FDA Fundamentals and What to Expect During a Sponsor Meeting with the FDA

Sep 13, 2017 1:00pm - 4:15pm

Speakers

Deborah M. Shelton
Partner, Leader of the Food & Drug Law Practice
McCarter & English, LLP

Naomi J.L. Halpern
Counsel
Arent Fox LLP

ETHICS: Ethical Considerations Relevant to Communications with FDA

Sep 13, 2017 4:30pm - 5:30pm

Speakers

Deborah M. Shelton
Partner, Leader of the Food & Drug Law Practice
McCarter & English, LLP

Naomi J.L. Halpern
Counsel
Arent Fox LLP

Day 1 - Thursday, September 14, 2017

8:00
Registration and Continental Breakfast
9:00
Chair’s Opening Remarks
9:15
Navigating the Approval Process for Drugs and Biologics
10:15
Expedited Approval Process and Unique Considerations in the Approval of Combination Products and Companion Diagnostics
11:15
Morning Refreshment Break
11:30
Understanding the Clinical Trial Process for Drugs and Biologics
12:30
Networking Luncheon
1:45
Drugs and Biologics: Labeling
2:30
PART 1: Patents, Trademarks, and Other IP Protections and Mechanisms
3:15
Afternoon Refreshment Break
3:30
PART 2: Hatch-Waxman and BPCIA Overview
5:15
Conference Adjourns to Day Two

Day 2 - Friday, September 15, 2017

8:00
Continental Breakfast
8:40
Chair’s Opening Remarks and Recap of Day One
8:45
Breaking News, Cases, Emerging Trends, and New Legislation Likely to Impact FDA Practice
9:45
Threading the Needle: Navigating Off-Label/ New Use
10:45
Morning Refreshment Break
11:00
Examining Current Good Manufacturing Practices and FDA’s Authority and Procedure Regarding Recalls
11:45
Adverse Events Monitoring, Pharmacovigilance, and Risk Management
12:30
Conference Concludes*

Hatch-Waxman and BPCIA in the Trenches: Deconstructing and Constructing an Exclusivity Dispute

Sep 15, 2017 1:30pm - 4:30pm

Speakers

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

Day 1 - Thursday, September 14, 2017

8:00
Registration and Continental Breakfast
9:00
Chair’s Opening Remarks

Christopher M. Mikson
Partner
Mayer Brown LLP

9:15
Navigating the Approval Process for Drugs and Biologics

Christopher M. Mikson
Partner
Mayer Brown LLP

Scott Lassman
Partner
Goodwin Procter LLP

Innovator Products: New Drug Applications and Biologic License Applications

  • The Drug Review Process
    • Fundamentals of applications; from submission, through filing
      and beyond
    • PDUFA Goals, Fast Track, Break Through Status, and Other Process
      Enhancements
    • Use of administrative appeals
  • NDAs and BLAs
    • 505(b)(1)s, 505(b)(2)s, and BLAs
    • Fixed-dose combination drugs
    • Complex molecules regulated through NDAs and differences from
      small molecules
    • Standards for approvals
    • REMS
  • Market exclusivities and protection:
  • Considerations during product development and FDA reviews
    • Hatch-Waxman
    • Orphan Exclusivity
    • Pediatric Exclusivity
    • Protection for Biologics

Follow-On Products: ANDAs and Biosimilars

  • ANDAs
    • Fundamentals of applications
    • ANDA Standards for approval and the concepts of sameness and
      bioequivalence
    • Special considerations: local acting drugs, labeling carve outs and
      other nuances
  • Biosimilars
    • Background on Biologics Price Competition and Innovation Act
    • Biosimilars basics: biosimilarity and interchangeability
    • FDA guidance on labeling of biosimilars
    • Issues for further discussion: substitution, naming, patents, and other nuances

OTC Drugs

  • Differences between approved and monographed OTC drug products
    • Rx-to-OTC switches

10:15
Expedited Approval Process and Unique Considerations in the Approval of Combination Products and Companion Diagnostics

Deborah M. Shelton
Partner, Leader of the Food & Drug Law Practice
McCarter & English, LLP

David M. Fox
Partner
Hogan Lovells US LLP

Expedited Approval Process

  • What is an accelerated approval? What’s a breakthrough therapy?
    A surrogate end point? A biomarker?
  • What are the different pathways for expedited approval?
    • What are the criteria for each pathway?
    • What are the pros and cons of each pathway?
  • How does expedited approval factor into a drug development strategy?

 

Unique Considerations in the Approval of Combination Products and Companion Diagnostics

  • Combination Products
    • What are the requirements for approval of combination products?
    • What is the regulatory pathway?
    • Request for designation process (RFD) and the newly-created pre-
      RFD process
    • Role of the Combination Product Policy Council
  • Companion Diagnostics
    • The regulation of laboratory developed tests (LDTs)
    • In vitro diagnostic devices (IVDs) and Next Generation Sequencing
      (NGS) IVDs

11:15
Morning Refreshment Break
11:30
Understanding the Clinical Trial Process for Drugs and Biologics

Amy Judge-Prein
Partner
Faegre Baker Daniels LLP

Gary C. Messplay
Partner
King & Spalding

  • Overview of clinical trials and how they are used (including different phases)
  • Different parties involved (sponsors, investigators, CROs, etc.)
  • Regulatory requirements and reporting (INDs, GCPs)
  • Human research protection (ICF, IRB)
  • Enforcement

12:30
Networking Luncheon
1:45
Drugs and Biologics: Labeling

Brian Walsh
Assistant General Counsel – Intellectual Property
Bristol-Myers Squibb

Ryan P. Blaney
Member
Cozen O’Connor

The labeling of the drug/biological product is the final stage of the approval process. It is the point of transition between the approval process and post-approval world.

  • Labeling overview: key regulatory requirements, information, and contents
    • How does the label get constructed and content of approved labeling
  • Review process for labeling
  • How does the final labeling control the scope of post-market activities?
  • How can and when should the labeling be amended post-market?
  • How is the labeling a defense in products litigation?
  • Regulatory enforcement of labeling requirements

2:30
PART 1: Patents, Trademarks, and Other IP Protections and Mechanisms

Donna M. Meuth
Associate General Counsel, Intellectual Property
Eisai Inc.

  • Summarizing the patenting process
  • Strategies for building patent protection
  • Seeking extension of patent term for time spent in the drug approval process (Patent Term Extension, Supplemental Protection Certificates), and/or time spent obtaining a patent at the United States Patent Office (Patent Term Adjustment)
  • 271(e)(1) “safe harbor”
  • Identifying the respective roles of the FDA and the PTO in the patenting of drugs and biological products

3:15
Afternoon Refreshment Break
3:30
PART 2: Hatch-Waxman and BPCIA Overview

Donald R. Ware
Partner and Chair of Intellectual Property Department
Foley Hoag LLP

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

Drugs

  • Comparing the NDA, 505(b)(2) and ANDA (Abbreviated New Drug
    Application) drug approval routes
  • Comparing and contrasting brand exclusivities
  • ANDA filing & Paragraph IV Certification
  • Orange Book patent listings
  • Formal and informal evaluation of patents and generating validity
    opinions

    • Uses of the opinion
    • Discoverability
    • Selection of counsel
  • The latest updates on 180-day exclusivity

 

Biologics

  • Identifying products approved/regulated as biologics
  • The rationale for safety and efficacy concerns surrounding second
    generation biologics

 

Biosimilars

  • Approvability of biologics as “biosimilar” or “interchangeable”
  • FDA rule-making and guidance relative to biosimilars
  • Continuing debate over exclusivity period
  • The Supreme Court’s decision in Sandoz v. Amgen
    • Can a biosimilar applicant “opt out” of the Patent Dance? Should they?
    • Is the 180-day notice of commercial marketing mandatory?
    • What are the consequences of a party’s non-compliance with
      the BPCIA?

      • Does either party have the right to enforce the BPCIA’s procedures?
  • What will be the next dispute over interpretation of the BPCIA?
  • Will the FDA embark upon a practice of granting tentative approval?
  • The FDA’s draft guidance on Non-proprietary Naming of Biological
    Products

5:15
Conference Adjourns to Day Two

Day 2 - Friday, September 15, 2017

8:00
Continental Breakfast
8:40
Chair’s Opening Remarks and Recap of Day One
8:45
Breaking News, Cases, Emerging Trends, and New Legislation Likely to Impact FDA Practice

Ginny Beakes-Read
Executive Director/Special Counsel, Regulatory Strategy and Law
Eisai Inc.

Andrea Masciale
Vice President, Regulatory Policy & Global Analytics
Johnson & Johnson Worldwide Government Affairs & Policy

  • Prescription Drug User Fee Act (PDUFA)
    • PDUFA VI Proposed Commitment Letter
    • PDUFA VI Legislation
  • Flexible approval standards
    • Understanding how FDA applies approval standards and the
      need for it to be more flexible in how it applies its standards of
      application for drugs and biologics
  • Right to try
  • Examining the results of the 21st Century Cures Act legislation
    (e.g., Regenerative Advanced Therapy Designation)

9:45
Threading the Needle: Navigating Off-Label/ New Use

Joseph G. Poluka
Partner
Blank & Rome LLP

Michael A. Walsh
Partner
Strasburger & Price, L.L.P.

  • Outline of the regulations and guidances
  • Explanation of what is new and controversial (i.e. the Intended Use Rule, status of FDA dockets on Manufacturer Communications)
  • Case study: (pre- and post-approval – what went right and what went wrong)
  • Prosecutions: (Park, DOJ and DeCoster)
  • Constitutional issues impacting the off-label landscape (Deference, Due Process and the First Amendment)

10:45
Morning Refreshment Break
11:00
Examining Current Good Manufacturing Practices and FDA’s Authority and Procedure Regarding Recalls

Allison Fulton
Partner
Sidley Austin LLP

  • Examining cGMPs (current Good Manufacturing Practices) and the scope of their importance in pharmaceutical/biological product commercialization
  • Looking at FDA’s authority to inspect companies pre and post commercialization
  • How are laboratory investigations in relation to cGMPs conducted?
  • Defining the term “quality systems”
  • How are cGMPs factoring into products litigation?
  • FDA enforcement actions: possible reasons for and what to expect when it does happen (i.e. warning letters, audits, etc.)

 

Recalls

  • 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
  • Evaluating the cost of enforcement actions: what happens to company stock when there is an announcement of an enforcement action?

11:45
Adverse Events Monitoring, Pharmacovigilance, and Risk Management

Robert E. Johnston
Partner
Hollingsworth 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
  • Risk Evaluation and Minimization Strategies (REMS)
  • Risk evaluation in the approval process
  • Risk minimization tools
  • Enforcement of ADE reporting and REMS requirements
  • Examining the relevance to product liability risks, including innovator and co-promoter liability risks

12:30
Conference Concludes*

(*Lunch will be served for delegates attending the Post-Conference Workshop beginning promptly at 12:30)

FDA Fundamentals and What to Expect During a Sponsor Meeting with the FDA

Sep 13, 2017 1:00pm - 4:15pm

$600

Speakers

Deborah M. Shelton
Partner, Leader of the Food & Drug Law Practice
McCarter & English, LLP

Naomi J.L. Halpern
Counsel
Arent Fox LLP

What is it about?

12:30 Registration to Workshop A

Aimed at providing a primer to professionals who have limited or no experience working with FDA on regulatory matters, this workshop will provide you with 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 the FDA and walk you through the pre-approval, approval, and post-approval process. Get the background you need to flow seamlessly into the conversations at FDA Boot Camp.

 

Topics to be discussed include:

 

  • FDA Mission
  • FDA Organization
  • Brief Historical Overview
  • Acronyms and Terminology
  • The Drug Approval Process
    • Overview of the research, development, and approval process for new drugs
  • Clinical Trials Process
    • The investigational new drug application (IND) – timing, content, and purpose
    • Outlining the phases of clinical trials (I-IV)
  • Types of New Drug Applications
    • ǔǔ The new drug application (NDA)—timing, content, purpose, and review process
  • Legal Barriers to Approval
  • The Hatch Waxman Act
    • Overview
    • The role of the Orange Book in the drug approval process: what is it, why is it Orange, and why is it important?
    • Regulatory Exclusivity (FDA)
      • Categories of regulatory (data) exclusivity— NCE (new chemical entity); NCI (new clinical investigation); ODE (orphan drug exclusivity); PED (pediatric exclusivity); New antibiotic exclusivity
      • Orange-Book Listed Patents
  • Biological Products
    • What are biological products? How do they differ from “drugs” and what is the same?
    • Brief Overview of the Biologics Price Competition and Innovation Act (BPCIA)
    • The role of the Purple Book: What is it, why is it Purple, and why is it important? How does it differ from the Orange Book?
  • Post-marketing issues and enforcement, including recalls
  • Advertising and Promotion Overview
    • Overview of laws and regulations controlling the advertising, marketing, and promotion of prescription drugs and biologics
    • Office of Prescription Drug Promotion (OPDP)— duties, responsibilities, and enforcement authority
    • Identifying the role of the FTC in the advertising and promotion of drugs

ETHICS: Ethical Considerations Relevant to Communications with FDA

Sep 13, 2017 4:30pm - 5:30pm

$100

Speakers

Deborah M. Shelton
Partner, Leader of the Food & Drug Law Practice
McCarter & English, LLP

Naomi J.L. Halpern
Counsel
Arent Fox LLP

What is it about?

4:15 Registration to Workshop B

This one-hour program will explore ethical issues that may arise in the context of communications with FDA on behalf of clients. The program is based on scenarios involving situations in which FDA requires full disclosure of adverse information and authority. For example:

 

  1. In the context of citizen petitions FDA requires certification that the petition includes all information and views on which the petition relies as well as data and information known to the petitioner which is unfavorable to the petitioner. 21 CFR 10.30. The discussion will cover the implications of that certification upon an attorney in light of Rules 1.6, 1.7 and 1.8 of the Rules of Professional Responsibility.
  2. In the context of an Advisory Committee meeting at which counsel is present, Committee members ask whether all data regarding adverse events have been reported to FDA. The discussion will cover the
    implications of the lawyer’s participation in light of the requirements of Rules 1.3, 3.4, and 4.1.
  3. Your client has retained a former FDA official and tells you that he will be contacting FDA to discuss a pending NDA. The discussion will cover the implications of Rule 1.11

Hatch-Waxman and BPCIA in the Trenches: Deconstructing and Constructing an Exclusivity Dispute

Sep 15, 2017 1:30pm - 4:30pm

$600

Speakers

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

What is it about?

1:00 – Registration to Workshop C

This working group will deconstruct, in a step by-step manner, complex exclusivity disputes, analyze FDA’s and the disputing parties’ various (and sometimes evolving) positions on exclusivity. Relevant court decisions will also be analyzed and their practical and future effects discussed. Working group attendees will have the opportunity to understand how the exclusivity “rules of the road” are applied in a real-world case. After the exclusivity case analyses are completed, attendees will have the opportunity to construct their own exclusivity dispute by choosing from various base facts. Once the case is constructed, the speaker will lead you through the exclusivity analysis. Working group attendees will have the opportunity to apply various Hatch-Waxman concepts learned during the Boot Camp.