Panel 2: Manufacturing Roadmaps & Industry Challenges

Donald Fink
US Food & Drug Administration
Donald FINK is an Expert Biologist at the U.S. Food and Drug Administration (FDA), in the Center for Biologics Evaluation and Research that is part of the FDA’s Office of Cellular, Tissue, and Gene Therapies. He received his degrees from the University of Minnesota, and has served in the FDA for over 23 years.

Dr. Fink holds expertise in biology and regulatory processes for stem and pluripotent cells, and has written extensively on the regulatory process from concept to market, and the FDA perspective translation from lab to clinic for regenerative medicine.

 
Samantha Maragh
US National Institute for Standards and Technology
Samantha MARAGH is a Research Biologist in the Bioassay Methods Group within the Biosystems and Biomaterials Division at the U.S. National Institute of Standards and Technology (NIST). Dr. Maragh began working at NIST after completing her undergraduate BS degree in Cellular & Molecular Biology from Loyola University in Baltimore, MD. While working for NIST, she went on to receive an MS in Biotechnology from Johns Hopkins University in the specialty area of Molecular Targets & Drug Discovery, followed by completing a PhD in Human Genetics & Molecular Biology from the Johns Hopkins School of Medicine, McKusick-Nathans Institute of Genetic Medicine.

Dr. Maragh is currently developing and leading NIST’s programs supporting genome editing for gene and cell therapies. She also leads a project supporting better measurements for early detection of prostate cancer biomarkers in collaboration with the National Cancer Institute. Her research and program goals are focused on understanding the reliability of measurements and technology development for genome editing, bioassays, and cancer biomarkers, with applications in engineering biology and precision medicine.


Stacy L. Springs
MIT BioMAN, Director
Stacy SPRINGS is the Director of the Biomanufacturing Program (BioMAN) and the Executive Director of the MIT Consortium on Adventitious Agent Contamination in Biomanufacturing (CAACB) at the MIT Center for Biomedical Innovation. BioMAN is a collaborative research and educational program in biotherapeutic manufacturing that involves biopharmaceutical manufacturers, vendors, regulators, other government stakeholders, and academics. The objective of this program is to develop new knowledge, science, technologies, and strategies for advancing the safe manufacture and global delivery of high-quality biopharmaceuticals. The CAACB was established to share information around adventitious agent contamination and risk mitigation for the benefit of the biopharmaceutical manufacturing industry and the patients receiving medications produced from cell culture.

Dr. Springs was a key convener of MIT’s participation in the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), the 11th Manufacturing USA Institute announced in 2016, which will focus on pre-competitive research in manufacturing of biologics including protein, cell, and gene products.

Dr. Springs holds a PhD in Chemistry from the University of Texas at Austin and gained postdoctoral training in protein and biophysical chemistry at Princeton University. Prior to joining MIT, Dr. Springs was a Senior Scientist and Director of Collaborative Projects at Tetralogic Pharmaceuticals, an oncology drug discovery company in the U.S.

 
Annie Koh
Singapore Management University
Annie KOH is Vice President for the Office of Business Development at Singapore Management University. Dr. Koh served previously as the Associate Dean of SMU Lee Kong Chian School of Business and then as Dean fo the Office of Executive and Professional Education. Dr. Koh is a Fulbright Scholar and earned her PhD in International Finance from the Stern School of Business, New York University.

Dr. Koh chairs the Asian Bond Fund 2 Supervisory Committee of the Monetary Authority of Singapore, and Chairs the World Economic Forum Global Agenda Council for Southeast Asia. Instrumental in bridging academia and the industry, Dr. Koh has spearheaded partnerships between SMU and the business world such as the Human Capital Leadership Institute in partnership with the Ministry of Manpower and the UOB-SMU Entrepreneurship Alliance.

 
Krystyn J. Van Vliet
SMART BioSystems and Micromechanics and Professor, MIT
Krystyn VAN VLIET is currently the Lead Principal Investigator of the SMART BioSystems & Micromechanics (BioSyM) team at CREATE. Prof. Van Vliet is also the Koerner Professor of Materials Science & Engineering  and Biological Engineering at the Massachusetts Institute of Technology (MIT). At SMART BioSyM and at MIT, Prof. Van Vliet’s research teams focus on coupling between chemistry and mechanics at material interfaces, including the interface between cells and between cells and materials. That research has enabled novel methods to identify mesenchymal stem cells via biophysical rather than biochemical markers, for label-free sorting of cells with predictive therapeutic response.

Prof. Van Vliet is also the Director of Manufacturing Innovation for MIT’s Innovation Initiative. She served as the MIT Faculty Co-lead of the the Advanced Manufacturing Partnership 2.0, co-chaired by MIT and Dow Chemical, which provided analysis of U.S. manufacturing challenges and options for innovation in manufacturing technologies, training, and partnerships. This analysis was conveyed via the President’s Council of Advisors for Science & Technology’s 2014 report, Accelerating U.S. Advanced Manufacturing. Prof. Van Vliet coordinates MIT’s participation in nine of the 14 Manufacturing USA Institutes that were launched to enable such innovation through public-private partnerships, including MIT’s role in the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL).

Panel 1: Clinical Challenges
 
Tricia Huang
Executive Director, National Medical Research Council at Ministry of Health Singapore
Tricia HUANG is the Executive Director of the National Medical Research Council in the Ministry of Health in Singapore. She received her Bachelor degree with Honours in Natural Sciences (Biological) and Masters from the University of Cambridge, United Kingdom in 1995 and 1999 respectively. Her education was sponsored by the Singapore Economic Development Board (EDB) under the GlaxoSmithKline-EDB Scholarship.
In her role as Executive Director in the National Medical Research Council, Ms. Huang manages research grants, talent awards as well as research policy to support translational and clinical research among the medical schools and healthcare institutions in Singapore. These are aimed at creating better health and wealth outcomes for Singapore through health research and innovation. 

Prior to joining the Ministry of Health in 2015, Ms. Huang worked at EDB for 11 years, and at the Agency for Science, Technology & Research (A*STAR) for 9 years. At EDB, she spent the majority of her time in the Biomedical Sciences cluster where she did investment promotion for the biotechnology sector and developed policies and plans for Singapore’s Biomedical Sciences initiative which was launched in 2000. She also spent one year on secondment to the Ministry of Trade & Industry. At A*STAR, she held appointments at the A*STAR Graduate Academy which manages scholarships and science outreach programs, the Biomedical Research Council which manages A*STAR’s 11 biomedical research institutes & consortia, and the Planning & Policy Department.

Ms Huang is a Training Fellow for the Australasian Research Management Society. She is also a Board member of the Singapore Science Centre, and serves on the School Advisory Committee of Tanjong Katong Girls’ Secondary School.

 
William Hwang
Singapore General Hospital and Singapore Cord Blood Bank
William HWANG  is Senior Consultant and Head of Department of Hematology of the Singapore General Hospital as well as Head of the SingHealth Duke-NUS Blood Cancer Centre. He is Principal Investigator of the Laboratory of Haematopoietic Stem Cells and Associate Professor of the Duke-NUS Medical School, as well as Senior Clinical Lecturer at the Yong Loo Lin Medical School. He serves as Medical Director of the Singapore Cord Blood Bank, the country’s only public cord blood bank and Director of SingHealth Transplants, Singapore’s largest healthcare cluster. He has served as President of the World Marrow Donor Association (WMDA) as well as President of the Singapore Society of Hematology (SSH). He is currently chairing the Chapter of Haematologists as well as the workgroup on Biobanking for the Ministry of Health. He is President of the 2016 Asia Pacific Blood and Marrow Transplant Group (APBMT) Congress in Singapore.

Prof. Hwang's research has centered on hematopoietic stem cell transplantation, particularly in the field of ex vivo expansion of cord blood hematopoietic stem cells and mesenchymal stromal cell (MSC) therapy, including the use of MSC substitutes for therapy.


Russell Gruen
LKC School of Medicine, Nanyang Technological University
Russell GRUEN (MD/PhD) is Professor of Surgery in the Lee Kong Chian School of Medicine, and Director of the Nanyang Institute of Technology in Health and Medicine, at Nanyang Technological University. He is also a Consultant General Surgeon at Tan Tock Seng Hospital.

Dr. Gruen obtained his MBBS from the University of Melbourne in 1992, and completed surgery training in Australia and the University of Washington in Seattle, USA. Prior to coming to Singapore in August 2015, Prof Gruen was Professor of Surgery and Public Health at Monash University, Director of Australia’s National Trauma Research Institute, and a trauma surgeon at The Alfred, the busiest trauma centre in Australia.

Prof. Gruen’s research training included a PhD in health systems research from Flinders University in 2004, a Harkness Fellowship in Health Policy at Harvard School of Public Health, a Fellowship in Medical Ethics at Harvard Medical School, and the Advanced Management Program at Harvard Business School.

 
Antonio Bertoletti
Duke-National University of Singapore
Antonio BERTOLETTI (MD/PhD) is an infectious disease doctor who has always been fascinated by the pathogenesis of viral infections. He began working in the field of viral hepatitis as a medical student at the University of Parma (Italy) and during his MD specialization (1989-93). He worked two years (1989-91) at The Scripps Research Institute (La Jolla) characterizing for the first time the Hepatitis B virus (HBV) specific cytotoxic T cell response in man. He worked in Italy (University of Parma 1991-95), in the MRC Unit in the Gambia (1995-97) and then in London at Institute of Hepatology-University College of London (1997-2005).

Dr. Bertoletti moved to Singapore in 2005 where he was the Director of Infection and Immunity Program at the Singapore Institute for Clinical Sciences (A*STAR) until 2013 before moving in 2013 at the Emerging Viral Disease Program at Duke-NUS Medical School. He keeps an Adjunct Position as Research Director, Viral Hepatitis at the Singapore Institutes for Clinical Sciences.

He was awarded the Singapore Translational Research Grant Award (STAR Award 2013-18) and is the current Vice-President of the Singapore Society of Immunology. The research in his laboratories (Duke-NUS Emerging Viral Diseases Program and SICS- A-STAR) is focused on the development of new immunological based therapies (TCR-redirected T cells, HLA-peptide specific antibodies) for the treatment of HBV and hepatocellularcarcinoma and on the characterization of the human intrasinusoidal hepatic immune system.

Stakeholder Panel Moderators

Charles L. Cooney
Professor Emeritus, MIT; Faculty Director Emeritus, Deshpande Center for Technological Innovation, MIT
Charles COONEY is Professor Emeritus of Chemical and Biochemical Engineering in the Department of Chemical Engineering of MIT, and was the founding Faculty Director of the Deshpande Center for Technological Innovation at MIT. His degrees include a Bachelor’s degree in Chemical Engineering from the University of Pennsylvania and Master’s and PhD degrees in Biochemical Engineering from MIT.

Dr. Cooney serves as a consultant to a number of biotech and pharmaceutical companies, is on multiple editorial boards of professional journals, and sits on the Boards of Directors of Mitra Biotech (India), GreenLight Bioscience, Pronutria, Boyd Technologies, Levitronix Technologies, and Innovent Biologics (China). He was previously on the Boards of Genzyme, Cuno, Pall Corporation, Biocon (India), Polypore International, and Astra AB.

Dr. Cooney chaired the FDA Advisory Committee for Pharmaceutical Science from 2004-2006. His research interests include manufacturing in the pharmaceutical, biotech, and bioprocess industries, as well as bioprocess design, operation, and control, processing of pharmaceutical powders, and technological innovation strategy. As founding faculty director of the Deshpande Center, he is interested in the process of stimulating technological innovation and translating innovation into new company creation.


Steve Oh
A*STAR Bioprocessing Technology Institute 
Steve OH is an Institute Scientist at the A*STAR Bioprocessing Technology Institute (BTI), and Director of BTI’s Stem Cell Bioprocessing team. In that role, Dr. Oh leads research to develop practical methods of producing high quality stem cells (human pluripotent, mesenchymal stem cells and their differentiated derivatives) for stem cell therapy. This includes development of microcarrier particles and monitoring tools for stem cell bioprocessing. This team’s work is collaborative within Biomedical Research Council (BMRC), and involves clinicians at NUH and other A*STARs including GIS, IMB, SIMTech, IMRE, and I2R.

Dr. Oh is also involved in the International Stem Cell Initiative, whose role is to better characterize the pluripotent stem cell state and develop robust differentiation protocols to the 3 germ layers. Dr. Oh also serves on the steering committee for the International Stem Cell Initiative (UK), and is a Member of the International Stem Cell Bank Initiative and Standards Committee of the International Society for Stem Cell Research.

He received his PhD in Chemical Engineering from the University of Birmingham, UK.

Panel 3: Technology Innovation – From Bench to Industry

Steve Oh
A*STAR Bioprocessing Technology Institute 
Steve OH is an Institute Scientist at the A*STAR Bioprocessing Technology Institute (BTI), and Director of BTI’s Stem Cell Bioprocessing team. In that role, Dr. Oh leads research to develop practical methods of producing high quality stem cells (human pluripotent, mesenchymal stem cells and their differentiated derivatives) for stem cell therapy. This includes development of microcarrier particles and monitoring tools for stem cell bioprocessing. This team’s work is collaborative within Biomedical Research Council (BMRC), and involves clinicians at NUH and other A*STARs including GIS, IMB, SIMTech, IMRE, and I2R.

Dr. Oh is also involved in the International Stem Cell Initiative, whose role is to better characterize the pluripotent stem cell state and develop robust differentiation protocols to the 3 germ layers. Dr. Oh also serves on the steering committee for the International Stem Cell Initiative (UK), and is a Member of the International Stem Cell Bank Initiative and Standards Committee of the International Society for Stem Cell Research. He received his PhD in Chemical Engineering from the University of Birmingham, UK.

 
Bruce Levine
Novartis-Penn Center for Advanced Cellular Therapeutics and University of Pennsylvania
Bruce LEVINE, Barbara and Edward Netter Professor in Cancer Gene Therapy, is the Director of the Clinical Cell and Vaccine Production Facility (CVPF) in the Department of Pathology and Laboratory Medicine and the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania. He received a B.A. in Biology from the University of Pennsylvania and a Ph.D. in Immunology and Infectious Diseases from the Johns Hopkins University.

Dr. Levine has overseen the production, testing and release of 2700 cellular products administered to >1000 patients in clinical trials since 1996. Through these technologies, personalized and enhanced immunity has been engineered. T lymphocytes from HIV+ subjects have been rendered resistant to HIV infection and reinfused. T lymphocytes from cancer patients have been redirected with chimeric antigen receptors to hunt and destroy their malignancies, an investigational therapy that received the first Breakthrough Designation from the FDA for an academic institution and is currently in commercial development.

In 2016, Novartis-Penn Center for Advanced Cellular Therapeutics (CACT) was launched and includes Dr. Levine. The Center expanded Penn’s groundbreaking research using chimeric antigen receptor (CAR) technology for treatment of cancers.

 
Phan Toan Thang
Cell Research Corporation
Toan Thang PHAN is a founding director and CSO of CellResearch Corporation Group of Companies. A graduate of the Military Medical University, Hanoi, Vietnam in 1991, Prof. Phan Toan Thang has had a strong interest in wound healing since the earliest days of his medical and scientific career. His interest led him to hands-on experience during his four-year surgical residency in Hanoi at the National Institute of Burns and at the Army Hospital 103. He then spent two years at the prestigious Wound Healing Institute and Department of Dermatology in Oxford, England. 

Dr. Phan is also an Associate Professor and Principal Investigator of the Wound Healing and Stem Cell Research Group, Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore. 


Chwee Teck Lim
NUS Biomedical Engineering and Clearbridge
Chwee Teck (CT) LIM is the Provost's Chair Professor in the Department of Biomedical Engineering at the National University of Singapore (NUS). He is also the NUS Deputy Head (Administration & External Relations) and part of the Mechanobiology Institute Research Center of Excellence. At NUS, Prof. Lim’s laboratory conducts basic and applied research in the mechanobiology of human diseases as well as the development of microfluidic biochips for the detection and diagnosis of cancer.

Prof. Lim is a cofounder of several medtech companies in Singapore, including Clearbridge mFluidics, NanoMedics, and BioMedics, and Clearbridge Accelerator. He received his PhD from the University of Cambridge, UK.

 
Luke Lee
NUS Biomedical Institute for Global Health Research & Technology
Luke P. LEE is the Director of the Biomedical Institute of Global Healthcare Research & Technology (BIGHEART), and the Arnold and Barbara Silverman Distinguished Professor of Bioengineering at the University of California, Berkeley, and Co-Director of the Berkeley Sensor & Actuator Center.

Prof. Lee’s current research interests are bionanoscience, nanomedicine for global healthcare and personalized medicine, and Bioinspired Photonics-Optofluidics-Electronics Technology and Science (BioPOETS) for green building with living skin. He was Chair Professor in Systems Nanobiology at the Swiss Federal Institute of Technology (ETH, Zurich) and has more than ten years of industrial experience in integrated optoelectronics, Superconducting Quantum Interference Devices (SQUIDs), and biomagnetic assays. Lee received his B.A. in Biophysics and Ph.D. in Applied Science & Technology: Applied Physics (major) / Bioengineering (minor) from the University of California, Berkeley.

SYMPOSIUM WELCOMES

Khiang Wee Lim 
CREATE, Executive Director; and National Research Foundation
Khiang-Wee LIM started as the Executive Director of CREATE (Campus for Research Excellence and Technological Enterprise) in August 2013. Dr. Lim is currently a member of the Engineering Accreditation Board of Singapore, the selection panel for the Singapore Youth Award, the Board of Governors of the NUS High School for Science and Mathematics and the Board of Trustees of the Singapore Institute of Technology.

 
Kong Peng Lam
A*STAR Bioprocessing Technology Institute, Executive Director
Kong-Peng LAM is an immunologist by training and is currently the Executive Director of A*STAR’s Bioprocessing Technology Institute (BTI).  Dr. Lam is also Professor of Microbiology & Immunology at the Yong Loo Lin School of Medicine at The National University of Singapore (NUS) and Adjunct Professor at the School of Biological Sciences at Nanyang Technological University (NTU).  Prof Lam is also Vice-President of the Asian Federation of Biotechnology (AFOB) and Vice-President of the Asia-Pacific International Molecular Biology Organisation (A-IMBN).

 
Daniel E. Hastings
Singapore MIT Alliance for Research and Technology (SMART), Director
Daniel HASTINGS is currently the CEO and Director of the Singapore MIT Alliance for Research and Technology (SMART), which operates at CREATE. Prof. Hastings is also the Cecil and Ida Green Education Professor of Aeronautics and Astronautics. Hastings served as the U.S. Air Force’s chief scientist (19970-99), and was a member of the National Science Board (2002-08). He became director of the MIT Technology and Policy Program in 2000, director of the Engineering Systems Division in 2004, and dean for undergraduate education in 2006.


Krystyn J. Van Vliet
SMART BioSystems and Micromechanics, Lead Principal Investigator
Krystyn VAN VLIET is currently the Lead Principal Investigator of the SMART BioSystems & Micromechanics (BioSyM) team at CREATE. Prof. Van Vliet is also the Koerner Professor of Materials Science & Engineering  and Biological Engineering at the Massachusetts Institute of Technology (MIT). Van Vliet is the Director of Manufacturing Innovation for MIT’s Innovation Initiative, and served in the Advanced Manufacturing Partnership that provided analysis through the President’s Council of Advisors for Science & Technology’s 2014 report, Accelerating U.S. Advanced Manufacturing.

Panel 4: Technology Innovation – From Lab to Clinic

Zhiyong Poon
Singapore General Hospital
Zhiyong POON is a Research Scientist in the Haematology Department at Singapore General Hospital. His work focuses on mesenchymal stem cells in clinical trials, including novel technologies to enrich subpopulations of these cells for specific indications. Dr. Poon also explores innovative treatments for pre-leukemia. He earned his PhD at MIT and was a Research Scientist at the Singapore MIT Alliance for Research and Technology (SMART) BioSystems and Micromechanics (BioSyM) team at CREATE, where he was awarded the SMART Innovation Centre’s Innovation Grant to develop new technologies for stem cell enrichment based on collaborative SMART BioSyM research. Dr. Poon then joined SGH to transition such technologies via human clinical trials.

 
Rajeev Ram
Massachusetts Institute of Technology (MIT)
Rajeev J. RAM is Professor of Electrical Engineering and Computer Science at MIT, where he is a MacVicar Fellow also recognized for his teaching. His group works on optical biosensing and microfluidic control of cellular processes. During the last decade, his focus has been on developing microbioreactors for bacterial, yeast, and mammalian cell lines. His group has developed and commercialized batch, fed-batch, perfusion, and continuous culture microbioreactors. Most recently, they have worked on the precise control of synthetic gene circuits using this platform. In addition to his work on microfluidics, his group has worked on rapid optical analysis techniques. They demonstrated the first quantitative Raman analysis in situ within a bioreactor. Prof. Ram’s group has developed Raman for the quantification of metabolites in microbial and mammalian cell culture as well as for medical applications. Recently, his group has been working on the development of Raman for quantitative analysis of therapeutic proteins with potential application in real time release.


Timothy K. Lu
Massachusetts Institute of Technology (MIT)
Timothy LU (MD/PhD) is an Associate Professor in the Department of Electrical Engineering and Computer Science and an Associate Member of the Broad Institute of MIT and Harvard.

Prof. Lu has pioneered new approaches to combat infectious diseases with synthetic biology, encode memory in the DNA of living cells, and perform both digital and analog computation in biological systems. His group’s research focuses on engineering fundamental technologies to enable the scalable design of biological systems and on applying synthetic biology to solve medical and industrial problems.

Prof. Lu received his undergraduate and M.Eng. degrees from MIT in Electrical Engineering and Computer Science. He obtained an M.D. from Harvard Medical School and Ph.D. from the Harvard-MIT Health Sciences and Technology Medical Engineering and Medical Physics Program.

 
Antonio Bertoletti
Duke-National University of Singapore
Antonio BERTOLETTI (MD/PhD) is an Infectious Diseases Doctor who has always been fascinated by the pathogenesis of viral infections. He began working in the field of viral hepatitis as a medical student at the University of Parma (Italy) and during his MD specialization (1989-93). He worked two years (1989-91) at The Scripps Research Institute (La Jolla) characterizing for the first time the Hepatitis B virus (HBV) specific cytotoxic T cell response in man. He worked in Italy (University of Parma 1991-95), in the MRC Unit in the Gambia (1995-97) and then in London at Institute of Hepatology-University College of London (1997-2005).

Dr. Bertoletti moved to Singapore in 2005 where he was the Director of Infection and Immunity Program at the Singapore Institute for Clinical Sciences (A*STAR) until 2013 before moving in 2013 at the Emerging Viral Disease Program at Duke-NUS Medical School. He keeps an Adjunct Position as Research Director, Viral Hepatitis at the Singapore Institutes for Clinical Sciences.

He was awarded the Singapore Translational Research Grant Award (STAR Award 2013-18) and is the current Vice-President of the Singapore Society of Immunology. The research in his laboratories (Duke-NUS Emerging Viral Diseases Program and SICS- A-STAR) is focused on the development of new immunological based therapies (TCR-redirected T cells, HLA-peptide specific antibodies) for the treatment of HBV and hepatocellularcarcinoma. Dr. Bertoletti is also the Scientific Advisor for LION TCR.

 
Samantha Maragh
US National Institute for Standards and Technology
Samantha MARAGH is a Research Biologist in the Bioassay Methods Group within the Biosystems and Biomaterials Division at the U.S. National Institute of Standards and Technology (NIST). Dr. Maragh began working at NIST after completing her undergraduate BS degree in Cellular & Molecular Biology from Loyola University in Baltimore, MD. While working for NIST, she went on to receive an MS in Biotechnology from Johns Hopkins University in the specialty area of Molecular Targets & Drug Discovery, followed by completing a PhD in Human Genetics & Molecular Biology from the Johns Hopkins School of Medicine, McKusick-Nathans Institute of Genetic Medicine.

Dr. Maragh is currently developing and leading NIST’s programs supporting genome editing for gene and cell therapies. She also leads a project supporting better measurements for early detection of prostate cancer biomarkers in collaboration with the National Cancer Institute. Her research and program goals are focused on understanding the reliability of measurements and technology development for genome editing, bioassays, and cancer biomarkers, with applications in engineering biology and precision medicine.

Cell Advanced Manufacturing & Production

CREATE Symposium | CREATE Tower | 1 CREATE Way | Singapore 138602