American Conference Institute's 43rd FDA Boot Camp - DS

EARN CLE/ETHICS CREDITS

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

Kurt Karst

Director Hyman, Phelps & McNamara, P.C.

Join us for Pre- and PostConference Workshops:

A

With Calendar-alt March 18th, 2025 1 hour Ethics FDA 101: A Guide to Bonus Agency Structure, Jurisdiction, Regulation, and Enforcement

Calendar-alt March 18th, 2025

edical Devices, Combination B MProducts, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations

C

Calendar-alt March 20th, 2025 Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group MEDIA PARTNERS

REGISTER NOW

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

AmericanConference.com/FDABootCamp • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

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.

T

he 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

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2 | LINKEDIN Pharmaceuticals, Biotech & Life Sciences: Legal, Regulatory, and Compliance Professionals

2025 FACULTY CONFERENCE CO-CHAIRS

Maarika Kimbrell

Kurt Karst

Partner Morgan, Lewis & Bockius LLP Former Director of FDA's New Drug Policy, OND, CDER

Director Hyman, Phelps & McNamara, P.C.

DISTINGUISHED FACULTY

Naomi Birbach

Bryant M. Godfrey

Cathy L. Burgess

Perham Gorji

Partner Goodwin Procter LLP

Partner, Leader of FDA, Food, Drug & Device Team Alston & Bird

Timothy A. Cook

Partner Wilmer Cutler Pickering Hale and Dorr LLP

Torrey Cope

Partner Sidley Austin LLP

Thomas J. Cosgrove

Partner Covington & Burling LLP

Bryan C. Diner

Partner Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

Partner Foley Hoag LLP

Partner DLA Piper LLP (US)

Joanne S. Hawana

Member Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

Michael H. Hinckle Partner K&L Gates LLP

Seth Mailhot

Partner, Leader of FDA Group Husch Blackwell LLP

Mercedes K. Meyer, Ph.D. Partner Banner Witcoff

Jennifer D. Newberger Director Hyman, Phelps, & McNamara, P.C.

George O'Brien

FDA Partner Mayer Brown LLP

Jonathan B. Roses Shareholder Wolf, Greenfield & Sacks, P.C.

Melissa Runsten Counsel Debevoise & Plimpton LLP

Rachel Turow

Of Counsel, FDA Regulatory Skadden, Arps, Slate, Meagher & Flom LLP and Affiliates

Continuing Legal Education 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 State Bar of California.

ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.

For more information on ACI’s CLE process, visit: www.AmericanConference.com/Accreditation/CLE

EARN CLE CREDITS

REGISTER NOW

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.

AmericanConference.com/FDABootCamp • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

PRE-CONFERENCE WORKSHOPS Tuesday, March 18, 2025

* Due to the hands-on nature of the workshops, they will only be available for in-person attendance.

9:30 am–12:30 pm (10:45–11:15 am Break)

With 1 hour Ethics Bonus

A 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

Seth A. Mailhot

Partner, Leader of FDA Group Husch Blackwell LLP

Joanne S. Hawana

Member Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

• 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)

• Defining drugs, biologics, and devices and understanding the role of labeling with respect to these definitions

• Understanding potential punishments, including civil seizure, injunction, civil monetary penalties, and criminal prosecutions

• Differentiating types of drug applications (INDs, NDAs, and ANDAs)

• 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

• 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

Utensils-alt

Light lunch will be served only to attendees attending both workshops

1:30–4:30 pm (2:45–3:15 pm Break)

Devices, Combination Products, and Companion Diagnostics Boot Camp: B Medical 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

Jennifer D. Newberger

Director Hyman, Phelps, & McNamara, P.C.

Rachel Turow

Of Counsel, FDA Regulatory Skadden, Arps, Slate, Meagher & Flom LLP and Affiliates

• Reviewing the history of FDA device regulations and recent Guidance (AI/ML and Predetermined Change Control Plans for Medical Devices)

• Determining premarket approvals

• Examining the basics of device classification and the FDA’s review process

• Exploring the 510(k)-clearance process

• Analyzing the clinical trials process for medical devices

• Discussing key regulatory requirements, information, and concepts

• 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

• 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

Companion diagnostics • Exploring the regulations of laboratory developed tests (LDTs) » Preparing for Stage 1 requirements under LDT Final Rule (taking effect early 2026)

• Examining the approval process for in vitro diagnostic devices (IVDs) and Next Generation Sequencing (NGS) IVDs • Utilizing companion diagnostics via smart technologies

4 | LINKEDIN Pharmaceuticals, Biotech & Life Sciences: Legal, Regulatory, and Compliance Professionals

DAY ONE Wednesday, March 19, 2025 7:15

Registration and Breakfast

8:15

Opening Remarks from the Co-Chairs and Year in Review Kurt Karst

Director Hyman, Phelps & McNamara, P.C.

8:45

Maarika Kimbrell

Partner Morgan, Lewis & Bockius LLP Former Director of FDA's New Drug Policy, OND, CDER

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

Mercedes K. Meyer, Ph.D. Partner Banner Witcoff

• 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

10:00

Morning Networking Break

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AmericanConference.com/FDABootCamp • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

DAY ONE | Wednesday, March 19, 2025

10:15

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

George O'Brien

FDA Partner Mayer Brown LLP

• 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

11:30

Lunch Break

12:30

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

Melissa Runsten

Counsel Debevoise & Plimpton LLP

• OTC Monograph Drug User Fee Program (OMUFA) • 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

1:15

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?

2:15

Afternoon Networking Break

6 | LINKEDIN Pharmaceuticals, Biotech & Life Sciences: Legal, Regulatory, and Compliance Professionals

DAY ONE | Wednesday, March 19, 2025

IP Overview for Drugs and Biologics: Hatch-Waxman, BPCIA, Trademarks, and More PART 1

2:30

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

Jonathan B. Roses

Shareholder Wolf, Greenfield & Sacks, P.C.

» 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

3:15

Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry

Drugs

Naomi Birbach

• Overview of Hatch-Waxman and reforms » 30-month stay; patent extensions

Partner Goodwin Procter LLP

» 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

REGISTER NOW

AmericanConference.com/FDABootCamp • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

DAY ONE | Wednesday, March 19, 2025

4:15

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.

Michael H. Hinckle Partner K&L Gates LLP

• 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

5:00

Conference Adjourns to Day Two

Very positive. Helpful topic coverage, flagging of issues and current regulatory climate.

Corporate Counsel, Ulrey

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8 | LINKEDIN Pharmaceuticals, Biotech & Life Sciences: Legal, Regulatory, and Compliance Professionals

DAY TWO Thursday, March 20, 2025 7:45

Registration and Breakfast

8:25

Co-Chairs' Remarks and Recap of Day One Kurt Karst

Director Hyman, Phelps & McNamara, P.C.

8:30

Maarika Kimbrell

Partner Morgan, Lewis & Bockius LLP Former Director of FDA's New Drug Policy, OND, CDER

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

Cathy Burgess

Partner, Leader of FDA, Food, Drug & Device Team Alston & Bird LLP

• 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 » 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

9:30

Drug and Biologics Advertising and Promotion 101

• Overview of laws and regulations controlling the advertising, marketing, and promotion of prescription drugs and biologics » 21 CFR Sections 202.1, 352(n), 314.81(b)(3); Section 352(n) of FD&CA

Bryant M. Godfrey Partner Foley Hoag LLP

» Guidance documents • 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

REGISTER NOW

AmericanConference.com/FDABootCamp • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

DAY TWO | Thursday, March 20, 2025 PART 2

10:30

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

Torrey Cope

Partner Sidley Austin LLP

• What to expect concerning proposed legislation, rules changes and Citizen Petitions • Cases and controversies: state AG actions and private tort claims

11:15

Morning Networking Break

11:30

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

Thomas J. Cosgrove Partner Covington Burling LLP

» 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 • 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

12:30

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

Perham Gorji

Partner DLA Piper LLP (US)

• 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 » 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)

1:15

Main Conference Ends

10 | LINKEDIN Pharmaceuticals, Biotech & Life Sciences: Legal, Regulatory, and Compliance Professionals

POST-CONFERENCE WORKSHOP Thursday, March 20, 2025 2:00–5:00 pm

C 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:

Timothy A. Cook

• Deconstruct complex exclusivity disputes,

Partner Wilmer Cutler Pickering Hale and Dorr LLP

• Analyze FDA’s and the disputing parties’ various (and sometimes evolving) positions on exclusivity

Bryan C. Diner

• 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

Partner Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

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.

Upcoming Events ACI’s

HatchWaxman SERIES

3rd Annual Forum on

21st Annual Conference on

Advanced Therapeutics

PARAGRAPH IV DISPUTES

March 19–20, 2025

April 29–30, 2025

Boston

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AmericanConference.com/FDABootCamp • 888 224 2480

23rd Advanced Summit on

LIFE SCIENCES PATENTS May 2025 New York

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

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ALL ACCESS PASS (Conference + 3 Workshops)

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In-Person Workshop B: Medical Devices, Combination Products

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In-Person Workshop C: Hatch-Waxman and BPCIA in the Trenches

$600

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