4th Annual Passport to Proficiency on the Essentials of
Hatch-Waxman and BPCIA
October 8–24, 2024 | Virtual Series (EST)
A comprehensive series designed to provide lawyers and executives in the life sciences industry with the essentials and intricacies of Hatch-Waxman and BPCIA litigation and regulation, as well as a solid foundation for understanding the commercialization and pre-approval processes for drugs, biologics and biosimilars.
2024
3 weeks, 2x weekly Clock 18 hours of interactive learning and professional development Comments
Your Hatch-Waxman Proficiency Series: CALENDAR-ALT
Dedicated questions and answer period each day video
Recordings of all sessions for future reference File-Alt
Substantive resource materials for your daily work
Join leading life sciences IP and regulatory counsel to help you understand:
y Interplay of the USPTO and FDA in the patenting of drugs and biologics
y Essentials of the FDA approval process and its link to pharma and biopharma patents
y In-depth and practical knowledge of Hatch-Waxman and BPCIA protocols, including:
» Orange Book vs Purple Book
» Bioequivalency
» Exclusivities
y Paragraph IV litigation and the BPCIA patent dance
y ‘Ins and outs’ of patent term extension
» Differences between NDAs, ANDAs, BLAs, aBLAs
» The Safe Harbor
Certificate of completion and CLE credits
Co-Chairs
Fangli Chen, Ph.D. Partner Proskauer Rose LLP
Jason Murata Partner Axinn, Veltrop & Harkrider
Associate Sponsor
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the pharma, biotech, and biopharma arenas.
Welcome to ACI’s Hatch-Waxman and BPCIA Proficiency Series, a three-week virtual proficiency series designed to provide new lawyers and executives in the life sciences industry with a solid foundation for understanding the essentials and intricacies of Hatch-Waxman and BPCIA litigation and regulation.
Everyone who works in the life sciences industry must be well versed in the regulatory components and IP subtleties that play such an integral role in the patenting of its products.
This series, presented virtually on our state of the art interactive platform, will provide an in-depth review of Hatch-Waxman and the BPCIA, as well as other IP basics relative to small molecules and biologics. Join our distinguished speaker faculty as they lay the necessary foundation to understand the dynamics of the applicable patent life cycles for pharma and biopharma products and business development plans.
Sessions will take place each Tuesday and Thursday afternoon in October for 3 weeks
Here’s what you can expect will be covered each week:
WEEK ONE: October 8 & 10
Regulatory Foundation
y Interplay of the FDA and PTO
y Pre-Commercialization Concerns
y Link between the FDA Approval and the Patent Process
y The Orange Book
WEEK TWO: October 15 & 17
Hatch-Waxman and BPCIA Framework
y The Hatch-Waxman Landscape
y Paragraph IV Disputes and Litigation
y Biosimilars: BPCIA and aBLA Overview
y Participating in the Patent Dance
y The Purple Book
WEEK THREE: October 22 & 24
Focus on Bioequivalence, Exclusivity, Extensions, and Exceptions
y Bioequivalence & Interchangeability
y 180-Day Exclusivity
y Non-Patent/ Regulatory Exclusivity
y Exploring the Safe Harbor
y Examining Patent Extensions
The Hatch-Waxman and BPCIA Proficiency Series is designed for new associates, junior partners, and business executives in the life sciences industry
LAW FIRMS WITH PRACTICE GROUPS IN
• Life Sciences, Pharmaceuticals, and Biopharmaceuticals
• Follow-on Biologics and Biosimilars
• Intellectual Property and Patent Prosecution
• Patent and IP Litigation
PHARMA AND BIOPHARMEUTICAL COMPANIES
• C-Suite Executives and Associate Executives
• In-House Counsel (IP, Regulatory, Corporate, Litigation)
• Hatch-Waxman and BPCIA Litigation
• Regulatory and Commercialization
• Trademark & Copyright
• Life Sciences IP Antitrust
• Business Development Executives and Managers
DISTINGUISHED SPEAKER FACULTY
2024 CO-CHAIRS
Brand:
Fangli Chen, Ph.D. Partner Proskauer Rose LLP
Legal and business professionals who work in the life sciences industry must be well versed in the regulatory components and IP issues that play an integral role in the protection of companies’ products. I am excited to be a part of this immersive series, which explores a variety of patent and regulatory issues, including essentials and intricacies of Hatch-Waxman and BPCIA litigation and regulation. The Series is so comprehensive, it truly stands apart as the best option to train newer lawyers and in-house counsel and I look forward to overseeing the Series as Co-Chair this October.
SPEAKERS
Caleb Bates Principal Fish & Richardson P.C.
Brianne Bharkhda Partner Covington & Burling LLP
Naomi Birbach Partner Goodwin Procter LLP
Thomas J. Campbell Jr. Partner Neal, Gerber & Eisenberg LLP
Shannon K. Clark Partner Venable LLP
Jason Conaty Counsel, Global Regulatory Hogan Lovells US LLP
Bradford C. Frese Partner
ArentFox Schiff
Claire Fundakowski Partner
Winston & Strawn LLP
Christopher M. Gallo Director
Sterne, Kessler, Goldstein & Fox PLLC
Tasha Francis Gerasimow, Ph.D. Partner Kirkland & Ellis LLP
Vishal Gupta Partner Steptoe LLP
Sandra Haberny, Ph.D Partner
Quinn, Emanuel, Urquhart & Sullivan LLP
Abeba Habtemariam Partner
Arnold & Porter LLP
Daniel J. Klein Partner
Groombridge, Wu, Baughman & Stone LLP
Sara Koblitz Director
Hyman, Phelps & McNamara P.C.
Generic: Jason Murata Partner
Axinn, Veltrop & Harkrider
Patent litigation continues to generate numerous consequential precedents that impact the strength and scope of patent rights covering pharmaceutical and biopharmaceutical innovations. Further, legislators and regulators continue to increase their oversight of the pharmaceutical and biopharmaceutical industries. This Series promises to cover the essentials of the litigation, regulatory, and business landscape relating to these industries to give attendees a proficiency with the fundamentals of patent prosecution, exclusivities, patent litigation, commercialization, and more. I’m proud to co-chair such a comprehensive Series, especially at a time where all attorneys increasingly need to have a holistic and multifaceted understanding of the legal and business aspects of these complex industries.
Samuel T. Lockner Partner
Carlson Caspers Vandenburgh & Lindquist, PA
Alejandro Menchaca Shareholder
McAndrews, Held & Malloy, Ltd.
Don J. Mizerk Partner
Husch Blackwell LLP
George O'Brien FDA Partner Mayer Brown
Matthew Piscitelli Attorney
Foley Hoag LLP
Tara M. Raghavan Partner
Benesch
Friedlander Coplan & Aronoff LLP
Christy G. Rothwell, Ph.D. Partner
FisherBroyles, LLP
Adam P. Samansky Member
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Andrew Wasson Partner
Haug Partners LLP
M. David Weingarten Partner
Finnegan, Henderson, Farabow, Garrett & Dunner LLP
April Weisbruch Partner
McDermott Will & Emery LLP
Joshua Whitehill Counsel
Brown Rudnick LLP
Samantha G. Wilson Partner
Young Conaway Stargatt & Taylor, LLP
Aviv Zalcenstein Partner
Gemini Law LLP
WEEK ONE | DAY ONE
Tuesday, October 8, 2024 (EST)
1:00 pm
Co-Chair Opening Remarks
1:15 pm
Brand:
Fangli Chen, Ph.D. Partner
Proskauer Rose LLP
Generic: Jason Murata Partner
Axinn, Veltrop & Harkrider
Key Agencies Overview: Understanding the Jurisdiction and Interplay of the FDA and the USPTO in the Patenting of Drugs and Biologics
Brand:
Naomi Birbach Partner
Goodwin Procter LLP
Generic: Adam P. Samansky Member
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Understanding the respective roles and interplay of the FDA and USPTO in the patenting and approval of drugs and biological products: FDA
• FDA overview and organization
» Department of Health and Human Services and the Commissioner
» The 6 FDA Centers and the Office of Regulatory Affairs and their functions
• CDER (Drug), and CBER (e.g., Office of Therapeutic Biologics and Biosimilars, OTBB) in-depth review
• Defining the scope of the FDA’s jurisdiction with respect to drugs, biologics and biosimilars
• Examining how the FDA exercises its jurisdiction:
» rule making
» product decisions
» enforcement
» informal mechanisms
• Reviewing the laws that the FDA enforces relative to the patenting of drug and biological products
» Food Drug & Cosmetic Act
» Prescription Drug Marketing Act
» Public Health Services Act
• Defining drugs and biologics
» Hatch-Waxman Act
» Other applicable laws
• Labeling: when is a drug a drug and not a biologic
• Working with the FDA
» Administrative Procedures Act
» Formal and informal dispute resolution mechanisms
The USPTO
• Review of the organizational structure of the PTO
• Patents: overview of drug and biological products that may be patented
• Who may apply for a patent? What are the requirements for patentability?
» agency and inventorship
• What is the PTO’s jurisdiction in the patenting of drugs and biologics?
• What laws and regulations does the PTO enforce relative to the patenting of drugs and biologics?
• Patent Reform Legislation
• Trademarks vis-à-vis drugs, biologics and biosimilars
2:30 pm Break
2:45 pm
Identifying and Comprehending Pre-Commercialization Concerns Relative to Small Molecules and Biologics
Brand:
Sandra Haberny, Ph.D Partner
Quinn, Emanuel, Urquhart & Sullivan LLP
Generic:
Christopher M. Gallo Director
Sterne, Kessler, Goldstein & Fox PLLC
The current pre-commercialization landscape:
• Reviewing the types of products that pharmaceutical, biotechnology and biopharmaceutical companies seeking to develop now
• Identifying impediments – through patent or regulatory restraint — which prevent these companies from pursuing the development of the desired product
• FDA hurdles that may not clear even if all patent and other IP hurdles are met
• Techniques for analyzing the value the product adds to the company's portfolio, and methods for proving value
• Assessing the competition and analyzing potential therapeutic interchange considerations
Considerations in light of Health Care Reform:
• Understanding how the introduction of follow-on biologics and biosimilars has changed the commercial landscape
• Examining the role of the Center for Medicare and Medicaid Services (CMS) in the approval process and its impact on R&D
» The connection between CMS approval and commercial viability via government payor systems and rebates
» Comparative effectiveness
3:45 pm
Questions and Answers
4:15 pm Day One Adjourns
WEEK ONE | DAY TWO
Thursday, October 10, 2024
(EST)
1:00 pm
Exploring the Link between the FDA Approval Process and the Patenting of Drugs and Biologics
Brand:
Thomas J. Campbell Jr. Partner Neal, Gerber & Eisenberg LLP
Regulatory: Matthew Piscitelli
Attorney Foley Hoag LLP
Rx Drugs (new drugs)
• Identifying the application process for the approval of a new drug, i.e., small molecule, new chemical entities, etc.
• NDA (New Drug Application): definition, contents and regulatory overview
• INDA (Investigational New Drug Application) aka “IND”
» how does it differ from an NDA?
• Accelerated approvals
» defining eligibility criteria for accelerated approval and priority reviews
» what portions of approval submissions might FDA release and when?
• Using advisory committees in the approval process
Biologics
• How does the approval process for a biologic differ from that of a drug?
• BLA (Biological Licensing Application): application and filing
» how does a biologic differ from a drug?
» which products require BLAs instead of NDAs?
2:15 pm Break
2:30 pm
Small and Large Molecule Drug Patents and Other Related IP Protections and Mechanisms
Brand:
Caleb Bates
Principal Fish & Richardson P.C.
Generic:
Samuel T. Lockner
Partner
Carlson Caspers Vandenburgh & Lindquist, PA
Patent Protections for Drug and Biologics
• Summarizing the patenting process for drugs and biologics
• Strategies for building patent protection for drugs and biologics
• Applying for and achieving extension of patent term for time spent in the drug approval process
• Patent Term Extension (“PTE”) / Patent Term Adjustment (“PTA”) synopsis
• Reviewing the 271(e)(1) “safe harbor” provision
• Distinguishing the patenting process for drugs from that of biologics
Trademark,
Trade Name, and Trade Dress Protections
• Overview of selecting a brand name for a proposed drug product
• Roles of the USPTO and FDA in the drug naming process
• Identifying the USPTO and FDA clearances necessary for trade name/ trademark approval on your product
• Understanding the importance of trade dress
• How does the branding process work for your product
3:30 pm
The Orange Book: Listings, De- Listings and Other Matters of Interest
Brand:
M. David Weingarten Partner
Finnegan, Henderson, Farabow, Garrett & Dunner LLP
Generic:
Bradford C. Frese
Partner
ArentFox Schiff
• What is the Orange Book, what does it contain, and why is it orange?
» FDA’s publication on Approved Drug Products with Therapeutic Equivalence Evaluations
• Understanding the role of Orange Book listings in patent life cycle management and patent portfolio management
• Exploring the continuing dilemma of which patents should be listed, delisted, and held in reserve
• Examining the FDA’s position on not listing a patent
• Understanding the FTC’s increased focus on listing and de-listing patents in the Orange Book
• Overcoming challenges associated with listing patented information in the product label and indications discovered in clinical testing
» incorporating long term patent listing strategies into label negotiations with FDA
» the ongoing skinny labeling and carve – out conundrum
• Assessing the scope of potential Orange Book listing controversies relative to:
» device patents
» product-by-process claims
» metabolites; polymorphs; intermediates
» patents on unapproved uses
4:30 pm
Questions and Answers
5:00 pm
Co-Chair Closing Remarks and Week One Adjourns
WEEK TWO | DAY ONE
Tuesday,
October 15, 2024 (EST)
1:00 pm
Co-Chair Opening Remarks
1:15 pm
The Hatch-Waxman Landscape: ANDAs, and Exclusivities
Brand:
Shannon K. Clark Partner
Venable LLP
Generic:
Samantha G. Wilson Partner
Young Conaway Stargatt & Taylor, LLP
• Overview of Hatch-Waxman and reforms
• Comparing the NDA, 505(b)(2), and ANDA (Abbreviated New Drug Application) drug approval routes
» Reviewing fundamentals of applications
• Examining ANDA Standards for approval and the concepts of sameness and bioequivalence
• Special considerations: local acting drugs, labeling carve outs and other nuances
» Understanding the role of the Orange Book in the drug approval process
» Listings, de-listings and use codes
• Market exclusivities and protection
• Identifying the different types of exclusivities
» Regulatory exclusivity (FDA)/ (data) exclusivity
NCE (new chemical entity)
» 5 years data exclusivity
indication (new indication or use)
» 3 years marketing exclusivity
NDF (new dosage formulation)
ODE (orphan drug exclusivity)
PED (pediatric exclusivity)
2:45 pm Break
3:00 pm
Paragraph IV Disputes and Litigation
Brand:
Brianne Bharkhda Partner
Covington & Burling LLP
Generic:
Don J. Mizerk Partner
Husch Blackwell LLP
• Exploring the ANDA Paragraph IV Certification, and response to Notice Letters
• Pre-suit considerations
» Initial pleadings
» Multiple ANDA filers
» Declaratory judgments
• Typical Paragraph IV litigation scenarios -hypotheticals
» 30-month stay; patent extensions; ANDA filer exclusivity (180 day)
• Preparing for parallel litigation before the PTAB
» IPR overview
• Hot buttons in Hatch-Waxman litigation
» Settlements
» Damages
» Double-patenting
4:30 pm
Questions and Answers
5:00 pm Day One Adjourns
Virtual Sponsorship Opportunities
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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
WEEK TWO | DAY TWO Thursday, October 17, 2024 (EST)
1:00 pm
Biosimilars: The BPCIA, aBLA Overview
Brand:
Abeba Habtemariam Partner
Arnold & Porter LLP
Generic: Aviv Zalcenstein Partner
Gemini Law LLP
• Overview of biosimilar legislation and regulations, i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA)
• Understanding the rationale for safety and efficacy concerns surrounding second generation biologics or aBLAs
• Exploring the concepts of “biosimilarity” or “interchangeability”
• FDA rulemaking and guidance relative to biosimilars
• Other points for consideration: substitution, naming, patents, and additional nuances
• The Purple Book
• Examining biosimilar exclusivities
2:30 pm Break
2:45 pm
“Shall We Dance” — Weighing the Pros and Cons of Participating in the BPCIA Patent Dance
Brand:
Vishal Gupta Partner
Steptoe LLP
Biosimilar: Claire Fundakowski Partner
Winston & Strawn LLP
• Deciding when to provide notice of commercial marketing
• Addressing contentions and controversies in the aBLA information exchange
• Understanding how biosimilar applicants can command the stride of litigation under the BPCIA
• Evaluating what is “manufacturing information”
• Appreciating the limitations on declaratory judgment actions
• Analyzing the biosimilar and innovator perspectives when deciding whether to dance
3:45 pm
The Purple Book
Brand: April Weisbruch Partner
McDermott Will & Emery
Generic: Claire Fundakowski Partner
Winston & Strawn LLP
• What is the book and what does it contain?
» Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations
• FDA’s interpretation of what is included in the list
• Understand the obligations of Reference Product sponsors under Section 325 (“Biological Product Patent Transparency”), ‘The Purple Book Act’
• Evaluating how new requirements of including patent information will impact the ‘patent dance’
• Appreciating the differences in the Orange Book and Purple Book listing
• Addressing how new information requirements will affect business strategies
4:15 pm
Questions and Answers
4:45 pm
Co-Chair Closing Remarks and Week Two Adjourns
Media Partners
WEEK THREE | DAY ONE
Tuessday, October 22, 2024 (EST)
1:00 pm
Co-Chair Opening Remarks
1:15 pm
In-Depth Drill-Down on Bioequivalence, “Same Active Ingredient”, and Interchangeability
Brand:
Jason Conaty Counsel, Global Regulatory Hogan Lovells US LLP
Generic: Joshua Whitehill Counsel Brown Rudnick LLP
• Defining bioequivalence in drugs and biologics
» drugs v. biologics
• What an ANDA-filer must demonstrate for bioequivalence?
» bioequivalence and dosage form – oral tablet/capsule, injection, nasal sprays, topical, nasal sprays
• How does bioequivalence relate to patents?
» patenting of bioequivalence characteristics – extended-release drug products
» bioequivalence v. Doctrine of Equivalents – what is the difference?
» arguments about bioequivalence raised in Paragraph IV patent litigation
infringement, copying (non-obviousness)
2:15 pm Break
2:30 pm
An In-Depth Look at 180- Day Exclusivity
Brand:
Andrew Wasson Partner Haug Partners LLP
Generic:
Alejandro Menchaca Shareholder McAndrews, Held & Malloy, Ltd.
• Understanding 180-day generic market exclusivity under the HatchWaxman Act
» what are the qualifying criteria for exclusivity?
• How can an ANDA applicant really determine who is "first-to-file" and win 180-day exclusivity?
• Identifying triggers for the running of the 180-day exclusivity period
• Deciphering the FDA’s new interpretation of pre- and post- MMA 180 day exclusivity
» what are the implications of this interpretation for products having ANDA’s filed prior to the enactment of the MMA?
• Exploring the interplay between the 30-month stay and 180-day exclusivity
• Forfeiture provisions: identifying circumstances under which exclusivity is forfeited
» Other circumstances that may trigger the loss of 180-day exclusivity
• When can the 180-day exclusivity period be transferred to another ANDA applicant?
• Evaluating when the 180-day exclusivity period can be relinquished, and exploring the consequences defining "shared exclusivity"
3:30 pm
Comprehending the Intricacies of Non-Patent/ Regulatory Exclusivity
Brand:
George O'Brien FDA Partner Mayer Brown
Generic: Sara Koblitz Director Hyman, Phelps & McNamara P.C.
• Understanding which drug products are eligible for regulatory exclusivity
» small biologics v. biologics
• The different modes and methods of regulatory exclusivity (non-patent)
» NCE (new chemical entity): 5 years marketing exclusivity/5 years data exclusivity
» indication (new indication or use): 3 years marketing exclusivity
» NDF (new dosage formulation)
» ODE (orphan drug exclusivity)
» PED (pediatric exclusivity)
• FD&C 505b2 (alternate pathway to ANDA) a/k/a paper NDA
• What role does the FDA play in regulating these modes of exclusivity?
• When are each of these methods sought?
• Using trade dress as means of exclusivity
4:30 pm
Questions and Answers
5:00 pm Day One Adjourns
1:00 pm
Assessing Patent Protections Afforded Under the Safe Harbor
Brand:
Tasha Francis Gerasimow, Ph.D.
Partner
Kirkland & Ellis LLP
Generic:
Tara M. Raghavan
Partner
Benesch Friedlander Coplan & Aronoff LLP
• Exploring the safe harbor of the Hatch-Waxman Act 35 USC § 271(e)(1)
• Understanding the safe harbor’s scope of protection for otherwise infringing activities
• Examining the safe harbor protections afforded to research tool patents
• Identifying safe harbor protections relative to:
» basic R&D
» new product screening
» optimization
» pre-clinical testing
» post-approval testing
2:15 pm Break
2:30 pm
Examining
Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration
Brand:
Daniel J. Klein
Partner
Groombridge, Wu, Baughman & Stone LLP
Generic:
Christy G. Rothwell, Ph.D. Partner
FisherBroyles, LLP
• Extension of patent term under 35 U.S.C. § 156 and 37 CFR 1.710 – 1.791
• Exploring the viability of extension applications to:
» basic and combination compounds; secondary patents
• Important benchmarks in the drug’s development and patent timelines
• Eligibility for patent term extension
• Regulatory review period determinations
• How to calculate the patent term restored
» respective roles of the FDA and PTO in granting patent extensions
» third-party challenges — “diligence”
• Patent term extensions outside the U.S.
• Examining patent term adjustment due to delays in prosecution before the USPTO
» strategies for:
diligence in prosecution by the patent applicant
calculating the adjustment period
• Understanding the link between patent extensions and exclusivity
» extensions obtained through FDA Pediatric Exclusivity and Orphan Drug Exclusivity
• Obtaining patent coverage for pharmaceuticals through the use of second-generation patents, e.g.,
» maintaining patent position for second-generation products
» approaches taken by pharmaceutical companies in obtaining second-generation patents
» enforcement of second-generation patents
4:00 pm
Question and Answer Wild Card
4:45 pm
Co-Chair Final Comments and Proficiency Series Adjourns
EARN CLE CREDITS
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.
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
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Fangli Chen, Ph.D. Partner Proskauer Rose LLP
Jason Murata Partner Axinn, Veltrop & Harkrider
2024 Co-Chairs
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