GoodLifeSci

Women’s Life Sciences Network Event – Brussels
2025-05-20 17:30 - 20:00 (America/Chicago) | Comet, Place Stephanie 50, Brussels, 1050, Belgium
Join us in Brussels for our next Women’s Life Sciences Network event on the occasion of the EU Pharmaceutical Law Forum. The event will feature a moderated discussion on topical issues of pharmaceutical legislation and policy.

RSVP here.
SPEAKERS

Rainer Becker, Director, DG SANTE, European Commission
Victoria Kitcatt, Vice President and Assistant General Counsel, Head of EU/International Regulatory Law, Pfizer
Laetitia Szaller, General Counsel, Head of Compliance and ESG, Egetis Therapeutics

A Q&A session will follow the discussion.
AGENDA
5:30 p.m. – Welcome
6:00 p.m. – Panel discussion
7:00 p.m. – Networking reception and canapés
All are invited to attend WLSN events.

Boston Life Sciences Roundtable
2025-05-19 | The Institute of Contemporary Art/Boston, 25 Harbor Shore Drive, Boston, MA, 02210, United States
Join Sidley’s Life Sciences team for an afternoon of thought-provoking and engaging discussions touching on the latest trends and hot topics including the new administration, new technologies, the investment landscape, and more.

For more information, contact bosevents@sidley.com.

This year’s fifth annual event will be held in the stunning Institute of Contemporary Art/Boston lobby, followed by a reception on the picturesque harbor front plaza.
Please see below for details on our newly announced panels and panelists.
WHO SHOULD ATTEND
Executives, Investors, General Counsel, and Company Counsel
AGENDA
Registration: 1:30 p.m. ET
Program: 2:00 p.m. ET
Reception: 5:00 p.m. – 6:30 p.m. ET
FEATURED PANEL TOPICS
The New Administration, Trade Wars, and GC Strategies For Managing A Changing Environment
As the New Administration brings personnel and policy changes to HHS and FDA, and trade wars add new considerations for product development and manufacturing, we reflect on key developments and strategies GCs use to successfully manage the opportunities and risks in a changing environment.
– Lana Gladstein, General Counsel, Seaport Therapeutics
– Jose Truzman, General Counsel – U.S., Intercept Pharmaceuticals, Inc.
– Aaron Applebaum, Counsel, Global Arbitration, Trade and Advocacy
– Jackson Garvey, Partner, Restructuring & Liability Management
– Becky Wood, Partner, Global Co-leader, Food, Drug and Medical Device and Former Chief Counsel, FDA
New Product Development Pathways for Success
This panel will discuss key areas of focus during product development to set companies up for success, including the use of artificial intelligence (AI), pre-approval compliance considerations, and pricing strategies.
– Meena Datta, Partner, Global Co-leader, Healthcare
– Deeona Gaskin, Partner, Food, Drug and Medical Device and Former Associate Chief Counsel for Enforcement, FDA
Navigating Life Sciences Transactions in a Dynamic Economic Landscape
This panel will discuss the evolving landscape of life sciences transactions, including emerging trends in the current investment climate.
– Shaan Gandhi, Head of Strategic Partnerships, Pfizer Ignite
– Paresh Kumar, Vice President, Biotech Private Equity, Ally Bridge Group
– Jason Tse, Vice President Corporate Development, McKesson
– Chris York, Vice President, General Counsel & Chief of Staff, Orchard Therapeutics
– Mat Eapen, Partner, Investment Funds
KEYNOTE ADDRESS
“Get Your Mindset Right”: Thriving in Change
A Conversation with Kirk Taylor, MD on Navigating Changing Times
Kirk Taylor, MD
President & CEO
Massachusetts Life Sciences Center
Kirk Taylor, MD is a global pharmaceutical executive with expertise in Phase II – IV drug development, including CNS, oncology and rare disease. As Chief Medical Officer, Chief Strategy Officer and SVP Medical Affairs, he has restructured organizations, created strategic operating plans, and shaped corporate culture. His entrepreneurial acumen assisted in leading biotech start-up companies to successful IPOs and multiple funding rounds. He is people-first focused, leading teams with respect and innovation. In recognition of his positive impact, he was awarded the 2023 PharmaVoice 100 Executives Award.
Dr. Taylor received his Bachelor of Arts from Harvard College and studied piano at the Longy School of Music in Cambridge. He completed his Doctor of Medicine from the State University of New York, Downstate, his neurology residency at Einstein College of Medicine, and a post-doc at UCSF.

Regulatory Know-How for Growth-Stage Life Sciences Innovators
2025-03-05 13:00 - 16:30 (America/Los_Angeles) | Torrey Heights, 11208 El Camino Real, San Diego, CA, 92130, United States
Please join Sidley’s Global Life Sciences team to lean into key early-stage and emerging growth regulatory issues, and how to tackle them.

If have questions or are interested in attending, please contact laevents@sidley.com.
Sessions will focus on:

All phases of clinical research and development
Press releases and disclosures
Regulatory wisdom from experienced emerging growth General Counsels

Connect with industry peers and investors during networking breaks and a post-program cocktail hour.
This program is designed for legal professionals and executives to provide a foundation in FDA, healthcare, and securities issues arising in development stage companies.
Featured Speakers

Himani Bhalla, Senior Managing Director, Chief Investment Officer, and Co-Founder, Symbiotic Capital
Greg Bowman, Senior Director, Leasing, Breakthrough Properties
Michael Brown, Executive Vice President and Chief, Legal Officer, DexCom, Inc.
Aneta Ferguson, Senior Vice President and General Counsel, Adverum Biotechnologies
Michael Mueller, General Counsel, Sidewinder Therapeutics, Inc.

Sidley Speakers

Torey Cope, Food, Drug, and Medical Device Regulatory
Meenakshi Datta, Healthcare: Drug and Medical Device Regulatory
Carlton Fleming, Capital Markets
Cindy Lovering, Global Finance
James Lu, Emerging Companies and Venture Capital
Jon Olsen, M&A, Emerging Companies and Venture Capital
Adam Welland, Technology and Life Sciences Transactions
Sharon Flanagan, M&A, Capital Markets, Corporate Governance

Agenda
1:00 p.m.: Registration
1:30 – 4:30 p.m.:

Clinical Research Challenges and Opportunities
Key Considerations for Press Releases and SEC Disclosures
Fireside Chat: The Importance of Regulatory Strategy and Compliance from Seasoned Emerging Growth GCs

4:30 – 6:30 p.m.: Cocktail Reception
CLE credit for this program is pending.

Good Manufacturing Practice 2024Swiss/FDA Mutual Recognition Agreement – State of Play
2024-11-14 14:00 - 18:30 (Europe/Zurich) | Memox, Peter-Merian Strasse 80, Basel, 4052, Switzerland
Join us in Basel, where Sidley and thought leaders will be discussing the FDA and Swissmedic Mutual Recognition Agreement on Good Manufacturing Practices for pharmaceutical products. This agreement aims to streamline regulatory processes and enhance cooperation between the two countries by recognizing each other’s GMP inspections, thereby reducing the need for duplicative inspections.

RSVP here.
We will discuss early experiences with the new framework — both positive outcomes and challenges — highlighting valuable lessons learned and exploring potential for future developments.
Topics will include:

FDA/Swiss Mutual Recognition Agreement
AI and Good Manufacturing Practice
EU’s New Revised Annex 1

Featured speakers:

Christian Schärer, Head of Inspectorate, Swissmedic, (keynote speaker)
Oliver Schläfli, Senior Vice President Global Quality, Lonza
Jay Jariwala, Senior Director Regulatory Compliance, Sidley
James Johnson, Partner, Sidley
Eva von Mühlenen, Senior Advisor, Sidley

WHO SHOULD ATTEND?
Executives, in-house counsel, quality and compliance managers and officers interested in and/or facing GMP compliance and quality management challenges in Switzerland.
For more information or questions, please contact gvaevents@sidley.com.

Combination Therapies – EU Regulatory and Competition Law Headwinds and Strategies
2024-10-22 17:30 - 21:00 (Europe/Zurich) | Memox, Peter-Merian Strasse 80, Basel, 4052, Switzerland
Join us in Basel for our next Women’s Life Sciences Network event. The panel will discuss key considerations related to authority expectations as well as challenges, and potential strategies for EU regulatory and competition law compliance for combination therapies.

RSVP here.

Speakers are:

Dr. Sandra Zaugg Kunz, Head Regulatory Assessment Deputy Head of Medicinal Product Authorisation and Vigilance, Swissmedic
Elisabeth Leimbacher, Global Legal Lead, Marketing and Commercial Excellence, Takeda
Celine Fang, Senior Antitrust Counsel, Novartis

The discussion will be moderated by Josefine Sommer and Anne Robert, Partner, Sidley.
AGENDA
5:30 p.m. – Arrival and registration
6:00 p.m. – Panel discussion and Q&A
7:30 p.m. – Networking and apéro riche
For more information, please contact gvaevents@sidley.com.
Click here to join the Women’s Life Sciences Network LinkedIn Group.
For more information about previous editions, please click here.

Sidley Healthcare Investment Conference 2024
2024-09-24 | The Francis Crick Institute, 1 Midland Road, London, NW1 1AT, UK, The Francis Crick Institute, 1 Midland Road, London, NW1 1AT, United Kingdom
Deal and investment activity remains critical to the success of life sciences and healthcare innovation.
RSVP Here

Sidley once again brings together senior pharma, biotech, healthcare, private equity, and venture capital executives to share their perspectives on critical issues, trends, and opportunities.
Join Sidley and industry leaders from across the globe, including from AstraZeneca, BioCentury, Compass Pathways, Financial Times, Flagship Pioneering, IQVIA, J.P. Morgan, LetterOne Health, Mestag Therapeutics, Morgan Stanley, Novartis, Onex, Permira, Perspectum, Rothschild & Co., Sofinnova Partners, Syncona, SV Health Investors, and Teva for this in-person, all-day event. Virtual attendance is available to those outside the UK.
View the agenda here.
View confirmed speakers here.
Panels will include:

Private Equity – What is the outlook for PE investment activity across Healthcare and Life Sciences? Which domains will be the “winners”?

Artificial Intelligence – To what extent, and where, does AI represent an investment opportunity across Healthcare and Life Sciences?

Fireside Chat – “A Life in Pharma and Pivoting to Innovation”- A conversation with Richard Francis, President and CEO, Teva.

A View From the Banks – Opinions, insights, and predictions on the market from a group of leading global healthcare dealmakers.

Pharma Business Development – Senior BD and biotech figures debate the M&A, licensing, and collaboration climate. Which therapeutic areas and geographies are garnering the most attention?

Venture/Growth Capital – How are global funds investing in a more muted market? How do investees stand out? Views from leading global life sciences investors.

Please note, due to space limitation for this event, registrations will be reviewed and confirmed by email in due course. We strongly encourage in-person attendance and remote participation will be available to those based outside of the UK.
For more information or questions, please contact lnevents@sidley.com.
SIDLEY HEALTHCARE INVESTMENT CONFERENCE 2023 HIGHLIGHTS

View the 2023 agenda
Sidley Healthcare Investment Conference 2023 Highlights Video
A Life Well Invented: A Discussion Between Moderna Co-Founder and Chairman Noubar Afeyan and Sidley’s Robert Darwin

Data Integrity and Governance Workshop
2024-09-09 - 2024-09-13
Live Oak Workshops, in collaboration with Sidley Austin, are designed to equip you with the knowledge and critical thinking strategies that lead to success in the advancement of your GXP career. As worldwide regulatory expectations in the world of data integrity and data governance change, our workshops prepare you with the skills necessary to interpret regulations, guidance, and regulatory action into simple approaches for managing your everyday GXP responsibilities with the efficiency needed to thrive.
Monday, September 9, 2024 – Tuesday, September 10, 2024 | Ahmedabad, India
Thursday, September 12, 2024 – Friday, September 13, 2024 | Hyderabad, India
Sign up now to join us as we discuss, debate, question, and tackle interesting regulatory case studies in the world of data integrity and data governance.
We are excited to now offer this worship in both Ahmedabad and Hyderabad this October. Click here to see the full two-day agenda.
Instructors include former FDA India Office alums:
Peter Baker, President, Live Oak
Former FDA Investigator
Peter Baker is a GXP consultant focused on improving the quality of medicines by providing training and consulting services to organizations looking to improve the quality of their data integrity assurance strategy. Pete is a former FDA investigator whose Agency leadership included serving as Assistant Country Director (Drugs) in New Delhi, where he performed high risk cGMP inspections of human drug manufacturers throughout India and the surrounding region, conducted a variety of training and development exercises for manufacturers and foreign regulators, performed joint GMP manufacturing inspections with a variety of foreign regulatory bodies, and conducted joint investigations alongside local and regional investigation teams to facilitate harmonized regulatory actions. In 2013, he was recognized as FDA Investigator of the year due to a significant number of FDA regulatory actions taken in India, including product recalls and import bans based on inspections where breaches in data integrity were uncovered which affected a wide variety of products in US distribution.
Jay Jariwala, Senior Director, Regulatory Compliance, Sidley
Former FDA Regulator
For over 13 years, Jay served as an FDA regulator and leader at multiple FDA centers, including CDER, the Center for Devices and Radiological Health (CDRH), and the Office of the Commissioner, applying the agency’s laws, regulations, guidance, and other technical and administrative policies on drugs, medical devices, and combination products to policy development, facility inspections, compliance, enforcement, and approval processes. His FDA leadership experience includes serving as assistant country director (Drugs) and supervisory Consumer Safety officer in the agency’s India Office in New Delhi, where he managed a team of investigators for all facility inspections conducted by the India Office and compliance follow-up. In addition to his responsibilities for resource planning and operational oversight for violative establishment inspection assessments and resulting regulatory actions, Jay trained FDA investigators on current good manufacturing practice (CGMP) requirements — particularly data integrity and quality investigations.
Dan Roberts, Senior Director, Regulatory Compliance, Sidley
Former FDA Investigator
Dan Roberts evaluates and assesses pharmaceutical quality systems and focuses on detecting and remediating data integrity concerns and evaluating compliant automated manufacturing processes and related computerized systems. He provides guidance and assists clients in responding to FDA-483 observations, corresponding with regulatory agencies, and conducting mock FDA facility audits. Dan has over 20 years of government regulatory and pharmaceutical/biopharmaceutical industry experience. He was an FDA investigator for eight years, including two years as the primary point of contact for conducting pharmaceutical inspections at the FDA India office located at the U.S. Embassy in New Delhi. He was also the first lead investigator for the first biosimilar inspection conducted by the FDA in India.
Jim Johnson, Partner, Sidley
Former FDA Associate Chief Counsel
Jim Johnson guides life sciences companies through complex FDA compliance and enforcement matters, including inspections, current good manufacturing practices (GMP) requirements, data integrity responsibilities, product quality issues, pharmacovigilance obligations, and enforcement actions. Jim previously served as Associate Chief Counsel for Enforcement in the FDA’s Office of the Chief Counsel, where he handled GMP enforcement and provided legal counsel on a range of inspectional and compliance issues to agency components, particularly the FDA’s Office of Regulatory Affairs (ORA) and Center for Drug Evaluation and Research’s (CDER) Office of Compliance. Jim uses his extensive agency and private practice experience to assist pharmaceutical and biotechnology companies worldwide, regularly conducting GMP assessments and investigations, resolving warning letters and import alerts, and appearing in front of the FDA on behalf of companies to resolve enforcement actions.
Discounts and Additional Information:

Contracts info@liveoakqa.com for groups of five or larger and receive a 10% discount code for checkout
Tea Breaks and lunch are included in the workshop.

Swiss MedTech 2024: Harnessing Market Dynamics for Profitability
2024-09-04 | Farelhaus, Oberer Quai 12, 2503 Biel, Switzerland, Switzerland
Join Sidley, ISS AG, and Swiss Medtech in Biel for an afternoon of practical tips and interactive discussions on current issues, including:

ESG and its development in the EU
Seizing the opportunities of Artificial Intelligence
Health data and clinical trials

2:00 p.m. – 6:30 p.m. CET
Followed by a networking drinks reception
RSVP here.
Industry speakers, regulators, scientific experts, and counsel will share tips and best practices for the challenges and opportunities that lie ahead for Swiss MedTech.
WHO SHOULD ATTEND?
Executives, investors, in-house counsel, and regulatory managers interested in and/or facing regulatory issues in Switzerland.
For more information, please contact Dafne Forni Zervoudaki at +32 2 504 6202 or at dafne.fornizervoudaki@sidley.com.

FDA’s New Wave of Promotion Enforcement: What You Need to Know Now
2024-05-14 13:00 - 14:00 (America/New_York)
After several years of relatively little enforcement, FDA has recently been flexing its muscles in the promotion area. The Office of Prescription Drug Promotion (OPDP) in particular has issued several notable warning and untitled letters in the past year, representing an increased volume in enforcement and increased scrutiny of efficacy claims. This includes more rigorous assessment of information “consistent with” FDA-required labeling (CFL) and enforcement of new expectations for presentation of quantitative efficacy information. Tune in to this overview session for an efficient rundown of what this means for drug, biological product, and device manufacturers in terms of key watchouts and practical approaches to risk mitigation.
RSVP here.

1:00 p.m. – 2:00 p.m. ET
CLE credit will be offered for this webinar.
Sidley Austin LLP is an accredited MCLE provider in IL, NY, and CA. Credit is available for CT, NJ, TX, and VA upon request.

ICCA 2024 Hong Kong Sidley Breakfast Seminar
2024-05-07 08:00 - 09:30 (America/Chicago) | The Clipper, The American Club, Floors 48-49, Two Exchange Square, Central, Hong Kong
Join us for an engaging and informative panel discussion on life sciences disputes as part of ICCA 2024 Hong Kong. Our panel comprising Sidley disputes and life sciences specialists as well as inhouse counsel will explore (i) general trends in life sciences transactions, (ii) the complexities and unique challenges involved in life sciences disputes with a focus on IP and cross-border issues, (iii) strategies on how to avoid and manage potential disputes in life sciences transactions, and (iv) case studies and practical insights.
RSVP Here

8:00 a.m. HKT: Registration
8:30 – 9:30 a.m. HKT: Panel discussion
Our international panel of specialists will comprise partners from Sidley’s Global Arbitration, Trade and Advocacy and Global Life Sciences practices, as well as representatives from the life sciences industry.

Boston Life Sciences Roundtable
2024-05-01 | MassBio Hub, 700 Technology Square, Cambridge, MA 02139
Join Sidley at our annual Boston Life Sciences Roundtable for an afternoon of engaging discussion addressing cutting-edge trends and hot topics.

1:30 p.m. Registration | 2:00 p.m. Program | 5:00 p.m. Reception
For more information, contact bosevents@sidley.com.
FEATURED PANEL TOPICS

I Used To Practice Law: A Conversation with Life Sciences Leaders
A rare few life sciences leaders have served in both chief legal and chief business officer roles during the course of their careers. Join our discussion of making the transition

Anna Barry, Venture Partner, Deerfield Management
Jerald Korn, Chief Executive Officer, Ropirio Therapeutics, Inc.
Asher Rubin, Partner, Global Co-leader, Technology and Life Sciences Transactions
Becky Wood, Partner, Global Co-leader, Food, Drug and Medical Device and former FDA Chief Counsel

Strategies for Success: Navigating Current Healthcare and FDA Trends for Life Sciences Companies
The session will cover hot topics and regulatory developments from both an FDA and healthcare perspective.

Scott Kaplan, Deputy General Counsel, Baxter International Inc.
Peter Smith, Head of Legal, argenx US, Inc.
Donielle McCutcheon, Partner, Healthcare
Jim Johnson, Partner, Food, Drug and Medical Device

Life Sciences Transactions: Updates and Perspectives on the Market
From green shoots and increased deal activity to supply chain disruptions and Congressional investigations, this panel will explore important updates affecting the environment for life sciences transactions.

Andy Meyerson, Managing Director, Locust Walk

Jason Russell, Managing Director, Global Head of Biotechnology, Morgan Stanley
Michael Borden, Partner, Leader, Government Strategies
Alison Lehner, Partner, Emerging Companies and Venture Capital
Adriana Tibbitts, Partner, Technology and Life Sciences Transactions

Sidley Healthcare Investment Conference 2023
2023-09-12 11:30 - 18:30 (Europe/London) | The Francis Crick Institute, 1 Midland Road, London, NW1 1AT, UK, The Francis Crick Institute, 1 Midland Road, London, NW1 1AT, United Kingdom
With deal and investment activity remaining critical for the success of the life sciences and healthcare industry, Sidley is bringing together senior pharma, biotech, healthcare, private equity, and venture capital leads to provide their insights on key topics, trends, and opportunities.
RSVP Here
Join Sidley and industry leaders from across the globe for this in-person, one-day event in London, with the option to stream and network virtually from outside the UK.
We look forward to incisive content, robust discussion, and valuable networking during a day looking at the continued combination of innovation and capital driving positive patient outcomes and investment returns.
View confirmed speakers.
View agenda.

Please note, due to space limitation for this event, registrations will be reviewed and confirmed by email in due course. We strongly encourage in-person attendance and remote participation will be available to those based outside of the UK.
The health of our clients, colleagues, and guests is important to us. If you are experiencing cold or flu-like symptoms please stay home and get better. If you are recovering from COVID-19 or have been recently exposed, please follow applicable guidelines.
For more information or questions, please contact lnevents@sidley.com.

Bay Area Lifesciences Roundtable
2023-06-28 13:00 - 16:30 (America/Chicago) | SFMOMA Outdoor Sculpture Garden, 147 Minna St., Floor 5, San Francisco, CA, 94105, United States
Please join Sidley for the Bay Area Lifesciences Roundtable, an afternoon of provocative discussions addressing cutting-edge trends and hot topics.

Featured Panels
Getting Approved: Creative Approaches to Ensuring Regulatory Success in New Product Development

Lisa Taylor Ash, General Counsel, Shape Therapeutics
Maryam Khotani, Associate General Counsel, Practice Group Leader, Genentech
Michael Listgarten, General Counsel, RAPT Therapeutics
Joel Silver, JD, RAC, Lead Regulatory Counsel at Gilead Sciences
Torrey Cope, Partner, Food, Drug and Medical Device, Sidley

Getting Paid: Strategies to address emerging issues in drug pricing and reimbursement at all phases of drug development, marketing, and business development activities.

Megan Duplanty, Vice President, Deputy General Counsel, BioMarin Pharmaceutical Inc.
Erin Quirk, M.D., President, Terns Pharmaceuticals
Rekha Ramesh, Vice President, Head of Global Policy, Government Affairs and Policy, Gilead Sciences
Meenakshi Datta, Partner, Global Co-leader, Healthcare, Sidley

Getting Funded: Prioritizing your pipeline and exploring funding alternatives and strategic opportunities to advance your initiatives.

Rekha Hemrajani, Member, Board of Directors, BioAge Labs
Grace McMahon, Head of Transactions, Merck
Frank Tang, Executive Director, Morgan Stanley
Frank Rahmani, Partner, Global Life Sciences and Capital Markets, Sidley

Agenda
1:00 p.m. – Registration
1:30 p.m. – Program
Cocktail reception to follow
Who Should Attend
Executives, Investors, General Counsel and Company Counsel
For questions, please contact GlobalLifeSci@sidley.com.

Sidley Networking Reception at BIO
2023-06-05 | Legal Sea Foods – Harborside, 3rd Floor East Deck 270 Northern Avenue, A 10 minute walk / 3 minute drive from the Boston Convention and Exhibition Center, Boston, MA, 02210, United States
Please join Sidley for a networking event during BIO 2023. Connect with fellow biotech and pharma colleagues and engage in discussion about industry trends and learnings from BIO.
RSVP Here
Please RSVP by Friday, May 26.

The health of our clients, colleagues, and guests is important to us. If you are experiencing cold or flu-like symptoms please stay home and get better. If you are recovering from COVID-19 or have been recently exposed, please follow current CDC guidelines.

The EU’s New Health Technology Assessments Regulation
2023-05-23 | Comet, Place Stephanie 50, Brussels, 1050, Belgium
Join us in Brussels for our next Women’s Life Sciences Network event, which will feature a special address by Ruta Janeckaite (European Commission).

The discussion will include:

Status of the Commission’s preparation and tasks ahead
Regulatory opportunities
Industry implementation path

A Q&A session will follow the moderated discussion.
6:00 p.m. CET
The panel discussion will be followed by networking drinks
Dr. Ruta Janeckaite, PhD
Legal Officer
European Commission
Ruta is a Lithuanian lawyer, graduate from the Law Faculty of Vilnius University. Since 2003, she has been working in the field of EU and EEA law: in the European Law Department under the Ministry of Justice of Lithuania from 2003 to 2013, in the EFTA Surveillance Authority from 2013 to 2020, and in the European Commission since 2020. Currently, she is part of DG SANTE health technology assessment team, responsible for legal issues relating to the implementation and application of Regulation (EU) 2021/2282 on health technology assessment.
In January 2022, Ms. Janeckaite was accorded a doctor’s degree by Vilnius University, for the dissertation, “The impact of the EU internal market freedoms and competition rules on the organisation and regulation of the Lithuanian system of health protection.”
For more information, please contact Cristina Menendez Ruiz at +32 2 504 6453 or at cmenendezruiz@sidley.com.

The health of our clients, colleagues, and guests is important to us. If you are experiencing cold or flu-like symptoms please stay home and get better. If you are recovering from COVID-19 or have been recently exposed, please follow applicable guidelines.

Boston Life Sciences Roundtable
2023-05-11 | MassBio Hub, 700 Technology Square, Cambridge, MA 02139
Please join Sidley for the Boston Life Sciences Roundtable, an afternoon of provocative discussions addressing cutting-edge trends and hot topics.

FEATURED PANELS
Please see below for discussion topics during the Boston Life Sciences Roundtable:
Leading Life Sciences Companies: A Conversation with Boston Area Life Sciences General Counsel

Ty Howton, Chief Administrative Officer and Secretary, Solid Biosciences Inc.
Joan Schmidt, Chief Legal Officer, Pharvaris
Asher Rubin, Partner, Co-leader, Technology and Life Sciences Transactions
Becky Wood, Partner, Co-leader, Food, Drug and Medical Device and former FDA Chief Counsel

Charting New Courses: Key Healthcare and FDA Developments for Life Sciences Companies

Joe Philipose, Chief Ethics and Compliance Officer, Emergent BioSolutions
Lynn Zuchowski, Vice President, Chief Counsel, Severe Genetic Diseases, bluebird bio, Inc.
Meena Datta, Partner, Co-leader, Healthcare
Scott Kaplan, Partner, Food, Drug and Medical Device

Prospecting in Uncertain Times: New Approaches to Funding the Next Blockbuster

Susan Graf, Senior Advisor & Entrepreneur In Residence, Locust Walk; Board Chair, Finch Therapeutics; Audit Committee Chair, Kaléo
Mike Mano, Senior Vice President and General Counsel, Karyopharm Therapeutics
Geoff Levin, Partner, Private Equity
Alison Lehner, Partner, Emerging Companies and Venture Capital

Keynote Presentation

Leading With Empathy: Understanding Compassion and Emotional Storytelling for Life Sciences Companies

Yotam Dagan
A former Israeli Navy SEALs commander, certified clinical psychologist, and hostage negotiator, Yotam has moved from leading soldiers on the battlefield to building their fighting capacity and caring for their wellbeing. A global resilience expert, Yotam founded Dugri Inc – a startup that builds real-talk-based, safe, vertical communities. His book, A Time to Kill, a Time to Heal – An Israeli Navy SEAL’s Journey, came out in 2021.
AGENDA
1:30 p.m. Arrival and Registration
2:00 p.m. Program
5:30 p.m. Reception
Join us on-site during the reception for a special hands-on service project.

Sidley Digital Health East
2023-05-10 14:00 - 16:00 (America/New_York) | 700 Technology Square, Cambrige, MA 02139
Please join us on Wednesday, May 10 for a digital health-focused roundtable hosted by Sidley and The Digital Therapeutics Alliance. Across two panels, we will discuss important and timely topics including marketing pathways, coverage and reimbursement issues, and more. Get industry tips and key watchouts from a look at the current marketplace.

What Does Success Look Like? Overcoming FDA Hurdles and Obtaining Reimbursement
Panelists will discuss how to successfully bring digital health to market by considering both FDA and post-approval coverage and reimbursement challenges and paths forward. Listen for an update on FDA’s latest guidance and how to make it work for you, as well as how to navigate benefit categories and reimbursement decisions across payors.

Annie Saha, Assistant Director, Digital Health Center of Excellence, FDA
Andy Molnar, CEO, Digital Therapeutics Alliance (DTA)
Deitzah Raby, General Counsel, AppliedVR
Everett Crosland, Chief Commercial Officer, Cognito Therapeutics

Fireside Chat with Seth Feuerstein, Founder and CEO of Oui Therapeutics, and Melissa Reilly, Chief Growth Officer at Evernorth Behavioral Health
Hear from two experts deeply engaged in digital health. We will hear them share their stories, discuss launching new digital health therapies, and speak to expertise that brought them to where they are today.

Seth Feuerstein, MD, JD, Founder and CEO, Oui Therapeutics and Executive Director and Founder, Center for Digital Health, Innovation and Excellence, Yale School of Medicine
Melissa Reilly, Chief Growth Officer, Evernorth Behavioral Health

For more information or questions, please contact globallifesci@sidley.com.
Boston Life Sciences Roundtable:
Looking for a deep dive on the current life sciences landscape? Join us for an afternoon of discussions addressing cutting-edge trends at the Boston Life Sciences Roundtable, on Thursday, May 11, following Sidley Digital Health East. Click here for more information and registration.
The health of our clients, colleagues, and guests is important to us. If you are experiencing cold or flu-like symptoms please stay home and get better. If you are recovering from COVID-19 or have been recently exposed, please follow applicable guidelines.

Women’s Life Sciences Network Event – Zürich
2022-12-01 17:00 - 20:00 (Europe/Zurich) | Kraftwerk, Selnaustrasse 25, Zürich, 8001, Switzerland
Digital Health and Artificial Intelligence: Drivers in Transforming the Life Sciences Industry
Join us in Zürich for our next Women’s Life Sciences Network event, which will feature a panel discussion with leading life sciences industry women about the use of artificial intelligence and digital health.

Moderated panel discussion:

Data augmenting in healthcare

Challenges and opportunities in digital health

Artificial intelligence in drug development and beyond

SPEAKERS
Fleur Herrenschmidt
Head Legal Region Europe Pharma
Novartis
Lisa Kinsella
Vice President and General Counsel
Moderna
Afua van Haasteren
Manager, Health Policy and External Affairs
Roche Diagnostics
RSVP HERE
5:00 – 8:00 p.m. CET
The panel discussion will be followed by a networking reception and walking dinner.
For more information, please contact Cristina Menendez Ruiz at +32 2 504 6453 or at cmenendezruiz@sidley.com.
Click here to join the Women’s Life Sciences Network LinkedIn Group.
Josefine Sommer
Senior Managing Associate, Sidley Austin LLP
WLSN Co-Founder
josefine.sommer@sidley.com
Tatjana Sachse
Counsel, Sidley Austin LLP
WLSN Lead
tsachse@sidley.com
Anna Pavlou
Head of Legal, Global R&D and Regulatory at Galderma
WLSN Co-Founder
Anna.Pavlou@galderma.com

In light of the COVID-19 pandemic, Sidley is taking precautions to safeguard the well-being of our clients, colleagues, and guests. We encourage you to practice social distancing and follow local guidelines. If you are experiencing cold- or flu-like symptoms or if you have been in contact with anyone who has been exposed to or infected with COVID-19 within the past 14 days, please refrain from attending this event. We appreciate your cooperation and concern for the health and safety of our guests.

Life Sciences Regulatory Bootcamp
2022-10-25 13:30 - 18:30 (America/Los_Angeles) | Sharon Heights Country Club, 2900 Sand Hill Rd, Menlo Park, CA, United States
Building a foundation for success in the medical products industry

Join us for an afternoon of discussions designed to provide a foundation in FDA, healthcare, and securities issues arising in the development of medical products. Whether you are relatively new to counseling and risk mitigation in these areas or more experienced counsel looking for an efficient way to focus on their application in pre-commercial contexts, this event is for you. Learn from Sidley’s experienced regulatory and disclosure lawyers and get answers to your most pressing questions.

Who Should Attend: Lawyers needing a practical introduction to legal and regulatory issues arising in the development of medical products.
FEATURED PANELS
Essential FDA Concepts and Strategic Considerations for Drug Development

FDA’s expectations of drug developers
FDA programs to expedite development and regulatory review
Non-patent exclusivities administered by FDA: considerations for lifecycle management and mitigating litigation risks
Disputing FDA Actions

Procedural options and definition of success
Key factors predicting outcomes
Appropriate means of influencing FDA

Engagement with Patients and HCPs, Including Compliance Considerations for Pre-Commercial Products

Obtaining coding, coverage, and reimbursement
Pricing considerations
Market access strategies, including expanded/post-trial access
Arrangements with HCPs and patients
Right-sized compliance infrastructure

Practical Approaches to SEC, Shareholder Litigation, and FDA Risks in Pre-Approval Communications

SEC and FDA requirements/coordination with respect to pre-approval communications and disclosures for public life science companies
Issues and trends in shareholder litigation
Practical approaches to mitigating regulatory, enforcement, and litigation risks

RSVP HERE
1:30 p.m. – 5:30 p.m. PT | Cocktail Reception: 5:30 p.m. – 6:30 p.m. PT

CLE credit for this program is pending.
For more information, contact Sidley Global Life Sciences.

Women’s Life Sciences Network Event – Boston
2022-09-22 16:00 - 18:00 (America/New_York) | The Royal Sonesta | Studio Patio, 40 Edwin H Land Blvd, Cambridge, MA, 02142, United States
Join us for our first U.S.-based Women’s Life Sciences Network event in Cambridge, a center of life sciences and technology. Keynote speaker Lara Sullivan, President and CEO of Pyxis Oncology, will share and discuss hot topics in the industry – followed by a networking reception with cocktails and hors d’oeuvres.

Click here to join the Women’s Life Sciences Network LinkedIn Group.
For more information, please contact Sidley Global Life Sciences.
Donielle McCutcheon
Partner, Healthcare
WLSN Boston Co-Leader
dmccutcheon@sidley.com
Adriana V. Tibbitts
Partner, Technology and Life Sciences Transactions
WLSN Boston Co-Leader
atibbitts@sidley.com
Josefine Sommer
Senior Managing Associate, Food, Drug and Medical Device Regulatory
WLSN Co-Founder
josefine.sommer@sidley.com

In light of the COVID-19 pandemic, Sidley is taking precautions to safeguard the well-being of our clients, colleagues, and guests. If you are experiencing cold or flu-like symptoms or if you have been in contact with anyone who has been exposed to or infected with COVID-19 within the past 14 days, please refrain from attending this event.

Swiss MedTech 2022 and Beyond: Mitigating Risks
2022-09-06 13:30 - 17:00 (Europe/Zurich) | Hotel Schweizerhof, Bahnhofplatz 11, Bern, Switzerland
Please join Sidley and ISS AG in Bern for an afternoon of practical tips and interactive discussions on current issues, including:

Bridging regulatory gaps across the EU, UK, and Switzerland
Managing risks associated with new developments

Industry speakers, regulators, scientific experts, and counsel will share tips and best practices for the challenges and opportunities that lie ahead for Swiss MedTech enterprises.
Location

Hotel Schweizerhof | Bahnhofplatz 11 | 3001 Bern
Register here
1:30 p.m. – 5:00 p.m. CET
Cocktail reception to follow
View agenda here

Topics include:

Sustainability
Digital Health
Cybersecurity

Who should attend?
Executives, investors, in-house counsel, and regulatory managers interested and/or facing regulatory issues in Switzerland.

For more information or questions, please contact gvaevents@sidley.com.
In light of the COVID-19 pandemic, Sidley is taking precautions to safeguard the well-being of our clients, colleagues, and guests. If you are experiencing cold- or flu-like symptoms or if you have been in contact with anyone who has been exposed to or infected with COVID-19, please refrain from attending this event.
Sidley Austin LLP and ISS AG will process delegate contact details for the purposes of organizing and administering this event and for contacting you about future events. Please note that delegate contact details may be passed between Sidley Austin LLP and ISS AG for the above purposes.

Boston Life Sciences Roundtable
2022-07-12 13:30 - 16:30 (America/New_York) | MassBio, 700 Technology Square 5th floor, Cambridge, MA, 02139, United States
Please join us for Sidley’s first in-person Boston Life Sciences Roundtable program, an afternoon of provocative discussions addressing cutting-edge trends and topics.
Tuesday, July 12, 2022
1:30 p.m. – 4:30 p.m.
Cocktail reception to follow
Featured Panels
Leading Life Sciences Companies: A Conversation with Boston Area General Counsel
Gina Mazzariello, Chief Legal Officer & General Counsel, Amylyx Pharmaceuticals, Inc.
Karen Tepichin, General Counsel, Ginkgo Bioworks
Joe Vittiglio, Chief Business and Legal Officer, Finch Therapeutics, Inc.
Scott Kaplan, Partner, Food, Drug and Medical Device Regulatory and former FDA Associate Chief Counsel, Enforcement
Becky Wood, Partner, Food, Drug and Medical Device Regulatory and former FDA Chief Counsel
Lessons from the Trenches – Navigating FDA, SEC, and Strategic Issues in Product Development and Commercialization Messaging
Pamela Connealy, Chief Financial Officer, Pyxis Oncology
Heather Turner, former Chief Legal Officer, Lyell Immunopharma, Inc.
Stephen Cohen, Partner, Securities Enforcement and Regulatory
Torrey Cope, Partner, Food, Drug and Medical Device Regulatory
Frank Rahmani, Partner, Capital Markets
Down, But Not Out – Dealing With a Challenging Capital Environment
Christian Schade, Chairman and Chief Executive Officer, Aprea Therapeutics
Geoff Levin, Partner, Private Equity
Asher Rubin, Partner, Technology and Life Sciences Transactions
Keynote Presentation
Natalie Silverstein, M.P.H.
Natalie Silverstein is an author, speaker, consultant and passionate advocate for family and youth service. She is the author of two books about giving back and kindness, including Simple Acts: The Busy Family’s Guide to Giving Back, and most recently Simple Acts: The Busy Teen’s Guide to Making A Difference.
Additional panelists to be announced.

WHO MAY BE INTERESTED IN ATTENDING
Executives, Investors, General Counsel, and Company Counsel
ABOUT THE PROGRAM
The Boston Life Sciences Roundtable is an annual event designed to address cutting-edge trends and hot topics in the life sciences sector. Sidley hosts an annual Life Sciences Roundtable in San Francisco and now in Boston.
For more information, contact globallifesci@sidley.com.
COVID-19 PROTOCOL
In light of the COVID-19 pandemic, Sidley continues to take precautions to safeguard the health and well-being of our clients, colleagues, and guests. Proof of vaccination is required to attend. If you are experiencing cold- or flu-like symptoms or if you have been in contact with anyone who has been exposed to or infected with COVID-19 within the past 14 days, we ask that you not attend the event. We appreciate your cooperation and concern for the health and safety of our guests.
Additional guidance will be provided prior to the event and in accordance with CDC and local guidelines.

Bay Area Life Sciences Roundtable
2022-06-22 13:30 - 16:30 (America/Los_Angeles) | SFMOMA, 147 Minna St. Floor 5, San Francisco, CA, 94103, United States
Please join Sidley at SFMOMA for the 7th Annual Bay Area Lifesciences Roundtable, an afternoon of provocative discussions addressing cutting-edge trends and hot topics.
We are thrilled to be back together in-person for this year’s event which will be held at a beautiful outdoor space—SFMOMA’s Sculpture Garden.

RSVP
Wednesday, June 22, 2022
1:30 p.m. – 4:30 p.m.
Cocktail reception to follow
Private access to the Fisher Collection and the Contemporary Optics Exhibit will be available during the cocktail reception.

FEATURED PANELS
Additional panelists to be announced.
Hot Topics in Managing Global Supply Chain Issues: Before, During, and After Launch
Gain valuable insights from in-house and former agency counsel who have been in the trenches.
Topics will include:

Common global supply chain patterns for pre-commercial and commercial companies
How to manage FDA compliance and quality risks associated with global supply chain
Evaluating key international reference pricing considerations and trends
Analyzing key case study examples

Featured Panelists
Angie Lewis-White, VP Commercial Supply Chain & Contract Manufacturing, Myovant Sciences
Raj Pai, Partner, Food, Drug and Medical Device Compliance and Enforcement; formerly with the FDA’s Office of Chief Counsel and former Special Assistant United States Attorney
Catherine Starks, Partner, Healthcare
Adriana Tibbitts, Partner, Technology and Life Sciences Transactions

Operationalizing Diversity for Positive Business and Clinical Results
Diversity is a laudable goal, sufficient in its own right. However, this panel will take the topic a step further, exploring concrete ways that diversity can be used to make and run a better life sciences company.
Topics will include:

Examining diversity in clinical trial design and recruitment to lead to better medicines
Steps to ensure that market access strategies deliver innovative products to appropriate, but often underserved, groups who would benefit
The myriad ways that diversity touches how companies operate, from the board room to the lunch room

Featured Panelists
Stanley Lewis, MD, Founder and CEO of A28 Therapeutics
Brandon Allgood, Ph.D., Chief Artificial Intelligence Officer, Valo Health
R’Kes Starling, Chief Executive Officer/President, Reveles Clinical Services
Deeona Gaskin, Partner, Food, Drug and Medical Device Compliance and Enforcement
Moderators
Stephen Abreu, Partner, Technology and Life Sciences Transactions
Mustafa Abdul-Jabbar, Managing Associate, Commercial Litigation and Disputes

Managing Your Message and Positioning: Navigating Strategic and Disclosure Considerations in Product Development and Launch
Deciding when and how to share non-public information about key events in your company’s life cycle in general and in transactional settings—such as clinical trial results, regulatory meetings, and product launch—raises complex questions at the intersection of SEC, FDA and First Amendment law. Our panel will help you:

Understand expectations from key federal regulators, with insights from seasoned practitioners, including former FDA Chief Counsel
Track evolving First Amendment protections for truthful and non-misleading commercial and scientific speech
Explore real-world scenarios, including: preparing for data release from clinical trials, charting next steps and regulatory pathways, and evaluating public statements about comparative and competitive positioning, regulatory meetings, and feedback
Understand the perspectives of seasoned practitioners and in-house counsel about managing disclosures in transactional settings, IPOs, and M&A

Featured Panelists
Heather Turner, former Chief Legal Officer, Lyell Immunopharma, Inc.
Frank Rahmani, Partner, Global Life Sciences and Capital Markets
Becky Wood, Partner, Food, Drug and Medical Device Regulatory and former Chief Counsel, FDA

COVID-19 PROTOCOL
In light of the COVID-19 pandemic, Sidley continues to take precautions to safeguard the health and well-being of our clients, colleagues, and guests. Proof of vaccination is required to attend. Please follow all CDC and local California guidelines. If you are experiencing cold- or flu-like symptoms or if you have been in contact with anyone who has been exposed to or infected with COVID-19 within the past 14 days, we ask that you not attend the event. We appreciate your cooperation and concern for the health and safety of our guests.
Additional guidance will be provided prior to the event and in accordance with CDC and local guidelines.

Who may be interested in attending
Executives, Investors, and Company Counsel
CLE credit for this program is pending.
For more information, contact GlobalLifeSci@sidley.com.

Digital Health App'ero and Life Sciences College
2022-06-22 - 2022-06-23 | THE HOTEL, Bd. de Waterloo 38, 1000 Bruxelles, Brussels
Digital Health App’ero
On the eve of the Life Sciences College 2022, we welcome you to our first Digital Health App’ero, which will feature a panel discussion with key industry representatives on the use of digital health tools by pharma and medtech companies. The panel will be followed by a networking forum for professionals in this space.
Staying Ahead of the Curve – Issues on the Radar for Pharma and Medical Devices Companies
Please join us for our annual life sciences legal conference, bringing together senior members of the European Commission and industry thought leaders. This edition will focus on a variety of topics, including the latest regulatory developments in the EU and the outlook for the life sciences industry as a whole. This year’s keynote address will be presented by Andrezj Rys, Director responsible for Health Systems, Medical Products and Innovation, Directorate General for Health and Food Safety (DG Sante), European Commission.
Agenda
Location

Digital Health App’ero
THE HOTEL – Bd. de Waterloo 38, 1000 Bruxelles
6:00 p.m. – 7:30 p.m.
Followed by networking drinks
Staying Ahead of the Curve – Issues on the Radar for Pharma and Medical Devices Companies
THE HOTEL – Bd. de Waterloo 38, 1000 Bruxelles
8:30 a.m. – 5:10 p.m. followed by networking drinks
Breakfast will be served from 8:30 a.m.
Register here for both events.

The event is open to in-house counsel, regulators, and regulatory personnel at pharmaceutical and medical devices companies. There is no registration fee to attend this event. For more information, please contact Cristina Menéndez Ruiz at +32 2 504 6453 or cmenendezruiz@sidley.com.
In light of the COVID-19 pandemic, Sidley is taking precautions to safeguard the well-being of our clients, colleagues, and guests. If you are experiencing cold or flu-like symptoms or if you have been in contact with anyone who has been exposed to or infected with COVID-19, please refrain from attending this event.

Key takeaways from Life Science College 2021 are available here.
Trendspotting 2022: On the Pulse of Life Sciences

Regulatory Reboot: What You Need to Know About Biopharma Regulation in 2022 and Beyond
2022-05-18 08:00 - 2022-05-19 16:00 (America/New_York) | Sidley’s New York Offices, 787 Seventh Avenue, New York, NY, 10019, United States
Join Sidley for a two-day program designed to provide a sophisticated, comprehensive foundation in regulatory law for in-house lawyers involved in biopharma development, manufacturing, and marketing. Whether you are relatively new to regulatory counseling and risk mitigation or more experienced counsel looking for an efficient way to catch up on developments in the law from the past two years, this event is for you. By the end of the second day, you’ll have the information and insights you need to tackle any biopharma regulatory issue and know when to worry, whom to call, and how and when to scale up.

Learn from Sidley’s most experienced biopharmaceutical regulatory lawyers and head back to work with high-quality substantive materials to make your job easier.
Get to know your instructors and peers during breaks and over dinner — networking is risk management.
Come as you are — we will provide the conditions you need for a comfortable, productive learning experience, from an on-demand barista to comfortable seating, great tech, and high-end supplies.
If need be, catch up on work in our newly refurbished, sunny, spacious break-out rooms.

Click here to view the full agenda.
Wednesday, May 18, 2022
FEATURED SESSIONS

Drug Development — Clinical Trials, Biostatistics, Real-World Evidence, and Disputes
Ethics — Ethics Issues Arising in FDA Regulatory Contexts
Statutory Exclusivities
AKS/Fraud & Abuse

Thursday, May 19, 2022
FEATURED SESSIONS

Supply Chain Essentials — DSCSA, PDMA, GMP
Public Company Disclosure Issues — Regulatory and Enforcement (FDA and SEC), Class Actions
Ethics Issues Arising in FDA Regulatory Contexts

WHO SHOULD ATTEND
In-house counsel with responsibility for regulatory compliance, analysis, engagement, and risk mitigation.

Register here
Wednesday, May 18
8:00 a.m. – 4:30 p.m.
Reception follows: 4:30 p.m. – 6:30 p.m.
Thursday, May 19
8:00 a.m. – 4:00 p.m.

CLE credit for this program is pending.
For more information, contact globallifesci@sidley.com.

Women’s Life Sciences Network Event: Global Review of Pharmaceutical Regulations
2022-05-17 18:00 (Europe/Brussels) | Comet, Place Stephanie 50, Brussels, 1050, Belgium
Join us in Brussels for our next Women’s Life Sciences Network event on the occasion of the EU Pharmaceutical Law Forum. A panel from the International and European pharmaceutical industry associations will share and discuss hot topics in the industry. The panel discussion will include:

Global trends on the review of pharmaceutical legislation
IP rights for innovation and incentives
Market access and reimbursement
Recent antitrust trends

Kristine Peers
General Counsel
EFPIA
Melinda Friend
General Counsel
IFPMA

6:00 p.m. CET
The panel discussion will be followed by a networking reception and canapés
Sidley Lawyers
Tatjana Sachse | Josefine Sommer

For more information, please contact Cristina Menendez Ruiz at +32 2 504 6453 or at cmenendezruiz@sidley.com.
Click here to join the Women’s Life Sciences Network LinkedIn Group.
In light of the COVID-19 pandemic, Sidley is taking precautions to safeguard the well-being of our clients, colleagues, and guests. If you are experiencing cold or flu-like symptoms or if you have been in contact with anyone who has been exposed to or infected with COVID-19 within the past 14 days, please refrain from attending this event.
