ABSTRACT
Pharmaceutical companies are implementing at an increasing pace stem cell technologies as discovery and diagnostic tools. In so doing, these companies pursue the objective of developing means to better understand the fundamental biology of human diseases and to optimize attrition rates as they bring to market new small molecules and biologics. For example, human embryonic stem cells (hESCs) and induced pluripotent stem (iPS) cells derived from hepatocytes or cardiomyocytes and cancer stem cells, or cells derived from diseased tissues enable practitioners to model diseases, screen compounds for ef–cacy, and assess compound safety using
12.1 Introduction .................................................................................................. 153 12.2 Constraints to the Pharma Business Model .................................................. 154 12.3 Accessing External and Internal Innovation as Strategic Response ............ 156 12.4 Stem Cell Technologies First Adopted by Big Pharma ................................ 160 12.5 Potential Big Pharma Business Models for Regenerative Therapies ............ 161 12.6 Building New Franchises in the Terra Incognita of Therapeutic
Stem Cells ..................................................................................................... 164 12.6.1 Patents ............................................................................................... 165 12.6.2 Product Concept, Indications, and Markets ...................................... 166 12.6.3 Regulatory Requirements ................................................................. 166 12.6.4 Manufacturing .................................................................................. 167 16.6.5 Logistics ............................................................................................ 168 16.6.6 Delivery ............................................................................................ 168 12.6.7 Pricing and Reimbursement ............................................................. 168
12.7 Perspective .................................................................................................... 169 Acknowledgment ................................................................................................... 169 References .............................................................................................................. 169
human-derived cellular screens that in principle more accurately model the molecular events that occur in patients.
