Utilising STAMP to define the First-into-Man system for medicines

The (so-called) pharmaceutical safety system is struggling. Part of the problem is failure to define the complexity of the system and design processes which are evidenced based and both adaptable and flexible for those who work in them. The size of the challenge is huge and global. This is why ACRES (Alliance Clinical Research Excellence and Safety) was established as a not-for-profit international organisation to develop a global system for clinical trials, responsibly conducted according to the highest standards of safety, quality and efficiency as this currently does not exist. When defining the safety system for clinical research into medicines where do we start? ACRES suggests examining and defining the current safety system for how medicines move from the laboratory into man applying the STAMP model. This has never been done which is why the influence of some stakeholders on safety remains unknown. The aim is to build on what we know about the scientific evidence, current legislation and regulatory guidance underpinning pharmacological and regulatory science in pharmaceuticals. We aim to build a multisciplinary team including safety engineers This includes working with pharmaceutical professionals with different expertise and safety engineers with experience in applying STAMP from both the EU and US to map out the system using STAMP.