Pre-Conference Workshop

A | FDA REGULATORY FUNDAMENTALS 101 WITH ETHICS BONUS SESSION

Mar 22, 2017 1:00pm – 5:00pm

Speakers

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

Day 1 - Thursday, March 23, 2017

8:00
Registration and Continental Breakfast
9:00
Co-Chairs’ Opening Remarks
9:15
PREAPPROVAL AND APPROVAL: Navigating the Approval Process for Drugs and Biologics
10:15
Unique Considerations in the Approval of Combination Products, Companion Diagnostics, and Stem Cell Therapies
11:00
Morning Refreshment Break
11:15
Exploring the Expedited Approval Process
12:00
Networking Lunch
1:15
Understanding the Clinical Trial Process for Drugs and Biologics
2:15
Drugs and Biologics: Labeling
3:00
Afternoon Refreshment Break
3:15
Part 1: Patents, Trademarks, and Other IP Protections and Mechanisms
4:00
Part 2: Hatch-Waxman and BPCIA Overview
5:15
Conference Adjourns to Day Two

Day 2 - Friday, March 24, 2017

7:15
Continental Breakfast
7:45
Co-Chairs’ Opening Remarks and Recap of Day One
8:00
Ripped from the Headlines: Breaking News, Hot Cases, and Emerging Post-Election Trends that Are Likely to Impact the FDA Practice
9:00
POST-APPROVAL: The Pendulum Has Swung: Off-Label Use and a New World Order
10:15
Morning Refreshment Break
10:30
cGMPs: Drugs and Biologics (current Good Manufacturing Practices)
11:15
RECALLS AND WITHDRAWALS: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls
12:00
Conference Concludes*

Post-Conference Workshop

B | HATCH-WAXMAN AND BPCIA IN THE TRENCHES

Mar 24, 2017 1:00pm – 4:00pm

Speakers

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

Day 1 - Thursday, March 23, 2017

8:00
Registration and Continental Breakfast
9:00
Co-Chairs’ Opening Remarks

Geoffrey M. Levitt
Senior Vice President and Associate General Counsel Regulatory
Pfizer Inc.

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

9:15
PREAPPROVAL AND APPROVAL: Navigating the Approval Process for Drugs and Biologics

Scott Lassman
Partner
Goodwin Procter LLP

Christopher M. Mikson
Partner
Mayer Brown 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
    • 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
Unique Considerations in the Approval of Combination Products, Companion Diagnostics, and Stem Cell Therapies

Suchira Ghosh
Counsel
Axinn, Veltrop & Harkrider LLP

  • Stem Cell Therapies
    • Standards for determining whether approval is required
    • Latest developments in regulatory pathway(s)
  • Companion diagnostics
    • The regulation of laboratory developed tests (LTDs)
    • In vitro diagnostic devices (IVDs) and Next Generation Sequencing (NGS) IVDs
  • 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

11:00
Morning Refreshment Break
11:15
Exploring the Expedited Approval Process

Geoffrey M. Levitt
Senior Vice President and Associate General Counsel Regulatory
Pfizer Inc.

  • 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 your drug development strategy?

12:00
Networking Lunch
1:15
Understanding the Clinical Trial Process for Drugs and Biologics

Cori Annapolen Goldberg
Partner
Norton Rose Fulbright US LLP

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

Natalie F. Zaidman
Senior Corporate Counsel
Pfizer Inc

  • Regulatory requirements (e.g., informed consent, IRBs, sponsor obligations, investigator obligations, etc.)
  • ICH-GCP
  • Discussing the roles and obligations surrounding CROs and SMOs
  • Disclosure of clinical trial information
  • Understanding recent updated joint guidelines for clinical trials

2:15
Drugs and Biologics: Labeling

Alan G. Minsk
Partner, Head of Food and Drug Team
Arnall Golden Gregory LLP

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

  • Labeling overview: key regulatory requirements, information, and contents
  • 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?

3:00
Afternoon Refreshment Break
3:15
Part 1: Patents, Trademarks, and Other IP Protections and Mechanisms

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

Jill K. MacAlpine
Partner
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

PATENT AND IP OVERVIEW FOR DRUGS AND BIOLOGICS: UNDERSTANDING THE CONNECTION BETWEEN FDA REGULATION AND IP AND RELATED MECHANISMS UNDER HATCH-WAXMAN AND BPCIA

  • Summarizing the patenting process for drugs and biologics
  • Strategies for building patent protection drugs and biologics
  • 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
 

4:00
Part 2: Hatch-Waxman and BPCIA Overview

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

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

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
  • The “Patent Dance”: can a biosimilar applicant “opt out”? Should they?
  • Notice of commercial marketing
    • Is it mandatory?
    • Does it add an extra 180 days of reference product sponsor exclusivity?
    • Will the FDA embark upon a practice of granting tentative approval?
  • Exploring FDA’s draft guidance on Nonproprietary Naming of Biological Products
 

5:15
Conference Adjourns to Day Two

Day 2 - Friday, March 24, 2017

7:15
Continental Breakfast
7:45
Co-Chairs’ Opening Remarks and Recap of Day One
8:00
Ripped from the Headlines: Breaking News, Hot Cases, and Emerging Post-Election Trends that Are Likely to Impact the FDA Practice

Linda Pissott Reig
Shareholder
Buchanan Ingersoll & Rooney

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

Kim Tyrrell-Knott
Member
Epstein Becker and Green

Nahrin Marino
Deputy General Counsel-Regulatory
Astellas Pharma

  • What do the results of the 2016 presidential election mean for pharmaceutical industry?
    • What are the priorities of the new HHS commissioner?
    • Staffing developments at the FDA
    • Regulatory developments
    • Legislative developments
  • The First Amendment and Off Label Enforcement: Understanding the impact of recent cases on pharmaceutical and FDA–related industries
    • Recent cases overview
    • How are these cases affecting FDA’s ability to regulate what companies can say?
    • What is FDA currently doing? What is Congress doing?
    • What are the next steps to take based on the current status of the cases?
  • Update on most recent criminal prosecutions of individuals under DOJ’s Yates Memorandum
  • What does this mean for the FDA-regulated industry?
  • Status of the DOJ pilot program announced in April 2016 for voluntary disclosure/selfreporting under FCPA investigations and prosecutions covered by the DOJ Fraud Section
  • Explore DOJ/SEC investigations, prosecutions, and settlements under the anti-fraud provisions of the federal securities’ statutes and SEC rules as well as related liability under the FDCA and False Claims Act for false or misleading statements concerning marketing and clinical use of FDA-approved drugs and other products
  • Drug price controversies and state efforts to influence drug pricing through mandatory disclosure of cost information and other regulatory intervention
  • M&A and what does the consolidation in the pharma world mean for the industry?
  • 21st Century Cures Act

9:00
POST-APPROVAL: The Pendulum Has Swung: Off-Label Use and a New World Order

Michael A. Walsh
Partner
Strasburger & Price LLP

James Beck
Partner
Reed Smith LLP (Philadelphia, PA)

Joseph G. Poluka
Partner
Blank & Rome LLP

The panel will lead a discussion of the hottest issues facing the FDA-regulated industry today, with an emphasis on off-label civil and criminal enforcement activity and product liability cases.

  • Labeling, Advertising, and Promotion; what you need to know to understand the issues
  • Off-Label/New Use—the past, present, and future. Claims, Defenses, and Preemption: How did we get to where we are today and where do we go from here?
  • Investigations, Enforcement, Litigation, and Defenses
  • 10 things you need to know and issues you need to follow about off-label use and promotion under the Trump Administration (FDA, DOJ, and SCOTUS)

10:15
Morning Refreshment Break
10:30
cGMPs: Drugs and Biologics (current Good Manufacturing Practices)

Christina M. Markus
Partner and Deputy Chair of FDA & Life Sciences Group
King & Spalding

  • Examining cGMPs (current Good Manufacturing Practices) and the scope of their importance in pharmaceutical/ biological product commercialization
  • Looking at how cGMPs factor into the scope of the FDA’s authority and history
  • Exploring the scope of the FDA’s cGMP Initiative and how the concept of “risk-based” cGMPs is defined
  • Defining the concept of validation
  • How are laboratory investigations in relation to cGMPs conducted?
  • Defining the term “quality systems”
  • How are cGMPs factoring into products litigation?
  • Evaluating the cost of enforcement actions: what happens to company stock when there is an announcement of an enforcement action?

11:15
RECALLS AND WITHDRAWALS: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls

Maya P. Florence
Counsel
Skadden, Arps, Slate, Meagher & Flom LLP (Boston, MA)

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
  • 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

12:00
Conference Concludes*

* Lunch will be served for delegates attending the Post-Conference Workshop beginning promptly at 12:00

A | FDA REGULATORY FUNDAMENTALS 101 WITH ETHICS BONUS SESSION

Mar 22, 2017 1:00pm – 5:00pm

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

What is it about?

1:00 Fundamentals of FDA Regulatory Law 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
  • History of FDA Laws
  • Acronyms and Terminology
  • The Nature of the Approval Process
    • Understanding the difference between “new drugs” and other drugs
    • Overview of the research, development, and approval process for new drugs
  • Clinical Trials Process
    • Outlining the phases of clinical trials (I-IV)
  • Types of New Drug Applications
    • The investigational new drug application (IND)—timing, content, and purpose
    • The new drug application (NDA)—timing, content, purpose, and review process
  • Legal Barriers to Approval
  • The Hatch Waxman Act
    • 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); new indication; NDF (new dosage formulation); ODE (orphan drug exclusivity); PED (pediatric exclusivity); New antibiotic exclusivity
      • Overview of Hatch-Waxman and reforms under MMA
  • Biological Products
  • What are biological products? What does it mean to say that they are also “drugs”?
  • 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
  • Privacy considerations
  4:00 Resolving Ethical Challenges Encountered During the Drug Approval Process 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.
  5:00 Pre Conference Workshop Concludes

B | HATCH-WAXMAN AND BPCIA IN THE TRENCHES

Mar 24, 2017 1:00pm – 4:00pm

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

What is it about?

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 speakers 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.   4:00 Post-Conference Workshop B Concludes

ElitePass Workshop Bundle

What is it about?

Both Workshops   Wednesday, March 22, 2017 | 1:00 – 5:00 PM (Registration starts at 12:00 PM) Pre-Conference Workshop A: FDA Regulatory Fundamentals 101 with Ethics Session    Friday, March 24, 2017 | 1:00 p.m. – 4:00 p.m. Post-Conference Workshop B: Hatch-Waxman and BPCIA in the Trenches:  Deconstructing and Constructing an Exclusivity Dispute