ACI's 41st FDA Boot Camp - DS

We're back in Boston!

FDA BOOT CAMP

September 20–21, 2023 |

Hampshire House, Boston, MA

Training in core regulatory concepts for life sciences attorneys, business executives, and policy analysts

Distinguished Conference Chairs:

Join us for Pre and Post Conference Workshops:

Pre-Conference Workshop A (with 1 hour Ethics Bonus)

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

Pre-Conference Workshop B

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

Post-Conference Workshop C

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

Preeminent members of the nation’s Food and Drug bar will drill you in the essentials of FDA law and regulation and help you:

• COMPREHEND the structure of FDA and the roles of the three major agency centers: CDER, CBER, and CDHR

• MASTER the basics of the application and approval processes for drugs and biologics

• APPRECIATE the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products

• GAIN a practical working knowledge of clinical trial process for pharmaceutical products

• RECOGNIZE the pivotal role of labeling in the drugs and biologics approval process

• DECIPHER the requirements for the advertising, marketing, and promotion of drugs and biologics

• UNDERSTAND the importance of cGMPs to the post-approval regulatory process

Torrey Cope Partner Sidley Austin

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

PLUS! updates on FDORA reforms.

The approval process…pre-approval concerns…product labeling…clinical trials… adverse events reports…patent concerns…and exclusivity—these are all critical aspects in the commercialization process for drugs and biologics that are governed by the FDA. Recent news stories — including Reforms under FDORA — and high-profile trials concerning FDA-regulated products have made it clear that it is critical for attorneys who do not have regulatory practices and life sciences executives who deal with FDAregulated products to have a familiarity with these concepts.

Learn from the Masters

A distinguished faculty of top FDA regulatory authorities — a “Who’s Who of the FDA Bar” — will share their knowledge and provide you with critical insights on:

• The organization, jurisdiction, functions, and operations of FDA

• The essentials of the approval process for drugs and biologics plus insights on accelerated approvals under FDORA

• Clinical trials for drugs and biologics including diversity updates under FDORA

• The role of the Hatch-Waxman Act in the patenting of drugs and biologics

• Labeling in the drug and biologics approval process

• cGMPs and other manufacturing concerns relative to products liability

• Proactive adverse events monitoring and signal detection

• Recalls, product withdrawals, and FDA oversight authority

For nearly two decades, this conference has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA law and regulation. It’s time for you to join their ranks.

We look forward to seeing you in Boston this September!

Get in the trenches with the FDA legal and regulatory elite and master the fundamentals of FDA regulatory law! Obtain the guidance you need at ACI’s 41st FDA Boot Camp, returning in-person to Boston for the first time since 2019!

DISTINGUISHED CO-CHAIRS

Torrey Cope Partner

Sidley Austin (Washington, DC)

DISTINGUISHED SPEAKER FACULTY

Maureen Bennett Partner, Life Sciences Co-leader for the Firm’s Health Care & Life Sciences Practice

Jones Day LLP (Boston, MA)

Hannah Bornstein Partner Nixon Peabody LLP

Delia Deschaine

FDA/DEA Regulatory Attorney - Member of the Firm (Partner)

Epstein Becker & Green, P.C. (Washington, DC)

Maya P. Florence Partner

Skadden, Arps, Slate, Meagher & Flom LLP (Boston, MA)

Joel Kurtzberg Partner

Cahill Gordon & Reindel LLP (New York, NY)

Alissa Lipton Partner

Finnegan, Henderson, Farabow, Garrett & Dunner LLP (Washington, DC)

Seth A. Mailhot Partner

Husch Blackwell LLP (Washington, DC)

Christopher Mikson Partner

DLA Piper LLP (Philadelphia, PA)

Global Sponsorship Opportunities

With conferences in the United States, Europe, Asia Pacific, and Latin America, the C5 Group of Companies: American Conference Institute, The 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: American Conference Institute

SponsorInfo@AmericanConference.com

Kurt R. Karst Director

Hyman, Phelps & McNamara, P.C. (Washington, D.C.)

Evan Phelps Partner

Amin Talati Wasserman (Washington, DC)

Eric T. Romeo Partner

Goodwin Procter LLP (Washington, DC)

Jonathan B. Roses Counsel

Wolf, Greenfield & Sacks, P.C. (Boston, MA)

Marc J. Scheineson Partner

Alston & Bird LLP (Washington, DC)

Beth Weinman Counsel

Ropes & Gray LLP (Washington, DC)

Emily Whelan Partner WilmerHale (Boston, MA)

James William Woodlee Partner

Kleinfeld, Kaplan & Becker, LLP (Washington, DC)

Benjamin Zegarelli Of Counsel

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. (New York, NY)

Pre-Conference Workshops

Tuesday, September 19th, 2023 (EST)

Pre-Conference Workshop A

CHEVRON-DOUBLE-RIGHT CHEVRON-DOUBLE-RIGHT

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

microphone-alt Christopher Mikson, Partner, DLA Piper LLP (Washington, DC)

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 postapproval 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

Pre-Conference Workshop B

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

microphone-alt Evan Phelps, Partner, Amin Talati Wasserman LLP (Washington, DC)

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

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

Main Conference Day 1

Wednesday, September 20th, 2023 (EST)

8:15 AM

Co-Chairs’ Opening Remarks

microphone-alt Torrey Cope, Partner, Sidley Austin (Washington, DC)

Kurt R. Karst, Director, Hyman, Phelps & McNamara, P.C. (Washington, D.C.)

8:30 AM

Exploring New FDA Initiatives

microphone-alt Torrey Cope, Partner, Sidley Austin (Washington, DC)

Kurt R. Karst, Director, Hyman, Phelps & McNamara, P.C. (Washington, D.C.)

This panel will discuss recent changes made to the Food Drug and Cosmetics Act by the FDA User Fee Reauthorization Act of 2022, and the Food and Drug Omnibus Reform Act (FDORA) of 2022, including frameworks for clinical trials and accelerated approval. In addition, the panel will highlight recent litigation against FDA and pending legislation of significance.

The Pre-Approval and Approval Process

9:15 AM

Navigating the Approval Process for Drugs and Biologics

microphone-alt James William Woodlee, Partner, Kleinfeld, Kaplan & Becker, LLP (Washington, DC)

Innovator Products: New Drug Applications and Biologic License Applications

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

OTC Products

• 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)

• Understanding How FDARA and the 21st Century Cures Act are impacting drug approvals through new evidentiary requirements

10:45 AM

Exploring FDA's Expedited Programs: Applicability and Eligibility

microphone-alt Benjamin Zegarelli, Of Counsel, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. (New York, NY)

• Distinguishing among the different FDA programs for expedited review, authorization 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

• Discuss recent changes to FDA’s Accelerated Approval program

» FDORA reforms

12:45 PM

Appreciating the Nuances of the Approval Process for Controlled Substances

microphone-alt Delia Deschaine, FDA/DEA Regulatory Attorney - Member of the Firm (Partner), Epstein Becker & Green, P.C. (Washington, DC)

• Defining the term “controlled substance”?

• Reviewing the scheduling process before (and after) FDA-approval by HHS and DEA

• Discussing the proper steps for companies who incorporate substances with abuse potential into their products

• Understanding what clinical (and pre-clinical) evidence is relevant or necessary to present to the proper agencies

• Exploring state regulations that apply when working with controlled substances

• Implementing the manufacturing quotas which exist for these products

• Marijuana and psychedelic medicine considerations

Clarifying the Clinical Trial Process for Drugs and Biologics

microphone-alt Maureen Bennett, Partner, Life Sciences Co-leader for the Firm’s Health Care & Life Sciences Practice, Jones Day LLP (Boston, MA)

• 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

• Updates under FDORA

2:30 PM Afternoon Break

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

2:45 PM

PART 1 – Patents and Related IP Protections and Mechanisms

microphone-alt Alissa Lipton, Partner, Finnegan, Henderson, Farabow, Garrett & Dunner LLP (Washington, DC)

Patent Protection for Drugs 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”)

• 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

3:30 PM

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

microphone-alt Eric T. Romeo, Partner, Goodwin Procter LLP (Washington, DC) Drugs

• Overview of Hatch-Waxman and reforms

» 30-month stay; patent extensions; ANDA filer exclusivity (180 day)

• 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)

ƒ ODE (orphan drug 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 rulemaking 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

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

microphone-alt Maya P. Florence, Partner, Skadden, Arps, Slate, Meagher & Flom LLP (Boston, MA)

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.

Main Conference Day Two

Thursday, September 21st , 2023 (EST)

8:40 AM

Co-Chairs’ Remarks and Recap of Day One

8:45 AM

• 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-market

• Using labeling as a defense in products liability litigation

• Exploring label carve outs

• Discussing the requirements for skinny and narrow labeling

• 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?

cGMPs:

Post Approval Process

in the

Discovering the Unique Role of Current Good Manufacturing Practices (“cGMPs”)

microphone-alt Seth A. Mailhot, Partner, Husch Blackwell LLP (New York, NY)

• 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 AM

PART 1 – Drug and Biologics Advertising and Promotion 101

microphone-alt Marc J. Scheineson, Partner, Alston & Bird LLP (Washington, D.C.)

• 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

• 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 AM

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

microphone-alt Joel Kurtzberg, Partner, Cahill Gordon & Reindel LLP (New York, NY)

• 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

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

microphone-alt Beth P. Weinman, Partner, Ropes & Gray LLP (Washington, DC)

• 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

Post-Conference Workshop

Thursday, September 21st , 2023 (EST)

Pre-Conference Workshop C

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

Understanding the Scope of FDA Enforcement Authority and Actions

microphone-alt Hannah Bornstein, Partner, Nixon Peabody 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

1:15 PM Main Conference Ends

CHEVRON-DOUBLE-RIGHT

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

microphone-alt Jonathan B. Roses, Counsel, Wolf, Greenfield & Sacks, P.C. (Boston, MA)

Emily Whelan, Partner, Wilmer Hale (Boston, MA)

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 realworld case.

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Venue Information:

Hotel: Hampshire House

Address : 84 Beacon St, Boston, MA 02108

Hotel Accommodations:

The following is a shortlist of hotels that are located close to the Hampshire House.

Hotel: Beacon Hill Hotel

Address : 25 Charles St., Boston, MA 02114

Reservations: (617) 865-8020

Hotel: The Newbury Boston

Address: 1 Newbury St, Boston, MA 02116

Reservations: (617) 536-5700

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American Conference Institute

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