Commercialization Considerations for Cell-Based Therapies: What We Have Learned So Far
- 70 Downloads
Abstract
Purpose of Review
Despite an increasing list of clinically impactful products in cancer, wound care, and graft versus host disease, cellular therapeutics have yet to be fully embraced by large pharma and biotech. While there have been several high-profile investments in the past 5 years, the list of clinically and commercially successful products is still a short one. Here, we highlight some of the critical considerations to increase the likelihood of commercial success.
Recent Findings
The field of Regenerative Medicine is poised to introduce several products that could have profound clinical impact. The recent acquisition of Kite Therapeutics suggests that large pharma sees not only the clinical value but also for the first time, multibillion dollar commercial value.
Summary
Cell and gene therapies require remarkably long developmental timelines and have complex manufacturing and scaling requirements. Successful commercialization models must accommodate this complex developmental pathway.
Keywords
Commercialization model Reimbursement Cell sourcing Regulatory pathway Manufacturing Scale-upNotes
Compliance with Ethical Standards
Conflict of Interest
The authors declare that they have no conflict of interest.
Human and Animal Rights and Informed Consent
This article does not contain any studies with human or animal subjects performed by any of the authors.
References
Papers of particular interest, published recently, have been highlighted as: • Of importance
- 1.• Dodson BP, Levine AD. Challenges in the translation and commercialization of cell therapies. BMC Biotechnol. 2015;15:70. A review of the commercialization pathway of seven cell based products CrossRefPubMedPubMedCentralGoogle Scholar
- 2.• Mason C, Brindley DA, CUlme-Seymour EJ, Davie NL. Cell therapy industry: billion dollar global industry with unlimited potential. Regen Med. 2011;6(3):265–72. A review of the unrealized potential of the field of cell and gene therapy CrossRefPubMedGoogle Scholar