Clinical studies using techniques such as microdosing and accelerator mass spectrometry (AMS) are being used in many more applications, particularly in the phase 2 area to provide biometric information such as bioavailability. Developments in personalized medicine are using these techniques to provide pharmaco-phenotyping in cancer patients to determine appropriate therapies. Although phase 0 is just starting to catch on, this represents taking these same innovative techniques all the way into the pre-clinical arena to provide human derived data in ways to improve decision making prior to commitment to full clinical development.
Gary Jones, M.D. will discuss the use of microdosing and phase “0” studies combined with highly sensitive detection based on AMS to provide first-in-human data as timely and cost effective support of innovative early therapeutic development projects as well as applications during later phase clinical trials and in the post-approval marketing arena.
- Understand basics of accelerator mass spectrometry (AMS) and microdose studies
- Recognize preclinical, early phase development and post-marketing situations in which microdose studies using AMS may provide important data
- Contrast preclinical data needed for, information available from as well as cost & time to results involved in exploratory IND/phase 0 microdose studies with conventional clinical development pathways
Dr. Jones applies his 25 years of experience and expertise, accumulated through his careers in academia, medical care, and clinical research, to direct involvement in the clinical development of innovative therapeutics and medical devices. He received his M.D. at the Oregon Health Sciences University (OHSU) and has had academic appointments at University of North Carolina and OHSU. Industry experience includes leadership roles in medical affairs and clinical development at Berlex and Bayer and he is a Founding Partner and Director of Clinic Development with C3 Research Associates.
C3 Research Associates is a full service CRO that conducts clinical and device trials for pharmaceutical, biotech, medical device and diagnostic companies. The C3 Research Associates team provides customized solutions for start-ups and small companies. Our goal is to help mitigate the risk of clinical trials by supporting companies early in the development process with protocol development and writing, site selection and recruitment strategy, biostatistics, cost projections and regulatory services. Over 70% of our projects have been phase I or phase II studies with innovative strategies for first-in-human studies. Experience in therapeutic areas include oncology, infectious disease, cardiology, neurology and pulmonary diseases.
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