This question is part of the following Ask The Expert session:
This is typically what investors refer to as “positioning” and is the crux of a good pitch. The key items to discern are how is your technology/product different from the competition? Is your technology entirely novel, or does it built upon and improve what is already on the market? What sets you apart from the current standard of care and importantly, why should insurers be willing to reimburse for your technology. Tackling the healthcare economic (i.e. reimbursement) argument early and upfront will show investors you are planning ahead which can all too often be the exception and not the norm for small start-up companies.
The best way to make your company stand-out is to focus on what makes your technology unique and better than what is currently available and/or in development. The other key to standing apart is to have realistic expectations and demonstrate you are planning ahead – if you are entering phase 1, demonstrate that you are acutely aware of how the results may inform your phase 3 trial to achieve the necessary endpoint for regulatory approval. Also, not all products will achieve +$1 billion in sales in the first five years of reaching the market – unrealistic revenue expectations are a sure sign of an inexperienced management team. Demonstrating you have realistic expectations and understand the dynamics of the marketplace will help separate you from the pack and provide investors and potential partners confidence you have the experience necessary to move the technology forward.
In the case of therapeutics, one great tool to help plan ahead is the Target Product Profile, or TPP. Successful product development begins with having the end in mind, and the TPP conveys the long-term aspirational product attributes and overall intent of the development program. This type of foresight and planning is exactly what will help separate you from the competition.
To learn more about the TPP, please see the following link where CIRM’s Vice President of R&D, Ellen Feigal, discuss the concept in detail: http://www.cirm.ca.gov/about-stem-cells/video/target-product-profile-ellen-feigal-2011-cirm-grantee-meeting.
In addition, the following link provides the Draft Guidance from the FDA for the TPP: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080593.pdf