Cell and Gene at the Abbey
Production, Scale-up and Global Harmonisation
- Benjamin GysiDirector Cell Therapy Operations at Takeda Pharmaceuticals
- Bernd KullmanHead of Supply Chain at Sigilon Therapeutics IncBernd KullmanHead of Supply Chain at Sigilon Therapeutics Inc
Bernd Kullmann is the Head of Supply Chain at Sigilon Therapeutics, Inc. Bernd is responsible for leading Sigilon’s Supply Chain organization including oversight of demand forecasting, supply planning, external manufacturing, and management of distribution activities. Prior to joining Sigilon, Bernd held Head of Supply Chain positions at BeiGene, Ltd. and Medivation, Inc., where he built global Clinical and Commercial supply networks, and held various supply chain roles at Biogen, Inc. Bernd started his career in Turnaround Consulting at KPMG and Mesirow Financial Consulting working with companies to diagnose and address operational causes of underperformance.
Bernd earned his MBA from Carnegie Mellon University and a Bachelor of Science in Business Administration from Norwich University.
- Bruce LevineFounding Director, Clinical Cell and Vaccine Production Facility at the University of PennsylvaniaBruce LevineFounding Director, Clinical Cell and Vaccine Production Facility at the University of Pennsylvania
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. (Biology) from Penn and a Ph.D. in Immunology and Infectious Diseases from Johns Hopkins.
First-in-human adoptive immunotherapy 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 3,000 cellular products administered to >1,200 patients in clinical trials since 1996. He is co-inventor of the first FDA approved gene therapy (Kymriah), chimeric antigen receptor T cells for leukemia and lymphoma, licensed to Novartis.
Dr. Levine is co-inventor on 27 issued US patents and co-author of >180 manuscripts and book chapters with a Google Scholar citation h-index of 84. He is a Co-Founder of Tmunity Therapeutics, a spinout of the University of Pennsylvania. Dr. Levine is a recipient of the William Osler Patient Oriented Research Award, the Wallace H. Coulter Award for Healthcare Innovation, serves as President Elect of the International Society for Cell and Gene Therapy and serves on the Board of Directors of the Alliance for Regenerative Medicine. He has written for Scientific American and Wired and has been interviewed by the NY Times, Wall Street Journal, Washington Post, NPR, Time Magazine, National Geographic, Bloomberg, Forbes, BBC, and other international media outlets.
- Francesco CurcioFull Professor of Clinical Pathology at Dipartimento di Area Medica. Università di Udine – School of MedicineFrancesco CurcioFull Professor of Clinical Pathology at Dipartimento di Area Medica. Università di Udine – School of Medicine
Dr. Francesco Curcio, Medical Degree, University of Napoli Medical School and Specialty Degree in “Biologia Clinica (Clinical Biology) is Full Professor of Clinical Pathology at Dipartimento di Area Medica, Università di Udine – School of Medicine.
Areas of research:
Pathophysiology of diabetes: effects of insulin on splancnic and peripheral glucose metabolism; effects of non-enzymatic glycosylation on the functions of several plasma proteins in diabetic patients and in opiate addicts and regulatory effects by drugs; effects of high glucose-generated oxidative stress on cardiovascular complications of diabetes.
Tissue Engineering: intra- and inter- specific hybridizations; obtainment, characterization and utilization of normal, continuous cell strains expressing tissue-specific functions in vitro, such as a rat parathyroid epithelial cell line, a rat parathyroid endothelial cell line, a bovine bone endothelial cell line and rat olfactory neuron cell lines; production of monoclonal antibodies to tissue specific proteins; in vitro tissue reconstruction; microenvironmental influence on the expression of tissue specific functions in culture; establishments of in vitro conditions to culture various human differentiated cells (Islet, liver, thyroid, parathyroid, parotid, muscle, endothelial and bone cells).
Design, development, test and use of different models of bioreactors for automated cell culture.
- Jason JonesChief Business Officer at Ori Biotech LtdJason JonesChief Business Officer at Ori Biotech Ltd
Jason has made cell and gene therapy manufacturing nearly his whole professional career, specifically on the technology and the processes to facilitate that manufacturing. From the early academic days of the field to the advent of the cell and gene therapy industry, the first approvals and now the imminent wave of commercialised products coming to market with the continuing promise that these approaches bring. With 18 years at Miltenyi Biotec, Jason lead the strategy around the launch and positioning of their CliniMACS Plus, Prodigy and Tyto platforms and raw materials in Europe and managed their global strategic partnerships with the likes of GSK and Autolus (publicly announced), experiencing the limitations of current generation technologies in scale out operations. Since 2018 Jason has been CBO at Ori Biotech, developing a next level, new generation CGT manufacturing platform to address the current challenges of scale. Partnering with therapeutics developers, manufacturers and other technology developers to bring together specific expertise to help bridge the chasm the industry is approaching between the patients in need and the capacity to produce these promising therapies.
- Jim FaulknerVenture Partner at Apple Tree Life SciencesJim FaulknerVenture Partner at Apple Tree Life Sciences
Jim Faulkner is a venture partner at ATP. A highly experienced biopharmaceutical development leader with specialist skills in gene and cell therapy, he has been significantly involved in taking more than 25 different medicines into the clinic, including multiple CAR-T assets. Prior to ATP, Jim headed Product Delivery for Autolus Ltd, a clinical-stage CAR-T company spun out of University College London. Prior to that, Jim held various leadership roles at GlaxoSmithKline, including overseeing the chemistry, manufacturing and controls (CMC) development and supply for their Rare Diseases Unit. Jim has a Degree in Biotechnology and completed his PhD in Molecular Biology.
- Knut NissChief Technology Officer at MustangBioKnut NissChief Technology Officer at MustangBio
Dr. Niss has served as Chief Technology Officer since March 2018. Dr. Niss joined Mustang in March 2017 as Vice President of Operations, where he initiated and oversees the establishment of Mustang’s cell therapy manufacturing facility. Prior to Mustang, Dr. Niss was Cell Therapy Asset Leader at Biogen, where he oversaw CMC-related activities for gene-edited hematopoietic stem cell and lentiviral gene therapy programs for sickle cell disease and hemophilia, respectively.
Earlier in his career, Dr. Niss was Senior Technical Project Leader at Novartis’ cell therapy manufacturing facility in Morris Plains, New Jersey, where he directed the transfer and implementation of the CTL019 process from Penn to Novartis. He also served as Senior R&D Program Manager at EMD Millipore, where he established processes for the large-scale expansion of adult and pluripotent stem cells.
Dr. Niss began his career in senior research positions in Pfizer’s Regenerative Medicine and Immunology groups. He holds a Ph.D. in molecular biology from Humboldt University of Berlin, and an M.S. in microbiology from the University of Göttingen in Germany. Dr. Niss completed his postdoctoral research at Boston Children’s Hospital and the Dana-Farber Cancer Institute.
- Máire QuigleyDirector at CRISPR TherapeuticsMáire QuigleyDirector at CRISPR Therapeutics
Máire Quigley is a proud NUI Galway graduate and has worked on novel immunotherapies for cancer for the past decade. She earned a doctorate in immunology from Karolinska Institutet in Stockholm and carried out post-graduate training at the University of Massachusetts Medical School and at the National Institutes of Health. As a principal scientist at Novartis, she supported the first ever CAR-T cell therapy approval by the FDA, and is currently director of technical operations at CRISPR Therapeutics, developing novel allogeneic CAR-T cell and regenerative medicine therapies.
- Mandana Haack-SørensenCell Processing Specialist at Rigshospitalet
- Mark LowdellCSO and Founder at InMuneBioMark LowdellCSO and Founder at InMuneBio
Professor Mark Lowdell PhD FRCPath FRSB is the Professor of Cell & Tissue Therapy at University College London and Director of the Centre for Cell, Gene & Tissue Therapeutics / Honorary Consultant Immunologist at Royal Free Hospital London. He is a qualified diagnostic immunopathologist as well as holding MHRA Qualified Person status for the release of ATMPs for clinical trials. He held the post of Vice President (Europe) of the International Society for Cell & Gene Therapy for two terms from 2014-2018.
Mark has over 25 years’ experience in adoptive immunotherapy of cancer and has targeted the role of the innate immune responses; especially the role of natural killer (NK) cells, although his experience includes a variety of adoptive T cell therapies (cancer and viral infection) as well as dendritic cell vaccines and CAR-T cells.
He has focussed particularly on translational research and established the first academic GMP facility in the UK for the production of human cells as medicines in 2003. This GMP facility now produces somatic cell medicines, gene therapies and tissue engineered products and is particularly adept at developing processes for scale-up of ATMP production.
His ATMP GMP suite at RFH/UCL consists of 12 state-of-the-art manufacturing labs and over 20 staff supporting multiple academic and commercial trials of somatic cell and tissue engineered therapies which has given him unique insight into the challenges of scaled provision of multiple types of ATMPs.
Professor Lowdell has held and holds numerous appointments to academic and government advisory boards in the UK and overseas. Recently he was a member of the UK Government Regenerative Medicine Expert Review Group and is a member of the scientific advisory boards, consultant to or founder of many of the key companies involved in ATMP development in the EU and USA including Achilles Therapeutics Ltd, Autolomous Ltd, Autolus Ltd, INmuneBio Inc and NWBio Therapeutics.
- Massimo DominiciAssociate Professor at University of Modena and Reggio EmiliaMassimo DominiciAssociate Professor at University of Modena and Reggio Emilia
Born in Lodi (Italy) 1972. MD degree at the University of Pavia in 1996. Post-graduate internship at the Vienna University (Austria). Residency in Hematology at the University of Ferrara. Post-Doctoral Associate at St. Jude Children’s Hospital in Memphis (USA, 2000-2003).
Currently, Associate Professor, Director of the Residency School of Medical Oncology, Director of the Division of Medical Oncology and of the Program of Cellular Therapy and Immuno-oncology at the University Hospital of Modena and Reggio Emilia (Italy).
Since 2005 he is heading the Laboratory of Cellular Therapies. Over 160 papers with more than 22000 citations, 12 patents, five book chapters published, three books published. 22 grants as principal investigator with 11 on competitive calls, 10 grants as co-investigator all on competitive calls, 11 grants from biotech industries for sub-contracting investigations with a total of 14,6 Mio € since 2004.
Founder of the university start-up Rigenerand raising 12,5 Mio € since 2009. Co-founder and coordinator of the Mirandola Science & Technology Park. 170 invited lectures as plenary speaker between national, international meetings and for University lectures, 14 peer reviewed oral communication and 31 posters presented in international meetings. Berlucchi Award for Research in Oncology (2012); “Fanfullino della Riconoscenza Premio Città Di Lodi” (2017); International Award Pico della Mirandola (2017). Referee and advisor for 16 research founding Bodies. He has been co-founder of the Forum of Italian Researcher on MSC (FIRST), board member of JACIE, WBMT and scientific advisor for the Italian Minister of Health.
He has been member of ISCT, ASH, ESCGT, IFATS, IPLASS. Consultant for the WHO INN for cellular therapies. He has been President of ISCT 2014-2016, now member Emeritus, Member of the Strategic Advisory Council and Chair of the ISCT Presidential task-force on unproven cell and gene therapies.
- Michael O’DwyerFounder, CSO & Director at ONK TherapeuticsMichael O’DwyerFounder, CSO & Director at ONK Therapeutics
Michael O’Dwyer is an experienced Clinician Scientist with a strong track record in clinical and translational research in blood cancers and has been involved in the clinical drug development of many ground-breaking treatments. He is a Founder of ONK Therapeutics and has been the company’s CSO since its inception in 2015.
Michael is also a Professor of Hematology at the National University of Ireland (NUI), Galway. In recent years his main research focus has been on Multiple Myeloma where he is studying the immune microenvironment, the impact of glycosylation on cell trafficking and immune evasion and the genetic modification of Natural Killer (NK) cells to enable cell therapy for cancer.
He has approximately 100 peer reviewed publications and is listed as an inventor on more than 10 patents.
He is a member of the American Society of Hematology (ASH), the European Hematology Association (EHA) Scientific Working Party on Immunotherapy of Hematologic Malignancies and the International Myeloma Working Group (IMWG).
Earlier in his career Michael was Assistant Professor at Oregon Health & Sciences University (OHSU), Portland, USA, where he worked on the development of imatinib.
Michael has an MD degree from NUI Galway and undertook training in Hematology in Ireland followed by a Fellowship in Hematology and Medical Oncology at OHSU.
- Niamh CurranPharmaceutical Assessor at HPRA - Health Products Regulatory AuthorityNiamh CurranPharmaceutical Assessor at HPRA - Health Products Regulatory Authority
Niamh holds a BSc/PhD in Pharmacology from University College Dublin where her area of research was in the field of innate immunology. Since 2007, Niamh has been a pharmaceutical assessor with the HPRA where she is responsible for quality assessment of biological medicinal products including ATMPs. Her work includes assessment of quality aspects of centralised product dossiers, scientific advice as well as clinical trials. Niamh has been the Irish alternate member of the EMA committee for advanced therapies (CAT) since 2016.
- Nisha DurandClinical and Translational Scientist, Center for Regenerative Medicine at Mayo Clinic FloridaNisha DurandClinical and Translational Scientist, Center for Regenerative Medicine at Mayo Clinic Florida
Nisha Durand is currently a Sr. Research Fellow at the Human Cell Therapy Lab within the Center for Regenerative Medicine at Mayo Clinic Florida. She has a Ph.D in Biochemistry and Molecular Biology from Mayo Clinic Graduate School of Biomedical Sciences.
At the Center for Regenerative Medicine, Nisha is responsible for translating research processes into the cGMP environment, developing processes and techniques in support of all phases of cellular product development, and Stem Cell Production in support of multiple phase I clinical trials.
In addition, she is also actively involved in the regulatory process with responsibility for generating pre-clinical safety and efficacy data and CMC development
- Patrick J. HanleyDirector, Cellular Therapy Laboratory Assistant Professor of Pediatrics at Children’s National Hospital The George Washington UniversityPatrick J. HanleyDirector, Cellular Therapy Laboratory Assistant Professor of Pediatrics at Children’s National Hospital The George Washington University
Dr. Hanley is an assistant research professor of pediatrics and Director of the Cellular Therapy Laboratory at Children’s National Hospital. He oversees processing for standard of care stem cell transplantation as well as the development, manufacture, and testing of novel cell therapies for patients enrolled on clinical trials. Trained as an Immunologist, Dr. Hanley has an extensive background and interest in cellular therapy and is passionate about improving regulations for cellular therapy, training the next generation of cell therapists, and facilitating the translation of new therapeutics. Over the past 14 years he has helped to translate more than 20 cell therapy protocols – ranging from mesenchymal stromal cells to cord blood virus-specific T cells and tumor-associated antigen specific T cells – into the clinic.
Dr. Hanley is on the board of directors of the Foundation for the Accreditation of Cellular Therapy (FACT), is an active inspector, is chair of FACT’s education committee, serves on their accreditation committee and is also on the immune effector cell standards subcommittee. He serves on the editorial boards of the journals Cytotherapy and Molecular Therapy: Methods and Clinical Development. In 2017, along with Drs Catherine Bollard and Russell Cruz, he founded Mana Therapeutics, a biotech company aimed at educating immune cells and eliminating cancer. In his free time he enjoys playing soccer, cooking, and traveling.
- Qasim RafiqAssociate Professor in Cell and Gene Therapy Bioprocessing at University College LondonQasim RafiqAssociate Professor in Cell and Gene Therapy Bioprocessing at University College London
Qasim Rafiq is an Associate Professor of Cell and Gene Therapy Bioprocess Engineering at University College London and Programme Director of a new MSc programme focused on the Manufacture and Commercialisation of Stem Cell and Gene Therapies. He is a multidisciplinary engineer working at the life science, engineering and commercial interfaces with a research focus on the bioprocessing, automation and biomanufacture of cell and gene-based therapies. He has a specific interest in addressing the large-scale manufacturing challenges and enhancing process and product understanding to enable the successful translation of therapeutics from the laboratory to the clinic.
Qasim is both a Chartered Engineer (CEng) and Chartered Scientist (CSci) and sits on multiple scientific and engineering committees including the UK Society for Cell Culture Biotechnology (ESACT-UK) where he is the Scientific Programme Lead, the IChemE Biochemical Engineering Subject Interest Group, British Standards Institute Biotechnology Committee and the BioIndustry Association’s Cell and Gene Therapy Advisory Committee.
He has won awards for his research and public engagement activities and in 2020 was recognised as one of the top 20 influential and inspirational individuals in Advanced Medicine by The Medicine Maker listed amongst Nobel Laureates, multi-national CEOs and leading scientists.
- Roisin O’CearbhaillMedical Oncologist at Memorial Sloan Kettering Cancer CenterRoisin O’CearbhaillMedical Oncologist at Memorial Sloan Kettering Cancer Center
Dr. Roisin O’Cearbhaill, MB BCh BAO, MRCPI, MRCPUK, is the Clinical Director of the Solid Tumor Program, Cellular Therapeutics Center and Research Director of the Gynecologic Medical Oncology Service at Memorial Sloan Kettering Cancer Center, with a joint faculty appointment at Weill Cornell Medical College. She is the Director, Patient and Family Centered Care Grant initiative and the Vice-Chair, Investigational New Drug/Device committee at MSKCC. She has extensive clinical and research experience in the treatment of gynecological cancers. Her research focuses on the development of novel targeted and cellular and immune-based approaches to improve outcomes for these cancers. She has been appointed to several international committees and is Chair, Developmental Therapeutics, NRG Oncology and serves on the Solid Tumor Task force for the Center for International Blood and Bone Marrow Transplant Research. She has received numerous awards for her work, including a Conquer Cancer Foundation Career Development Award, Young Investigator Award from the Kaleidoscope of Hope Foundation, Excellence in Research Award from MSKCC and Excellence in teaching award from Weill Cornell Medical College.
- Scott OlsonAssistant Professor in the Department of Pediatric Surgery, Children’s Program in Regenerative Medicine, University of Texas Health Science Center at Houston.Scott OlsonAssistant Professor in the Department of Pediatric Surgery, Children’s Program in Regenerative Medicine, University of Texas Health Science Center at Houston.
Dr. Scott Olson is an Assistant Professor in the Department of Pediatric Surgery, Children’s Program in Regenerative Medicine, University of Texas Health Science Center at Houston. Dr. Olson completed his doctorate in the lab of Dr. Darwin Prockop at Tulane University’s Center for Gene Therapy studying novel methods by which mesenchymal stem cells (MSC) can contribute to tissue repair. At University of California at Davis’s Health Sciences Institute for Regenerative Cures, Dr. Olson worked to apply MSC as a platform to develop new treatments for Huntington’s Disease. Dr. Olson joined the faculty of UT Health in September 2011 and has published over 40 papers on adult stem cell biology. At UTHealth, Dr. Olson works as a pre-clinical translational biologist in collaboration with clinicians, clinician-scientists, regulatory scientists, cell manufacturers, and a number of industry partners to advance various cell therapies from research labs to clinical trials.
- Shirley O'DeaChief Scientific Officer at AvectasShirley O'DeaChief Scientific Officer at Avectas
Shirley co-founded Avectas in 2012 and is the company’s CSO, in addition to serving on the Board of Directors. She is charged with evaluating, overseeing and implementing both the internal and external scientific programs.
With an accomplished scientific career in cell biology extending over 25 years, prior to co-founding Avectas Shirley completed research fellowships at University of Edinburgh Medical School and also served as a Principal Investigator for several industry collaborations.
Shirley has extensive experience in leading large scientific groups from her tenure as Associate Professor and PI at Maynooth University.
- Steve CharleboisVice President, Engineering at MED Institute
Fee & Cancellation Policy
Rate includes 2.5 days conference attendance with workshop on Day 2, coffees, lunches, a drinks reception and 2 dinners.
Early Bird Registration, before April 30th, 2021
€1,250 per attendee 2 or more from one company €1,000 per attendee
General Registration, after May 01st, 2021
€1,500 per attendee
2 or more from one company €1,250 per attendee
Academic rate available upon request.
Cancellation possible until September 30th subject to a €100.00 cancellation fee.
Accommodation is available at the Glenlo Abbey Hotel, and can be booked directly via the hotel or via e-mail at firstname.lastname@example.org using promo-code ‘HiTechHealth’. Special rate of €160 B&B single or €170 for Twin or Double.
In addition, rooms are also available at the Harbour Hotel (www.harbour.ie) located in Galway City. Bookings can be made directly via the hotel or via e-mail at email@example.com using promo-code ‘HiTechHealth’. Special rate of €129 B&B single or €139 for Twin or Double. Transfer will be organised for attendees staying in this hotel to the venue each morning of the meeting.
Apr 22, 2021 | HiTech Health Latest News
HiTech Health awarded with €7m government funding for 'disruptive' project HiTech Health and our partners, Relevium Medical and Professor Garry Duffy’s Laboratory at NUI Galway are honoured to receive €7 million from the Disruptive Technologies Innovation Fund...
Apr 20, 2021 | HiTech Health Latest News
HiTech Health and blood cancer charity Anthony Nolan have entered into an agreement to facilitate the development of novel cell and gene therapies. Anthony Nolan Cell & Gene Therapy Services will support HiTech Health’s supply chain through the provision of a...
Mar 29, 2021 | HiTech Health Latest News
HiTech Health, SextonBio and MedInstitute announce collaboration to develop and publish workflows for integrating unit operations in cell therapy manufacturing using flexible automation systems. Sexton Biotechnologies, in partnership with HiTech Health and Med...
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