Getting Beyond the Transactional Drug Development Approach
The venture capital model of funding drug development is probably familiar to many of your clients. As companies raise funds they often perform an initial study or small series of studies and then continue as more funding is acquired – potentially with various outsourcing vendors. This transactional, study-by-study approach may seem like their only option; however, it can be extremely costly and time-intensive resulting in:
Loss of historical knowledge or duplication of effort
Delay between studies and nonclinical and clinical phases
Data loss or misinterpretation – having to coordinate data from multiple vendors
Increased cost and time spent managing nonscientific logistics - evaluating, selecting, negotiating, contracting, MSAs, etc.
Furthermore, today’s marketplace is more competitive and development partners seeking licensing or co-development agreements are requiring regulatory approval, Phase I and preliminary proof of concept data before considering novel molecules. The desired target milestone is to progress quickly through the IND/CTA and first in human (FIH) trial.
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Continuity for Your Client’s Drug Development Journey
Help your clients benefit from a more efficient and cost effective way to manage the drug development process and maximize their asset’s value. Check out our Early Phase Development Solutions – a unique programmatic outsourcing model that provides continuity for the program while adding value to the asset:
A singular strategy and full drug development program with an overview of time and cost savings defined at the outset
A target product profile that outlines the asset’s ideal final destination and defines the plan to get there
Insight into a molecule’s market potential in the form of a Global Value Dossier, which may be shared with potential partners and investors
A regulatory strategy that outlines the approval path – including efficient steps to procure parallel multi-country approvals as necessary
Flexible financing models – creative options that align to funding rhythms and stakeholder milestone goals
A cohesive, expert team that guides the science and the program and simplifies project management
Now, you have a new way to enhance your client’s competitiveness – with a strategy that’s unique for their asset and enables them to achieve success. Interested in learning more?Contact me about Early Phase Development Solutions by phone or email.