Discovery and biopharmaceutical product development process

Given the discussion in the article (link is below), please opine on how the drug discovery and biopharmaceutical product development process can be improved to better support evaluations of safety and efficacy for these products.

For example, should the approved indication(s) for use for new biomedical products be constrained to specific populations in which genetic analysis has been thoroughly analyzed as part of the clinical development process? Should all pivotal Phase III clinical trials be limited in scope with respect to the genetic composition of patients included within the study? Please justify your responses with examples from the article (link) below.

0 replies

Leave a Reply

Want to join the discussion?
Feel free to contribute!

Leave a Reply

Your email address will not be published. Required fields are marked *