Non-Alcoholic Steatohepatitis (NASH) Liver Disease Drug Development Solutions

Address the urgent unmet need for NASH liver disease treatments with our unique combination of cross-functional expertise and programmatic experience.

  • 招募并保留智慧场所选择的关键患者

  • 依靠肝脏活组织检查,生物标志物,新型成像技术和长期结果研究的强烈经验

  • 通过纳什计划访问全面的医疗,科学和监管支持

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Your Needs

Meeting today’s unmet needs in NASH (Non-Alcoholic Steatohepatitis) treatment requires more than an ideal drug candidate to reach the market. Accelerating your NASH program demands specialized support that encompasses several key success factors:

  • 形成战略临床发展计划
  • Designing a customized protocol
  • Finding specialized sites to work with liver biopsy, imaging and biomarker needs

Let Covance help you execute a comprehensive strategy that addresses the unique challenges of NASH and meets your requirements—at every stage of development.

Don’t let site selection and patient recruitment challenges hamper your progress. We can keep your NASH drug development timeline on track through site-specific recruitment plans, drawing on our strong network of referral network, key opinion leaders and patient advocacy groups.

With our proprietaryXcellate.®信息学Platform, including the industry’s largest clinical knowledgebase and outreach across more than 600 global sites across 26 countries, we’ll help you find the right locations for your trial to reach your rapid study start-up goals and employ ongoing initiatives that proactively manage patient retention.

NASH holds many uncertainties in its diagnosis, evaluation, management and progression, but one thing is certain: a dedicated partner with relevant NASH experience can increase your chance of tackling this disease.

依靠我们2型糖尿病,肥胖和脂质的试验的全球历史,以及肝活组织检查,新的生物标志物,成像方法和结果试验的裁决以及在您的计划中提供有价值的见解。我们可以共同努力为您的纳什学习创造新的可能性,并为更加周到,高效的发展造成一条路径。

我们的能力

NASH represents a rapidly developing field with several potential therapeutic options in the pipeline and many more on the horizon, yet none have made it to market. At Covance, we recognized this opportunity to harness our regulatory, medical, scientific and operational expertise and transform results in the field.

我们的投资从积极参与纳什科学界,肝脏论坛和其他与糖尿病相关的专业协会开始了解赞助商的需求。我们已准备好满足您的近期纳什目标,作为持续承诺改变前景的一部分,并对赞助商和患者产生差异。

监管机构支持努力加快纳什这样解决未满足医疗需求的药物的发展。通过许多不同的方法来减少您的产品到营销批准的时间,依靠我们的专业知识来帮助您选择并融入最佳的策略。

We work with NASH experts to shepherd indications and advise submissions to meet global, regional and local approvals. Building off our foundation of strategic preclinical and clinical trial methodologies, we can fully support your approval process—and create the maximum value for your novel NASH product.

As a global CRO that supports novel development with hundreds of sponsors each year, we know how to advance compounds to the clinic and the market. NASH development relies on proven processes, along with additional strategies to:

  • Apply adaptive trial designs to improve study efficiency and advance your program
  • Incorporate specialized operational experience with novel imaging methods and coordinated interpretation of liver biopsies
  • 识别和管理基于风险的监测的风险
  • 满足快速研究初创次的时间表并保留患者
  • Support global testing and biomarker development
  • 利用高级信息学工具并采用电子数据收集表格

With our medical and regulatory team solely devoted to NASH, deep scientific experience and key operational solutions to overcome development hurdles, we’ll help you make an impact in this competitive landscape.

We know NASH and what it takes to get ahead. Now, get to know us to discuss how we can reveal new opportunities for your critical studies.

Meet Our Experts

如果您对其中一个纳什专家有问题,请单击下面的按钮。

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Claudia Filozof,MD,PHD
Executive Medical Director, CVMER (cardiovascular, metabolic, endocrine, renal) group

Dr. Claudia Filozof joined Covance in 2014 and is responsible of the medical oversight and consultant for NAFLD/NASH projects. She is board-certified in nutrition and metabolism and has broad expertise in diabetes, obesity and related metabolic disorders, including in non-alcoholic fatty liver disease and steatohepatitis (NAFLD/NASH). Her career spans almost 20 years in academia and 15 years of service in the pharmaceutical industry.

Fileozof博士领导了肥胖症,脂质,糖尿病的多个发展计划,并自2011年以来积极参与纳什。她是肝脏论坛的成员,AASLD * STEATOHPATITITITION和EAFD ** NAFLD集团,并发表了肥胖症的多个手稿,脂质,糖尿病和肿瘤。

* AASLD - 美国肝病研究协会

**EASD – European Association for the Study of Diabetes

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Peter Alfinito,PHD
高级总监,战略和规划,CVMER(心血管,代谢,内分泌,肾)组

Since joining Covance in 2015, Dr. Peter Alfinito has led clinical plan design, site identification and protocol feasibility to optimize study placement, minimize cost and maximize recruitment potential. Prior to Covance, he worked for IMS Health and several large pharmaceutical companies including Merck Research Laboratories, Bristol-Myers Squibb and Wyeth Pharmaceuticals, where he cultivated a broad background in drug development with leadership roles in clinical development, translational medicine and drug discovery groups.

通过他作为基础研究科学家和临床发展战略家的职业经验,Alfinito博士获得了有价值的科学和运营洞察力,以帮助建立数据驱动的策略,为研究提供高效,经济效益和优化的解决方案。

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Margery A. Connelly, PhD, MBA
Labcorp,NMR R&D战略董事

Joining LabCorp in 2013, Dr. Margery Connelly has over 20 years of experience in academia and the pharmaceutical industry. She has spent the last three years applying her scientific expertise toward the development and clinical validation of new NMR-based biomarkers for various disease indications, including cardiovascular disease, inflammation and metabolic disorders such as metabolic syndrome, diabetes, obesity, NAFLD, non-alcoholic steatohepatitis (NASH) and liver fibrosis.

她的深度经验包括在约翰逊和约翰逊的8/2岁期间的领导力,识别和验证2型糖尿病和心力衰竭目标,并管理小型和大分子方案的动脉粥样硬化,糖尿病和肥胖症的新疗法的所有阶段以及在Labcorp的四年内,监督R&D启动到IVD发布的NMR测定/产品管道。Connelly博士还教授药理学,病理和免疫学的医疗和研究生课程,作为Stony Brook大学的研究助理教授。

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Richard N. Williams, PhD, JD
Executive Strategist, Global Regulatory Affairs

Since joining Covance in 2013, Dr. Richard Williams has advised clients on global, regional or local regulatory strategy associated with preclinical or clinical study design and regulatory agency interactions. He has substantial experience in the cardiovascular and metabolic space, including NASH, T1DM and T2DM, and has more than 20 years of experience in strategic drug development.

In addition to leading and managing successful programs in multiple therapeutic areas, he has also interacted directly with regulatory agencies in the United States, Europe, Japan and India. He is an advocate for applying contemporary science to strategic drug development and is active member in several scientific societies such as the American Society for Clinical Pharmacology and Experimental Therapeutics, the American Society for Gene & Cell Therapy and the American Heart Association. Dr. Williams is especially interested in the integration of business with science, particularly with regard to the changing global landscape for product development.