Agenda
- Jump to:
- At a Glance
- Day 1
- Day 2
- Add-Ons
- Print-friendly Format
Pre-Conference Workshops
Workshop A — FDA 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Applicable Laws
Sep 19, 2023 9:00am – 12:00 PM
Speakers

Christopher Mikson
Partner
DLA Piper LLP
(Washington, DC)
Workshop B — Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations
Sep 19, 2023 1:30pm – 04:30 PM
Speakers

Evan Phelps
Partner
Amin Talati Wasserman LLP (Washington, DC)
Day 1 - Wednesday, September 20, 2023
8:15 |
Co-Chairs’ Opening Remarks |
8:30 |
Exploring New FDA Initiatives |
9:15 |
THE PRE-APPROVAL AND APPROVAL PROCESSNavigating the Approval Process for Drugs and Biologics |
10:15 |
Morning Break |
10:45 |
Exploring FDA’s Expedited Programs: Applicability and Eligibility |
12:00 |
Lunch Break |
12:45 |
Appreciating the Nuances of the Approval Process for Controlled Substances |
1:30 |
Clarifying the Clinical Trial Process for Drugs and Biologics |
3:00 |
IP Overview for Drugs and BiologicsPart 1 – Patents and Related IP Protections and Mechanisms |
3:45 |
IP Overview for Drugs and BiologicsPart 2 – Hatch-Waxman and BPCIA Fundamentals: Understanding 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 - Thursday, September 21, 2023
Post-Conference Workshop
Workshop C — Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group
Sep 21, 2023 2:30pm – 05:30 PM
Speakers

Jonathan B. Roses
Counsel
Wolf, Greenfield & Sacks, P.C. (Boston, MA)

Emily Whelan
Partner
WilmerHale
(Boston, MA)
Day 1 - Wednesday, September 20, 2023
8:15 |
Co-Chairs’ Opening Remarks![]() Torrey Cope ![]() Kurt R. Karst |
8:30 |
Exploring New FDA Initiatives![]() Torrey Cope ![]() Kurt R. Karst This panel will discuss recent changes made to the law by the FDA User Fee Reauthorization Act of 2022, and the Food and Drug Omnibus Reform Act of 2022, including with respect to clinical trials and accelerated approval. In addition, the panel will highlight recent litigation against FDA and pending legislation of significance. |
9:15 |
THE PRE-APPROVAL AND APPROVAL PROCESSNavigating the Approval Process for Drugs and Biologics![]() James William Woodlee Innovator Products: New Drug Applications and Biologic License Applications The Drug Review Process
Rx Drugs (Small Molecules)
Biological Products (Large Molecules)
NDAs and BLAs
OTC Products
|
10:15 |
Morning Break |
10:45 |
Exploring FDA’s Expedited Programs: Applicability and Eligibility![]() Benjamin Zegarelli Distinguishing among the different FDA programs for expedited review and approval of drug products
Expedited Approval Case Study: Chasing the COVID-19 Vaccine This case study will focus on the expedited approval process and other related health submissions to further access a COVID-10 vaccine for Americans. Experts will also identify any legislation that is being used to support the approval process. |
12:00 |
Lunch Break |
12:45 |
Appreciating the Nuances of the Approval Process for Controlled Substances![]() Delia Deschaine
|
1:30 |
Clarifying the Clinical Trial Process for Drugs and Biologics![]() Maureen Bennett
|
3:00 |
IP Overview for Drugs and BiologicsPart 1 – Patents and Related IP Protections and Mechanisms![]() Bryan C. Diner Patent Protection for Drugs and Biologics
Trademarks
|
3:45 |
IP Overview for Drugs and BiologicsPart 2 – Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry![]() Alexandra D. Valenti Drugs
Biologics
|
4:45 |
Drugs and Biologics Labeling: Appreciating the Importance of the Final Step of the Approval Process![]() Maya P. Florence 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.
|
5:30 |
Conference Adjourns to Day Two |
Day 2 - Thursday, September 21, 2023
8:40 |
Co-Chairs’ Remarks and Recap of Day One |
8:45 |
cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (“cGMPs”) in the Post approval Process![]() Seth A. Mailhot
|
9:45 |
Advertising, Promotions, and Related First Amendment Concerns: Part 1 – Drug and Biologics Advertising and Promotion 101![]() Marc J. Scheineson, Esq.
|
10:30 |
Morning Break |
11:00 |
Advertising, Promotions, and Related First Amendment Concerns: Part 2 Exploring the Subtleties and Safe Zones of Off-Label Communications![]() Joel Kurtzberg
|
11:45 |
Preparing for the Worse: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls![]() Beth Weinman
|
12:45 |
Understanding the Scope of FDA Enforcement Authority and Actions![]() John Fuson
|
1:30 |
Main Conference Ends |
Workshop A — FDA 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Applicable Laws

Christopher Mikson
Partner
DLA Piper LLP
(Washington, DC)
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:
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 — Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations

Evan Phelps
Partner
Amin Talati Wasserman LLP (Washington, DC)
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
- Discussing key regulatory requirements, information, and concepts
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
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
Workshop C — Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group

Jonathan B. Roses
Counsel
Wolf, Greenfield & Sacks, P.C. (Boston, MA)

Emily Whelan
Partner
WilmerHale
(Boston, MA)
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.