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A programmatic approach

Early phase development strategies

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.

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. 

Choose a programmatic model that can save up to 30% on your timeline

Discover a clear path with Early Phase Development Solutions. It's a programmatic approach for meeting your drug development goals that teams you up with drug development strategists to prospectively plan and execute the required studies efficiently. By making every day of the journey count, Early Phase Development Solutions has helped hundreds of biotech firms reach their program goals up to 30% faster over the past three years.

  • Enact a proactive strategy to enable operational efficiency, connected insights and program continuity

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

  • Work with one focused team to bring together scientific insight, regulatory guidance and program management

Explore the benefits of a programmatic approach

Scientific & operational continuity

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 contracting options

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.

Candidate identification

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 studies

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 get what you need for your IND/CTA submission. 

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