tierney

Chief Of Staff - Office of The Commissioner

Food & Drug Administration (FDA)

2023 Program Highlights:

Insights from Leading Industry Stakeholders:

• Alnylam Pharmaceuticals

• Azurity Pharmaceuticals

• BioCryst Pharmaceuticals

• BMS

• Corza Medical

CHEVRON-RIGHT An Exploration of Key Legislative, Enforcement, and Policy Developments Influencing Life Sciences IP, Products Liability and Compliance in 2023

CHEVRON-RIGHT Focus Session on How the Inflation Reduction Act Will Impact Innovation, R&D, and Commercialization

CHEVRON-RIGHT Moving the Needle on Clinical Trial Diversity: Navigating New FDA Requirements for Diversity Action Plans

• Eisai

• Eli Lilly and Company

• EMD Serono

• GSK

• Incyte Corportation

Senior Corporate Counsel Litigation & Government Investigations

Bristol Myers Squibb

Lora Spencer

Principal Litigation & Investigations Counsel

Medtronic

Fireside Chat with:

The Importance of Allyship in Fostering Diversity, Equity and Inclusion

Sandra Leung

Executive Vice President, General Counsel

Bristol Myers Squibb

• Medtronic

• Merck

• Moderna

• Panavance Therapeutics

• Pfizer

• Regeneron

• Seer

• Spero Therapeutics

• Sumitovant Biopharma

• Vertex

CHEVRON-RIGHT Spotlight on the “FemTech” Revolution: Examining the Legal and Compliance Challenges Associated with Digitizing Women’s Health

CHEVRON-RIGHT Navigating Detours in Your Career Journey: Q+A with Women Leaders in Life Sciences Law Who Have Changed Career Paths

Join Us in Boston this July to Commemorate the 10th Anniversary of ACI’s Flagship Summit for Women Leaders in Life Sciences Law.

Every year for the past 9 years, ACI’s “WILS” conference has brought together over 200 female attorneys and executives from the biotech, pharmaceutical, and medical device industries to celebrate the achievements of women leaders in life sciences law.

This unique event has earned its standing as the one and only forum where today’s and tomorrow’s female leaders can convene and discuss the latest legal, administrative and policy developments impacting the life sciences industry, as well as strategize on professional development, career advancement and increasing the prominence and recognition of women within the field.

This year, our esteemed faculty of remarkable female leaders will examine new regulatory frameworks impacting drug pricing, innovation and commercialization, and will also tackle the unique legal and compliance challenges surrounding FemTech and the latest AI-driven tools and technologies. Attendees will receive practical insights on improving clinical trial diversity, as well as on mitigating compliance risks across life science company operations. This year’s event will additionally deliver effective tips and strategies for “rainmaking,” navigating detours in your career journey and earning a seat on life science company boards.

Whether you're a seasoned legal professional or just starting out in your career, this event is the perfect opportunity to connect with other like-minded women, learn from inspiring role models, and gain valuable insights into advancing in the world of life sciences law. Don't miss this chance to be inspired, empowered, and motivated by some of the most accomplished women leaders in the industry.

We look forward to seeing you this July!

2023 ADVISORY BOARD

Sonia Arnold

Associate VP, Assistant General Counsel

– Consumer/Customer Operations

Eli Lilly and Company

Lori Cohen

Co-Chair, Global Litigation

Chair, Pharmaceutical, Medical Device & Health Care Litigation Group

Chair, Trial Practice Group

Greenberg Traurig LLP

Tamara Joseph

Chief Legal Officer

Spero Therapeutics

Elona Kogan

General Counsel and Corporate Secretary Seer Inc.

Deborah A. Logan

Associate General Counsel

EMD Serono, Inc.

Donna M. Meuth

Associate General Counsel, Intellectual Property Eisai Inc.

Honorable Teresa Rea Partner

Crowell & Moring LLP

(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 Global Litigation & Investigations Counsel

Medtronic

Gael Tisack

Deputy General Counsel, IP Olympus Corporation

Robin Walker

Chief Legal Officer and Corporate Secretary Areteia Therapeutics

Thank you to our Sponsors & Partners

2023 DISTINGUISHED FACULTY

CO-CHAIRS

Aileen Fair Senior Corporate Counsel Litigation & Government Investigations

Bristol Myers Squibb

Lora Spencer Principal Global Litigation & Investigations Counsel Medtronic

DISTINGUISHED FACULTY

Amy Altshul

Senior Vice President

Head of Legal for Global R&D, Global Oncology and Global Commercial Activities

GlaxoSmithKline

Sonia Arnold

Associate VP, Assistant General Counsel – Consumer/Customer Operations

Eli Lily and Company

Anna Aryankalayil Partner

Orrick Herrington & Sutcliffe LLP

Dorothy Auth, Ph.D. Partner Cadwalader, Wickersham & Taft LLP

Alane Barnes Chief Legal Officer BioCryst Pharmaceuticals, Inc

Margaret Bolce Brivanlou Partner Ballard Spahr LLP

Maureen Bresnahan Assistant General Counsel Eisai Inc.

Sarah Cummings Stewart Partner

Reed Smith LLP

Adrienne Franco Busby Partner

Faegre Drinker Biddle & Reath LLP

Rebecca Clegg Counsel

Axinn, Veltrop & Harkrider LLP

Kellie Combs Partner Ropes & Gray LLP

Jennifer DiFruscio Assistant General Counsel Vertex

Alicia J. Donahue Partner

Shook, Hardy & Bacon LLP

Alexis Early Partner

King & Spalding LLP

Ronni Fuchs Partner

Troutman Pepper Hamilton Sanders LLP

Kathleen Gersh Partner Loeb & Loeb LLP

Jamie Haney General Counsel North America and Head of Legal Specialty Care

GBU

Sanofi

Elizabeth Holland Partner Allen & Overy LLP

Lauren Ingegneri Vice President, Legal and Chief Compliance Officer Corza Medical

Lisa Jakob Managing Counsel, Trademarks & Copyrights

Merck

Rajini Jayasuriya Associate Principal

Charles River Associates

Jennifer Jones-McMeans, PhD Divisional Vice President, Global Clinical Affairs

Abbott

Tamara Joseph CLO

Spero Therapeutics

Kathleen Kelly Sr Director Commercial Counsel, Legal Department

Azurity Pharmaceuticals

Kristen Klesh Partner

Loeb & Loeb LLP

Elona Kogan General Counsel and Corporate Secretary Seer Inc.

Janet Kwuon Partner

Reed Smith LLP

Sarah Lau Partner

Kilburn & Strode LLP

Sandra Leung Executive Vice President, General Counsel

Bristol Myers Squibb

Diane Lifton

Senior Vice President, Head of Legal, Regenerative Medicine and Gene Therapy Sumitovant Pharma

Trang Hoang Lin Partner

Rakoczy Molino Mazzochi Siwik LLP

Liz Lindquist Partner, Life Sciences & Healthcare Regulatory Arnold & Porter LLP

Katrina Long

Senior Director, Assistant General Counsel Regeneron

Deborah Logan Associate General Counsel EDM Serono

Jeny Maier Partner

Axinn, Veltrop & Harkrider LLP

Kimberly Maney Assistant General Counsel | Lead Digital, Privacy and Innovation US Pharma GSK

Nicole Mantini Partner Torys LLP

Rebecca M. McNeill

Founding and Managing Partner McNeill Baur PLLC

Whitney Meier Howard Partner Venable LLP

Mercedes Meyer, Ph.D. Shareholder Banner Witcoff

Lucy Muzzy

Vice President, Compliance, Digital Health, Medicines and Artificial Intelligence Business Unit Pfizer

Allison Ng Shareholder Greenberg Traurig LLP

Sapna Palla Partner Allen & Overy LLP

Deirdre Parsons Senior Director, Global Public Policy & Government Relations Alnylam Pharmaceuticals

Maria Pasquale

EVP/GC and Corporate Secretary Incyte

Marla Persky

President & CEO, WOMN LLC

Member, Board of Directors

Xeris Biopharma Inc

(NASDAQ:XERS), Panavance Therapeutics Inc., Revolo Biotherapeutics Inc.

Pamela Politis

Associate Vice President, North American Legal Incyte Corporation

Kathryn Potalivo

Senior Counsel, Commercial Legal Moderna

Jennifer A. Prioleau

SVP, Chief Legal Officer & Chief Compliance Officer B. Braun Medical Inc.

Elizabeth Richards Partner Latham & Watkins LLP

Melanie Rupert Partner Paul Hastings LLP

If law firms and law departments are serious about developing women leaders, then they’ll send them to this conference. The who’s who of health care lawyers are here and there are multiple opportunities for informal networking and mentoring conversations.

– General Counsel, Enzyvant

Emer Simic Partner

Neal, Gerber & Eisenberg LLP

Kate Skagerberg Partner

Nelson Mullins Riley & Scarborough LLP

Lora Spencer Principal Global Litigation & Investigations Counsel Medtronic

Julia Tierney Chief Of Staff –Office of The Commissioner Food & Drug Administration (FDA)

Malaika Tyson Shareholder

McAndrews, Held & Malloy Ltd

Eveline Van Keymeulen Partner

Latham & Watkins LLP

Emily van Tuyl Partner Dechert LLP

Sophie Wang Partner

Choate Hall & Stewart LLP

Annsley Ward Partner

Wilmer Hale

Jennifer Willcox

Senior Vice President, General Counsel & Chief Governance Officer

Dana-Farber Cancer Institute

Rebecca K. Wood Partner

Sidley Austin LLP

Betty Yan Partner Arnold & Porter LLP

Jane Yoon Partner Paul Hastings LLP

Rachel Yu Partner Sullivan & Cromwell LLP

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

PRE-CONFERENCE WORKSHOPS

W ORKSH OP A 9:00 am – 12:30 pm (Registration starts 8:00 am)

– Tuesday, July 25th, 2023

WORKSHOP B 1:30 - 5:00 pm (Registration starts 12:00 pm)

Career Advancement Boot Camp: Developing Strategies for Communication, Negotiation and Management That Will Help You Win at Work (And in Life)

microphone-alt Adrienne Franco Busby, Partner, Faegre Drinker Biddle & Reath LLP

Dorothy Auth, Ph.D., Partner, Cadwalader, Wickersham & Taft LLP

Rebecca M. McNeill, Founding and Managing Partner, McNeill Baur PLLC

Amy Altshul, Senior Vice President, Head of Legal for Global R&D, Global Oncology and Global Commercial Activities, GlaxoSmithKline

Jennifer Willcox, Senior Vice President, General Counsel & Chief Governance Officer, Dana-Farber Cancer Institute

This interactive working group will help you to cultivate the three core “power skills” which are often needed to attain career success and thrive in leadership roles. Our workshop leaders will help you to think critically about the leadership identity you want to create, and will then share strategies for communication, negotiation and management that will help you win in the workplace while also manifesting your authentic leadership presence.

COMMUNICATION

• Identifying your personal ‘leadership language’: communicating your core narratives in a way that relays your strengths, passions, values and goals

• Learning to voice your opinions confidently across all levels of your organization so that your ideas are heard, your value is clear and your opinions are remembered

• Capitalizing on informal workplace conversations as leadership opportunities, both in person and virtually

• Identifying flawed communication patterns: understanding when you are saying too much or too little

NEGOTIATION

• Learning how to display confidence, position your message and ask the right questions to get to “yes” in a variety of negotiation settings and scenarios

• Understanding how gender norms continue to shape ideas about male/female negotiation styles, and skills women can employ to overcome gendered perceptions

• Identifying the personal negotiation style that works best for you, and leveraging lessons from past successes to improve future negotiations

• Employing effective negotiation techniques such as “reframing” and “creative visualization”

MANAGEMENT

• Articulating your management style and values through every-day interactions

• Navigating the challenges of managing others in a hybrid/virtual work environment

• Strategies for managing difficult people: understanding when you may need to adapt your management style to a particular person or situation

• Increasing your visibility within your organization to ensure that your contributions and achievements as a manager are recognized

“What 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 Tamara Joseph, Chief Legal Officer, Spero Therapeutics

Maria Pasquale, Executive Vice President & General Counsel, Incyte Corporation

Alane Barnes, Chief Legal Officer, BioCryst Pharmaceuticals, Inc

Jennifer A. Prioleau, SVP, Chief Legal Officer & Chief Compliance Officer, B. Braun Medical Inc.

Jamie Haney, General Counsel North America and Head of Legal Specialty Care GBU, Sanofi

Back by popular demand, ACI is proud to deliver this not-to-miss workshop which will set the stage for our main event. 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 guidance for women at all stages in their career on how to advance within the ranks of the Life Sciences legal world. Come prepared with the questions you’ve always wanted to ask but never had the chance to and take advantage of this intimate mentorship opportunity in advance of our main conference. Our esteemed panelists will discuss topics including:

• Their roads to the GC office

• Advice for shattering the glass ceiling

• Skills necessary to thrive at the executive level

• What they look for in relationships with outside counsel and with their legal teams

• Lessons in running a good legal department: navigating new challenges associated with “return to work” policies, vaccine mandates and managing and mentoring in a hybrid workplace model

• Balancing management of a successful department with a robust and full personal life

5:00 pm

Welcome Cocktail Reception Sponsored by

MAIN CONFERENCE DAY 1 – Wednesday, July 26th, 2023

7:15 Registration and Continental Breakfast

8:15

Co-Chairs’ Opening Remarks and Audience Ice Breaker

8:45

Year in Review: A High-Level Look at the Most Significant Legislative, Enforcement and Policy Developments Influencing Life Sciences IP, Products Liability and Compliance in 2023

microphone-alt Trang Hoang Lin, Partner, Rakoczy Molino Mazzochi Siwik LLP

Sophie Wang, Partner, Choate Hall & Stewart LLP

Jane Yoon, Partner, Paul Hastings LLP

MODERATOR:

Liz Lindquist, Partner, Life Sciences & Healthcare Regulatory, Arnold & Porter LLP

In the year since we last met, there have been significant legal, regulatory and political developments impacting different facets of the life sciences legal industry. In this opening session, our esteemed panel of female leaders will set the stage for the conference with an exploration of the most influential developments impacting life sciences IP, products liability and compliance in 2023, as well as how these latest developments will impact your future practices.

9:45

Grappling with the Implications of the Inflation Reduction Act: Exploring the True Impact of This Legislation on Innovation, R&D, and Commercialization

microphone-alt Deirdre Parsons, Senior Director, Global Public Policy & Government Relations, Alnylam Pharmaceuticals

Rebecca Clegg, Counsel, Axinn, Veltrop & Harkrider LLP

Elizabeth Holland, Partner, Allen & Overy LLP

Margaret Bolce Brivanlou, Partner, Ballard Spahr LLP

In the year since its passage, many life sciences companies are still struggling to understand the full impact of the Inflation Reduction Act of 2022 (IRA) on their business strategies and operations. IRA reforms go beyond drug pricing and negotiation to have far reaching effects on everything from R&D to patent strategies to product commercialization. This panel will dissect IRA provisions and explore the deeper implications of this legislation for the industry.

• Forecasting the anticipated effects of the IRA on drug research and development, innovation, market entry, investment decisions, and competition

• Exploring how the IRA may influence future patent litigation strategies for both branded and generic drug companies

• Examining the nuances of the IRA drug pricing reform provisions: how will pricing reform and negotiation affect how future products and product lines are developed?

10:45 Morning Coffee Break

11:15

Keynote Interview

microphone-alt Julia Tierney, Chief Of Staff - Office of The Commissioner, Food & Drug Administration (FDA)

Rebecca Wood, Partner, Sidley Austin LLP

12:00

Mastering the Art of Rainmaking: Pro Tips for Perfecting Your Pitch, Bringing in Business and Ensuring You Get the Credit

microphone-alt Alicia J. Donahue, Partner, Shook, Hardy & Bacon LLP

Mercedes Meyer, Ph.D., Shareholder, Banner Witcoff

Janet Kwuon, Partner, Reed Smith LLP

MODERATOR:

Malaika D. Tyson, Ph.D., Shareholder, McAndrews, Held & Malloy Ltd

Attracting and bringing in business to a law firm is a skill that yields a greater likelihood of advancing to leadership positions. However, for some women lawyers, this activity of “rainmaking” can be both intimidating and mystifying. In this session, the panelists will share critical tools for mastering the art of rainmaking.

• Best practices for marketing yourself in a way that relays authenticity, both in person and online

• Tools for developing a strong and diversified network, and maximizing the benefits of that network

• Learning how to ask for what you want, and effective tactics for turning a “no” into a “yes”

• Effective approaches to ensuring that you receive origination credit – and understanding how the client can play a role in that process

12:45

Networking Luncheon Sponsored by Utensils

1:45

Spotlight on the “FemTech” Revolution: Examining the Latest Technological Advancements and Legal Challenges in The Digitalization of Women’s Health

microphone-alt Elizabeth Richards, Partner, Latham & Watkins LLP

Kristen Klesh, Partner, Loeb & Loeb LLP

Kimberly Maney, Assistant General Counsel | Lead Digital, Privacy and Innovation US Pharma, GSK

Lucy Muzzy, Vice President, Compliance, Digital Health, Medicines and Artificial Intelligence Business Unit, Pfizer

MODERATOR:

Sonia Arnold, Associate VP, Assistant General Counsel –Consumer/Customer Operations, Eli Lilly and Company

FemTech – i.e., the use of technology and related components to enhance women’s healthcare – has rapidly grown to encompass a wide range of solutions to improve healthcare for women across a number of female-specific conditions, as well as general health conditions that affect women disproportionately or differently. This panel will explore the exciting new technologies that have entered the FemTech market in recent years, as well as the various legal and compliance considerations for the life sciences industry.

• Assessing the myriad regulatory and compliance considerations for life sciences companies getting involved in the FemTech space:

» FDA and state law regulation of FemTech digital health tools

» Potential Anti-Kickback Statute pitfalls to watch out for

» Gray areas of risk to be aware of, and effective risk mitigation strategies

• Examining new innovations in FemTech: wearables, trackers, at-home diagnostics, and digital therapeutics

• Exploring the use of AI tools like ChatGPT and BioGPT in enhancing FemTech innovation

• Navigating the patchwork of privacy and data laws at the federal and state levels

» Exploring how the Dobbs decision has raised concerns about FemTech companies disclosing reproductive health data to law enforcement

• Understanding the unique legal considerations surrounding:

» FemTech software being used in communications related to prescription drug use

» FemTech being categorized as a medical device

3:00

Moving the Needle on Clinical Trial Diversity: Navigating New FDA Requirements for Diversity Action Plans

microphone-alt Katrina Long, Senior Director, Assistant General Counsel, Regeneron

Kellie Combs, Partner, Ropes & Gray LLP

Ronni Fuchs, Partner, Troutman Pepper Hamilton Sanders LLP

Jennifer Jones-McMeans, PhD, Divisional Vice President, Global Clinical Affairs, Abbott

• Devising a clinicical trial diversity action plan: what can industry do in practice to improve diversity in clinical trials and overcome operational challenges and obstacles in this endeavor

• Understanding the different roles of sponsors, patients, and investigators in conducting more equitable clinical trials

• Examining the new FDA clinical trial diversity requirements set forth by the Food & Drug Omnibus Reform Act of 2022

» Understanding what will be required in the development of Diversity Action Plans to improve the enrollment of racial and ethnic populations in clinical trials

» Exploring FDA’s toolkit for encouraging study sponsors to meet diversity goals

• Taking a look at specific strides life sciences companies are making to increase clinical trial diversity – what is working and what is not?

4:00 Afternoon Networking Break

4:15

The Present and Future Landscape of Life Sciences M&A: Behind the Scenes of the Deal Making Re-Shaping an Industry

microphone-alt Rachel Yu, Partner, Sullivan & Cromwell LLP

Anna Aryankalayil, Partner, Orrick Herrington & Sutcliffe LLP

Jeny Maier, Partner, Axinn, Veltrop & Harkrider LLP

The life sciences industry continues to see increasing mergers and acquisitions despite pressure from volatile markets, and regulatory scrutiny. This high-level discussion will analyze the current life sciences M&A landscape, and highlight anticipated trends in pharma and biotech dealmaking going forward.

• Opportunities and risks: Defining the new dealmaking landscape

• Examining recent involvement by the FTC and antitrust authorities in life sciences mergers and acquisitions: navigating the challenges and understanding the overall impact on the industry

• Forecasts for future dealmaking in the industry

5:00

Secrets from the Boardroom: Women on Life Sciences Corporate Boards Share Insights on How to Earn, Utilize and Retain Your Seat at the Table

microphone-alt Elona Kogan, Secretary/General Counsel, Seer Inc.

Marla S. Persky, President & CEO, WOMN LLC Member Board Of Directors, Xeris Biopharma Inc (NASDAQ:XERS), Panavance Therapeutics Inc., Revolo Biotherapeutics Inc.

MODERATOR:

Lora Spencer, Principal Litigation & Investigations Counsel, Medtronic

It is no secret that joining a board can help boost your career to the next level, but how do you get there? Hear from women who have ‘been there and done that’ on what strategies they implemented to achieve their seat at the boardroom table and join a rounded discussion on what life sciences industry leaders should be doing to help more women get boardroom ready.

• Building and tailoring your resume to increase your chances of being accepted onto a board

• Preparing women to take a seat at the boardroom table: how women can best support women in this endeavor

• Tips for navigating the board experience and standing out as an effective board member

• Strategies for moving from a seat at the table to the head of the table

• Analyzing boardroom diversity strategies that are yielding effective results

5:45 Conference Adjourns

Cocktail Reception Sponsored by

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/

MAIN CONFERENCE DAY 2 – Thursday, July 27th, 2023

7:30 Registration & Continental Breakfast

8:20

Co-Chairs’ Welcome Back and Recap of Day 1

8:30

Shining a Light on the Top 10 Court Cases Impacting the Life Sciences Industry in 2023

microphone-alt Maureen Bresnahan, Assistant General Counsel, Eisai Inc.

Whitney Meier Howard, Partner, Venable LLP

Sapna Palla, Partner, Allen & Overy LLP

Emer Simic, Partner, Neal, Gerber & Eisenberg LLP

MODERATOR:

Allison Ng, Shareholder, Greenberg Traurig LLP

In this session, our panelists will analyze high-profile cases and decisions that are shaking up the life sciences industry. Understand how these precedents will affect future cases in your life sciences practice.

9:45

Life Sciences Around the Globe: Exploring Key International Developments Impacting the Global Life Sciences Stage

microphone-alt Rajini Jayasuriya, Associate Principal, Charles River Associates

Sarah Lau, Partner, Kilburn & Strode LLP

Nicole Mantini, Partner, Torys LLP

Eveline Van Keymeulen, Partner, Latham & Watkins LLP

hands-helping BECOME A SPONSOR

MODERATOR:

Annsley Ward, Partner, Wilmer Hale

This panel will consider current developments and future forecasts for the global life sciences stage. Points of discussion will include:

• Examining the implications of the newly commenced Unified Patent Court and Unitary Patent in Europe: Gearing up for a new era of patent prosecution and litigation overseas

• Analyzing the latest proposed reforms to the European Union’s general pharmaceutical legislation: What can we anticipate from the proposed revisions expected in 2023?

• Assessing the latest developments in international IP rights as well as anticompetitive concerns

10:45 Morning Coffee Break

11:15

Navigating Detours in Your Career Journey: Interactive Q+A with Women Leaders Who Have Successfully Switched Career Paths in the Life Sciences

microphone-alt Lisa Jakob, Managing Counsel, Trademarks & Copyrights, Merck

Kathleen Kaly, Sr Director Commercial Counsel, Legal Department, Azurity Pharmaceuticals

Kathleen Gersh, Partner, Loeb & Loeb LLP

Lauren Robinson, Vice President, Larson Maddox

We’ve all been taught the importance of making a 5 or 10-year career plan, but what happens when we realize we might want to deviate from that plan? Hear from women leaders in life sciences law who have changed their career path and found success in their new roles. Whether you are seeking to move into an in-house, law firm or government position, gain insights

on the risks and rewards that come with trying something new, as well as how to best position yourself for transitioning into a newly desired role.

• Preparing to take the leap

» Determining what experience you might lack for a new role and making a plan for how to get it

» Stepping outside your comfort zone and pushing your boundaries to best enhance your skill set

• Understanding how to make your resume appealing to the type of role you aspire to transition into, and what companies/ organizations/agencies are really looking for when recruiting for the particular role

• Factoring external commitments and responsibilities into your decision-making on where you want to be

• Utilizing all connections, tools and resources available to help you thrive in a new role

12:15 Networking Luncheon

1:30

Spotlight Interview: The Importance of Allyship in Fostering Diversity, Equity and Inclusion

Sandra Leung

Executive Vice President, General Counsel Bristol Myers Squibb

With conferences in the United States, Europe, Asia Pacific, and Latin America, the C5 Group of Companies: American Conference Institute, The 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

2:00

Regulatory Compliance Planning for Life Sciences Companies: Mitigating Risk Across Core Areas of Life Science Company Operations

The life sciences industry continues to face evolving regulatory and compliance challenges which pose a constant threat to operations and sustainability. Companies that effectively manage these concerns will ultimately develop a competitive advantage. This twopart compliance planning session will examine best practices for mitigating risk across core areas of life science company operations.

PART 1:

Avoiding Compliance Pitfalls Associated with Trade, Customs and Export Control Laws

microphone-alt Lauren Ingegneri, Vice President, Legal and Chief Compliance Officer, Corza Medical

Deborah Logan, Associate General Counsel, EDM Serono

Alexis Early, Partner, King & Spalding LLP

• Examining the impact of the current customs and trade regulatory environment on cross-border movements of life science company materials and products

• Staying up to date with the latest export regulations to mitigate life sciences trade compliance risks

• Making sure that you include customs and export control considerations in your regulatory compliance and supply chain planning to avoid enforcement activity and unwanted penalties

PART 2: Combating Bribery, Fraud and Collusion in the Life Sciences Sector

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

Kathryn Potalivo, Senior Counsel, Commercial Legal, Moderna

Sarah Cummings Stewart, Partner, Reed Smith LLP

• Analyzing recent FCPA and FCA activity affecting the Life Sciences Industry

• Examining recent enforcement activity against life sciences companies based on corruption, collusion and fraud

• Developing a coherent compliance strategy and implementing Codes of Conduct to minimize compliance risks

• Anticipating and preparing for investigations

Following the panel’s discussion, engage in a Q+A with all of the panelists to get answers to all of your most pressing compliance planning questions.

3:20 Afternoon Break

3:40

“The Best Thing I Ever Learned from a Mentor or Mentee”: 2023 Edition

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

Jennifer DiFruscio, Assistant General Counsel, Vertex

Kate Skagerberg, Partner, Nelson Mullins Riley & Scarborough LLP

Melanie Rupert, Partner, Paul Hastings LLP

MODERATOR:

Emily van Tuyl, Partner, Dechert LLP

Returning for its second year by popular demand, we will close our event with a panel of esteemed female 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 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 this space

4:45 Conference Ends

Bed VENUE

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 Law”.

Hotel: Omni Parker House

Address: 60 School St, Boston, MA 02108

Reservations: 1-800-THE-OMNI

Please note that the guest room block cut-off date is July 7, 2023. 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 15th.

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 15.

3–4

5–6

call customer service.

7

*Team/group registrations must be from the same organization/firm and register together in one transaction.

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/