Deciphering the Therapeutic Stem Cell Strategies of Large and Midsize Pharmaceutical Firms

Abstract

The slow adoption of cytotherapeutics remains a vexing hurdle given clinical progress achieved to date with a variety of stem cell lineages. Big and midsize pharmaceutical companies as an asset class still delay large-scale investments in this arena until technological and market risks will have been further reduced. Nonetheless, a handful of stem cell strategic alliance and licensing transactions have already been implemented, indicating that progress is actively monitored, although most of these involve midsize firms. The greatest difficulty is, perhaps, that the regenerative medicine industry is currently only approaching the point of inflexion of the technology development S-curve, as many more clinical trials read out. A path to accelerating technology adoption is to focus on innovation outliers among healthcare actors. These can be identified by analyzing systemic factors (e.g., national science policies and industry fragmentation) and intrinsic factors (corporate culture, e.g., nimble decision-making structures; corporate finance, e.g., opportunity costs and ownership structure; and operations, e.g., portfolio management strategies, threats on existing businesses and patent expirations). Another path is to accelerate the full clinical translation and commercialization of an allogeneic cytotherapeutic product in any indication to demonstrate the disease-modifying potential of the new products for treatment and prophylaxis, ideally for a large unmet medical need such as dry age-related macular degeneration, or for an orphan disease such as biologics-refractory acute graft-versus-host disease. In times of decreased industry average research productivities, regenerative medicine products provide important prospects for creating new franchises with a market potential that could very well mirror that achieved with the technology of monoclonal antibodies.

Keywords::

• big pharma
• cytotherapeutics
• disruptive innovation
• licensing and partnerships
• midsize pharmaceutical firms
• radical innovation
• stem cells
• technology adoption
• technology deployment

Acknowledgements

The author thanks Terrapinn for providing data on the evolution of the number of attendees at the World Stem Cell & Regenerative Medicine Congress.

Financial & competing interests disclosure

AA Vertès discloses that, at the time of writing this manuscript, he held professional positions at Eli Lilly, Pfizer and, particularly, Roche, where he managed the strategic alliance between Roche and Alnylam, and initiated in 2007 and led until 2010 Roche’s global therapeutic stem cell initiative. He holds active consultancies including in regenerative medicine and/or has financial involvement with Mesoblast, Targazyme (formerly America Stem Cell) and New Jersey-based Saint-Peter’s University; he is also a member of CellCure’s scientific and medical advisory board. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Additional information

Funding

AA Vertès discloses that, at the time of writing this manuscript, he held professional positions at Eli Lilly, Pfizer and, particularly, Roche, where he managed the strategic alliance between Roche and Alnylam, and initiated in 2007 and led until 2010 Roche’s global therapeutic stem cell initiative. He holds active consultancies including in regenerative medicine and/or has financial involvement with Mesoblast, Targazyme (formerly America Stem Cell) and New Jersey-based Saint-Peter’s University; he is also a member of CellCure’s scientific and medical advisory board. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.