Workshop A – FDA 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Applicable Laws

Sep 17, 2019 9:00am - 12:30pm

Speakers

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

Day 1 - Wednesday, September 18, 2019

7:00
Registration and Continental Breakfast
8:00
Co-Chairs’ Opening Remarks
8:15
Predicting How Changes Under a New FDA Commissioner Will Impact the Life Sciences Community
9:15

The Pre-Approval and Approval Process

Navigating the Approval Process for Drugs and Biologics
10:15
Networking Break
10:30
Exploring the Expedited Approval Process: Applicability and Elgibility
11:15
Understanding How FDARA and the 21st Century Cures Act Are Impacting Drug Approvals through New Evidentiary Requirements
12:15
Networking Lunch
1:15
Clarifying the Clinical Trial Process for Drugs and Biologics
2:15
Networking Refreshment Break
2:30
Appreciating the Nuances of the Approval Process for Controlled Substances
3:00

IP Overview for Drugs and Biologics: Hatch-Waxman, BPCIA, Trademarks, and More

Part 1 – Patents and Related Protections and Mechanisms
3:45
Part 2 – Hatch-Waxman and BPCIA Fundamentals: Examining FollowOn Products and the Rules of Generic Entry
4:45
Drugs and Biologics Labeling: Appreciating the Importance of the Final Step of the Approval Process
5:30
Conference Adjourns to Day Two

Day 2 - Thursday, September 19, 2019

7:15
Continental Breakfast
8:00
Co-Chairs’ Remarks and Recap of Day One
8:15

Post Approval

cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (“cGMPs”) in the Post -Approval Process
9:00

Advertising

Part 1 – Drug and Biologics Advertising and Promotion 101
9:45
Morning Refreshment Break
10:00
Part 2 – Exploring the Subtleties and Safe Zones of Off-Label Communications
10:45
Reviewing the FDA’s Perspective on the Ever-Expanding Role of Digital Health
11:15
Preparing for the Worst: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls
12:00
Understanding FDA Enforcement Authority and Actions
12:45
Luncheon for Post-Conference Workshop Attendees

Workshop C – Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group

Sep 19, 2019 2:00pm - 5:30pm

Speakers

Scott Cunning
Partner
Haynes Boone LLP (Washington, D.C.)

Day 1 - Wednesday, September 18, 2019

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

Esther Bleicher
Head of Regulatory and Legal Affairs
Ohana Biosciences, Inc. (Cambridge, MA)

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

8:15
Predicting How Changes Under a New FDA Commissioner Will Impact the Life Sciences Community

Patrick Gallagher
Partner
Duane Morris LLP (Boca Raton, FL)

Deborah Shelton
Partner
Arent Fox LLP (Washington, D.C.)

With Dr. Gottlieb having resigned as FDA Commissioner, many questions now exist in regard to the agency, including the focus of the agency going forward, as well as potential policies and regulations that may be enacted under a new Commissioner. This opening session will offer a look at some of the potential changes to the agency, as well as how these changes will alter the regulatory policies of the pharmaceutical, biologics, and medical device industries.

9:15

The Pre-Approval and Approval Process

Navigating the Approval Process for Drugs and Biologics

Bethany Hills
Partner
Morrison & Foerster LLP (New York, NY)

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

Innovator Products: New Drug Applications and Biologic License Applications

The Drug Review Process

  • Reviewing the fundamentals of applications; from submission, through filing and beyond
  • Making sense of PDUFA Goals, fast track, break through status, and other process enhancements
  • Use of administrative appeals

 

Rx Drugs (Small Molecules)

  • Understanding the difference between “new drugs” and other drugs
  • Examining the research, development, and approval process for new drugs
  • Dissecting the investigational new drug application (IND) vs. the new drug application (NDA)
  • Determining the difference between traditional IND’s and Investigator IND’s

 

Biological Products (Large Molecules)

  • What are biological products in relation to traditional drugs?
  • Deciphering the biologics license application (BLA)
    • Stem cell therapies
  • How do the research, development, and approval processes for biological products differ from the process for drugs?
  • Exploring key similarities and differences between the drug and biological product schemes

 

NDAs and BLAs

  • Differentiating between 505(b)(1)s, 505(b)(2)s, and BLAs
  • Identifying applications for fixed-dose combination drugs
  • Distinguishing complex molecules regulated through NDAs from small molecules
  • Examining standards for approvals

 

OTC Products

  • Understanding the concept of “OTC” (OTC-ness)
  • Examining the OTC Review and monographs
    • Differences between approved and monographed OTC drug products

10:15
Networking Break
10:30
Exploring the Expedited Approval Process: Applicability and Elgibility

Marian Lee
Partner
Gibson, Dunn & Crutcher LLP (Washington, D.C.)

David L. Rosen
Partner
Foley & Lardner LLP (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
  • Discussing the limitations that exist for orphan and breakthrough drugs
  • Obtaining waivers for rare diseases

11:15
Understanding How FDARA and the 21st Century Cures Act Are Impacting Drug Approvals through New Evidentiary Requirements

Barry Boise
Partner
Pepper Hamilton LLP (Philadelphia, PA)

In recent years, both the FDA Reauthorization Act (FDARA) and the 21st Century Cures Act have created new considerations for the approval process related to the incorporation and evaluation of new types of evidence. This session will explore the requirements for these new evidentiary proofs.

  • Examining the key provisions found in FDARA and the 21st Century Cures Act
  • Defining the key terms used within the guidelines
  • What is Real World Evidence (RWE)?
  • What is the Patient Perspective?
  • Exploring the new types of evidence required for FDA approval
  • Ensuring the evidence presented is accurate
    • Are double blind studies necessary to support findings?
  • Discussing the uses of RWE within these guidelines
    • What are the proper methods for utilizing and presenting comparative analysis?
  • Evaluating how is the patient perspective used in the approval of FDA regulated products?
  • Understanding the current administration’s perspective to FDARA and the 21st Century Cures Act
  • Must a combination product go through the full designation process if it has already been established as a device?

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

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

  • Overview of clinical trials and how they are used (including different phases)
  • Identifying the different parties involved (sponsors, investigators, CROs, etc.)
  • Understanding human research protections (ICF, IRB)
  • Enforcement
  • Review of the “Right to Try” laws and their requirements during the clinical trials process

2:15
Networking Refreshment Break
2:30
Appreciating the Nuances of the Approval Process for Controlled Substances

Seth Mailhot
Partner
Husch Blackwell LLP (Washington, D.C.)

  • Defining the term “controlled substance”?
  • Reviewing the scheduling process for both approval as well as post-marketing approval with both the DEA and FDA
  • Discussing the proper steps for companies who incorporate CBD’s into their products
  • What clinical trial lab work is necessary to demonstrate to the proper agencies?
  • Exploring state regulations which exist when working with controlled substances
  • Implementing the manufacturing quotas which exist for these products

3:00

IP Overview for Drugs and Biologics: Hatch-Waxman, BPCIA, Trademarks, and More

Part 1 – Patents and Related Protections and Mechanisms

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

Patent Protection for Drugs and Biologics

  • Summarizing the patenting process for drugs and biologics
  • Strategies for building patent protection for drugs and biologics
  • Applying for and achieving extension of patent term for time spent in the drug approval process
    • Patent Term Extension (“PTE”)
    • Patent Term Adjustment (“PTA”)
  • Reviewing the 271(e)(1) “safe harbor” provision
  • Distinguishing the patenting process for drugs from that of biologics
  • Identifying the respective roles of the FDA and the PTO in the protection of drugs and biological products

 

Trademarks

  • Overview of selecting a brand name for a proposed drug product
  • Roles of the USPTO and FDA in the drug naming process
  • Identifying the PTO and FDA clearances necessary for trade name/trademark approval on your product
  • How does the branding process work for your product?

3:45
Part 2 – Hatch-Waxman and BPCIA Fundamentals: Examining FollowOn Products and the Rules of Generic Entry

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

Melanie Rupert
Partner
Paul Hastings LLP (New York, NY)

Drugs

  • Overview of Hatch-Waxman and reforms
    • 30-month stay; patent extensions; ANDA filer exclusivity (180 day)
  • Comparing the NDA, 505(b)(2), and ANDA (Abbreviated New Drug Application) drug approval routes
    • Reviewing fundamentals of applications
  • Exploring the ANDA Paragraph IV Certification, and response to Notice Letters
  • Examining ANDA Standards for approval and the concepts of sameness and bioequivalence
  • Special considerations: local acting drugs, labeling carve outs and other nuances
    • Understanding the role of the Orange Book in the drug approval process
    • Listings, de-listings and use codes
  • Market exclusivities and protection
  • Identifying the different types of exclusivities
    • Regulatory exclusivity (FDA)/(data) exclusivity
      • NCE (new chemical entity)
    • 5 years data exclusivity
      • Indication (new indication or use)
    • 3 years marketing exclusivity
      • NDF (new dosage formulation)
      • ODE (orphan drug exclusivity)
      • PED (pediatric exclusivity)

 

Biologics

  • Overview of biosimilar legislation and regulations, i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA)
  • Understanding the rationale for safety and efficacy concerns surrounding second generation biologics
  • Exploring the concepts of “biosimilarity” or “interchangeability”
  • FDA rule-making and guidance relative to biosimilars
  • Other points for consideration: substitution, naming, patents, and additional nuances
  • Examining biosimilar exclusivities
  • “Shall we dance” — weighing the pros and cons of participating in the patent dance
  • Deciding when to provide notice of commercial marketing

4:45
Drugs and Biologics Labeling: Appreciating the Importance of the Final Step of the Approval Process

Michael Hinckle
Partner
K&L Gates LLP (Research Triangle Park, NC)

George O’Brien
Attorney
Hogan Lovells LLP (Washington, D.C.)

The labeling of the drug/biologic is the final stage of the approval process. 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.

  • Labeling overview: key regulatory requirements, information, and contents
  • Exploring the review process for labeling
  • Incorporating clinical trial data on the label
  • Appreciating the influence of final labeling on the scope of post-market activities
  • Amending labeling post-marketing
  • Using labeling as a defense in products liability litigation
  • Exploring label carve outs
  • Discussing the requirements for skinny and narrow labeling

5:30
Conference Adjourns to Day Two

Day 2 - Thursday, September 19, 2019

7:15
Continental Breakfast
8:00
Co-Chairs’ Remarks and Recap of Day One
8:15

Post Approval

cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (“cGMPs”) in the Post -Approval Process

Todd Halpern
Partner
Venable LLP (Washington, D.C.)

Arif Noorani
Partner
Sidley Austin LLP (Washington, D.C.)

  • 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 liability litigation
  • Evaluating the costs and impact of enforcement actions

9:00

Advertising

Part 1 – Drug and Biologics Advertising and Promotion 101

Daniel Dwyer
Partner
Kleinfeld Kaplan & Becker LLP (Washington, D.C.)

Scott S. Liebman
Partner
Loeb & Loeb LLP (New York, NY)

  • Overview of laws and regulations controlling the advertising, marketing, and promotion of prescription drugs and biologics
    • 21 CFR Sections 202.1, 352(n), 314.81(b) (3); Section 352(n) of FD&CA
    • Guidance documents
  • Exploring the role of DDMAC (Division of Drug Marketing, Advertising and Communications)
    • What duties and responsibilities is DDMAC charged with?
    • What are its enforcement capabilities and jurisdiction?
  • Identifying the role of the FTC in the advertising and promotion of drugs
    • SEC?
  • Advertising requirements for prescription v. nonprescription products
  • Reviewing the steps which DDMAC takes for the review of launch campaigns and promotional materials
    • Overview of the promotional materials submission and review process
  • What constitutes a launch?
  • What defines an advertisement?
    • What information must a drug advertisement include?
  • Exploring the role of the label in advertising

9:45
Morning Refreshment Break
10:00
Part 2 – Exploring the Subtleties and Safe Zones of Off-Label Communications

Lee Rosebush
Partner
Baker, Donelson, Bearman, Caldwell & Berkowitz, P.C. (Washington, D.C.)

Marc J. Scheineson
Partner
Alson & Bird LLP (Washington, D.C.)

  • Clarifying FDA’s current position on First Amendment and off-label promotion
    • The 21st Century Cures Act
    • FDAMA 114
  • What to expect concerning proposed legislation, rules changes and Citizen Petitions
  • Cases and controversies: state AG actions and private tort claims

10:45
Reviewing the FDA’s Perspective on the Ever-Expanding Role of Digital Health

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

  • Examining the FDA’s Digital Health Innovation Action Plan
  • Assessing the Digital Health Pre-Cert Program
  • Discussing expected draft guidance on clinical decision support software
  • Distinguishing software that falls under FDA guidance from that which does not
  • When must a 510k be submitted for a software change to an existing device?
  • Reviewing FDA cyber security policies and proper methods to exchange information on digital health

11:15
Preparing for the Worst: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls

Michael Stern
Of Counsel
Covington & 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
  • Exploring protocols for Risk Evaluation and Minimization Strategies (REMS)
  • Understanding the role of risk evaluation in the approval process
  • Identifying risk minimization tools
  • Enforcing 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
Understanding FDA Enforcement Authority and Actions

Maya Florence
Partner
Skadden, Arps, Slate, Meagher & Flom LLP (Boston, MA)

Frederick A. Stearns
Partner
Keller and Heckman LLP (Washington, D.C.)

  • 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
  • Exploring FDA compliance and enforcement mechanisms
    • Inspections
      • For cause inspections vs. routine inspections
      • Communication with the FDA during inspections
    • EIRs
    • Form FDA 483 observations
    • Untitled and Warning Letters
      • Related to inspections
      • Resulting from non-inspection data or information
  • Examining enforcement actions related to digital advertising and social media
  • Managing and minimizing the risks of warning letters

12:45
Luncheon for Post-Conference Workshop Attendees

Workshop A – FDA 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Applicable Laws

Sep 17, 2019 9:00am - 12:30pm

$600

Speakers

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

What is it about?

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. Topics of discussion will include:

  • Examining the FDA’s structure, authority, and organization
  • The 3 major FDA centers and their roles
    • CDER (Drug); – CBER (Biologics); – CDRH (Device)
  • Reviewing major FDA regulations and applicable laws
  • Defining drugs, biologics, and devices
  • Understanding the role of labeling with respect to these definitions
  • Differentiating types of drug applications (INDs, NDAs, and ANDAs)
  • Exploring the clinical trials process
  • Investigating biological products and biosimilars
  • Evaluating post-market dilemmas and enforcement
  • Understanding recalls and withdrawals
  • Examining recent developments at FDA
  • FDA’s policies and procedures
  • Administrative Procedures Act
  • Working with the FDA through formal and informal dispute resolution mechanisms
  • 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

Workshop B – Introduction to Medical Devices, Combination Products, Companion Diagnostics, and Medical Apps: A Review of FDA Guidelines and Regulations

Sep 17, 2019 1:30pm - 5:00pm

$600

Speakers

Stephanie Philbin
Counsel
Goodwin Procter LLP (Washington, D.C.)

What is it about?

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:

 

Medical Devices

  • Reviewing the history of FDA device regulations
  • Examining the basics of device classification and the FDA’s review process
  • Analyzing the clinical trials process for medical devices
  • Assessing strategies to obtain clinical data
  • Determining premarket approvals
  • Exploring the 510(k) clearance process and the lab work necessary to display
  • Discussing key regulatory requirements, information, and concepts
  • Reviewing the FDA approval process for self-diagnosing devices
  • Exploring the FDA’s role in Clinical Laboratory Improvement Amendments (CLIA)
  • How does this impact the home use of a product?
  • What waivers are available?

 

Combination Products

  • Defining the requirements for combination product classification and approval
  • Selecting the proper regulatory pathway
  • 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
  • Examining existing cGMP’s for combination products
  • Discussing the role of artificial intelligence and machine learning in combination products

 

Companion Diagnostics

  • Reviewing the software validation required for companion diagnostics
  • Exploring the regulations of laboratory developed tests (LDTs)
  • Examining the approval process for in vitro diagnostic devices (IVDs) and Next Generation Sequencing (NGS) IVDs
  • Utilizing companion diagnostics via smart technologies
  • When does a smartphone app require medical device clearance when doesn’t it?
  • Implementing methods to display data integrity

Workshop C – Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group

Sep 19, 2019 2:00pm - 5:30pm

$600

Speakers

Scott Cunning
Partner
Haynes Boone LLP (Washington, D.C.)

What is it about?

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:

  • Deconstruct complex exclusivity disputes,
  • Analyze FDA’s and the disputing parties’ various (and sometimes evolving) positions on exclusivity
  • Explore bioequivalency conundrums

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.