FDA Boot Camp

Basic Training for Products Liability and Patent Lawyers

Monday, September 22, 2008

About

The approval process…pre-approval concerns…product labeling…clinical trials…adverse events reports…patent concerns…exclusivity. FDA law and regulations govern these critical aspects in the commercialization process for drugs, biologics, and devices. Plus, the FDA Amendments Act of 2007 (FDAAA) is one of the most comprehensive revisions of FDA law in decades. And recent court cases and high-profile trials concerning FDA regulated products send a clear signal that attorneys who do not have regulatory practices – but who do deal with FDA-regulated products – must understand these concepts. The same demands fall on securities experts and business executives in the life sciences arena.

However, many products liability lawyers, patent counsel, and business and investment experts — despite their tenure in working with FDA-regulated products — are not well-versed in the essentials of the approval process and the regulatory hurdles of the post-approval period.

ACI’s FDA Boot Camp has been designed to give products or patent litigators, as well as patent prosecutors and life sciences investment and securities experts, a strong working knowledge of core FDA regulatory competencies, including the nuances of FDAAA.

In the is publication a distinguished faculty of top FDA regulatory experts — a “Who’s Who of the FDA Bar” — share their knowledge and give you critical insights on:

  • The organization, jurisdiction, functions, and operations of the FDA
  • The essentials of the approval process for drugs, biologics, and devices, including:
    • NDAs
    • INDs
    • BLAs
    • OTC approval
    • 510 K submissions
    • PMA process
  • Clinical trials for drugs and biologics and the clearance process for devices
  • The classification of devices and the concept of “risk-based” classification
  • The role of the Hatch-Waxman Act in the patenting of drugs and biologics
  • Labeling in the drug and biological products approval process
  • cGMPs and other manufacturing concerns relative to products liability
  • Proactive adverse events monitoring
  • Recalls, product withdrawals, and FDA oversight authority

Contents & Contributors

About

The approval process…pre-approval concerns…product labeling…clinical trials…adverse events reports…patent concerns…exclusivity. FDA law and regulations govern these critical aspects in the commercialization process for drugs, biologics, and devices. Plus, the FDA Amendments Act of 2007 (FDAAA) is one of the most comprehensive revisions of FDA law in decades. And recent court cases and high-profile trials concerning FDA regulated products send a clear signal that attorneys who do not have regulatory practices – but who do deal with FDA-regulated products – must understand these concepts. The same demands fall on securities experts and business executives in the life sciences arena.

However, many products liability lawyers, patent counsel, and business and investment experts — despite their tenure in working with FDA-regulated products — are not well-versed in the essentials of the approval process and the regulatory hurdles of the post-approval period.

ACI’s FDA Boot Camp has been designed to give products or patent litigators, as well as patent prosecutors and life sciences investment and securities experts, a strong working knowledge of core FDA regulatory competencies, including the nuances of FDAAA.

In the is publication a distinguished faculty of top FDA regulatory experts — a “Who’s Who of the FDA Bar” — share their knowledge and give you critical insights on:

  • The organization, jurisdiction, functions, and operations of the FDA
  • The essentials of the approval process for drugs, biologics, and devices, including:
    • NDAs
    • INDs
    • BLAs
    • OTC approval
    • 510 K submissions
    • PMA process
  • Clinical trials for drugs and biologics and the clearance process for devices
  • The classification of devices and the concept of “risk-based” classification
  • The role of the Hatch-Waxman Act in the patenting of drugs and biologics
  • Labeling in the drug and biological products approval process
  • cGMPs and other manufacturing concerns relative to products liability
  • Proactive adverse events monitoring
  • Recalls, product withdrawals, and FDA oversight authority

Contents & Contributors

THE FOOD AND DRUG ADMINISTRATION: AUTHORITY, ORGANIZATION AND OPERATION A PRACTICAL GUIDE
Robert B. Nicholas, McDermott Will & Emery LLP (Washington, DC)

THE NATURE OF THE APPROVAL PROCESS
Erika Lietzan, Covington & Burling LLP (Washington, DC)

UNDERSTANDING THE CLINICAL TRIAL PROCESS FOR DRUGS AND BIOLOGICS
Scott M. Lassman, WilmerHale (Washington, DC)

BASIC TRAINING FOR PRODUCTS LIABILITY AND PATENT LAWYERS
Carmen Shepard, Buc & Beardsley (Washington, DC)
William D. Hare, Concentrx Biosciences, Inc. (Princeton, NJ)

TRADEMARK CLEARANCE AND FDA ISSUES
Patrick J. Concannon, Edwards Angell Palmer & Dodge LLP (Boston, MA)

DRUGS AND BIOLOGICAL PRODUCTS: LABELING
Sheldon T. Bradshaw, Hunton & Williams LLP (Washington, DC)

BASIC TRAINING FOR PRODUCTS LIABILITY AND PATENT LAWYERS
Robert A. Dormer, Hyman, Phelps & McNamara, P.C. (Washington, DC)

NON-PATENT EXCLUSIVITY
Aaron F. Barkoff, Ph.D., McDonnell Boehnen Hulbert & Berghoff LLP (Chicago, IL)

BIOEQUIVALENCE: WHAT PATENT LAWYERS NEED TO KNOW
Chad A. Landmon, Axinn, Veltrop & Harkrider LLP (Hartford, CT)

FOLLOW-ON BIOLOGICS: THE EVOLUTION OF AN APPROVAL PATHWAY
Donald R. Ware, Foley Hoag LLP (Boston, MA)

ADVERTISING AND PROMOTION
Joseph J. Leghorn, Nixon Peabody LLP (Boston, MA)
James W. Weller, Esq., Nixon Peabody LLP (Boston, MA)

DIRECT-TO-CONSUMER ADVERTISING
Daniel R. Dwyer, Kleinfeld, Kaplan & Becker, LLP (Washington, DC)

(SOME) LEGAL AND REGULATORY ISSUES TO CONSIDER WITH DISSEMINATION OF OFF-LABEL INFORMATION
Alan G. Minsk, Arnall Golden Gregory LLP (Atlanta, GA)

ADVERSE EVENTS MONITORING (AND OTHER PHARMACOVIGILANCE)
William W. Vodra, Arnold & Porter LLP (Washington, DC)

MEDICAL DEVICES: CLASSIFICATION AND THE ESSENTIALS OF THE DEVICE PREMARKET REVIEW PROCESS
Grail Walsh Sipes, Covington & Burling LLP (Washington, DC)

POST-MARKET OBLIGATIONS MEDICAL DEVICES
Ralph F. Hall, Baker & Daniels LLP (Indianapolis, IN)

INTRODUCTION TO FDA REGULATION OF MEDICAL DEVICE LABELING AND ADVERTISING
Laurie A. Clarke, King & Spalding LLP (Washington, DC)

RECALL GUIDANCE FOR DRUGS, BIOLOGICS, AND MEDICAL DEVICES: WHAT YOU NEED TO KNOW
Neil F. O’Flaherty, Olsson Frank Weeda Terman Bode Matz PC (Washington, DC)



DOCUMENT TYPES: PPT PRESENTATIONS AVAILABLE: 18

7:45
Registration and Continental Breakfast
8:45
Co-Chairs' Opening Remarks
Mr. Scott M. Lassman
Partner
Kleinfeld‚ Kaplan and Becker‚ LLP
Ms. Grail Walsh Sipes
Partner
Covington & Burling LLP
9:00
The Basics: Understanding and Working with the FDA - Jurisdiction‚ Functions‚ Organization‚ and Operations
Mr. Rob B Nicholas
Partner
McDermott Will & Emery LLP
1 file
NicholasR
843 KB 64 pages Presentation
PPT - NicholasR
10:00
Morning Coffee Break
10:15
The Nature of the Approval Process
Ms. Erika Lietzan
Partner
Covington & Burling LLP
1 file
LietzanE
375.5 KB 37 pages Presentation
PPT - LietzanE
11:15
Understanding the Clinical Trial Process for Drugs and Biologics
Mr. Scott M. Lassman
Partner
Kleinfeld‚ Kaplan and Becker‚ LLP
1 file
LassmanS
683 KB 43 pages Presentation
PPT - LassmanS
12:15
Networking Luncheon
13:25
Patent and IP Overview: Hatch-Waxman‚ Trade Dress‚ and More
Carmen Shepard, Esq.
Partner
Buc & Beardsley
Mr. William Hare
Legal Director
Concentrx BioSciences‚ Inc.
1 file
ShepardC.HareW
2.1 MB 42 pages Presentation
PPT - ShepardC.HareW
Mr. Patrick J. Concannon
Counsel
Edwards Angell Palmer & Dodge LLP
1 file
ConcannonP
1.3 MB 15 pages Presentation
PPT - ConcannonP
14:45
Afternoon Refreshment Break
15:00
Drugs and Biological Products: Labeling
Mr. Sheldon T. Bradshaw
Partner
Hunton & Williams LLP
1 file
BradshawS
27.2 MB 66 pages Presentation
PPT - BradshawS
16:00
cGMPs: Drugs and Biologics (current Good Manufacturing Practices)
- Mr. Robert A. Dormer
Director
Hyman‚ Phelps & McNamara‚ P.C.
1 file
DormerR
509.5 KB 41 pages Presentation
PPT - DormerR
17:00
Conference Adjourns
7:30
Continental Breakfast
8:00
Co-Chairs' Opening Remarks
8:10
Non-Patent Exclusivity
- Aaron F. Barkoff
Partner
McDonnell Boehnen Hulbert & Berghoff LLP
1 file
BarkoffArevised
192 KB 23 pages Presentation
PPT - BarkoffArevised
8:10
Advertising and Promotion
Joseph J. Leghorn
Partner
Nixon Peabody LLP
1 file
LeghornJ
1.6 MB 51 pages Presentation
PPT - LeghornJ
9:10
Bioequivalence: What Patent Lawyers Need to Know
Mr. Chad A. Landmon, Esq.
Partner
Axinn Veltrop Harkrider LLP
1 file
LandmonC
1.4 MB 33 pages Presentation
PPT - LandmonC
9:10
Special Concerns for DTC Advertising
Mr. Daniel R. Dwyer
Partner
Kleinfeld‚ Kaplan & Becker LLP
1 file
DwyerD
356.5 KB 35 pages Presentation
PPT - DwyerD
9:55
Morning Coffee Break
10:10
Follow-On (Comparable or Biosimilar) Biologics
Donald R. Ware, Esq.
Partner
Foley Hoag LLP
1 file
WareDrevised
2.6 MB 37 pages Presentation
PPT - WareDrevised
10:10
Regulation and Dissemination of Off-Label Information
Mr. - Alan G Minsk
Partner
Arnall Golden Gregory LLP
1 file
MinskA
442.5 KB 36 pages Presentation
PPT - MinskA
10:55
Adverse Events Monitoring‚ Pharmacovigilance and Risk Management
Mr. William . W. Vodra
Senior Counsel
Arnold & Porter LLP
1 file
VodraW
752 KB 48 pages Presentation
PPT - VodraW
11:55
Networking Luncheon
13:05
Medical Devices: Classification and the Essentials of the Device Premarket Review Process
Ms. Grail Walsh Sipes
Partner
Covington & Burling LLP
1 file
SipesG
292 KB 26 pages Presentation
PPT - SipesG
14:05
Post-Market Requirements and Concerns for Medical Devices
Mr. Ralph F. Hall
Counsel
Baker & Daniels LLP
1 file
HallR
1003 KB 64 pages Presentation
PPT - HallR
15:05
Afternoon Refreshment Break
15:20
Medical Device Labeling and Advertising
Laurie A. Clarke, Esq.
Partner
King & Spalding
1 file
ClarkeL
504.5 KB 51 pages Presentation
PPT - ClarkeL
16:05
Recall Guidance for Drugs‚ Biologics‚ and Medical Devices: What You Need to Know
Mr. Neil F. O'Flaherty
Partner
Olsson Frank Weeda Terman Bode Matz PC
1 file
OFlahertyN
207 KB 51 pages Presentation
PPT - OFlahertyN
17:05
Conference Ends