Philosophy
Science
The science must demonstrate objective experimental and unbiased clinical evidence of safety and efficacy at every stage of advancement. In the very earliest days of development, the first evidence of activity against a target must be at a concentration that is, at least initially, projected to be achievable in patients. Results as development proceeds must build upon prior experience; the data should tell a scientifically compelling story.
Regulatory
All animal and human trials must be conducted with the highest ethical criteria. During clinical trials, the safety and welfare of subjects must always come first and investigational treatment must be interwoven with the highest standards of medical care. Frequent advice from regulatory authorities should be sought to insure timely and successful approval of the product under study ultimately insuring access to patients with ongoing medical needs.
Business
Investors deserve a return on their investment so there should be a clear pathway to commercial success, even in the earliest days of development. Constant and current awareness of the status of potential competitors, changes to the market for the product under study, changes to reimbursement or patterns of patient care, must constantly be taken into consideration, with sponsors ready to change the development plan as needed. Plans for the product’s lifecycle management should be available as a potential launch date nears.