Organizational Structure and Terminology
What does the OBM stand for?
Oncology Biometrics
What is the primary goal of the Clinical Development department in pharmaceutical companies?
To design and conduct clinical trials to ensure the safety and efficacy of new drugs
What Essential Aspects does Site Quality Risk Assessment (SQRA) evaluate to enhance clinical trial success and what is the goal of Centralized Statistical Monitoring (CSM)?
SQRA – the historical reported issues and risk levels associated with a trial site, CSM – to identify non-random data errors and potential risk issues with data integrity such as fraud.
What is the primary goal of Precision Medicine in Oncology?
To match the right treatment to the right patient by using biomarkers and diagnostics to guide therapy decisions.
Do patients without BRCA gene mutations also respond to treatment with PARP inhibitors such Olaparib/Lynparza?
Yes, there are other genes which when mutated cause synthetic lethality with PARP inhibitors.
Name at least 2 Oncology Biometrics Functions present in Warsaw
Learning & Development, Information Practice, Statistics, Programming, GMA Payer
Which of the following is not a role within the Clinical Development department:
Global Clinical Head, Global Clinical Program Lead, Global Safety Program Lead, Global Development Medical Director?
Global Safety Program Lead
Name at least 2 programming languages we use in Oncology Biometrics?
SAS, R, Python
How many CDx regulatory approvals has AstraZeneca received so far?
(you can be wrong by +/- 10)
66
Is it possible to examine broadly a proteome (all proteins) of a tumor form just one 5-10nM (micrometer) section of an FFPE block and 1-2um (microliter) of plasma?
Yes (with advancements in proteomics techniques like deep profiling and the use of enrichment methods)
What does GMA stand for?
Global Medical Affairs
What is a critical factor evaluated during Phase III clinical trial?
The effectiveness of the drug compared to existing treatments or placebos
In which phase of (pre)clinical testing of a new drug is translational medicine needed?
In every phase, from the creation of the molecule to its introduction as a new drug
Which biomarker is more effective for continuous monitoring of cancer progression over time: circulating tumor DNA (ctDNA) or tissue biopsy?
Circulating tumor DNA (ctDNA) is more effective, as it provides non-invasive, real-time genetic profiling through blood samples, allowing for dynamic tracking of tumor evolution and treatment response.
How stable is circulating tumor DNA in blood circulation?
Not very stable, with half-life from minutes up to 2.5 hours
Expand the acronym PTAP to its full name
Post Trail Access Program
Which phase of clinical trails primarily focuses on assessing the safety and tolerability of a new drug?
Phase I
What are the key benefits of Evinova’s decentralized clinical platform (Unify) for patients, sites and sponsors/CROs?
Several key benefits:
Enabling remote data capture, reducing patient burden, integrating functionalities such as biosample tracking, telehealth, compliance, and remote patient monitoring, and providing seamless experience for patients and sites. This platform helps to simplify and streamline operations for sponsors/CROs and sites, ultimately improving patient-specific care and reducing the burden on people and health systems.
Is it already possible to diagnose brain tumors based on the presence of ctDNA in the blood?
No, it’s not possible – the presence of brain cancer can be confirmed by ctDNA, but the absence of ctDNA does not mean the tumor is not there.
What is ESR in OBU about?
Externally Sponsored Research