EXPERIENCE YOU CAN TRUST

Scientific Consulting

Put Calyx's experience to work for you.

Your compound deserves every chance to succeed. But when your endpoints require medical imaging, risks are increased. Does your team have the experience needed to meet the scrutiny of regulatory review?

Rely on Calyx Scientific Consulting to drive the success of your development program. With experience from 2,600+ imaging studies and having supported over 250 new drug approvals – including half of the recently approved oncology treatments designated as Breakthrough Therapies – Calyx can help you design and implement an imaging strategy that gets your compound across the finish line. Faster.

MEET OUR EXPERTS

Meet the Experts

Extend the deep and diverse experience of Calyx’s highly tenured scientific experts to your own clinical development team.

Contact us today for a complimentary 1-hour consulting session with our experts.

SCHEDULE TODAY
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Chief Medical Officer

Stephen M. Bravo, MD

An acknowledged expert in Neuroradiology, Musculoskeletal Radiology, and Interventional Radiology, Stephen brings more than 30 years of broad experience to Calyx. His expertise stems from having served as a board-certified diagnostic radiologist at highly acclaimed healthcare centers, as a senior faculty member at leading academic institutions, and as a trusted scientific advisor to numerous global pharmaceutical companies.

 

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Chief Scientific Officer

Peter Steiger, PhD

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.

 

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Vice President, Medical Imaging & Head of Oncology

Oliver Bohnsack, MD PhD MBA

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).

 

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Associate Director, Medical Imaging

Surabhi Bajpai, MD

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.

 

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Medical Director Oncology

Jayant Narang, DNB

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 engage with KOLs to seek clarifications on response assessment criteria. He has presented abstracts with Dr. Bruce Cheson as co-author in the CLL space.

 

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Vice President, Medical Imaging

Manish Sharma, MD DMRE

Having held senior medical roles at global biopharmaceutical companies and CROs and having worked as an investigator, Manish has a wealth of experience in understanding and executing clinical trials from each stakeholder’s perspective. Manish is a well-established medical and scientific SME for imaging in clinical trial design and execution and has been instrumental in the incorporation of innovative study designs including but not limited to biomarkers including imaging. Manish also has the additional responsibility of leading the Calyx Data Science team focusing on variability analysis, data-driven quality monitoring, and predictive analytics.

 

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Director, Scientific & Medical Services

Farhan Syed, PhD

Farhan applies his extensive training and knowledge in bone loss mechanisms and imaging ‒ both in pre-clinical and clinical settings ‒ to leading and overseeing varied clinical trials involving the musculoskeletal system. He also serves as a subject matter expert in this area, contributing and facilitating protocol reviews as well as imaging-focused discussions with clients as well as consultation and networking with Key Opinion Leaders in the field.

 

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Medical Director, Scientific & Medical Services

Elif Sikoglu, PhD

Elif provides scientific oversight of clinical trials employing advanced MRI modalities. She has lead the development of complex image acquisition guidelines and has been instrumental in developing imaging assessment criteria and analysis methods across indications including neuro-oncology, neuro-degenerative diseases, and neuro-psychiatry. She has worked extensively with diverse key-opinion-leaders to bring novel image acquisition and analysis methods into clinical trials. She has authored many peer-reviewed papers and presented at scientific meetings.

 

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Director, Scientific & Medical Services

Manuela Lesch, RT

Manuela is responsible for providing scientific advice on implementing medical imaging into clinical trials, conducting investigator, internal staff, and independent reviewer trainings, supporting the development of independent review charters, providing guidance to R&D and application development in the customization of image analysis software tools, and monitoring independent reviewer performance. Manuela has significant experience in leading and managing the imaging component of multiple neurology and oncology clinical trials, with expertise in applying neuro-oncology image assessment criteria such as RANO, iRANO, LANO, REiNS and volumetric analysis.

 

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Contact us today for a complimentary 1-hour consulting session with our experts.

SCHEDULE TODAY

Optimize your imaging ROI.

Whether you’re in early phase development looking to partner or planning to take your compound through to regulatory approval, Calyx Scientific Consulting offers valuable services to optimize your medical imaging investment. The benefits of working with Calyx Scientific Consulting include:

Enabling the success of early phase clinical trials and laying a foundation for later phase strategies

Use our time-tested design methodology to build assurance and confidence among your investors.
- Select the optimal imaging biomarker arrangement to best demonstrate safety and efficacy at each trial phase
- Choose the ideal image acquisition strategy to best support your biomarker requirements
- Find, vet, and select the right vendors based on your unique requirements
- Learn from our team of scientific advisors what to look for as you select the ideal investigators and sites
- Gain better data to make the critical decision whether to advance to the next phase of your clinical trial
- Enable better target patient populations with a better trial design
- Accelerate your success: Improve your chances of achieving Breakthrough Therapy designation and help alleviate the suffering of more people, faster

Identifying risk and efficacy signals at the earliest possible moment

Tune the data science to improve outcomes and reduce the risk of delaying failure.
- Calculate optimal trial size and duration with greater accuracy using better biomarker performance assumptions
- Properly monitor the performance of the imaging biomarker to help ensure the study is generating the expected results
- Avoid costly mistakes by consulting with our imaging biomarker experts when designing your study protocols

Streamlining Regulatory Approvals

Don’t get blindsided by unanticipated regulatory requirements, timelines, and scrutiny.
- Reduce delays by anticipating challenges surrounding regulatory filings, inspections, and agency meetings
- Ensure you have the evidence to support the decisions you make in order to support regulatory filings, inspections, and agency meetings.
- Make sure you have the data needed for regulatory submission by defining the right strategy around blinded central and investigator review