2024 Annual Conference Brochure - Flipbook - Page 11
FRIDAY, SEPTEMBER 27, 2024
BREAKOUT SESSIONS
TRACK 1: ONCOLOGY
TRACK 2: DEVICE
Fri., Sept. 27 1:15 to 2:00
Track: Oncology Research
Adverse Events: Use of the Common Terminology
Criteria for Adverse Events (CTCAE) and Documentation
Best Practices
Ms. Kingsford will review the history of the CTCAE and
review how to use it in practice through case studies. Best
practices for documentation will also be discussed.109
Presenter: Rachel Kingsford, MS, CCRP, Senior Clinical
Research Manager, Huntsman Cancer Institute
Fri., Sept. 27 1:15 to 2:00
Track: Device Research
How Decentralized Clinical Trials Can Facilitate Trials
Involving Medical Devices
Mr. Faget will explore the advantages and hurdles
presented by decentralized clinical trials. Topics will
include FDA’s draft guidance regarding decentralized
clinical trials and telemedicine laws and regulations that
must be considered when implementing such trials. 209
Presenter: Kyle Faget, JD, AB, Partner, Co-Chair Health Care
Practice Group, Foley & Lardner, LLP
Fri., Sept. 27 2:05 to 2:50
Track: Oncology Research
CAR-T, Bispecifics, TILS: What Do They All Mean and
What's Next in Cellular Therapy
With the future moving more towards cellular and
individualized therapies we will get to understand the
different types, terminology and common adverse events.
111
Presenter: Elizabeth Fitzgerald BS, MMS, PA-C, Physician
Assistant Mayo Clinic
Fri., Sept. 27 3:25 to 4:10
Track: Oncology Research
Changing Lifestyle after Cancer Diagnosis
How do smoking cessation, healthy diet, and exercise
improve cancer outcomes? Patients with a healthy lifestyle
are more likely to survive longer after a cancer diagnosis.
Exercise can help improve a multitude of side effects
associated with cancer therapies such as fatigue, pain,
anxiety/depression, and others. 113
Presenter: Gracy Zachariah, MSN, CCRP, RN, Research Nurse
Manager, MD Anderson Cancer Center
Fri., Sept. 27 2:05 to 2:50
Track: Device Research
Medical Device Clinical Evidence Needs with MDD to
MDR Transition
Ms. Yohannan will discuss how the EU MDR came about,
the overall differences between MDD and MDR and
required changes to our safety; performance needs with
clinical evidence generation; and why it’s important to
plan clinical evidence generation immediately after
preclinical studies of a device. We will consider planning
of premarket and post-market clinical trials, registries,
user surveys, and Real World Evidence collection, as well
as vigilance reporting. 211
Presenter: Mary Sophy Yohannan, MBBS, CCRC, Director
Medical Safety & Clinical Science, Bolt Medical, Inc.
Fri., Sept. 27 3:25 to 4:10
Track: Device Research
Cultural Considerations for Diversity in Clinical
Research: A Global and Domestic Context
Join us for a discussion of aspects of culture to consider
in the conduct of global clinical trials as well as some
strategies for inclusion that can be used both abroad and
domestically. 213
Presenter: Joy Beeler, MPH, CCRA, ACRP-CPM, Deputy
Director, Office of Clinical Research Affairs, NIH, Divison of
Microbiology & Infectious Diseases
Fri., Sept. 27 4:15 to 5:00
Track: Device Research
Demystification of IVD Clinical Trials
Ms. Delabruere will discuss many aspects as they apply
to IVD clinical trials including regulatory requirements of
812.2 (c), study design considerations and IRB
requirement for review of Non-Significant Devices.
Informed consent and use of leftover samples as well as
submission of data to the FDA, will also be discussed 215
Presenter: Narvelle Delabruere, MS. BS, CCRC, Senior Clinical
Program Manager, Hologic
SOCRA ANNUAL CONFERENCE BROCHURE
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