There is an investment gap between research funding programs and venture capital investors where early-stage biotechnology companies struggle to obtain funding. As such, companies have to be creative on where they raise funds and how they allocate it. They must also use different strategies to shorten the regulatory process, enabling them to maximize their patent portfolio life. The article examines how companies are using new business models, reducing costs, accelerating development as well as obtaining alternative capital.
Some of the business models we will be looking into are the virtual company model (a model where the company hires a minimal amount of permanent staff), as well as discussing new partnering arrangements with CROs (such as the one with CatoBioventures). Also examined are some of the ways companies can use to reduce costs such as Microdosing (also called Human Phase 0 studies) and Outsourcing Abroad (mostly for CMO and CRO services).
Then follows a brief overview of the different FDA programs available to increase the speed of an early biotech regulatory process: the four main programs examined in this article are Fast Track Designation, Breakthrough Therapy, Priority Review, and Accelerated Approval Designation. Finally, we complete our overview with a short presentation on two innovative funding opportunities, Philanthropy foundations Venture Capital (which are VC arms of traditional philanthropies) and Equity Crowdfunding (raising funds through a large number of individuals in exchange for equity).
The object of this article is to generate thoughts and ideas for early biotechnology companies, and should be a useful thought starter for many starting their journey in fundraising.
Author: Jean-François Denault is a consultant specialized in Market Research for Life Sciences companies. With 15 years of experience, he has worked with many clients, from start-ups to global pharmaceuticals. He can be reached at email@example.com