Inside the Minds provides readers with proven business intelligence from C-Level executives (Chairman, CEO, CFO, CMO, Partner) from the world's most respected companies nation-wide, rather than third-party accounts from unknown authors and analysts. Each chapter is comparable to an essay/thought leadership piece and is a future-oriented look at where an industry, profession, or topic is headed and the most important issues for the future. Through an exhaustive selection process, each author was hand-picked by the Inside the Minds editorial board to author a chapter.

Chapters Include:

• 1. Ivan J. Wasserman, Partner, Kelley Drye Collier Shannon - "An Overview of the Challenges We Face and How to Survive Them"
• 2. R. Mark McCareins, Capital Partner, Winston & Strawn LLP - "Reflections of an Intellectual Property and Antitrust Litigator on Pharmaceutical Disputes"
• 3. William H. Kitchens, Managing Partner, Arnall Golden Gregory LLP - "Tactical Approaches to Common Problems Affecting FDA-Regulated Companies"
• 4. Eric M. Kraus, Partner, Sedgwick, Detert, Moran & Arnold LLP - "Managing and Avoiding Mass Tort Litigation"
• 5. Robert E. Colletti, Partner, Frommer Lawrence & Haug LLP - "The Role of the Food and Drug Attorney in Hatch-Waxman Lawsuits"
• 6. Kathleen M. Sanzo, Partner and Practice Group Leader, FDA/Health Care Regulation Practice Group, Morgan Lewis - "Keys to Successful Interactions with Governing Bodies"
• 7. Mark S. Cheffo, Partner, Skadden, Arps, Slate, Meagher & Flom LLP - "Protecting the Client Against Current and Future Problems"
• 8. Martin R. Dix, Shareholder, Akerman Senterfitt - "Navigating the Pharmacy and Drug Law Requirements"
• 9. Robert F. Lewis, Shareholder, GrayRobinson PA - "Developing and Realizing the Client's Business Goals"

Appendices:

• Appendix A: Brief - Baxter Healthcare v. Abbott Laboratories, 315 F. 3d 829 (7th Cir. 2002)
• Appendix B: Brief - Abbott Laboratories v. Baxter Healthcare, 334 F. 3d 1274 (Fed. Cir. 2003)
• Appendix C: Clinical Study and Research Agreement
• Appendix D: Standard Operating Procedure for Development, Review, and Approval of Promotional Material
• Appendix E: Guidance for Industry: Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products"Content and Format
• Appendix F: Memorandum of Law in Support of Motion for Judgment on Pleadings
• Appendix G: Reply Memorandum of Law in Further Support of Motion for Judgment on Pleadings
• Appendix H: OIG Safe Harbor and CMS Stark Exception for E-Prescribing and E-Recordkeeping Chart
• Appendix I: Memorandum Regarding the Reviewing of Agreements for Anti-Kickback and Stark Law Purposes
• Appendix J: Memorandum Regarding Co-Payments Due from Patients Covered by Private Third-Party Prescription Drug Programs

See Above.