Since induced pluripotent stem cells (iPSCs) were first produced in 2006 from mouse cells and in 2007 from human cells, scientists have recognized the incredible potential of the cell type, including their utility in drug and toxicology screening, disease modeling, and cellular therapy applications ranging from gene correction, to whole tissue regeneration, individualized medicine, and more. Given the financial potential of the cell type, it is important to have strategies for accessing key individuals, events, and iPSC facilities.
The following considers five of the most influential people operating within the iPSC marketplace right now. These individuals are all renowned industry experts, innovative thought leaders, and of course, highly-sought after speakers, advisers, and board members. Their individual opinions on iPSC topics can substantially alter public perception. As such, it is critical to be aware of the role that these individuals have played, and continue to play, within the iPSC marketplace.
- Robert J. Palay, CEO of Cellular Dynamics International (a FUJIFILM Holdings Company)
The first place award for the honor of iPSC industry influencer is given to Robert J. Palay, the CEO of Cellular Dynamics International (CDI), because CDI is the world’s leader in industrial scale production of iPSC, as well as differentiated (tissue-specific) cell types derived from iPSCs through the company’s proprietary methods. The company has also been a trailblazer and a key innovator in the area of utilizing iPSCs for drug discovery, drug screening, and toxicology applications. Importantly, the company has also been driving progress in large-scale iPSC biobanking through its joint California Institute for Regenerative Medicine (CIRM) grant awarded to the company in conjunction with the Coriell Institute for Medical Research. In addition, CDI has an expansive “iCell” product line that includes a dozen iPSC-derived cell types, that include: iCell Cardiomyocytes, iCell Hepatocytes, iCell Astrocytes, iCell Neurons, and iCell Skeletal Myoblasts, among others. The company also holds one of the strongest patent positions in the iPSC industry, with intellectual property (IP) holdings that include more than 800 patents to date.
However, CDI was recently acquired by FujiFilm Holdings in a $307 million deal in April of 2015, so the President of Fujifilm holdings, Shigehiro Nakajima, deserves honorable mention as well.
- Masayo Takahashi of the RIKEN Center for Developmental Biology (Kobe, Japan)
The second place award for the honor of iPSC industry influencer is given to Dr. Takahashi. This is for being the first clinical researcher to oversee the implantation of iPSCs into humans.
Without a doubt, the most momentous milestone since discovery of iPSCs in 2006 has been the first clinical research trial involving transplant of autologous iPSCs into humans. Previously, all clinical trials using iPSCs involved only the creation of iPSC lines from specific patient populations and evaluation of these lines to determine if they could represent a good “model” for a specific disease within that population. 2013 was the first year in which clinical research involving transplant of iPSCs into humans was initiated, led by Masayo Takahashi of the RIKEN Center for Developmental Biology in Kobe, Japan. Dr. Takahashi and her team are investigating the safety of iPSC-derived cell sheets in patients with wet-type age-related macular degeneration.
The trial was initiated in 2013, and production of iPSCs from patients began at that time. The first patient, a Japanese woman, was then implanted with retinal tissue generated using iPSCs derived from her own skin cells in August of 2014. A team of three eye specialists, led by Yasuo Kurimoto of the Kobe City Medical Center General Hospital, implanted a sheet of iPSC-derived retinal pigment epithelium cells into her retina. Preliminary results are indicating positive results for the participants in Dr. Takahashi trial.
- Prof. Jun Takahashi at CiRA for Developmental Biology (Kobe, Japan)
The third place award for the honor of iPSC industry influencer is given to Dr. Jun Takahashi for his ambition to launch the world’s second clinical trial involving the transplantation of iPSCs into human patients.
Currently, Prof. Jun Takahashi’s team at the Center for iPSC Research and Application (CiRA) at Kyoto University is positioned to request approval to begin a clinical trial in humans that would involve transplantation of “iPSC-derived dopaminergic neural progenitor cells” into the brains of patients afflicted with Parkinson’s Disease (PD). PD is a progressive disease of the nervous system that is caused by degeneration of specific regions of the brain and suppressed levels of dopamine, an important neurotransmitter and messaging molecule. Research to date indicates that replacement of dopamine neurons through a cellular therapy approach could be an effective treatment for improving the symptoms of individuals afflicted with PD.
Both groups in Japan and China are now assessing the safety of this cell replacement approach within primate systems, which are one of the nearest models available to assess how humans may respond to a protocol. If all goes well, Prof. Takahashi could potentially explore his approach of iPSC-erived dopamine neuron replacement in human clinical trials as early as 2016, depending on the approval timeline of Japanese authorities.
Prof. Takahashi also happens to be the husband of Dr. Takahashi, recognized above for initiating the first ever clinical trial implanting iPSCs into humans.
The fourth place award for the honor of iPSC industry influencer is given to Chikafumi Yokoyam for his track record of developing and manufacturing the world’s earliest iPSC specific research products for the scientific community through his company, ReproCELL, Inc.
ReproCELL is an innovative company founded in 2003 on the basis of technologies developed by Professor Nakatsuji , who had established the first human embryonic stem cells in Japan in that year at Kyoto University, and Professor Nakauchi at Tokyo University. The first human embryonic stem cells were established at Wisconsin University in 1998, while the first human iPSCs were generated in 2007 at Kyoto University in Japan.
ReproCELL has been playing a pivotal and pioneering role in the ES/iPS cell business by starting to commercialize culture media for human ES/iPS cells in 2005, the world’s first cardiomyocytes derived from human iPS cells in 2009, and the world’s first neurons derived from human iPS cells in 2010. Without question, the company has been the most progressive and innovative company developing iPSC research reagents, as well as tools for using iPSCs for drug development and discovery.
ReproCELL’s innovation in the area of iPSC commercialization has been driven in part by joint research relationships it established in 2003 with Tokyo University and in 2004 with Kyoto University. ReproCELL has also furthered its dominance in the area of iPSC products through a series of strategic acquisitions, including acquisition of Reinnervate, Stemgent, and BioServe Biotechnologies, all occurring in 2014.
As the CEO of ReproCELL, Dr. Yokoyama deserves recognition. He joined the team early in 2004 as a manager of the Business Development (BD) Division and subsequently became CEO of the company in 2005. He has been responsible for launching new iPSC products, creating strategic industry alliances, and raising funds for product expansions.
- Dr. Robert Lanza, CSO of Ocata Therapeutics (previously Advanced Cell Therapuetics, “ACT”)
The final award for the honor of iPSC industry influencer is given to Dr. Robert Lanza, Chief Scientific Officer of Ocata Therapeutics (previously Advanced Cell Therapeutics). He is honored both for his specific involvement in early-stage, pioneering iPSC research, as well as for his influence as the CSO of Ocata Therapeutics, a clinical-stage biotechnology company focused on commercialization of regenerative medicine and cell therapy technologies.
Lanza’s work in the area of iPSCs first received wide-spread recognition in 2009 when Lanza and a team lead by Kwang-Soo Kim at Harvard University reported a method for generating human iPSCs from skin cells via direct delivery of proteins, which removed the risks associated with genetic manipulation. This method created a significantly safer and less controversial source of patient-specific iPSCs for use in clinical applications. The Editors of the journal Nature selected Lanza and Kim’s paper on protein reprogramming as one of five “Research Highlights” of 2009.
Furthermore, Ocata Therapeutics (at the time named Advanced Cell Technology) was one of the earliest companies to begin exploring iPSCs for clinical purposes, although it discovered problematic issues while conducting experiments in 2010 before applying for U.S. Food and Drug Administration approval to use iPSCs in therapeutic applications. Concerns such as premature cell death, mutation into cancer cells, and low proliferation rates were some of the problems that surfaced.
As a result, Ocata Therapeutics has shifted its induced pluripotent stem cell approach to producing iPSC derived human platelets. The benefit of a platelet-based product is that they do not contain nuclei, and therefore, cannot divide or carry genetic information. While nothing is risk-free, iPSC derived platelets remove the concern of uncontrolled proliferation. More recently, Ocata Therapeutics announced in March 2015 that it had entered into an agreement with Allele Biotechnology & Pharmaceuticals, Inc. to access Allele’s proprietary technology for generating human iPSCs. The agreement is part of Ocata’s strategy to strengthen its regenerative ophthalmology technologies by using iPSCs to produce commercially viable human tissue for transplantation.
In addition, Dr. Lanza had been honored in 2013 by the Terrapin Group as one of the “Top 50 Global Stem Cell Influencers,” along with James Thomson and Nobel laureate Shinya Yamanaka, and has authored hundreds of research publications and books about stem cell related topics.
To learn more about induced pluripotent stem cell (iPSC) industry trends and events, view the “Compete 2015-16 Induced Pluripotent Stem Cell (iPSC) Industry Report.”
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