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.
Step into the virtual world and experience Early Phase Development Solutions. It may be the most valuable 3 minutes you spend today.
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.
How far you go is up to you
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?
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.
A Programmatic Approach – Why it Matters
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” whitepaper. What’s more, we can sit down and do an economic valuator session – to estimate the likely time savings for your specific program.
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.
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.