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Dr. Koji Tanabe, Ph.D. is the Founder and CEO of I Peace, Inc. Dr Tanabe has been involved in iPSC research since its inception and is the second author of the first ever paper that reported the successful creation of human iPS cells. He studied the mechanism of reprogramming for 7 years in the laboratory of Dr. Shinya Yamanaka. As a post-doctoral researcher at the laboratory of Dr. Marius Wernig of Stanford University—who succeeded in the world’s first direct reprogramming of skin cells to neurons— Dr. Tanabe’s work focused on the mechanism of direct reprogramming from blood cells to neurons and iPSC reprogramming. He has contributed to numerous iPSC papers and papers on direct reprogramming to neurons.

Please share with us some details about your background.

Back when I was just a kid in high school, I became fascinated with newts after discovering how they possess the unique ability to regenerate their limbs and eyes indefinitely. While other amphibians can do this at an earlier stage, they ultimately lose this ability after a certain point. Newts, on the other hand, keep this attribute independent of their age. I wanted to know the secrets to this mechanism and thought that other animals and also humans could potentially regenerate their own tissues. For some reason, I could not get this idea out of my head for years. Up through college, I reached out to a lot of famous scientists in the field of developmental biology and discussed my idea of reprogramming somatic cells to an undifferentiated cell fate. After years of being rejected and sometimes even laughed at, one professor—Dr. Shinya Yamanaka—accepted me into his lab as a Master’s student. Two weeks after I joining, he gave me a draft manuscript. It was the manuscript of the world’s first mouse induced pluripotent stem cell (iPSC) paper.

Two strong emotions washed over me: an incredible amazement at such a scientific feat and a disappointment to find out what I thought would be my life’s work was already achieved by Shinya. I started to try to generate human iPSCs, and immediately afterwards, I was able to develop a new system to efficiently introduce reprogramming factors into somatic cells, eventually succeeding in generating the world’s first human iPSCs a year later. This discovery was a key factor for Dr. Shinya Yamanaka to win the 2012 Nobel Prize in Physiology or Medicine. Ever since we created the world’s first human iPSCs, I began thinking deeply about how to bring iPSC technology to patients and people to enrich their lives.

I was born in Osaka, Japan, where the entrepreneurial spirit is a part of its essence. This type of culture helped fuel my efforts to make the discovery of iPSCs accessible for the greater good of humanity.

“What can I do to make this possible?” – with this question in mind, I researched how technology and innovation impacts the world. Eventually, I found that Silicon Valley was producing the lion’s share of the most successful start-ups. Luckily, I got an opportunity in 2013 as a Postdoctoral Fellow at Dr Marius Wernig lab in the Institute for Stem Cell Biology and Regenerative Medicine at Stanford University. Soon I was fascinated by the local start-up ecosystem and didn’t wait too long to apply to participate in StartX, which was the beginning of I Peace, Inc. Ever since, the I Peace team has been achieving every planned milestone dating back to 2015 through our commitment to bring iPSC technology bedside.

I Peace has continued to innovate its processes as if our lives depended on it—because we know patients’ lives do depend on it. In under 6 years, we were able to produce and provide clinical-grade iPSCs and succeeded in developing technology that takes conventional iPSC manufacturing in a clean room costing 1 million USD per line, to the point where iPSCs can be manufactured in a letter-sized plastic plate for a few tens of thousands of dollars. This was made possible because we’ve succeeded in forming alliances with more than 20 world-class companies. The executives and founders of these companies have supported I Peace’s mission and vision, fueling our Series A, A-1, and B financing rounds.

Tell us about the commercialization of I Peace.

I Peace emerged from stealth mode in mid-2020, hallmarking our shift from an R&D-focused company to a company in the commercialization phase. The number of companies developing iPSC-derived cell therapies have exploded in the past few years, and I Peace is uniquely positioned to provide high quality clinical-grade iPSCs. Our key achievements for our first year in the commercialization phase include:

1) creation of GMP manufacturing system and facility compatible with both the US and Japanese regulations,

2) establishment of a strong B2B customer base, and

3) a successful Series B capital raise.

(1) GMP Manufacturing: Client needs are at the forefront of I Peace’s business model. Until last year, there were no clinical-grade iPSCs on the market that could be commercially used in more than one country, though many cell therapy developers were looking to launch their product in global markets. One of the solutions that I Peace has provided to the industry is off-the shelf clinical-grade iPSCs that comply with both US and Japanese regulatory requirements for clinical use. Within the last 12 months, I Peace has been licensed by Japanese’s Ministry of Health, Labour and Welfare to manufacture clinical-grade cell products and also received a third-party certification as US FDA cGMP compliant for its manufacturing facility in Kyoto, Japan. We also have the capability for custom iPSC manufacturing.

(2)Strong and Growing Client Base: Leveraging our unique manufacturing system and facility, I Peace has entered into commercial contracts with more than 10 clients in the last 12 months. These clients are developing iPSC-derived cell therapies and are planning to do Phase1/2 clinical trials in the near future.

(3) Series B Fundraising: To further support I Peace’s growth at a rapid speed, I Peace has been raising capital through a Series B round and will complete the first closing in the second week of June 2021. Despite the difficulty of raising capital due to COVID-19, I Peace welcomes new strategic partners as investors to further expedite the development of the technology innovation and global business footprint.

How has I Peace overcome obstacles on its journey so far?

iPSC production is a resource-intensive process with additional hurdles in donor sourcing, intellectual property, and regulatory compliance. With the conventional method, it takes roughly one year and one million USD to fully develop a clinical-grade iPSC line from just one individual, and there are only a few institutions with the technical capabilities to manufacture iPSCs. To fulfill our mission to democratize access to clinical grade iPSCs, a novel system incorporating novel methodology was needed. Being a start-up means that we don’t have large R&D budgets, existing client base, and brand recognition. Innovation is the only way we can solve problems. Consequently, we completely reinvented the iPSC induction and culturing process, and through biological and engineering innovation, we're able to develop a one-stop plate to produce established iPSCs starting from whole blood.

We developed our proprietary GMP iPSC medium and succeeded in increasing the reprogramming efficiency to more than 90%. This system can be fully-automated and can continuously generate, culture, cryopreserve, and evaluate iPSCs suitable for transplantation in a GMP-compliant environment. This device enables a dramatic cost reduction for manufacturing clinical-grade iPSCs, making personal iPSC banking affordable.

We launched our personal iPSC banking service in Japan in 2020 and have already established and banked customers’ iPSCs for their future use. Our automation system will enable the mass production of not only iPSCs but also cell therapy product for transplantation. Through our manufacturing capability and service infrastructure, I Peace hopes to make iPSC-derived cell therapy an affordable, widely used medical procedure in the near future.

I Peace is mass producing, selling, and storing clinical-grade iPSCs for cell therapy developers as well as for the general public. We have a state-of-the-art, licensed GMP facility with both manual and automated cell manufacturing capabilities. In this facility, we have succeeded in generating more than 10 GMP grade iPSC lines in the past six months, and their corresponding research grade lines are available for immediate use. We also provide custom GMP iPSC manufacturing service.

Our informed consent and tissue acquisition process is approved by a US-based independent IRB. Our tissue acquisition process conforms with US, Japanese, and EU regulations and principles. Our GMP facility and GMP documentation are compliant with US cGMP and Japanese GMP standards. PMDA audited our facility and we’ve received a license from the Japan’s Ministry of Health, Labour, and Welfare. Our cells have worldwide FTO. We are iPSC manufacturing pioneers, and all of our technicians are certified to manufacture clinical-grade cells.

  • Innovation is the only way that a start-up company can compete against industry giants that dominate the market.

  • Leading companies in various industries acknowledged the value of innovation that I Peace brings to the manufacturing of iPSCs and supported I Peace in various ways such as funding, building production system or collaborating in application of iPSCs in clinical and pharmaceutical use.

  • I Peace devised a novel method for iPSCs manufacturing that enables automated production in a closed system, paving the way for mass production of iPSCs with reasonable cost.

"I Peace has continued to innovate its processes as if our lives depended on it — because we know patients’ lives do depend on it."

For your customers, what makes I Peace the best supplier?

I Peace has both B2B and B2C customers.

Our B2B customers value the high quality, freedom to operate, and regulatory compliance of our iPSCs. As described in question No. 2 above, the limited number of clinical-grade iPSC lines and their limited scope for global commercial use are current pain points of cell therapy developers (our B2B clients). I Peace became aware of this issue faster than any of our competitors and carefully designed our manufacturing method and facility to tackle these bottlenecks for our customers. We provide multiple clinical-grade off-the-shelf lines that our clients can access immediately, accelerating their clinical research.

With our iPSCs, clients can develop cell therapy in both the US and Japan (and soon in the EU). Customers also like the fact that I Peace has the shortest lead time in the industry to manufacture high-quality clinical-grade cells for any custom manufacturing services. The other strong positive feedback from our B2B customers is our deep expertise and knowledge regarding iPSCs. I Peace’s key members have been involved in the development of iPSCs technology from its early days. This invaluable experience with iPSCs is behind our 100% success rate for all iPSC generation projects. I Peace’s customer base largely consists of iPSC experts—companies headed by famous iPSCs researchers and professors worldwide—that trust us to generate iPSCs for them, highlighting our capability and expertise manufacturing clinical-grade iPSCs.

Our B2C customers appreciate the fact that I Peace is a pioneer in making personal iPSCs for future use. Since the Nobel Prize that Dr. Shinya Yamanaka received in 2012, there has been a lot of buzz and hope to utilize iPSCs technology to cure incurable diseases such as Parkinson’s or cancer. Some people wished to make their own iPSCs but there was no way to do so since it was only available for institutional research and therapy development uses. With our mass-manufacturing capability, I Peace succeeded in significantly reducing the manufacturing cost as described in question #3 and started offering the individual iPSCs manufacturing service in 2020.

  • High quality clinical-grade iPSCs with the shortest lead time on the market.

  • Strong human and business network both in the US - the hottest cell therapy market, and in Japan - the birthplace of iPSC technology.

  • Service to bank clinical-grade iPSCs for individuals.

"Our approach to Corporate Social Responsibility is to make this technology available, accessible, and affordable for all."

Please tell us about I Peace's social mission.

1. iPSCs to drive societal impact: I Peace’s mission is to democratize access to iPSCs. iPSCs can be generated from anyone’s cells and can be used to generate any somatic cell in the body, in any number needed to replace lost or damaged cells. For example, iPSCs can be converted to kidney cells and transplanted in patients with kidney failure, as an alternative to lifelong dialysis. Since iPSCs can be converted to any somatic cell, it can also be used for drug discovery and screening. iPSC technology has immense potential to positively impact society and cure presently incurable diseases. Our approach to Corporate Social Responsibility is to make this technology available, accessible, and affordable.

2. Building social responsibility and sustainability into our business model: iPSCs are uniquely suitable for autologous applications. Although, the biggest problem with autologous application is its cost, particularly when considering needs of underprivileged communities.

We have successfully developed iPSC generation technology to enable production of clinical-grade iPSCs at a few percentages of the cost of conventional iPSC manufacturing. Our GMP facility can manufacture 50 individuals’ iPSCs/year currently and will expand its capacity to manufacture 5000 individuals’ iPSCs/year by 2025. This technology allows us to provide iPSC banking service to individuals at an affordable price. The quicker lead time and smaller footprint is also friendlier to the environment.

We also have a small but rapidly growing network of partner clinics and hospitals that are eager to deliver iPSC-derived cell therapies. There are 28.9 million Americans and 2.8 million Californians without health insurance, limiting their access to medical care. Our mass-manufacturing capabilities combined with lower cost makes it possible to offer access to iPSC-derived cell therapies to patients with and without health insurance through our medical network.

"It is a good leader’s job to instill a strong sense of mission to improve humanity with innovation as part of the company culture."

Share with us some insight into the unique requirements of leadership in your position.

Start-ups are constantly inundated with unpredictable, unexpected, unclear situations. A good leader must be decisive even when there’s not enough information. When I Peace was first considering the shift to commercialization, our presumption was that the main market for clinical-grade iPSCs would be Japan and clients would come as long as we made high quality iPSCs. As we started to speak with potential clients, it became clear that although Japan was the leader in clinical application of iPSC-derived cell therapy in the early years, the US had already not only caught up but was way ahead in terms of number of clinical trials and development. Furthermore, making high quality iPSCs was not enough. Companies were (and still are) looking for high quality clinical-grade iPSCs with freedom to operate (FTO) and full regulatory compliance, particularly with US regulations. We quickly pivoted our target market and solved FTO and regulatory issues in less than a year. Situations like this, both big and small, are part of everyday life at I Peace because we are trying to solve a new problem. Even if no one knows what the right answer is, leaders should find a path forward or create it, with creative, agile, and adapting decision-making. It is also important to set milestones that the team can feel a sense of achievement when accomplished and will have something to strive towards. I Peace has always hit all milestones set because we always found or created a solution.

Start-ups also make or break through the magnitude of positive impact to society. A good product, technology, or team is not enough to keep going through the obstacles a young company in a highly complex and emerging field can face. Because we have a strong sense of mission to make iPSCs accessible and improve patient lives with iPSC technology, we are able to carve a path forward. It is a good leader’s job to instill a strong sense of mission to improve humanity with innovation as part of the company culture.

Leaders also need to understand what makes each and every one of their team members tick—what their passion, skillset, and limitations are. I Peace team members come from a diverse background, though each member has their own area of expertise such as manufacturing, basic science research, regulations, or finance. We have always hit all of our milestones because these diverse backgrounds riff off of each other to create solutions that would be impossible to conceive without that diversity. A good leader should find, leverage, and empower strengths of each team member.

A good leader, particularly one leading a startup in a complex and emerging technological industry, needs to:

  • Be able to communicate well with both industry and academia, and convince them to collaborate when necessary.

  • Understand finance, at least to be able to allocate resources effectively and maximize financial efficiency as funds are often a scarce resource.

  • Be knowledgeable about managing intellectual property.

  • Have a broad vision that includes contribution to the future of mankind.

  • Be able to show team members the roadmap to success and have strong willpower to implement what has been stated. I Peace has a live document created with input from all team members that states what the priorities are for the current and upcoming year, and what the goals are for each team.

  • Be able to balance quality, quantity, and speed to deliver the most impact. Integrity is non-negotiable.

  • Be decisive.

  • Be accessible. My calendar is visible to all I Peace members and everyone is encouraged to schedule a time with me when needed.

  • Empower team members and believe in them to do more than they themselves think was possible. At I Peace, everyone is given the authority to make their own decisions as appropriate.

  • Frequently recognize success and do not tolerate mediocracy. At I Peace, all successes small and big are shared at a weekly All Hands meeting.

  • Empathize with customers, colleagues, and collaborators.

Final words for our audience about iPSC technology.

We at I Peace always ask ourselves how we can create a world where iPSC technology truly improves and saves patient lives, in the shortest possible time. iPSC technology is a terrific enabler of personalized medicine, drug discovery, and autologous transplantation. Our vision is a near future where people commonly get their iPSCs generated and stored at birth, because we believe iPSC technology can bring joy and happiness to millions of patients suffering from suboptimal quality of life, pain, and despair.

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