Safety Pharmacology has been and continues to be a very important piece of the IND process. It investigates the undesirable side effects that could happen with any test substance. The group of specialists leading the way in this field is the Safety Pharmacology Society and as a proud member, Attentive will be attending this year’s event in Montreal next month.
Members of the Attentive team who are going to be at this upcoming meeting have been part of the Safety Pharmacology Society since around 2001 – really, since the inception of the society itself. “I have literally attended every single annual meeting. And currently our COO, Phil Atterson, is on the board. We feel the society plays a very important part in our industry. In the past, I and others on our Attentive team here have had the opportunity to present at the events and lead courses on subjects such as radio telemetry, data acquisition, best practice methods and other topics,” said Alfred Botchway, CEO of Attentive Science.
These, of course, are all services that we provide to our clients at Attentive. Safety Pharmacology is a specialty field and incorporates pharmacology, toxicology and physiology. There are a number of factors such as use of non-toxic doses, inclusion of a therapeutic dose and its multiples, that have to be considered when designing a good Safety Pharmacology study. At Attentive, we support our clients by conducting the cardiovascular, respiratory and CNS assessments amongst other IND enabling studies. The purpose of these studies are to identify undesirable pharmacodynamic properties, evaluate adverse pharmacodynamic and/or pathophysiological effects and to investigate the mechanism of the adverse pharmacodynamic effects observed and/or suspected. The Safety Pharmacology studies really distinguish what could be going on with the major organ systems in the background of a test system – the things that are not blatantly obvious, for instance – that might be detrimental in the long run.
This entire industry came about because of undesirable side effects that were being observed with medications for non life-threatening diseases such as allergies roughly 30 years ago. The prime example was an antihistamine called Terfenadine, which was eventually removed from the market due to the risk of a particular type of disruption of the electrical rhythms of the heart (and leading to a cardiac arrhythmia Torsades de pointes). A drug that had been developed for hay fever- been prescribed for a long period –before it was discovered that women of childbearing age who were taking this drug who drank grapefruit juice around lunchtime had an increased incidence of cardiac events. In some extreme cases, these events even led to death. It was later found that administration of grapefruit juice concomitantly with terfenadine led to an increase in systemic terfenadine bioavailability and resulted in increases in QT interval. All of this made it clear that this new part of the industry was here to stay, and the Safety Pharmacology Society was officially incorporated in 2000.
Since then, the SPS has authored white papers, we have issued guidance, and most importantly, we have been able to help engineer out of most drugs anything that would bind to the notorious cardiac channel. In fact, now it is one of the very first screening studies conducted (the cardiac channel blocking effect of any drug). Since this has been put into place, there haven't been any drugs that have managed to make it to the market with these potential effects. So now that we have established this precedent and shown what an effect change like this can have on our health, the time has come for us to meet again and explore ways of continuing to prevent other undesirable side effect. These will be the sort of important discussions we will have when we meet in Montreal.
In addition to taking part in these sorts of discussions, we look forward to seeing our colleagues again – some of whom we’ve still not seen since before COVID – and reengaging with current and prospective clients as well.
If you would like to meet with any of our Attentive team members in Montreal during this year’s SPS meeting, please use the form below to let us know and request a time to sit with us while we are there or find us at booth #906. We are ready to meet you and discuss your current and future programs. Let us show you how we can support you and your team in the most attentive way.