GoodLifeSci

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.
