Day 1 - Tuesday, June 23, 2020

7:00
Registration and Continental Breakfast
8:00
Co-Chairs’ Opening Remarks
8:15
The Year in Review: Understanding how the Events of 2019 that will Impact FDA Regulations in 2020
9:15

THE PRE-APPROVAL AND APPROVAL PROCESS

Navigating the Approval Process for Drugs and Biologics
10:15
Morning Coffee Break
10:30
Exploring the Expedited Approval Process: Applicability and Eligibility
11:15
Clarifying the Clinical Trial Process for Drugs and Biologics
12:15
Networking Luncheon
1:15
Understanding How FDARA and the 21st Century Cures Act Are Impacting Drug Approvals through Real World Evidence
2:15
Afternoon Coffee Break
2:30
Appreciating the Nuances of the Approval Process for Controlled Substances
3:15

IP OVERVIEW FOR DRUGS AND BIOLOGICS: HATCH-WAXMAN; BPCIA; TRADEMARKS; AND MORE

Part 1 – Patents and Related IP Protections and Mechanisms
3:45

IP OVERVIEW FOR DRUGS AND BIOLOGICS: HATCH-WAXMAN; BPCIA; TRADEMARKS; AND MORE

Part 2 – Hatch-Waxman and BPCIA Fundamentals: Examining Follow-On Products and the Rules for 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 - Wednesday, June 24, 2020

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; PROMOTIONS; AND RELATED FIRST AMENDMENT CONCERNS

Part 1 – Drug and Biologics Advertising and Promotion 101
9:45
Morning Coffee Break
10:00

ADVERTISING; PROMOTIONS; AND RELATED FIRST AMENDMENT CONCERNS

Part 2 – Exploring the Subtleties and Safe Zones of Off-Label Communications
10:45
Examining the FDA’s Perspective on the Ever-Expanding Role of Digital Health
11:30
Preparing for the Worst: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls
12:15
Understanding FDA Enforcement Authority and Actions
1:00
Luncheon for Post-Conference Workshop Attendees

Day 1 - Tuesday, June 23, 2020

7:00
Registration and Continental Breakfast
8:00
Co-Chairs’ Opening Remarks
8:15
The Year in Review: Understanding how the Events of 2019 that will Impact FDA Regulations in 2020

By the close of 2019, four individuals will have held the title of FDA Commissioner. With the departure of Dr. Scott Gottlieb – who industry watchers have described as one of the most influential Commissioners since the agency’s inception – to former Acting Commissioner Dr. Ned Sharpless to Deputy Health and Human Services Secretary Brett Giroir, who is presently serving as Acting Commissioner, and finally to pending nominee Dr. Stephen Hahn, who we anticipate will be Commissioner by the time of this conference – there has never been a time of greater anticipation as to what the Agency’s new policies may be in the face of mounting healthcare controversies.

This opening session will explore the potential changes to FDA policies under the new Commissioner, recent guidance put into effect by the Agency, as well as the potential impact of these changes and guidance to the life sciences industries.

9:15

THE PRE-APPROVAL AND APPROVAL PROCESS

Navigating the Approval Process for Drugs and Biologics

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
    Morning Coffee Break
    10:30
    Exploring the Expedited Approval Process: Applicability and Eligibility

    • 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
    Clarifying the Clinical Trial Process for Drugs and Biologics

    • 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
    • New and novel ways in which clinical trials are being conducted

    12:15
    Networking Luncheon
    1:15
    Understanding How FDARA and the 21st Century Cures Act Are Impacting Drug Approvals through Real World Evidence

    With both the FDA Reauthorization Act (FDARA) and the 21st Century Cures Act having created new considerations towards 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 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 the patient perspective is used in the approval of FDA regulated products
    • Understanding the current Administration’s perspective on FDARA and the 21st Century Cures Act

    2:15
    Afternoon Coffee Break
    2:30
    Appreciating the Nuances of the Approval Process for Controlled Substances

    • 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 into their products
    • What clinical trials are necessary to demonstrate safety and efficacy to the proper agencies?
    • Exploring state regulations which exist when working with controlled substances
    • Implementing the manufacturing quotas which exist for these products

    3:15

    IP OVERVIEW FOR DRUGS AND BIOLOGICS: HATCH-WAXMAN; BPCIA; TRADEMARKS; AND MORE

    Part 1 – Patents and Related IP Protections and Mechanisms

    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
    Trade Names and 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

    IP OVERVIEW FOR DRUGS AND BIOLOGICS: HATCH-WAXMAN; BPCIA; TRADEMARKS; AND MORE

    Part 2 – Hatch-Waxman and BPCIA Fundamentals: Examining Follow-On Products and the Rules for Generic Entry

    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

    The labeling of an FDA regulated drug/biologic/ medical device is the final stage of the approval process. The label controls what you can do once a product reaches the market, and as such begins a products lifecycle within the 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-market
    • Using labeling as a defense in products liability litigation
    • Exploring the allowance of label carve outs
    • Discussing the requirements for skinny and narrow labeling

    5:30
    Conference Adjourns to Day Two

    Day 2 - Wednesday, June 24, 2020

    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

    • 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; PROMOTIONS; AND RELATED FIRST AMENDMENT CONCERNS

    Part 1 – Drug and Biologics Advertising and Promotion 101

    • 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 OPDP (Office of Prescription Drug Promotion)
      • 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?
    • Ensuring the language of influencers on social media meet FDA regulations
    • Exploring the role of the label in advertising

    9:45
    Morning Coffee Break
    10:00

    ADVERTISING; PROMOTIONS; AND RELATED FIRST AMENDMENT CONCERNS

    Part 2 – Exploring the Subtleties and Safe Zones of Off-Label Communications

    • 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, rule changes and Citizen Petitions
    • Cases and controversies: state AG actions and private tort claims

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

    • Examining the FDA’s Digital Health Innovation Action Plan
    • Assessing the Digital Health Pre-Cert Program
    • Discussing expected draft guidance on clinical
    • 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?
    • Methods for utilizing digital metric from products such as cell phones, etc.

    11:30
    Preparing for the Worst: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls

    • 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 and categorization in the approval process
    • Identifying risk minimization tools
    • Implementing a Medical Device Single Audit Program (MDSAP) process
    • 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
    • Ensuring pharmacovigilance when utilizing a social media platform

    12:15
    Understanding FDA Enforcement Authority and Actions

    • 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

    1:00
    Luncheon for Post-Conference Workshop Attendees