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