AmericanConference.com/FDABootCamp • 888 224 2480REGISTER NOW Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES EARN CREDITSCLE/ETHICS FDA BOOT CAMP AMERICAN CONFERENCE INSTITUTE’S 39 th September 14–15, 2022 (EST) | Virtual Conference Training in core regulatory concepts for life sciences attorneys, business executives, and policy analysts 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 Distinguished Conference Chairs:
U.S. FDA)
Morrison Forester (Former Chief Counsel,
Kurt R. Karst Partner Hyman, Phelps & McNamara, P.C.
Preeminent members of the nation’s Food and Drug bar will drill you in the essentials of FDA law and regulation and help you: ĉ COMPREHEND the structure of FDA and the roles of the three major agency centers: CDER, CBER, and CDHR ĉ MASTER the basics of the application and approval processes for drugs and biologics ĉ APPRECIATE the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products ĉ GAIN a practical working knowledge of clinical trial process for pharmaceutical products ĉ RECOGNIZE the pivotal role of labeling in the drugs and biologics approval process ĉ DECIPHER the requirements for the advertising, marketing, and promotion of drugs and biologics ĉ UNDERSTAND the importance of cGMPs to the post-approval regulatory process
Stacy Cline Amin Partner
The role of the Hatch-Waxman Act in the patenting of drugs and biologics
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:
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Proactive adverse events monitoring and signal detection
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Recalls, product withdrawals, and FDA oversight authority
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Labeling in the drug and biologics approval process
Through nearly 19 years, ACI’s FDA Boot Camp has been the Training Grounds for Life Sciences Attorneys and Executives to Master the Fundamentals of FDA Regulation. Don’t miss your opportunity to join their ranks.
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The essentials of the approval process for drugs and biologics
cGMPs and other manufacturing concerns relative to products liability
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 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 FDA-regulated products to have a familiarity with these concepts.
The organization, jurisdiction, functions, and operations of FDA
For this reason, ACI’s FDA Boot Camp returns for its 39th iteration—in a fully virtual format—with the continued intent of providing these individuals with an essential working knowledge of core FDA concepts, and real-world examples that will help them to excel in their everyday practices.
Clinical trials for drugs and biologics
Morrison Forester (Washington, DC) (Former Chief Counsel, U.S. FDA)
Torrey Cope Partner
DISTINGUISHED CO-CHAIRS
DLA Piper LLP (Washington, DC)
Veleka R. Peeples-Dyer
Evan Phelps Partner
K&L Gates LLP (Washington, D.C.)
Hyman, Phelps & McNamara, P.C. (Washington, D.C.)
Kinsey Reagan Partner
David L. Rosen Partner
Jonathan B. Roses Counsel
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Wolf, Greenfield & Sacks, P.C. (Boston, MA)
Beth P. Weinman Partner
Ropes & Gray LLP (Washington, DC)
Michael Hinckle Partner
DISTINGUISHED SPEAKER FACULTY
Maureen Bennett
Adam L. Perlman Partner
Lynn Mehler Partner Hogan Lovells
Skadden LLP (Washington, DC)
Stephanie Philbin Partner
Foley & Lardner LLP (Washington, DC)
John Fuson Partner
Wilmer Hale (Washington, DC)
Marc J. Scheineson Partner
Jennifer L. Bragg Partner
Partner, Life Sciences Co-leader for the Firm’s Health Care & Life Sciences Practice
Christopher Mikson Partner
Opentrons Labworks, Inc. (Washington, DC)
Goodwin Procter LLP (Washington, D.C.)
Amin Talati Wasserman LLP (Washington, DC)
Alston & Bird LLP (Washington, D.C.)
Finnegan, Henderson, Farabow, Garrett & Dunner LLP (Washington, DC)
McDermott Will & Emery LLP (Washington, DC)
Kurt R. Karst Partner
Emily Whelan Partner
Sidley Austin (Washington, DC)
Chad Landmon Partner
Axinn, Veltrop & Harkrider LLP (Hartford, CT)
Husch Blackwell LLP (Washington, DC)
Kleinfeld Kaplan & Becker LLP (Washington, DC)
Brian Malkin Partner
Latham & Watkins LLP (Washington, DC)
Chief Legal Officer, Corporate Secretary and Chief Compliance Officer
Crowell (Washington, DC)
Jones Day LLP (Boston, MA)
Seth A. Mailhot Partner
Stacy Cline Amin Partner
Bryan C. Diner Partner
» CBER (Biologics)
• The 3 major FDA centers and their roles
• Working with the FDA through formal and informal dispute resolution mechanisms
• Defining the requirements for combination product classification and approval
• Reviewing major FDA regulations and applicable laws
Evan Phelps, Partner, Amin Talati Wasserman LLP (Washington, DC)
• Evaluating post-market dilemmas and enforcement
• Reviewing the history of FDA device regulations
12:00–1:30 PM Lunch Break
• Examining the FDA’s structure, authority, and organization
• 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
• Understanding the role of labeling with respect to these definitions
• Determining the role of the Combination Product Policy Council and agencies regulating combination products
» CDRH (Device)
microphone-alt Christopher Mikson, Partner, DLA Piper LLP (Washington, DC)
Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations
• Assessing strategies to obtain clinical data
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• Analyzing the clinical trials process for medical devices
• Differentiating types of drug applications (INDs, NDAs, and ANDAs)
EARN 1 ETHICS BONUS CREDIT
• Understanding recalls and withdrawals
Pre-Conference Workshops
• Discussing key regulatory requirements, information, and concepts
• Examining existing cGMP’s for combination products
• Investigating biological products and biosimilars
• Utilizing companion diagnostics via smart technologies
• Determining premarket approvals
Companion Diagnostics
1:30–4:30 PM (2:30–3:00 PM Break)
Tuesday, September 13th, 2022 (EST)
• Examining the approval process for in vitro diagnostic devices (IVDs) and Next Generation Sequencing (NGS) IVDs
WorkshopPre-ConferenceB
• Examining recent developments at FDA
9:00 AM–12:00 PM (10:30–11:00 AM Break)
Topics of discussion will include:
» CDER (Drug)
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:
WorkshopPre-ConferenceA
• Selecting the proper regulatory pathway
• FDA’s policies and procedures
Medical Devices
• Defining drugs, biologics, and devices
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microphone-alt Stephanie Philbin, Partner, Goodwin Procter LLP (Washington, D.C.)
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FDA 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Applicable Laws
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• Examining the basics of device classification and the FDA’s review process
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.
• Exploring the regulations of laboratory developed tests (LDTs)
• Exploring the 510(k)-clearance process
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Combination Products
• Exploring the clinical trials process
• Administrative Procedures Act
• Exploring the Request for designation (RFD) process and the newly created pre-RFD process
This panel will discuss how the Agency—now under the leadership of Dr. Califf will move forward with new initiatives including an evolving response to COVID-19 and examine key priorities.
NDAs and BLAs
• Understanding How FDARA and the 21st Century Cures Act are impacting drug approvals through new evidentiary requirements
• What clinical trial lab work is necessary to demonstrate to the proper agencies?
Exploring FDA's Expedited Programs: Applicability and Eligibility
» Differences between approved and monographed OTC drug products
Kurt R. Karst, Partner, Hyman, Phelps & McNamara, P.C. (Washington, D.C.)
• What are biological products in relation to traditional drugs?
• Identifying applications for fixed-dose combination drugs
12:00 Lunch Break
• Discussing the proper steps for companies who incorporate CBD’s into their products
• Making sense of PDUFA Goals, fast track, break through status, and other process enhancements
• Examining standards for approvals
OTC Products
microphone-alt Kurt R. Karst, Partner, Hyman, Phelps & McNamara, P.C. (Washington, D.C.)
12:45
• Examining the research, development, and approval process for new drugs
• Examining the OTC Review and monographs
• Assessing the breakthrough therapy, regenerative medicine advance therapy (RMAT), and fast track designation programs
• Evaluating the criteria for eligibility, benefits, and limitations of each program
TheApplicationsDrugReview Process
• Understanding accelerated approval, surrogate, and intermediate clinical endpoints
1:1 Networking Break
9:15
Wednesday, September 14th, 2022 (EST)
• Deciphering the biologics license application (BLA)
microphone-alt Stacy Cline Amin, Partner, Morrison Forester (Washington, DC), (Former Chief Counsel, U.S. FDA)
• Use of administrative appeals
microphone-alt Kinsey Reagan, Partner, Kleinfeld Kaplan & Becker LLP (Washington, DC)
Main Conference Day 1
Biological Products (Large Molecules)
• Defining the term “controlled substance”?
Navigating the Approval Process for Drugs and Biologics
The Pre-Approval and Approval Process
• Exploring key similarities and differences between the drug and biological product schemes
• REMS
• Reviewing priority review
microphone-alt Lynn Mehler, Partner, Hogan Lovells
• Implementing the manufacturing quotas which exist for these products
Co-Chairs’ Opening Remarks
8:15
• Differentiating between 505(b)(1)s, 505(b)(2)s, and BLAs
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• Dissecting the investigational new drug application (IND) vs. the new drug application (NDA)
• Reviewing the fundamentals of applications; from submission, through filing and beyond
• Understanding the difference between “new drugs” and other drugs
10:45
• How do the research, development, and approval process for biological products differ from the process for new drugs?
Stacy Cline Amin, Partner, Morrison Forester (Washington, DC)
Exploring New FDA Initiatives Under Commissioner Robert M. Califf
• Distinguishing complex molecules regulated through NDAs from small molecules
Rx Drugs (Small Molecules)
Appreciating the Nuances of the Approval Process for Controlled Substances
microphone-alt David L. Rosen, Partner, Foley & Lardner LLP (Washington, DC)
• Understanding the concept of “OTC” (OTC-ness)
Innovator Products: New Drug Applications and Biologic License
• Exploring state regulations which exist when working with controlled substances
• Factoring expedited programs into your drug development strategy
8:30
11:45
• Distinguishing among the different FDA programs for expedited review, authorization and approval of drug products
10:15 Morning Break
• Reviewing the scheduling process for both approval as well as postmarketing approval with both the DEA and FDA
Drugs
IP Overview for Drugs and Biologics: Hatch-Waxman, BPCIA, Trademarks, and More
Trademarks
• Strategies for building patent protection for drugs and biologics
• Review of the “Right to Try” laws and their requirements during the clinical trials process
• Deciding when to provide notice of commercial marketing
2:30 Afternoon Break
• Applying for and achieving extension of patent term for time spent in the drug approval process
• Overview of Hatch-Waxman and reforms
• “Shall we dance” — weighing the pros and cons of participating in the patent dance
• Exploring the ANDA Paragraph IV Certification, and response to Notice Letters
• Roles of the USPTO and FDA in the drug naming process
» Understanding the role of the Orange Book in the drug approval process
» Patent Term Adjustment (“PTA”)
Biologics
3:00
• Enforcement
• How does the branding process work for your product
microphone-alt Chad Landmon, Partner, Axinn, Veltrop & Harkrider LLP (Hartford, CT)
• Examining biosimilar exclusivities
• Understanding human research protection (ICF, IRB)
3:45
» Patent Term Extension (“PTE”)
1:30
• Other points for consideration: substitution, naming, patents, and additional nuances
• Summarizing the patenting process for drugs and biologics
» Reviewing fundamentals of applications
PART 1 Patents and Related IP Protections and Mechanisms
• Market exclusivities and protection
• Identifying the different types of exclusivities
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 selecting a brand name for a proposed drug product
microphone-alt Bryan C. Diner, Partner, Finnegan, Henderson, Farabow, Garrett & Dunner LLP (Washington, DC)
• Comparing the NDA, 505(b)(2), and ANDA (Abbreviated New Drug Application) drug approval routes
• Identifying the different parties involved (sponsors, investigators, CROs, etc.)
• Identifying the PTO and FDA clearances necessary for trade name/ trademark approval on your product
PART 2 Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry
» 5 years data exclusivity Indication (new indication or use)
• Understanding the rationale for safety and efficacy concerns surrounding second generation biologics
• Exploring the concepts of “biosimilarity” or “interchangeability”
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• Overview of clinical trials and how they are used (including different phases)
» 30-month stay; patent extensions; ANDA filer exclusivity (180 day)
• Overview of biosimilar legislation and regulations, i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA)
• FDA rulemaking and guidance relative to biosimilars
• Distinguishing the patenting process for drugs from that of biologics
Clarifying the Clinical Trial Process for Drugs and Biologics
• Identifying the respective roles of the FDA and the PTO in the protection of drugs and biological products
» Regulatory exclusivity (FDA)/ (data) exclusivity NCE (new chemical entity)
» 3 years marketing exclusivity NDF (new dosage formulation) ODE (orphan drug exclusivity) PED (pediatric exclusivity)
Patent Protection for Drugs and Biologics
• Reviewing the 271(e)(1) “safe harbor” provision
Adam L. Perlman, Partner, Latham & Watkins LLP (Washington, DC)
• Examining ANDA Standards for approval and the concepts of sameness and bioequivalence
• Special considerations: local acting drugs, labeling carve outs and other nuances
Kurt R. Karst, Partner, Hyman, Phelps & McNamara, P.C. (Washington, D.C.)
• Reviewing the steps which DDMAC takes for the review of launch campaigns and promotional materials
The labeling of the drug/biologic is the final stage of the approval process.
PART 1 Drug and Biologics Advertising and Promotion 101
» Guidance documents
• Exploring the review process for labeling
cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (“cGMPs”) in the Post Approval Process
» 21 CFR Sections 202.1, 352(n), 314.81(b)(3); Section 352(n) of FD&CA
• What defines an advertisement?
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.
10:30 Morning Break
4:45
• Identifying the role of the FTC in the advertising and promotion of drugs
• What constitutes a launch?
PART 2 Exploring the Subtleties and Safe Zones of Off-Label Communications
Drugs and Biologics Labeling: Appreciating the Importance of the Final Step of the Approval Process
microphone-alt Marc J. Scheineson, Partner, Alston & Bird LLP (Washington, D.C.)
microphone-alt Stacy Cline Amin, Partner, Morrison Forester (Washington, DC), (Former Chief Counsel, U.S. FDA)
• Incorporating clinical trial data on the label
Advertising, Promotions, and Related First Amendment Concerns
Thursday, September 15th, 2022 (EST)
Co-Chairs’ Remarks and Recap of Day One
microphone-alt Seth A. Mailhot, Partner, Husch Blackwell LLP (Washington, DC)
• Exploring the scope of the FDA’s cGMP Initiative and the concept of “risk-based” cGMPs
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• Understanding the influence of cGMPs in products liability litigation
• Exploring the role of the label in advertising
» What duties and responsibilities is DDMAC charged with?
• Cases and controversies: state actions and
• 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
AG
Main Conference Day Two
Michael Hinckle, Partner, K&L Gates LLP (Washington, D.C.)
» Overview of the promotional materials submission and review process
• Exploring label carve outs
• Labeling overview: key regulatory requirements, information, and contents
» SEC?
• Clarifying FDA’s current position on First Amendment and off-label promotion
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» What are its enforcement capabilities and jurisdiction?
• Appreciating the influence of final labeling on the scope of post-market activities
» FDAMA 114
• Conducting laboratory investigations in relation to cGMPs
8:40
9:45
• What to expect concerning proposed legislation, rules changes and Citizen Petitions
microphone-alt Seth A. Mailhot, Partner, Husch Blackwell LLP (Washington, DC)
• Advertising requirements for prescription v. nonprescription products
• Overview of laws and regulations controlling the advertising, marketing, and promotion of prescription drugs and biologics
8:45
• Exploring the role of DDMAC (Division of Drug Marketing, Advertising and Communications)
• Amending labeling post-ingmarket
11:00
5:30 Conference Adjourns to Day Two
• Using labeling as a defense in products liability litigation
» What information must a drug advertisement include?
• Discussing the requirements for skinny and narrow labeling
» The 21st Century Cures Act
microphone-alt Torrey Cope, Partner, Sidley Austin (Washington, DC)
• Evaluating the costs and impact of enforcement actions
Veleka R. Peeples-Dyer, Chief Legal Officer, Corporate Secretary and Chief Compliance Officer, Opentrons Labworks, Inc. (Washington, DC)
• Exploring FDA compliance and enforcement mechanisms
Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group
» How regulatory agencies use ADE reports
» EIRs
• Examining the relevance to product liability risks, including innovator and co-promoter liability risks
• Examining enforcement actions related to digital advertising and social media
• Explore bioequivalency conundrums
Post-Conference Workshop Thursday, September 15th, 2022 (EST) CHEVRON-DOUBLE-RIGHTWorkshopPost-ConferenceC Clock 2:30–5:30 PM (3:30–4:00 PM Break)
Preparing for the Worse: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls
microphone-alt Beth P. Weinman, Partner, Ropes & Gray LLP (Washington, DC)
» Voluntary recalls versus mandatory recalls
For cause inspections vs. routine inspections
• How pharmacovigilance uses adverse event reports
» Causality assessments
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:
John Fuson, Partner, Crowell (Washington, DC)
• Understanding the role of risk evaluation in the approval process
microphone-alt Jennifer L. Bragg, Partner, Skadden LLP (Washington, DC)
• Enforcement overview—identifying the players and their positions
• Analyze FDA’s and the disputing parties’ various (and sometimes evolving) positions on exclusivity
12:45
» Investigations, enforcement, litigation, and defenses
» Pre-and post-market ADE reporting requirements
• What is pharmacovigilance?
• Understanding potential punishments, including civil seizure, injunction, civil money penalties, and criminal prosecutions
microphone-alt Brian Malkin, Partner, McDermott Will & Emery LLP (Washinton, DC)
Jonathan B. Roses, Counsel, Wolf, Greenfield & Sacks, P.C. (Boston, MA)
• Identifying risk minimization tools
Related to inspections
» Market withdrawals and stock recoveries
• Exploring protocols for Risk Evaluation and Minimization Strategies (REMS)
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.
» Direct versus indirect reports
Emily Whelan, Partner, Wilmer Hale (Washington, DC)
» Inspections
• Interaction between recalls and corrective and preventive action
• Enforcing ADE reporting and REMS requirements
» Guidance versus regulation
» Form FDA 483 observations
» Labeling changes
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• Deconstruct complex exclusivity disputes
Understanding the Scope of FDA Enforcement Authority and Actions
Communication with the FDA during inspections
» Untitled and Warning Letters
• What is the FDA’s recall and oversight authority (overview of 21 CFR Part 7)?
11:45
Resulting from non-inspection data or information
1:30 Main Conference Ends
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AmericanConference.com/FDABootCamp Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES Emma McAdam VP, Government Affairs Janet Smith VP, General Counsel Olivia Thomson Chief Compliance Officer Luis Santos Director Ramesh Kumar Jean Roux VP, Business Development Patricia Harden Head of Sanctions Miyuki Johnson VP, Manufacturing
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