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.
Partnership. Continuity. Value.
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.
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.
Watch Peter Sausen, PhD explain how a programmatic approach to early development can shave up to 30% off your timelines to maximize your asset value at point of sale.
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:
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, 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.
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.
Your drug development strategy – enhanced
The success of your drug development program starts with your compound’s unique overall strategy. With our experience in partnering with more than 600 biotech companies per year, you have instant access to a focused team of experts that can help you build a strategy to de-risk your molecule development and add value to your asset.
Early Phase Development Solutions can be aligned to meet your desired start and end milestones:
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 and into first in human clinical studies.
First-in-Human (FIH) 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.
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.