American Conference Institute's 42nd FDA Boot Camp - WEB

American Conference Institute’s 42 nd

Stacy Cline Amin Partner

Morrison & Foerster (Former Chief Counsel, U.S. FDA)

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

Cĉ Understanding the Structure of FDA and the Roles of the Three Major Agency Centers: CDER, CBER, and CDHR

ĉ Navigating the Application and Approval Processes for Drugs and Biologics

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

ĉ Clarifying the Clinical Trial Process for Pharmaceutical Products

ĉ Unveiling the Importance of Current Good Manufacturing Practices (cGMPs) in the Post Approval Process

ĉ Recognizing the Pivotal Role of Labeling in the Drugs and Biologics Approval Process

ĉ Grasping the Essentials of Advertising, Marketing and Promotion of Drugs and Biologics

ĉ Comprehending the Protocols of Adverse Events Monitoring, Signal Detection, Product Withdrawals, and Recalls

For nearly 20 years, ACI’s FDA Boot Camp has served as the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulations. This is your opportunity to join their ranks.

Recent news stories, high profile enforcement actions and mounting litigation have made it clear that all eyes are currently on FDA-regulated products. If you are an attorney without a regulatory background or practice, or a life sciences executive who deals with FDA-regulated products, it is critical that you have a familiarity with the fundamentals of FDA regulation and the core concepts underpinning the commercialization process for drugs and biologics that are governed by the FDA.

For this reason, ACI’s FDA Boot Camp returns for its 42nd iteration — LIVE IN NEW YORK CITY — with the continued intent of providing you with an essential working knowledge of core FDA concepts, and real-world examples that will help you to excel in your everyday practice.

Our program features an esteemed panel of top FDA regulatory leaders who 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 authority

Co-Chairs

Stacy Cline Amin Partner

Morrison & Foerster (Former Chief Counsel, U.S. FDA)

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

Distinguished Faculty

Christopher M. Mikson, M.D. Partner

DLA Piper LLP (US)

Abeba Habtemariam Partner

Arnold & Porter LLP

Elizabeth Richards Partner Latham & Watkins LLP

Benjamin Zegarelli Of Counsel

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

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

Jessica Tierney Of Counsel

Jones Day

Seth Mailhot Partner Husch Blackwell LLP

Sonia Nath Partner Cooley Joshua Oyster Partner Ropes & Gray LLP

Marc J. Scheineson, Esq. Partner

Alston & Bird LLP

Jennifer Bragg Partner

Skadden, Arps, Slate, Meagher & Flom LLP

John D.W. Partridge Partner Gibson, Dunn & Crutcher LLP

Bryant M. Godfrey Counsel Foley Hoag LLP

Bryan C. Diner Partner

Finnegan, Henderson, Farabow, Garrett & Dunner LLP

Jason F. Conaty Counsel, Global Regulatory Hogan Lovells US LLP

Samantha Hong Partner

Kleinfeld, Kaplan & Becker LLP

Susan Lee Partner

Goodwin Procter LLP

Maarika L. Kimbrell Partner

Morgan, Lewis & Bockius LLP

James C Shehan (Jim)

Senior Counsel |Chair, FDA Regulatory Practice Lowenstein Sandler LLP

Julia Post Of Counsel

Covington & Burling LLP

Cristopher Noyes Partner WilmerHale

C5 celebrates 40 years of excellence! We are thrilled to have provided exceptional conference experiences globally with our outstanding team, speakers, sponsors, partners, and attendees. To mark this milestone, we're launching a new logo which represents our commitment to innovation, growth, and excellence, represented by the five Cs of C5: Current, Connected, Customer-Centric, Conscientious, and Committed.

Looking back on 40 years, we are grateful for our achievements—hosting global conferences, uniting industry leaders, and supporting business growth. However, we are not done yet! We are committed to pushing boundaries and creating impactful experiences and we're excited for the next 40 years of success.

PRE-CONFERENCE WORKSHOPS

March

12th, 2024

9:00 AM–12:30 PM (10:30 AM–11:00 AM Break)

AFDA 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Applicable Laws

Microphone-alt Christopher M. Mikson, M.D., Partner, DLA Piper LLP (US)

Sonia Nath, Partner, Cooley

+1

1:30 PM–5:00 PM (2:30 PM–3:00 PM Break)

B

Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations

Microphone-alt Abeba Habtemariam, Partner, Arnold & Porter LLP

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, and post-approval 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

• The 3 major FDA centers and their roles

» CDER (Drug)

» CBER (Biologics)

» CDRH (Device)

• Reviewing major FDA regulations and applicable laws

• Defining drugs, biologics, and devices

• Understanding the role of labeling with respect to these definitions

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

• Exploring the clinical trials process

• Investigating biological products and biosimilars

• Evaluating post-market dilemmas and enforcement

• Understanding recalls and withdrawals

• Examining recent developments at FDA

• FDA’s policies and procedures

» Administrative Procedures Act

• Working with the FDA through formal and informal dispute resolution mechanisms

• 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

12:30 PM–1:30 PM Lunch

Elizabeth Richards, Partner, Latham & Watkins LLP

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

• 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

• Determining premarket approvals

• Exploring the 510(k)-clearance process

• Discussing key regulatory requirements, information, and concepts

Combination Products

• Defining the requirements for combination product classification and approval

• Selecting the proper regulatory pathway

• Exploring the Request for designation (RFD) process and the newly-created pre-RFD process

• 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)

• Examining the approval process for in vitro diagnostic devices (IVDs) and Next Generation Sequencing (NGS) IVDs

• Utilizing companion diagnostics via smart technologies

MAIN CONFERENCE DAY 1

March 13th, 2024

8:15

Co-Chairs’ Opening Remarks

Microphone-alt Stacy Cline Amin, Partner, Morrison & Foerster, (Former Chief Counsel, U.S. FDA) Kurt Karst, Director, Hyman, Phelps & McNamara, P.C.

EXPLORING NEW FDA INITIATIVES

Our co-chairs will delve into the recent changes made to the Food Drug & Cosmetic Act by the FDA User Fee Reauthorization Act of 2022, and the Food and Drug Omnibus Reform Act of 2022 (FDORA), including new provisions for clinical trials and accelerated approval. In addition, they will highlight recent litigation against FDA and pending legislation of significance.

The Pre-Approval and Approval Process

9:15

Navigating the Approval Process for Drugs and Biologics

Microphone-alt Jason F. Conaty, Counsel, Global Regulatory, Hogan Lovells US LLP

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 from small molecules

• Examining standards for approvals

• REMS

• Gaining comprehensive insight into the multitude of sponsor meetings, their timing, purposes, and the overarching procedural aspects

10:15 Morning Break

10:45

Exploring FDA’s Expedited Programs: Applicability and Eligibility

Microphone-alt Jessica Tierney, Of Counsel, Jones Day

Benjamin Zegarelli, Of Counsel, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

• 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

• Factoring expedited programs into your drug development strategy

• Examining recent changes to FDA’s Accelerated Approval program

12:00 Lunch Break

12:45

Analyzing the Regulatory Landscape of OTC (Over-the-Counter) Drugs

Microphone-alt Samantha Hong, Partner, Kleinfeld, Kaplan & Becker LLP

• Understanding the concept of “OTC” (OTC-ness)

• Examining the OTC Review and monographs

• Differences between approved and monographed OTC drug products

• 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

1:30

Clarifying the Clinical Trial Process for Drugs and Biologics

Microphone-alt Julia Post, Of Counsel, Covington & Burling LLP

• 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?

2:30 Afternoon Break

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

3:00

PART 1 – Patents and Related IP Protections and Mechanisms

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

Patent Protection for Drugs and Biologics

• Summarizing the patenting process for drugs and biologics

• Patentability requirements and differing patent strategies 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”)

• 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

• Patent validity challenges and infringement proceedings for drugs and biologics under the Hatch-Waxman Act and Biologics Price Competition and Innovation Act (BPCIA)

3:45

PART 2 – Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry

Microphone-alt Maarika L. Kimbrell, Partner, Morgan, Lewis & Bockius LLP

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

» 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

ƒ NCE (new chemical entity)

» 5 years data exclusivity

ƒ Indication (new indication or use)

» 3 years marketing exclusivity

ƒ NDF (new dosage formulation)

» 7 years marketing exclusivity

ƒ ODE (orphan drug exclusivity)

» 6 months marketing exclusivity

ƒ 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

4:45

Drugs and Biologics Labeling: Appreciating the Importance of the Final Step of the Approval Process

Microphone-alt Susan Lee, Partner, Goodwin Procter LLP

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

• Discussing the requirements for skinny and narrow labeling

5:30 Conference Adjourns to Day Two

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.

Questions about CLE credits for your state? Visit our online CLE Help Center at www.americanconference.com/accreditation/cle/

MAIN CONFERENCE DAY TWO March 14th, 2024

8:40

Co-Chairs’ Remarks and Recap of Day One

Microphone-alt Stacy Cline Amin, Partner, Morrison & Foerster, (Former Chief Counsel, U.S. FDA)

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

8:45

cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (“cGMPs”) in the Post approval Process

Microphone-alt Seth Mailhot, Partner, Husch Blackwell LLP

Joshua Oyster, Partner, Ropes & Gray LLP

• 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

• Conducting laboratory investigations in relation to cGMPs

• Understanding the influence of cGMPs in products liability litigation

• Evaluating the costs and impact of enforcement actions

Advertising, Promotions, and Related First Amendment Concerns

9:45

PART 1 – Drug and Biologics Advertising and Promotion

101

Microphone-alt Marc J. Scheineson, Esq., Partner, Alston & Bird LLP

• 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

» Guidance documents

• Exploring the role of the Office of Prescription Drug Promotion (OPDP)

» 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 OPDP 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

10:30 Morning Break

11:00

PART 2 – Exploring the Subtleties and Safe Zones of Off-Label Communications

Microphone-alt Jennifer Bragg, Partner, Skadden, Arps, Slate, Meagher & Flom LLP

John D.W. Partridge, Partner, Gibson, Dunn & Crutcher LLP

• 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

11:45

Preparing for the Worse: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls

Microphone-alt James C Shehan (Jim), Senior Counsel |Chair, FDA Regulatory Practice, Lowenstein Sandler LLP

• 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

• 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

12:45

Understanding the Scope of FDA Enforcement Authority and Actions

Microphone-alt Bryant M. Godfrey, Counsel, Foley Hoag LLP

• 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

• Exploring FDA compliance and enforcement mechanisms

» Inspections

ƒ For cause inspections vs. routine inspections

ƒ Communication with the FDA during inspections

» EIRs

» Form FDA 483 observations

» Untitled and Warning Letters

ƒ Related to inspections

ƒ Resulting from non-inspection data or information

• Examining enforcement actions related to digital advertising and social media

1:30 Main Conference Ends

POST-CONFERENCE WORKSHOP

CSee next page for details.

March 14th, 2024

C2:30 PM–5:30 PM (3:30 PM–4:00 PM Break)

Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group

Microphone-alt Bryan C. Diner, Partner, Finnegan, Henderson, Farabow, Garrett & Dunner LLP

Cristopher Noyes, Partner, WilmerHale

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 conundrums

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.

Bed Venue Information

Hotel: SpringHill Suites NY Manhattan Times Square South

Address: 338 West 36th Street, New York, NY 10018

Reservations: 1 212-216-9244

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”.

Please note that the guest room block cut-off date is February 12, 2024. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

Book with confidence!

Register and pay to lock in your early rate and be eligible for a full refund until February 27, 2024.

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 February 27, 2024.

REGISTRATION