TGA Liaison & Scientific Meeting

September 15, 2017 QIMR Berghofer Medical Research Institute 300 Herston Road, Herston, Queensland INTERNATIONAL SOCIETY FOR CELLULAR THERAPY: ISCT is a global association driving the translation of scientific research to deliver innovative cellular therapies to patients. ISCT is the only group focused on pre-clinical and translational aspects of developing cell therapy products. As such, ISCT helps academic, government and biotech/pharma sectors transform research into practice and product.

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2018 ISCT Global Meeting

Message from ISCT North America Regional VP David DiGiusto Dear colleagues,

It is with great pleasure to remind you of next year’s ISCT 2018 Annual Meeting in Montreal. This is the first time since 2005 that the meeting has been held in Canada, and we look forward to welcoming you to such a beautiful and historic city – one of the oldest in North America.

As those who attended the ISCT 2017 Annual Meeting in London can attest, it was a huge success. We saw our largest turnout yet with delegates from over 60 countries around the globe. We also had an extensive program with a wealth of knowledge. Montreal 2018 will be no exception and will not disappoint!

These meetings are a way for the best and the brightest people in cellular therapy to come together globally, to promote excellence and drive technological advances in this industry. We use this time to network among colleagues and peers, collaborate on innovation, share information, learn what is new, and to help shape the future of cellular therapy.

The ISCT 2018 Annual Meeting website isct2018.com is now live, with registration and abstract submissions opening Tuesday, September 12. Until then, don’t forget to view the Montreal preview video to see all the city has to offer. See you in Montreal!

David DiGiusto, PhD ISCT North America Regional Vice-President ISCT 2018 Montreal Co-Chair

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ISCT ANZ Regional Meeting 15 September, 2017

Brisbane, Queensland

The International Society for Cellular Therapy ANZ regional committee welcomes you to our regional meeting in Brisbane. The program will focus on discussions with representatives from the TGA regarding regulation of Biologicals and is designed to maximise interaction between delegates and regulators. In addition, there will be an afternoon of scientific presentations from Professor Bruce Levine (University of Pennsylvania), Professor John Rasko (ISCT Global President-Elect), Professor John Pimanda (UNSW), and Professor Rajiv Khanna (QIMR Berghofer). Past regional meetings were held in Adelaide, SA (2009), Margaret River, WA (2010), Sydney, NSW with HAA (2011), Sydney with ATBF (2012), Lorne with ASSCR (2014), Adelaide (2015) and Melbourne (2016). In 2013 we were fortunate to have the global ISCT annual scientific meeting in the region in Auckland. The upcoming Regional Meeting in Brisbane Is focussed on discussion with the TGA on regulation of Biologicals.

Before and after the meeting visit our website www.celltherapysociety.org/page/ANZRegional for information on local initiatives. Welcome to Brisbane! Rosemarie Bell Dominic Wall & Annette Trickett Janet Macpherson Chair, Organising Committee Co-chairs, ISCT ANZ LRA Committee ISCT ANZ Regional Vice President

Organising Committee Vicki Antonenas Rosemarie Bell Ngaire Elwood Cheryl Hutchins Janet Macpherson Annette Trickett Zlatibor Velickovic Dominic Wall

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PROGRAM International Society for Cellular Therapy

Australia and New Zealand (ISCT ANZ) and TGA Liaison Meeting Friday 15th September 2017

8:30 - 9:00 Breakfast and Registration

9:00 - 9:10 Dr Janet Macpherson Welcome by ISCT ANZ Regional Executive

9:10 - 10:30 CHAIR: Dominic Wall Regulatory Session 1

9:10 - 9:50

Dr Tony Manderson

Scientific Evaluation Branch TGA, Canberra

Current regulatory framework and planned

changes

9:50 – 10:10 Francesco Cicirello

Manufacturing Quality Branch TGA, Canberra

Global harmonisation

10:10 - 10:30 Alyce Maksoud

Manufacturing Quality Branch TGA, Brisbane

Licensing cell therapy manufacturers

10:30 - 11:00 Morning Tea

11:00 - 12:15 CHAIR: Annette Trickett Regulatory Session 2

11:00 - 11:30

Dr Ngaire Elwood FACT Board of Directors / BMDI Cord Blood Bank,

Melbourne

FACT Standards for Immune Effector Cells

11:30 - 12:15

Moderator: Dr Dominic Wall

Cell Therapies Pty Ltd, Peter MacCallum Cancer

Centre, Melbourne

Regulatory Q & A session

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12:15 - 13:00 Lunch

13:00 - 13:15 Miltenyi Biotec

Automated manufacturing and in-process control of

CAR T cells for cellular therapy

13:15 - 14:30 CHAIR: Janet Macpherson Scientific Session 2

13:15 - 14:00

Professor John Rasko Gene and Stem Cell Therapy Program, Royal Prince Alfred

Hospital, Sydney

Unproven or proven: cell therapies in the twilight

zone?

14:00 - 14:30 Professor John Pimanda

Adult Cancer Program UNSW, Sydney

Generating multipotent stem cells from primary

human adipocytes for tissue regeneration

14:30 - 15:00 Afternoon Tea

15:00 - 16:45 CHAIR: John Rasko Scientific Session 2

15:00 - 16:00

Professor Bruce Levine University of Pennsylvania

Perelman School of Medicine, Philadelphia, USA

Clinical development of Chimeric Antigen Receptor

(CAR) T Cells: from boutique to global

16:00 - 16:30

Professor Rajiv Khanna

Tumour Immunology Lab, QIMR Berghofer, Brisbane

Challenges in driving success of cellular immune therapies to infectious complications,

solid cancers and autoimmune diseases

16:30 – 16:45

ISCT ANZ Executive Closing Remarks

Note regarding program change: Unfortunately, Professors Malcolm Brenner and Cliona Rooney are unable to travel to Australia due to the effects of tropical storm Harvey.

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ISCT ANZ would like to thank our Sponsors: Venue / meeting support: QIMR Berghofer Product showcase: Miltenyi Biotec Educational grant: Cell Therapies Exhibitors: Eurofins ams Laboratories Fluid Biosolutions / Saint Gobain Lonza / Peprotech QIMR Berghofer / Q-Gen Cell Therapeutics Morning & afternoon tea: Biomerieux Lunch: GE Healthcare

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SPEAKER BIOGRAPHIES & ABSTRACTS

Dr Tony Manderson is currently the Head of the Cell & Tissue Therapy Unit at the Therapeutic Goods Administration. The Unit is responsible for regulating human and live animal cell and tissue-based products (known as biologicals) and HPCs. Tony first joined the TGA in 2007 and has worked in different areas, including the evaluation and testing of vaccines, regulation of blood and plasma-derived medicines, and most recently the regulation of HPCs and human and live animal cell and tissue-based therapies (biologicals). Prior to this he worked as a post-doctoral research scientist at Imperial College in London and the Institute of Molecular Biosciences in Brisbane, with a focus on complement biology, autoimmunity and macrophage biology, after obtaining his PhD in Immunology from the Australian National University in Canberra, Australia.

Francesco Cicirello is a GMP Inspector within the Medical Devices & Product Quality, Manufacturing Quality Branch. Francesco has been with Therapeutic Goods Administration (TGA) since 2014 and performs inspections across a wide range of manufacturing activities and has conducted inspections of Biological manufacturers across Australia. He represents Australia in the PIC/S Subcommittee of Harmonisation (SCH), in the ad hoc drafting working group on ATMP and is part of the coordinating committee of Expert Circle on Human Blood, Tissues, and Cells & ATMPs and has contributed to the development of a number of guidance and chapter revisions. Francesco has a degree in Chemistry and Pharmaceutical Technology, MSc in Oncology Pharmacy and an MSc in production of cosmetic products. Francesco is a registered pharmacist -General Pharmaceutical Council (GPhC-UK) and the Federal Office of Public Health (FOPH – CH). Prior to joining the TGA, he worked in the biochemical industry for over 15 years in varied capacity including Production, Quality Assurance and Compliance management roles comprising small molecules and ATMPs.

Alyce Maksoud is a Senior GMP Inspector within the Medical Devices & Product Quality, Manufacturing Quality Branch. Alyce has been with Therapeutic Goods Administration (TGA) since 2005. Alyce has extensive experience in all aspects of Cellular Therapy Product manufacture, including processing, quality management, quality assurance and quality control. Alyce was involved in the development of the Australian Code of GMP for Human Blood, Human Blood Components, Human Tissues and Human Cellular Therapy Products, in conjunction with key internal and external stakeholders. Alyce is instrumental in developing the licenses for Blood, Tissues and Cellular Therapy Products and was the Chair of the Manufacturing Quality Branch Working Group (Human Tissue and Cellular Therapy [HCT]) working group.

Dr Ngaire Elwood is the Director of the BMDI Cord Blood Bank and Head of the Cord Blood Stem Cell Research program at the Murdoch Childrens Research Institute in Australia. She has more than 30 years’ research experience in the field of cellular therapy, cord blood, stem cells and leukaemia. Ngaire is a member of the international Board of Directors for the Foundation for the Accreditation of Cellular Therapy (FACT) and currently serves as Vice-President of FACT. As Director of the BMDI Cord Blood Bank, a TGA-licensed cell therapy manufacturing facility, and with appointments on the FACT Cord Blood Standards and Accreditation committees, Ngaire has much experience in regulatory compliance. ABSTRACT: FACT Standards for Immune Effector Cells Since 1996, the international Foundation for the Accreditation of Cellular Therapy (FACT) has been a leader in improving the quality of cellular therapy processes in the fields of HPC transplantation, cord blood banking, and regenerative medicine through its program of professional standards and voluntary accreditation. Since the development of the first set of Standards, FACT Standards have been developed by experts active in the field, evidence-based wherever possible, and agreed upon by consensus. The major objective of the FACT Standards for Immune Effector Cells (IEC), published in January 2017, is to promote quality practice in IEC administration. These Standards apply to IECs used to modulate an immune response for therapeutic intent, and includes genetically engineered chimeric antigen receptor T cells (CAR-T cells) and therapeutic vaccines. These Standards are intended to be flexible to accommodate various models of patient care and use of cellular therapy products. This presentation will provide general information about the FACT IEC Standards and Accreditation, the characteristics of Programs seeking FACT accreditation under the IEC Standards and guidance in applying the Standards.

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Professor John Rasko is an Australian pioneer in the application of adult stem cells and genetic therapy. He directs the Department of Cell and Molecular Therapies at Royal Prince Alfred Hospital and heads the Gene and Stem Cell Therapy Program at the Centenary Institute, University of Sydney. John is a clinical haematologist, pathologist and scientist with an international reputation in gene and stem cell therapy, experimental haematology and molecular biology. In over 150 publications he has contributed to the understanding of stem cells and haemopoiesis, gene transfer technologies, oncogenesis, human genetic diseases and non-coding RNAs. He serves on Hospital, state and national bodies including Chair of GTTAC, Office of the Gene Technology Regulator – responsible for regulating all genetically-modified organisms in Australia - and immediate past Chair of the TGA Advisory Committee on Biologicals. Contributions to scientific organisations include co-founding (2000) and past-President (2003-5) of the Australasian Gene Therapy Society; Vice President (2008-12) and President-Elect (2016-17) of ISCT; Scientific Advisory Committees and Board member for philanthropic foundations; and several Human Research Ethics Committees. He is a founding Fellow of the Australian Academy of Health and Medical Sciences and the recipient of national (RCPA, RACP, ASBMB) and international awards in recognition of his commitment to excellence in medical research, including appointment as an Officer of the Order of Australia. ABSTRACT: Unproven or proven: cell therapies in the twilight zone? Substantial evidence of improved clinical outcomes in cell and gene therapies has now been demonstrated in haemophilia B, immune deficiencies, haemoglobinopathies, immunotherapies and blindness. Medical and, in particular, stem cell tourism has become a billion dollar industry with increasing examples of false claims. Embryonic and induced pluripotent stem cells have been mired in controversy and clinical development has been forestalled. We reported an analysis of global distribution of businesses marketing stem cell-based interventions, having identified and curated more than 400 unique entities. Many of these online entities promote clinical applications of ‘stem cells’ beyond present-day standards of care. These data should be of immediate concern to governments and ethicist being lobbied to amend laws governing the manufacture, distribution and clinical use of human cell-based medical products. Unregulated, untested or unsafe stem cell ‘therapies’ place the field at a difficult crossroad. Blurring the lines that distinguish evidence-based cell therapies from those that are not remains a fundamental public health concern. Publications include: Cell Stem Cell 2016; 19(2):158-162. Science Translational Medicine 2017; 9(397). Nature 2017 543:174-175.

Professor John Pimanda is Head of Pathology and Professor of Medicine at UNSW Sydney. He is a Fellow of the Royal Australasian College of Physicians and College of Pathologists, Australasia and a haematologist at the Prince of Wales Hospital (POWH) in Sydney. Following the award of his PhD at UNSW in 2004, he undertook post-doctoral research at the University of Cambridge as an RG Menzies/CJ Martin research fellow. He returned in 2008 to set up a research program in stem cell biology, cancer and tissue regeneration at UNSW and POWH. ABSTRACT: Generating multipotent stem cells from primary human adipocytes for tissue regeneration A.Yeola1, D.Kang1, R.Oliver2, T.Hung3, M.Tursky4, C.Artuz4, P.Fortuna5, P.Hardy6, C.Power3, D.Ma4, E.Wolvetang5, B.Walsh2, R.Mobbs7, V.Chandrakanthan1, J.E.Pimanda1,8. 1Adult Cancer Program, Lowy Cancer Research Centre, UNSW; 2Surgical and Orthopaedic Research Lab, UNSW; 3Biological Resources Imaging Lab, UNSW; 4St Vincent’s Centre for Applied Medical Research, Darlinghurst, NSW; 5Australian Institute for Bioengineering and Nanotechnology, University of Queensland; 6Cytolabs, WA; 7Dept of Neurosurgery, POWH; 8Dept of Haematology, POWH, Randwick, NSW. Current trends in regenerative medicine are focused on generating tissue specific stem cells to repair/regenerate damaged tissues and organs. However, given the complexity of most tissues and organs, the ideal tissue regenerative stem cell would be one that was sufficiently plastic to contribute to the repair of multiple tissue types in a context dependent manner. We have developed a vector and transcription factor free method using a demethylating agent (5’-azacitidine (AZA)) and a cytokine (platelet derived growth factor (PDGF)-AB) to reprogram terminally differentiated somatic cells into multipotent stem (iMS) cells by synergistically activating the JAK/STAT and JNK/c-JUN pathways. Murine iMS cells contribute directly to in vivo tissue regeneration in a context dependent manner without scar formation or malignant transformation (Chandrakanthan et al. PNAS 2016). This method has now been modified to reprogram human primary adipocytes into iMS cells in xeno-free conditions. These iMS cells display a stable karyotype and can be expanded in serum-free conditions, display colony forming unit potential, serial re-plating ability and multi-lineage differentiation. When transplanted in NOD/SCID mice using a postero-lateral inter-lumbar vertebral injury model, iMS cells were retained at the transplant site for more than a year with no evidence of metastasis or spontaneous teratoma formation. Transplanted human iMS cells contribute to the formation of new blood vessels, bone, cartilage and smooth muscle at sites of injury.

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Dr. Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, is the Founding 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. The CVPF develops and tests novel cell and gene therapies in clinical trials in patients with hematologic malignancies, solid tumors, HIV infection, and genetic disease. First-in-human trials include the first use of a lentiviral vector, the first infusions of gene edited cells, and the first use of lentivirally-modified cells to treat cancer. Dr. Levine has overseen the production, testing and release of 2800 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. This investigational therapy received unanimous recommendation for approval by the FDA Oncologic Drug Advisory committee to treat pediatric, young adult r/r B-cell ALL. Dr. Levine is co-inventor on 23 issued US patents and co-author of >130 publications with a Google Scholar citation h-index of 68. He has been interviewed by the NY Times, Wall Street Journal, Time Magazine, National Geographic, Forbes, BBC, and other international media outlets. @BLLPHD https://pathbio.med.upenn.edu/cvpf/site/ ABSTRACT: Clinical Development of Chimeric Antigen Receptor (CAR) T Cells: From Boutique to Global Since the 1990’s, we have conducted clinical trials of gene modified T cells. Chimeric antigen receptor (CAR) T cells targeting CD19 on B cells leukemias and lymphomas have induced durable complete responses in patients who are relapsed or refractory to all other available treatments. This synthetic biology technology has now undergone global multi-center clinical trials and submission for regulatory approval. CAR T cells targeting new targets in hematologic malignancies and in solid tumors are underway and provide demonstration that it is possible to design immunity at will for therapeutic application.

Professor Rajiv Khanna obtained his doctorate degree from India and undertook post-doctoral training at the University of Adelaide and the Queensland Institute of Medical Research (QIMR). He is the founding Director of Australian Centre for Vaccine Development (now QIMR Berghofer Centre for Immunotherapy and Vaccine Development). He holds Senior Principal Research Fellowship from the NHMRC and is also appointed as Adjunct Professor at the University of Queensland and Griffith University, Brisbane. Rajiv is a Fellow of Australian Academy of Health and Medical Sciences with extensive expertise in immunotherapy clinical trials, cancer immunology and vaccine development. Over two decades, his group has successfully translated his research towards the development of novel T cell-based immunotherapeutic strategies for the treatment of cancer patients and transplant recipients. He has been appointed as a consultant to Atara Biotherapeutics (US), CSL Ltd, Cellestis Ltd and Oxford Immunotech (UK) for the development of novel immunotherapeutics, diagnostic technologies and vaccines. Prof. Khanna has been invited by International Transplant Society to participate in the development of guidelines for the clinical management of CMV infection in solid organ transplant patients and his group is collaborating with international biopharmaceutical organizations to develop a prophylactic vaccine against human CMV. ABSTRACT: Challenges in Driving Success of Cellular Immune Therapies to Infectious Complications, Solid Cancers and Autoimmune Diseases The field of cellular therapeutics is rapidly emerging as an exciting therapeutic strategy for the treatment of many diseases including cancer and autoimmune disorders. Since 1999, ground-breaking research carried out by research teams at QIMR Berghofer resulted in the development of a novel cellular adoptive immunotherapy for virus-associated lymphoma in solid organ transplant patients. While autologous T cell therapies have been successfully used for the treatment of various diseases, especially haematological malignancies, manufacturing these autologous therapies is often highly laborious and time consuming, resulting in the exclusion of many patients who may need these therapies urgently. Development of allogenic antigen-specific “off-the-shelf” T cell therapies from healthy volunteers have provided new exciting opportunities. These allogeneic T cell therapies show minimal toxicity and long term reconstitution of protective anti-viral immunity following their adoptive transfer back into the patients. In collaboration with MSKCC and Atara Biotherapeutics, we are developing “off-the-shelf” T cell therapies which will be used for the treatment of various virus-associated cancers and autoimmune disorders. These T cell therapies can be combined with immune monitoring technology (e.g. QuantiFERON-CMV) which will allow us to identify high risk patients who may develop virus-associated diseases.

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SUBMITTED ABSTRACT

Live Imaging of CART therapy: Immune response under a new light Kajal Chaudry 1, Ning Xu 2, Sylvie Shen2,3, Liyuan Wang 1, Alla Dolnikov 2,3, Robert Nordon 1 1 Graduate School of Biomedical Engineering, University of New South Wales, Sydney, NSW; 2 Children’s Cancer Institute, Lowy Cancer Research Centre, Randwick, NSW; 3 Blood and Marrow Transplant Laboratory, Sydney Children’s Hospital, Sydney, NSW.

Chimeric Antigen Receptor (CAR) T-cell therapy has been established as a promising treatment for lymphoma/leukaemia. A patient’s own T cells can be genetically modified and amplified in the laboratory to target antigens expressed on tumour cells through the introduction of CAR genes. Early-phase clinical trials for leukaemia in adult and paediatric patients resulted in disease remission in the majority of patients. However, clinical success with solid tumour is still limited. In vitro study of CART-cell cytotoxicity for solid tumours is limited by 2D culture which does not mimic the tumour’s 3D environment. We developed a 3D culture systems that more accurately mimics tumour microenvironment, and applied light-sheet microscopy to track cytotoxic killing of target cells by CART-cells. We aim to use 3D imaging of cytotoxic killing to examine the role of chemotaxis, physical barriers, and tumour immunosuppressive pathways. Methodology: A 2D culture system was first applied using CAR targeting CD19 antigen on leukaemia cells (CAR19T). CAR19T-cells were generated using a piggy-bac transposon / transposase system. The CD19+ leukaemia cell lines, NALM6 and Raji cells, were co- cultured with CAR19T or untransduced T cells. Conjugate formation and cell lysis were observed directly by live cell imaging on grid arrays (Microsurfaces Pty Ltd). In-house software (MATLAB) was used to track individual cell fates and the dynamics of cell death and conjugate formation. To observe cyto killing in 3D, T cells and Nalm6 cells were mixed at a 1:1 ratio in matrigel and incubated at 37 degree C for 30 min before imaging with a Zeiss light sheet Z.1 microscope. The 3D trajectory and fate of cells was tracked using Arivis software. Additionally, flow cytometry was used to monitor conjugate frequency, CART-cell division and effector and target cell death. To test the feasibility of live imaging of solid tumor in a 3D culture system, GD2-positive neuroblastoma SK-N-As cell spheroids were generated in 96-well plates over 15 days of culture: Each well containing agar DMEM high glucose media was seeded with 5000 SK-N-As cells. Tumour cell spheroids were imaged by the Zeiss light sheet Z.1 microscope. Results and Conclusions: Both 2D live cell imaging studies and flow cytometry have demonstrated that targets are more susceptible to conjugation and death against CAR19T- cells in comparison to unmodified T cells. High E:T gives more effective target conjugation and killing with less effector cell death. CART cell/NALM6 cell conjugation not only induced direct cytolysis of tumour cells but arrested cell division and migration. Growth arrest of target cells is likely to be mediated by IFNγ released by activated CART-cells. Thus 2D live cell imaging has demonstrated non-cytolytic mechanisms that may play an important role in determining the antileukaemic potency of CART-cells. We have also demonstrated light sheet imaging of tumour spheroids so that the antitumour potency can be related to target / effector conjugation, tumour growth and cytolysis. The 3D culture and imaging system will be compared with 2D culture, to further illucidate mechanisms of CART-cell cytotoxicity.

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Build Your Career: Become an ISCT Member ISCT Members gain access to an influential global community of peers, experts and organizations invested in cellular therapy. With it's origins in laboratory technology ISCT continues to set quality and operations standards in cell therapy. Bringing together Key Opinion Leaders, government regulators, commercial partners and cell therapy technologists, ISCT offers and unique collaboration between academia, regulatory bodies and industry in cell therapy translation.

Membership Benefits • Discounted member rates at ISCT-sponsored events, including webinars, technical workshops,

research and clinical symposia, and the ISCT Annual Meeting. • A yearly subscription consisting of 12 issues to Cytotherapy, the Society's official scientific

journal. • A subscription to Telegraft, the members-only bi-monthly online newsletter. • Access to a members networking database to connect with your peers. • Access to BEACON - Suite of Navigational Tools —the newly expanded repository of cell therapy

resources created by ISCT members, for ISCT members. • Access to members-only web resources, including presentations and other materials from past

ISCT meetings, as well as past webinar recordings. • Join and support the many active committees chaired by thought leaders in the field that focus on

advancing cellular therapies.

ISCT Active Membership provides a hardcopy of Cytotherapy, the official journal of ISCT, along with electronic access. E-Membership provides electronic access to the journal only.

2017 Individual Membership Rates* (All rates listed are in USD)

Active Membership E-Membership

Regular Rate $185 $175 Technologists $135 $125 Advanced Practice Professionals (i.e. Physician Assistants, Advanced Practice Nurses/Nurse Practitioners, Pharmacists)

$135 $125

Residents and Fellows (Student)** $90 $65 *ISCT Membership is based on the calendar year (January 1 to December 31) ** Must be accompanied by a letter from program director/supervisor confirming student status.

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SPONSOR INFORMATION

QIMR Berghofer is a world-leading

translational research institute. Our research

focuses on cancer, infectious diseases, mental health and chronic disorders. With almost 900 scientists, students and support staff, and more than 50 state-of-the-art laboratories, QIMR Berghofer is ranked in the top two medical research institutes in Australia and has established an international reputation for research excellence. Working in close collaboration with clinicians and other research institutes, our aim is to improve health by developing new diagnostics, better treatments and prevention strategies.

The Q-Gen Cell Therapeutics

facility has over 1000m2

dedicated space within the QIMR Berghofer Medical Research Institute. We are located in Brisbane, Australia, on the campus of a large teaching hospital and co-located with Q-Pharm, a dedicated clinical trials company. Our GMP infrastructure, including our certified quality system, is designed to meet your medical research, contract manufacture, clinical trial or start-up needs.

Q-Gen Cell Therapeutics, QIMR Berghofer Medical Research Institute, 300 Herston Road, Herston QLD 4006

Cell Therapies Pty Ltd (CTPL) is the leading contract manufacturer and distributor of cellular therapies in the Asia Pacific region. For over 15 years, CTPL has collaborated with some of the world’s leading cell and gene therapy companies, developing products and processes that are

compliant with international regulatory requirements and successfully integrating with global manufacturing networks. Our affiliation with the Peter MacCallum Cancer Centre in Melbourne provides access to Australia’s leading clinicians and researchers to support clinical translation and commercial delivery of life-saving therapies. Our alliance with Pharmabio in Japan extends our reach, allowing us to provide clients a single gateway for Asia Pacific. Nathan Smith, Project Portfolio Manager nathansmith@celltherapies.com , T: +61 3 8559 7321 M: +61 477 738 404 Victorian Comprehensive Cancer Centre Level 9, 305 Grattan St, Melbourne, VIC 3000 www.celltherapies.com.au

Eurofins | ams is a provider of World-Class Analytical & Consulting Services in Microbiology. Eurofins | ams is part of Eurofins' BioPharma Product Testing group. It is the largest network of harmonized bio/pharmaceutical GMP product testing laboratories

worldwide providing comprehensive laboratory services for the world's largest pharmaceutical, biopharmaceutical and medical device companies. At Eurofins | ams, we strive to be a sophisticated provider of quality microbiological analyses and services to the pharmaceuticals, medical devices, biotechnology, consumer products, environmental and nutrition industries. To assist in this development, we have a team of highly qualified and experienced microbiologists. We are committed to the provision of world-class testing and consulting services through attention to Client needs, continuous quality improvement to internationally recognised standards, excellence in service provision and fostering the professional development of our staff. Joey Tan, Sales and Marketing Manager JoeyTan@eurofins.com M: +61 478 001 570 P: +61 2 9704 2300 Eurofins | ams , 8 Rachael Close, Silverwater NSW 2128 Australia www.eurofins.com.au/biopharma-services

GE Healthcare Life Sciences: Cell-based therapy has the potential to transform treatment for millions of patients suffering from life-threatening diseases. Through our scale and innovation we are committed to accelerating access to safe and ground-breaking

treatments. Xuri products deliver integrated solutions to help make cellular therapies a clinical reality, supporting the transition from research to clinics with confidence. Jon Ince BSc MBA, BioProcess Strategic Account Manager jon.ince@ge.com M: +61 404 027 237 T: +612 9846 4964 GE Healthcare, Life Sciences ANZ

2017 ISCT ANZ Meeting Program (15/9/2017) 13

Fluid

Biosolutions, as well as being the Australian agent

for Saint Gobain, work with other suppliers to provide additional products to support our cell therapy customers. Key amongst these are the Vante range of RF tube sealers, for fast and reliable sealing of tube lines within the manufacturing process fluid path. The perfect accompaniment to your closed system solution.

Saint Gobain designs and manufactures VueLife cell culture bags and KryoSure bags and overwraps from fluorinated ethylene propylene (FEP) utilising

a proprietary laser welding process. Saint Gobain is proud to take part in providing solutions for a multitude of cell therapy applications, including the manufacturing of standard products and collaborating with our clients to develop custom, single-use systems. It is our goal to be an integral part of the cell therapy field by providing advanced closed system solutions.

Richard Whiley, Director Fluid Biosolutions Pty Ltd +61(0)455599168 richard@fluidbiosolutions.com.au

Lonza is a leading supplier of products and services including

cell-based research tools and endotoxin detection systems to the pharmaceutical, healthcare and life science industries from research to final product manufacture. Lonza Pharma & Biotech ̶̶ Bioscience Solutions: Provider of Endotoxin Detection Assays, Rapid Microbial Detection Technology, Nucleofector™ Technology, Clonetics™ and Poietics™ Cells and Media, BioWhittaker™ Media, FlashGel™ System, PAGEr™ Precast Gels, and SeaKem® Agarose.

PeproTech is a world leader in manufacturing and supplying high

quality cytokine products including E. coli, insect, and mammalian cell-derived recombinant proteins, GMP grade, related monoclonal/polyclonal antibodies, ELISA development kits.

Morgan Donaghy, Territory Manager QLD, NT, SA Mobile: +61 413 479 061 morgan.donaghy@lonza.com Bioscience.australia@lonza.com Head Office: Lvl 2, 541 Blackburn Road, Mt Waverley VIC 3149 P:1300 657 508

For a quarter century, Miltenyi Biotec has helped brilliant minds advance scientific discovery and cellular therapies. On our 25th anniversary, we look back at the milestones that got us where we are today, and the breakthroughs that inspire us for tomorrow. Our commitment is to the advancement of biomedical research and cellular therapy. Our passion is the development of technologies that impact on basic research and clinical applications. Our

customers value our reputation and years of experience in providing products that make a difference. Miltenyi Biotec Australia Pty. Ltd., Unit 16 A, 2 Eden Park Drive, Macquarie Park NSW 2113 Australia Phone: +61 2 8877 7400 Fax:+61 2 9889 5044 E-Mail: macs@miltenyibiotec.com.au : www.miltenyibiotec.com

World leader in the field of in vitro diagnostics, bioMérieux has been providing diagnostic solutions for 50 years, and is now operating in more than 150 countries through 42 subsidiaries and a large network of distributors. bioMérieux Industry provides a wide range of solutions for microbiological control dedicated to the biopharmaceutical industries, including blood banks, cord blood banks and cell therapy. Solutions include microbial monitoring of air and surfaces, rapid microbiological methods for detecting and enumerating bacterial pathogens and contaminants, and

automated microbial identification. bioMérieux offers an array of integrated solutions to provide efficient and reproducible microbiological results and data integrity. Melissa J BOURKE Key Account Manager-bioPharma melissa.bourke@biomerieux.com Tel: 1800 333 421 | Mobile: +61 (0) 416 036 443 | Fax: +61 (0) 2 8852 4777 www.biomerieux.com Unit 25 Parkview Business Centre 1 Maitland Place Baulkham Hills NSW 2153 www.biomerieux-industry.com

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2017 DELEGATES# urname First Name Qty Ticket Type Payment Status Ambrosoli, Paula Amies, Joanne Antonenas, Vicki Barter, Matthew Bell, Rosemarie Bellingham, Matt Bohnenkamp, Hermann Brock, Paul Carr, Rebekah Chaudhry, Kajal Chiang, Amy Chojnowski, Grace Cicirello, Francesco Dastoor, Simone Donaghy, Morgan Driscoll, Dawn Elwood, Ngaire Fleming, Wendy Gabutero, Elwyn Harness, Jackie Hickey, Beth Hong Nguyen, Tam Hutchins, Cheryl Hyde, Claire Jackson, Dayna Jackson-Matthews, Dianne Jennings, Helen Johnson, Phillip Kaukova, Tatiana Kelly, Kilian Keyse, Martha Khanna, Rajiv Kramer, Belinda Kravets, Lucy Laing, Darron Lao, Osmond Leonard, Victoria

Levine, Bruce Ling, Jean Luck, Karl Macpherson, Janet Maksoud, Alyce Manderson, Tony McCutchan, Andrew McKiernan, Gerry McVeigh, Natasha Myatt, David Nordon, Robert Parker, Noor Pimanda, John Rasko, John Ritchie, Josephine Rizzitelli, Alex Rodwell, Robyn Ross, Naomi Shen, Sylvie Smith, Nathan Stanley, Amanda Stoddart, Paula Swain, Michael Tan, Joey Taylor, Debra Tey, Siok Thomas, Mark Trickett, Annette Velickovic, Zlatibor Wall, Dominic Wang, Liyuan Ward, Robyn Watson, Tracey Whiley, Richard Wright, Craig Youngson, Joanna

# Correct as at 12/9/2017

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