CURRICULUM • FACULTY · Fresenius Kabi Scholar North American Scholars Monzr Al Malki, MD City of Hope National Medical Center ... This Regulatory Affairs Case Studies discussion

OCTOBER 23–27, 2017 SEATTLE, WASHINGTON, USA

CURRICULUM • FACULTY

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THE ISCT-ASBMT CELL THERAPY TRAINING COURSE IS SPONSORED IN PART BY THE FOLLOWING ORGANIZATIONS:

Partner

Institutional Host

Full Scholarship Funding Provided By:

Additional Support Provided By:


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Planning Committee

Lizabeth Cardwell, MT(ASCP), MBA, RACPrincipal ConsultantCompliance ConsultingSeattle, WA, USA

Colleen Delaney, MD, MScFounder and Chief Medical OfficerNohla TherapeuticsMember, Fred Hutchinson Cancer Research Center Director, Cord Blood Transplant Program Professor, University of WashingtonSeattle, WA, USA

Shelly Heimfeld, PhDExecutive Vice President Manufacturing and ResearchNohla Therapeutics Director of SCCA Cellular Therapy LaboratoryMember, Fred Hutchinson Cancer Research CenterSeattle, WA, USA

Helen Heslop, MD, DSc (Hon)Professor of Medicine and Pediatrics Director, Center for Cell and Gene TherapyBaylor College of MedicineHouston, TX, USA

Co–Chairs

John Barrett, MDChief Stem Cell Allotransplantation Section Hematology BranchNational Heart, Lung, and Blood Institute Bethesda, MD, USA

David DiGiusto, PhDExecutive DirectorStem Cells and Cellular Therapeutics OperationsFounding Director, Stanford Laboratory for Cell and Gene MedicineSenior Research Scientist, Division of Pediatric Stem Transplantation and Regenerative MedicineStanford Health Care/ Stanford School of MedicineStanford, CA, USA

PLANNING FACULTY

COURSE VENUE

Fred Hutchinson Cancer Research Center M1-A303 – Behnke Conference Room1100 Fairview Ave. N.Seattle, Washington 98109

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Session LeadsJennifer E. Adair, PhDAssistant Member, Clinical Research Division

Fred Hutchinson Cancer Research CenterResearch Assistant Professor, Department of Medical OncologyUniversity of WashingtonSeattle, WA, USA

John Barrett, MDChief

Stem Cell Allotransplantation SectionHematology BranchNational Heart, Lung and Blood InstituteBethesda, MD, USA

Marie Bleakley, MD, PhD, M.MSCAssociate Professor, Pediatrics

University of Washington School of MedicineSeattle, WA, USA

Catherine Bollard, MD, MBChBISCT President 2016-2018

Professor of Pediatrics and of Microbiology, Immunology and Tropical Medicine, Director, Program for Cell Enhancement and Technologies for Immunotherapy (CETI), Director, Center for Cancer and Immunology ResearchChildren’s National Health SystemThe George Washington University School of Medicine and Health SciencesWashington, DC, USA

Lizabeth Cardwell, MT(ASCP), MBA, RACPrincipal Consultant

Compliance ConsultingSeattle, WA, USA

Colleen Delaney, MD, MScFounder and Chief Medical Officer

Nohla TherapeuticsMember, Fred Hutchinson Cancer Research Center Director, Cord Blood Transplant Program Professor, University of WashingtonSeattle, WA, USA

David DiGiusto, PhDExecutive Director

Stem Cells and Cellular Therapeutics OperationsFounding Director, Stanford Laboratory for Cell and Gene MedicineSenior Research Scientist, Division of Pediatric Stem Transplantationand Regenerative MedicineStanford Health Care/ Stanford School of MedicineStanford, CA, USA

Shelly Heimfeld, PhDExecutive Vice President Manufacturing and Research

Nohla Therapeutics Director of SCCA Cellular Therapy LaboratoryMember, Fred Hutchinson Cancer Research CenterSeattle, WA, USA

Krishna Komanduri, MDASBMT President 2017-2018

Medical Director, Adult Stem Cell Transplant ProgramProfessor of Medicine, Microbiology and ImmunologyUniversity of Miami Health SystemMiami, FL, USA

Bruce Levine, PhDBarbara and Edward Netter Professor in Cancer Gene Therapy

Department of Pathology and Laboratory MedicineCenter for Cellular ImmunotherapiesPerelman School of Medicine and Abramson Cancer CenterUniversity of PennsylvaniaPhiladelphia, PA, USA

COURSE FACULTY


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Session SpeakersSergei Doulatov, PhDAssistant Professor

Department of MedicineUniversity of WashingtonSeattle, WA, USA

Boro Dropulic, PhD, MBAChief Science Officer and General Manager

Lentigen Technology, Inc., A Miltenyi Biotec CompanyGaithersburg, MD, USA

Thomas Fleming, PhDProfessor, Biostatistics and Statistics

University of WashingtonGraduate Faculty, Biostatistics and Statistics, University of WashingtonMember, Vaccine and Infectious Disease DivisionMember, Public Health Sciences DivisionSeattle, WA, USA

Ahmed Ibrahim, MPH, PhDFaculty

Cedars Sinai Heart Institute Capricor Therapeutics, IncLos Angeles, CA, USA

Thong LeChief Executive Officer

Accelerator CorporationSeattle, WA, USA

Patrick MaunderDirector Quality Control and Analytical Development

Nohla TherapeuticsSeattle, WA, USA

Elizabeth “EJ” Read, MDSenior Vice President, Product Development

Medeor Therapeutics, Inc.San Mateo, CA, USA

Stanley Riddell, MDScientific Director

Immunotherapy Integrated Research CenterFred Hutchinson Cancer Research CenterProfessor, School of MedicineUniversity of WashingtonSeattle, WA, USA

Niki Robinson, PhDVice President of Business Development and Strategy

Fred Hutchinson Cancer Research CenterSeattle, WA, USA

Darin J. Weber, PhDHead, Regulatory Affairs and Quality

Medeor Therapeutics, Inc.Seattle, WA, USA

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THE SCHOLARS

International ScholarsBechara Mfarrej, MSInstitut Paoli–CalmettesMarseilles, FranceBecton Dickinson Scholar

Anton Terwisscha van Scheltinga, PhDLeiden UniversityLeiden, NetherlandsISCT Scholar

Charan Thej, MSManipal UniversityBangalore, IndiaISCT Scholar

Carrie van der Weyden, MBBSPeter MacCallum Cancer CenterVictoria, AustraliaThermo Fisher Scientific Scholar

Zlatibor Velickovic, PhDRoyal Prince Alfred HospitalSydney, AustraliaFresenius Kabi Scholar

North American ScholarsMonzr Al Malki, MDCity of Hope National Medical CenterDuarte, CA, USATerumo BCT Scholar

Mark DeWitt, PhDUniversity of CaliforniaBerkeley, CA, USAASBMT Scholar

Daniel Dever, PhDStanford UniversityStanford, CA, USAASBMT Scholar

Melanie Grant, PhDChildren’s National Medical CenterWashington, DC, USAASBMT Scholar

Folashade Otegbeye, MBChB, MPHUniversity Hospitals Cleveland Medical CenterCleveland, OH, USA ASBMT Scholar

Host Institutional ScholarsElizabeth Krakow, MD, CM, MScFred Hutchinson Cancer Research CenterSeattle, WA, USA

Corinne Summers, MDUniversity of WashingtonSeattle, WA, USA

Robson Dossa, PhDFred Hutchinson Cancer Research CenterSeattle, WA, USA


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MONDAY, OCTOBER 23, 2017Fred Hutchinson Cancer Research Center

08:00 – 08:15 Introduction by Course Co-Chairs Behnke Conference Room

08:15 – 10:00 Scholar Presentations

10:00 – 10:15 Coffee Break


12:00 – 12:45 Lunch


14:00 – 18:30 Design, Conduct and Analysis of Clinical Trials Room D1-080/084, Thomas Building

PRESENTED BY:Thomas Fleming, PhD, University of Washington, Seattle, WA

Confirmatory & Exploratory Analyses Biomarkers & Surrogate Endpoints Addressing Missing Data in Clinical Trials Key Considerations in Non-Inferiority Trials: PrEP and Microbicide Studies

TUESDAY, OCTOBER 24, 2017Fred Hutchinson Cancer Research Center

08:00 – 10:00

Quality Systems Development Lectures Behnke Conference Room

This section will introduce the regulations, guidance, and make recommendations for establishing Quality System elements consistent with the needs for early phase clinical studies.

LEARNING OBJECTIVES Understanding Regulatory Requirements for Quality Systems Understanding what constitutes a Quality System Understanding the role Quality System plays in product development Developing Quality Systems appropriate to the stage of the project

SESSION LEADLizabeth Cardwell, MT(ASCP), MBA, RAC, Compliance Consulting, Seattle, WA

SPEAKERSLizabeth Cardwell, MT(ASCP), MBA, RAC, Compliance Consulting, Seattle, WA

Patrick Maunder, Nohla Therapeutics, Seattle, WA


ProgramCO–CHAIRS

David DiGiusto, PhDExecutive Director, Stem Cell and Cellular Therapeutics Operations, Stanford Healthcare, Stanford, CA, USA

John Barrett, MDChief, Stem Cell Allotransplantation Section, Hematology Branch, National Heart, Lung, and Blood Institute, Bethesda, MD, USA

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10:15 – 12:00 IND Development Lectures

This section will cover the format, topics, inclusions, and strategies for filing an Investigational New Drug (IND), with focus on the non-clinical and clinical data expectations required by the eCTD format. The session will also include discussion of translating the early phase R&D product into GMP including development of specifications pertinent to the Chemistry, Manufacturing and Controls (CMC) of the IND.

LEARNING OBJECTIVES Learn the components of the IND submission, the clinical research protocol and the related and required

monitoring plans Understand the components of the CMC and how develop and present those components for inclusion in the IND Recognize the importance of gathering appropriate previous human and preclinical data to support the IND Recognize the importance of working closely with the GMP lab to design SOPs for product generation Learn the CTD/eCTD modular format and be able to identify nuances and differences of the format as

compared to the FDA IND format

SESSION LEADLizabeth Cardwell, MT(ASCP), MBA, RAC, Compliance Consulting, Seattle, WA

SPEAKERSChemistry, Manufacturing & Controls (CMC) for an Advanced Therapy INDEJ Read, MD, Medeor Therapeutics Inc, San Mateo, CA

IND Components, Sources of Data and How to Successfully Integrate into an IND Darin Weber, PhD, Medeor Therapeutics Inc, Seattle, WA

12:00 – 13:00 Lunch

13:00 – 14:00 Roundtable Discussion: Regulatory Affairs Case Studies

This Regulatory Affairs Case Studies discussion will focus on real world experiences in developing and interpreting the regulatory requirements for cell and gene therapy.

LEARNING OBJECTIVES Planning and preparing for Pre-IND/scientific guidance meetings Non-clinical efficacy, safety & toxicology – challenges for Advanced Therapies Product characterization & potency Comparability of non-clinical material with clinical material Comparability for process and product changes Tips for study report and submission compilation and writing

SESSION LEADDavid DiGiusto, PhD, Stanford Healthcare, Stanford, CA

SPEAKERSDarin Weber, PhD, Medeor Therapeutics Inc, Seattle, WA

EJ Read, MD, Medeor Therapeutics Inc, San Mateo, CA Shelly Heimfeld, PhD, Nohla Therapeutics and Fred Hutchinson Cancer Research Center, Seattle, WA

14:00 – 15:00 Breakout Session: Career Development

This panel session will feature multiple faculty members and will highlight the many career path options in the cell and gene therapy space. The faculty will describe critical decisions that they have made along their career development, what transitions they have made within their careers, lessons learned and advice on how to positively influence your career path forward. Included in the panel will be faculty who have remained in research/academia and others who have made transitions between academia and industry. This session will be interactive and the scholars will have extensive opportunity to ask questions of the faculty with respect to career development.

SESSION LEADColleen Delaney, MD, MSc, Nohla Therapeutics, Seattle, WA

SPEAKERSCourse Planning Faculty


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15:00 – 16:00 Travel to Nohla Therapeutics

16:00 – 17:00 Tour of Nohla Therapeutics

Nohla Therapeutics is a leading developer of universal donor cell therapies for patients with hematologic malignances and other critical diseases. The company’s lead product, NLA101, is a regenerative cell therapy consisting of ex vivo expanded stem and progenitor cells derived from umbilical cord blood, available off the shelf without the need for HLA matching.

LEARNING OBJECTIVES: Operation of a commercial start-up Process Development and Process-transfer activities

TOUR FACILITATORSColleen Delaney, MD, MSc, Nohla Therapeutics, Seattle, WA Shelly Heimfeld, PhD, Nohla Therapeutics and Fred Hutchinson Cancer Research Center, Seattle, WA

17:00 – 18:00Networking Reception with Faculty Sponsored by Nohla Therapeutics

WEDNESDAY, OCTOBER 25, 2017Fred Hutchinson Cancer Research Center

08:00 – 09:45

Manufacturing and Release Testing Cells Behnke Conference Room

These lectures will cover basic principles and practices for the manufacturing and release testing of cell and gene therapy products according to Good Manufacturing Practices. Examples from instructor experiences will be used to provide context for interpretation of federal regulations. Instructors will address production of gene-edited HSPC, expanded HSPC and CAR-T production.

LEARNING OBJECTIVES Principles of GMP as applied to manufacturing operations Raw materials specifications and vendor selection Working with primary cells from patients and patient specific product manufacturing Creation and testing of Master and Working Cell banks for allogeneic products Open vs closed systems for manufacturing Application of automation and product manufacturing In process testing and setting metrics for success Developing and qualifying appropriate release tests (compendial vs product specific) Product packaging, sampling, storage and stability testing

SESSION LEADDavid DiGiusto, PhD, Stanford Healthcare, Stanford, CA

SPEAKERSBruce Levine, PhD, University of Pennsylvania, Philadelphia, PA

David DiGiusto, PhD, Stanford Healthcare, Stanford, CA Shelly Heimfeld, PhD, Nohla Therapeutics and Fred Hutchinson Cancer Research Center, Seattle, WA


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10:00 – 11:00 MSC and Exosomes

In this session Dr. Barrett will discuss the current and potential clinical applications of mesenchymal stromal cell therapy and the special challenge for product characterization of this polyfunctional cell product. Dr. Ibrahim will describe new research and early clinical trial experience with intracoronary cardiosphere-derived cells for heart regeneration after myocardial infarction.

LEARNING OBJECTIVES To develop an understanding of the status of MSC in clinic trials as well as pre-trial development To understand the evolving role of cardiospheres in therapeutic applications, how cardiospheres are isolated,

characterized and released in the context of cell and gene therapy

SESSION LEADJohn Barrett, MD, National Heart, Lung and Blood Institute, Bethesda, MD

SPEAKERSMesenchymal stromal cells in regenerative medicineJohn Barrett, MD, National Heart, Lung and Blood Institute, Bethesda, MD

Intracoronary cardiosphere-derived cells for heart regeneration after myocardial infarction Ahmed Ibrahim, MPH, PhD, Cedars Sinai Heart Institute, Beverly Hills, CA

11:00 – 12:00 Manufacturing and Release Testing Vectors

This session will describe the regulations and standards that govern the production and release testing requirements for viral vectors intended for ex vivo or in vivo clinical use. Dr. Heimfeld will present a brief and selected overview of current therapeutic settings where viral vectors are being investigated. Dr. Dropulic will discuss specific case studies covering the components involved in manufacturing and testing of viral vectors, along with the quality control/quality assurance processes and test method developments necessary to ensure accuracy and compliance.

LEARNING OBJECTIVES To understand the general principles of good manufacturing practices (GMPs) To understand issues associated with the manufacturing of viral vector products, including scale and lot-to-lot

variability To understand the basic regulatory requirements governing the manufacture of viral vector products To understand the requirements for release testing of viral vector products including RCR/RCL testing To understand any differences in manufacturing and regulatory requirements for in vitro versus in vivo use of

viral vectors

SESSION LEADShelly Heimfeld, PhD, Nohla Therapeutics and Fred Hutchinson Cancer Research Center, WA

SPEAKERSBoro Dropulic, PhD, MBA, Lentigen Technology, Gaithersburg, MD

12:00 – 13:00 Lunch

13:00 – 14:00 Routes to Commercialization

This session will focus on transition of cell therapy projects from an academic setting into industry. The evolution from the non-profit to the for-profit sector brings potential advantages of scale and resources. The challenge will be whether industry has the capital and bandwidth to drive the cycles of innovation necessary to achieve success, and how pre-clinical and clinical science within academia can efficiently participate in ongoing product development. We will also discuss funding and capital sourcing strategies for early stage companies. The invited speakers will share their personal experiences, strategies and lessons learned in making this often-difficult transition.

LEARNING OBJECTIVES To understand the product development life cycle and drivers of commercialization of cell and gene therapy products

SESSION LEADBruce Levine, PhD, University of Pennsylvania, Philadelphia, PA

SPEAKERSMoving Biomedical Discoveries Beyond the BenchThong Le, Accelerator Corporation, Seattle, WA Niki Robinson, PhD, Fred Hutchinson Cancer Research Center, Seattle, WA


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14:00 – 16:00 Pre–Clinical Development

In this session Dr. Delaney will introduce the session, followed by a description of the bench to bedside development of methods to ex vivo expand hamatopoietic stem and progenitor cells ex vivo for clinical application. Dr. Bleakley will describe the Seattle experience in developing T cell receptor gene modified T cell products for treatment of patients relapsing with leukemia after stem cell transplantation. Dr. Barrett will describe the route to product development and approval and the development of early phase clinical trials using mesenchymal stromal cells to treat tissue damage after allogeneic stem cell transplantation.

LEARNING OBJECTIVES To learn the challenges that have to be overcome to translate from the idea to the reality of cell product

manufacture for the clinic To learn the history behind the current manufacture of specific cell therapies To understand the particular problems that had to be overcome for specific cell products (Stem cells, NK cells

MSC and T cells)

SESSION LEADColleen Delaney, MD, MSc, Nohla Therapeutics, Seattle, WA

SPEAKERSDevelopment of TCR gene-modified T cell immunotherapy for relapse prevention after allogeneic hematopoietic stem cell transplantationMarie Bleakley, MD, PhD, M.MSC, Fred Hutchinson Cancer Research Center, Seattle, WA

Challenges and pitfalls in the development of mesenchymal stromal cell products and associate clinical trials at the National Institutes of Health.John Barrett, MD, National Heart, Lung and Blood Institute, Bethesda, MD

16:00 – 17:30 Clinical Trial Case Studies: Delivery of Cell Therapy Products (Infusion)

This session will focus on the nuances and issues related to delivering various cell and gene therapy products to patients including shipping, storage, infusion, managing product related adverse events and reporting.

LEARNING OBJECTIVES To understand the issues related to shipping cell and gene therapy products To understand the issues related to storage of cell and gene therapy products To understand the issues related to infusing of cell and gene therapy products, monitoring and reporting

product-related adverse effects To understand the issues related to managing product-related adverse events

SESSION LEADMarie Bleakley, MD, PhD, M.MSC, Fred Hutchinson Cancer Research Center, Seattle, WA


17:30 – 18:30 Travel to the Pan Pacific Seattle

18:30 – 20:30Dinner at the Pan Pacific SeattleGuest Lecture by Stanley Riddell, MD, Fred Hutchinson Cancer Research Center, Seattle, WA

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THURSDAY, OCTOBER 26, 2017Fred Hutchinson Cancer Research Center

08:00 – 10:00

Correlative Studies Lectures Behnke Conference Room

This session will discuss immune correlative studies for immune based therapies. Dr. Komanduri will discuss challenges when performing immune monitoring studies as correlates in a high through put setting. Dr. Bollard will discuss her experience performing immune monitoring studies in a cooperative group setting and how to track adoptively transferred T cells which do not have a marker gene and Dr. Heimfeld will discuss the importance of correlative studies when infusing genetically modified cells.

LEARNING OBJECTIVES To understand the importance of correlative studies in accurately assessing aspects such as

• Delivery and efficiency of gene transfer• Target specificity• Immunogenicity and toxicity - genotoxicity: insertional mutagenesis• Long term versus short term expression

SESSION LEADShelly Heimfeld, PhD, Nohla Therapeutics and Fred Hutchinson Cancer Research Center, Seattle, WA

SPEAKERSCatherine Bollard, MD, MBChB, Children’s National Health System and The George Washington University, Washington, DC Krishna Komanduri, MD, University of Miami Health System, Miami, FL


10:15 – 11:00 Future of Cell Therapy

ProvengeTM, StrimvelisTM, and KymriahTM are approved cellular therapies in the US and Europe, with additional approvals pending. What was once a boutique field has evolved into one of the most vibrant areas of science and drug development. As the field evolves, what can we expect to see in scientific translation and academic to industry translation? With greater attention comes greater scrutiny in terms of expectation for providing wider access to more patients, drug pricing and reimbursement. Providing wider access will require engineering solutions and the merging of technologies previous used to manufacture inanimate objects (automobiles) with biologics. The higher profile of the field requires cell therapy professionals to be versed is these issues and able to communicate to colleagues, the media, and the public.

LEARNING OBJECTIVES To gain insight as to the future of cell and gene therapy. What might change, what is likely to stay the same,

what are the expectations of the medical community and patients

SESSION LEADBruce Levine, PhD, University of Pennsylvania, Philadelphia, PA

SPEAKERSBruce Levine, PhD, University of Pennsylvania, Philadelphia, PA


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11:00 – 12:00 Team Science & Ethics Roundtable

In this session Dr. Komanduri will discuss the ideal formation of the team involved in translational science. The group incorporates scientists and clinicians regulatory experts, data collectors, data managers, and research coordinators. The regulatory process as it applies to product manufacture, clinical trials and investigator competence will be reviewed. Dr. Barrett will address the problem of “medical tourism” – the risks of unscrupulous exploitation of vulnerable individuals seeking cell therapy cures for multiple disorders, and the international efforts being set up to regulate cellular therapy.

LEARNING OBJECTIVES To understand current ethical principles governing human clinical research To understand the process of ethical review and oversight governing human clinical research To understand unique ethical issues for human cellular therapy products To understand the challenges and risks posed by widespread use of unproven cellular therapies To review scholar projects for ethical issues and discuss management of ethical questions and risks

SESSION LEADKrishna Komanduri, MD, University of Miami Health System, Miami, FL

SPEAKERSJohn Barrett, MD, National Heart, Lung and Blood Institute, Bethesda, MD

Course Planning Faculty

12:00 – 13:00 Lunch

13:00 – 14:00 Challenges for Gene Modified Cells/iPSC

In this session, ongoing phase I clinical trials in blood stem cell gene therapy will be used to illustrate challenges and points to consider for gene modified cell products. Dr. Adair will discuss the current state of blood stem gene therapy as it applies to different diseases, and will highlight recent work that could change how these products are manufactured and tested. Dr. Doulatov will present considerations and challenges for clinical implementation of iPSC products and will present on the current state of iPSC applications and testing.

LEARNING OBJECTIVES To appreciate the subtleties of gene therapy products, their production, testing and use in the clinic To understand manufacturing issues related to gene therapy products Consideration of immunogenicity, graft rejection and durability of engineered cell products Insight into new technologies that are quickly advancing the field to overcome current challenges

SESSION LEAD Jennifer Adair, PhD, Fred Hutchinson Cancer Research Center, Seattle, WA

SPEAKERS Jennifer Adair, PhD, Fred Hutchinson Cancer Research Center, Seattle, WA

Sergei Doulatov, PhD, University of Washington, Seattle, WA

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14:00 – 16:00 Breakout Sessions – Building a Multidisciplinary Research Team

In this session Dr. Bollard will discuss her experience building a team and setting up a cell therapy program.

LEARNING OBJECTIVES To understand how to create a research team that addresses all of the requirements for creating, qualifying

and delivering a cell therapy product to the clinic How to motivate and keep the team together during the lengthy translational stages of product development

SESSION LEADCatherine Bollard, MD, MBChB, Children’s National Health System and The George Washington University, Washington, DC


16:00 – 18:00 Tour of Fred Hutchinson cGMP Facility

The cGMP Cell Processing Facility (CPF) at the Fred Hutchinson Cancer Research Center comprises four ISO 7 clean rooms focused solely for manufacturing cellular therapy products. CPF manufactures a wide range of products supporting ~20 FDA Investigational New Drug (IND) applications, with the majority of patients treated under Immunotherapy protocols at the Seattle Cancer Care Alliance. The facility includes support areas providing quality control, materials management, quality assurance and flow cytometry analysis and sorting.

LEARNING OBJECTIVES Design and operation of a multi-product cGMP Facility Understand logistics and basic infrastructure of a cGMP facility, including personnel and supply access flow,

suite preparation, environmental monitoring, air quality classification and handling, cleaning and sanitation Lessons learned from 15 years of manufacturing

TOUR FACILITATORShelly Heimfeld, PhD, Nohla Therapeutics and Fred Hutchinson Cancer Research Center, Seattle, WA

FRIDAY, OCTOBER 27, 2017Fred Hutchinson Cancer Research Center

08:00 – 09:45 Scholar Presentations Behnke Conference Room



11:30 – 12:30 Lunch (Grab–and–Go)


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About the PartnersInternational Society for Cellular Therapy

The International Society for Cellular Therapy (ISCT) is a global society of clinicians, regulators, technologists, and industry partners with a shared vision to translate cellular therapy into safe and effective therapies to improve patients’ lives worldwide. ISCT is the leading group focused on pre–clinical and translational aspects of developing cell therapy products, thereby driving the transition of scientific research to innovative cellular therapies for patients. As such, ISCT helps academic, government and biotech/pharma sectors advance research into practice and product. ISCT Members are part of an influential global community of peers, experts, and organizations invested in cell therapy, offering a unique collaboration between academia, regulatory bodies, and industry partners in cell therapytranslation.

American Society for Blood and Marrow Transplantation

The American Society for Blood and Marrow Transplantation is an international professional membership association of more than 2,200 physicians, investigators and other healthcare professionals promoting blood and marrow transplantation and cellular therapy research, education, scholarly publication and clinical standards. From its beginning, ASBMT activities have been in eight broad areas, representing the interests of transplant clinicians and investigators and the patients they serve: Research; Representation; Clinical Standards; Regulation; Communications; Accreditation; Reimbursement; Recruitment and Training.

About the Institutional HostFred Hutchinson Cancer Research Center

The Fred Hutchinson Cancer Research Center is comprised of interdisciplinary teams of world-renowned scientists and humanitarians who work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Our researchers, including three Nobel laureates, bring a relentless pursuit of, and passion for, health knowledge and hope to their work and the world. Together, our researchers are discovering new ways to detect cancers earlier, when cure rates are highest; developing effective treatments with fewer side effects; and learning how to prevent cancers from growing in the first place. Our groundbreaking discoveries began in the 1970s with Dr. E. Donnall Thomas’s pioneering work in bone marrow transplantation, which led to him receiving the 1990 Nobel Prize in physiology or medicine. Since then, Hutch researchers have made a number of breakthroughs, including developing immunotherapies that use the immune system to defeat cancer and advancing the understanding of human biology.

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About the Full Scholarship Sponsors

Becton Dickinson

BD is a leading medical technology company that benefits countless lives worldwide. We advance health by improving the ways that discovery, diagnostics and delivery of care are conducted. With 45,000 employees at work in more than 50 countries, we work in close collaboration with customers and partners to develop innovative products and solutionsthat enhance outcomes, better manage healthcare delivery costs, increase efficiencies, improve healthcare safety, and expand access to health. Because we’ve been doing this for over 100 years, our portfolio, leadership and partnerships make a difference for global healthcare. For more information, please visit: www.bdbiosciences.com

Fresenius Kabi

Fresenius Kabi (www.fresenius-kabi.us/lovo) is a leading global health care company that focuses on pharmaceuticals and medical devices used to care for critically and chronically ill patients. We recently launched Lovo, the only cell processing system that washes and concentrates white blood cells using filtration technology, specifically to serve the cellular therapies community. Fresenius Kabi’s U.S. headquarters are located in Lake Zurich, Illinois.

Thermo Fisher Scientific

As the world leader in serving science, Thermo Fisher Scientific is uniquely positioned to provide the quality materials, services and support needed to accelerate the pace of advanced therapy development. We understand the complexity of this rapidly evolving industry and partner with our customers as they transition from discovery to clinical research and commercial manufacturing. Our portfolio of trusted and recognized products and services, combined with over 50 years of cell culture expertise enables us to provide comprehensive solutions to support every step of the advanced cell therapy process – from cell collection through manufacture to clinical site delivery. Through our Thermo Scientific, Applied BioSystems, Invitrogen, Fisher Scientific, Fisher BioServices, Unity Lab Services, and Gibco Cell Therapy Systems (CTS) brands, we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. www.thermofisher.com.

Terumo BCT

Terumo BCT is a global leader in blood component, therapeutic apheresis and cellular technologies, and the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.


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Documents

CURRICULUM • FACULTY · Fresenius Kabi Scholar North American Scholars Monzr Al Malki, MD City of Hope National Medical Center ... This Regulatory Affairs Case Studies discussion