Development Guidance for Rx and Generic Ophthalmic Drug Products

The Need For Focused Development 

Maximum commercial value of pharmaceutical products is obtained through a precise product “image” combined with efficient development.  These require a clear understanding of the product being developed:  how it will be utilized by patients and doctors, what will the customers see as the product’s value, and how will the product be differentiated from competitor products.

Davio Pharma Consulting takes a strategic approach to project initiation, with emphasis on the target product profile (TPP).  The TPP is developed with input from all stakeholders, including commercial, regulatory, clinical, and product development.  Full alignment and commitment to the TPP is critical to the overall success of the project.  The TPP is a living document and will be re-examined at key milestones in the project timeline, and in response to changing market conditions.    
The many challenges of new drug development

The Davio Pharma Consulting Difference

Davio Pharma Consulting facilitates Chemistry, Manufacturing, and Control (CMC) development activities with concentration on ophthalmic pharmaceutical products.  CMC project planning is conducted with full participation from formulation, analytical methods, process, and packaging development functions, with input from pre-clinical safety, and with visibility to Quality, Regulatory Affairs, Manufacturing (Operations), and Senior Leadership.  Project plans must be appropriately aggressive, yet flexible.  Each stage of the plan must be “owned” by the functions actually doing the work, and must have buy-in from the other significant stakeholders. 

Lack of development focus, development mis-steps resulting in repeat stability studies, inadequate product challenge testing resulting in post-launch recalls…these are all costly mistakes.  For a modest Rx drug product with potential to earn $50M/year, delays due to these mistakes can cost…well…$1M per week of delay.

Davio Pharma Consulting stands ready to work with your company to ensure that delays and product development mistakes are brought to an absolute minimum.  We also believe we can help you find time-savings in your development plan which will accelerate your path to commercial success.