值得信赖的经验

科学咨询

值得信赖的经验

科学咨询

让凯理斯的经验为您提供服务

您的化合物应享有每一次成功机会。但当您的端点需要进行医学影像时,风险就会增加。您的团队是否具备满足监管审查要求所需的经验?

依靠凯理斯科学咨询来推动您研发计划的成功。凯理斯拥有2600多项影像研究的经验,并为250多个新药审批提供支持-超过半数最近被批准为突破性疗法-凯理斯可以帮助您设计和实施一个影像策略,使您的项目更快获得成功。

与我们的专家讨论

与我们的专家讨论

将凯理斯资深科学专家的深厚和多样的经验带到您的临床开发团队。

立即联系我们,与我们的专家进行1小时的免费咨询。

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CALYX-20-Headshots-StephenBravo-FINAL

首席医疗官

Stephen M. Bravo,医学博士

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。

 

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CALYX-20-Headshots-PeterSteiger-FINAL

首席科学官

Peter Steiger,博士

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。

 

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CALYX-20-Headshots-Oliver-FINAL

Vice President, Medical Imaging & Head of Oncology

Oliver Bohnsack,医学博士、博士、工商管理硕士

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。他是《免疫相关疗效标准》(irRC,2009 年)的共同作者、《免疫相关实体瘤疗效评价标准》(irRECIST,2014 年)的第一作者、Eggleton P. 等人《对根据实体瘤疗效评价标准 (RECIST) 与 irRECIST 进行的评价的比较》(2020 年)的共同作者。

 

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CALYX-20-Headshots-Surabhi-FINAL

Associate Director, Medical Imaging

Surabhi Bajpai,医学博士

利用在医学和放射学方面接受过的培训,Surabhi 主导了约 50 项肿瘤学试验(包括实体瘤和血液学恶性肿瘤)的影像部分,并就标准化疗效评估标准的复杂方面提供了咨询。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。

 

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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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CALYX-20-Headshots-SallyWarner-FINAL

Vice President, Scientific and Medical Services

Sally (Sarah) Warner, PhD, CCD

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.

 

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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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CALYX-20-Headshots-FarhanSyed-FINAL

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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立即联系我们,与我们的专家进行1小时的免费咨询。

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优化您的影像 ROI

无论您是处于寻找合作伙伴的早期开发阶段还是计划让您的化合物获得监管批准,凯理斯科学咨询都能提供有价值的服务来优化您的医学影像投资。与凯理斯科学咨询合作的益处包括:

使早期临床试验取得成功,并为后期策略奠定基础

采用我们历经考验的设计方法,在您的投资者中建立信任和信心。
- 选择最佳的影像生物标志物排列,以最大程度地证明各试验阶段的安全性和疗效
- 选择理想的影像采集策略,以最大程度地支持您的生物标志物要求
- 根据您的独特要求,发现、审查并选择合适的供应商
- 我们的科学顾问团队会告诉您,在选择理想的研究者和研究中心时需要关注哪些方面
- 获得更好的数据,以作出是否进入临床试验下一阶段的关键决策
- 通过更好的试验设计拥有更好的目标患者人群
- 加速您的成功:提高获得突破性疗法认定的几率,并帮助更快地缓解更多人的痛苦

尽早识别风险和疗效信号

协调数据科学以改善结局并减少延迟失败的风险。
- 根据更好的生物标志物表现假设,以更高的准确度计算最佳试验规模和持续时间
- 适当监控影像生物标志物的表现,以帮助确保研究生成预期结果
- 设计研究方案时,通过咨询我们的影像生物标志物专家来避免发生代价高昂的错误

简化监管批准

不要因非预期的监管要求、时间表和审查而措手不及。
- 通过预测监管备案、检查和机构会议方面的挑战来减少延迟
- 确保拥有支持所作决策的证据,以支持监管备案、检查和机构会议
- 通过围绕盲态中心和研究者审查明确适当的策略来确保拥有监管提交所需的数据

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