CATTI's Educational Committee
SVEN ANSORGE, Director of Manufacturing, ExCellThera
Scientist holding a Ph.D. in biotechnology with team building and management experience; specialized in bioprocessing for the production of viral vectors, vaccines and recombinant proteins. Demonstrated ability to lead and manage teams (>5 years of management experience) and projects within academic, industrial and GMP environments. Team lead experience in small biotech and public research and technology organization. Currently leading the manufacturing and process development activities at ExCellThera Inc, a clinical stage cell therapy company (excellthera.com). Expertise validated through a solid publication, presentation and tech transfer track record; expert knowledge in permittivity technology, viral vector production and mammalian cell culture scale-up. Recognized for being open minded, highly-motivated and an active team player with outstanding leadership skills.
JACQUELINE BARRY, Chief Clinical Officer, UK Cell and Gene Therapy Catapult
Jacqueline Barry is the Chief Clinical Officer, responsible for Clinical Translation and Delivery activities and an Executive Director of the Cell and Gene Therapy Catapult. She has extensive experience in the development of advanced therapy medicinal products and leads a multi-disciplinary team of Nonclinical, Regulatory, Clinical Operations and Programme Management specialists. She also leads the coordination of the UK Advanced Therapy Treatment Centre Network and is a Director of the Global Alliance for iPSC Therapies. She feels passionately about making advanced therapies available for patients and works closely with the MHRA and the NHS on the development of the ecosystems to support the adoption of these therapies. Prior her time at Cell and Gene Therapy Catapult, Jacqueline worked at the Scottish National Blood Transfusion Service where amongst other activities she designed the regulatory strategy for the Cellular Therapies for the Blood Transfusion Service and acted as Qualified Person for their release. She has a PhD from the University of Aberdeen and did post-doctoral research in neurophysiology at the University of Edinburgh.
DAVID COURTMAN, PhD, Director, Biotherapeutics Manufacturing Center, The Ottawa Hospital
Dr. David Courtman is trained in cellular and molecular pathology and biophysics with extensive expertise in the development of novel therapies for cardiovascular disease. He obtained undergraduate and Master’s degrees in Medical Biophysics from the University of Western Ontario and a PhD in Cellular and Molecular Pathology at the University of Toronto. He completed postdoctoral training in the Vascular Pathobiology program at the University of Washington, Seattle and subsequently took up an appointment as Assistant Professor in the departments of Surgery, Pathology and Biomedical Engineering at the University of Toronto at St. Michael’s Hospital. In 2008 he moved to the Ottawa Hospital Research Institute to continue his research and take up the directorship the clinical cell manufacturing facility.
ADRIANO D’AMBROSIO, Director of Operations, CCRM
Adriano D’Ambrosio joined CCRM as Director of Operations in November 2019, with over fourteen years of previous experience working for a Global 500 healthcare provider, with a focus on large scale GMP manufacturing of globally distributed vaccines. He has held a number of leadership roles across multiple platforms in commercial GMP manufacturing overseeing key areas of the business including media preparation, cell propagation, purification and final drug product formulation. This broad exposure has given him the opportunity to develop a deep understanding of commercial operations. Over the years he has successfully executed several regulatory inspections with Health Canada, the FDA and other global regulatory bodies and been involved in a number of strategic capital projects. These projects have included a number of capacity expansion projects including the design, build, qualification and licensing of a new vaccine facility.
MARTIN GIROUX, PhD, Director of the Cell Processing Facility, Center of Excellence Cellular Therapy (CETC), Hopital Maisonneuve Rosemont
After graduate studies at McGill University, a PhD in immunology and virology at INRS-IAF, working in the crossmatch histocompatibility laboratory for Transplant Québec and a post-doc with Dr Claude Perreault in hematopoietic graft and graft versus host disease, I was project manager in multiple projects in the Translation Platform of Hopital Maisonneuve Rosemont. Since 2013 I am the Director of operation (CSO and COO) of the Center of Excellence in Cellular Therapy (CETC). The CETC is a GMP-compliant manufacturing center for cell therapies with 13 cleanrooms and regulated by Health Canada, FACT, EMA and FDA for more than minimal manipulations. Along with C3i, the CETC partners with companies and researchers to accelerate the translation, qualification, regulatory-acceptation and clinical production of Phase I to Phase III clinical trials.
CRAIG HASILO, MSc., PhD(C) Chief Scientific Officer CellCAN Regenerative Medicine and Cell Therapy Network
Craig has over 15 years of experience in cell manufacturing and medical device development in the biotechnology sector. In his current role as Chief Scientific Officer at CellCAN, Craig unites efforts between GMP cell manufacturing sites, scientists and physicians and interactions with regulatory authorities. The thrust of Craig’s efforts are focused on breaking down the barriers to collaboration across the country and strengthening the Canadian regenerative medicine sector through efforts such as developing unique GMP-focused knowledge dissemination activities and HQP training opportunities. Prior to joining CellCAN in 2017, Craig was the Scientific Director at the Human Islet Transplant Laboratory at the McGill University Health Centre, where he initialized the Health Canada registered GMP-designed islet isolation laboratory to treat type 1 diabetic patients with intraportal infusions of pancreatic islet preparations. Craig led his team through several successful procedures and auditing by the Health Canada Inspectorate. He is currently completing his PhD in Experimental Surgery at McGill University and was the recipient of the Canadian National Transplant Research Program & Astellas Pharma Trainee Award. Between 2005 and 2009, Craig initialized the London Health Sciences Centre Clinical Islet Transplant Program as a Research Associate and Clinical Research Manager after completing his Master of Science degree at Western University. Here Craig was instrumental in the launch of Sernova Corp., a biotech company focused on alternate sites of transplant and mitigating the need for immunosuppressive drugs in cellular therapies. Craig is the primary inventor of Sernova’s Cell PouchTM, a medical device currently being used in clinical trials for subcutaneous implantation (and other sites) of cellular therapies for disease indications, such as type 1 diabetes and hemophilia.
MEGAN MAHONEY, PhD, Director, Scientific Affairs and Training Programs
Megan currently works as Director, Scientific Affairs and Training Programs at BioCanRx, a federally funded Network of Centres of Excellence focused on the development of novel approaches in the treatment of cancer using immunotherapy. Since joining BioCanRx in 2017, she has developed and overseen training initiatives aimed at bridging the gap and growing the talent pool in translational expertise related to cell and virus-based therapeutic development. Prior to joining BioCanRx, Megan was Operations Manager for the Biotherapeutics Manufacturing Centre (BMC) Virus Facility at the Ottawa Hospital Research Institute. In this role, she oversaw the operational activities of the BMC, which specializes in virus and vaccine development and manufacturing services for products destined for pre-clinical and clinical research. Megan is also a program advisor for the Science to Business Network and a program committee member for the Canadian Science Policy Centre. Megan received her PhD in Neuroscience from Queen's University in 2014.
DELARA MOTLAGH, PhD, MBA Vice President, Cell Therapy Technologies, Terumo BCT
Delara is the Vice President of the Cell Therapy Technologies Business at Terumo BCT, committed to delivering integrated solutions and services across the continuum of care in cell and gene therapy space.
Delara received a PhD in Physiology and Biophysics from the University of Illinois, fellowship in Vascular Tissue Engineering at Northwestern University, and Executive MBA from Kellogg School of Management. With more than 15 years in various cross-functional roles in the biomedical and healthcare field, she brings a unique perspective and a deep understanding of the technical, manufacturing and commercialization elements of the industry with a passion to make a difference in the lives of patients.
VERONIQUE MOULIN PhD University teacher-researcher, LOEX
Following her training in Paris, France, Dr. Moulin was recruited in 1998 to better understand the complex process of healing. Since 1998, she has been a professor at the Laval University School of Medicine, Department of Surgery, but also a researcher at the LOEX Center at Laval University, and at the Research Center of the CHU de Quebec. Her work focuses on the normal and pathological mechanisms of skin healing. To perform this, she uses different cell culture models reconstituted by tissue engineering to reproduce in vitro fibrotic skin diseases (hypertrophic scars, scleroderma). Concurrently, she also uses the tissue engineering method to reconstruct cutaneous substitutes to treat skin deficient patients, for example, after burns. Myofibroblasts in normal or pathological scars. These cells appear during wound healing and play an important role in the contraction of the edges of the wound. Dr. Moulin’s team has shown that these cells also play a central role in the production of extracellular matrix, as well as in angiogenesis. They also have a role in the formation of disabling scars such as hypertrophic scars. Dr. Moulin’s team analyzes the different functions of myofibroblasts in normal or pathological scarring; investigates existing interactions between endothelial cells, keratinocytes, fibroblasts and myofibroblasts, and analyzes the role of extracellular matrix secreted by cells in various cellular functions such as apoptosis, angiogenesis or cell differentiation. Systemic scleroderma. This pathology is a fibrotic disease that stiffens all organs, including the skin, and is eventually fatal. Dr. Moulin uses a tissue-engineering method to understand this pathology, but especially to determine new treatments to reduce fibrosis. Clinical application of tissue engineering. Tissue engineering skin production is carried out from patients’ cells and then grafted onto them to allow wound closure in patients who are unable to heal after extensive burns or other pathologies. The properties of skin reconstructed by our method are being evaluated in a clinical trial accepted by Health Canada to cover burn victims.
GAYLE PIAT, Manager, Alberta Cell Therapy Manufacturing
Gayle Piat has a background in Medical Laboratory Technology and has over 30 years’ experience working in the life science field with 12 years spent specializing in Good Laboratory Practice (GLP) and 8 years in Good Manufacturing Practice (GMP). In 2003 she earned the designation of Registered Quality Assurance Professional in GLP through the Society of Quality Assurance while working at the Alberta Research Council as the Quality Assurance Manager at a GLP toxicology facility. In 2011 Gayle joined the University of Alberta as Project Manager for construction of a GMP cell therapy manufacturing facility. Gayle is currently the manager of Alberta Cell Therapy Manufacturing (ACTM). In 2016 she earned Regulatory Affairs Certification through the Regulatory Affairs Professionals Society. Gayle is a member of CellCAN and participates in the Cell Therapy Stakeholders group that meets with Health Canada to discuss regulatory policy issues for cell and gene-based therapies.
RODNEY RIETZ, CEO, iVexSol
Dr. Rod Rietze is the CEO of iVexSol (intelligent Vector Solutions) a newly formed vector manufacturer founded on the ability to rapidly produce stable lentiviral vectors at scale. Prior to this, Rod was the Director of Strategic Development and Innovation at Novartis (Cambridge, MA), where he supported the clinical and commercial development of a number of next generation cell and gene therapies, including Kymriah™, the first FDA approved CART cell-based gene therapy. Before joining Novartis, Rod led research and development teams of both small molecule and cell-based therapeutics at Pfizer Regenerative Medicine in Cambridge, UK, and was a co-founder of the 400 member Queensland Brain Institute (Brisbane, Australia), where his lab focused on harnessing the regenerative capacity of resident neural stem cells to slow age-related cognitive decline. His work was featured on the front covers of Nature and Science, and received numerous awards including Science Magazine’s “Breakthrough of the Year”. Rod has nearly two decades of technical, operational and strategic leadership experience in the development of novel therapeutics and is passionate about delivering innovative technologies and medicines to transform the treatment of disease. He holds a BSc and MSc from the University of Calgary, Canada and a PhD from The Walter and Eliza Hall Institute of
Medical Research (University of Melbourne, Australia).
SOWMYA VISWANATHAN, PhD, Assistant Professor, Institute of Biomaterials and Biomedical Engineering, University of Toronto
Affiliate Scientist, Krembil Research Institute, University Health Network
CellCAN Manufacturing Platform Leader
Dr. Viswanathan is an Affiliate Scientist at the Krembil Research Institute, University Health Network, and an Assistant Professor at the Institute of Biomaterials and Biomedical Engineering and at the Department of Medicine of the University of Toronto. Her research interest is focused on developing cellular therapy approaches with anti-inflammatory functionality. This includes developing next generation mesenchymal stromal cells (MSCs) and polarized monocytes/macrophages using small molecules, gene editing and culture engineering approaches. Dr. Viswanathan’s primary research focus is applying these novel cellular therapy products to targeting inflammation and cartilage degradation in osteoarthritis. Dr. Viswanathan is a co-Principal Investigator of Canada’s first autologous MSCs to treat osteoarthritis. Dr. Viswanathan’s lab is also focused on statistical approaches to systematically optimize bioprocesses and develop rapid and relevant bioanalytical techniques. Dr. Viswanathan co-chairs a Cell Therapy Stakeholder Group that engages Health Canada on cell therapy related policy issues. Dr. Viswanathan is manufacturing team lead for CellCAN, a regulatory and manufacturing advisor for OIRM, and a Canadian expert member of the International Standards Organization (ISO)’s technical committee (TC 276) on cell and gene therapies. Dr. Viswanathan is an elected formal liaison between International Society of Cellular Therapy (ISCT) and ISO. Dr. Viswanathan serves on the MSC scientific and the North American Legal and Regulatory Affairs committees at ISCT. She was recently appointed as an Associate Editor of Cytotherapy, official journal of ISCT.
JOHN WEBB, PhD, Senior Project Leader, BC Cancer
Dr. Webb completed his graduate training at the University of British Columbia and spent several years working in industry before becoming a faculty member at the University of Ottawa. Following this, he returned to industry and developed an interest in vaccines for human malignancies. Dr. Webb joined the Deeley Research Centre as the T cell Projects Leader continuing his work in cancer immunotherapy. In addition, Dr. Webb has been studying new vaccine strategies to induce T cell-mediated immune responses.