AATB Update
Scott A. Brubaker, CTBS - Chief Policy Officer AATB
Objectives: Describe efforts to harmonize cell/tissue requirements nationally and internationally.; Examine
information obtained from scientific studies funded by AATB.; Discuss input needed from the Physicians’ Council.
Dementia and Risk Listing in the FDA Regulations
Elizabeth Lybarger Regulatory Review Officer Food and Drug Administration
Objectives: Review FDA HCT/P donor eligibility regulations that involve dementia; Summarize resources related to
HCT/P donor eligibility and dementia.
Use of Allograft Stem Cells
Ross Wilkins, MD Vice Chair PC AlloSource
Objectives: Differentiate between stem cells and other types of cells; identify the differences between cultured
stem cells and naturally occurring cells.; Define the various sources of allograft stem cells.; Describe the clinical
results of surgical procedures using allograft stem cells; Discuss the pros and cons of stem cell use and the future
of stem cell biology.
Risk Associated with Sexually Transmitted Diseases
J Dennis Hancock, MD Associate Medical Director LifeNet Health
Objectives: Determine STD's and their relationship to tissue transplantation; Identify the significant STD's in tissue
transplantation.
Update on Risk Associated with Non-IV Illicit Drug Use
David Gocke, MD Musculoskeletal Transplant Foundation
Objectives: Indicate the relationship between donor risk behavior and positivity for viral markers; Identify the
epidemiologic information regarding transmission of HIV and Hepatitis viruses.
Bill Anderson Memorial Lecture - Influence of Regenerative Medicine in Clinical Use
Anthony Atala Director Wake Forest Institute for Regenerative Medicine
Objectives: Describe the field of tissue engineering and regenerative medicine; apraise the current state of stem
cell research; Describe some of the current research and clinical applications.
Donate Life, What's New?
David Fleming President and CEO Donate Life America
Objectives: Indicate information on national initiatives to increase organ, eye and tissue donation in the United
States; identify initiatives to launch within their community to assist in this vital lifesaving effort; identify ways in
which their organization can partner in the national work of Donate LIfe America.
Ask the FDA?
Elizabeth Lybarger Regulatory Review Officer Food and Drug Administration
Objectives: Describe current FDA updates related to HCT/P policy and regulation; Express clarifications to common
industry questions and compliance related observations.
Continuous Improvement in Gamma Sterilization of Allograft Tissue
Emily Craven Senior Radiation Physicist Nordion
Objectives: Recognize critical parameters in tissue irradiation; Categorize radiation effects on tissue products.;
Explain tissue irradiation validation activities.
Cafe Conversations
Rick Kolovich Program Committee Chair and Organ Recovery Coordinator The Living Legacy Foundation
Objectives: #1: Discuss issues and topics supplied by attendees during registration; #2: Provide answers to
attendee submitted question/topics.
Cognitive Studies & the UDHQ - OTE: The Use of Cognitive Studies for Qualifying the Uniform Donor History
Questionnaire
Stephanie Willson, PhD Survey Methodologist National Center for Health Statistics
Objectives: Review the purpose of the validation study planned for the UDHQ; specify the method of cognitive
interviewing as an evaluation tool; Describe the methodological plan of the UDHQ validation study.
First Look at Microbiological Surveillance Program Guidance Document
Martell Winters Nelson Laboratories
Objectives: Identify the main concepts in the Microbiological Surveillance Guidance Document; Describe some of
the changes which the document makes to previous industry practice; Relate some of the details provided in the
document related to process validation, environmental monitoring and test method validation.
Logistical Issues with Frozen and Vitrified Samples
Erik J. Woods, PhD, HCLD Genome Resources
Objectives: Review and discuss the issues related to handling, packaging and shipping vitrified samples; Examine
the methods currently used, their origins and potential drawbacks when used with new processing technologies;
Propose potential means of improvement and discuss the practicality of their implementation.
Overview of the On-line Tissue Banking Program Offered Through Transplant Procurement Management
Ed Ferreol, MD, CTBS - Senior Manager Technical Training and Education LifeNet Health
Objectives: Describe the content of the online version of the annual TPM training course versus the face-to-face
training course; Provide an overview of attendee demographics who have finished TPM-sanctioned tissue banking
courses; Discuss feedback received from students and faculty that led to changes in curriculum.
The Future of Tissue Banking as it Relates to Tissue Engineering
Barbara Boyan, MD Professor and Associate Dean for Research, College of Engineering Georgia Institute of
Technology
Peter Johnson, MD Vice President, Research and Development, Avery Dennison Medical Products Division President
and CEO, Scintellix, LLC
Jeffrey Ross, PhD Vice President Product Development Miromatrix
Objectives: Appraise the direction and velocity of the near and distant applications of tissue engineering
technology; Distinguish the relative roles of cellular and preformed multicellular and non-cellular constructs in
tissue engineering; Specify the role(s) of preserved tissues in tissue engineering; identify the hurdles that tissue
engineered medical products must overcome to be successful in the marketplace; Analyze the immediate and
longer range applications of stem cells in tissue engineering.
Developing an Effective Environmental Monitoring Process (Part 1 and 2)- Panel Presentation
Linda Martin Director, Tissue Work System Mid-America Transplant Services
Alan Taylor Donor Network of Arizona
Bruce Zalneraitis, CTBS Chief Executive Officer Life Alaska Donor Services
Objectives: Demonstrate environmental testing and monitoring of a surgical recovery suite; Collect and record
information on temperature and humidity along with microbiological sampling of recovery suite; Review
environmental monitoring of a surgical recovery suite
Hospital Development's impact on Increasing Tissue Donation (Part 1 and 2) - Panel Presentation
Gina Garcher OPO LifeBanc
Kathy M. Selden OPO LifeSource
Lawrence F. Suplee, III Manager- Transplant Information Center Gift of Life Donor Program
Allen D. Ward Manager of Hospital Services California Transplant Donor Network
Objectives: Define critical process elements in the identification of tissue donation potential, screening practices
and barriers to conversion of referred candidates through Referral Outcome Reports; Construct, utilize and
distribute individual, teams and departments; Define best practices to increase tissue consent and conversion
rates in referring hospitals by partnering with hospital staff to facilitate telephonic approach for tissue donation by
OPO staff with family while they are still present at the hospital.; Utilize staff voiceprint recordings during staff
“consent workshops” to ensure staff’s competence in utilization of the organization’s philosophy (Dual Advocacy);
Analyze the benefits of using cross functional HD teams in maximizing efforts to increase organ eye and tissue
donation in partner hospitals; Explore the use of rounding tools to standardize follow up and explore the impact of
donation in your facilities,
Medical Examiners, Transplant Professionals, and Supportive Public Policy: A Partnership for LIFE
Kim Collins, MD, FCAP Fulton County ME
Teresa Shafer, RN, MSN, CPTC COO, OPO LifeGift
Jack M. Titus, MD Deputy Chief ME Office of the Chief Medical Examiner: State of Maryland
Objectives: Discuss methods and necessity to create a collaborative relationship in which all parties exhibit
commitment to transplantation an institutional priority and to assuring the necessary resources to ma; Examine
the need for creation and maintenance of high-performance relationships among medical examiners and coroners
(ME/Cs), organ and tissue recovery professionals (OTRPs) and physicians/nurses (HCP.; Establish necessity and
strategy for enacting good public policy ensuring zero organ/tissue denial by medical examiner/coroners; Review
NCCUSL UAGA language on ME/Cs and their role in organ donat; Discuss the nurturing and development of
Institutional Vision and Commitment within ME/C Office to saving lives every time, one at a time, with zero
denials; assist ME/C office in seizing this white-h; Review responsibilities and collaborative roles of all parties
involved in saving lives through organ and tissue donation and in conducting death investigations.
Stem Cell Therapies
Simon Bogdansky Consultant Bogdansky and Associates
Nancy L. Dock Senior Director Tissue Acquisition Lonza
Mary-Beth Fisk, CTBS
Chad Ronholdt Director, Business Development LABS, Inc.
Charles Sims, MD
Objectives: Establish a fundamental understanding of the opportunities and challenges to member companies in
entering the human cell therapy market.; Relate the opportunities afforded the AATB by providing information and
services specific to this market (e.g., increased industry participation, larger membership base, collaborative
opportunities with other societies, focus groups etc.; Review initiatives the AATB will undertake to add value to its
accredited members, or those considering becoming accredited, who are participating in providing these products
and services to other companies.
Vitrification and Slow Freezing: Concepts and Misconceptions
Erik J. Woods, PhD, HCLD Genome Resources
Objectives: Discuss the physical-chemical differences between vitrification and cryopreservation; Describe the
terminology currently used correctly and incorrectly with respect to vitrification and cryopreservation, and relate
specific terminology with specific processes and events in the cryopreservation and vitrification processes;
Propose potential means of clarifying misconceptions with respect to: (1) classical cryopreservation generally; (2)
vitrification procedures generally; and (3) preservation of reproductive cells and tissues using classical
cryopreservation and vitrification procedures
Final Recommendations to Change Consent-Related Standards
Christina Strong, JD Principal Law Office of Christina W. Strong
Objectives: Identify the core points of the Revised AATB Consent Standards; Use and define updated terminology
and concepts in obtaining authorization for anatomical gifts for transplant; Describe the basis in law, ethics and
clinical practice for the concepts added to the AATB Consent Standards.;
Roadblocks in Cross-Border Reproductive Care: Are Parents Getting What They Expect and Deserve When They
Have Children in Other Countries? (Part 1 - 3)
Steven Snyder, Esq. International Assisted Reproduction Center
Steven Thal, Esq.
Objectives: Identify issues in Cross-Border Reproductive Care.; Summarize care shortfalls by Country.; Discuss
efforts to resolve issues.
Electronic Medical Records: What's New and How it Affects You
Peter Mecenas, PhD, HCLD, CTBS Director, Tissue Donation Services New England Organ Bank
Azita Sharif CEO Daedalus Software, Inc.
Mark Strong Associate Executive Director LifeLink Tissue Bank
Mary Szaro Vice President, Technical Operations Musculoskeletal Transplant Foundation
Objectives: Discuss issues to consider when using "paper and electronic hybrid" systems to provide donor records
to processors; Describe of the "paper and electronic hybrid" system used by NEOB to provide donor records to
processors.
Serological Testing: Expecting the Unexpected
Michael J. Bauer LABS, Inc
Scott Jones Vice President of Laboratory Services Qualtex Laboratory
Benedict A. Marchlewicz Director, Blood Screening Technical Operations Abbott Diagnostics
Objectives: Relate importance of infectious disease testing of their products.; Recognize potential risks of new and
emerging infectious agents in the are of tissue and organ transplantation.
Staying Informed with ISBT 128
Paul Ashford Executive Director ICCBBA
Objectives: Identify the importance of a standard structured coding system in ensuring effective traceability and
biovigilance; Describe the work of the North American Tissue Technical Advisory Group (NATTAG) on ISBT 128;
Describe the proposed guidelines for coding and labeling of tissue products using ISBT 128; Describe international
initiatives for the coding and labeling of cells, tissues and organs.
An ISO 13485 Design Control Model for Tissue Banking
Lisa Simpson Director, Regulatory Affairs RTI Biologics, Inc.
Objectives: Recognize the value in applying the ISO 13485 design control standard to tissue banking.; Describe the
elements of the design control standard.; Correlate the concepts of the design control standard to tissue banking.;
List the best practices for establishing a design control process.; Relate the concepts of design control and risk
management.
Fundamentals of Process Validation
Carrie Hartill, CTBS Chief Scientific Officer RTI Biologics
Objectives: Describe the validation requirements specified in the AATB Standards.; Identify the basic elements of
validation.; Explain the difference between verification, qualification, and validation.
Hospital Tissue Services - Can You Hear Us?
Megan Sawchuk, MT(ASCP) Associate Director, Standards Interpretation Group The Joint Commission
Susan C. Sharpe, MS, MT(ASCP) SBB Transfusion Service & Tissue Bank Supervisor Northside Hospital
Missy Cohen Tissue Dispensary Coordinator Transfusion Medicine Boston Medical Center
Objectives: Describe the purpose of utilizing a blood bank for managing tissue.; Discuss a method of tracking and
documenting implanted tissue.; Review storage and monitoring of the various temperatures that tissues are
maintained at.;
Review of Public Comments Submitted for Draft NTAD Standards
Maggie Deuel Director, Education and Special Projects AATB
Objectives: Summarize the plan for finalizing the NTAD Standards; Differentiate between the Standards for
Transplant and the Standards for Non-Transplant Donation;
Closing Keynote Address: Advancing Regenerative Medicine Through Perfusion Decellularization
Jeffrey Ross, PhD Vice President Product Development Miromatrix
Objectives: Describe the current state of regenerative medicine pertaining to cellular therapies and biomaterials
for tissue regeneration.; Describe the importance of decellularized tissues and organs for the advancement of
regenerative medicine.; Describe the perfusion decellularization and how it enables who organ decellularization.