History of monoclonal antibodies and lessons for the development of stem cell therapeutics

Vertès, Alain A.; Dowden, Nathan J.

doi:10.1002/9781118846193.ch33

Cited by 4 publications

(2 citation statements)

References 161 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Considering that Centocor was acquired in 1999 by Johnson & Johnson for $4.9 billion, this case constitutes an outstanding example of why partne rships with large established companies can be so critical for Society, patients, and investors as stakeholders to capitalize on biotechnology innovation. [19][20][21] Another parallel to derive useful lessons for the adoption of cytotherapeutics on the path to creating a novel economic space is that with the case of biofuels. 22 Revisiting the history of industrial biotechnology, a first lesson is that JV have constituted a primary means of technology diffusion.…”

Section: Translating Disruptive Innovation Into Economic Activity -Amentioning

confidence: 99%

Turning Regenerative Medicine Breakthrough Ideas and Innovations into Commercial Products

Bayon

Vertès

Ronfard

et al. 2015

Tissue Engineering Part B: Reviews

Self Cite

View full text Add to dashboard Cite

The TERMIS-Europe (EU) Industry committee intended to address the two main critical issues in the clinical/commercial translation of Advanced Therapeutic Medicine Products (ATMP): (1) entrepreneurial exploitation of breakthrough ideas and innovations, and (2) regulatory market approval. Since January 2012, more than 12,000 publications related to regenerative medicine and tissue engineering have been accepted for publications, reflecting the intense academic research activity in this field. The TERMIS-EU 2014 Industry Symposium provided a reflection on the management of innovation and technological breakthroughs in biotechnology first proposed to contextualize the key development milestones and constraints of allocation of financial resources, in the development life-cycle of radical innovation projects. This was illustrated with the biofuels story, sharing similarities with regenerative medicine. The transition was then ensured by an overview of the key identified challenges facing the commercialization of cell therapy products as ATMP examples. Real cases and testimonies were then provided by a palette of medical technologies and regenerative medicine companies from their commercial development of cell and gene therapy products. Although the commercial development of ATMP is still at the proof-of-concept stage due to technology risks, changing policies, changing markets, and management changes, the sector is highly dynamic with a number of explored therapeutic approaches, developed by using a large diversity of business models, both proposed by the experience, pitfalls, and successes of regenerative medicine pioneers, and adapted to the constraint resource allocation and environment in radical innovation projects.

show abstract

Section: Translating Disruptive Innovation Into Economic Activity -Amentioning

confidence: 99%

Turning Regenerative Medicine Breakthrough Ideas and Innovations into Commercial Products

Bayon

Vertès

Ronfard

et al. 2015

Tissue Engineering Part B: Reviews

Self Cite

View full text Add to dashboard Cite

show abstract

“…Through manufacture scale-up by moving from inefficient manual processes to automated large-scale bioreactors, manufacturers of biologics were able to bulk produce consistently complex biological products such as monoclonal antibodies and drive down the cost of goods, deliver effective treatments to patients 5 , growing into an industry predicted to reach nearly $125 billion global annual sales in 2020 6,7 . This manufacturing and distribution model has been shown to offer benefits such as more efficient resource planning, easier monitoring and reducing cost per treatment through spreading regulatory, equipment and capital costs over a large volume of products 8 . The manufacturing of autologous cell products such as those for CAR-T therapy, however, does not benefit from the same extent of economies of scale.…”

Section: Introductionmentioning

confidence: 99%