Oncology Webinar: Introduction

Making Adaptive Dose-Finding Trials Easy For Clinicians

This is a transcript from an Oncology XTalk given by ARG on Making Adaptive Dose-Finding Trials Easy For Clinicians. ARG is an oncology CRO with over 50 market authorizations.

Ryan Muse

Good day to everyone joining us and welcome to today’s Xtalks webinar. Today’s talk is entitled “How To Make Adaptive Dose-Finding Trials Easy For The Clinician.”

My name is Ryan Muse and I’ll be your Xtalks host for today.

Today’s webinar will run for approximately 60 minutes and this presentation includes a Q&A session with our speakers. Now, the webinar is designed to be interactive and webinars work best when you’re involved, so please feel free to submit your questions and comments for our speakers throughout the presentation using the questions chat box and we’ll try to attend to your questions during the Q&A session.

This chat box is located in the control panel, which is on the right-hand side of your screen, and if you require any assistance along the way, please contact me at any time by sending a message using this same chat panel.

At this time know that all participants are in listen-only mode and please note that the event will be recorded and made available for streaming on Xtalks.com.

At this point I’d like to thank Atlantic Research Group (ARG), who developed the content for this presentation. ARG is an oncology, immunology, rare and neurodegenerative disease-focused contract research organization that provides comprehensive clinical program development services ranging from pre-launch consulting to commercialization, achieving over 50 market authorizations. Founded in 2004 with the vision that every project should be highly individualized, ARG has experienced consistent growth across the globe expanding their reach to include drug and device strategic consulting, clinical trial management services and clinical data and analytics solutions.

Now I would like to introduce our speakers for today’s event:

Dr. Friend has more than 17 years of global drug development and medical affairs expertise in hematology/oncology as well as a variety of other therapeutic indications. He is currently the Chief Medical Officer of Cellectar Biosciences, leading its research and development, clinical, medical affairs and regulatory affairs divisions. He completed his post-graduate residency program in family medicine and subsequently served as Clinical Director and Faculty Attending Physician at Cabarrus Family Medicine Residency Program in North Carolina

Dr. Schnipper is a widely recognized expert in innovative design and management of clinical trials in several indications, particularly in oncology. He has established a reputation for being able to determine quickly and cost-effectively as to whether a drug is safe and effective. Currently the Head of Clinical Development at X-37, Dr. Schnipper has played key roles in drug development from IND to NDA in diverse organizations. He practiced medical oncology in both academic and private practice settings before beginning his pharmaceutical career with Hoffmann-La Roche.

Dr. Wisniewski has over 30 years experience as a statistician in clinical research. He is currently the VP or Biostatistics and Data Informatics at ARG. Previously, he held similar positions at Covance (formerly Chiltern), PPD and GSK where he has built and led international teams of statisticians. He has designed and led projects in many therapeutic areas including oncology, rare diseases, infectious diseases, respiratory, GI, and metabolic diseases. He has worked on several regulatory submissions and has led teams that have worked on others.
So what is this webinar about?

If it could be summed up in one sentence, it is about using adaptive design techniques to reach the MTD (Maximum Tolerated Dose) in early phase trials, which could result in clear measurable benefits to both patients and sponsors without adding complexity and anxiety.

And so now, without further ado, I would like to hand the mic over to our first speaker, Dr Schnipper. You may begin when you’re ready.