| The small, start-up biotechnology company faces many challenges not inherent to large drug companies. With limited funds, start-up companies must try to do more with less, while accelerating the development timeline. The “ Virtual” Biotechnology Company, loosely defined as an organization where all development processes are outsourced but managed by a central unit, predominantly made up of business and finance people, has been a model adopted by many start-up biotechnology companies out of necessity, as a way to generate capital and more closely manage finance and resource allocation. However, in striving to closely manage these variables, the appropriate in-house development and/or regulatory infrastructure is not always proactively established. This lack of infrastructure and expertise can potentially result in delays in the development program that translate into a more rapid spending that often times cannot be overcome before funding runs out. The result is a downward spiral that leaves a promising therapy potentially never to reach the patient population it was targeted to treat.; Another potential model that must be considered, contrary to the virtual model, is one of a “regulatory-compliant” infrastructure. This model allows for developmental consistency in execution and mission by incorporating the appropriate internal expertise in specific drug development areas with focused plans/systems to manage, guide and potentially accelerate the drug development process. This model's expertise lies firmly on the development side with limited financial investment and business support. Currently in the area of drug development, more specifically Regulatory Compliance, there is no one comprehensive source for a young virtual biotechnology company, inexperienced in drug development, to go to that provides guidance and assistance in establishing a regulatory-compliant infrastructure. This PDE entitled, “Establishing a Regulatory-Compliant Infrastructure to Assist Virtual Companies in U.S. Drug Development”, will provide a comprehensive guide to assist the young, virtual biotechnology company, inexperienced in drug development and regulatory compliance in establishing a regulatory-compliant infrastructure, in an attempt to maneuver them through the perils and pitfalls of the development process. |
