Early Phase Development & Strategy

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.

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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.

  • 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

  • Your Needs

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

    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. 

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

    Drug development journey timeline

    Scientific and operational continuity — from the start.

    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 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. 

    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

    Which candidate is best?

    Get integrated solutions to rapidly identify and 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. 

    IND/CTA-enabling nonclinical assessment

    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.

  • Related Resources


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