Event Calendar

Agenda

Oncology Clinical Trials Conference

Oncology Pre-Conference Workshop

- Optional ½ Day Workshops | Wednesday March 13, 2019 -
(Requires Separate Registration)
Good Clinical Practice (GCP) E6 (R2) Basics Preconference Workshop    

7:30 – 8:00       Registration and Continental Breakfast
8:00 – 11:30     Good Clinical Practice (GCP) E6 (R2) Basics   (Break 9:45 - 10:00)
This Pre-Conference Half-day Workshop, which also meet the NIH requirements for  GCP Training, will teach to the fundamental knowledge of clinical trial quality standards for designing, conducting, recording and reporting trials that involve human research participants.

Oncology Research Fundamentals Preconference Workshop

11:30 – 12:00   Registration and Welcome

12:00 – 12:45   Basics of Oncology Research
This session will provide a basic overview Oncology Research. Topics include: Cancer statistics, Oncology terminology, development of cancer, understanding cancer diagnosis, staging and grading, and what makes oncology trials unique. 

12:45 – 1:30     Treatment Modalities
This session will look at the goals for cancer treatment as well as the different options available, such as surgery, radiation therapy, chemotherapy, immunotherapy and other medical treatments.  

1:30 – 2:15       Response Criteria in Oncology Research
In this session, we will review the standard approach to response evaluation in oncology. Response Evaluation Criteria in Solid Tumors (RECISIT) will be discussed as well as definitions for objective assessment of change in tumor size for use in oncology trials.   

2:15 – 2:35       Break

2:35 – 3:35      Oncology Protocol Review
This session will inform how to critically review a protocol concentrating on specific sections such as, the schema, primary and secondary objectives, eligibility, dosing and adverse events. We will discuss the how to read and then build a test schedule on the protocol provided.

3:35 – 4:30     Oncology Case Study
This session will be an interactive activity incorporating the information gained throughout today’s program.

4:30 – 4:45      Helpful resources and tips for a new oncology professional
4
:45 – 5:10      Question and Answer Session
This session is an opportunity to discuss questions and answers related to the topics presented in preconference.     

Day One: Thursday, March 14, 2019

8:00 – 8:30       Registration and Continental Breakfast

8:30 – 8:45 Introduction to SOCRA

Susanna Sellman, RTT, BS, CCRP, Quality Assurance Manager, Princess Margaret Cancer Center
Ms. Sellman will provide an introduction to the Society of Clinical Research Associates (SOCRA) and review the benefits of being a SOCRA member.

8:45 – 9:05 Oncology Clinical Research

Tammy Neseth, MA, CCRP, CIP, Research Compliance Manager, Mayo Clinic
Ms. Neseth will provide an introduction and overview of the Oncology Clinical Research Conference. During this time there will be discussion to assist the faculty in getting to know the attendees and their learning objectives.

9:05– 10:05 Challenges and Opportunities in Oncology Research

Scott Okuno, MD, Consultant, Department of Oncology, Mayo Clinic
Dr. Okuno will discuss the challenges of oncology research and suggest ways to address new opportunities.

10:05 – 10:20 Break (with opportunity for poster review)

10:20 – 12:20 Budgeting and Staffing Oncology Trials

Teresa Stewart, MS, Vice President, Consultant, Mantos Consulting, Inc
In this session, Ms. Stewart will address the evolving and increasing complexity of oncology trials. We will discuss how a site assesses workload and effectively negotiate budgets to successfully manage a trial.

 

12:20 – 1:05 Lunch (provided)

1:05 – 1:50 Clinical Trial Site Selection for Oncology Trials and Monitoring from the CRA’s Perspective

Aubri Lang, CCRP, Senior Clinical Research Associate, TESARO
Ms. Lang will share sponsor expectations for a successful oncology clinical trial. Site selection from pre-qualification through initiation and site-ready status will be discussed. The speaker will also provide examples of monitoring findings along with a few tips and tools that can be used decrease future findings.

1:50 – 3:20 Pharmacology 101: An Introduction to Pharmacokinetics, Pharmacodynamics and Sample Stability for Clinical Research Professionals

Gregory Staios, MSc, Research Monitor, Centre for Addiction and Mental Health Assurance Coordinator
Mr. Staios will discuss how drugs interact within the biological system and in turn how the biological system acts on the drug. This presentation will also provide an introduction to pharmacokinetic evaluations and how they are used to characterize the dose response relationships for new pharmaceutical products. The importance of sample integrity and stability and their future use will also be discussed.

3:20 – 3:35 Break (with opportunity for poster review)

3:35 - 4:20 Correlative Science: The Business of Quality Specimen Management

Vanessa Speers, MSc, BEd, Manager, Correlative Studies Program, Princess Margaret Cancer Centre
Ms. Speers will discuss the procurement, processing, and quality of biospecimens as it relates to the advent of personalized medicinewhich exponentially increased the number of biospecimens that are being collected in clinical trials. Matched with the ideology of personalized medicine, with its specialized portfolio of services, a need has been generated for a centralized specimen management program to govern the collection and processing of biospecimens. This presentation will discuss the logistics managing correlative science in detail.

4:20 – 4:50 Day 1 Wrap-up

Day Two: Friday, March 15, 2019

8:00 – 8:30 Continental Breakfast

8:30 – 9:30 Improving the Oncology Research Participant Experience

Tammy Neseth, MA, CCRP, CIP, Research Compliance Manager, Mayo Clinic
This session will focus on gaining a better understanding of the point of view of the oncology research participant. Participants’ stories will be shared in order to understand what makes a research experience positive or negative. Ms. Neseth will include practical advice and participant suggestions on how to improve the overall research experience.

9:30 – 10:15 Phase 1 Clinical Oncology Trials

Joyce Tungol, BS, CCRP, Clinical Research Associate, Duke Cancer Network
A Phase I clinical oncology trial is the first step in testing an investigational treatment approach, as it determines a drug’s safety, dosage, tolerability, and side effects. This session will provide an overview of the importance, purpose, and objectives of Phase I clinical trials. Early phase study design, logistics/characteristics and challenges will also be discussed. Additionally, we will cover the Phase I study coordinator perspective and the common day-to-day challenges encountered in the Phase I clinical trial environment.

10:15 – 10:30 Break (with opportunity for poster review)

10:30 – 11:30 Basic Principles of Clinical Trial Design, Conduct and Choice of Endpoints

Sumithra J. Mandrekar, PhD, Professor, Biostatistics and Oncology, Mayo Clinic
This presentation will review the basic principles of clinical trial design. Dr. Mandrekar will explain the importance for upfront investment in planning by the study in terms of endpoints, data collection and analyses. Dr. Mandrekar will also provide the audience with a few do’s and don’ts of clinical trial monitoring.

11:30 – 12:30 Imaging in Oncology Clinical Trials

Stuart Bentley-Hibbert, MD, Columbia University
Dr. Bentley-Hibbert will discuss imaging in oncology clinical trials. The topics covered include modalities, response assessment metrics and changes to response criteria.

12:30 – 1:15 Lunch (provided)

1:15 – 1:30 Poster Winner Presentations

1:30 – 2:00 Adverse Event Reporting for Oncology Trials

Nicole Luimes, HBSc, CCRP, Education Specialist Lead, Princess Margaret Cancer Centre
Ms. Luimes will discuss the Common Terminology Criteria for Adverse Events (CTCAE) coding dictionary for adverse events, its use in oncology research, and challenges faced in coding. Tips on navigating the CTCAE dictionary will be discussed. Special NCI reporting requirements will also be covered.

2:00 – 2:45 The Next Generation: Immunotherapy and Personalized Medicine

Jamie Harper, MHA, CCRP, Director of Clinical Research, Illinois CancerCare
Immunotherapy is an emerging class of cancer treatment that uses the body’s own immune system to help fight cancer cells. Using treatments designed to target specific tumor markers, the goal is to boost or restore the body’s immune function in some manner. Ms. Harper will give an overview of immunotherapy and cancer, the different approaches currently available and how this information is used to develop a personalized treatment regimen.

2:45 – 3:15 Adverse Events specific to Immunotherapy

Nancy Williams, BS, CCRP, Pharmaceutical Trials Coordinator, Illinois CancerCare
As the Pharmaceutical trials coordinator for a large oncology practice, Ms. Williams has worked on studies from the first CTLA-4 drug in research, single agent anti PD-1/PD-L1 drugs in trials to the current combination trials with these drugs. Ms. Williams will discuss how the AE profile for these drugs has evolved, just as the management of these toxicities.

3:15 – 3:35 Break (with opportunity for discussion)

3:35 – 4:35 Regulatory Inspection Minimizing Findings by Actively Incorporating Good Clinical Practices (GCP)

This session will examine common FDA findings during clinical investigator BIMO inspections. We will discuss what these findings mean and the unique challenges in Oncology studies. We will also outline ways to build in quality into the study in order to avoid these issues.

4:35 – 4:50 Day Two Wrap-up

4:50 – 5:00 Closing Remarks and Adjournment

 

 

 

8:30 – 8:45      Introduction to SOCRA
Susanna Sellman, RTT, BS, CCRP, Quality Assurance Manager,
Princess Margaret Cancer Center
Ms. Sellman will provide an introduction to the Society of Clinical Research Associates (SOCRA) and review the benefits of being a SOCRA member.   
8:45 – 9:05     Oncology Clinical Research
Tammy Neseth, MA, CCRP CIP, Research Compliance Manager, Mayo Clinic
Ms. Neseth will provide an introduction and overview of the Oncology Clinical Research Conference. During this time there will be discussion to assist the faculty in getting to know the attendees and their learning objectives.
9:05– 10:05     Challenges and Opportunities in Oncology Research
Scott Okuno, M.D., Consultant in Department of Oncology,
Mayo Clinic
Dr. Okuno will discuss the challenges of oncology research and suggest ways to address new opportunities.
10:05 – 10:20         Break (with opportunity for poster review)
10:20 – 12:20        Academic and Community Challenges and Opportunities             Break-out Sessions
Regulatory Considerations in Oncology Research
An overview of the regulatory requirements and management strategy of clinical trials.
Budgeting and Staffing Oncology Trials
In this session, we will address the evolving and increasing complexity of oncology trials. We will discuss how a site assesses workload and effectively negotiate budgets to successfully manage a trial
12:20 – 1:05      Lunch (provided)
1:05 – 1:50       Clinical Trial Site Selection for Oncology Trials and                             Monitoring from the CRA’s Perspective
Aubri Lang, CCRP, Senior Clinical Research Associate, TESARO
Ms. Lang will share sponsor expectations for a successful oncology clinical trial. Site selection from pre-qualification through initiation and site-ready status will be discussed. The speaker will also provide examples of monitoring findings along with a few tips and tools that can be used decrease future findings.
1:50 – 3:20          Pharmacology 101: An Introduction to Pharmacokinetics,                                     Pharmacodynamics and Sample Stability for Clinical                    
                            Research Professionals
Gregory Staios, M.Sc., Research Monitor, Centre for Addiction and Mental Health Assurance Coordinator
Mr. Staios will discuss how drugs interact within the biological system and in turn how the biological system acts on the drug. This presentation will also provide an introduction to pharmacokinetic evaluations and how they are used to characterize the dose response relationships for new pharmaceutical products. The importance of sample integrity and stability and their future use will also be discussed.

3:20 – 3:35    Break (with opportunity for poster review)
3:35 - 4:20     Correlative Science: The Business of Quality Specimen                                                       Management
Vanessa Speers, MSc, BEd, Manager,
Correlative Studies Program, Princess Margaret Cancer Centre
Ms. Speers will discuss the procurement, processing, and quality of biospecimens as it relates to the advent of personalized medicinewhich exponentially increased the number of biospecimens that are being collected in clinical trials. Matched with the ideology of personalized medicine, with its specialized portfolio of services, a need has been generated for a centralized specimen management program to govern the collection and processing of biospecimens. This presentation will discuss the logistics managing correlative science in detail.
4:20 – 4:50          Day 1 Wrap-up
Day Two: Friday, March 15, 2019
8:00 – 8:30         Continental Breakfast
8:30 – 9:30         Improving the Oncology Research Participant Experience
Tammy Neseth, MA, CCRP CIP, Research Compliance Manager, Mayo Clinic
This session will focus on gaining a better understanding of the point of view of the oncology research participant. Participants’ stories will be shared in order to understand what makes a research experience positive or negative. Ms. Neseth will include practical advice and participant suggestions on how to improve the overall research experience.
9:30 – 10:15        Phase 1 Clinical Oncology Trials
A Phase I clinical oncology trial is the first step in testing an investigational treatment approach, as it determines a drug’s safety, dosage, tolerability, and side effects. This session will provide an overview of the importance, purpose, and objectives of Phase I clinical trials. Early phase study design, logistics/characteristics and challenges will also be discussed. Additionally, we will cover the Phase I study coordinator perspective and the common day-to-day challenges encountered in the Phase I clinical trial environment.
10:15 – 10:30       Break (with opportunity for poster review)
10:30 – 11:30        Basic Principles of Clinical Trial Design, Conduct and                                   Choice of Endpoints
Sumithra J. Mandrekar, PhD, Professor, Biostatistics and Oncology,            Mayo Clinic    
This presentation will review the basic principles of clinical trial design. Dr. Mandrekar will explain the importance for upfront investment in planning by the study in terms of endpoints, data collection and analyses. Dr. Mandrekar will also provide the audience with a few do’s and don’ts of clinical trial monitoring.
11:30 – 12:30         Imaging in Oncology Clinical Trials
Stuart Bentley-Hibbert, MD, Columbia University
    Dr. Bentley-Hibbert will discuss imaging in oncology clinical trials. The topics covered include modalities, response assessment metrics and changes to response criteria.
12:30 – 1:15     Lunch (provided)
1:15 – 1:30       Poster Winner Presentations
1:30 – 2:00       Adverse Event Reporting for Oncology Trials
Nicole Leymen, BS, CCRP, Education Specialist Lead,
Princess Margaret Cancer Centre
Ms. Leymen will discuss the Common Terminology Criteria for Adverse Events (CTCAE) coding dictionary for adverse events, its use in oncology research, and challenges faced in coding. Tips on navigating the CTCAE dictionary will be discussed. Special NCI reporting requirements will also be covered.
2:00 – 2:45      The Next Generation: Immunotherapy and Personalized                                  Medicine
Jamie Harper, MHA, CCRP, Director of Clinical Research, Illinois CancerCare
Immunotherapy is an emerging class of cancer treatment that uses the body’s own immune system to help fight cancer cells. Using treatments designed to target specific tumor markers, the goal is to boost or restore the body’s immune function in some manner. Ms. Harper will give an overview of immunotherapy and cancer, the different approaches currently available and how this information is used to develop a personalized treatment regimen.
2:45 – 3:15        Adverse Events specific to Immunotherapy
Nancy Williams, BS, CCRP, Pharmaceutical Trials Coordinator,                    Illinois CancerCare
As the Pharmaceutical trials coordinator for a large oncology practice, Ms. Williams has worked on studies from the first CTLA-4 drug in research, single agent anti PD-1/PD-L1 drugs in trials to the current combination trials with these drugs. Ms. Williams will discuss how the AE profile for these drugs has evolved, just as the management of these toxicities.
3:15 – 3:35         Break (with opportunity for discussion)
3:35 – 4:35         Regulatory Inspection Minimizing Findings by Actively             
                            Incorporating Good Clinical Practices (GCP)
This session will examine common FDA findings during clinical investigator BIMO inspections. We will discuss what these findings mean and the unique challenges in Oncology studies. We will also outline ways to build in quality into the study in order to avoid these issues.
4:35 – 4:50         Day Two Wrap-up
4:50 – 5:00         Closing Remarks and Adjournment