International Cord Blood Symposium Scientific Program


Wednesday, June 8, 2016

Noon – 7:00 p.m.
Registration Open

2:00 p.m. – 5:00 p.m.
Speaker Ready Room

Thursday, June 9, 2016

6:30 a.m. – 5:30 p.m.
Registration Open

6:30 a.m. – 5:00 p.m.
Speaker Ready Room Open

7:30 a.m. – 8:00 a.m.
Breakfast in Exhibit Hall

Opening Plenary Session
8:00 a.m. – 10:00 a.m.

8:10 a.m. – 8:30 a.m. Keynote Presentation

CIRM 2.0 Building a Better Stem Cell Agency
C. Randal Mills, PhD, President & CEO
California Institute for Regenerative Medicine (CIRM)

Plenary Session
Challenges Faced by the U.S. Public Cord Blood Banking Industry
Chair: Brian Freed, PhD, DABHI, Executive Director
ClinImmune Labs

8:30 a.m. – 9:00 a.m.
Impact of BLA/IND Requirements on Public Cord Blood Banks
Brian Freed, PhD, DABHI, Executive Director
ClinImmune Labs

9:00 a.m. – 9:30 a.m.
FDA Perspectives on Cord Blood BLA Requirements
Yong Fan, MD, Division of Cellular and Gene Therapies
Office of Cellular, Tissues and Gene Therapies
Food and Drug Administration

9:30 a.m. – 10:00 a.m.
NCBI Units: Is it Time to Revisit the Collection Criteria?
Merry Duffy, Director, Cord Blood, Biorepository, and Affiliated Services
National Marrow Donor Program

10:00 a.m. – 10:30 a.m.
Refreshment Break

Concurrent Workshops
10:30 a.m. – Noon

UCB Transplantation Workshop: Selection of CB Units in 2016 Workshop

Chair: Claudio Brunstein, MD, PhD, Associate Professor, Department of Medicine Blood and Marrow Transplant Program
University of Minnesota

Session Description: This workshop will have two presenters, Dr. Sanz (Hospital Universitari i politècnic La Fe, Valencia, Spain) and Dr. Ooi (Teikyo University School of Medicine, Tokyo, Japan), from institutions with a long track record in cord blood transplantation briefly review the data and criteria used in their institutions for cord blood selection. These brief presentations will be followed by the active discussion of practical examples of cord blood selection for audience participation.


The Spanish Experience
Jaime Sanz, MD, PhD, Hematologist
University Hospital La Fe, Spain 


The Japanese Perspective
Jun Ooi, MD, Associate Professor Department of Hematology/Oncology
Teikyo University School of Medicine
 


 

Selection of Units for Expansion
Rebecca Haley, MD MT(ASCP)SBB, Medical Director
Cord Blood Bank Bloodworks Northwest 

Public CBB Inventory Considerations and Challenges Workshop

Chair: Donna Regan, MT(ASCP)SBB, Director
St. Louis Cord Blood Bank & Cellular Therapy Laboratory

Session Description: This workshop will address inventory challenges such as assessment of risk on assigning product disposition and how product designations affect perception of quality. Panelists will lead interactive discussions about how current practices – manufacturing, documentation and testing – impact sustainability today and maintain relevance into tomorrow.

Panel:
Sharon Miller, MT (ASCP), CHS(ABHI), Director of Regulatory Affairs
Clinimmune Labs–UCCBB
Tina Krieg, Quality Systems Specialist,
Bloodworks Northwest
Amanda Parrish, PhD, RAC, Director, Regulatory Affairs and Quality
Duke Translational Medicine Institute

Noon – 1:15 p.m.
Lunch in the Exhibit Hall

Plenary Session
1:15 p.m. – 3:00 p.m.

Plenary Session
Outcomes of Allogeneic CB Transplantation
Chair: Mark Walters, MD, Director, Blood and Marrow Transplantation (BMT) Program
Division of Hematology/Oncology
UCSF Benioff Children's Hospital Oakland

1:15 p.m. – 1:45 p.m.
Outcomes of CB Transplants from HLA Matched Sibling Donors – An Update
Mark Walters, MD, Director, Blood and Marrow Transplantation (BMT) Program
Division of Hematology/Oncology
UCSF Benioff Children's Hospital Oakland

1:45 p.m. – 2:15 p.m.
Impact of Residual Disease on Outcomes of CBT
Filippo Milano, MD, PhD, Assistant Member, Associate Director, Cord Blood Transplant Program
Fred Hutchinson Cancer Research Center
Manuscript submission in progress.

2:15 p.m. – 2:45 p.m.
Gut Microbiota and Outcomes After CBT
Robert Jenq, MD, Medical Oncologist
Memorial Sloan Kettering Cancer Center

2:45p.m. – 3:00 p.m.
Optimal Practices in CBT for Hematologic Malignancies: a Multicenter Initiative of the ASBMT CB Special Interest Group
Juliet Barker, MD, Memorial Sloan Kettering Cancer Center

3:00 p.m. – 3:30 p.m.
Refreshment Break

Concurrent Programs
3:30 p.m. – 5:00 p.m.

Potency Assays for Cord Blood Units: What Do Banks Do? What Do Transplant Centers Look For?

Chair: Rebecca Haley, MD MT(ASCP)SBB, Medical Director
Cord Blood Bank Bloodworks Northwest

Session Description: This interactive session will begin with short cord blood bank presentations on their potency measures. Transplant centers representatives will follow with what they look for and value from these assays and how they use the results. A panel discussion including questions from the audience concerning test methods, their significance and usefulness, will follow.

Panel:
Rebecca Haley, MD MT(ASCP)SBB, Medical Director
Cord Blood Bank Bloodworks Northwest
Kristin Page, MD, Assistant Professor of Pediatrics
Duke University School of Medicine
Brian Freed, PhD, DABHI, Executive Director
ClinImmune Labs
Andromachi Scaradavou, MD, Pediatric Hematologic Oncologist
Associate Member Memorial Sloan Kettering Cancer Center
Medical Director, National Cord Blood Program
New York Blood Center

Standards and Regulations in Cell Therapy Session

Chair: Naynesh Kamani, MD, Vice President
Center for Cellular Therapies and Research
AABB

Standards are currently available for the collection, processing, storage, administration and clinical application of conventional hematopoietic stem cell based therapies.  As promising novel stem cell therapies and other cell and gene therapies are developed and move from the academic cell processing laboratory to pharmaceutical and biotech industry based global large-scale manufacturing facilities, there is a need for standards that address relevant additional safety, efficacy and quality issues.  There are regulatory challenges in defining potency and long term safety of these therapies and a need for harmonization of standards.  This session will address some of these regulatory challenges and update the audience on efforts to harmonize cell and gene therapy manufacturing standards.


NIST’s Role in Cell and Gene Therapy Manufacturing
Anne Plant,
PhD Division Chief
Biosystems and Biomaterials Division
Materials Measurement Laboratory,
National Institutes of Standards and Technology


Standards Coordinating Body for Cellular/Gene and Regenerative Therapies: An Update
Elena Kfoury,
Director
Business Development & Strategic Alliances
Axiogenesis (North America)


Standards and Regulations in Cellular Therapy
Suzanne Pontow,
PhD, Co-Director
University of California Umbilical Cord Blood Program
University of California, Davis

5:00 p.m. – 6:30 p.m.
Networking and Poster Reception in the Exhibit Hall

Friday, June 10, 2016

7:00 a.m. – 5:00 p.m.
Registration Open

7:00 a.m. – 5:30 p.m.
Speaker Ready Room Open

7:45 a.m. – 8:15 a.m.
Breakfast in Exhibit Hall

Plenary Session
8:15 a.m. – 10:00 a.m.

Plenary Session
CB Expansion Technologies – What is New?
Chair: Colleen Delaney, MD, MSc, Director, Program in Cord Blood Transplantation
Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance

The past decade has seen an increase in the number of successful and clinically relevant cord blood derived hematopoietic stem and progenitor cell expansion technologies. This session will focus on a few examples of these expansion methodologies that are under clinical development to enhance engraftment in the cord blood transplant setting as well as a product intended for use to prevent the complications associated with chemotherapy induced neutropenia. Results from Phase I/II clinical trials in these areas will be presented as will the preclinical development of an expansion technology now entering proof of concept clinical trials. In addition, each speaker will address future directions in the field and potential indications that may be addressed with novel cell therapies that are emerging in the field of cord blood derived ex vivo expansion technologies.

8:15 a.m. – 8:50 a.m.
Results of Nicord Phase I–II Trials and Plans for Phase III Trial
Mitchell Horwitz, MD, Associate Professor of Medicine
Duke University School of Medicine

8:50 a.m. – 9:25 a.m.
Off the Shelf Expanded CB Units for Chemotherapy–Induced Neutropenia
Colleen Delaney, MD, MSc, Director, Program in Cord Blood Transplantation
Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance

9:25 a.m. – 10:00 a.m.
Cord Blood Expansion Using Pyrimidoindole Derivatives
Silvy Lachance, PhD, FRCP, Director, Fellowship Program in Stem Cell Transplantation, Associate Professor of Medicine, Clinical Researcher; Director, Medical and Administrative
Rosemont Hospital Université de Montréal

10:00 a.m. – 10:30 a.m.
Refreshment Break

Workshop
10:30 a.m. – Noon

Optimizing Approaches to Public and Family Cord Blood Banking; Preparing for The Future
Chair: Joanne Kurtzberg, MD, Director, Carolinas Cord Blood Bank; Chief Scientific Officer, Robertson Clinical and Translational Cell Therapy Program; Director, Pediatric Blood & Marrow Transplant Program

Please join the Cord Blood Association and experts in public and family cord blood banking to discuss current advantages, challenges and opportunities in the field. The format will be like speed dating experience where each attendee will rotate through 10 tables, each dedicated to a key topic involved in cord blood banking. Topics from family and unrelated donor recruitment and screening, collection, processing, cryopreservation, testing, regulations, expansion technologies, the current cord blood market, differences between and opportunities for private/family, hybrid and public banks, and novel future applications will be addressed. Differences and similarities between private and public banking models will be discussed. Experts at each table will facilitate discussion and summarize points raised at their tables during the end of the session.

Noon – 1:15 p.m.
Lunch in the Exhibit Hall

Joint AABB/Perinatal Stem Cell Society Plenary Session
1:15 p.m. – 3:00 p.m.

Review of Potential Clinical Uses of Perinatal Cells and Cord Tissue Derived Cells
Chair: Morey Kraus, Chief Scientific Officer of the Diagnostics Division
PerkinElmer, Inc.

1:15 p.m. – 1:50 p.m.
Human Placenta–Derived Adherent Cells: Biology and Therapeutic Potential
Robert Hariri, MD, PhD, Co–Founder, President
Human Longevity Cellular Therapeutics

1:50 p.m. – 2:25 p.m.
Role of Cord Derived CD 105 Positive MSC in Cardiac Repair
Joshua Hare, MD, Founding Director
Interdisciplinary Stem Cell Institute

2:25 p.m. – 3:00 p.m.
Heterogeneous Populations of Perinatal Stem Cells from Cord Tissue and Their Potential Use in Newborns with Hypoxic Ischemic Injuries
Morey Kraus, Chief Scientific Officer of the Diagnostics Division
PerkinElmer, Inc.

3:00 p.m. – 3:30 p.m.
Refreshment Break

Concurrent Programs
3:30 p.m. – 5:00 p.m.

Isolation and Cryopreservation of Cord Related Tissue Workshop
Chair: Aby J. Mathew, PhD, Senior Vice President & Chief Technology Officer
BioLife Solutions, Inc.

Session Description: As the source of cells for potential cellular therapies continues to expand beyond traditional hematopoietic stem cells from blood or marrow, the methods of processing to manufacture these cells also continue to evolve. These developing methods have varying levels of overlap and novelty in comparison to clinical processing of cells from marrow or blood. Isolation methods from tissue sources are not only different, but some methods are also novel patented approaches. This session will discuss some of the sources of potentially therapeutic cells in birth tissue beyond cord blood itself, as well as discussion about the methods of isolation, processing, and cryopreservation of the cells from these cord/birth-related tissues, including amniotic and placental cells.


Cryopreservation of Cord Tissue
Kate Brown, PhD, Principal Scientist, Cord Blood Registry
 


Perinatal Mesenchymal Stem Cell Banking for Umbilical Cord Blood-Derived Regenerative Medicine
Rouzbeh Taghizadeh, PhD, Director, and Founder
Perinatal Stem Cell Society Cofounder and Chief Scientific Officer,
Auxocell Laboratories, Inc.
 

Regenerative Medicine Applications of UCB: Results of Preclinical Studies Session
Chair: Mervin C. Yoder, MD, Distinguished Professor,
Indiana University
Director, Herman B. Wells Center for Pediatric Research
Indiana University School of Medicine


Mesenchymal Stem (Stromal) Cells: Biology and Potential Therapeutic Value for ARDS
Carolyn Hendrickson
, MD MPH MA
Research Fellow, Clinical Instructor
Pulmonary and Critical Care Medicine,
University of California San Francisco


A Cord Blood Monocyte–Derived Cell Therapy Product Accelerates Brain Remyelination
Speaker: Arjun Saha, PhD, Project Leader
Robertson Clinical and Translational Cell Therapy Program,
Duke University Medical Center  


Cord Blood Derived Endothelial Colony-Forming Cells for Regenerative Medicine Applications
Mervin C. Yoder, MD, Distinguished Professor,
Indiana University
Director, Herman B. Wells Center for Pediatric Research
Indiana University School of Medicine


Saturday June 11, 2016

7:00 a.m. – 1:30 p.m.
Registration Open

7:00 a.m. – 1:30 p.m.
Speaker Ready Room Open

7:45 a.m. – 8:15 a.m.
Breakfast in Exhibit Hall

Plenary Session
8:15 a.m. – 10:00 a.m.

Plenary Session
Regenerative Medicine Applications of UCB in the Clinic: Results of Current Clinical Trials
Chair: Joanne Kurtzberg, MD, Director, Carolinas Cord Blood Bank; Chief Scientific Officer, Robertson Clinical and Translational Cell Therapy Program, Director, Pediatric Blood & Marrow Transplant Program

Cord blood cells can work through paracrine and trophic mechanisms to help endogenous cells heal brain tissue damaged by disease or injury. Learning from observations made using unrelated donor umbilical cord blood transplantation after myeloablative chemotherapy to treat children with certain inherited metabolic diseases, cord blood (CB) therapies have been developed to treat children with acquired brain injuries, like hypoxic ischemic encephalopathy, cerebral palsy and autism. Results of preclinical and Investigational New Drug (IND)-enabling studies will be presented to provide information about safety and potential mechanisms of action of CB cells in this setting. Data from early phase human clinical trials for safety and efficacy in these diseases will be presented by the speakers in this session.

8:15 a.m. – 8:50 a.m.
Phase I Trial of autologous CB Cells in Young Children with Autism Spectrum Disorders
Geraldine Dawson, PhD, Professor, Departments of Psychiatry and Behavioral Sciences, Pediatrics, and Psychology and Neuroscience and Director
Duke Center for Autism and Brain Development

8:50 a.m. – 9:25 a.m.
Results of a Randomized Trial of CB Infusions in Cerebral Palsy
MinYoung Kim, MD, PhD, Professor & Director, Department of Rehabilitation Medicine, Director, Rehabilitation & Regeneration Research Center, Director, International Health Care Center
CHA Bundang Medical Center, CHA University, Seongnam, Korea

9:25 a.m. – 10:00 a.m.
A Randomized Study of Autologous Umbilical Cord Blood Reinfusion in Children with Cerebral Palsy
Joanne Kurtzberg, MD, Director, Carolinas Cord Blood Bank; Chief Scientific Officer, Robertson Clinical and Translational Cell Therapy Program, Director, Pediatric Blood & Marrow Transplant Program

10:00 a.m. – 10:30 a.m.
Refreshment Break

Plenary Session
10:30 a.m. – Noon

Best Oral Abstract Presentations

Chair: Heather Brown, MS, CGC, Vice President, Scientific and Medical Affairs, Cord Blood Registry

Noon – 1:15 p.m.
Lunch in the Exhibit Hall

Workshop
1:15 p.m. – 3:00 p.m.

Review of Best Practices for Cord Blood Collection
Chair: Joanie Y. Hare, MD, FACOG, Maternal Fetal Medicine
Houston Perinatal Associates

This session offers the perfect opportunity for attendees, including Obstetricians and nurses to understand the latest advances in cord blood collection. The discussion includes why an OB provider should collect cord blood, explores different collection models and their success rates as well as addresses training and maximizing collection volumes. The session will wrap up with a presentation on current and future applications of cord blood therapies.
 

Overview: Why Should an OB Provider Collect Cord Blood?
Joanie Y. Hare, MD, FACOG, Maternal Fetal Medicine
Houston Perinatal Associates

Models for Cord Blood Collection
Sharon Miller, MT (ASCP), CHS(ABHI), Director of Regulatory Affairs
ClinImmune Labs-UCCBB

Training for Cord Blood Collection
Del Steckler, RN, BSN, MMA, Be The Match Cord Blood Recruitment Manager
National Marrow Donor Program

How Does the Collected Cord Blood Help Patients in the Clinic? A Review of Current and Future Cord Blood Therapies
Joanne Kurtzberg, MD, Director, Carolinas Cord Blood Bank; Chief Scientific Officer, Robertson Clinical and Translational Cell Therapy Program, Director, Pediatric Blood & Marrow Transplant Program

3:30 p.m.
Closing and Adjournment