Registration and Continental Breakfast

Co-Chairs’ Opening Remarks and Audience Ice Breaker

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

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.

Grappling with the Implications of the Inflation Reduction Act: Exploring What the True Impact Will be on the Future of Drug Pricing, Innovation and Commercialization

Rebecca Clegg
Attorney
Axinn, Veltrop & Harkrider LLP

Elizabeth Holland
Partner
Allen & Overy LLP

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

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?

Morning Coffee Break

Keynote Interview

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

Alicia J. Donahue
Partner
Shook, Hardy & Bacon

Janet H. Kwuon
Partner
Reed Smith LLP

Mercedes Meyer, Ph.D.
Shareholder
Baner Witcoff

Moderator:

Malaika Tyson
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

Networking Luncheon
Sponsored by:

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

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

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

Elizabeth Richards
Partner
Latham & Watkins LLP

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

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

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

Katrina Long
Senior Director, Assistant General Counsel
Regeneron Pharmaceuticals, Inc.

• 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?

Afternoon Break: Speed Networking and Business Card Exchange

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

Anna Aryankalayil
Partner
Orrick Herrington & Sutcliffe LLP

Jeny Maier
Partner
Axinn, Veltrop & Harkrider LLP

Rachel Yu
Partner
Sullivan & Cromwell 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

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

Elona Kogan
General Counsel and Corporate Secretary
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 Global 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

Conference Adjourns
Cocktail Reception
Sponsored by:

Registration & Continental Breakfast

Co-Chairs’ Welcome Back and Recap of Day 1

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

Maureen Bresnahan
Assistant General Counsel
Eisai Inc.

Whitney Meier Howard
Partner
Venable LLP

Allison Ng
Attorney
Greenberg Traurig LLP

Sapna Palla
Partner
Allen & Overy LLP

Emer Simic
Partner
Neal, Gerber & Eisenberg 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.

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

Rajini Jayasuriya
Associate Principal
Charles River Associates

Sarah Lau
Partner
Kilburn & Strode LLP

Annsley Ward
Partner
Wilmer Hale

Eveline Van Keymeulen
Partner
Latham & Watkins LLP

Nicole Mantini
Partner
Torys LLP

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

Morning Coffee Break

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

Jennifer Fox
EVP External Affairs, General Counsel, and Corporate Secretary, Legal
Emergent BioSolutions

Kathleen Gersh
Partner
Loeb & Loeb LLP

Lisa Jakob
Managing Counsel, Trademarks & Copyrights
Merck

Kathleen Kelly
Sr Director Commercial Counsel, Legal Department
Azurity Pharmaceuticals

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

Networking Luncheon

Spotlight Interview

Sandra Leung
Executive Vice President, General Counsel
Bristol Myers Squibb

The Importance of Allyship in Fostering Diversity, Equity and Inclusion

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

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

Deborah A. Logan
Associate General Counsel
EMD Serono

Alexis Early
Partner
King & Spalding LLP

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 two-part 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

• 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

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

Afternoon Break

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

Jennifer DiFruscio
Assistant General Counsel
Vertex

Diane E. Lifton
Senior Vice President, Head of Legal, Regenerative Medicine and Gene Therapy
Sumitovant Pharma

Melanie Rupert
Partner
Paul Hastings LLP

Kate Skagerberg
Partner
Nelson Mullins Riley & Scarborough LLP

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

Conference Ends