作为神经放射学、肌肉骨骼放射学和介入放射学方面的一位知名专家，Stephen 为凯理斯带来了逾 30 年的广泛经验。其专业知识来源于在备受赞誉的医疗保健中心担任经委员会认证的放射科诊断医生、在顶尖学术机构担任高级教员，以及在众多全球制药公司担任值得信赖的科学顾问。
Peter 在利用影像和其他生物标志物记录临床试验新药的安全性、疗效和有效性方面拥有丰富的经验。他带领由逾 75 名科学家组成的凯理斯全球科学和医疗服务团队，并积极参与开发和实施适用于全球临床开发项目的高效影像策略。他著作了多篇论文，并定期参加科学会议上提出的研究。
在引导凯理斯全球客户的肿瘤学研究的影像工作方面，Oliver 利用其在支持逾 600 项临床试验后获得的经验，其中这些试验涵盖各种不同的适应症、复杂情况并处于开发的各个阶段，他的经验致使逾 20 ...<i>了解更多信息</i>
在引导凯理斯全球客户的肿瘤学研究的影像工作方面，Oliver 利用其在支持逾 600 项临床试验后获得的经验，其中这些试验涵盖各种不同的适应症、复杂情况并处于开发的各个阶段，他的经验致使逾 20 种肿瘤治疗获得批准。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 Manitz J. et al. 的共同作者。
Surabhi 利用她在医学和放射学方面的培训，引导大约 50 项肿瘤学试验（包括实体瘤和血液学恶性肿瘤）的影像工作，并在规范化疗效评估标准的复杂方面提供咨询。她在多发性骨髓瘤、淋巴瘤和慢性淋巴细胞性白血病 (CLL) 方面的专业知识让她能够为临床试验申办方提供明确的指导，并告知独立审核人关于标准的复杂性，以免产生异质性。
Having held senior medical roles at global biopharmaceutical companies and CROs and having worked as...<i>了解更多信息</i>
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.
As the Head of Calyx Musculoskeletal Imaging, Dr. Warner applies her 25+ years of medical imaging re...<i>了解更多信息</i>
As the Head of Calyx Musculoskeletal Imaging, Dr. Warner applies her 25+ years of medical imaging research experience and the expertise she’s gleaned from supporting over 200 imaging trials to help pharmaceutical companies and CROs succeed. She holds certifications by the International Society for Clinical Densitometry (ISCD) as a Clinical Densitometrist and a DXA technologist as well as a Radiology Practicing Technologist License in the state of Utah. Dr Warner’s musculoskeletal research has included the use of many different modalities for the assessment of bone metabolism including bone histomorphometry, 3-point bending, radiography, ultrasound, DXA, QCT, and high-resolution CT imaging.
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.
Farhan applies his extensive training and knowledge in bone loss mechanisms and imaging ‒ both in ...<i>了解更多信息</i>
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.
In his present role as Neurology Therapeutic Lead, Dr. Rohit Sood has contributed as a scientific le...<i>了解更多信息</i>
In his present role as Neurology Therapeutic Lead, Dr. Rohit Sood has contributed as a scientific lead on over 160 imaging clinical trials spanning the entire spectrum, from early to late phase, across multiple therapeutic areas including more than 40 in neurological indications. He has contributed to the science on several Neuro-oncology, Neurodegenerative, Neuropsychiatry and Rare disease clinical trials and has collaborated with our study sponsors to develop criteria for evaluating the eligibility, efficacy, and safety aspects of their studies. As a senior member of several scientific organizations and societies, Dr. Sood is actively engaged in furthering the science in the clinical trial space.
As a Senior Scientist at Calyx, Alice Motovylyak leverages her extensive knowledge in CNS disorders, including Alzheimer’s disease and spinal cord injury, as she designs and implements workflows for clinical trials involving imaging-based endpoints in these areas. To this end, she is involved in all study-related aspects including image acquisition, review design, development of independent reviewer charters, analysis application development, and independent reviewer training. Prior to joining Calyx, Alice was a post-doctoral researcher at the Alzheimer’s Disease Research Center (ADRC) at the University of Wisconsin where she focused on imaging biomarkers of aging and understanding how aging and risk factors of Alzheimer’s disease influence brain structure using diffusion weighted imaging.
Kim has held roles of increasing responsibility in Medical Writing since joining Calyx in 2019. 2009...<i>了解更多信息</i>
Kim has held roles of increasing responsibility in Medical Writing since joining Calyx in 2019. Currently the director of a global medical writing team, she standardizes processes to enhance the productivity, quality and timeliness of Calyx’s medical writing services while actively contributing to documentation requirements describing central review assessments in clinical trials involving imaging-based endpoints. Throughout her career, Kim has been motivated by opportunities to create and add value to the teams she has worked on, drawing on her experience and lessons learned from regulatory feedback to improve the quality and rigor of medical writing deliverables.
Since joining the Medical Imaging team in 2003, Nicholas has held extensive, diverse roles and escal...<i>了解更多信息</i>
Since joining the Medical Imaging team in 2003, Nicholas has held extensive, diverse roles and escalating responsibilities within Calyx’s Imaging Operations, Project Management, Medical Imaging Leadership, and Medical Writing, teams. He has a wealth of scientific, regulatory, and operational experience related to the use of medical imaging within the clinical trials setting, having supported over 600 trials, and being published several times during his tenure. His scientific and medical writing experience spans all major therapeutic areas.
Since joining Calyx in 2009, Katarina has had multiple, escalating roles in the department of medica...<i>了解更多信息</i>
Since joining Calyx in 2009, Katarina has had multiple, escalating roles in the department of medical writing. She leverages her extensive medical writing experience to create comprehensive and reliable Independent Review Charters, including those intended for regulatory submission. Her expertise spans multiple indications across a wide array of therapeutic areas, including oncology, CNS, and musculoskeletal disease states, with a strong emphasis in haemato-oncology. A dedicated medical writing professional, Katarina is frequently featured at industry conferences and has published numerous times in peer-reviewed journals.
As a Senior Medical Writer with Calyx since 2020, Paivi is responsible for creating independent revi...<i>了解更多信息</i>
As a Senior Medical Writer with Calyx since 2020, Paivi is responsible for creating independent review charters and other clinical documents intended for submission to regulatory authorities on behalf of Calyx’s clients. She leverages her extensive experience to provide subject matter expertise to sponsor teams conducting imaging clinical trials across various therapeutic areas such as neurology, oncology, ophthalmology, and cardiology. Paivi has authored more than 15 peer reviewed publications in such prestigious journals as the Journal of Neuroscience, the Journal of Neurophysiology, and Frontiers in Molecular Neuroscience.
A Medical Writer with Calyx since 2018, Hema Veesam leads Calyx’s internal and external project te...<i>了解更多信息</i>
A Medical Writer with Calyx since 2018, Hema Veesam leads Calyx’s internal and external project teams throughout the development of frameworks, modules, templates, and general guidelines that dictate the successful use of medical imaging in clinical development. She has authored several documents to support clinical trial imaging, including Independent Review Charters (IRCs), reviewer manuals, and imaging case report forms (CRFs), and often assists other medical writers with quality control check such as copy editing, content editing.
As a Medical Writer at Calyx, Sally Han develops Independent Review Charters (IRCs), clinical data f...<i>了解更多信息</i>
As a Medical Writer at Calyx, Sally Han develops Independent Review Charters (IRCs), clinical data forms, results reports, and other protocol-specific documents in support of independent review. Leveraging her training in pharmacy and English‑Chinese interpreting, she has provided support on Chinese and global clinical trials. Prior to joining Calyx, Sally was a Medical Copywriter at a private hospital in Shanghai, where she created and translated physician-related policies, SOPs, medical record templates and other documents.