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Oliver Bohnsack, MD, PhD, MBA

Vice President, Head of Oncology, Scientific and Medical Services, Calyx, Medical Imaging

Bio

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).

Role at Calyx

- Head of Oncology

- Scientific and Medical Services at Calyx Medical Imaging

Industry Experience

- Global Head of Oncology, Calyx, January 2021 – Present
- Vice President Scientific and Medical Affairs, Parexel Informatics, 2018-2021
- Senior Director Medical Affairs, PAREXEL Informatics, 2009 – 2018
- Medical Director, Perceptive Informatics, 2006 – 2009
- Associate Medical Director, Perceptive Informatics, 2004 – 2006
- Director, Strategic Development, Perceptive Informatics, 2003 – 2004

Academic Experience

-M.D. Medical University, Essen Germany

- MBA in Health Care Management, University of California, Irvine U.S.A.

- Ph.D. in Radiology in Computer Tomography Radiation Modulation and Reduction, University Munich Germany

Therapeutic Experience

- Strong experience in Oncology by medically and scientifically designing, leading and managing the imaging component of clinical trials, developing numerous protocols and imaging charters with various indications and various complexities, in phase I, II and III, with and without regulatory submission.
- Scientific advisor, consultant and Steering Committee member.
- Co-author of the irRC criteria (Wolchok), author of irRECIST
- All Oncology indications that require central imaging (Phase I - III)

Publications

- Bohnsack O, Narang J, Bajpai S, Lesch M, Jarecha R, Sharma M, Lencioni R, Response assessments in hepatocellular carcinoma - What is the best criteria to utilize? mRECIST or RECIST 1.1? - A retrospective meta-analysis of multiple phase III trials; ePoster #168 at ESMO Asia 2020

- Narang J, Bajpai S, Jarecha R, Sharma M, Bohnsack O, Comparison of response using mRECIST versus RECIST 1.1 Criteria in advanced hepatocellular carcinoma – A retrospective analysis of multi-center clinical trials; ePoster at ASCO 2020

- Narang J, Bajpai S, Jarecha R, Sharma M, Bohnsack O, Identification of new lesions with disease progression in Ovarian cancer per RECIST 1.1; ePoster at ASCO 2020

- Manitz J, Eggleton P, Bajars M, Bohnsack O, Gulley J Association between response assessments using RECIST and irRECIST in 1,765 patients with advanced solid tumors treated with avelumab monotherapy; Poster No. P351. Presented at the SITC 2019 Congress, November 6-10, 2019; National Harbor, Maryland, USA.

- Sharma M, O'Connor M, Bohnsack O, et al. Impact and influence of PET on imaging related endpoints in patients with Lymphoma using IWG-NHL or Lugano classification, ASCO 2019, e19061 Poster

- Sharma M, O'Connor M, Bohnsack O, et al. Reader Disagreement Index, a better indicator for monitoring reviewer discordance and underlying variability, CSCO 2019 Poster

- Sharma M, Bohnsack O et. al., Metastatic new disease in ovarian cancer: organ location and impact, Poster at European Congress in Radiology Feb. 2019, 10.26044/ecr2019/C-2951

- Devashanam A, Bohnsack O, Fotinos-Hoyer K, Bennet D, McMahon M, Enus N, Assessing prostate cancer on imaging in clinical trials, A Summary of Recommendations from PAREXEL Informatics, Patient Technology Solutions, Medical Imaging, White Paper, PAREXEL 2018

- Sharma M, Bohnsack O, Singareddy A, Implementation of RECIST 1.1 in Lung Cancer, White Paper, PAREXEL, May 2018

- Miller D, Bohnsack O, Jacobs R, The Past, Present & Future of Cancer Immunotherapy: An Overview, White Paper, PAREXEL 2015

- Luby K, Bohnsack O, Ferreira A, Schmid A, Vilardi J, Assessing Prostate Cancer on Imaging in Clinica l Trials, A Summary of Recommendations from PAREXEL Medical Imaging, White Paper, PAREXEL 2015

- Storim L., Bohnsack O., Lesch M., Higher Data Reliability of Blinded Independent Central Review compared to Local Evaluation, poster ECR 2015, 10.1594/ecr2015/C-0225

- Bohnsack O., Ludajic K, Hoos A Adaptation and modification of the immune related response criteria irRC: irRECIST, poster ESMO 2014, Ann Oncol (2014) 25 (suppl 4): iv369

- Bohnsack O., Lesch M., Urbank A., Blinded, independent, central image review in oncology trials: How the study endpoint impacts the adjudication rate, poster ESR 2014, 1705

- Bohnsack O, Schmid MS, Chen L, Chandler B, Pitfalls with the independent audit method of PFS endpoint trials with central imaging, ECCO poster 1176, 2013

- Bohnsack O, Schmid MS, Chen L, Chandler B, Challenges in the ODAC proposed Central Image Review Audit methodology, ASCO Abstract 117705, 2013

- Bohnsack O, Shared Vision, Imaging – the definitive biomarker in oncology drug development; EPC Journal, Sep. 2013

- Urbank A., Bohnsack O., Blinded, independent, central image review in oncology trials: Will the study endpoint impact the adjudication rate or will the adjudication rate impact the study endpoint?, poster EACR-22 2012, program and abstract book number: 765

- Gebauer B, Bohnsack O, Riess H, Radiological Evaluation of Tumor Response in Oncological Studies (Tumor Response Evaluation), Fortschr Röntgenstr 2011; 183: 695–703

- Bohnsack O, Schmid A, RECIST in the Real World of Cancer Research, Applied Clinical Trials, May 2010 ASCO Special Edition

- Bohnsack O, Core Strength, Int. Clin. Trials Feb. 2010

- Kemsley K, Ghiorghiu D, Bohnsack O, et.al., Use of Progression Free Survival in advanced melanoma: Comparison of central and site review of RECIST data in a randomised phase II trial, Poster ASCO 2009

- Wolchok JD, Hoos A, Bohnsack O, et.al., Guidelines for the Evaluation of Immune Therapy Activity in Solid Tumors: Immune-Related Response Criteria, Clin Cancer Res 2009;15(23) December 1, 2009

- Chica S, Bohnsack O, Schmid A, Recommendations For Consistent Application of RECIST 1.1 To Specific Trial Indications, White Paper, PAREXEL 2009

- Lesch M, Bohnsack O, Expect the Unexpected, Unexpected Benefits From Centralized Imaging Reviews, Int. Clin. Trials 2008

- Bohnsack O, Seeing is Believing, Good Clinical Practice Journal, Jan. 2006

Presentations

Dr. Bohnsack regularly presents at international conferences and publishes on Imaging in Clinical Trials, especially regarding the use of standardized review criteria and imaging based endpoints with a more recent focus on immune-oncology.

Associations and Affiliations

ASCO, ESMO

Library

Utilizing Medical Imaging to Support Accelerated Approval

Earning the FDA’s prized Breakthrough Therapy designation is just the beginning of the race, one that likely requires the use of an imaging surrogate for preclinical evidence and accelerated approval.
Read more

Impact of PET on imaging related endpoints in lymphoma trials

We know that PET imaging is critical in determining response assessments in hematology trials but what do you do when PET scans are not always available? See what our experts have to say.
Read more

Behind the Breakthrough

Earning the FDA’s prized Breakthrough Therapy designation is just the beginning of the race, one that likely requires the use of an imaging surrogate for preclinical evidence and accelerated approval.
Read more

Reviewer Performance Monitoring in Blinded Independent Central Review Setting

This white paper reviews how the assessment of imaging data in support of surrogate endpoints by an independent entity reduces evaluation bias and improves assessment consistency in clinical trials.
Read more

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