Oncology Research Fundamentals Preconference Workshop (Optional)

Wednesday, March 23, 2022 

12:00 – 1:20 Basics of Oncology Research and Protocol Review
Andrea Skafel, MSc, CCRP, Clinical Research Support Office Director, UCSF Helen Diller 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

1:20 – 2:00 Treatment Modalities
Jamie Harper, MHA, CCRP, Director of Clinical Research, Illinois CancerCare
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.

2:00 - 2:15 Break

2:15 – 2:55 Response Criteria in Oncology Research
Andrea Skafel, MSc, CCRP, Clinical Research Support Office Director, UCSF Helen Diller Comprehensive Cancer Center
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.

2:55 – 3:20 Adverse Events in Oncology Research
Jamie Harper, MHA, CCRP, Director of Clinical Research, Illinois CancerCare, PC
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.

3:20 - 3:35 Break

3:35 – 4:15 Oncology Case Study
All Workshop Faculty
This session will be an interactive activity incorporating the information gained throughout today’s program.

4:15 – 4:45 Helpful Resources and Tips for a New Oncology Professional/ Q&A
All Workshop Faculty

Main Conference - Day One

Thursday, March 24, 2022

Session 1

10:00am  - Welcome

10:15 – 11:00 am ET: 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.

11:00 – 11:45 am ET: Regulatory Considerations in Oncology Research
Connie Szczepanek, BSN, RN, CCRP, Director, Cancer Research Consortium of West Michigan NCORP
This session will provide an overview of regulatory requirements and strategies for conducting oncology clinical trials across a network of community research sites. Mrs. Szczepanek will share suggestions for working with the Central Institutional Review Board, addressing challenges faced by research networks, and managing clinical trials at satellite institutions. She will also discuss the unique regulatory challenges resulting from the COVID 19 pandemic

11:45 – 12:05 pm ET:  Session 1 Q&A with presenters

12:05 – 12:30 pm ET: Break

 Session 2

12:30 – 1:15 pm ET: Budgeting and Staffing Oncology Trials
Teresa Stewart, MS, Vice President, Consultant, Mantos Consulting, Inc
Ms. Stewart 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.

1:15 – 2:00 pm ET: Developing Sponsor-Site Partnerships: The Key to Success in Oncology Trials
Kara Lee McWatters, BSC, MSC, CCRP, RQAP-GCP, Consultant, 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.

2:00 – 2:20 – Session 2 Q&A with presenters.
2:20 – 2:30 - Break

2:30 – 3:15 pm ET: Basic Principles of Clinical Trial Design, Conduct and Choice of Endpoints
Sumithra Mandrekar, PhD, Professor of 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. She will also provide the audience with a few dos and don'ts of clinical trial monitoring. She will also briefly introduce the concept of master protocols and precision medicine.

3:15 – 4:00 Regulatory Inspection Minimizing Findings by Actively Incorporating Good Clinical Practices (GCP)

Kara Lee McWatters, BSC, MSC, CCRP, RQAP-GCP, Consultant, McWatters Clinical Research Consulting
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.

4:00 – 4:20 – Session 3 Q&A with presenters.

4:20 – 4:50 - Cell Therapy – FACT accredited program

4:50 – 5:00 Day 1 Wrap up



Main Conference - Day Two

Friday, March 25, 2022

Session 4

10:00 – 10:40 am ET: 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.

10:40 - 11:20 am ET: 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.

11:20 – 11:40 – Session 4 Q&A with presenters

11:40 - 12:05 Break

Session 5

12:05 – 12:35 pm ET: Phase 1 Clinical Oncology Trials
Joyce Tungol, BS, CCRP, Clinical Study Leader, Science 37
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.

12:35 – 1:05 CarT 

2:05 – 1:35 pm ET: Hematologic Malignancies
Joseph Vadakara, MD, Director Hematology/Oncology Fellowship Program, Geisinger
This session will focus on therapeutic advances over the years. We will discuss challenges and opportunities in clinical trials in this field

1:35 – 1:55 – Session 5 Q&A with presenters

1:55 - 2:15 Break 

Session 6

2:15 – 3:05 pm ET: 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 in clinical trials.

3:05 – 3:50 pm ET: Proton Beam Therapy
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.

3:50 – 4:10 pm ET: Session 4 Q&A with presenters.

4:10 – 4:30 pm ET: Conference Wrap-up