December 4–5, 2024 | Seaport Hotel, Boston, MA
Life Sciences IP Due Diligence
A Life Sciences Due Diligence Industry Summit for Assessing and Reinforcing IP Value in a Shifting Regulatory Environment
GAIN INSIGHTS FROM KEY INDUSTRY STAKEHOLDERS AT:
PhRMA
Gilead Sciences
Johnson & Johnson
Memorial Sloan-Kettering Cancer Center
Merck
Novo Nordisk
Orna Thereapeutics
Sanofi
Servier
Vertex Pharmaceuticals
Zentalis Pharmaceuticals
December 3, 2024
Exclusive Working Group
The New Life Sciences IP Due Diligence Checklist: Customizing Your IP Due Diligence Checklist to Account for Legal, Regulatory, and Policy Shifts
Impacting the Life Sciences
Learn how to create a bespoke checklist for all your IP Due Diligence applications, from the everyday must-haves to the deeper-dive add-ons.
CO-CHAIRS
Tom Irving Partner
The Marbury Law Group, PLLC
Forrester Liddle
Head of Intellectual Property and Legal for US R&D Novo Nordisk
FACING THE PERFECT STORM YEAR, THE 2024 CONFERENCE HIGHLIGHTS INCLUDE:
ĉ IP Policy Deep Dive: Understanding the wider implications of Loper on agency determinations as well as IP due diligence reviews in the life sciences
ĉ Spotlight on Cellect and Xencor: analyzing new obviousness and means-plusfunction due diligence considerations
ĉ Think Tank on Terminal Disclaimers and Double Patenting
ĉ Focus on International Diligence Concerns from the UPC to the BIOSECURE Act
ĉ New Administration Forecast: Anticipating How new Executive Branch leadership will impact IP due diligence strategies
Special Session on IP Due Diligence in the Age of AI with:
Charles Kim Deputy Commissioner for Patents
TWO EXCLUSIVE ROUNDTABLES focusing on Dealmaking, Investing, and the IP Due Diligence Process
Business Leaders and Investors let the cat out of the bag
ACI’s 7th Annual Summit on Life Sciences IP Due Diligence returns to Boston this December, to bring you the critical information you need to develop winning strategies and ensure strong, valuable, and protected IP Assets that can hold up under pressure.
Over the last year, a perfect legal and regulatory storm has been unleashed on the life sciences industry and is greatly impacting IP Due Diligence. From Supreme Court decisions such as Loper and Amgen, to the Federal Circuit’s rulings in Cellect and Xencor, to pending USPTO guidance on terminal disclaimers, charting a course through the choppy waters of IP Due Diligence can be a real challenge in the life sciences arena. A strong IP portfolio, coupled with a forward-thinking due diligence strategy, will allow you to build the solid foundation you need to weather the storm and avoid disaster.
Redesign your IP Due Diligence Checklist for a tailored and bespoke approach that can withstand turbulent changes.
This conference will bring you up-to-date on regulatory and policy changes, case law, and new and emerging technologies including AI, that are having a profound effect on IP due diligence. With patent protection under the policy microscope, you’ll learn how to leverage a variety of IP protections, from traditional patents to trade secrets, to maintain valuable IP portfolios. Get the inside scoop on red flags in diligence reviews, and avoid potential patent pitfalls from ensuring training data ownership to avoiding the loss of a bundle of patents tied together by terminal disclaimers.
Working with your fellow practitioners, you will develop strategies and tools necessary to customize your IP due diligence approach by working side-by-side on real-world problems. Learn to navigate through IP thickets, adjust for tectonic shifts in the Life Sciences landscape, and shore up IP value to maximize deal potential.
Hear first-hand how dealmakers and investors rely on IP Due Diligence at all stages. Industry stakeholders will explain what business leaders look for when making the deal and what diligence results may hinder investment.
And, for those newer to IP Due Diligence looking to learn the ropes or those looking to brush up on the latest tips and tricks, join us the day before the Conference for our IP Due Diligence Checklist Workshop, “The New Life Sciences IP Due Diligence Checklist: Customizing Your IP Due Diligence Checklist to Account for Legal, Regulatory, and Policy Shifts Impacting the Life Sciences”
DISTINGUISHED FACULTY
CO-CHAIRs
Tom Irving Partner
The Marbury Law Group, PLLC
Forrester Liddle Head of Intellectual Property and Legal for US R&D Novo Nordisk
GOVERNMENT
Charles Kim
Deputy Commissioner for Patents United States Patent and Trademark Office
Hon. András Kupecz Judge United Patent Court - Court of First Instance, Central Division
ASSOCIATIONS
John Nappi
Assistant General Counsel PhRMA
IN-HOUSE COUNSEL
Tashica Amigholizadeh
Senior Associate General Counsel, IP Gilead Sciences
Anna L. Cocuzzo Managing Counsel, Patents, Boston Merck
Jason Derry Life Sciences Intellectual Property Counsel (Former Associate General Counsel, Intellectual Property, Synthego)
Debbie Drazen, Ph.D., J.D. Assistant General Counsel –Patents Johnson & Johnson
Julie Anne Gillespie Executive IP Strategist Former Vice President, Head of Intellectual Property, BioNTech
Henry Gu SVP, Head of Intellectual Property Zentalis Pharmaceuticals
Konstantina Katcheves Senior Vice President, Business Development, Alliance Management and Acquisitions Teva Pharmaceuticals
Hilary J. Libka, J.D.
Chief Intellectual Property Counsel and Associate General Counsel Memorial Sloan-Kettering Cancer Center
Erica Norey
Senior Counsel, Intellectual Property for Global Business Development and M&A Sanofi
William Vickery Due Diligence Director Servier
Lulu Wang
Head of Intellectual Property Orna Therapeutics
OUTSIDE COUNSEL
Thorsten Bausch Partner Hoffman Eitle
Margaret Bolce Brivanlou, Ph.D. Partner Ballard Spahr LLP
Jennifer J. Chheda Ph.D. Partner Jones Day
Richard B. Emmons Partner Withersworldwide
Michael L. Fuller Partner
Knobbe Martens
Kathleen Gersh Co-Chair, Life Sciences Loeb & Loeb LLP
James Matthew Gould Of Counsel | Intellectual Property | Life Sciences Buchanan, Ingersoll & Rooney P.C.
Keisha Hylton-Rodic, Ph.D., Esq.
Managing Principal Hylton-Rodic Law PLLC
Michael P. Kahn Partner
Akin Gump Strauss Hauer & Feld LLP
Kurt R. Karst Director
Hyman, Phelps & McNamara, P.C.
Chris Katopis Principal Association Counsel IP Consultant American Bar Association
Sherry M. Knowles, Esq. Owner / Principal Knowles Intellectual Property Strategies
Anne Elise Herold Li Partner Crowell & Moring LLP
Mercedes K. Meyer, Ph.D. Attorney Banner Witcoff
Jeffrey Morton, Ph.D. Partner Haynes and Boone, LLP
Kevin E. Noonan, Ph.D. Partner
McDonnell Boehnen Hulbert & Berghoff LLP
Kevin A. O'Connor, Ph.D. Partner
Neal, Gerber & Eisenberg LLP
Caitlin E. Olwell Counsel
Akin Gump Strauss Hauer & Feld LLP
Alicia A. Russo Partner Venable LLP
Robert N. Sahr, Ph.D. Shareholder | Biotechnology Wolf, Greenfield & Sacks, P.C.
Mary C. Till Of Counsel
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Andrew Wasson Partner
Haug Partners
Advisory Board
American Conference Institute’s Life Sciences IP Due Diligence Advisory board was created as a part of ACI’s ongoing effort to provide industry leading content and a world renowned speaker faculty. The board is composed of a selection of all-in-house advisers from the leading pharmaceutical companies in the country. This ‘inner circle’ counsels ACI on the impact of emerging trends and current best practices.
Wei Campbell Director, Patent Counsel
Alnylam Pharmaceuticals (Cambridge, MA)
Kiera Mathey
Assistant General Counsel, Patents Johnson & Johnson
Hilary Libka
Chief IP Counsel, Associate General Counsel Memorial Sloan-Kettering Cancer Center
Sapna Mehtani, Ph.D., J.D. VP, Head of IP and Legal Affairs Sonata Therapeutics
Forrester Liddle
Head of IP and Legal, US R&D
Novo Nordisk (Cambridge, MA)
Adam Poulin-Kerstien
Vice President, Intellectual Property Mersana Therapeutics
PRE-CONFERENCE WORKSHOP
DECEMBER 3, 2024
1:00 pm–4:30 pm (Registration opens at 12:30 pm)
The New Life Sciences IP Due Diligence Checklist: Customizing Your IP Due Diligence Checklist to Account for Legal, Regulatory, and Policy Shifts Impacting the Life
For life sciences companies, the intellectual property, and particularly the patent estate in the US and other relevant global jurisdictions, serves as the bedrock for any and all deals, profits, and products. Doing your best to ensure your IP covers both current and future products and is enforceable against competitors is critical. It is important to establish freedom-to-operate in all relevant jurisdictions and to confirm inventorship and ownership.
IP due diligence is not one-size-fits-all nor is it immune from the constantly evolving political, legal and regulatory developments impacting the IP landscape. The Supreme Court’s decision in Loper, recent Federal Circuit cases such as Cellect and Xencor, and the USPTO’s Proposed Terminal Disclaimer Rule will all have an impact on the diligence process.
Sciences
Keisha Hylton-Rodic, Ph.D., Esq. Managing Principal
Hylton-Rodic
Law PLLC
Lulu Wang
Head of Intellectual Property
Orna Therapeutics
As such, creating a bespoke checklist will set you up for a strong, efficient, and thoroughly effective diligence process – especially in the life sciences.
This workshop will provide you with the nuts and bolts of a comprehensive and adaptable checklist, giving you the tools you need to continuously maintain and enforce rights and value in your company or clients’ IP.
Topics will include:
• Systems and strategies for proper rights-holder assessment, including updating your checklist for new concerns in:
» Ownership
» Inventorship
» Assignments
» Licenses
• Search methods to verify freedom-to-operate in the US and globally
» Market assessment
» Patent specifics
» Multi-national searches
Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.
ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.
• Evaluation of patent validity and strength
» Global enforceability
» Rights to research data
» Accounting for new case law, regulation, and policy changes impacting IP value
• Customizing your checklist for a tailored, business-oriented, and cost-effective approach
• Valuation methods for use by business development teams
• Ensuring privilege and confidentiality requirements are met
• Preparing for diligence review in cases of distressed debt and bankruptcy
• Considerations for innovators and third party infringers
ACI certifies this activity has been approved for CLE credit by the State Bar of California.
ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.
For more information on ACI’s CLE process, visit: www.AmericanConference.com/Accreditation/CLE
EARN CLE CREDITS
DAY ONE | DECEMBER 4, 2024
7:15 Registration and Breakfast
8:15 Opening Remarks from the Co-Chairs
Navigating the Perfect Storm Year: Assessing the Impact of Monumental Legal and Regulatory Developments in the Life Sciences on Intellectual Property Due Diligence
2024 has been a year of monumental developments in case law, policy, and regulations in the Life Sciences that have affected IP due diligence review. Hear from in-the-know practitioners on how the due diligence process has shifted, and how to ensure successful and thorough review processes, guiding you through the eye of the storm.
8:45 Looking Ahead: Surveying the Changing Life Sciences Policy Landscape and its Effect on IP Due Diligence
This session will provide insights on the shifting life sciences policy landscape as an introduction to themes discussed in more detail later in the program.
• Understanding the impact of the Supreme Court’s decision in Loper Bright Enterprises v. Raimondo on regulatory agency determinations from the Food and Drug Administration (FDA), the US Patent and Trademark Office (USPTO), and Federal Trade Commission (FTC)
• Analyzing the significance of the FTC’s position on Orange Book delistings and how this may affect diligence reviews
• Assessing the impact of the government’s potential use of march-in rights on life sciences intellectual property and how this would affect IP value
• Examining the impact of the PTO’s proposed rule on Terminal Disclaimers and the request for comments on the experimental use exception
• Revisiting the Inflation Reduction Act and the challenges it presents to patent value
• Analyzing recent reforms to patent eligibility following the introduction of the Patent Eligibility Restoration Act
• Anticipating the position of the next administration on life sciences IP rights, policies, and regulations
9:45 Morning Networking Break
10:00 The
Cellect and Xencor are among the most ground shifting life sciences patent cases in the last year—if not decade. They go to the very heart of patent claims through their holdings on obviousness-type double patenting and mean plus function claims, adding another layer of consideration to life sciences IP due diligence review. These developments create new demand for a patent portfolio that’s not too big and not too little, but juuuust right.
• Analyzing the Federal Circuit’s decisions in Cellect and Xencor, and understanding their impact on obviousness considerations in IP due diligence reviews
» Obviousness type double patenting
» Means-plus-function claims
• Anticipating whether the Supreme Court will grand certiorari to Cellect and how the Court may decide
• Mitigating double patenting concerns to ensure a robust IP portfolio
• Flagging potential means-plus-function claims to avoid pitfalls in IP valuation review
Chris
Principal Association Counsel American Bar Association
John Nappi Assistant General PhRMA
MODERATOR
Mercedes K. Meyer, Ph.D. Attorney Banner Witcoff
Michael P. Kahn Partner
Akin Gump Strauss Hauer & Feld LLP
Erica Norey Senior Counsel, Intellectual Property for Global Business Development and M&A Sanofi
Alicia A. Russo Partner Venable LLP
» How Goldilocks means-plus-function claims could lead to different results in cases like Amgen, and Baxalta
• Understanding the use of means-plus-function limitations to claim antibodies
Tom Irving Partner
The Marbury Law Group, PLLC
Forrester Liddle Head of Intellectual Property and Legal for US R&D Novo Nordisk
Katopis
11:00 Terminal Disclaimers and Double Patenting Analysis and Think Tank Part I
Understanding the Proposed Rules and their Implications for Life Sciences IP Due Diligence
In May of 2024 the USPTO released its proposed rule on Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting, with commenting closed in July.
Under the proposed rule, in an attempt to reduce patent thickets, all tied-together patents will be limited by each of the other’s terminal disclaimer claims. The rule’s intent is promoting competition and incentivizing innovation. The FTC has offered a comment in support of the proposed rule, but IPO and AIPLA have expressed concern.
Mary C. Till Of Counsel
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Terminal Disclaimers and Double Patenting Analysis and Think Tank Part II – Roundtable Working Groups
Untangling the Thicket: Working Together to Develop Strategies for Terminal Disclaimers and Double Patenting Concerns
Work with fellow practitioners to develop due diligence strategies and best practices for addressing terminal disclaimer and double patenting concerns in the midst of a review.
Share your approach to mitigation and issue spotting and learn new methods from your peers in the IP due diligence space.
12:15 Networking Lunch
1:30
In July of 2023 the Supreme Court issued its decision in Amgen v. Sanofi, unanimously holding that several of Amgen’s patent claims were invalid for lack of enablement. A year and a half later, the lower courts and Federal Circuit have begun to rely on this decision in their own case analyses.
• Understanding how the lower courts and Federal Circuit are interpreting Amgen and how this will affect your IP due diligence review
• Determining whether the claims in your patents are narrow enough to survive while remaining broad enough to protect your IP
• Comparing US enablement and European plausibility assessments to inform patent strategy
• Developing claims both offensively and defensively
Robert N. Sahr, Ph.D.
Shareholder | Biotechnology
Wolf, Greenfield & Sacks, P.C.
Jason Derry Life Sciences Intellectual Property Counsel (Former Associate General Counsel, Intellectual Property, Synthego)
Jeffrey Morton, Ph.D. Partner
Haynes and Boone, LLP
Kevin E. Noonan, Ph.D. Partner
McDonnell Boehnen Hulbert & Berghoff LLP
2:45 Focus on Europe: Revisiting the Significance of Unitary Patents, the Unified Patent Court, and Other Developments in Key European Jurisdictions for U.S. IP Due Diligence Strategies
Hear from UPC practitioners about how the Court’s decisions over the last year and a half have informed due diligence strategies, IP reviews, and mitigation methods not only in the EU, but in the US and globally. Key points of discussion will include:
• Zooming-in on the distinction between the US and EU treatment of Amgen v. Sanofi
• How the UPC is determining essentiality and their decisions regarding standard essential patents
• Regulatory differences between American and European treatment of pediatric exclusivity, orphan drugs, biologics, and patent term extensions
• Examining the impact of these developments on global patent reviews
Thorsten Bausch Partner
Hoffman Eitle
James Matthew Gould Of Counsel
Buchanan Ingersoll & Rooney PC
Hon. András Kupecz
Judge
United Patent Court - Court of First Instance, Central Division
3:30 Ensuring Freedom-to-Operate in the Current IP Landscape: Defusing Landmines and Avoiding Pitfalls to Get the “All-Clear” for the Deal
• Examining how new case law, as well as new legal and regulatory developments, are influencing Freedom to Operate (FTO) reviews in the life sciences
• Exploring different approaches to FTO analysis based on these developments
• Finding solutions to potential areas of infringement
• Assessing the scope of FTO potential FTO impediments to products and technologies with or without patent protection
Tashica Amigholizadeh Senior Associate General Counsel, IP Gilead Sciences
Richard B. Emmons Partner Withersworldwide
4:30 Life Sciences Business Development Leaders Roundtable
Kevin A. O'Connor, Ph.D. Partner Neal, Gerber & Eisenberg LLP
Investigating How Deal Makers Rely on IP Due Diligence Findings When Preparing for a Deal
Hear from leading life sciences Business Development professionals on pressing IP concerns and critical patent portfolio considerations for successful life sciences deals.
Inform due diligence reviews by identifying focus-points and prioritizing value-indicators while remaining on the lookout for potential red flags. Gain key understanding on best methods to value intellectual property rights.
Anna L. Cocuzzo Managing Counsel, Patents, Boston Merck
Debbie Drazen, Ph.D., J.D. Assistant General Counsel – Patents Johnson & Johnson
5:15 Conference Adjourns
Global Sponsorship Opportunities
With conferences in the United States, Canada, Latin America and Europe, the C5 Group of Companies: American Conference Institute, Canadian Institute, and C5 Group, provides a diverse portfolio of conferences, events and roundtables devoted to providing business intelligence to senior decision makers responding to challenges around the world. Don’t miss the opportunity to maximize participation or showcase your organization’s services and talent. For more information please contact us at: SponsorInfo@AmericanConference.com
William Vickery Due Diligence Director Servier
DAY TWO | DECEMBER 5, 2024
7:45 Registration and Breakfast
8:45 Opening Remarks from the Co-Chairs
9:00 Ownership and Inventorship: Who
Holds the Rights
Ownership and Inventorship determinations are key to a thorough life sciences IP due diligence review, but the systems are becoming more complicated. Considering patent application process changes, the impact of the Bayh-Dole Act, and system searches, confirming ownership of rights is critical to finalization of a deal.
• Identifying ownership and inventorship concerns that are unique to the life sciences in the current IP atmosphere
• Demystifying ownership systems and developing review processes to determine proper licensing and assignment of rights
• Determining if inventors and owners are properly listed, named, and identified on patent applications and issued patents
• Addressing federal ownership questions rooted in the Bayh-Dole Act
10:00 Morning Networking Break
10:30
Margaret Bolce Brivanlou, Ph.D. Partner Ballard Spahr LLP
Kathleen Gersh Co-Chair, Life Sciences Loeb & Loeb LLP
Hilary J. Libka, J.D.
Chief Intellectual Property Counsel and Associate General Counsel Memorial Sloan-Kettering Cancer Center
The Intersection of Life Sciences and AI: Analyzing Life Sciences IP Due Diligence in the Age of Artificial Intelligence
Following the ever-growing prevalence of AI in research and development, clinical trials, and other pre- and post-commercialization stages for life sciences inventions, understanding the impact of AI on the Life Sciences has become significantly more important to the IP due diligence process. This session will examine evolving policy and protections for your IP due diligence review.
• Evaluating existing portfolios for risks rooted in the utilization of AI in the research and development process
• Clarifying USPTO guidance on the use of AI tools by parties and practitioners
» The EU AI Act
• Determining licensing requirements and restrictions around AI generated data and AI training data
• Identifying inventorship and ownership red flags when reviewing AI generated products
Michael L. Fuller Partner Knobbe Martens
Charles Kim Deputy Commissioner for Patents United States Patent and Trademark Office
• Mitigating obviousness concerns for AI generated inventions and products in patent filing and diligence reviews
11:30 Patents and Price Controls: Understanding the Continuing Impact of the Inflation Reduction Act on Life Sciences IP
• Revisiting the Inflation Reduction Act’s (IRA’s) impact on pharmaceutical pricing, patent value and the resulting effect on IP due diligence
• Analyzing the IP and due diligence implications of the dismissal of IRA challenges brought by AstraZeneca, Bristol Meyers Squibb, and Johnson & Johnson
• Determining best practices for maximizing IP protection under this unyielding regulatory structure
• Assessing the impact on patent value determination and diligence review for drugs on the negotiation list
Jennifer J. Chheda Ph.D. Partner Jones Day
Caitlin E. Olwell Counsel
Akin Gump Strauss Hauer & Feld LLP
• Identifying investor fears with a chilling effect on dealmaking that may result from due diligence review
• Understanding the red flags that keep investors from financing new products in the life sciences
• Monitoring key market concerns that limit VC interest in new pharma products
The FTC has focused in on Orange Book listings as a hindrance to competition from generics manufacturers for many years. Twice in the last year, the Commission has made announcements about improper Orange Book listings and its intentions to bring possible actions for delisting.
In June 2024 US District Judge Stanley Chesler of New York ordered Teva Pharmaceuticals to delist their asthma inhaler patents from the Orange Book, attracting the attention of the FTC.
Hear from our panel about the effect of the FTC’s push for delisting on patent portfolios, due diligence reviews, and deal strategies following the decision. 3:00 Networking
Michael L. Fuller Partner Knobbe Martens
Kurt R. Karst Director Hyman, Phelps & McNamara, P.C.
Andrew Wasson Partner Haug Partners
3:15 Cross Border Business: Understanding the BIOSECURE Act and Its Impact on Due Diligence and International Deal Making
In May 2024, the U.S. House Committee for Oversight and Accountability voted to approve the BIOSECURE Act. This bi-partisan act prohibits federal “executive agencies” from contracting with certain biotechnology companies, with a specific focus on Chinese companies, and prohibits government funding for any company that contracts with the named “compan[ies] of concern.” This Act has the potential to significantly disrupt business in the life sciences, limiting access to international manufacturers and data-providers. Understanding and anticipating these disruptions will be critical in diligence processes.
Topics of this panel will include:
• Identifying IP and other diligence concerns around utilizing Chinese manufacturers
• Understanding potential implications for current business structures
• Squaring IP rights and requirements across multiple regulatory landscapes
• Ensuring IP access and enforcement abilities when undertaking platform and product hybrid deals
Konstantina Katcheves
Senior Vice President, Business Development, Alliance Management and Acquisitions Teva Pharmaceuticals
Sherry M. Knowles, Esq.
Owner / Principal Knowles Intellectual Property Strategies
Anne Elise Herold Li Partner
Crowell & Moring LLP
4:00 Beyond Traditional Patents: Standing Out and Increasing Value by Expanding Your IP in a Shifting Policy and Regulatory Landscape
• Leveraging trade secrets and data exclusivity to strengthen your IP portfolio in anticipation of continuing shifts in life sciences IP regulation and policies in order to survive and thrive in a diligence review
• Traversing the current regulatory landscape to identify deal stumbling blocks before you reach them and prepare for potential pitfalls
• Ensuring long-term success and reducing risk through anticipatory action
» To whom is the duty of confidentiality owed in the transition period?
4:45 Conference Concludes
Julie Anne Gillespie
Executive IP Strategist
Former Vice President, Head of Intellectual Property, BioNTech
Henry Gu
SVP, Head of Intellectual Property Zentalis Pharmaceuticals
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