At one point, Phase I was the time you enrolled a few healthy souls into a study that could give you a clear human check on safety. These days, Phase I is far more likely to be a key checkpoint on efficacy as well as developers try to determine ahead of Phase II if they really have a good therapy to work with or need to move on to other projects. And in some cases, particularly with rare diseases, a good Phase I design can look a lot more like Phase II, even with only small patient groups taking experimental drugs.
Next Thursday at 11 a.m. EST I'll be discussing these points in a webinar with three hands-on trial investigators: Jared Gollob, the vice president of clinical research at Alnylam; Hubert Chen, the VP of clinical development at Aileron (Chen also had worked at Regulus earlier); and Karen Cornelissen, the scientific director at Covance Clinical Research Unit in Leeds, U.K.
Close to 400 trial investigators from around the world have already signed up for the webinar and there's virtual room for plenty more. Following their presentations I'll be coordinating a Q&A session, which is a great way to explore these topics. I hope to see you online next Thursday. Click here to register for the webinar. -- John Carroll, Editor-in-Chief. Follow me on Twitter and LinkedIn.