Table 1 Challenges for stem cell biotechnology companies
From: LULL(ed) into complacency: a perspective on licenses and stem cell translational science
Hindrances to stem cell translation | Consequences |
|---|---|
Fractured history of embryonic stem cell rules | A slowed and staggered entry of commercial entities into the field [2, 3] |
Lack of government leadership to develop a consensus | The lack of early federal standards and infrastructure caused states and countries to lead initiatives that were not coordinated [4]. |
Complexity of the therapeutic solutions proposed | Unlike chemical compounds, manufacturing techniques and regulations for cellular biologics have not been straightforward and clear [5]. |
Technological strategies being used | The fast pace of technological breakthroughs in the field can render products and processes developed only a few years earlier less competitive or even obsolete. |
Lack of expertise with patent laws by the new players | New and small companies in the field of regenerative medicine cannot find lawyers with the expertise and background in the stem cell field to efficiently navigate the patent landscape [6]. |