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8:00 a.m. – 9:00 a.m.

Registration/Continental Breakfast

9:00 a.m. – 9:15 a.m.

Co-Chair Welcome and Introduction

9:15 a.m. – 10:00 a.m.

FDA's Outlook for Labeling
This keynote presentation from the Office of New Drugs will describe current
approaches to the labeling approval and review process. Attendees will also understand the outlook for how the FDA is working to manage the label approval process while balancing safety and efficacy.

Capt. Laurie Beth Burke, Leader, Study Endpoints and Label Development Team, Office of New Drugs, CDER, FDA

10:00 a.m. – 10:45 a.m.

The Aftermath of Wyeth v. Levine — Preemption Considerations in Regulatory Negotiations and Submissions
Wyeth v. Levine certainly changed the landscape for preemption in drug product liability cases, but what are the implications from a regulatory perspective? How has Levine changed company decision-making and the dynamics of negotiations with the FDA over labeling changes? What impact has the decision had on labeling changes under the FDA’s “Changes Being Effected” regulation? How does it impact submissions and discussions regarding REMS, and how does it relate to other new authorities under FDAAA?   

Attendees will learn:

  • How preemption considerations affect labeling
  • Why REMS and other FDAAA requirements impact submissions and regulatory negotiations

Daniel Kracov, Partner, Arnold & Porter LLP

10:45 a.m. – 11:00 a.m.

Morning Break

11:00 a.m. – 11:45 a.m.

How SPL Is Shaping the Future of Labeling
Many are interested to learn how the current SPL implementation approach is actually
defining what the content of labels will say and look like — especially in a world of electronic prescribing and pharmacy communications. A quick peek at the intricacies of SPL and what the future holds.

Attendees will learn:

  • Update on SPL implementation and its implications for labeling
  • Review of FDA guidance on SPL to reflect advances in electronic labeling
  • How has industry responded to the Drug Establishment Registrations and Product Listings electronic requirements

Lonnie Smith, Project Manager, FDA Data Standards Council, CDER, FDA

11:45 a.m. – 12:30 p.m.

Implementation of Company Core Data Sheets and Implications for Local Labels
The company core data sheet (CCDS) represents the company’s position on safety information, indications, dosing, pharmacology and other information concerning the product. Local product labels created by affiliates are based on it, and it is a required part of periodic safety reports.

Attendees will learn:

  • How CCDSs impact global and local labeling and the most practical ways to use them
  • Understanding the CCDS concept for worldwide labeling and its impact on harmonization
  • Development and implementation of CCDS: CIOMS III/V                 
  • Format and content of a core data sheet, Company Core Safety Information

Alan Hassell, Independent Consultant, former Drug Regulatory Affairs Specialist, Hoffmann-LaRoche

12:30 p.m. – 1:30 p.m.

Lunch Break

1:30 p.m. – 2:15 p.m.

The Impact of Labeling on Advertising and Promotion
Each word chosen to be a part of a drug's label can both positively and negatively impact its marketing potential. Open communications between labeling professionals and marketing departments have proven to be an important part of the labeling process. This session will discuss the ways to create open communication between labeling professionals and their marketing colleagues and how important labeling decisions impact successful promotion.

Attendees will learn:

  • Defining the roles of labeling and marketing during initial labeling submission and subsequent labeling negotiations
  • Understanding the impact of how a single word could affect commercial potential

Maria Adriano, Scientist, Regulatory Affairs, Genentech

2:15 p.m. – 3:00 p.m.

FDAAA Authority to Mandate Labeling Changes
FDAAA established new authority permitting FDA to mandate labeling changes. Section 505(o)(4) of the Food, Drug and Cosmetic Act now sets forth a detailed procedure for the FDA to require inclusion of safety information in drug labeling. If the company disagrees with the FDA's proposed revisions, the statute provides procedures governing discussions with the sponsor and the ability of the FDA to order labeling changes.

Attendees will learn:

  • What you should know about section 505(o)(4) of the Act and how it affects labeling interactions between a sponsor and the FDA
  • The history of the FDA's use of 505(o)(4)
  • Questions regarding the FDA's exercise of authority

Scott Danzis, Partner, Covington & Burling LLP, former Special Assistant to the Chief Counsel, FDA

3:00 p.m. – 3:15 p.m.

Afternoon Break

3:15 p.m. – 4:00 p.m.

Determining Threshold and Causality When Considering Label Updates — How Safety Signals, REMS and Pharmacovigilance Are Influencing Labeling Decisions
The issue of safety labeling is the concept of threshold and causality, i.e., how close of an association is needed between the drug and event to warrant a label update. How to walk that fine line is a gray area that often develops into a struggle between FDA and sponsor. This presentation will give you best practices for identifying threshold and causality.

Attendees will learn:

  • What safety data the FDA expects you to be reviewing and how resulting signals might affect revisions in labeling
  • Best practices for integrating medically driven decisions with regulatory labeling changes
  • Examining the gray area between FDA concerns and sponsor interests

Mary Mease, Senior Director, Lifecycle Safety, Quintiles

4:00 p.m. – 5:15 p.m.

Panel Discussion: Tips on Working With the FDA on Adding Claims, Outcomes and Benefits Language
With a greater emphasis on product efficacy, working with the FDA to include various types of claims/outcomes statements can be the difference between a commercial success and a laggard. Understanding the regulatory standards the FDA review divisions use for including an indication or other benefit information in package inserts and how much and what type of data are needed to support certain kinds of benefit information is vital.

  • Moderator: Dr. Alicia Tatro, Associate Director, Regulatory Affairs, Labeling, Stiefel Laboratories
  • Panelist 1: Scott Danzis, Partner, Covington & Burling LLP, former Special Assistant to the Chief Counsel, FDA
  • Panelist 2: Maria Adriano, Scientist, Regulatory Affairs, Genetech

5:15 p.m.



8:00 a.m. – 8:30 a.m.

Continental Breakfast

8:30 a.m. – 8:45 a.m.

Co-Chair Welcome and Introduction

8:45 a.m. – 9:30 a.m.

Is the FDA-Approved Labeling the Only Acceptable Form of Speech About Approved Drug Products?
Rigid restrictions on the exchange of off-label information may provide an expedient way to enforce the law, but establishing the FDA-approved labeling as a "script" for speech about drug products ignores the fact that labeling does not include the most current or accurate information about the effectiveness of medical products.

Attendees will learn:

  • Whether the usual justifications for the restrictive environment for manufacturer participation in scientific discussions of new uses of approved products hold up under scrutiny
  • Whether the government's continuing crusade against the exchange of information about new uses of approved drugs is yielding a net benefit to industry and patient safety

Coleen Klasmeier, Partner, Sidley Austin, former Special Assistant to the Chief Counsel, FDA

9:30 a.m. – 10:15 a.m.

Pharmacogenomics and Labeling — Threat or Opportunity?
This presentation will discuss the impact of labeling on employer and health plan payers as they consider drugs and genetic testing. Dr. Epstein will share direct experiences interfacing with thousands of payers on this topic and will share real-life experiences, both good and bad.

Attendees will learn:

  • How payers are increasingly interested in pharmacogenomics and what sponsors should be on the lookout for
  • Strategies for improving precision in the label and how it impacts sponsors, payers and patients
  • How labeled information can influence both testing and coverage decisions

Dr. Robert Epstein, Chief Medical Officer and President, Medco Research Institute

10:15 a.m. – 11:00 a.m.

Put Away the PowerPoint Panel Discussion and Closing Comments
The final panel discussion of the summit — your moment to review highlights, get answers to nagging questions and pick the brains of expert panelists and your fellow attendees. Highlight: Discussion of the single most interesting idea or strategy you and other attendees plan to bring back to your companies.

  • Moderator: Alan Hassell, Independent Consultant, former Drug Regulatory Affairs Specialist, Hoffmann-LaRoche
  • Panelist 1: Dr. Robert Epstein, Chief Medical Officer and President, Medco Research Institute
  • Panelist 2: Gerrit-Jan Nijveldt, Senior Director Regulatory Labeling, Sanofi-Aventis
  • Panelist 3: Coleen Klasmeier, Partner, Sidley Austin, former Special Assistant to the Chief Counsel, FDA
  • Panelist 4: Jeffrey Fetterman, President, ParagonRx, An inVentiv Health Company

11:00 a.m.