Agenda

2024 Conference Agenda

Oncology Pre-Conference Workshop

- Optional ½ Day Workshops | (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 – 1:30 Basics of Oncology Research and Protocol Review
Andrea Skafel MS, CCRP, Director, Clinical Research Support Office, UCSF Helen Diller Family Comprehensive Cancer Center
Ms. Skafel 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. How to critically review a protocol concentrating on specific sections such as, the schema, primary and secondary objectives, eligibility, dosing, and adverse events will also be discussed. We will discuss the how to read and then build a test schedule on the protocol provided.
1:30 – 2:15 Treatment Modalities
Jasmine Grant, MEd, BHSc, CCRP, Manager, Clinical Research, Princess Margaret UHN
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.
2:15 – 2:30 Break
2:30 – 3:15 Response Criteria in Oncology Research
Scott Okuno, MD, Consultant, Department of Oncology, Mayo Clinic
In this session, we will review the standard approach to response evaluation in oncology. Response Evaluation Criteria in Solid Tumors (RECIST) will be discussed as well as definitions for objective assessment of change in tumor size for use in oncology trials.
3:15 – 4:00 Adverse Events in Oncology Research
Jasmine Grant, MEd, BHSc, CCRP, Manager, Clinical Research, Princess Margaret UHN
This presentation 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.
4:00 – 5:00 Oncology Case Study
This session will be an interactive activity incorporating the information gained throughout today’s program.
5:00 – 5:30 Helpful resources and tips for a new oncology professional/Q&A
This session is an opportunity to discuss questions and answers related to the topics presented in preconference

Day One:

8:00 – 8:30 Registration and Continental Breakfast

8:30 – 8:45 Introduction to SOCRA

Susanna Sellmann, RTT, BS, CCRP, Program Director, Cancer Clinical Research Unit, Princess Margaret Cancer Center
Ms. Sellmann will provide an introduction to the Society of Clinical Research Associates (SOCRA) and review the benefits of being a SOCRA member.

8:45 – 9:00 Oncology Clinical Research

Tammy Neseth, MA, CCRP, CIP
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.

9:00– 10:00 Challenges and Opportunities in Oncology Research

Scott Okuno, MD, Consultant, Department of Oncology, Mayo Clinic
In this presentation, Dr. Okuno will discuss opportunities and challenges facing clinical oncology in 2023 and beyond. We will cover both NCI sponsored and industry funded studies. Questions are encouraged.

10:00 – 10:20 Break (with opportunity for poster review)

10:20 – 11:20 Regulatory Considerations in Oncology Research

Erin Lynch, MS, CCRP, Research Operations Manager - Regulatory & Compliance, Dartmouth Cancer Center
This session will provide an overview of regulatory requirements over the life of an oncology clinical trial. Ms. Lynch will outline evaluation of study feasibility at the site level, and methodology for regulatory responsibilities through start-up, maintenance, and study close-out. Strategies and recommendations for organization and maintenance of essential regulatory documents will be discussed.

11:20 – 12:20 Navigating the Complex Landscape of Research Billing: A Research Nurse Coordinator’s Guide to Ethical and Effective Practices.

Joanna Hill, MBA, CCRP, Director, Cancer Research Center, HealthPartners Institute
Research coordinators and nurses play a crucial role in clinical research studies, even when they are not directly involved the budgeting process. Understanding research billing is essential for ensuring the financial aspects of a study run smoothly and ethically. This topic will cover the challenges and strategies for managing research billing while emphasizing ethical and effective approaches, which is crucial in the field of oncology clinical research.

12:20 – 1:05 Lunch (provided)

1:05 – 2:05 Developing Sponsor-Site Partnerships: The Key to Success in Oncology Trials

Jessica Hotter, BS, Senior CRA & Early Development Leader, Bristol Myers Squibb
Ms. Hotter will discuss common challenges in conducting and managing Oncology trials. Common management issues and monitoring findings will be reviewed. Strategies to reduce findings, improve efficiency and communication as well as strengthen the Sponsor-site relationship will be discussed. Participants will leave with recommendations that can be implemented in current and future trials.

2:05 – 3:05 Pharmacokinetics/Pharmacodynamics and Drug Interactions

Jeffrey Doi, HonBSc, BScPharm, RPh, BCPS, Clinical Trials Pharmacist, Princess Margaret Cancer Centre, UHN

Determining how drugs act within the biological system and in turn how the biological system acts on drugs are important to guide pharmaceutical development. Mr. Doi will provide an introduction to pharmacokinetic and pharmacodynamic evaluations and how they are used to characterize the dose response relationships for new drug products. In this session, an overview of the mechanisms and significance of drug-drug interactions in oncology will also be provided.

3:05 – 3:25 Break

3:25 - 4:25 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 medicine which 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

4:25 – 5:25 Phase 1 Clinical Oncology Trials

Joyce Tungol, BS, Clinical Trial Manager, LumaBridge

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.

5:25 – 5:55 Day 1 Wrap-up

Day Two:

8:00 – 8:30 Continental Breakfast

8:15-8:30 Poster Review & Presentations

8:30 – 9:20 Why Would I Participate in a Clinical Trial When I Don’t Trust You?” – Medical Mistrust, Clinical Trial Perceptions, and Participation Among Under-Resourced Cancer Patients

Audrey Davis, Senior Director, Health Equity, Cancer Support Community

The Cancer Support Community’s Justified Medical Mistrust: Acknowledging the Past to Change the Future docuseries was created alongside, and not just about, Black and African American patients interested in learning more about clinical research. Through facilitation of our advisory board and qualitative focus group research, we gained insight into factors that may make someone more or less likely to engage in a clinical trial. We also learned about the impacts of this docuseries on patients’ willingness to reconsider clinical trial participation in the future.

9:20 – 10:20 Hematologic Malignancies

Elizabeth Fitzgerald, PA-C, MMS, Physician Assistant, Mayo Clinic
Ms. Fitzgerald will review current areas of interest in hematologic studies and what is coming on the horizon.

10:20 – 10:40 Break (with opportunity for poster review)

10:40 – 11:40 Chimeric Antigen Receptor Therapy (CAR-T) in Hematologic Malignancies

Elizabeth Fitzgerald, PA-C, MMS, Physician Assistant, Mayo Clinic
Cellular therapy, in particular CAR-T and Bispecific Antibodies is an advancing field utilizing a person’s native immune system to target cancer cells and induce cell death. This novel therapy has received FDA approval in select Hematologic Malignancies with ongoing clinical trials for further advancement as well as use in solid tumor malignancies.

11:40 - 12:40 Basic Principles of Clinical Trial Design, Conduct and Choice of Endpoints

Jay Mandrekar, PhD, Professor of Biostatistics and Neurology, Mayo Clinic
This presentation will review the basic principles of clinical trial design and challenges encountered while conducting clinical trials. Dr. Mandrekar will explain the importance for upfront investment in planning by the study team in terms of endpoints, databases, recruitment of participants and handling of missing data. He will provide the audience with a few do’s and don’ts of clinical trial monitoring using real life examples from other clinical trials.

12:40 – 1:25 Lunch (provided)

1:25 – 2:25 Imaging in Oncology Clinical Trials - An Update

Stuart Bentley-Hibbert, MD, PhD, Division Chief, Body Imaging, Columbia University Medical Center
Dr. Bentley-Hibbert will discuss the role of imaging interpretation and updated imaging criteria clinical trials.

2:25 – 3:25 Overview of Proton Therapy

Mark McDonald, MD, Medical Director, Associate Professor, Winship Cancer Institute of Emory University
This presentation will provide an overview of radiation therapy focused on the role of proton therapy and how it is different from x-ray radiation treatments. Using example cases and existing clinical data, the potential for proton therapy to reduce immediate and/or long-term side effects and risks will be reviewed. The presentation will include information about ongoing clinical trials incorporating proton therapy, as well as an overview of the technology and implementation of proton therapy.

3:25 – 3:45 Break (with opportunity for discussion)

3:45 – 4:45 Minimizing Inspection Findings by Actively Incorporating Good Clinical Practices (GCP)

Flora Noitsis, Hons BSc, Senior Associate, Compliance and Regulatory, BioAcuity Consulting Inc.

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 to avoid these issues.

4:45 – 4:55 Day Two Wrap-up

4:55 – 5:10 Closing Remarks and Adjournment

Agenda

2024 Conference Agenda

Oncology Pre-Conference Workshop

Day One:

Day Two:

Oncology Clinical Trials Conference