Ethics and Compliancein Oncology Research

ECOR

Annual

Ethics and Compliance in Oncology Research ConferenceEnsuring Ethics and Compliance in an Oncology Research Environment

October 6-8, 2012The University of Texas MD Anderson Cancer Center

R. Lee Clark Clinic, Floor 11, Hickey Auditorium1515 Holcombe Boulevard, Houston, Texas

Confirmed speakers from the Food and Drug Administration (FDA), and the Office for Human Research Protections (OHRP)

Aman U. Buzdar, MD* Program Chair Vice President, Clinical Research Administration

Richard L. Theriault, DO, MBA*Program Co-Chair, Advisory Board Chair Professor, Breast Medical Oncology

Amin Majid Alousi, MDClinical Research Committee (CRC) ChairAssistant Professor, Stem Cell Transplantation

Oliver Bogler, PhDSenior Vice President, Academic Affairs

James Cavalier, MSN, MBA*Nurse Planner, Nursing Extramural Programs

Janice A. Chilton, DrPHInstructor, Center for Research on Minority Health

Jorge E. Cortes, MDInstitutional Review Board (IRB) ChairProfessor, Leukemia

Najat C. Daw, MDProfessor, Pediatrics-Patient Care

Rita Dotson*Program Coordinator, Protocol Research

Cathy Eng, MDCRC ChairAssociate Professor, GI Medical Oncology

Carol J. Etzel, PhDPsychosocial, Behavioral, and Health Services Research Committee (PBHSRC) ChairFaculty Senate, ChairAssociate Professor, Epidemiology

Michael J. Fisch, MD, MPHChair/Associate Professor, General Oncology

Ralph Freedman, MD, PhD*IRB ChairProfessor, Gynecologic Oncology & Reproductive Medicine

Colleen Gallagher, PhDAssociate Professor, Critical Care Executive Director, Integrated Ethics

Eric Gagneaux*Logistics Manager, CME/Conference Management

Leola Griffin, CCRP, BS*Senior Educational Specialist, Protocol Research

Kristofer Griffith, CIP*Manager, Human Research Regulations Protocol Research

Chiq Hatten, MSN, CCRC, CCRA*Director, IND Office

Cynthia E. Herzog, MDProfessor, Pediatrics-Patient Care

David Hong, MDCRC ChairAssistant Professor, Investigational Cancer Therapeutics

Ty Hoover, MD, JD*Director, Biorepository Regulatory Support Clinical Research

Jennifer Irvin Vidrine, PhDPBHSRC ChairAssistant Professor, Health Disparities Research

Stella K. Kim, MDAssociate Professor, Ophthalmology

Scott Kopetz, MD, PhDCRC ChairAssistant Professor, GI Medical Oncology

Laura Lam, PhD*Research Analyst, Clinical Research

Sylvie M. Marcy, MHA*Director, Clinical Research Support Center

Jessica A. Moore, DHCE, MAAssistant Professor, Integrated Ethics

Susan O’Brien, MDIRB ChairProfessor, Leukemia

Peter Pisters, MDVice President, UTMDACC Regional Care System

Madhu Purewal, PhD, JDSenior Legal Officer, Institutional Compliance

Wanda A. Quezada, CIP, CCRP*Ad Interim Director of Operations, Protocol Research

Alyssa G. Rieber, MDAssistant Professor, General Oncology

Mary Beth Rios, CCRP, RNResearch Nurse Manager, Leukemia

Kenneth J. Sapire, MDPBHSRC ChairProfessor, Anesthesiology & Perioperative Medicine

Jatin Shah, MDCRC ChairAssistant Professor, Lymphoma/Myeloma

Advisory Board & Planning Committee-MD Anderson

Mira Shah, CIM, CCRP*Manager, Human Research Regulations Protocol Research

DeLynn M. Shetter, BBA*Project Director, Clinical Research

Barbara L. Summers, PhD, MSNVice President and Chief Nursing Officer

Sherry L. Teel*Operations Manager, Clinical Research

Welela Tereffe, MDCRC ChairAssistant Professor, Radiation Oncology

Karen N. Terrell, MBA/HCMHuman Research Regulations Specialist Protocol Research

Anne Tsao, MDCRC ChairAssociate Professor, Thoracic/Head & Neck Medical Oncology

Brendell C. Williams, RN, BS, CCRP*Director, Multicenter Clinical Research

* member of Advisory Board and Planning Committee

Accreditation/Credit DesignationThe University of Texas MD Anderson Cancer Center is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The University of Texas MD Anderson Cancer Center designates this live activity for a maximum of 16.25 AMA PRA Category 1 CreditsTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

EthicsThis course has been designated by The University of Texas MD Anderson Cancer Center for 16.25 AMA PRA Category 1 CreditsTM in medical ethics and/or professional responsibility.

CME Certificates and Attendance Verification CertificatesCertificates awarding AMA PRA Category 1 CreditsTM or certificates documenting attendance will be distributed to participants when an individual departs the conference. To obtain a CME certificate, physicians must submit a completed evaluation questionnaire and a CME Verification Form.

Upon request, a record of attendance (certificate) will be provided on-site to other health care professionals for requesting credits in accordance with state nursing boards, specialty societies or other health care associations.

Educational ObjectivesAt the conclusion of this educational activity, the participant should be able to

• provide examples of “best practices” in the conduct of oncology research (knowledge, competence, performance)• interpret and apply good Clinical Practices and the Code of Federal Regulations to enhance the protection of human subject participants in oncology research (knowledge, competence, performance, patient outcomes)• illustrate the different institutional models of protocol development, review, and approval (knowledge, competence)• demonstrate the role of conflict of interest and independent reviews for ethical conduct of oncology research (knowledge, competence)• incorporate the principles of the responsibilities of the investigator and the research team in the implementation and performance of ethical research (knowledge, competence, performance)

GoalThe goal of this conference is to improve compliance with federal regulations related to human subject research protection in order to contribute to better patient outcomes.

EvaluationA course evaluation form will provide participants with the opportunity to comment on the value of the program content to their practice decisions, performance improvements activities, or possible impact on patient health status. Participants will also have the opportunity to comment on any perceived commercial bias in the presentations as well as to identify future educational topics.

Target AudienceThis program should be of interest to oncology researchers, oncologists in private practice, research nurses, institutional review board professionals, research fellows, and graduate students.

Educational Methods• Lectures •Question-and-Answer Sessions• Case Studies •Exhibit Program

Ethics and Compliancein Oncology Research

ECOR

PROGRAM

Saturday, October 6, 2012 10:30 am Registration and Coffee

11:15 Introduction to Benchmarking Sessions Linda S. Elting, DrPH

11:30 Lunch (provided)

12:00 pm Part One: Pre-Conference Concurrent Best Practices & Benchmarking Collaboration Individual Sessions in the following areas: 1. Roles and Responsibilities of the IRB & IRB Chairs This session will focus on the following:

•Addressing some of the many issues that Institutional Review Board (IRB) chairs face in a regulatory environment and the tools they have for handling them

Moderator: Richard L. Theriault, DO, MBA Jorge E. Cortes, MD; Linda S. Elting, DrPH

2. Understanding the Scientific Review and Approval Process This session will focus on the following:

•Discussing what the scientific review and approval process entails •Examining the responsibilities of the Principal Investigators throughout the review process and presentation • Identifying the roles and responsibilities of the Scientific Review Chairs and Committee Members

Moderator: Mira Shah, CCRP, CIM Jenny L. Gay, CCRP, CIM; Welela Tereffe, MD

3. Informed Consent: An Editorial Services Model This session will focus on the following:

•Discussing methods for lowering the informed consent document (ICD) reading level to improve patient understanding •Emphasizing the importance of encouraging consistent phrasing among institutional ICDs • Identifying solutions for addressing the specific ICD-related needs of the institution, study sponsors, and prospective patients

Moderator: Kristofer S. Griffith, CIP Jennifer Hackworth, BA; Lisa Shilling Wright, MA, CIP

Ethics and Compliancein Oncology Research

ECOR

Saturday, October 6, 2012 (continued)

4. Multicenter Clinical Trial Management This session will focus on the following:

• Increasing awareness and knowledge of requirements for multicenter trial management •Discussing common pitfalls/challenges for multicenter trial management • Identifying potential problems that may arise when working with collaborators at multiple research institutions

Moderator: Brendell C. Williams, CCRP, RN Marilyn Davis, RN

5. Auditing and Quality Improvement (QI) This session will focus on the following:

•Discussing difficult findings in diverse human subject trials •Examining the role of the PI’s discretion when discussing protocol interpretation •Reviewing the importance of a well-written protocol

Moderator: Jan M. Yungclas, RN, MHA/Ed, CCRP Cathy Eng, MD; Gabriela Rondon, MD; Sara S. Strom, PhD

6. Centralized IND Management for Investigator-Initiated Studies This session will focus on the following:

•Describing the MD Anderson module for centralized IND sponsorship • Identifying other models for centralized IND sponsorship and/or support • Identifying challenges, benefits, and best practices for centralized IND sponsorship

Moderator: Chiq Hatten, MSN, CCRC, CCRA Cathy Henceroth, BSN, CCRP, RN; Eliana Turk, MPH

7. Biobanking: Ethicopractical Concerns in an Era of Personalized Medicine This session will focus on the following:

•Know current sources of best practices guidance for biorepositories •Define and understand role of an honest broker system in relation to biorepositories •Be aware of current state of “ownership” of human research tissue samples under U.S. law

Moderator: Ty Hoover, MD, JD Mary Elizabeth Edgerton, MD, PHD; Ralph Freedman, MD, PhD; Funda Meric-Bernstam, MD

PROGRAM

Ethics and Compliancein Oncology Research

ECOR

1:45 Break

2:00 Part Two: Pre-Conference Concurrent Best Practices & Benchmarking Collaboration Individual Sessions in the Following areas: 1. Providing Administrative Support for an Institutional Review Board This session will focus on the following:

• Identifying methods for establishing and enhancing communications with ancillary departments •Reviewing models for developing procedures for implementing standard operating procedures and writing effective IRB policies, based on IRB Requirements •Discussing how to analyze and track metrics to assure appropriate resources in a regulatory office

Moderator: Evanna Thompson, MBA, MPH, CIP; Marion B. Olson, CCRP, CIP, BS; Wanda A. Quezada, CIP, CCRP

2. Collaborating Globally to Fight Cancer This session will focus on the following:

•Presenting a wide-range picture of MD Anderson’s global engagement •Showing how education programs can bring our research-driven, multidisciplinary treatment approach to other countries •Demonstrating the value of international collaborations to our clinical research programs

Moderator: Oliver Bogler, PhD Ohad Benjamini, MD; Aviad Hoffman, MD, Kathleen M. Schmeler, MD; Naoto T. Ueno, MD, PhD

3. Vulnerable Populations This session will focus on the following:

•Defining vulnerable populations in research • Identifying investigator and institutional responsibilities to vulnerable populations in research •Highlighting opportunities for research in vulnerable populations

Moderator: Alyssa G. Rieber, MD Jessica A. Moore, DHCE, MA

PROGRAM

Ethics and Compliancein Oncology Research

ECOR

PROGRAM Saturday, October 6, 2012 (continued) 4. Clinical Trials Registration: NIH Clinical Trials Registry & NCI Clinical Trials Reporting Program This session will focus on the following: •Clinical Trials Registration Requirements •Registration Processes •Differences and Similarities Between Registries •Future Requirements

Moderator: Laury Finn, CCRP Michelle Morgan, CCRP

5. Managing Investigator and Institutional Conflicts This session will focus on the following: •Federal and state regulations that apply to sponsors of studies, investigators, and institutions •How an effective Conflict of Interest (COI) program and policy for researchers and team members can benefit human subjects in research •The consequences of non-compliance with COI regulations and policies

Moderator: Ralph Freedman, MD, PhD Michelle Colvard, MS; Madhu Purewal, PhD, JD

6. Is it research or standard of care? Understanding the coverage analysis from initiation to implementation by the research nurse This session will focus on the following: •Describing the legal issues surrounding the coverage analysis •Overview of the coverage analysis process and its role in research billing •Describing the impact of protocol revisions and unforeseen charges on the coverage analysis

Moderator: Mary Beth Rios, CCRP, RN Carol A. Bivins, RN; Miriam Flores, MA; Rachael L. Holley, RN, CHC, CHRC, CCRC, CCRA; Ryan D. Meade, JD; Cherie Perez, CCRP, RN; Suhail Qureshi, MD, CCRP

7. Investigational Pharmacy Services This session will focus on the following: •Discussing the pharmacist role in clinical trials development, review, and support •Describing a protocol review program for pharmacy personnel •Discussing unique challenges present with Phase 1 studies

Moderator: Mark Kramer, MS, RPh Sapna Amin, PharmD, RPh; Jason Reed, PharmD, RPh

3:45 Break 4:00 Closing Summary 4:30 pm Adjourn

Ethics and Compliancein Oncology Research

ECOR

Sunday, October 7, 2012 8:00 am Registration and Continental Breakfast

8:30 Welcome & Introduction of Keynote Speaker #1 Raymond N. DuBois, MD, PhD

Keynote Address “Therapeutic Research Centers” Tom Beauchamp, PhD

9:30 Break

9:45 Introduction of Keynote Speaker #2 Aman U. Buzdar, MD

Keynote Address “Understanding and Managing Early Stage Cancers” Ronald A. DePinho, MD

10:30 Panel Discussion # 1 Molecular Testing: Science, Human Subjects Research, and the Regulatory Environment

Moderator: Stanley R. Hamilton, MD

10:30 Elizabeth Mansfield, PhD 10:45 Ivor Pritchard, PhD 11:00 Ronald A. DePinho, MD

11:30 Lunch (provided)

12:30 pm Introduction of Keynote Speaker #3: Richard L. Theriault, DO, MBA

Keynote Address “Clinical Outcome Assessment of Treatment Benefit” Laurie Burke, RPh, MPH

1:15 Panel Discussion #2 Patient-Reported Outcomes and Quality of Life, and Health Disparities Research

Moderator: Jennifer Irvin Vidrine, PhD

1:15 Tom Beauchamp, PhD 1:30 Laurie Burke, RPh, MPH 1:45 Karen Basen-Engquist, PhD, MPH; David W. Wetter, PhD 2:00 Natalie Compagni Portis, PsyD, MFT

2:30 Break

PROGRAM

Ethics and Compliancein Oncology Research

ECOR

PROGRAM Sunday, October 7, 2012 (continued) 2:45 Breakout Sessions: Part One (participants choose one of the following)

1. The Analysis of Biomarkers in Determining Eligibility and Efficacy Endpoints

Moderator: Ty Hoover, MD, JD Jorge E. Cortes, MD; Ralph Freedman, MD, PhD

2. Supervisory Responsibilities of Principal Investigators

Moderator: Richard L. Theriault, DO, MBA Sylvie M. Marcy, RN, MHA; James C. Yao, MD

3. Challenges Regarding Community-Based Participatory Research (CBPR)

Moderator: Janice Chilton, DrPH Guadalupe R. Palos, DrPH, LMSW, RN; Ivor Pritchard, PhD

4. Clinical Research in Children: Challenges and Solutions

Moderator: Najat C. Daw, MD Douglas S. Diekema, MD, MPH; Victor M. Santana, MD

5. Health Insurance Portability and Accountability Act (HIPAA) & Health Information Technology and Economic Clinical Health Act (HITECH)

Moderator: Madhu Purewal, PhD, JD Max C. Weber, MBA, JD

4:15 Break

4:30 Panel Discussion #3 Conflict of Interest Beyond the Investigator

Moderator: Ralph Freedman, MD, PhD

4:30 Dianna Cody, PhD 4:45 Wesley Harrott, BS 5:00 Judith Jordan, BS

5:30 pm Adjourn – (Welcome Reception Immediately Following)

Ethics and Compliancein Oncology Research

ECOR

Monday, October 8, 2012 7:30 am Registration and Continental Breakfast

8:00 Introduction of Keynote Speaker #4: Aman U. Buzdar, MD

Keynote Address “Challenges in Developing Oncology Drugs” Richard Pazdur, MD

9:00 Break

9:15 Introduction of Keynote Speaker #5: Oliver Bogler, PhD

Keynote Address “Barriers and Challenges & Community Perceptions of Community-Engaged Research” Charles P. Mouton, MD, MSc

10:00 Break

10:15 Panel Discussion #4 Appreciating and Understanding Our Limitations:

The Community-Based Participatory Research (CBPR) Experience

Moderator: Lewis E. Foxhall, MD

10:15 Rick A. Kittles, Ph.D. 10:30 Charles P. Mouton, MD, MSc 10:45 Carletta Tilousi

11:30 Lunch (provided)

12:30 pm Breakout Sessions: Part Two (participants choose one of the following)

1. Opportunities and Potential Obstacles in Clinical Research with Biospecimens

Moderator: Ty Hoover, MD, JD Mary Elizabeth Edgerton, MD, PhD; Michael Katz; Carletta Tilousi

2. Vulnerable Populations: Protection from Harm

Moderator: Colleen Gallagher, PhD Cynthia Herzog, MD; Judith Jordan, BS

PROGRAM

Monday, October 8, 2012 (continued)

3. Preparing for an FDA inspection & Responding to a FDA Form 483

Moderator: Madhu Purewal, PhD, JD Nancy B. Ainslie, BS, RN; Muzaffar Qazilbash, MD; Patrick Stone, MS

4. Participant Perspectives and Community Concerns in Community- Based Participatory Research

Moderator: Lovell Jones, PhD Karen Jackson; Rick A. Kittles, PhD

5. More than Words (and Numbers) Can Say: Clinical Research Contract and Billing Issues

Moderator: Raymond T. Rufer, MBA, JD Ryan D. Meade, JD

2:00 Break

2:15 Closing Remarks Aman U. Buzdar, MD

2:30 pm Adjourn

PROGRAM

Ethics and Compliancein Oncology Research

ECOR

Nancy B. Ainslie, BS, RNResearch Nurse ManagerUrology

Sapna Amin, PharmD, RPhManager, Clinical Pharmacy ServicesInvestigational Drugs

Karen Basen-Engquist, PhD, MPHProfessorBehavioral Science

Carol A. Bivins, RNResearch Nurse ManagerLeukemia

Oliver Bogler, PhDSenior Vice PresidentAcademic Affairs

Aman U. Buzdar, MDVice PresidentClinical Research Administration

Janice Chilton, DrPHInstructorCenter for Research on Minority Health

Dianna Cody, PhDConflict of Interest Committee ChairProfessor, Imaging Physics

Michelle Colvard, MSManagerOffice of Research Administration

Jorge E. Cortes, MDIRB ChairProfessor, Leukemia

Marilyn Davis, RNClinical Research Projects ManagerOffice of Multicenter Research

Najat C. Daw, MDProfessorPediatrics-Patient Care

Ronald A. DePinho, MDPresident

Raymond N. DuBois, MD, PhDProvost and Executive Vice President

Mary Elizabeth Edgerton, MD, PhDAssociate ProfessorPathology

Cathy Eng, MDCRC ChairAssociate Professor, GI Medical Oncology

Linda S. Elting, DrPHIRB ChairProfessor, Biostatistics

Laury Finn, CCRPSupervisor, Research Regulations Systems Protocol Research

Miriam Flores, MADirector, Patient Business Services

Lewis E. Foxhall, MDVice President, Healthcare Policy

Ralph Freedman, MD, PhDIRB ChairProfessor, Gynecologic Oncology & Reproductive Medicine

Colleen Gallagher, PhDAssociate Professor, Critical Care Executive Director, Integrated Ethics

Jenny L. Gay, CCRP, CIMSupervisor, Human Research RegulationsProtocol Research

Kristofer S. Griffith, CIPManager, Human Research RegulationsProtocol Research

Jennifer Hackworth, BAHuman Research Regulations EditorProtocol Research

Stanley R. Hamilton, MDDivision HeadPathology & Laboratory Medicine

Wesley Harrott, BSExecutive DirectorOffice of Research Administration

Chiq Hatten, MSN, CCRC, CCRADirectorIND Office

MD Anderson Faculty

Cathy Henceroth, BSN, CCRN, RNManagerIND Office

Cynthia E. Herzog, MDProfessorPediatrics-Patient Care

Rachael Holley, RN, BSN, CHC, CHRC, CCRAProject DirectorClinical Research Finance

Ty Hoover, MD, JDDirector, Biorepository Regulatory SupportClinical Research

Jennifer Irvin Vidrine, PhDPBHSRC Chair Assistant Professor, Health Disparities Research

Lovell Jones, PhDProfessorHealth Disparities Research

Mark Kramer, MS, RPhDirectorPharmacy Research

Sylvie M. Marcy, RN, MHADirectorClinical Research Support Center

Funda Meric-Bernstam, MDMedical Director, Institute of Personalized Cancer TherapyProfessor, Surgical Oncology

Jessica A. Moore, DHCE, MAAssistant ProfessorIntegrated Ethics

Michelle Morgan, CCRPSenior Protocol Research Information Specialist Protocol Research

Marion B. Olson, CCRP, CIP, BSSupervisor, Human Research RegulationsProtocol Research

Guadalupe R. Palos, DrPH, LMSW, RNManager, Clinical Protocol Administration Cancer Survivorship

Cherie Perez, CCRP, RNQuality Assurance Specialist Genitourinary Medical Oncology

Madhu Purewal, PhD, JDSenior Legal OfficerInstitutional Compliance

Muzaffar Qazilbash, MDAssociate ProfessorStem Cell Transplantation

Wanda A. Quezada, CIP, CCRPAd Interim Director of OperationsProtocol Research

Suhail Qureshi, MD, CCRPAssistant DirectorClinical Research Finance

Jason Reed, PharmD, RPhPharmacistInvestigational Drugs

Alyssa G. Rieber, MDAssistant ProfessorGeneral Oncology

Mary Beth Rios, CCRP, RNResearch Nurse ManagerLeukemia

Gabriela Rondon, MDAssociate ProfessorStem Cell Transplantation and Cellular Therapy

Raymond T. Rufer, MBA, JDSenior Legal OfficerLegal Services

Kathleen M. Schmeler, MDAssistant ProfessorGynecologic Oncology & Reproductive Medicine

Mira Shah, CCRP, CIMManager, Human Research RegulationsProtocol Research

Lisa Shilling Wright, MA, CIPSupervisor, Human Research RegulationsProtocol Research

MD Anderson Faculty (Continued)

Sara S. Strom, PhDAssociate ProfessorEpidemiology

Welela Tereffe, MDCRC Chair Assistant Professor, Radiation Oncology

Richard L. Theriault, DO, MBAIRB ChairProfessor, Breast Medical Oncology

Evanna Thompson, MBA, MPH, CIPSupervisor, Human Research RegulationsProtocol Research

Eliana Turk, MPHManagerIND Office

Naoto T. Ueno, MD, PhDProfessorBreast Medical Oncology

Max C. Weber, MBA, JDSenior Legal OfficerInstitutional Compliance

David W. Wetter, PhDProfessor & Cullen Trust for Healthcare ChairHealth Disparities Research

Brendell C. Williams, CCRP, RNDirectorMulticenter Clinical Research

James C. Yao, MDProfessorGI Medical Oncology

Jan M. Yungclas, RN, MHA/Ed, CCRPManagerClinical Research Support Center

Tom Beauchamp, PhDProfessor of Philosophy and Senior Research ScholarKennedy Institute of EthicsWashington, DC

Ohad Benjamini, MDThe University of Texas MD Anderson Cancer Center Postdoctoral Fellow Department of Leukemia The Chaim Sheba Medical Center at Tel Hashomer, Israel

Laurie Burke, RPh, MPHDirector, Study Endpoints and Label DevelopmentOffice of New Drugs (OND)/Center for Drug Evaluation and Research (CDER)/Food and Drug Administration (FDA) Silver Spring, Maryland

Natalie Compagni Portis, PsyD, MFTPatient RepresentativeOncologic Drugs Advisory Committee (ODAC) Food and Drug Administration (FDA)Oakland, California

Douglas S. Diekema, MD, MPHDirector of EducationTreuman Katz Center for Pediatric BioethicsChildren’s Hospital and Medical CenterSeattle, Washington

Aviad Hoffman, MDThe University of Texas MD Anderson Cancer Center Postdoctoral Fellow Department of Leukemia The Chaim Sheba Medical Center at Tel Hashomer, Israel

Karen JacksonCEO/FounderSisters Network, Inc.Houston, Texas

Judith Jordan, BSIRB Community Member The University of Texas MD Anderson Cancer CenterHouston, Texas

Guest Faculty

Guest Faculty (continued)

Michael KatzVice President International Myeloma FoundationChair, Eastern Cooperative Oncology Group (ECOG) Patient Representative CommitteeBayside, New York

Rick A. Kittles, PhDAssociate Professor Section of Hematology/OncologyDepartment of Medicine and Division of Epidemiology and Biostatistics School of Public Health Associate Director, Cancer Center Director Institute of Human GeneticsUniversity of Illinois at ChicagoChicago, Illinois

Elizabeth Mansfield, PhDDirector, Personalized Medicine StaffOffice of In Vitro Diagnostics (OIVD)/Center for Devices and Radiological Health (CDRH) Food and Drug Administration (FDA)Silver Spring, Maryland

Ryan D. Meade, JDAttorney and ConsultantMeade & Roach, LLP Chicago, Illinois

Charles P. Mouton, MD, MScSenior Vice President for Health Affairs andDean of the School of MedicineMeharry Medical CollegeNashville, Tennessee

Richard Pazdur, MDDirector, Office of Hematology Oncology Products, Center for Drug Evaluation and Research (CDER) Food and Drug Administration (FDA) Silver Spring, Maryland

Ivor Pritchard, PhDSenior Advisor to the OHRP DirectorUnited States Department of Health and Human Services (DHHS)The Office for Human Research Protections (OHRP)Washington, DC

Victor M. Santana, MDVice President, Clinical Trials AdministrationMember, Department of OncologySt. Jude Children’s Research Hospital Memphis, Tennessee

Patrick Stone, MS BiotechnologyPresidentTradeStone QA, LLC.Austin, Texas

Carletta TilousiPlaintiff and Member of the Havasupai TribeCarefree, Arizona

Registration Information• On-site registration and check-in opens at 10:30 am on Saturday, October 6, 2012, in the Hickey Auditorium Foyer on Floor 11 of the R. Lee Clark Clinic, MD Anderson, 1515 Holcombe Boulevard, Houston, Texas.• The Pre-Conference Best Practices and Benchmarking Collaboration Sessions will begin at 11:15 am on Saturday, October 6, 2012.• The opening session of the conference will begin at 8:30 am on Sunday, October 7, 2012, in the Hickey Auditorium, and the conference will adjourn at 2:30 pm on Monday, October 8, 2012.• Advance registration is encouraged as space and materials are limited. Please see the registration form for applicable fees.• The deadline for advance registration is September 21, 2012.

There are three ways to register:• Mail to Department of CME/Conference Management, Unit 1381, The University of Texas MD Anderson Cancer Center, P.O. Box 301439, Houston, TX 77230-1439• Fax to 713-794-1724• On-line at www.mdanderson.org/conferences

We accept the following forms of payment:• Check (payable through U.S. banks only)• Money order• Credit cards (MasterCard, VISA, and American Express)• Cash (on-site registration only)

A receipt and confirmation letter will be sent to you within ten working days of receipt of your registration. The conference registration fee includes the tuition, syllabus, continental breakfasts, breaks, lunches and reception.

Refund/Cancellation Policy: The registration fee, minus a $50 administrative handling fee, is re-fundable if a written request is received on or before September 21, 2012. No refunds will be granted after that date. The request for a registration refund must include the tax identification number of the company or institution if registration was paid by a company or institution check. For additional information, contact CME/Conference Management at 713-792-2223 or toll free at 866-849-5866 or via e-mail: register@mdanderson.org.

The Department of CME/Conference Management reserves the right to cancel activities prior to the scheduled date, if low enrollment or other circumstances make it necessary. Each registrant will be notified by mail, e-mail, or at the phone or fax numbers given on the registration form.

In case of activity cancellation, the liability of the Department of CME/Conference Management is limited to the registration fee. CME/Conference Management will refund the full registration fee. The Department of CME/Conference Management reserves the right to limit the number of participants in a program and is not responsible for any expenses incurred by an individual whose registration is not confirmed and for whom space is not available.

Special Assistance Contact the Department of CME/Conference Management at 713-792-2223 or toll free at866-849-5866 if you have any special dietary or ADA accommodation needs.

AccommodationsThe conference is providing a block of rooms at the Houston Marriott at the Texas Medical Center Hotel, 6580 Fannin Street, Houston, TX 77030. Hotel phone number 713-796-0080.

When making hotel reservations be sure to use the Group Rate code of MORMORA to obtain the $129 room rate for single/double occupancy. Please add 17% Texas State and local taxes.

You may also visit www.hotels.com for other hotels within the Texas Medical Center area of Houston, Texas.

Air TravelThe University of Texas MD Anderson Cancer Center has a program with United Airlines for discounted air travel. For discounts, call your travel professional or United’s Meeting Works toll free at 800-468-7022. Outside of the United States, please call your local United Airlines Reser-vation Office. The offer code is Z Code: ZM6M and Agreement Code: 488954.

Lower fares may be available on the Internet or through your travel agency.

Ground Transportation• Houston is served by two airports, George Bush Intercontinental (IAH) and William P. Hobby (HOU).• Taxicabs are available at an estimated cost of $40-60, to or from William P. Hobby Airport or George Bush Intercontinental Airport. • Super Shuttle operates a shuttle bus between George Bush Intercontinental Airport and the Marriott for $23 one-way and $42 round-trip. For more information, call 713-523-8888 or toll-free at 800-258-3826 or on-line at www.supershuttle.com.• Super Shuttle operates a shuttle bus between William P. Hobby Airport and the Marriott for $18 one-way and $32 round-trip. For more information, call 713-523-8888 or toll-free at 800-258-3826 or on-line at www.supershuttle.com.

Please let us know what specific topics, issues or questions you wish to see addressed or emphasized in this activity. Fax or e-mail CME/Conference Management. All responses will be forwarded to the Program Chairs for consideration.

The University of Texas MD Anderson Cancer Center has implemented a process whereby everyone who is in a position to control the content of an educational activity must disclose all relevant financial relationships with any commercial interest that could potentially affect the information presented. MD Anderson also requires that all faculty disclose any unlabeled use or investigational use (not yet approved for any purpose) of pharmaceutical and medical device products. Specific disclosure will be made to the participants prior to the educational activity.

Agendas are subject to change because we are always striving to improve the quality of your educational experience. MD Anderson may substitute faculty with comparable expertise on rare occasions necessitated by illness, scheduling conflicts, and so forth.

Photographing, audio taping, and videotaping are prohibited.

SYM

POSI

UM R

EGIS

TRAT

ION-

0601

Et

hics

and

Com

plia

nce

in O

ncol

ogy

Rese

arch

(ECO

R) O

ctob

er 6

-8, 2

012

THIS

IS N

OT A

SEL

F-M

AILE

R. A

ddre

ss to

:Et

hics a

nd C

ompli

ance

in O

ncolo

gy R

esea

rch (

ECOR

)

Depa

rtmen

t of C

ME/C

onfe

renc

e Man

agem

ent –

Unit

138

1Th

e Univ

ersit

y of T

exas

MD

Ande

rson

Canc

er Ce

nter

PO B

ox 3

0143

9, H

ousto

n, TX

772

30-1

439

or fa

x to

713

-794

-172

4Ma

ke ch

eck

or m

oney

orde

r pay

able

to:

The U

niver

sity o

f Tex

as M

D An

derso

n Ca

ncer

Cent

er

Last

Nam

e

Fi

rst

M

I

H

ighe

st D

egre

e

Depa

rtmen

t (in

clud

e bo

x no

.)

Spec

ialty

Inst

itutio

n

Phys

icia

n q

Yes

q

No

Stre

et

City

St

ate/

Fore

ign

Coun

try/Z

ip o

r Mai

l Cod

e

Dayt

ime

Phon

e (w

ith a

rea

code

)

Ce

ll Ph

one

(with

are

a co

de)

Fax

(with

are

a co

de)

E-m

ail A

ddre

ss

E

mer

genc

y Co

ntac

t

P

hone

(with

are

a co

de)

Char

ge th

e fo

llow

ing:

o

VISA

oM

aste

rCar

d

o

Amer

ican

Exp

ress

Cred

it Ca

rd N

umbe

r or M

D An

ders

on In

terd

epar

tmen

tal T

rans

fer (

IDT)

No.

Expi

ratio

n Da

te

Cred

it Ca

rd H

olde

r Nam

e (F

irst/L

ast)

C

redi

t Car

d Ho

lder

Bill

ing

Addr

ess

& Z

IP C

ode

Auth

orize

d Si

gnat

ure

REQU

IRED

for c

redi

t car

d or

IDT

MD

Ande

rson

Em

ploy

ee ID

No.

(REQ

UIRE

D)

IDT

Appr

over

Nam

e (F

irst/L

ast)

plea

se p

rint

IDT

Appr

over

E-m

ail

Cred

it Ca

rd H

olde

r Nam

e (F

irst/L

ast)

Cr

edit

Card

Hol

der B

illin

g Ad

dres

s &

Zip

Cod

e

REGI

STRA

TION

FEES

Sund

ay a

nd M

onda

y, Oc

tobe

r 7-8

, 201

2

Phys

icia

n/Sc

ient

ist (

MD,

PhD

)1 P

ostm

arke

d by

9/21

/201

2......

........

........

.....$6

00.00

1 P

ostm

arke

d af

ter 9

/21/

2012

.......

........

.......$

650.0

0

Heal

thca

re P

rofe

ssio

nal

(

Nurs

e, P

hysic

ian

Assis

tant

, Oth

er)

1 P

ostm

arke

d by

9/21

/201

2......

........

........

.....$2

00.00

1 P

ostm

arke

d af

ter 9

/21/

2012

.......

........

.......$

250.0

0

1 M

D An

ders

on Fa

culty

/Sta

ff/Tr

aine

e .....

..$ 5

0.00

The

full c

onfe

renc

e fe

e in

clud

es th

e tu

ition

, syll

abus

, co

ntin

enta

l bre

akfa

sts,

lunc

hes,

brea

ks, a

nd

wel

com

e re

cept

ion.

Satu

rday

, Oct

ober

6, 20

12Be

nchm

arkin

g Se

ssio

n (n

o ex

tra c

harg

e)1 I

will

atte

nd

THE

UNIV

ERSI

TY O

F TE

XAS

MD

ANDE

RSON

CAN

CER

CENT

ERCM

E/CO

NFER

ENCE

MAN

AGEM

ENT,

UNI

T 13

8117

6700

/300

7060

1PO

BOX

301

439

HOUS

TON,

TEX

AS 7

7230

-143

9

NoN-

Prof

itU.

S. P

oSta

geP

a i D

HoUS

toN,

tX

Perm

it N

o. 7

052