v
Acknowledgments .........................................................................................................................................viii
Foreword .........................................................................................................................................................ix
Chapter 1: Introduction to Regulatory Strategy. ............................................................................................1
By Darin S. Oppenheimer, Jessica L. Hale, Suraj Ramachandran and George A. Cusatis
Chapter 2: The Regulatory Team....................................................................................................................9
By Naseem Kabir, Susan Capps and Grace Jiang
Chapter 3: Regulatory Intelligence Step 1: Information Collection—A Compilation of Website Addresses. ....23
By William K. Sietsema, PhD
Chapter 4: The Elements of Global Regulatory Strategy—the Basics............................................................31
By Neal E. Storm
Chapter 5: Assembling and Utilizing Target Product Profiles........................................................................45
By Anastassios Retzios, PhD
Chapter 6: Preclinical Safety Guidelines Supporting International Drug Registration. ................................57
By John C. Kapeghian, PhD, DABT
Chapter 7: CMC Regulatory Strategy. .........................................................................................................79
By Stephen Antonelli and Michael Craig
Chapter 8: Strategies for Clinical Development Planning.............................................................................89
By William Sietsema, PhD and Eric Brass, MD, PhD
Chapter 9: Clinical Trial Application Planning.............................................................................................99
By Sharry Arora
Chapter 10: Global Orphan Drug Regulations ............................................................................................107
By Jocelyn Jennings, MS, RAC
Chapter 11: Pediatric Strategies....................................................................................................................117
By Klaus Rose, MD, MS
Chapter 12: So Your Drug has a Friend? Companion Diagnostic Codevelopment Strategies........................133
By Catherine Lofton-Day, Dave Kern and Mya Thomae
Chapter 13: Interacting With Regulators. ....................................................................................................145
By Eric Brass, MD, PhD and William Sietsema, PhD
Chapter 14: Regulatory Pathways.................................................................................................................155
By Pallavi Trivedi, MPH, RAC
Chapter 15: Global Regulatory Strategy.......................................................................................................187
By Chris Walker and Tina Soulis
Chapter 16: Preparing for an FDA Advisory Committee: High Risk, High Reward. ....................................205
By Michael J. Vivion
Chapter 17: Considerations for Healthcare Products’ Lifecycle Management. ..............................................221
By Timothy Pang
Chapter 18: Medical Writing Strategies: Aligning Regulatory Documents with Strategic Goals....................235
By Kathy Wekselman
Index ............................................................................................................................................................243
Contents
Acknowledgments .........................................................................................................................................viii
Foreword .........................................................................................................................................................ix
Chapter 1: Introduction to Regulatory Strategy. ............................................................................................1
By Darin S. Oppenheimer, Jessica L. Hale, Suraj Ramachandran and George A. Cusatis
Chapter 2: The Regulatory Team....................................................................................................................9
By Naseem Kabir, Susan Capps and Grace Jiang
Chapter 3: Regulatory Intelligence Step 1: Information Collection—A Compilation of Website Addresses. ....23
By William K. Sietsema, PhD
Chapter 4: The Elements of Global Regulatory Strategy—the Basics............................................................31
By Neal E. Storm
Chapter 5: Assembling and Utilizing Target Product Profiles........................................................................45
By Anastassios Retzios, PhD
Chapter 6: Preclinical Safety Guidelines Supporting International Drug Registration. ................................57
By John C. Kapeghian, PhD, DABT
Chapter 7: CMC Regulatory Strategy. .........................................................................................................79
By Stephen Antonelli and Michael Craig
Chapter 8: Strategies for Clinical Development Planning.............................................................................89
By William Sietsema, PhD and Eric Brass, MD, PhD
Chapter 9: Clinical Trial Application Planning.............................................................................................99
By Sharry Arora
Chapter 10: Global Orphan Drug Regulations ............................................................................................107
By Jocelyn Jennings, MS, RAC
Chapter 11: Pediatric Strategies....................................................................................................................117
By Klaus Rose, MD, MS
Chapter 12: So Your Drug has a Friend? Companion Diagnostic Codevelopment Strategies........................133
By Catherine Lofton-Day, Dave Kern and Mya Thomae
Chapter 13: Interacting With Regulators. ....................................................................................................145
By Eric Brass, MD, PhD and William Sietsema, PhD
Chapter 14: Regulatory Pathways.................................................................................................................155
By Pallavi Trivedi, MPH, RAC
Chapter 15: Global Regulatory Strategy.......................................................................................................187
By Chris Walker and Tina Soulis
Chapter 16: Preparing for an FDA Advisory Committee: High Risk, High Reward. ....................................205
By Michael J. Vivion
Chapter 17: Considerations for Healthcare Products’ Lifecycle Management. ..............................................221
By Timothy Pang
Chapter 18: Medical Writing Strategies: Aligning Regulatory Documents with Strategic Goals....................235
By Kathy Wekselman
Index ............................................................................................................................................................243
Contents