Early Phase Development Solutions

Accelerate your molecule’s success with a programmatic approach to drug development that advances your molecule swiftly through critical milestones while maximizing the value of your asset. Shave off as much as 30% on your early drug development timeline.

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Partnership. Continuity. Value.

  • Shave off as much as 30% on your early drug development timeline – from lead candidate to Proof of Concept – with a prospective strategy and plan.

  • Leverage a world-class drug development team that has led hundreds of small and large molecules in a plethora of therapeutic areas.

  • 与一个专注的团队合作,由药物开发专家领导,汇集了科学洞察力,监管指导和方案管理,以实现分子的顺利发展。

  • 您的需求

    Start with the end in mind to make smarter decisions—at every stage.

    在药物开发过程中具有如此多的关键决策点,对早期药物开发效率的洞察力增加可以帮助您揭示潜在的风险和机会,并回答沿途所产生的众多问题:

    • 如何加快我的计划,更容易回复投资者和利益相关者要求?
    • How do I identify challenges early allowing me to make adjustments without losing time or money?
    • How do I demonstrate that my compound will be commercially attractive to licensors or partners?
    • Is this the best regulatory strategy to mitigate risk?
    • How do I align my nonclinical plan with my clinical endpoints and expedite my path into first-in-human?

    从一开始,您将潜在上市获得正确的计划策略。通过灵活的解决方案和持续支持来克服不确定性,您将达到您的关键决策点,更快。

    Your Journey is prospectively mapped out to optimize time and maximize value:

    Drug development journey timeline

    科学和运营连续性 - 从一开始。

    连续性对您的分子发育的成功至关重要。早期阶段开发解决方案为您提供直接访问聚焦的非临床,临床和监管专家团队,这将在整个方案中留在您身边。结果是一个统一的方法和一致的数据包,使您设置成功。

    Flexible solutions to match your unique needs.

    Early Phase Development Solutions also brings a flexible, tailored approach to contracting, with options such as study-by-study or targeted milestones invoicing, all with guaranteed deliverables to meet your unique financial needs. It’s just another way you can maximize your asset’s value—and your bottom line.

  • Our Capabilities

    你走了多远,取决于你

    Whether you plan to complete an IND/CTA-enabling program or you need to gain the clinical insight that a first-in-human (FIH) or proof-of-concept (PoC) study can provide, you can enjoy the journey with a dedicated team and a singular, cohesive strategy that transitions seamlessly between nonclinical and clinical development.

    Which candidate is best?

    获得集成的解决方案,以便快速识别和发展您最好的领导候选人。从早期表征和开发批次制定,对于早期鉴定药理的非GLP筛查,或与毒性相关的问题 - 放心,您将向前移动您的最佳候选人。

    IND / CTA-支持非临床评估

    Take advantage of the vast knowledge of an expert team who manages drug development programs to support hundreds of regulatory submissions each year. With Early Phase Development Solutions, you seamlessly integrate the complete array of nonclinical services, including lead optimization, safety pharmacology, toxicology, pathology, bioanalytical, drug metabolism and pharmacokinetics, to assure successful design and conduct of your program—all the way through IND/CTA submission and into first in human clinical studies.

    首先(FIH)的研究

    With Early Phase Development Solutions, you benefit from the retained knowledge from nonclinical study results to move your compound across drug development phases more effectively. The focus will be on two critical aspects of your FIH studies: scientific integrity and human subject safety. As early research continues to demand more complex studies requiring special populations, multiple endpoints and adaptive protocol designs, you’ll gain the advantage through 35+ years of insights and industry-leading human AME expertise.

    Proof of Concept (PoC)

    Waiting until you have a complete data package before designing your Proof of Concept (PoC) study can waste valuable time. Instead, you’ll enjoy innovative approaches to these shorter, scientifically demanding studies by parallel processing study feasibility and site assessments, incorporating relevant biomarkers and leveraging adaptive trial designs. Increase your clinical ROI by applying the right level of medical, scientific and therapeutic expertise resources and patient stratification strategies to your program.

    程序方法 - 为什么它很重要

    如何在您的计划上刮起高达30%的人?这是为了简化您的旅程,取出空白,并重新思考风险管理。阅读更多“估计时间对药物发展计划,资产价值和金融公司绩效的影响” whitepaper. What’s more, we can sit down and do an economic valuator session – to estimate the likely time savings for your specific program.

  • 相关资源

观看Peter Sausen,PHD解释了节目的早期发展方法如何促使您的时间表高达30%,以最大限度地发挥您的资产价值。

然后,加入超过225甲型肝炎病毒的生物技术企业e experienced the real-world benefits of a programmatic approach over the course of the last three years.

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