American Conference Institute's 43rd FDA Boot Camp - DS
American Conference Institute’s 43 rd
March 19–20, 2025 | New York Bar Association, New York, NY
Pre- and Post- Conference Workshops: March 18 and 20, 2025
Training in core regulatory concepts for life sciences attorneys, business executives, and policy analysts
Distinguished Co-Chairs
Join us for Pre- and PostConference Workshops:
A
Calendar-alt March 18th, 2025
FDA 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Enforcement
Calendar-alt March 18th, 2025
B
C
Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations
Calendar-alt March 20th, 2025
Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group
Kurt Karst Director Hyman, Phelps & McNamara, P.C.
Maarika Kimbrell Partner
Morgan, Lewis & Bockius LLP
Former Director of FDA's New Drug Policy, OND, CDER
Program highlights:
ĉ Navigating the Approval Process for Drugs and Biologics
ĉ Clarifying the Clinical Trial Process for Drugs and Biologics
ĉ Understanding the structure of FDA and the roles of the three major agency centers: CDER, CBER, and CDHR
ĉ Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry
ĉ cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (“cGMPs”) in the Post approval Process
ĉ Advertising, Promotions, and Related First Amendment Concerns
ĉ Understanding the Scope of FDA Enforcement Authority and Actions
ACI’s FDA Bootcamp has served as the premier platform for life sciences attorneys and executives to hone their expertise in FDA regulation. Now, the opportunity awaits for you to become a part of this esteemed community. Join us and elevate your knowledge in the fundamentals of FDA regulation.
The conference will cover all FDA essentials including the Approval Process for Drugs and Biologics, Understanding the structure and authority of the FDA, the role of cGMPs, Advertising, Promotion, FDA Enforcement and Adverse Events, Hatch-Waxman and BPCIA Fundamentals and more.
The objective of this conference is to equip legal professionals without prior regulatory expertise and life sciences executives engaged in FDA-regulated products with a comprehensive grasp of fundamental FDA principles. This will be achieved by delivering firsthand insights, real-world examples, and case studies drawn from FDA-regulated products.
Our program features an esteemed panel of top FDA regulatory leaders, will generously share their wealth of knowledge and provide invaluable insights on:
ç The organization, jurisdiction, functions, and operations of FDA
ç The essentials of the approval process for drugs and biologics
ç The role of the Hatch-Waxman Act in the patenting of drugs and biologics
ç Clinical trials for drugs and biologics
ç Labeling in the drug and biologics approval process
ç cGMPs and other manufacturing concerns relative to products liability
ç Proactive adverse events monitoring and signal detection
ç Recalls, product withdrawals, and FDA oversight and enforcement authority
The speakers and content were second to none. It was a fantastic experience for me to attend.
Senior Counsel, GSK
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
2025 FACULTY
CONFERENCE CO-CHAIRS
Kurt Karst Director
Hyman, Phelps & McNamara, P.C.
DISTINGUISHED FACULTY
Naomi Birbach Partner Goodwin Procter LLP
Cathy L. Burgess Partner, Leader of FDA, Food, Drug & Device Team Alston & Bird
Jason F. Conaty Counsel, Global Regulatory, Hogan Lovells US LLP
Torrey Cope Partner
Sidley Austin LLP
Thomas J. Cosgrove Partner
Covington & Burling LLP
Maarika Kimbrell Partner
Morgan, Lewis & Bockius LLP
Former Director of FDA's New Drug Policy, OND, CDER
Seth Mailhot Partner, Leader of FDA Group Husch Blackwell LLP
Jennifer D. Newberger Director
Hyman, Phelps, & McNamara, P.C.
George O'Brien Partner Mayer Brown LLP
Jonathan B. Roses Shareholder Wolf, Greenfield & Sacks, P.C.
Melissa Runsten Counsel Debevoise & Plimpton LLP
Adam P. Samansky Member
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Continuing Legal Education Credits
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
PRE-CONFERENCE WORKSHOPS
Tuesday, March 18, 2025
9:30 am–12:30 pm (10:45–11:15 am Break)
A* Due to the hands-on nature of the workshops, they will only be available for in-person attendance.
FDA 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Enforcement
This workshop provides a basic overview of FDA regulations and will prepare you for the more in-depth discussions that will take place throughout the conference. Topics addressed during this workshop will set the stage for the main conference by helping you thoroughly comprehend the structure of FDA and obtain a basic understanding of the pre-approval, approval, post-approval and enforcement processes. This session also provides a built-in hour of ethics credit. Topics of discussion will include:
• Examining the FDA’s structure, authority, and organization, including the 3 major FDA centers and their roles: CDER (Drug); CBER (Biologics); CDRH (Device)
• Reviewing major FDA regulations, policies, procedures, and applicable laws
» Examining recent developments at FDA
• Defining drugs, biologics, and devices and understanding the role of labeling with respect to these definitions
• Differentiating types of drug applications (INDs, NDAs, and ANDAs)
• Exploring the clinical trials process
• Understanding post-market dilemmas, recalls and withdrawals
• Identifying the enforcement and investigations players and their positions
12:30–1:30 pm Lunch Break
Light lunch will be served only to attendees attending both workshops
1:30–4:30 pm (2:45–3:15 pm Break)
B• Unpacking FDA compliance and enforcement mechanisms
» Inspections (for cause versus routine inspections) and communications with FDA during inspections
» Form FDA 483 observations, Untitled and warning Letters, and establishment inspection reports (EIRs)
• Understanding potential punishments, including civil seizure, injunction, civil monetary penalties, and criminal prosecutions
• Analyzing ethical dilemmas that may occur throughout various stages of interaction with the FDA, including the approval process related to the disclosure of adverse information
Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations
This workshop will provide an introduction and in-depth overview of medical devices, combination products, and companion diagnostics as well as the FDA regulations which govern these products. Topics of discussion will include:
Medical Devices
• Reviewing the history of FDA device regulations and recent Guidance (AI/ML and Predetermined Change Control Plans for Medical Devices)
• Examining the basics of device classification and the FDA’s review process
• Analyzing the clinical trials process for medical devices
• Assessing strategies to obtain clinical data
Combination Products
• Defining the requirements for combination product classification and approval
» Unpacking the FDA's Draft Guidance Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products
• Exploring the Request for designation (RFD) process and the newly-created pre-RFD process
Companion diagnostics
• Exploring the regulations of laboratory developed tests (LDTs)
» Preparing for Stage 1 requirements under LDT Final Rule (taking effect early 2026)
Director
• Determining premarket approvals
• Exploring the 510(k)-clearance process
• Discussing key regulatory requirements, information, and concepts
• Selecting the proper regulatory pathway
• Determining the role of the Combination Product Policy Council and agencies regulating combination products
• Examining existing cGMP’s for combination products
• Examining the approval process for in vitro diagnostic devices (IVDs) and Next Generation Sequencing (NGS) IVDs
• Utilizing companion diagnostics via smart technologies
Seth A. Mailhot Partner, Leader of FDA Group Husch Blackwell LLP
Adam P. Samansky Member Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Jennifer D. Newberger
Hyman, Phelps, & McNamara, P.C.
Wednesday, March 19, 2025
7:15 Registration and Breakfast
8:15 Opening Remarks from the Co-Chairs
Kurt Karst Director
Hyman, Phelps & McNamara, P.C.
Maarika Kimbrell Partner
Morgan, Lewis & Bockius LLP
Former Director of FDA's New Drug Policy, OND, CDER
8:30
This panel will discuss, at a high level, the impact or anticipated impact of recent amendments to regulations; pending legislation of significance; new FDA initiatives; and decisions and citizen petitions impacting regulatory and litigation strategy. Topics of discussion will include:
• Changes to the Food, Drug & Cosmetic Act by the Food and Drug Omnibus Reform Act of 2022 (FDORA), the CURES Act, the CARES Act, the Drug Supply Chain Security Act, and more
• Proposed legislation such as the PREVAIL Act, the Patent Eligibility Restoration Act, and more
• SCOTUS cases: Loper Bright and SEC v Jarkesy
• Warning Letters
9:15 Navigating the Pre-Approval and Approval Process for Drugs and Biologics
The Drug Review Process
• Reviewing the fundamentals of applications; from submission, through filing and beyond
• Making sense of PDUFA Goals, fast track, break through status, and other process enhancements
• Use of administrative appeals
Rx Drugs (Small Molecules)
• Understanding the difference between “new drugs” and other drugs
• Examining the research, development, and approval process for new drugs
• Dissecting the investigational new drug application (IND) vs. the new drug application (NDA)
Biological Products (Large Molecules)
• What are biological products in relation to traditional drugs?
• Deciphering the biologics license application (BLA)
• How do the research, development, and approval process for biological products differ from the process for new drugs?
• Exploring key similarities and differences between the drug and biological product schemes
NDAs and BLAs
• Differentiating between 505(b)(1)s, 505(b)(2)s, and BLAs
• Identifying applications for fixed-dose combination drugs
• Distinguishing complex molecules regulated through NDAs from small molecules
• Examining standards for approvals
• REMS
10:30 Morning Networking Break
10:45 Exploring FDA's Expedited Programs: Applicability and Eligibility
• Distinguishing among the different FDA programs for expedited review and approval of drug products
• Evaluating the criteria for eligibility, benefits, and limitations of each program
• Understanding accelerated approval, surrogate and intermediate clinical endpoints
• Assessing the breakthrough therapy, regenerative medicine advance therapy (RMAT), and fast track designation programs
• Reviewing priority review and the status of the Rare Pediatric Disease Priority Review Voucher (expiring December 2024, pending the Give Kids a Chance Act of 2024)
• Factoring expedited programs into your drug development strategy
• Examining recent changes to FDA’s Accelerated Approval program
12:00 Lunch Break
George O'Brien Partner Mayer Brown
LLP
1:00 Unveiling the Regulatory Landscape of OTC (Over-the-Counter) Drugs
• Understanding the concept of “OTC” (OTC-ness)
• Examining the OTC Review and monographs
» Differences between approved and monographed OTC drug products pursuant to the 2020 CARES ACT reformation and modernization of the OTC drug review process
• OTC Monograph Drug User Fee Program (OMUFA)
Melissa Runsten Counsel
Debevoise & Plimpton LLP
• FDA’s Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use (ACNU)
• Understanding How FDARA and the 21st Century Cures Act are impacting drug approvals through new evidentiary requirements
• Understanding the homeopathic drug industry's challenge to the FDA's December 2022 Final Guidance on Homeopathic Drug Products
1:45 Clarifying the Clinical Trial Process for Drugs and Biologics
• Overview of clinical trials and how they are used (including different phases)
• Identifying the different parties involved (sponsors, investigators, CROs, etc.)
• Understanding human research protection (ICF, IRB)
• Enforcement
• Review of the “Right to Try” laws and their requirements during the clinical trials process
• Examining new FDA requirements for Diversity Actions Plans for clinical trials
• Delving into the categories of meetings available both prior to filing an IND and at various stages throughout a clinical trial
» What type of meeting can you get? (in-person/written response)
» What should you submit?
» How to prepare for it?
2:45 Afternoon Networking Break
IP Overview for Drugs and Biologics: Hatch-Waxman, BPCIA, Trademarks, and More
PART 1
3:00 Patents and Related IP Protections and Mechanisms
Patent Protection for Drugs and Biologics
• Summarizing the patenting process for drugs and biologics
• Strategies for building patent protection for drugs and biologics
» Understanding the potential implications of the proposed Patent Eligibility Restoration Act (PERA)
• Applying for and achieving extension of patent term for time spent in the drug approval process
» Patent Term Extension (“PTE”)
» Patent Term Adjustment (“PTA”)
• Reviewing the 271(e)(1) “safe harbor” provision
• Distinguishing the patenting process for drugs from that of biologics
• Identifying the respective roles of the FDA and the PTO in the protection of drugs and biological products
Trademarks
• Overview of selecting a brand name for a proposed drug product
• Roles of the USPTO and FDA in the drug naming process
• Identifying the PTO and FDA clearances necessary for trade name/trademark approval on your product
• How does the branding process work for your product
PART 2
3:45 Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry
Drugs
• Overview of Hatch-Waxman and reforms
» 30-month stay; patent extensions
» ANDA filer patent challenge and competitive generic therapy 180-day exclusivities
• Comparing the NDA, 505(b)(2), and ANDA (Abbreviated New Drug Application) drug approval routes and reviewing fundamentals of applications
• Exploring the ANDA Paragraph IV Certification, and response to Notice Letters
• 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, such as: NCE (new chemical entity); indication (new indication or use); NDF (new dosage formulation); ODE (orphan drug exclusivity); and PED (pediatric exclusivity) Biologics
• 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
• Exploring the concepts of “biosimilarity” or “interchangeability”
• FDA rule-making and guidance relative to biosimilars
• Other points for consideration: substitution, naming, patents, and additional nuances
• Examining biosimilar exclusivities
• “Shall we dance” — weighing the pros and cons of participating in the patent dance
• Deciding when to provide notice of commercial marketing
Jonathan B. Roses Shareholder Wolf, Greenfield & Sacks, P.C.
Naomi Birbach Partner Goodwin Procter LLP
4:45 Drugs and Biologics Labeling: Appreciating the Importance of the Final Step of the Approval Process
The labeling of the drug/biologic is the final stage of the approval process. The label controls what you can do post-approval and as such it is the point of transition between the approval process and post-approval world.
• Labeling overview: key regulatory requirements, information, and contents
• Exploring the review process for labeling
• Incorporating clinical trial data on the label
• Appreciating the influence of final labeling on the scope of post-market activities
• Amending labeling post-marketing
• Using labeling as a defense in products liability litigation
• Exploring label carve outs and the 2024 Novartis v. FDA case
» Discussing the requirements for skinny and narrow labeling
Michael H. Hinckle Partner K&L Gates LLP
5:30 Conference Adjourns to Day Two
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DAY TWO
Thursday, March 20, 2025
7:45 Registration and Breakfast
8:40 Co-Chairs' Remarks and Recap of Day One
Kurt Karst Director
Hyman, Phelps & McNamara, P.C.
Maarika Kimbrell Partner
Morgan, Lewis & Bockius LLP
Former Director of FDA's New Drug Policy, OND, CDER
8:45 cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (“cGMPs”) in the Post Approval Process
• Examining cGMPs (current Good Manufacturing Practices) and the scope of their importance in pharmaceutical/biological product commercialization
• Factoring cGMPs into the scope of the FDA’s authority
• Exploring the scope of the FDA’s cGMP Initiative and the concept of “risk-based” cGMPs
• Unpacking the FDA's Draft Strategy Document on Innovative Manufacturing Technologies
• Conducting laboratory investigations in relation to cGMPs
• Understanding the influence of cGMPs in products liability litigation
Cathy Burgess Partner, Leader of FDA, Food, Drug & Device Team Alston & Bird LLP
» PFAS and the FDA's new guidance regarding the testing of ethylene glycol (EG) and diethylene glycol (DEG) in high-risk drug components
• Evaluating the costs and impact of enforcement actions
Advertising, Promotions, and Related First Amendment Concerns
PART 1
9:45 Drug and Biologics Advertising and Promotion 101
• Overview of laws and regulations controlling the advertising, marketing, and promotion of prescription drugs and biologics
• Exploring the role of DDMAC (Division of Drug Marketing, Advertising and Communications)
» What duties and responsibilities is DDMAC charged with?
» What are its enforcement capabilities and jurisdiction?
• Identifying the role of the FTC in the advertising and promotion of drugs
» SEC?
• Advertising requirements for prescription v. nonprescription products
• Reviewing the steps which DDMAC takes for the review of launch campaigns and promotional materials
» Overview of the promotional materials submission and review process
• What constitutes a launch?
• What defines an advertisement?
» What information must a drug advertisement include?
• Exploring the role of the label in advertising
10:45 Morning Networking Break
Bryant M. Godfrey Partner Foley Hoag LLP
PART 2
11:00 Exploring the Subtleties and Safe Zones of Off-Label Communications
• Clarifying FDA’s current position on First Amendment and off-label promotion
» The 21st Century Cures Act
» FDAMA 114
• What to expect concerning proposed legislation, rules changes and Citizen Petitions
• Cases and controversies: state AG actions and private tort claims
Torrey Cope Partner
Sidley Austin LLP
11:45 Preparing for the Worse: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and
Recalls
• What is pharmacovigilance?
• How pharmacovigilance uses adverse event reports
» Direct versus indirect reports
» Causality assessments
» Labeling changes
» Pre-and post-market ADE reporting requirements
» How regulatory agencies use ADE reports
• Exploring protocols for Risk Evaluation and Minimization Strategies (REMS)
• Understanding the role of risk evaluation in the approval process
• Identifying risk minimization tools and when long-term safety studies are required
• Enforcing ADE reporting and REMS requirements
Thomas J. Cosgrove Partner
Covington Burling LLP
• Examining the relevance to product liability risks, including innovator and co-promoter liability risks
• What is the FDA’s recall and oversight authority (overview of 21 CFR Part 7)?
» Guidance versus regulation
» Voluntary recalls versus mandatory recalls
» Market withdrawals and stock recoveries
• Interaction between recalls and corrective and preventive action
12:45
Understanding the Scope of FDA Enforcement Authority and Actions
• Enforcement overview—identifying the players and their positions
» Investigations, enforcement, litigation, and defenses
• Understanding potential punishments, including civil seizure, injunction, civil money penalties, and criminal prosecutions
• Unpacking two recent SCOTUS decisions impacting FDA enforcement authority:
» Civil monetary penalties (SEC v Jarksey)
» Injunctions (Starbucks Corp. v McKinney)
• Exploring FDA compliance and enforcement mechanisms
Perham Gorji Partner
DLA Piper LLP (US)
» For cause inspections vs. routine inspections and communication with the FDA during inspections
» EIRs, Form FDA 483 observations, Untitled Letters, and Warning letters related to inspections
• Examining enforcement actions related to digital advertising and social media
» The use of influencers for direct-to-consumer advertisements (e.g., the Untitled Letter to AbbVie Inc. regarding its UBRELVY commercial, featuring tennis-star Serena Williams)
1:30 Main Conference Ends
POST-CONFERENCE WORKSHOP
Thursday,
March 20, 2025
2:30–5:30 pm (3:45–4:15 pm Break)
Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group
This workshop will build upon the content covered during the main conference on the regulatory and IP interplay in the Hatch-Waxman and BPCIA schematics. Our workshop leaders will in a step by-step manner:
• Deconstruct complex exclusivity disputes,
• Analyze FDA’s and the disputing parties’ various (and sometimes evolving) positions on exclusivity
• Explore bioequivalency and interchangeable conundrums, including the elimination of switching study requirements
• Address the complications that arise when sponsors seek to seek to modify products, production processes, or quality controls for approved biologics license application (BLA) biosimilar and interchangeable products under the change notification process outlined in 21 C.F.R. Part 601.12
Relevant court decisions will also be analyzed, and their practical and future effects discussed. Workshop attendees will have the opportunity to understand how the exclusivity “rules of the road” are applied in a real-world case.
Jason F. Conaty Counsel, Global Regulatory Hogan Lovells US LLP
New York City Bar Association 42 West 44th Street, New York, NY 10036
American Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a negotiated rate. To take advantage of these rates, please contact the hotel directly and quote “ACI’s FDA Boot Camp”.
Book with confidence!
Register and pay to lock in your early rate and be eligible for a full refund until March 7, 2025. If you are unable to attend for any reason, you will have the following options:
y A full credit note for you, or a colleague to attend another event.
y A full refund.
All cancellations and changes must be submitted to CustomerService@AmericanConference.com by March 7, 2025.
