Registration and Continental Breakfast

Breakfast Breakouts with the Advisory Board

New to the conference this year? Or a returning attendee looking to make new connections? Take advantage of the opportunity to join one of our breakfast break-out tables where an esteemed Advisory Board member will facilitate attendee introductions and the sharing of information through a fun Q+A exercise. Kick off the conference by making connections that you can build upon during the remainder of the event and beyond.

Co-Chairs’ Opening Remarks and Audience Ice Breaker

Tamara Joseph
Chief Legal Officer
Spero Therapeutics

Robin Walker
Chief Legal Officer and Corporate Secretary
Areteia Therapeutics

In this opening session, our conference co-chairs will kick off the event with an interactive game of “2 truths 1 lie.” You will then break into small groups at your tables as our conference.

YEAR IN REVIEW

Looking Back and Moving Forward: Analyzing Key Legal, Administrative, and Policy Developments Impacting the Life Sciences Industry and Influencing Your Career

Aileen M. Fair
Senior Corporate Counsel
Litigation & Government Investigations |Antitrust & Competition Law
Bristol Myers Squibb

Deborah A. Logan
Associate General Counsel
EMD Serono, Inc.

Sapna Palla
Partner
Allen & Overy LLP

Jeny Maier
Partner
Axinn, Veltrop & Harkrider LLP

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)

Moderator:

Kellie Combs
Partner
Ropes & Gray LLP

Join us for a high-level discussion of the most influential legal, regulatory, and political developments affecting all facets of the life sciences industry. Explore the impact that these developments will have on your future practices and careers in the year ahead and beyond. This panel will discuss topics including:

• What we can glean from key agency developments?
• How new leadership at the FDA, evolving approval standards, and the Administration’s New Intended Use Regulation are impacting the industry
• Anticipating how new leadership appointments at the PTO will impact life sciences innovation
• Navigating recent dramatic antitrust developments transforming the life sciences industry
• How the nomination of Judge Ketanji Brown Jackson to the Supreme Court may impact future decisions affecting the life sciences industry
• Understanding how anticipated new policies from the Biden Administration are likely to dramatically affect reimbursement, pricing, and innovation of prescription drugs
• What implications will recent proposed amendments to Rule 702 (Daubert) have on the future of drug and device product liability litigation?

KEYNOTE INTERVIEW

Lessons in Leadership from the Covid-19 Pandemic

Sally Susman
Executive Vice President and Chief Corporate Affairs Officer
Pfizer

Morning Networking Break

Making Your Personal Brand Work for You as a Woman in the Life Sciences Industry

Prajakta Sonalker
Counsel
Venable LLP

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

Sheila Connor
Vice President and Chief US Counsel
Biogen

Lauren Robinson
VP, Head of Legal Recruitment - Life Sciences
Larson Maddox

Moderator:

Brenda Herschbach Jarrell
Partner
Chair, Life Sciences Group
Choate Hall & Stewart LLP

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 is an essential step to making you a viable candidate for upward mobility within the industry. This panel will help you develop strategies for:

• Harnessing your superpower: understanding what makes you unique and learning to articulate it
• Positioning yourself in a way that differentiates you from your peers
• Building your brand in a way that demonstrates your deep understanding of your client
• Learning to become recognized as a thought leader in the life sciences arena and expanding your market presence
• Identifying opportunities for growth within the life sciences legal market at large as well as in your organization

Networking Luncheon

ATTAINING SUCCESS IN THE HYBRID WORKPLACE

Town Hall on Work-Life “Integration” in the Life Sciences Industries: How We Can Strive to Achieve the Best of Both Worlds in a Hybrid Work Environment

Larissa A. Eustice
Senior Assistant General Counsel
Bayer

Sheea Sybblis
Assistant General Counsel & Practice Group Leader
Genentech

Joy Dowdle
Partner
Paul Hastings LLP

Lisa Pirozzolo
Partner, Co-Chair, IP Litigation Practice Group
Wilmer Cutler Pickering Hale and Dorr LLP

As a result of the pandemic, many of us have learned to adopt the concept of “work-life integration,” which as opposed to work-life “balance,” largely abandons boundaries between work and life and instead embraces the notion that the two must coexist in harmony. This panel will tackle key questions such as:

• What will work-life integration look like now that many of us will be shifting into a hybrid virtual/in-person work environment?
• How can we strive to achieve the best of both worlds, and avoid facing a “worst of both worlds” scenario?
• How have client expectations shifted due to the pandemic and what will expectations look like in a future hybrid work model?
• How is virtual work creating a war for talent across the nation and will we ever be able to go back to the way things were pre-pandemic?
• How can women attain balance and best manage their time in a virtual or hybrid work model?

Let your voice be heard in this unique “open floor” session, designed to give attendees an opportunity to grab the microphone and add to the dialogue.

Focus Group on Ensuring the Success of the Next Generation of Female Life Sciences Lawyers: Tools for Effectively Managing, Training and Mentoring in a Virtual World

Diane E. Lifton
Senior Vice President, Legal
Sumitovant Biopharma, Inc.

Heather J. DiPietrantonio, PhD
Shareholder
Wolf, Greenfield & Sacks, P.C.

Melanie Rupert
Partner
Paul Hastings LLP

Colleen Tracy James
Partner
White & Case LLP

With hybrid remote work looking like the way of the future, there is a growing concern that the physical distance will inevitably continue to reduce practical experiences for junior lawyers at the start of their careers.

This panel will address topics including:

• Overcoming a training deficit of junior attorneys as we emerge from the pandemic: How leadership can make up for limited opportunities by junior lawyers to observe senior lawyers interacting with clients/outside counsel or appearing in court
• Taking deliberate measures to ensure that the junior generation will be adequately prepared for the passing of the torch by their predecessors
• Understanding how junior attorneys can play an active role in building their presence, reputation and skill set in a hybrid world

Afternoon Networking Break

Lessons Learned From the “Top 10” Court Decisions Impacting the Life Sciences Industry: Incorporating Key Takeaways Into Your Future Practice

Alison Hanstead
Partner
White & Case LLP

Chelsea A. Loughran
Shareholder
Wolf, Greenfield & Sacks, P.C.

Regina Nelson
Counsel
Reed Smith LLP

Irena Royzman
Partner, Head of Life Sciences
Kramer Levin Naftalis & Frankel LLP

In this lightning round session, our panelists will walk you through the top 10 cases impacting the life sciences industry in the last year and their key implications for your future practice.

Cases to be discussed will include:

• GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 7 F.4th 1320 (Fed. Cir. Aug. 5, 2021)
• Genus Medical Technologies LLC v. United States Food and Drug Administration, No. 20-5026 (D.C. Cir. 2021)
• In re: Zofran (Ondansetron) Prods. Liability Litig., 2021 WL 2209871 (D. Mass. June 1, 2021)
• Biogen International GMBH v. Mylan Pharmaceuticals Inc., Appeal No. 2020-1933 (Fed. Cir. Nov. 30, 2021)
• Regents of Univ. of California v. Broad Institute, Inc., Patent Interference No. 106,115 (PTAB Feb. 28, 2022)

Analyzing How the Latest Tech and AI Innovations Are Transforming the Life Sciences Industry and Your Role in It

Sonia Chen Arnold
Sr. Director, Assistant General Counsel – Consumer/Customer Operations
Eli Lilly and Company

Dan Liu
Attorney
Loeb & Loeb LLP

Kate Middleton
Partner, Co-Lead of Digital Health Artificial Intelligence Team
Faegre Drinker Biddle & Reath LLP

Camila Tobón
Partner
Shook, Hardy & Bacon LLP

• Assessing the latest innovations and new developments in tech and AI affecting drugs, biologics, devices and diagnostics
• Analyzing the host of complex legal challenges created by the latest innovations and the new and emerging regulatory landscapes aiming to govern these new technologies
• Understanding the types of innovative licensing and collaboration agreements that are required to unlock the full potential of these new products
• Exploring recent trends in IP disputes resulting from the novel form of many emerging products

Networking Cocktail Reception Sponsored By:

Continental Breakfast

Co-Chairs’ Recap of Day 1 and Morning Warm-Up Game

Audience Polling

What Would You Do If….? Female Life Sciences Leaders Share Personal Stories of Combatting Exclusionary Practices in the Workplace, Boardroom and Courtroom

Christiana Jacxsens
Vice President
Deputy General Counsel, Head of Investigations and Litigation
B. Braun Medical Inc.

Sara Thompson
Shareholder
Chair, Pharmaceutical, Medical Device & Health Care Litigation Practice
Greenberg Traurig LLP

Gael Tisack
Deputy General Counsel, IP
Olympus Corporation

We’ve all been there. Perhaps you’ve had an idea appropriated by a male colleague, been left out of the “meeting after the meeting,” or watched a female colleague be excluded from a client interaction. This panel of senior level women executives will lead a polling exercise of “what would you do” – and share insights on:

• How they’ve personally handled exclusionary practices in their own workplace
• How women in the life sciences can work together to transform culture, policies and programs that will result in more equity and opportunity for women
• How women in leadership roles can create opportunities for female employees to talk about their experiences of marginalization and discrimination and set the standards for behaviors in their own organizations

FOCUS ON DIVERSITY & INCLUSION - SPOTLIGHT SPEAKER

Diversity, Equity and Inclusion: How to Drive Sustaining Change

Celeste Warren
Vice President, Global Diversity & Inclusion Center of Excellence
Merck

Morning Networking Coffee Break

The Importance of Diversity in Clinical Trials: Implementing DE&I Principles Into the Development, Approval and Commercialization of Drugs and Devices

Alana Wexler
Senior Counsel
Amgen

Ronni Fuchs
Partner
Troutman Pepper

LaShell Robinson
Director, Diversity & Inclusion in Clinical Trials
Takeda Pharmaceuticals

The life sciences industry has seen a growing focus on patient diversity in clinical trials in recent years, with the COVID-19 pandemic shining an even brighter spotlight on the importance of achieving diverse patient recruitment. This panel will share critical insights on:

• Analyzing the obstacles that continue to stifle patient diversity in clinical trials as well as the implications and consequences this has for patients
• Identifying what industry can do in practice to improve diversity in clinical trials and overcome operational challenges to achieving diverse patient inclusion in clinical research
• Understanding the different roles of sponsors, patients and investigators in conducting more equitable clinical trials
• Examining the latest FDA guidance for drugmakers and medical device manufacturers regarding plans for making their studies more inclusive and setting goals for more diverse trial participant enrollment and retention

What Does ESG Mean for Life Sciences?: How Women in Leadership Can Effectively Integrate ESG Priorities Into Their Organization’s Strategy and Purpose

Shannon Thyme Klinger
Chief Legal Officer
Moderna

Lorie Foster
Division Counsel
Abbott

Lisa Jakob
Managing Counsel, Trademark Group
Merck

Anat Hakim
Senior Vice President, General Counsel and Secretary
Eli Lilly and Company

As the world starts to adjust to life after the COVID-19 pandemic, we have seen that life sciences companies are focusing even greater attention on developing and strengthening their environmental, social, and corporate governance (ESG) initiatives. This panel will shed key insights on the role of female leadership in furthering ESG efforts, as well as:

• Understanding how to embed ESG within your organization’s business to make it more financially and environmentally sustainable in the longer term
• Operating under demonstrated ESG principles in a way that makes your company more attractive to investors, regulators, employees, and customers
• Strategies for assessing, improving, and creating new and effective ESG practices and initiatives related to:
• Environmental impact
• Fostering diversity and inclusion initiatives
• Access to healthcare and medicine pricing
• Clinical trial practice, product quality and patient safety
• Business ethics, integrity, and compliance
• Human capital management
• Supply chain management

Networking Luncheon

THE GLOBAL LIFE SCIENCES STAGE

Charting the Path for the Advancement of Women in the Global Life Sciences Sphere

Dorothy Flower
Partner
Head of Medical & Life Sciences
Reynolds Porter Chamberlain (RPC)

Carolina del Río
Partner
Dentons

Yoshie Tanigawara
Associate Director, Corporate Strategy
Eisai Co., Ltd.

This panel of international female life sciences leaders from the UK, Canada, Asia and South America will shed light on growth opportunities for women in the international life sciences legal sector, as well as key considerations for US attorneys looking to enter different international markets.

Broadening Your Horizons: Key International Developments Impacting the Global Life Sciences Industry

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

Donna M. Meuth
Associate General Counsel, Intellectual Property
Eisai Inc.

Lily Vakili
Principal
Faber Daeufer & Itrato PC

Research & Development

• Considerations for cross-border clinical trials access and management
• Addressing current and emerging CMC and supply chain challenges in the development and manufacturing of drug products
• Intellectual Property
• Assessing the latest developments in international IP rights as well as anticompetitive concerns

Drug Commercialization and Pricing

• Examining the latest strides being taken by Canada and the EU in connection to drug pricing and implications for cross-border transactions
• Survey of how different countries are currently treating the regulation of prescription drug advertising and how they contrast to the US

South American and Asian Markets

• Analyzing the evolving regulatory landscape in China: how recent changes to China’s pharma IP protection laws, vaccine laws and data privacy laws are impacting the way the life sciences industry is working there
• Addressing the latest life sciences legal developments in South America, and major changes to the regulatory approval system for biosimilars, medicines and medical devices

Afternoon Break

“The Best Thing I Ever Learned from a Mentor — or a Mentee”

Katrina Long
Director, Corporate Counsel
Regeneron Pharmaceuticals, Inc.

Terra Reynolds
Partner
Latham & Watkins LLP

Rebecca Clegg
Attorney
Axinn, Veltrop & Harkrider LLP

Studies show that women with professional guides are five times more likely to advance in their workplaces. Join this panel of female leaders in life sciences law as they share:

• Personal stories of the best lessons they’ve learned from their own mentors
• Experiences with a mentee that have helped them in their own job performance and job satisfaction
• Advice they would impart on the next generation of women preparing to lead in this space

End of Conference Wrap-Up: Champagne Toast and Takeaways

As we wrap up the event, the conference co-chairs will share insights on key takeaways from the last two days. As we say cheers to a great event and celebrate one another with a glass of bubbly, attendees will write down one personal takeaway and how it could be used to improve her work or life. They will each then pass their paper to the woman to their right who will share the takeaway with the table, followed by an opportunity for group feedback and discussion.

Conference Concludes