2023 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
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. 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 (RECISIT) 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
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, Quality Assurance Manager, 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 E. Lynch, MS, CCRP, Research Operations Manager – Regulatory & Compliance, Dartmouth Cancer Center
This session will provide an overview of regulatory requirements and strategies for conducting
oncology clinical trials across a network of community research sites. The speaker will share suggestions for working with the Central Institutional Review Board, addressing challenges faced by research networks, and managing clinical trials at satellite institutions.

11:20 – 12:20 Budgeting and Staffing Oncology Trials

Joanna Hill, MBA, CCRP, Director – Cancer Research Center HealthPartners Institute
Ms. Hill will address the evolving and increasing complexity of oncology trials, how does a site build a budget and successfully negotiate contracts to manage their portfolio of clinical trials.

12:20 – 1:05 Lunch (provided)

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

Kara Lee McWatters, BSC, MSC, CCRP, RQAP-GCP, Director/Consultant, Stiris Research Inc/McWatters Clinical Research Consulting
Ms. McWatters 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

Jeff 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

Maribelle Guloy, DHSc, MS, CCRP, Director, Clinical Development, American Regent – A Daiichi Sankyo Co.
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

8:30 – 9:20    Improving the Oncology Research Participant Experience

Cate O'Reilly, MSW, Vice President, Patient Planning Services, a Cancer Support Community Company
This session will focus on gaining a better understanding of the point of view of the oncology research participant. Putting yourselves in the shoes of someone with a cancer diagnosis who is contemplating participating in a clinical trial. Participants’ stories will be shared to understand what makes a research experience positive or negative. Ms. O'Reilly will include practical advice and participant suggestions on how to improve the overall research experience.

9:20 – 10:20 Hematologic Malignancies

Megan Spychalla, PA-C, Supervisor Inpatient Advance Practice Providers, Division of Hematology, Mayo Clinic
This session will focus on therapeutic advances over the years. Ms. Spychalla will discuss challenges and opportunities in clinical trials in this field.

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

10:40 – 11:40        Chimeric Antigen Receptor Therapy (CAR-T) in Hematologic Malignancies
Megan Spychalla, PA-C, 
Supervisor Inpatient Advance Practice Providers, Division of Hematology, Mayo Clinic.
CAR-T 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. Mitigation and management of CAR-T related toxicity as well as the timing of this novel therapy is a focus of many current clinical trials.

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 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

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   Proton Beam Thearpy

Mark McDonald, MD, Medical Director, Associate Professor, Winship Cancer Institute of Emory University
More than half of all people with cancer receive radiation therapy. This session will discuss the alternative to conventional radiation therapy. Proton beam therapy uses the positively charged particles in an atom (protons) that release their energy within the tumor.

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

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

Tammy Neseth, MA, CCRP, CIP

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