Pre-Conference Workshops

Workshop A | FDA Pharmaceutical Law 101: Introduction to the Fundamentals

Sep 26, 2018 1:00pm – 4:00pm

Speakers

Seth A. Mailhot
Partner
Michael Best & Friedrich LLP (Washington, D.C.)

Workshop B | Resolving Ethical Challenges Encountered during the Drug Approval Process

Sep 26, 2018 4:15pm – 5:15pm

Speakers

Seth A. Mailhot
Partner
Michael Best & Friedrich LLP (Washington, D.C.)

Day 1 - Thursday, September 27, 2018

7:00
Registration and Continental Breakfast
8:00
Co-Chairs’ Opening Remarks
8:15
Clarifying the Clinical Trial Process for Drugs and Biologics
9:15
Navigating the Approval Process for Drugs and Biologics
10:15
Networking Break
10:30
Drugs and Biologics: Labeling
11:30
Exploring the Expedited Approval Process
12:30
Networking Luncheon
2:00
Unique Considerations in the Approval of Combination Products and Companion Diagnostics
3:00
Afternoon Refreshment Break
3:15
Part 1: Patents and Related IP Protections and Mechanisms
4:15
Part 2: Hatch-Waxman and BPCIA Overview
5:15
Conference Adjourns to Day Two

Day 2 - Friday, September 28, 2018

7:15
Continental Breakfast
8:00
Co-Chairs’ Remarks and Recap of Day One
8:15
Ripped from the Headlines: Breaking News and Emerging Trends Impacting FDA Practice
9:15
Current Good Manufacturing Practices (“cGMPs”) for Drugs and Biologics
10:00
Morning Refreshment Break
10:15
Promotion, Off-Label Communications, and First Amendment Concerns
11:00
Enforcement
11:45
Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls
12:30
Luncheon for Skills Session Participants

Post-Conference Workshop

Workshop C | Skills Session: Tips and Strategies for Communicating with FDA

Sep 28, 2018 2:00pm – 5:00pm

Speakers

Mark Mansour
Partner
Foley Hoag LLP (Washington, D.C.)

Alexis Reisin Miller
Senior Director
Sanofi (Washington, D.C.)

Day 1 - Thursday, September 27, 2018

7:00
Registration and Continental Breakfast
8:00
Co-Chairs’ Opening Remarks

Donna M. Meuth
Associate General Counsel, Intellectual Property
Eisai Inc. (Andover, MA)

8:15
Clarifying the Clinical Trial Process for Drugs and Biologics

James Czaban
Partner
DLA Piper LLP (Washington, D.C.)

Gary C Messplay
Partner
King and Spalding LLP (Washington, D.C.)

  • 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

9:15
Navigating the Approval Process for Drugs and Biologics

Suchira Ghosh
Counsel
Axinn, Veltrop & Harkrider LLP (New York, NY)

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

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
    • 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
Networking Break
10:30
Drugs and Biologics: Labeling

Ryan P. Blaney
Partner
Cozen O’Connor P.C. (Washington, D.C.)

George A. O’Brien
Senior Associate
Hogan Lovells (Washington, D.C.)

  • Labeling overview: key regulatory requirements, information, and contents
  • Review process for labeling
  • Influence of final labeling on the scope of post-market activities
  • Amending labeling post-marketing
  • Using labeling as a defense in products litigation

11:30
Exploring the Expedited Approval Process

Mark Mansour
Partner
Foley Hoag LLP (Washington, D.C.)

Christopher Mikson
Partner
Mayer Brown LLP (Washington, D.C.)

Alexis Reisin Miller
Senior Director
Sanofi (Washington, D.C.)

  • Understanding accelerated approval, breakthrough therapy, surrogate end points, and biomarkers
  • Reviewing the different pathways for expedited approval
    • Evaluating the criteria for each pathway
    • Weighing the pros and cons of each pathway
  • Factoring expedited approval into your drug development strategy

12:30
Networking Luncheon
2:00
Unique Considerations in the Approval of Combination Products and Companion Diagnostics

Dr. Phoebe Mounts
Partner
Morgan, Lewis & Bockius LLP (Washington, D.C.)

  • Combination Products
    • Requirements for approval of combination products
    • Selecting the proper 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

3:00
Afternoon Refreshment Break
3:15
Part 1: Patents and Related IP Protections and Mechanisms

Donna M. Meuth
Associate General Counsel, Intellectual Property
Eisai Inc. (Andover, MA)

Andrew Wasson
Partner
Haug Partners LLP (New York, NY)

This session will walk through the patenting process with a sample patent. This step-by-step analysis will cover:

  • Understanding the process and identifying the respective roles of the FDA and the PTO in the patenting of drugs and biological products
  • Strategies for building patent protection drugs and biologics
  • The Orange Book – how to list, determining eligibility for listing
  • Applying for and Achieving extension of patent term
  • Patent Term Extension (“PTE”) – for time spent in the drug approval process
  • Patent Term Adjustment (“PTA”) – for time spent obtaining a patent at the United States Patent Office
  • Reviewing the 271(e)(1) “safe harbor” provision

4:15
Part 2: Hatch-Waxman and BPCIA Overview

Scott Lassman
Partner
Goodwin Procter LLP (Washington, D.C.)

Donald R. Ware
Partner
Foley Hoag LLP (Boston, MA)

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 the exclusivity period
  • “Shall we dance” — weighing the pros and cons of participating in the patent dance
  • Deciding when to provide notice of commercial marketing

5:15
Conference Adjourns to Day Two

Day 2 - Friday, September 28, 2018

7:15
Continental Breakfast
8:00
Co-Chairs’ Remarks and Recap of Day One
8:15
Ripped from the Headlines: Breaking News and Emerging Trends Impacting FDA Practice

Alexandra M. Gorman
Partner
Skadden, Arps, Slate, Meagher & Flom LLP (Boston, MA)

  • Reviewing Commissioner Gottlieb’s actions as his one year anniversary approaches
  • FDARA: One year later
  • Reviewing the legal battles stemming from state efforts to influence drug pricing
  • Examining the effects of mid-term elections on federal legislation and potential FDA regulations

9:15
Current Good Manufacturing Practices (“cGMPs”) for Drugs and Biologics

Benjamin M. Zegarelli
Associate
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. (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 litigation
  • Evaluating the costs and impact of enforcement actions

10:00
Morning Refreshment Break
10:15
Promotion, Off-Label Communications, and First Amendment Concerns

Alan G. Minsk
Partner
Arnall Golden Gregory LLP (Atlanta, GA)

  • Labeling, Advertising, and Promotion; Understanding FDA’s regulations and relevant guidances
  • Clarifying FDA’s current position on First Amendment and off-label promotion
  • What to expect concerning proposed legislation, rules changes and Citizen Petitions
  • Cases and Controversies: state AG actions and private tort claims

11:00
Enforcement

Andrew S. Ittleman
Partner
Fuerst Ittleman David & Joseph PLLC (Miami, FL)

Stephen C. Payne
Partner
Gibson, Dunn & Crutcher 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
  • FDA compliance, enforcement mechanisms, and best practices
    • Inspections
    • EIRs
    • Form FDA 483 observations
    • Untitled and Warning Letters
      • Related to inspections
      • Resulting from non-inspection data or information
      • Opioids — the new frontier?

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

Torrey Cope
Partner
Sidley Austin LLP (Washington, D.C.)

Michael Labson
Partner
Covington and Burling LLP (Washington, D.C.)

  • 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
  • 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

12:30
Luncheon for Skills Session Participants

Workshop A | FDA Pharmaceutical Law 101: Introduction to the Fundamentals

Sep 26, 2018 1:00pm – 4:00pm

Seth A. Mailhot
Partner
Michael Best & Friedrich LLP (Washington, D.C.)

What is it about?

(Registration begins at 12:30 PM)   This workshop, tailored for professionals who have limited or no experience working with FDA on regulatory matters, provides a basic overview of FDA device 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 process. Get the background you need to flow seamlessly into the more in-depth discussions that will take place throughout the main conference.   Topics include:
  • Introduction to FDA
  • History of FDA regulations
  • Types of New Drug Applications (INDs and NDAs)
  • Clinical Trials Process
  • The Hatch Waxman Act and the role of the Orange Book in the approval process for new drugs
  • Review of regulatory exclusivities
  • Biological Products
  • Post-market issues and enforcement
  • Recalls and Withdrawals
  • Recent Developments at FDA

Workshop B | Resolving Ethical Challenges Encountered during the Drug Approval Process

Sep 26, 2018 4:15pm – 5:15pm

Seth A. Mailhot
Partner
Michael Best & Friedrich LLP (Washington, D.C.)

What is it about?

(Registration begins at 4:00 PM)   This one-hour ethics session will cover common ethical issues that arise while communicating with FDA during the approval process. The session will address various scenarios that raise questions on the extent of disclosure of adverse information such as:  

Scenario 1:

  • 21 C.F.R. 10.30 requires a petitioner to certify that a citizen 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. This session will address the implications of this certification on an attorney in light of Rules 1.6, 1.7, and 1.8 of the Rules of Professional Responsibility.
 

Scenario 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. This segment will cover the implications of the lawyer’s participation in light of the requirements of Rules 1.3, 3.4, and 4.1.
 

Hypothetical:

  • Your client has retained a former FDA official and tells you that he will be contacting FDA to discuss a pending NDA. This segment will cover the implications of Rule 1.11.
 

Workshop C | Skills Session: Tips and Strategies for Communicating with FDA

Sep 28, 2018 2:00pm – 5:00pm

Mark Mansour
Partner
Foley Hoag LLP (Washington, D.C.)

Alexis Reisin Miller
Senior Director
Sanofi (Washington, D.C.)

What is it about?

Learn from our FDA experts as they lead you through the FDA engagement opportunities during the product development process. They will discuss strategic practices and tips for each step, from the initial decision of choosing the best pathway, creating and maintaining open communication with FDA along the way, and navigating the unexpected. This interactive workshop will provide practical guidance for building a positive working relationship with FDA and for being an effective advocate for your positions.