Testing and securing marketing approval for a new drug takes years and can cost hundreds of millions of dollars according to estimates by drug companies and industry experts. Other industry estimates indicate that pharmaceutical companies may lose millions for each week of delay in bringing a drug to market. If your company is looking to get new drugs to market, Squire Sanders can help you avoid unnecessary delays.
Our lawyers work closely with clients from the conception of an idea through commercialization including counsel on early-stage product development and premarket clinical trials. The following are examples of our relevant experience:
- Negotiating and executing clinical trial agreements that often involve securing marketing approval in several jurisdictions simultaneously.
- Advising on the conduct of clinical trials for approval of new drugs and medical devices for trials that are conducted throughout the world on behalf of sponsors and research institutions.
- Counseling in the development of clinical trials, sponsored research arrangements and Traditional Chinese Medicine commercialization projects.
- Counseling governments’ scientific academies regarding approaches to the commercialization efforts of their researchers and private co-investment and licensing arrangements.
- Advising pharmaceutical and biotechnology companies on structuring agreements with clinical research organizations (CROs) and academic research organizations (AROs).
- Advising global medical device manufacturers with clinical trial agreements at medical institutions in the United States.