ABSTRACT

Despite the media hype that often accompanies some of the more signi–cant advances in medicine and healthcare technology, there seems little doubt that collaboration among scientists of different disciplines is now giving rise to truly astounding developments within the realm of life sciences. Gene therapy, stem cell transplantation, and tissue engineering are examples of the novel, often game-changing approaches brought to bear on hitherto intractable healthcare challenges. However, as with any

24.1 Insurance for Regenerative Medicine ........................................................... 379 24.2 If You Build It, Will They Insure It? ............................................................380 24.3 Common Traits ............................................................................................. 381 24.4 Confronting the Challenges .......................................................................... 382 24.5 Critical Elements of Insurance Portfolios ..................................................... 383

24.5.1 Security and Expertise ....................................................................384 24.5.2 Research and Development Operations ..........................................384 24.5.3 Changes in Environmental Conditions ...........................................384 24.5.4 Unrecoverable Expenses .................................................................384 24.5.5 Directors and Of–cers (Management) Liability Coverage ............. 385 24.5.6 Supplier Dependencies .................................................................... 385 24.5.7 Machinery Breakdown and Transit Risks ....................................... 386 24.5.8 Clinical Trials ................................................................................. 386 24.5.9 Terrorism and Attacks by Activists ................................................. 386 24.5.10 Intellectual Property Protection ...................................................... 386 24.5.11 Self-Insurance Option ..................................................................... 387

24.6 Roles of Risk Management and Business Continuity Management ............. 387 24.6.1 Timelines ......................................................................................... 389 24.6.2 Budgeting for Disaster .................................................................... 389 24.6.3 Collaboration with Insurers............................................................. 389

24.7 The Future .................................................................................................... 389

emerging –eld of technology, it is important to identify, quantify, and control the new risks that inevitably shadow such innovations.