'Project launch': from research finding to therapeutic product.
Only 0.1-0.5% of new therapy candidates gains marketing approval; just 10-20% of the approved ones ultimately recoup the ~0.6-0.9$USbn invested into their R&D until marketing authorisation. One reason is the high inherent risk of new therapeutic products development. Further reasons are suboptimal decisions during R&D and, too often, lack of adequate experience. To bridge the latter gap, this article succinctly reviews identification of new product opportunities and their patent protection, the resulting commercial opportunity and portfolio valuation, planning and conduct of the ensuing preclinical and clinical tests, as well as therapeutic product registration and price reimbursement, covering risk management as an aside. The article also clarifies the key terms, identifies the main pit falls, highlights the essential requirements for and the goals of different product development steps, to facilitate communication between researchers and developers. By combining public information with personal experience and recommendations the article aims at informing more broadly those who are familiar mainly with some of the (strictly regulated) activities involved in design, development and launch of new therapeutic products, be it that they are medicinal products or medical devices. Taken together, this should support initiation and evolution of new therapeutic products and assist researchers in finding-and better and more smoothly co-operating with-consultants or partners in development and marketing.
The Advanced Treatments Institute, Tassilostr. 3, 82131 Gauting, Germany. Electronic address: Cevc@advanced-treatments.org.
Gregor
G
Cevc
D000818:Animals; D017277:Drug Approval; D006801:Humans; D004364:Pharmaceutical Preparations; D012106:Research
D004364:Pharmaceutical Preparations
Characterisation; Clinical studies; Evaluation; Manufacturing; Preclinical studies; Product development; Reimbursement