Not all regulatory approvals are created equal, and FDA clearance is among the toughest to obtain. The capital requirements to get an FDA-regulated product into the US market have continued to rise. The average pharmaceutical drug in the United States costs over $2 billion to get to patients’ hands from R&D to pharmacy pick-up. The clinical trials for the FDA alone cost more than $18 million to obtain clinical efficacy.
Do those costs sound otherworldly? Definitely. But the opportunity to speed the path and reduce the cost of getting to consumers may be an ocean away. Biotech startups need to start thinking globally to get to market faster.
The Global Startup Accelerator is designed to help. The GSA leverages the expertise of those that have had success in global expansion; the Welcoming Center for New Pennsylvanians and the Science Center are teaming up to leverage local resources for global growth.
The CE mark in the EU and FDA approval in the US serve the same function — ensuring the safety of patients. However, the FDA approval process requires the additional step of showing efficacy. While this is an important standard for consumers, it is a difficult and costly one to meet for new companies and their products. Pursuing a CE mark allows the company to certify it is using health, safety and environmental protection standards for products sold within the European Economic Area (“EEA”). Once approval is obtained, companies may begin to run trials in the EU. For some technologies, timelines can be a year faster in Europe. Better yet, often those trials can obtain customer, consumer, and patient data required to show clinical levels of efficacy for the FDA as well. Even if your product or service does not require an FDA approval, companies in the life sciences or digital health can still benefit from the GSA curriculum.
The Global Startup Accelerator is designed to help companies access international markets, learn soft skills, and make local, national, and international connections to develop relationships that will help them enter the European market with a strong framework to build on – all while leveraging our local expertise.
The program includes pitching at the 2019 BIO International Convention in Philadelphia.
The application deadline is November 11, 2018.