There is a lot of nuance when it comes to medical imaging for early phase oncology trials. Although imaging biomarkers are often used to support go/no-go decision making in early phase trials, this is also a critical time to set the imaging strategy for later study phases. Many researchers find themselves questioning:
- What imaging biomarkers should we target?
- Are central reads necessary?
- Should we just collect & hold images?
- What clinical data should be collected?
- What types of support do we need?
We have you covered. During this interactive virtual event, experts in the field of medical imaging will answer all your questions, based on their broad experience in oncology clinical development, as well as current regulatory and industry trends.
WHEN
May 25, 2021
11AM-12PM EDT
Speakers
Peter Steiger, PhD
Chief Scientific Officer, Calyx
Peter has a wealth of experience in the use of imaging and other biomarkers for documenting the safety, efficacy, and effectiveness of new drugs in clinical trials. He leads Calyx’s Global Scientific and Medical Services team of over 75 scientists and is actively engaged in developing and implementing effective imaging strategies for global clinical development programs. He has authored numerous papers and is regularly involved in research presented at scientific meetings.
Rudresh Jarecha, MBBS, DMRE, DNB
Senior Medical Director, Head of Haemato-Oncology, Calyx
Rudresh’s expertise in managing the imaging components of more than 200 oncology and haemato-oncology clinical trials resulted in the submission and approval of more than 20 regional and global oncology indication treatments. Building strong teams in the USA and APAC, he manages the USA, China, and Japan markets’ unique drug development challenges. A board-certified Radiologist, Rudresh serves as Co-Chair of a CT Coordinating Committee and CT Volumetry Biomarker Committee in QIBA, RSNA.
Surabhi Bajpai, MD
Associate Director, Medical Imaging, Calyx
Leveraging her training in medicine and radiology, Surabhi has led the imaging components of approximately 50 oncology trials – both solid tumors and hematology malignancies – and provided consultation on complicated aspects of standardized response assessment criteria. Her expertise in Multiple Myeloma, Lymphoma, and CLL enables her to provide clear guidance to clinical trial sponsors and communicate complexities of criteria to independent reviewers to avoid heterogeneity.
Jayant Narang, MD, DNB
Medical Director Oncology, Calyx
Having served as an independent reviewer and as a veteran board-certified radiologist, Jayant has a wealth of experience in using imaging to document the safety, efficacy, and effectiveness of new drugs in clinical trials. He has supported hundreds of hematology and oncology trials, multiple with immuno-oncology and CAR-T therapy, and frequently engages with KOLs to seek clarifications on response assessment criteria. He has presented abstracts with Dr. Bruce Cheson as co-author in the CLL space.
Oliver Bohnsack, MD PhD MBA
Vice President, Medical Imaging and Head of Oncology, Calyx
In leading the imaging component of oncology studies for Calyx’s global customers, Oliver leverages his experience from supporting over 600 clinical trials – with various indications, complexities, and in all phases of development – which led to the approval of over 20 oncology treatments. He is co-author of the immune-related response criteria (irRC, 2009), first author of irRECIST (2014), and co-author of Comparison of Assessments using RECIST and irRECIST by Eggleton P. et al. (2020).
