For more information and to register, Click Here! Session 2. Pre-Clinical Proof of Concept: Establishing Activity, Bioavailability, and Associated Effect, in Cancer Relevant Models - July 30, 2021, 12 pm – 2:30 pm ET Topic 1: Establish therapeutic activity of … Read more
For more information and to register, Click Here! Session 3. Non-Clinical Toxicology - August 6, 2021, 12 pm – 2:30 pm ET Topic 1: Preliminary and IND-directed toxicology studies Elizabeth Glaze, Ph.D., National Cancer Institute Topic 2: Assays and endpoints … Read more
For more information and to register, Click Here! Session 4. Chemistry Manufacturing and Controls for Small Molecules - August 20, 2021, 12 pm – 2:30 pm ET Topic 1: What is a certificate of analysis, and the assays and analytical … Read more
For more information and to register, Click Here! Session 5. Development of Biological Products - September 10, 2021, 12 pm – 2:30 pm ET Topic 1: Overview of product types and various applications in cancer Jason Yovandich, Ph.D., National Cancer … Read more
For more information and to register, Click Here! Session 6. Regulatory Considerations - September 24, 2021, 12 pm – 2:30 pm ET Topic 1: FDA overview and perspective on regulatory requirements for an IND filing for oncology products Rachel McMullen, … Read more
For more information and to register, Click Here! Session 7. Clinical Translation - October 29, 2021, 12 pm – 2:30 pm ET Topic 1: Biomarkers and companion diagnostics in IND filing and clinical trial design Tracy Lively, Ph.D., National Cancer … Read more
For more information and to register, Click Here! Session 8. Entrepreneurship: Partnering and Advertising - November 19, 2021, 12 pm – 2:30 pm ET Topic 1: Engaging with development partners Jeremy Caldwell, Ph.D., Inception Sciences, Incorporated Topic 2: Creating a … Read more
For more information and to register, Click Here! Session 9. NCI Translational Resources and Programs - December 3, 2021, 12 pm – 2:30 pm ET NCI Experimental Therapeutics (NExT) Program, Barbara Mroczkowski, Ph.D., National Cancer Institute Small Business Innovation Research (SBIR), Kory … Read more
Click here to register and learn more! FDA CLINICAL INVESTIGATOR TRAINING COURSE (CITC) The U.S. Food and Drug Administration’s Clinical Investigator Training Course (CITC) has been conducted in person for more than ten years. Given ongoing concerns about COVID-19, this … Read more
Click here to register and learn more! FDA CLINICAL INVESTIGATOR TRAINING COURSE (CITC) The U.S. Food and Drug Administration’s Clinical Investigator Training Course (CITC) has been conducted in person for more than ten years. Given ongoing concerns about COVID-19, this … Read more
