Organization in Special Consultative Status with the UN Economic and Social Council
www.allianceforum.org/en
2015 World Alliance Forum in San Francisco
Regenerative Medicine: Let’s Talk Business!
Golden Gate Club November 12 - 13, 2015
Organized by: Alliance Forum Foundation Government of Japan
www.wafsf.org Table of Contents
Page
Greetings 3
Program 6
Speakers’ Biography 10
Sponsors & Major Supporting Organizations 27
Alliance Forum Foundation 37
2 Greetings
Organization in Special Consultative Status with the UN Economic and Social Council
Greetings from George Hara
Chairman of the Board, Alliance Forum Foundation
The Alliance Forum Foundation began holding its annual World Alliance Forum in the 1990s with a goal to nurture emerging technologies in the fields of IT and healthcare. Since then, the Forum has continued to be a catalyst for many new alliances among businesses, research institutions, governments, and local and international organizations that enable commercialization of innovative technologies.
Since 2013, the Foundation has been inviting leading researchers engaged in stem cell research and development in Japan and the US to come together in San Francisco. Dr. Shinya Yamanaka, a 2012 Nobel Prize laureate in Physiology or Medicine and who discovered induced pluripotent stem cells (iPSC), has accelerated the development and translation of regenerative medicine. It became clear that this revolutionary technology would not only change our healthcare system but also impact our society in the most fundamental way.
At this year's Forum “Regenerative Medicine: Let’s Talk Business!,” I look forward to seeing top researchers and business leaders from the US, Japan and other parts of the world come together to discuss current developments in clinical applications and business opportunities in regenerative medicine and share information which is vital to building social consensus towards regenerative medicine and coming Life Science Revolution. We will also hear about exciting opportunities for investors and businesses in this burgeoning field. It is my hope that as new and existing businesses achieve success, a portion of the profits will be directed back to funding further research in the spirit of public interest capitalism so that the stem cell technology may continue to make huge strides toward becoming a new engine of industrial growth for the benefit of all.
I thank all the presenters who are coming together to make the 2015 World Alliance Forum in San Francisco “Regenerative Medicine: Let’s Talk Business!” a valuable and important program of shared expertise and dialogue. I also want to recognize the generosity of our sponsors who made this year's Forum possible.
Ambassador George Hara Chairman of the Board, Alliance Forum Foundation Organization in Special Consultative Status with the UN ECOSOC Special Advisor to the Cabinet Office of the Prime Minister of Japan
3
Greetings from Jun Yamada
Consul General of Japan in San Francisco
Facing a rapidly aging population, the Government of Japan places serious focus on the field of health and science. The United States will eventually enter into the same situation. There is no doubt that our two countries need to cooperate in the closest manner to overcome this structural problem in our common future.
Earlier this year, Prime Minister Abe visited San Francisco and the Bay Area. It was the first such visit in 26 years and turned out to be so productive. During his stay, PM Abe managed to visit many academic and research facilities. At the Gladstone Institutes, he made a speech and held private meetings with its leadership. He addressed a gathering of 100 young Japanese researchers from the University of California and at Stanford University he announced the “Innovation Kakehashi Project”. One of its components is to facilitate collaboration through its Biodesign program.
It is my hope that such initiatives will further enhance the bridge between our two countries across the Pacific. The steadfast mission of the World Alliance Forum, “to identify cutting-edge technologies, encourage sustainable social and industrial development founded on those technologies, and promote social change for the advancement of our society”, is exactly in line with this most encouraging recent development. Please accept my heartfelt congratulations on the opening of the 2015 World Alliance Forum in San Francisco. I sincerely look forward to enlightening myself on the newest US-Japan collaborations in the field of regenerative medicine through this wonderful forum.
Consul General Jun Yamada Consul General of Japan in San Francisco
4 Event Summary
2015 World Alliance Forum in San Francisco
Theme: Regenerative Medicine: Let’s Talk Business!
Date & Time: Thursday November 12th, 2015 9:00 am – 5:30 pm (Reception: 5:30 pm – 6:30 pm) Friday November 13th, 2015 9:00 am – 4:30 pm (Reception: 4:30 pm – 5:30 pm)
Location: Golden Gate Club (135 Fisher Loop, San Francisco, CA 94129)
Organizers: Alliance Forum Foundation (Organization in Special Consultative Status with the UN ECOSOC) Government of Japan
Platinum Astellas Pharma Inc. DEFTA PARTNERS Sponsors: Mitsui Fudosan Co., Ltd. MUFG Union Bank, N.A. ROHTO Pharmaceutical Co., Ltd. Takeda Pharmaceutical Company Ltd.
Gold California Institute for Regenerative Medicine (CIRM) Chugai Pharmaceutical CO., LTD. Sponsors: Fujifilm Corporation / Cellular Dynamics International Lonza Mitsubishi Tanabe Pharma Corporation
Silver Sponsors: Terumo Corporation Yorozu Law Group
Bronze Sponsor: Cesca Therapeutics SanBio, Inc.
Wi-Fi Sponsor: Lonza
In-Kind AlphaGraphics ITO EN (North America) Inc. Sponsors: JFC International, Inc. KOBE SHU-SHIN-KAN BREWERIES, LTD. SAPPORO U.S.A., Inc. Ms. Tomoko Tsuji (IKENOBO Flower Arrangement)
Major Alliance for Regenerative Medicine (ARM) BioCentury Supporting Center for iPS Cell Research and Application (CiRA), Forum for Innovative Regenerative Medicine (FIRM) Organizations: Kyoto University Gladstone Institutes Hara Research Foundation (HRF) International Society for Stem Cell Research (ISSCR) The Japanese Society for Regenerative Medicine (JSRM)
Supporting Alliance Forum Executive Club Japan Bio Community (JBC) Organizations: Japan Society of Northern California Japanese Chamber of Commerce of Northern California Japanese University Network of the Bay Area (JUNBA) (JCCNC) JETRO (Japan External Trade Organization) Keizai Society Student Society for Stem Cell Research (SSSCR) US-Asia Technology Management Center at Stanford University
Advisory Dr. Chihiro Akazawa, Vice Dean & Professor, Department of Biochemistry and Biophysics, Graduate School of Board: Health Care Sciences, Tokyo Medical Dental University Dr. Ken-ichi Arai, Professor Emeritus and former Dean, the Institute of Medical Science, The University of Tokyo (IMSUT), Founder & Chairman, SBI Biotech, Co., Ltd. Dr. Robert Mahley, Founder & President Emeritus, Gladstone Institutes Dr. Henry A. McKinnell, Jr., former Chairman and CEO of Pfizer, Inc. Dr. Hiromitsu Nakauchi, Professor, Stanford University and The University of Tokyo Dr. Hideyuki Okano, Dean, Keio University School of Medicine; Professor, Department of Physiology, Keio Univer- sity School of Medicine Dr. Yoshiki Sawa, Dean & Professor, Graduate School of Medicine, Osaka University Dr. Deepak Srivastava, Director, Gladstone Institutes Dr. Irving Weissman, Director, Institute for Stem Cell Biology and Regenerative Medicine, Stanford University Dr. Shinya Yamanaka, Director & Professor, Center for iPS Cell Research and Application, Kyoto University
5 Program: Thursday, November 12, 2015
09:00-09:05 MC: Ms. Yoriko Kishimoto, Former Mayor, City of Palo Alto 09:05-09:10 Opening Remark Mr. Isao “Steve” Matsuura, Council Member, Alliance Forum Foundation 09:10-09:15 Welcome Remark The Hon. Jun Yamada, Consul General of Japan, Consulate General of Japan in San Francisco 09:15-09:20 Guest Remark Dr. Jonathan Thomas, Chair, Governing Board of the California Institute for Regenerative Medicine (CIRM) (Independent Citizens Oversight Committee)
Session I: Regenerative Medicine Industry Update
09:20-09:30 2015 Regenerative Medicine Research Update Ms. Susan Solomon, Co-Founder & CEO, The New York Stem Cell Foundation 09:30-09:40 2015 Regenerative Medicine Industry Update (USA) Mr. Michael Werner, Executive Director, Alliance for Regenerative Medicine 09:40-09:50 2015 Regenerative Medicine Industry Update (Japan) Mr. Yuzo Toda, Representative Director & Chairman, Forum for Innovative Regenerative Medicine 09:50-10:20 Panel Discussion: 2015 Regenerative Medicine Industry Update Moderator: Dr. Jonathan Thomas, Chair, Governing Board of the CIRM (Independent Citizens Oversight Committee) Ms. Susan Solomon, Chief Executive Officer, The New York Stem Cell Foundation Mr. Yuzo Toda, Representative Director, Forum for Innovative Regenerative Medicine Mr. Michael Werner, Executive Director, Alliance for Regenerative Medicine
10:20-10:40 Coffee Break
10:40-10:45 Guest Remark Mr. Kan Suzuki, Advisor, Ministry of Education, Culture, Sports, Science and Technology
10:45-10:55 Company Presentation 1: ROHTO Pharmaceutical Co., Ltd. Dr. Katsuya Hisamichi, Executive Officer, Rohto Pharmaceutical Co., Ltd.
Session II: Road to Commercialization (Part 1)
10:55-11:00 Moderator: Ms. Susan Solomon, Co-Founder & CEO, The New York Stem Cell Foundation 11:00-11:25
12:30-13:30 Lunch Break (Hawthorne Room & Cypress Room)
6 Program: Thursday, November 12, 2015
13:30-13:40 Company Presentation 2: Lonza Mr. David Smith, Senior Vice President, Global Business Development, Lonza
Special Announcement: Regenerative Medicine Top News of the Year
13:40-13:55 2015 Top News of the Year Mr. Kevin McCormack, Senior Director of Public Communications, CIRM
Session III: Regenerative Medicine’s Frontier
13:55-14:15 Regenerative Medicine in the Future Dr. Hiromitsu Nakauchi, Professor, Stanford University School of Medicine & The University of Tokyo 14:15-14:30 Regenerative Medicine Front Line 1 Dr. Koji Eto, Professor, Center for iPS Cell Research and Application, Kyoto University 14:30-14:45 Regenerative Medicine Front Line 2 Dr. Takanori Takebe, Associate Professor, Yokohama City University School of Medicine
14:45-14:55 Company Presentation 3: Minerva Biotechnologies Dr. Cynthia Bamdad, CEO, Minerva Biotechnologies
14:55-15:15 Coffee Break
Session IV: What’s Next in Regenerative Medicine Translation?
15:15-15:20 Moderator: Dr. Brock Reeve, Executive Director, Harvard Stem Cell Institute 15:20-15:40 Dr. Arnold Kriegstein, Director & Professor, UCSF Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research 15:40-16:00 Dr. Hideyuki Okano, Dean, Keio University School of Medicine, Professor, Department of Physiolo- gy, Keio University School of Medicine 16:00-16:20 Dr. Brock Reeve, Executive Director, Harvard Stem Cell Institute, Harvard University 16:20-16:40 Dr. Xianmin Zeng, Associate Professor, Buck Institute for Aging Research 16:40-17:25 Panel Discussion: What’s Next in Regenerative Medicine? Moderator: Dr. Brock Reeve, Executive Director, Harvard Stem Cell Institute Dr. Arnold Kriegstein, Director & Professor, UCSF Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research Dr. Hideyuki Okano, Dean, Keio University School of Medicine, Professor, Department of Physiolo- gy, Keio University School of Medicine Dr. Xianmin Zeng, Associate Professor, Buck Institute for Aging Research
17:25-17:30 Day 1 Concluding Remark
17:30-18:30 Networking & Cocktail Reception (Hawthorne Room)
7 Program: Friday, November 13, 2015
09:00-09:05 MC: Ms. Tasha Yorozu, Managing Attorney, Yorozu Law Group 09:05-09:10 Guest Remark Dr. Satoshi Imamura, Vice President, Japan Medical Association
Session V: Japan and its Bold Initiatives
09:10-09:20 Regulatory Changes in Japan Mr. Hidetaka Nishimura, Director, Bio-Industry Division, Ministry of Economy, Trade and Industry 09:20-09:30 Industry Initiatives Mr. Yuzo Toda, Representative Director & Chairman, Forum for Innovative Regenerative Medicine 09:30-09:55 Academic Initiatives: Development of iPSC Technology & Beyond Dr. Yoshiki Sawa, Dean & Professor, School of Medicine, Osaka University
09:55-10:25 Panel Discussion: Japan - Regenerative Medicine’s Go-To Place? Moderator: Dr. Ellen Feigal, Partner, NDA Partners, LLC and Adjunct Professor, College of Law, ASU Mr. Hidetaka Nishimura, Director, Bio-Industry Division, Ministry of Economy, Trade and Industry Dr. Yoshiki Sawa, Dean & Professor, School of Medicine, Osaka University Mr. Yuzo Toda, Representative Director, Forum for Innovative Regenerative Medicine
10:25-10:45 Coffee Break
Session VI: Enabling Regenerative Medicine
10:45-11:30 Panel Discussion: Bringing Cell Therapies to the Market (Cell Culture, Pro- cessing, Safety & Quality Control) Moderator: Dr. Chihiro Akazawa, Vice Dean & Professor, Graduate School of Health Care Sciences, Tokyo Medical and Dental University Ms. Yukiko Araki, Executive General Manager, Government and External Relations Division, Hitachi Ltd. Healthcare Company Dr. Stewart Craig, Vice President of Manufacturing, Sangamo BioSciences Dr. Anthony Davies, President, Dark Horse Consulting Dr. Keiichi Fukuda, Professor, Department of Regenerative Medicine and Advanced Cardiac Thera- pies, Graduate School of Medicine, Keio University Dr. David Smith, Senior Vice President, Global Business Development, Lonza 11:30-12:10 Panel Discussion: Current Use of Stem Cells – Drug Screening & Development Moderator: Dr. Arlene Chiu, Director of the Office of New Research Initiatives, Beckman Research Institute, City of Hope Dr. Paul August, Senior Director, Discovery Biology Department Head, Sanofi Tucson Innovation Center Dr. Seigo Izumo, Senior Vice President & Global Head of Regenerative Medicine Unit, Takeda Phar- maceutical Company, Ltd. Dr. Danilo Tagle, Associate Director for Special Initiatives, National Center for Advancing Transla- tional Sciences, NIH
12:10-12:20 Company Presentation 4: Asterias Biotherpeutics Dr. Katharine Spink, Chief Operating Officer, Asterias Biotherapeutics
12:20-13:20 Lunch Break (Hawthorne Room & Cypress Room)
8 Program: Friday, November 13, 2015
Session VII: Road to Commercialization (Part 2)
13:20-13:25 Moderator: Dr. Karen Tkach, Staff Writer, BioCentury Innovations 13:25-13:50
14:40-14:50 Company Presentation 5: Takeda Pharmaceutical Company Limited Dr. Seigo Izumo, Senior Vice President & Global Head of Regenerative Medicine Unit, Takeda Phar- maceutical Company, Ltd.
14:50-15:10 Coffee Break
Session VIII: Regenerative Medicine – Now and the Future
15:10-15:30 Keynote Speech: Future of Regenerative Medicine Dr. Shinya Yamanaka, Nobel Laureate, Director & Professor, Center for iPS Cell Research and Appli- cation, Kyoto University 15:30-16:10 Panel Discussion: Regenerative Medicine 2020 & 2030 Moderator: Ms. Susan Solomon, Co-Founder & CEO, The New York Stem Cell Foundation Mr. Robert Klein, Chairman Emeritus, CIRM Dr. Jonathan Thomas, Chair, Governing Board of the CIRM (Independent Citizens Oversight Com- mittee) Dr. Shinya Yamanaka, Nobel Laureate, Director & Professor, Center for iPS Cell Research and Appli- cation, Kyoto University
16:10-16:30 Concluding Remark Amb. George Hara, Chairman, Alliance Forum Foundation & DEFTA PARTNERS; Special Advisor to the Cabinet Office of the Prime Minister of Japan
16:30-17:30 Networking & Cocktail Reception (Hawthorne Room)
9 Speakers: Thursday, November 12, 2015
Steve Matsuura is Chairman of MIK International. He served as a Visiting Professor of Law at Osaka University (since 1999 to 2013) and a Board director of Bank of the West (2002 to 2014). His career in international banking has taken him to London, Japan, New York, Los Angeles, and San Francisco. He served as Chairman, President, and CEO of Sanwa Bank California from 1992-1994 and 1998-2002. Mr. Matsuura joined Sanwa Bank Ltd. Head Office in Japan right after graduation from Kyoto Univer- sity in 1963. Over the years he has held many positions, including General Manager of Corporate Plan- ning, Assistant to the President & CEO, General Manager of Corporate Communications, General Man- ager of the New York Branch, Chairman of the Management Committee of Sanwa Securities (USA) Co., LP and Sanwa Financial Products Co., LP. He served on the Board of Directors of Sanwa Bank, Ltd., Japan and of Sanwa Bank California (1990-1998).
Mr. Matsuura was Chairman of the Board of Directors of the Japan Society from 2011 to 2015. He is also on the board of numerous non-profit organizations including the Japanese Chamber of Commerce Isao “Steve” of Northern California, International House at University of California, San Francisco-Osaka Sister Matsuura City. Mr. Matsuura has long been an advocate for strengthening US-Japan understanding. In 2007 he Council Member, was named Distinguished Alumnus of the Year by I-House at UC Berkeley and in 1984 he received the Alliance Forum Foundation Outstanding Corporate Executive of the Year Award from the Asian Business League of Los Angeles. Steve Matsuura received his LLB degree from Kyoto University in 1963, his LLM degree from Kobe University in 1969, and studied as a Visiting Scholar in 1970-71 at the University of California, Berkeley School of Law-Boalt Hall. His interests include playing the flute, singing, and playing golf.
Consul General Jun Yamada began his career with the Ministry of Foreign Affairs of Japan in 1982 and has been involved in the foreign service for over 30 years. His assignments overseas have included postings in Russia, the United States, Thailand, and the European Union. His domestic assignments in Tokyo have included work at the Economic Affairs Bureau, Cabinet Office, and Ministry of Finance.
Mr. Yamada began his current assignment as the Consul-General of Japan in San Francisco in May 2015. He was born in Morioka, Iwate Prefecture in Japan, and received a BA in law from Tokyo Uni- versity in 1982 and a Master of Laws degree from the University of London in 1985.
Jun Yamada Consul General of Japan in San Francisco
Jonathan Thomas, Ph.D., J.D., is the Chair of the governing Board of California’s stem cell agency, the California Institute for Regenerative Medicine (CIRM). As Chair he is responsible for helping guide the funding decisions of the agency’s 29 member Board, charged with distributing $3 billion to fund the development of stem cell therapies and cures for people in need.
JT’s interest in science is a long-running one. He majored in Biology and History at Yale. As a George C. Marshall Scholar at Oxford, he then earned a PhD with a medical focus in Commonwealth History before returning to Yale Law School.
His career has spanned finance, the law and politics. Before joining CIRM he was a Co-Founding Part- ner at Saybrook, an investment banking and private equity firm based in Santa Monica, California. His legal experience includes clerking for White House Counsel Lloyd Cutler in the last year of the Carter Jonathan Administration. He has also served on a number of Boards working closely with political officials at the Thomas federal, state and local level on a variety of projects for over 25 years Chair, Governing Board of the California Institute JT also has a long-standing commitment to patient advocacy, serving more than 15 years on the Board for Regenerative AbilityFirst, which assists children with spinal cord injuries and mental disabilities that could be tar- Medicine gets of stem cell therapies.
10 Susan L. Solomon is Founder and CEO of The New York Stem Cell Foundation (NYSCF) Research Institute, the world’s leading non-profit research institute dedicated to translating cutting-edge stem cell research into clinical breakthroughs. Privately funded, NYSCF is unconstrained and therefore unique in its ability to expedite the most promising stem cell research both at its own independent laboratory employing 45 full-time scientists and through its collaborations with more than 50 academic, philanthropic, and corporate institutions around the globe. From a standing start in 2005— only 10 years ago—NYSCF has raised and invested more than $150 million in “tipping point” stem cell research, acceler- ating progress in finding treatments and cures for diabetes, ALS, multiple sclerosis, Parkinson’s, Alzeheimer’s, heart disease, cancer, schizophrenia, macular degeneration, and bone degeneration, among other diseases.
Ms. Solomon is a frequent keynote speaker at global conferences including TED Global, South by Southwest Interactive, and the Karolinska Institutet’s Days of Molecular Medicine Conference. She has also published extensively on the sub- jects of stem cell research and pioneering the non-profit biotechnology sector.
A veteran healthcare advocate, Ms. Solomon serves on the boards of a number of prominent diabetes and regenerative medicine organization including the College Diabetes Network and the Centre for Commercialization of Regenerative Susan Medicine. She has received numerous awards for her work with NYSCF, including the New York State Women of Excel- Solomon lence Award from the Governor of New York and the Triumph Award from the Brooke Ellison Foundation. Co-Founder & Chief Executive A lawyer by training and a chief executive and entrepreneur by experience, Susan L. Solomon brings decades of leader- Officer, The New York ship experience in starting and building effective and focused organizations. Ms. Solomon started her career as an attor- Stem Cell Foundation ney at Debevoise & Plimpton, then held executive positions at MacAndrews and Forbes and APAX (formerly MMG Patricof and Co.). She was the founder and President of Sony Worldwide Networks, the Chairman and CEO of Lancit Media Productions, an Emmy award-winning television production company, and then served as the founding CEO of Sothebys.com, prior to starting her own strategic management consulting firm Solomon Partners LLC in 2000. She received her BA cum laude from New York University and her JD from Rutgers University School of Law, where she was as an editor of the Law Review.
Michael Werner has more than 25 years of healthcare law, lobbying, policy development, and regulato- ry experience in Washington. In addition to forming the Alliance for Regenerative Medicine and serv- ing as its Executive Director, he is also a Partner at the law firm Holland & Knight, LLP. He focuses on issues affecting biotechnology and pharmaceutical companies, researchers and research institutions, health care investors, physicians, and patients with particular expertise in regenerative medicine. His work with clients include helping them obtain federal funds through the appropriations and grants processes; FDA drug/biologic legislation and regulations including regulation of cell therapy and re- generative medicine products; FDA and NIH oversight of clinical trials including registries and report- ing of trial results; approval and marketing of orphan drugs; as well as conflicts of interest and other bioethics issues arising from research and uses of new technologies. Michael Werner Executive Director, Alliance for Regenerative Medicine
Yuzo Toda received a MSc degree in the Graduate School of Engineering from Chiba University, Japan in 1973. He has worked for over 20 years in the Fujifilm Corporation, including positions as Corporate Vice President and General Manager, Life Sciences Products Division; then Director, Senior Vice Presi- dent of the Pharmaceutical Products Division and, from 2013, Senior Vice President of Regenerative Medicine. He is Director of Fujifilm Kyowa Biologics Co. Ltd and is Chair of the Forum for Innovative Regenerative Medicine, Japan.
Yuzo Toda Representative Director & Chairman, Forum for Innovative Regenerative Medicine
11 Dean, Keio University School of Medicine
Board of Director, International Society of Stem Cell Research (ISSCR)
Hideyuki Okano received an M.D. in Physiology from Keio University in 1983, and served as a research associate at Keio University School of Medicine and Osaka University Institute for Protein Research. After he obtained a Ph.D. degree from Keio University in 1988, he held a postdoctoral position at Johns Hopkins University Medical School. He was appointed full professor at Tsukuba University School of Medicine in 1994, and at Osaka University School of Medicine in 1997, and he returned to Keio Univer- sity Medical School in 2001 as a full professor of Physiology. From 2007 to 2011, he had been the Dean of Keio University Graduate School of Medicine. He is acting as a Dean of Keio University School of Medicine. Since 2011, he has served on the Board of Directors of the International Society of Stem Cell Research (ISSCR). He has been conducting basic research in the field of restorative medicine including Hideyuki neural stem cells and iPS cells, spinal cord injury, developmental genetics, and RNA binding proteins Okano such as Musashi. Among many research areas, he is actively working on i) transplantational research Dean, Keio University on spinal cord injury and strokes using iPS technologies and ii) neuroscience research using transgenic School of Medicine; technology of non-human primates, which was originally developed by his own collaborative team. His Professor, Department of group is aiming to start the first human trials of iPSCs-based cell therapy for spinal cord injury in the Physiology, Keio University next three years. He has received many awards and honors including the Medal with Purple Ribbon School of Medicine from the Japanese Government in 2009.
Mr. Mori has been Co-Chief Executive Officer and has served as a member of the Board since SanBio's inception in 2001. Prior to founding SanBio, Mr. Mori was Head of New Product Development from 2000 to 2001 at Xuma, an informatics startup in San Francisco. From 1993 to 1999, Mr. Mori held positions of increasing responsibility in R&D and Manufacturing at Kirin Brewery, Ltd. in Japan. Mr. Mori has an MBA degree from the University of California, Berkeley and a master's degree in Biochem- istry from University of Tokyo.
Keita Mori Co-CEO, Chairman & Co-Founder, SanBio, Inc.
Dr. Linda Marbán, Co-founded Capricor Inc. in 2005 and has served as Chief Executive Officer since 2010. She com- bines her background in research with her business experience to lead Capricor and create a path to commercializa- tion for its novel stem-cell cardiac therapies.
Dr. Marbán was the lead negotiator in procuring the license agreements that are the foundation of Capricor’s intellec- tual property portfolio. Under her direction, Capricor secured approximately $27.0 million in nondilutive grants and a loan award which funds Capricor’s R & D programs and clinical trials involving its CAP-1002 products.
Her deep knowledge of the cardiac space allows her to provide unique direction for the company’s development and growth.
From 2003-2009, Dr. Marbán was with Excigen Inc. where she was responsible for business development, opera- tions, pre-clinical research, and supervising the development of gene therapy products in a joint development agree- Linda ment with Genzyme Corp. She also negotiated a joint development and sublicense agreement with Medtronic Corp. utilizing Exigen’s technology and supervised the building of a lab in which the work was to be performed. Marban President, CEO Dr. Marbán began her Ph.D career at the Cleveland Clinic Foundation working on the biophysical properties of cardi- & Director ac muscle. She continued her work in a postdoctoral fellowship at John Hopkins University, or JHU. Dr. Marbán Capricor Therapeutics advanced to the rank of Research Assistant Professor in the Department of Pediatrics, where she focused on the mechanism of contractile dysfunction in heart failure. Her tenure at JHU ran from 2000 to 2003. Dr. Márban earned a Ph.D from Case West Reserve University in cardiac physiology.
12 Neil Littman is the Business Development Officer at the California Institute for Regenerative Medi- cine. Mr. Littman is responsible for establishing and maintaining relationships with current and pro- spective partners, including companies, academic institutions, international agencies, and investors. Mr. Littman actively pursues potential partners and licensees for CIRM’s portfolio of >70 active thera- peutic programs. In addition, Mr. Littman proactively identifies and screens external stem cell pro- grams for inclusion in CIRM’s $3 billion portfolio. Mr. Littman also helps to manage CIRM’s interna- tional partnerships and other collaborations including CIRM’s iPSC Bank and the Alpha Clinical Net- work.
Prior to joining CIRM in 2012, Mr. Littman was a Senior Associate in the Merchant Banking Group at Burrill & Company, a diversified global financial services firm focused on the life sciences industry based in San Francisco. Prior to joining Burrill & Company in 2009, Mr. Littman worked in the Neil Healthcare Investment Banking group at Thomas Weisel Partners where he focused on strategic advi- Littman sory and public and private financings. Prior to Thomas Weisel Partners, Mr. Littman worked in the Business Development Healthcare Investment Banking group at Deutsche Bank Securities. Officer, California Institute Mr. Littman received a Master of Science in Biotechnology with a concentration in Biotechnology En- for Regenerative Medicine terprise from The Johns Hopkins University, and a Bachelor of Arts in Molecular, Cellular and Devel- opment Biology from the University of Colorado Boulder.
Elona Baum is Managing Director of DEFTA Partners and has 20 years of biotech and regenerative medicine management experience. Prior to joining DEFTA Partners, Ms. Baum served as a senior ex- ecutive (General Counsel & VP Business Development) for five years at the California Institute for Re- generative Medicine (“CIRM”). During her tenure, CIRM invested nearly $1 billion in regenerative medicine programs, created a $40 million iPSC bank and launched annual roundtable meetings with FDA. Prior to joining CIRM, Ms. Baum held senior positions in the legal and regulatory departments at Genentech Inc. for over a 13 year span. Ms. Baum received her BA in Economics from the Universi- ty of California (Cum Laude) and her JD from the University of San Francisco School of Law (Magna Cum Laude). She served as an extern for Justice John A. Arguelles, California Supreme Court. Ms. Baum is a frequent speaker at industry conferences and is an active mentor with Enterprise Futures Network.
Elona Baum Managing Director, DEFTA PARTNERS
Amy focuses on healthcare new business creation for GE Ventures/healthymagination. In addi- tion to venture investments, Amy is driving growth strategy for new business creation portfolio companies as well as scoping and seeding independent business opportunities. Amy was Chief Business Officer at Navigenics, a genomics company sold to Life Technologies in 2012. She was the co-founder and Executive Director of Proposition 71, California’s $3B stem cell research ini- tiative passed in 2004, as well as Chief of Staff at the resulting state grant oversight agency. Ear- lier in her career, Amy was an early employee at E-Loan, Inc., the first online consumer mort- gage company, with that company through its IPO. She also worked for the World Bank Group to scale and deliver leapfrog technologies to developing economies. Amy holds an MBA and MA/ BA in English from Stanford University. She was also a Coro Fellow and an Aspen Institute Soc- rates Fellow. Amy DuRoss Executive Director, GE Ventures, New Business Creation
13 Perry Karsen is currently Chief Executive Officer of Celgene Cellular Therapeutics (CCT), Celgene’s placental stem cell research and development division. Previously, he was Executive Vice President and Chief Operations Officer at Celgene Corporation. Perry served as President and Chief Executive Officer at Pearl Therapeutics, a privately-held biotechnology company that was subsequently acquired by Astra -Zeneca, from February 2009 until July 2010. From 2004-2009, Perry was Senior Vice President and Head of Worldwide Business Development at Celgene and was also responsible for emerging business- es as President, Asia/Pacific Region. Perry also held executive roles at Human Genome Sciences, Bris- tol-Myers Squibb, Genentech and Abbott Laboratories. In addition, Perry was a General Partner at Pe- quot Ventures.
Perry is a member of the Board of Directors of the Biotechnology Industry Organization (BIO) and a member of the Executive Committee; he is a member of the Board of Directors for the Life Sciences Foundation; a member of the Board of Directors of Agios Pharmaceuticals, a member of the Board of Perry Directors of Alliqua, Inc., and a member of the Board of Directors of Voyager Therapeutics. Karsen Perry has a Masters of Management degree from Northwestern University’s Kellogg Graduate School of CEO, Celgene Management, a Masters in Teaching of Biology from Duke University, and a B.S. in Biological Sciences Cellular Therapeutics from the University of Illinois, Urbana.
Geoff Nichol is currently Executive Vice President, Research and Development, at Sangamo BioScienc- es in San Francisco. He has over twenty years of experience in the pharmaceutical and biotechnology industries, and has been closely associated with the development of over 15 new drug candidates and the approval and/or launch of several marketed drugs, including Augmentin BID, Foradil® (formoterol) and Yervoy™ (ipilimumab). He started his career in drug development with SmithKline Beecham, then served on the senior global Development management team at Novartis. He then led all aspects of product development for Medarex Inc, pioneering the pharmaceutical development of the novel immunotherapeutic antibodies ipilimumab, the first agent to improve survival in advanced melanoma, and nivolumab. Following the acquisition of Medarex by Bristol-Myers Squibb Company in 2009, he served as CMO at Ikaria, prior to joining Sangamo. Geoffrey Nichol Executive VP, R&D, Sangamo BioSciences
Dr. Isaac Veinbergs is a Director in Sanofi’s External Science & Partnering team. Isaac’s main area of focus is leveraging healthcare innovation in ecosystems across western North America in order to evolve and enhance Sanofi’s pipeline. This is accomplished via the cultivating of relationships and bringing forward innovative external opportunities from academic institutions, biotech & pharma companies, non-profit organizations and the investment community to Sanofi. Prior to joining Sanofi, Isaac was head of Research Operations and Business Development at Brains On-Line, where he man- aged BOL’s research project portfolio, consisting of Industry and academically funded contract re- search projects. Before transitioning to the partnering side of healthcare, Isaac spent over 10 years as a scientist. While at Elan, Amgen, FoldRx, and Acadia Pharmaceuticals Isaac held roles of increasing responsibility worked on small molecule and biologics approaches in therapeutic areas like Neuro- degeneration and Psychiatry. His research and leadership contributed to multiple INDs and NDAs. Isaac Isaac has co-authored multiple peer-reviewed papers that have garnered nearly 3000 citations. He has Veinbergs a Ph.D. in Molecular Pathology from University of California, San Diego School of Medicine. Director, External Science & Partnering, Sanofi R&D
14 Kevin McCormack is the communications director at CIRM, the state’s stem cell agency. He considers himself to be the official translator for the agency, working to turn complex language about equally complex science into everyday English that anyone can understand. Before joining the agency he spent more than 20 years working as a journalist, most of that in TV news here in San Francisco.
Kevin McCormack Sr. Director, Public Communications & Patient Advocate Outreach, CIRM
Hiro Nakauchi obtained a M.D. from Yokohama City University School of Medicine and a Ph.D. in im- munology from University of Tokyo Graduate School of Medicine. He isolated CD8 genes during his post-doc period at the Laboratory of late Prof. Leonard Herzenberg at Stanford University. After re- turning to Japan, he started working on hematopoietic stem cells in his laboratory at RIKEN. In 1994, he became Professor of Immunology at the University of Tsukuba where he demonstrated that a single hematopoietic stem cell could reconstitute the entire hematopoietic system, a definitive experimental proof for the “stemness”. Since April 2002, he has been a Professor of Stem Cell Therapy in the Insti- tute of Medical Science at The University of Tokyo (IMSUT). In 2008, he was appointed Director of newly established Center for Stem Cell Biology and Regenerative Medicine at IMSUT. In February 2014, he returned to Stanford University as a faculty to continue his stem cell research at the Institute of Stem Cell Biology and Regenerative Medicine. Goals of his work are to translate discoveries in basic research into practical medical applications. Hiromitsu Nakauchi Professor, Stanford University & The University of Tokyo
Dr. Eto is originally clinical physician of cardiovascular medicine. After he started cell biology research at The Scripps Research Institute in 1999, he changed the focus from thrombosis to platelet biology and biogenesis. In 2003, Dr. Eto became an Assistant Professor at Institute of Medical Science, The University of Tokyo. In 2009, he was appointed Associate Professor at The University of Tokyo. He took his current position as a professor at Center for iPS Cell Research and Application, Kyoto Univer- sity in 2011. His laboratory focuses on blood generation, particularly working for bioengineering plate- let biogenesis system using iPS cell technology. Dr. Eto earned an MD in 1990 and a PhD in 1996.
Koji Eto Professor, Center for iPS Cell Research and Application, Kyoto University
15 Associate Professor, Yokohama City University Graduate School of Medical Science Visiting Associate Professor, Stanford University, Institute for Stem Cell Biology and Regenerative Medicine Researcher, PRESTO, Japan Science and Technology Agency Researcher, Mirai Design Lab co-founded by DENTSU Inc. & Hakuhodo Inc.
Takanori Takebe graduated from the Yokohama City University School of Medicine in 2011, after spells as a researcher at the Scripps Research Institute Department of Chemistry (US) in 2009 and as an in- tern at the Columbia University Department of Transplantation Surgery (US) in 2010. The same year, he became a Research Associate at Yokohama City University. Within three years, he had published a number of exceptional pioneering works in the field of organ generation from iPS cells, proposing a new transplant approach to combat intractable organ failure – stem cell-derived organ bud transplan- Takanori tation therapy. Concurrently, he held a joint appointment as a researcher at Mirai Design Lab spon- sored by Dentsu to establish a new field, termed ‘Advertising Medicine,’ to study the role of communi- Takebe cation in the next-generation healthcare system. He has successfully administered more than six na- Associate Professor, tionally funded projects as PI. His recent appointment as Associate Professor at age 26 made him one Yokohama City University of the youngest faculty members ever in Japan. His areas of expertise are Regenerative Medicine and Graduate School of Medical Advertising Medicine. Science
Brock Reeve is Executive Director of the Harvard Stem Cell Institute. In partnership with the Faculty Directors, he has overall responsibility for the operations and strategy of the Institute whose mission is to use stem cells, both as tools and as therapies, to understand and treat the root causes of leading de- generative diseases.
HSCI is comprised of the schools of Harvard University and all its affiliated hospitals and research institutions. Under the leadership of the Executive Committee, HSCI invests in scientific research and its faculty has grown to include over 300 Principal and Affiliated members. The Institute is engaged with several leading pharmaceutical companies and foundations in joint research projects and its fac- ulty have founded several stem cell-related startup companies and serve on leading Scientific Advisory Boards. Brock Brock came to this role from the commercial sector with extensive experience in both management Reeve consulting and operations for technology-based companies, with a focus on life sciences. Brock re- Executive Director, ceived a BA and MPhil from Yale University and an MBA from Harvard Business School. Harvard Stem Cell Institute
Dr. Kriegstein received a BS from Yale University (1971), and MD and PhD from New York University (1977) with Dr. Eric Kan- del as thesis advisor. He completed Neurology Residency at the Brigham and Women’s, Children’s, and Beth Israel Hospitals, Boston, and is a board-certified clinical neurologist. He has held academic appointments at Stanford, Yale, and Columbia before joining UCSF in 2004. In 2001 he was named the John and Elizabeth Harris Professor of Neurology and became the founding Director of the Neural Stem Cell Program at Columbia University. Dr. Kriegstein is currently the John Bowes Distinguished Professor in Stem Cell and Tissue Biology and Founding Director of the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research at UCSF. He oversees one of the largest and most comprehensive stem cell programs in the US, encom- passing over 70 laboratories focused on disorders ranging from heart disease and diabetes to cancer and diseases of the nervous system.
Dr. Kriegstein’s research focuses on the stem cell niche and ways neural stem and progenitor cells produce neurons in the devel- oping brain. He was one of the first to find that radial glia (RG), long thought to simply guide neuron migration, are the primary neural stem cell population in the embryonic brain. He also described a second type of precursor cell, an intermediate progeni- tor, produced by RG that contributes to the generation of neuronal diversity. Recently he described oRG cells, a neural stem cell type in the human outer subventricular zone, that accounts for the bulk of human cortical neurogenesis. Lineage analysis links this cell type to transit amplifying daughter cells and helps explain evolutionary cortical expansion. Currently he is analyzing gene expression profiles of single cells to link human precursor cell diversity with the generation of specific adult cortical neuron subtypes. In addition, together with colleagues at UCSF, he has developed methods to derive human inhibitory cortical inter- neurons from pluripotent stem cells, a finding that may provide cell-based therapy for disorders including epilepsy and neuro- Arnold pathic pain.
Kriegstein Dr. Kriegstein serves on the editorial boards of Cell Stem Cell, Stem Cell Reports, Developmental Neuroscience, and Journal of Experimental Neurology and is currently Chair of the Publication Committee of the ISSCR. He has been an external reviewer for Director, Broad Center RIKEN, ANR, Welcome Trust, and MRC, and reviewer and Chair of the NIH Stem Cell Study Section. He has served as SAB of Regeneration member for Pfizer and advisory board member for the John Merck Scholars Program and the Allen Brain Institute. He was Medicine and Stem elected to the Institute of Medicine of the National Academies and was twice awarded a Javits Neuroscience Investigator Award Cell Research, UCSF from the NINDS. Among other honors, he was the Dodge lecturer (Washington University), the Hunt-Wilson Lecturer (American Association of Neurological Surgeons), the Lippard Lecturer (Columbia University), the Cotzius lecturer (American Academy of Neurology), and received the Solomon A. Berson Medical Alumni Achievement Award (NYU). He was selected Senior Visiting Professor by the Chinese Academy of Sciences (2012), and Astor Visiting Professor, University of Oxford (2013).
16 Dr. Zeng is a leading stem cell biologist with expertise in human pluripotent stem cells. One of her research focuses is to study neural development in human and to model neurodegenerative diseases, with a focus on Parkinson’s disease, using patient-specific and engineered isogenic iPSC lines. She has developed scalable processes of generating functional CNS and PNS cells from ESC/iPSC for cell ther- apies and drug screening.
Dr. Zeng received her PhD in Molecular Biology from the Technical University of Denmark in 2000 and had her postdoctoral training at the NIH in 2000-2005. She joined the faculty of the Buck Insti- tute in 2005 where she builds the Institute’s Stem Cell Program, and has been the Director of North Bay Shared Research Laboratory for Stem Cell and Aging at the Institute since 2008. Dr. Zeng is a recipient of several major funding by California Institute for Regenerative Medicine including a trans- Xianmin lational grant to develop clinically grade dopaminergic neurons from pluripotent stem cells for Park- inson’s disease. She is also the Founder and Chief Scientific Officer of XCell Science Inc, a biotech Zeng company dedicated to providing reagents and services in neural space. Associate Professor, Buck Institute for Aging Research
Master of Ceremonies
Former Mayor of Palo Alto
Board Director, Midpeninsula Regional Open Space District
Yoriko Kishimoto is an international consultant, author and political leader. She has worked with tech- nology executives across the Pacific negotiating partnerships and technology transfers. Prior to joining the Midpeninsula Regional Open Space District as elected board member, Yoriko Kishimoto was a member of the Palo Alto City Council where she promoted walkable communities, open government, high environmental standards, and fiscal responsibility. She became Mayor in 2007 and played a lead- ership role to “build a green economy through innovation” by convening many public-private collabo- rations. In addition to her work in the City of Palo Alto, Ms. Kishimoto also served on the boards of Hidden Villa, the Bay Area Air Quality Management District, and the Valley Transportation Authority. Yoriko She attended Wesleyan University where she earned her Bachelor of Arts degree in East Asian Studies. Kishimoto She earned her Masters in Business Administration from Stanford University. Former Mayor, City of Palo Alto
17 Speakers: Friday, November 13, 2015
Dr. Satoshi Imamura graduated the Akita University Faculty of Medicine in 1977. His specialty is anes- thesiology. He firstly worked as resident in the Mitsui Memorial Hospital in 1977 to 79. He worked for the Hamamatsu University School of Medicine from 1983 to 1987. After that he served as department chief of the Shizuoka General Hospital. He has been working as Director of Imamura Clinic since 1991. He was serving as a Board Member of the Tokyo Medical Association in 2004 to 2006. He was also serving as an Executive Board Member of the Japan Medical Association (JMA) in 2006 to 2012. He has been working as Vice-President of the JMA since 2012. At the JMA, he is mainly in charge of gen- eral affairs, health policy, financial affairs, member’s welfare, pension, taxation policy and public health. He is a core member of many important committees of the Ministry of Health, Labor and Wel- fare related to the restructuring of the social security system, cancer screening system, advanced clini- cal training program and others. He is also involved in the areas as a committee member of the public Satoshi organizations for health protection of the workers such as the industrial health program, life-style re- lated diseases control, safety in the work place, and many others. Imamura Vice President, Japan Medical Association
Hidetaka NISHIMURA has been Director, Bio-industry division, Ministry of Economy, Trade and In- dustry (METI) since April 2015. He is in charge of the promotion of bio-industry including R&D of new pharmaceuticals, industrialization of regenerative medicine and support for bio-technology.
Japanese government has established new legal framework for regenerative medicine. Japan became thereby the most suitable country for application of regenerative medicine in last November. To pro- mote industrialization of regenerative medicine, he is tackling to develop and standardize the technol- ogy relating to regenerative medicine.
His earlier appointments include Director for Fine Chemicals Office, Economic Counsellor, Embassy of Japan in Canada and Executive Advisor for State Minister of Economy, Trade and Industry. Hidetaka He also engaged in several other policy fields since he joined METI in 1993: policy for small and medi- Nishimura um enterprises, industrial policy (machine industry and service industry), security export control poli- Director, cy, industrial technology policy and energy policy. Bio-industry Division, Ministry of Economy, Trade and Industry
Yuzo Toda received a MSc degree in the Graduate School of Engineering from Chiba University, Japan in 1973. He has worked for over 20 years in the Fujifilm Corporation, including positions as Corporate Vice President and General Manager, Life Sciences Products Division; then Director, Senior Vice Presi- dent of the Pharmaceutical Products Division and, from 2013, Senior Vice President of Regenerative Medicine. He is Director of Fujifilm Kyowa Biologics Co. Ltd and is Chair of the Forum for Innovative Regenerative Medicine, Japan.
Yuzo Toda Representative Direc- tor & Chairman, Fo- rum for Innovative Regenerative Medicine
18 Dr. Yoshiki Sawa is Professor in the Department of Cardiovascular Surgery, Osaka University Gradu- ate School of Medicine. He earned a medical degree from Osaka University Faculty of Medicine in 1980 and joined the First Department of Surgery, Osaka University School of Medicine. In 1989 he pursued further education in both the departments of cardiovascular physiology and cardi- ac surgery at the Max-Planck Institute in Germany.
After returning to Japan, he became an assistant surgeon in the First Department of Surgery, Osaka University School of Medicine. He also served as a senior member of the medical staff and then a lec- turer before he became an assistant professor in 2002. In 2006, he became Professor and Dean of the Department of Cardiovascular Surgery at the Osaka University Graduate School of Medicine. He be- came Director of the Center for Advanced Medical Engineering and Informatics of Osaka University in Yoshiki 2010, Vice Chair of the Medical Innovation Promotion Office, Cabinet Secretariat in 2011, and Assis- Sawa tant Director of Osaka University Hospital and Director of the Medical Center for Translational Re- search in 2012. He was appointed as a Vice Dean at Osaka University Graduate School of Medicine in Dean & Professor, 2013. Graduate School of Medicine, Osaka University
Dr. Ellen G. Feigal is Partner, NDA Partners (NDAP), a global strategy firm focused on improving the development efficiency and speed and commercial success rate of medical products. Prior to joining NDAP in December, 2014, Dr. Feigal was Senior Vice President, Research and Development at the California Institute for Regenerative Medicine (CIRM). In this role, she was responsible for the scientific leadership and implementation of the development pro- grams, and integration of the interface with business development, research and development, of this $3B, California voter-initiative, whose mission is to advance stem cell research for the discovery and development of cures, therapies, diagnostics and research technologies for patients with chronic diseases and injuries. Prior to joining CIRM in Janu- ary, 2011, Dr. Feigal was Executive Medical Director, Global Development, at Amgen, where her primary focus was in clinical development of therapeutics in hematology/oncology. From 2007 until joining CIRM, Dr. Feigal was adjunct professor and founding Director of the American Course on Drug Development and Regulatory Sciences, UC San Francisco, School of Pharmacy. The course was developed under her leadership as a collaborative effort with the FDA, UCSF’s Department of Bioengineering and Therapeutic Sciences, its Center for Drug Development Sciences and the European Center of Pharmaceutical Medicine at the University of Basel. It is taught in Washington, D.C. with a separate parallel course in San Francisco. Prior to joining Amgen in 2008, she worked in clinical research and drug development in positions at the Federal Government, non-profit and for-profit institutes and companies. She was Chief Medical Officer, Insys Therapeutics 2007-2008, Director of Medical Devices and Imaging at the Critical Path Ellen Feigal Institute, and Vice President of Clinical Sciences and Deputy Scientific Director at the Translational Genomics Re- search Institute from 2004 to 2007. She directed the National Cancer Institute’s (NCI) Division of Cancer Treatment Partner, NDA Partners and Diagnosis from 2001 to 2004, served as Deputy Director from 1997 through 2001, and as senior investigator in LLC and the Cancer Therapy Evaluation Program, NCI from 1992-1997. Dr. Feigal earned a BS in biology and a MS in molec- Adjunct Professor, ular biology and biochemistry from UC Irvine, her MD from UC Davis, completed her residency in internal medicine College of Law, ASU at Stanford University, and her fellowship in hematology/oncology at UC San Francisco. She was on the faculty at UC San Francisco, and UC San Diego before joining the NCI, and is currently Adjunct Professor, Sandra Day O’Connor College of Law, ASU.
Chihiro Akazawa, MD, PhD, is the Vice Dean and the professor of Department of Biochemistry and Biophysics, Graduate School of Health Care Sciences, Tokyo Medical and Dental University (TMDU), Tokyo, Japan. He received PhD from TMDU after the clinical training at the Department of Internal Medicine, University Hospital of TMDU, followed by post-doctoral training with Dr. Stefan F. Heine- mann at the Salk Institute for Biological Studies. His research field is the somatic stem cell research such as skeletal satellite cells. He is also serving as an Associate Program Supervisor of the Research Center Network of Regenerative Medicine and a Program Officer of the Strategic Research Program for Brain Sciences, in Japan, which was funded by AMED, Japan.
Chihiro Akazawa Vice Dean & Professor, Department of Biophys- ics, Tokyo Medical and Dental University
19 Yukiko Araki serves as Corporate Officer, Executive General Manager of both the CSR & Environmen- tal Strategy Division of Hitachi, Ltd., and the Governmental and External Division of Hitachi, Ltd. Healthcare Company.
After graduating from The University of Tokyo in 1983, Ms. Araki joined The Ministry of International Trade and Industry (MITI) in Japan. She had worked for over 20 years in The Japanese government, in roles such as Director of Medical and Welfare Equipment Industries and Vice Governor of Yamagata Prefecture, Japan. Meanwhile, she studied at The Graduate School of Political Science, Massachusetts Institute of Technology, USA in 1988. Ms. Araki had developed The Japanese regenerative medicine industry while in the position of Director, Division of Bio Industries at The Ministry of Economy, Trade and Industry (METI) from 2009 to 2011. She was involved in the establishment of The Forum of Innovative Regenerative Medicine (FIRM) in Japan in 2011. In 2012, she joined Hitachi, Ltd. Ms. Ara- Yukiko ki is a member of The Japan Urban Planning Society and a councilor of The Japanese Society of Well- Araki being Science and Assistive Technology. Corporate Officer, Hitachi, Ltd.
Dr. Craig currently heads Technical Operations at Sangamo BioSciences and has over 30 years of bio- technology industry experience with recombinant biotherapeutics, antibodies, cell-based therapies and gene therapies. Prior to joining Sangamo, Dr. Craig held executive positions leading the development, manufacturing, quality systems and regulatory functions at a variety of pioneering cell and gene thera- py companies, including, StemCells, Inc.; Progenitor Cell Therapy; Xcyte Therapies; Osiris Therapeu- tics and SyStemix, Inc.
Stewart Craig Vice President of Manufacturing, Sangamo BioSciences
Dr. Anthony Davies spent the last two decades working the biotech industry, mostly in California and mostly in the fields of cell therapy, gene therapy and regenerative medicine. Last year Dr. Davies in- corporated Dark Horse Consulting, Inc. which seeks to serve these and related fields. The practice primarily focus on process, analytical and manufacturing issues, but frequently solve problems in al- lied areas such as project/program management, quality systems, regulatory affairs, drug distribution and contractor oversight. Dark Horse also has deep expertise in ‘classical’ monoclonal antibody devel- opment and more complex biologicals such as radio-labelled and otherwise conjugated products.
Anthony Davies President, Dark Horse Consulting
20 Keiichi Fukuda is a pioneer of the cardiac regeneration field and has been at its cutting edge for the past 20 years. His laboratory has made several contributions to our understanding of both the funda- mental biology of the stem cells and how to regenerate cardiomyocytes and to transplant them into the in vivo heart. He first reported that bone marrow mesenchymal stem cells can be induced to dif- ferentiate into cardiomyocytes in vitro. He also regenerated human cardiomyocytes from ES and iPS cells for clinical use. He first developed a method to generate iPS cells from peripheral circulating T lymphocytes using sendai virus containing Yamanaka factors, which enables us to obtain iPS cells from 0.1 ml of peripheral blood. He then found several factors such as noggin and Wnt were expressed at the fetal future heart forming area of the embryo, and application of these factors to ES and iPS cells can induce cardiomyocytes. Moreover, he found that G-CSF/G-CSF receptor is an autocrine growth factor for fetal cardiomyocytes, and its administration to regenerated cardiomyocytes can ex- pand their cell number. He also developed novel method to purify the cardiomyocytes from ES or iPS- Keiichi derivatives by the difference of metabolic energy pathway from the ES or iPS cells. The purified cardi- Fukuda omyocytes do not contain undifferentiated cells and do not form teratoma after transplantation. Professor, School of Medicine, Keio University
In January 2002, Mr. Smith joined Cambrex Bioproducts as the Business Unit Director of the emerging cell therapy contract manufacturing business. In 2004, he was promoted to Vice President, Business Development, and in De- cember 2005 to Vice President, Cellular Therapeutics. In this role, he assumed responsibility for contract manufac- turing, process development, and clinical/commercial development of Cambrex owned Engineered Skin Substitute (ESS) for catastrophic burns. In 2009, two years following Lonza’s acquisition of Cambrex Bioproducts, Mr. Smith became Head of Therapeutic Cell Solutions; with additional responsibilities for biotherapeutic media, process devel- opment, viral vaccines and gene therapies.
In 2015, Mr. Smith became Vice President, Global Business Development, focusing on strategic agreements and alliances for the Emerging Technologies Business Unit, which includes cell, viral therapy, antibody drug conjugates (ADCs). He is an active member of numerous government expert panels; company executive committees and advi- sory boards. Under Mr. Smith leadership the cell therapy contract manufacturing business as grown from start-up to market leader.
David Smith Prior to joining Cambrex, Mr. Smith was Vice President, Corporate Development at Claragen, Inc. and Business Unit Senior Vice President, Director at Invitrogen. Mr. Smith has spent 14 years at The Upjohn Company in various sales and marketing roles, Global Business including leading the launch of the Parkinson’s therapeutic, Mirapex. Development, Lonza Mr. David Smith holds a B.S. in Pharmacy from Duquesne University in Pittsburgh, Pennsylvania and a M.B.A. from Wheeling Jesuit University in Wheeling, West Virginia.
After graduate school at Caltech and post-doctoral training at Washington University and Caltech, Dr. Chiu joined City of Hope as the first woman recruited to the faculty in the Division of Neurosciences. Her research, on diseases afflicting motor neurons and on the role of the extracellular matrix in synapse formation, was supported by the Na- tional Science Foundation, the National Institutes of Health (NIH) and foundations such as ALSA, the March of Dimes and the Christopher and Dana Reeve Foundation. In 1998 she joined the NIH serving as program director for Spinal Cord Injury and establishing the first program for Stem Cell Research at the National Institute for Neurologi- cal Disorders and Stroke. She was one of the founding members of the NIH Stem Cell Task Force and initiated and co-chaired a monthly meeting between NIH and the Office of Cellular, Tissue and Gene Therapies of the Food and Drug Administration. Later she joined the National Institute for Biomedical Imaging and Bioengineering as associate director overseeing the Office of Research Administration. In 2004, she received the NIH Director’s Award for her contributions to the development of stem cell research. In 2005, Dr. Chiu was recruited by the California Institute for Regenerative Medicine, the state’s stem cell agency as Director of Scientific Activities and later served as Interim Chief Scientific Officer. As one of the founding members of this new agency, Dr. Chiu played a key role in the organi- zation and execution of the review process, in developing grants administration policy and procedures, and in the Arlene Chiu formation of a comprehensive, 10 year Strategic Plan. She returned to the City of Hope in 2008 as director of the Director of the Office of Office of New Research Initiatives, and Professor-in-residence in the Beckman Research Institute where she fosters New Research Initiatives, new research and partnerships to bring cell-based therapies to the clinic. She currently serves on several advisory Beckman Research boards and has played a pivotal role in helping Peking University establish its first Embryonic Stem Cell Oversight Institute, Committee. Dr. Chiu continues to be a strong mentor to young scientists, especially women, and a keen supporter of City of Hope responsible conduct in research.
21 Dr. August obtained his Ph.D. from the University of Minnesota, Department of Microbiology, Immu- nology, and Cancer Biology, and pursued his interest in pharmaceuticals with a NIH Post-Doctoral fellowship at the University of Washington, Seattle in the Department of Organic Chemistry. Dr. Au- gust has held key scientific and leadership roles at Sanofi in the US over his last seventeen years with Sanofi. Dr. August began his Sanofi career in 1998 at the Hoechst-Ariad Genomics Center in Cam- bridge Massachusetts. In recent years however, he relocated to Tucson Arizona where he has led the Discovery Biology department at the Sanofi Tucson Innovation Center. In this role, Dr. August has pur- sued innovative, entrepreneurial, business and scientific strategies to identify and develop therapeutics in partnership with academic investigators, biotechnology companies and rare disease patient founda- tions. Dr. August’s research has been particularly focused on developing disease relevant, human cellu- Paul August lar models for rare neuromuscular diseases. Leveraging the high volume biology infrastructure and Senior Director, novel chemistry capabilities at the Tucson Innovation Center, Dr. August and his team are applying Sanofi R&D, these models and state of the art stem cell technologies to deliver transformative therapeutics to pa- Discovery Biology tients with rare diseases. Department Head, Sanofi Tucson Innovation Center
Dr. Seigo Izumo is Senior Vice President, Global Head of Regenerative Medicine Unit and Head of Sci- entific Affairs in Japan at Takeda Pharmaceutical Company. Previously he served as Senior VP & Head of Cardiovascular Therapeutics at Gilead Sciences, and VP & Global Head of Cardiovascular Research at Novartis. Prior to joining the industry, Dr. Izumo was Professor of Medicine, Harvard Medical School and Director of Cardiovascular Research, Beth Israel Deaconess Medical Center, Boston, and Chief of Cardiology Division, Professor of Internal Medicine & Biological Chemistry and Director of the Center for Organogenesis, University of Michigan Medical School. Dr. Izumo graduated from Universi- ty of Tokyo and received clinical and research trainings at Harvard-affiliated Beth Israel Hospital and The Children’s Hospital, Boston. He is a board-certified physician in internal medicine and cardiovas- Seigo Izumo cular disease. Senior Vice President & Global Head of Regenerative Medicine Unit, Takeda Pharmaceutical Company Ltd.
Dr. Danilo Tagle is Associate Director for Special Initiatives at the National Center for Advancing Translational Sci- ences (NCATS). He leads and provides scientific and programmatic oversight and coordination to the following trans -NIH programs: 1) NIH Microphysiological Systems (a.k.a. tissue chip) program http://www.ncats.nih.gov/ research/reengineering/tissue-chip/tissue-chip.html and http://commonfund.nih.gov/regulatoryscience/index , 2) Extracellular RNA Communication programhttp://commonfund.nih.gov/Exrna/index , and 3) SPARC (Stimulating Peripheral Activity to Relieve Conditions) programhttp://commonfund.nih.gov/sparc/index . These activities in- volve coordination with other NIH institutes and centers, as well as partnerships with other government agencies, such FDA, DARPA, DTRA and the private sector. Prior to joining NCATS, Dr. Tagle was a Program Director for Neu- rogenetics at the National Institute of Neurological Disorders and Stroke (NINDS) where he was involved in develop- ing programs in genomics–based approaches for basic and translational research in inherited brain disorders. Dr. Tagle obtained his Ph.D. in Molecular Biology and Genetics from Wayne State University School of Medicine in 1990. He was an NIH NRSA postdoctoral fellow in Human Genetics at the laboratory of Dr. Francis S. Collins at the Uni- versity of Michigan. Prior to joining NINDS in 2001, Dr. Tagle was an Investigator and Section Head of Molecular Neurogenetics at the National Human Genome Research Institute (NHGRI) beginning in 1993, and has been in- Danilo Tagle volved in the highly collaborative effort towards the positional cloning of genes for Huntington’s disease, ataxia- telangiectasia, and Niemann-Pick type C disease. In addition to being Associate Director for Special Initiatives, Dr. Associate Director for Tagle recently served as Acting Director for the NCATS Office of Grants Management and Scientific Review, and Special Initiatives, currently serves as Executive Secretary to the NCATS Advisory Council, as well as the Cures Acceleration Network National Center for Review Board. He has served in numerous committees and advisory boards, and was on the Editorial Board of the Advancing Translation- journal Gene, as well as International Journal of Biotechnology. He has more than 150 scientific publications, and al Sciences (NCATS), has garnered numerous awards and patents. Central to Dr. Tagle’s accomplishments and goals is leveraging key re- NIH sources and expertise through partnerships with various stakeholders in biomedical research, including various gov- ernment agencies, non-profits and patient advocacy groups, industry and pharmaceutical corporations.
22 Dr. Karen Tkach is a staff writer for BioCentury's translational publication BioCentury Innovations, where she writes about science at the academia-industry interface and preclinical developments from "idea to IND." She earned her bachelor's degree in molecular and cell biology and English literature at UC Berkeley, where she investigated the role of the natural killer cell receptor NKG2D in type 1 diabe- tes. She subsequently earned her PhD in immunology and quantitative biology through a joint pro- gram between Weill Cornell Medical College and Memorial Sloan Kettering Cancer Center, where she studied how feedback loops in T cell antigen and cytokine signaling create a power law relationship between antigen quantity and interleukin-2 secretion. Dr. Tkach then trained as a postdoctoral fellow in the Chemical and Systems Biology department at Stanford University, exploring how glucocorticoid rhythms impact adipocyte differentiation from mesenchymal stem cell precursors. Dr. Tkach has served as a scientific consultant for the computational drug discovery company twoXAR Inc., and a Karen writer for the former New York Academy of Sciences blog "Pathways to Science." Tkach Staff Writer, BioCentury Innovations
Dr. Chris Armstrong is the President and Chief Executive Officer of Stem Cell Theranostics, Inc. and has over 15 years of experience in the Life Sciences Industry. He was previously the Vice President and General Manager of the Cell Biology Business Unit at Thermo Fisher Scientific, where he had global P&L responsibility for research cell culture, primary and stem cells, transfection, drug discovery and ADME/Tox portfolios. Prior to this, Dr. Armstrong held various leadership roles in general manage- ment, R&D, product management and sales at Life Technologies, Invitrogen and Upstate Biotechnolo- gy. Dr. Armstrong holds a Ph.D in molecular biology and biochemistry from the University of Dundee, UK, an M.Sc in biophysics from the University of Leicester, UK, and has authored numerous papers and patents.
Chris Armstrong President & CEO, Stem Cell Theranostics, Inc.
Mark Powers has been focused on the innovation and commercialization of cell-based tools, reagents, and systems for nearly 15 years. He currently serves as Senior Director of R&D for Cell Biology at Thermo Fisher Scientific, overseeing the development of novel products and technologies related to the generation, culture, manipulation and analysis of diverse cell systems. Prior to his current role, Mark was actively involved in research initiatives directed towards tissue engineering and the creation of physiologically relevant primary and stem cell model systems for use in research, drug discovery and cell therapy. He received his Ph.D. in Chemical Engineering from the Massachusetts Institute of Technology, and completed postdoctoral appointments in Surgical Research and Biological Engineer- ing at Harvard Medical School and the Massachusetts Institute of Technology.
Mark Powers Senior Director, R&D, Cell Biology Business Unit, Thermo Fisher Scientific
23 Mr. Stracey was appointed Chief Executive Officer in June 2015 after serving as Interim CEO and Di- rector since October 2014. Mr. Stracey has been a member of the Board since July 29, 2011. In July 2012, Mr. Stracey became Director, President and Chief Executive Officer of Integrated Fluidics, Inc., a privately-held microfluidics company. From December 2007 to April 2012 he was the President and Chief Executive Officer of Cantimer Incorporated, a privately-held biosensor company. From Novem- ber 2003 to March 2007, Mr. Stracey was Director, President and Chief Executive Officer of Applied Imaging Corporation, a publicly-traded, computer-aided diagnostics company that is now part of Dan- aher Corporation. Previously, Mr. Stracey was the Vice President and General Manager of a Chroma- tography and Mass Spectrometry business unit of Thermo Electron Corporation, now Thermo Fisher Scientific, the world’s largest supplier of laboratory equipment and reagents to life scientists. He also served as a Corporate Vice President at Dade Behring Inc., a leading supplier of clinical diagnostic products that is now part of Siemens Healthcare. Mr. Stracey has a B.S. degree with honors from the Robin University of Nottingham in the United Kingdom and is a graduate of the Executive Program at the Stracey Stanford University Graduate School of Business. CEO & Director, Cesca Therapeutics
Dr. Sethi served as a Clinical Scientist with TotipotentRX Corporation from February 2012 through the merger with ThermoGenesis Corp. in February 2014 that created Cesca Therapeutics Inc. Following the merger he was appointed Senior Clinical Scientist. Dr. Sethi holds a Ph.D. Biotechnology from In- stitute of Genomics & Integrative Biology, New Delhi, and a Masters in Organic Chemistry from Hansraj College, Delhi University, India. Dr. Sethi was trained at Thomas Jefferson University, School of Medicine, as a Postdoctoral fellow in the field of receptor targeted Peptide-PNA conjugates for can- cer diagnostics. Dr. Sethi has extensive experience in point-of-care devices, methods and diagnostics employed in autologous cell therapy clinical trials in treatment of cardiovascular and orthopedic dis- eases. Dr. Sethi has In-depth knowledge of cellular product analysis that comprises coulter and flow- cytometry methods for progenitor cell enumeration, cytokine profiling, in-vitro and in-vivo bioactivity and potency assays. Dalip Sethi Senior Clinical Scientist, TotipotentRX
Dr. Nuwaysir currently holds the position of President of Cellular Dynamics International, Inc. – a Fujifilm company. Prior to that, he was Chief Operating Officer and Vice President of R&D, Manufac- turing and Quality Systems of Cellular Dynamics International (CDI) from 2008 - 2015. He is a Found- er and Vice-Chairman of Invenra, a Madison-based drug discovery company with a propriety platform for biologics drug discovery, since the company’s inception in 2011. Prior to CDI, he was Senior Vice President of Program Management (PM) and Chief Technical Officer (CTO) at Roche NimbleGen, a division of Roche Diagnostics, from 2007 to 2008. In the PM role, he oversaw product portfolio and lifecycle management for Roche NimbleGen products, and managed all Business Development activi- ties. In the CTO role, he managed a team in optical, mechanical, and fluidics engineering, bioinfor- matics, molecular biology, photochemistry, and software development. Prior to Roche Diagnostics, he was the first employee hired at NimbleGen Systems, where he worked from 2000 to 2007, and served in various roles including Vice President of Business Development, and Group Leader of Molecular Emile R&D. Prior to NimbleGen, he held a Postdoctoral Fellowship at the National Institutes of Health (NIEHS), a postdoctoral fellowship at the University of North Carolina-Chapel Hill and a research po- Nuwaysir sition at EI DuPont de Nemours Stine-Haskell Laboratory. He earned his B.A. from the University of President & COO, Delaware and his Ph.D. in Molecular and Environmental Toxicology with a focus in Oncology from the Cellular Dynamics University of Wisconsin-Madison in the McArdle Laboratory for Cancer Research. International, Inc
24 Toshikazu Ban has been in pharmaceutical industries for over two decades. He served as several posi-
tions of R&D Management and Licensing & Business Development at Takeda Pharmaceuticals Inc, in Japan and also the United States, including a position of Senior Vice President, Global Business De- velopment. He joined Fujifilm Corp in 2013, and actively been involved in developing regenerative medicine business in the global basis. He holds a Bachelor of Pharmaceutical Science from The Uni- versity of Tokyo, and a Master of Science from Kyoto University.
Toshikazu Ban President, Cellular Dynam- ics International Japan & GM, Regenerative Medi- cine Business Development Office, Fujifilm Corp.
Professor Shinya Yamanaka is most recognized for his discovery of induced pluripotent stem cells (iPSC), which are differentiated cells that have been reprogrammed to the pluripotent state. He is Di- rector of the Center for iPS Cell Research and Application (CiRA), which was founded in 2008 in re- sponse to his discovery at Kyoto University, and Senior Investigator at the Gladstone Institutes.
Since his breakthrough finding, he has been the recipient of many prestigious awards including the Albert Lasker Basic Medical Research Award, the 100th Imperial Prize and Japan Academy Prize, and the Wolf Prize in Medicine. The significance of iPSC was culminated with Dr. Yamanaka being award- ed the Nobel Prize in 2012.
Shinya Professor Yamanaka also serves as a foreign associate of the NAS, an international member of the Yamanaka NAM, fellow of the AACR, and member of EMBO, Pontifical Academy of Sciences, and the Japan Academy. Nobel Laureate, Director & Professor, Center for iPS Cell Research and Application, Kyoto University
Mr. Klein authored and Chaired the campaign for Proposition 71: the California Stem Cell Research and Cures Initiative, which established the California Institute for Regenerative Medicine (CIRM). Mr. Klein served as the Chairman of the Governing Board of CIRM which manages the peer review and grant process for the $3 billion in stem cell research funding authorized by the Ini- tiative. Mr. Klein was elected Chairman Emeritus of CIRM in 2011. Mr. Klein is an accomplished philanthropist and innovator who has been named to Time Maga- zine’s "100 Most Influential People,” as well as the Scientific American's “The Scien- tific American 50” as a leader shaping the future of science. Mr. Klein’s public service awards include: the Biotechnology Industry Organization’s Inter- national Conference’s "Biotech Humanitarian Award”, Research!America’s "Gordon & Llura Gund Leadership Award,” and the International Society for Stem Cell Re- search (ISSCR) “ISSCR Public Service Award.” Mr. Klein is a currently a Member of the Board of Directors of the Ontario Institute for Cancer Re- Robert Klein search. He has served on the Boards of the Global Security Institute, Genome Canada, and the Cali- Chairman Emeritus, fornia Housing Finance Agency. California Institute for Regenerative Medicine Mr. Klein serves as the current President of Klein Financial Corporation, a real estate development and investment banking company focused on multi-family housing, with an affordable component.
25 Jonathan Thomas, Ph.D., J.D., is the Chair of the governing Board of California’s stem cell agency, the California Institute for Regenerative Medicine (CIRM). As Chair he is responsible for helping guide the funding decisions of the agency’s 29 member Board, charged with distributing $3 billion to fund the development of stem cell therapies and cures for people in need.
JT’s interest in science is a long-running one. He majored in Biology and History at Yale. As a George C. Marshall Scholar at Oxford, he then earned a PhD with a medical focus in Commonwealth History before returning to Yale Law School.
His career has spanned finance, the law and politics. Before joining CIRM he was a Co-Founding Part- ner at Saybrook, an investment banking and private equity firm based in Santa Monica, California. His legal experience includes clerking for White House Counsel Lloyd Cutler in the last year of the Carter Administration. He has also served on a number of Boards working closely with political officials at the Jonathan federal, state and local level on a variety of projects for over 25 years Thomas Chair, Governing Board JT also has a long-standing commitment to patient advocacy, serving more than 15 years on the Board of the California AbilityFirst, which assists children with spinal cord injuries and mental disabilities that could be tar- Institute for gets of stem cell therapies. Regenerative Medicine
Chairman of the Board, Alliance Forum Foundation Group Chairman & CEO, DEFTA PARTNERS Special Advisor to the Cabinet Office of the Prime Minister of Japan Visiting Professor, Graduate School of Medicine, Osaka University International Council Member, Salk Institute for Biological Studies
George Hara has been active in venture capital and high technology global alliances for over two dec- ades. After founding DEFTA Partners in 1985, he became one of the most prominent Silicon Valley venture capitalists responsible for the emergence of numerous industry pioneering firms including Actuate, Borland, SCO, PictureTel, Tradex, Zoran Corporation, and Fortinet. Mr. Hara is international- ly known as a leading edge technology capitalist and visionary architect in the field of post-computer technology. Since 2005, he has been actively involved with deploying next-generation technology in developing countries to improve their standard of living. Mr. Hara has served as Special Advisor to the George Hara Cabinet Office of the Prime Minister of Japan, Chairman of the Board for the Alliance Forum Founda- Ambassador; tion, Prime Minister’s Special Commissioner on the Tax Panel (Japan), Counselor to the Japanese Chairman, Alliance Ministry of Finance, Ambassador Extraordinary and Plenipotentiary for IIMSAM Permanent Observer Forum Foundation & Mission to UN ECOSOC, and WAFUNIF Representative Ambassador. He holds a Bachelor of Law DEFTA PARTNERS from Keio University, Tokyo, and a Master of Science from Stanford University.
Master of Ceremonies
Tasha Yorozu, managing attorney at Yorozu Law Group, has been serving international corporate clients for over 18 years. With a dedicated team of lawyers and staff, Yorozu Law Group specializes in commercial transactions, tax strategy, M&A, strategic alliances, technology/media licensing, and employment law.
Growing up in the Kyoto area and having lived in the US for most of her professional life, Ms. Yorozu is perfectly posi- tioned to serve as outside general counsel to Japanese corporations doing business in the US. Her effectiveness in strategizing and negotiating deals for her clients stems from her ability to seamlessly navigate between Japanese and US corporate cultures, social mores, languages, and legal frameworks.
Ms. Yorozu serves on the Board of Directors for the Japanese Chamber of Commerce of Northern California and San Francisco-Osaka Sister City Association, and is on various committees with Alliance Forum Foundation and U.S.- Japan Council.
When she is not working, Ms. Yorozu enjoys competing in triathlons with the family. Her goal in 2016 is to beat her 11 year old son and 15 year old daughter in sprint distance triathlons, while cheering on her husband in Olympic dis- tance races.
Tasha Yorozu Education: Willamette University College of Law, Salem, Oregon (JD) Managing Attorney, Willamette University Atkinson Graduate School of Management, Salem, Oregon (MBA) Yorozu Law Group Bryn Mawr College, Bryn Mawr, Pennsylvania (BA in Economics)
Languages: Native in English and Japanese
26 Sponsors
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In-kind Sponsors
Ms. Tomoko Tsuji (IKENOBO Flower Arrangement)
Major Supporting Organizations
Hara Research Foundation
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Major Supporting Organizations
Hara Research Foundation 40