- You’ve successfully navigated through the potential minefield of pre-clinical and Phase I and II and now you’re planning your pivotal trials for submission of your NDA to the Regulatory Authorities.
- Commercial support to date consists of market research studies estimating price and market size.
- You’re expecting a 3 year window to launch. Two years clinical trials and analysis and one year review.
- You’d like to create a sales and marketing team to launch the product but you think you have plenty of time prior to approval and launch.
Why you should not move ahead without input from Averitas Health:
Three years prior to launch seems like a long time, however there are any number of things that need to get done in this very short period of time. If you’re a small company you can’t be expected to do everything that Big Pharma does but you’ve got to know what are the most critical things and these must be done well.
Although the Target Product Profile (TPP) should have been created prior to Phase II, let’s assume this hasn’t been done yet. It’s still not too late to create a TPP based on the data already collected and the vision for the final indication. This will be helpful in designing the Phase III so that what the Regulatory authorities review in the NDA matches the language for the package insert. In addition it’s important to know if you need to add Health Economics Outcomes data to your phase III design. This is critical in that weak labeling can ruin your chances for economic success. Averitas can help with expert Commercial input in order to design the most impactful trial to gain both approval and strong labeling.
In addition to the TPP, there are several critical steps that need to be understood at this point. To name just a few there are: therapeutic area landscape, competitive landscape, price sensitivity analysis, market segmentation and positioning including message testing, KOL identification and mapping, patient profiling and journey, Publication strategies, conference presentation, potential awareness campaigns, Clinical services review and requirements, supply chain analysis, distribution strategy, Society/Foundation engagement……. Many other steps should be undertaken as well, but these stand as an example of just how much is to be done and how expert Commercial partners could be a beneficial addition to your clinical/scientific team.
Visit the links below to learn more about our services, at every stage of your product’s life cycle:
|EARLY STAGE||LATE STAGE||PRE-LAUNCH/RE-LAUNCH|
|Early StageNew Product or NCE|
Pre-IND and IND
|Post NDA Submission
(awaiting regulatory approval)
Phase IV (Post Launch)