World Stem Cell Summit 2014 report part 2: industry and business

Written by Norio Nakatsuji

Part 2 from the conference scene of the World Stem Cell Summit (WSCS) 2014 held in San Antonio (3—5 December, San Antonio, Texas)

World Stem Cell Summit (WSCS) 2014 was held in San Antonio, Texas, USA from December 3 to 5. Among the many international conferences in the field of stem cells and regenerative medicine, WSCS is distinct in focusing its efforts to serve as the meeting point by multi-sector communities of research, clinics, industry, regulation, policy making and ethics. All are aiming at advancing stem cell innovation and new therapies, under the banner of “connect, collaborate and cure.” As same as past years, presenters and attendees included not only researchers but also clinicians, funding agencies, government officials, industries and patients. Thus, many sessions focused on the clinical translation from basic research. Another important agenda were industrial and social aspects, and problems to be solved before realization of practical and sustainable stem cell-based therapies.

Industry and business

WSCS proactively deals with business-related discussion. In the Regenerative Medicine and Cell Therapy — Multi-Billion Industries with Unlimited Potential session, three speakers gave valuable lectures. Jane Andrews (Frost & Sullivan) provided a global perspective of the stem cells and regenerative medicine industry. She stressed that the cardiovascular and oncology as potential areas of regenerative medicine where small firms will be leading clinical trials and achieving key milestones. Chris Mason (University College London) stated that regenerative medicine is a platform-independent business that enables firms to exert new technology, new products and a new infrastructure. Currently up to 700 firms including 70 public firms are being engaged in the stem cell and regenerative medicine business and leading the fourth and probably the final pillar of healthcare. Notably, he gave an insight beyond the current regenerative medicine industry where ongoing cell-based therapies, stem cell technology and genetically modified cell technology will be gradually converged into a unified concept in upcoming 20 years, as shown by an example of emerging CAR-T-based anti-cancer immunotherapy. Gregory Bonfiglio (Proteus RM) propagated a recent context of financial and economic environment. His presentation endorsed an increasing trend of investment from a private sector into representative firm cases as well as contributions from public sector into translational institutes. These provided fact bases that strongly support the substances for the solicitation of multi-dollar industry with a wider range of commercial opportunities and increased number of enabling factors.

Another session, Creative Way to Organize, Finance and Launch Manufacturing Initiatives, focused on the capability of manufacturing infrastructure and equipment which is currently considered to be a critical element to realize regenerative medicine at an industry scale. However, it is a consensus that full-on commercial grade manufacturing is prohibitive for most individual organizations; academic and research organizations are not structurally equipped to ramp-up manufacturing capability; contracted manufacturing organizations (CMOs) are cost restrictive thus less in process development services. Chris Mason (University College London) proposed so-called ‘ABC approach’ which consists of academics, bio-processors and clinicians, with three step route map: (1) R&D scale by academic groups and individual firms; (2) preclinical or phase 1/2 scale by hospital based GMP units, publicly funded facilities, individual firms and a few CMOs; (3) full scale commercial manufacturing by firms and CMOs and their consortia. He indicated substantial case examples of public-private sector relationship such as Cell Therapy Catapult in the UK, CCRM in Canada, NEDO in Japan, and CTM-CRC in Australia. Steven Lynum (Panasonic Healthcare) spoke about a vision of product lines with their product series for ultra-low temperature storage, GMP-compliant manufacturing: regionalized manufacturing and total lab systems design. Gerald Parker (Center for Innovation in Advanced Development and Manufacturing, Texas A&M Health Science Center) represented a regional effort to build up a global hub for process engineering and manufacturing platform, suggesting key outstanding issues such as the geographical coverage and distribution of centers, differences between allogenic and autologous business models and also some considerations from financial and investment viewpoints.

The Japan Symposium session presented stem cell-related research & commercialization products in a Japanese government (METI/NEDO)-sponsored project. It included low cost mass culture system, 3D tissue construction, new freezing system, and delivery system to build the total manufacturing system to make clinical grade regenerative medical products in near future. Tomomi Yamazaki (NEDO) introduced the NEDO Project, and Norio Nakatsuji (Kyoto University) gave the session overview. Kouichi Hasegawa (Kyoto University) presented a simple, defined and low cost culture medium for hPSCs. Tomoki Aoyama (Kyoto University) talked about development of transport system for regenerative medicine. Taito Nishino (Nissan Chemical Industries) presented a 3D mass culture system using functional polymers for hPSCs. Masanori Kitagawa (Takara Bio) talked about development of the genome/epigenome analysis regents for quality evaluation of hPSCs and differentiated cells. Koji Kuchiishi (Cyfuse Biomedical) talked about their platform of scaffold-free 3D tissue fabrication. Chikafumi Yokoyama (ReproCELL) talked about progress of iPSC business and technology in ReproCELL. Michiyoshi Nakamichi (Tamai Kasei) talked about technology of temperature controlled shipping packaging “TACPack”.

New summit agenda this year was company sessions in which selected firms shared their strategy, business models and perspectives, which included Texas-based firms such as StemBioSys and Aperion Biologics and other regional contributors, which were helped by a successful case in the formation of high-tech industry cluster in Austin.

Authors: Kouichi Hasegawa, Takashi Asada, Shintaro Sengoku and Norio Nakatsuji (Institute for Integrated Cell-Materials Sciences, Kyoto University, Kyoto, Japan)

Disclosure: This work was partially supported by a grant from the New Energy and Industrial Technology Development Organization. N. Nakatsuji is a founder and shareholder of a hESC/iPSC-related company, ReproCELL, Inc.

The full conference scene is scheduled to be published in Volume 10 Issue 4 of Regenerative Medicine.