Validating Your Imaging Data to Secure Funding
This is an interactive Q/A style session discussing how early phase centralized image storage can help you secure funding. As background, image repository services are the prospective collection and quality control of imaging data for a clinical study, that is – getting your study images to a “ready-to-read” state.
- Data from early phase trials is vital for generating publications, defining larger clinical programs, and securing funding
- Prospective collection of imaging data from early phase trials allows for central review to validate locally observed response data
- This approach may significantly reduce the cost of full central image review
- A key benefit is the sponsor’s ability to demonstrate the study/treatment effect has been independently validated
3 key questions
that are answered:
- What are the fundamentals of Lugano Classification?
- What data collection elements are needed when reading Lugano classification?
- What are the challenges and updated recommendations from industry/academia in Lymphoma reading assessments?
Gene Kim, PharmDASSOCIATE DIRECTOR OF MEDICAL AFFAIRS & INNOVATION, ONCOLOGY
Gene is MERIT’s Associate Director of Medical Affairs & Innovation for our oncology division. He provides subject matter expertise and helps design and configure MERIT’s flexible oncology reading platform to accommodate various reading paradigms. Gene has experience in evidence-based patient care and academic research, a background in pharmacy, and 6 years supporting clinical trials. He implements software workflows to support oncology trials with response criteria such as RECIST 1.1, iRECIST, Lugano, and RANO, and helps to increase the efficiency and accuracy of clinical data collection for imaging endpoints. Gene received his Doctor of Pharmacy (Pharm.D.) from the University of Wisconsin-Madison and has a bachelor’s degree in Neurobiology.
Jim GolandoClinical Operations and Imaging Clinical Trial Expert
Jim Golando has 30+ years of experience in the pharmaceutical and biotech industries. His expertise ranges from Phase I through late-stage development and lifecycle management, with particular strengths in imaging clinical trials, clinical research, clinical operations, procurement/outsourcing, project/team leadership, and project management. He has overseen the operational and developmental planning and execution of global clinical trials in imaging, oncology, respiratory, endocrine, anti-infectives, and cardiology. Jim held senior leadership positions as Chief of Operations at Ora, Inc. and Median Technologies. He was previously VP of Medical Affairs at BioClinica, and held clinical operation positions at Schering-Plough, Novartis, and Hoffman-La Roche. Jim founded Golando Advisory Group and has been consulting since 2012.
Catherine Chintala, PMPPROJECT MANAGER, ONCOLOGY
Catherine Chintala works at MERIT as a Project Manager in our oncology division. With 20 years of experience working in clinical trials and the CRO industry, she has expertise managing oncology clinical trials from start up to close out. Catherine works closely with sponsors, designing and implementing processes to meet project timelines and helping to ensure study needs are clearly communicated across key stakeholders. Drawing upon her experience in a variety of indications and response criteria, Catherine can partner with your team to help make your clinical trial a success.