The cell therapy industry has an encyclopaedic void. But is this void one that needs addressing?”
London cabbies have the Blue Book, gastronomy has Larousse, the Chinese Cultural Revolution had the Little Red Book and every religion has a sacred text. The cell therapy industry has an encyclopaedic void. But is this void one that needs addressing?
After much musing and mental cul-de-sacs it dawned on me that these codifying tracts supported well-defined, and in many respects discrete, pursuits: navigation around the streets of London; the creation of fine foods; and, the realization of ideologies. But, the reality is that the delivery of cellular therapies to improve global health and wealth is a multi-stakeholder effort and, as such, is unlikely to sport a single codifying tract.
Ultimately, I was led to question the optimal future relationship of the cell therapy industry to the established health care sector. Namely, whether the Cell Therapy Industry 2027 should be a lone ranger (a distinct and independent industry) or team player (a complementary component of the established global health sector).
Existing contributions to this debate focus on the relationship of cellular therapies to other technological modalities. For example, the relationship(s) between cell therapy and regenerative medicine; cell therapy and gene therapy; and, cell therapy and its relationship to biotech. While these debates are of academic value, they are in many respects unhelpful distractions that do not meaningfully advance our understanding: isolated playground scraps on a vast health care battlefield.
Cell therapy is not an empire. It cannot deliver sustainable and practicable benefits to patients by simply fighting turf wars against technological contemporaries. Ultimately, it will lose the war. The monoclonal antibody industry rightly stopped caring long ago about whether it was a distinct industry or whether it had a stronger relationship to the established pharmaceutical industry. The needs of patients and investors resonate the loudest and (despite a few recent setbacks) these needs are most effectively answered by the global pharma industry which, like it or not, will eventually absorb the cell therapy industry (irrespective of how we choose to define it). Even the mighty biotech start-up success Genentech was ultimately acquired by pharma veteran Roche.
If the Cell Therapy Industry 2027 is to be an effective team player to big pharma, what should be its New Year manifesto? Here are my suggestions:
1. Focus on industry tangible outputs
The breadth in applicability of cellular technologies, from therapeutics to screening tools, is something of a ‘Catch 22:’ while the industry doesn’t want to undersell its potential, it also needs to remain mindful that it needs to provide a portfolio of tangible outputs to demonstrate its utility and credibility. These include, although are not necessarily restricted to:
- Advances in fundamental (basic) science.
- Development of enabling technologies (e.g. assays to elucidate product mechanisms of action and critical quality attributes).
- Cell based drug-screening tools.
- Cellular therapeutics.
- ‘True’ regenerative medicines including whole organ tissue engineering (a long-term goal).
2. Focus on relationship(s) with Big Pharma
They need sources of growth. We need their support to grow.
3. Accept that the development process of cellular technologies will take time and contain unpredictable risks
By its nature R&D is a process riddled with uncertainties; however, the extent of such risks are likely to be elevated for the initial vanguard of cellular technologies that will encounter ‘first in class’ problems. Therefore, we need to shrewdly manage stakeholder expectations and avoid hype!
4. Seek standardization in technologies and regulation
A driver and consequence of the development of enabling technologies (see above) is standardization in all aspects of the cell therapy industry’s operation. What does ‘minimally manipulated’ [in cell bioprocessing] actually mean? And how can you prove that one candidate’s mesenchymal stem cell is different from another and what, if any, different properties does it have?
5. Stop fighting brand wars
Is the cell therapy industry a freestanding component of the global health care sector, a subset of biotech or perhaps even organ transplantation? Who cares? Such debates, initially intended to provide a clear message to politicians, investors, regulators and patients have become simply convoluted and counter-productive.
To date, the cell therapy industry has been reasonably effective in delivering intra-(cell therapy) community collaborations. However, it has been less successful in spurring and sustaining inter-(health care) community collaborations. This transition will be a mission critical step in the evolution of the Cell Therapy Industry 2027.
Therefore, it is my pleasure to welcome 2013 and the prospect of a new no-nonsense cell therapy industry: an effective team player in the global health care sector.
Note: In addition to any prior disclosures (see author bio, below), D.A.B. has been a paid and/or pro bono consultant of a number of organizations developing cell based screening tools and cellular therapeutics.
Latest posts by David Brindley (see all)
- If cell therapy isn’t about the cells or the therapy, what is it about? - November 19, 2014
- Revolution and reimbursement in the cell therapy industry - November 13, 2014
- Of seismic waves and closing days: take home messages - October 1, 2014