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.

  • 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.

  • Work with one focused team, led by a drug development expert, that brings together scientific insight, regulatory guidance and program management for a smooth development of your molecule.

Step into the virtual world and experience Early Phase Development Solutions. It may be the most valuable 3 minutes you spend today.

Your Needs

With so many critical decision points in the drug development process, increased insights into early drug development efficiencies can help you uncover potential risks and opportunities, and answer the multitude of questions arising along the way:

  • How can I expedite my program to respond more readily to investor and stakeholder requirements?
  • 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?

From the beginning, you’ll prospectively get the right strategy for your unique program. With flexible solutions and continuous support to overcome uncertainties, you’ll reach your critical decision points, faster.

药物开发旅程时间表

Continuity is vital to the success of your molecule development. Early Phase Development Solutions provides you with direct access to a focused team of nonclinical, clinical and regulatory experts that will remain with you throughout your program. The result is a unified approach and consistent data package that sets you up for success.

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.

我们的能力

您是否计划完成IND / CTA启用计划,或者您需要获得临床洞察,即首次(FIH)或概念验证(POC)学习可以提供,您可以享受享受的旅程专用团队和单数,凝聚力战略,无缝过渡非临床和临床发展。

让集成解决方案迅速识别和develop your best lead candidate. From early characterization and formulation on development batches, to non-GLP screening for early identification of pharmacology, or toxicity-related issues—rest assured, you’ll move your best candidates forward.

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.

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.

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.

How is it possible to shave up to 30% on your program? It's about streamlining your journey, taking out whitespaces, and rethinking risk-management. Read more in the “Estimate the Impact of Time Savings on Your Drug Development Program, Asset Value and Financial Company Performance“白皮书。更重要的是,我们可以坐下来做一个经济估值员会议 - 估计特定计划的可能节省时间。

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。

Then, join more than 225 biotech ventures that have experienced the real-world benefits of a programmatic approach over the course of the last three years.