1. NCI Division of Cancer Prevention Ongoing Activities at Frederick Facilities Presented By: Lori Minasian, M.D. Robert Shoemaker, Ph.D. October 1, 2015

2. 2 Overview of Mission and Purpose

3. 3 The Division of Cancer Prevention (DCP) conducts and supports research to determine a person's risk of cancer and to find ways to reduce that risk.  DCP funds researchers and collaborative scientific networks, including clinical trials networks  DCP provides scientific support to develop interventions for cancer prevention and markers for the early detection of cancer

4. 4 Major DCP Programs That Use FNLCR Resources Community Research Programs  Current: NCI Community Oncology Research Program (NCORP).  Closed: Community Clinical Oncology Research Program (CCOP) conducted two large breast cancer prevention trials and two large prostate cancer prevention trials that generated specimens.  http://prevention.cancer.gov/clinical-trials/major-trials http://prevention.cancer.gov/clinical-trials/major-trials

5. 5  The Early Detection Research Network (EDRN) is an investigator- initiated infrastructure to support development and validation of early detection biomarkers and markers of progression; foster interaction between academic, clinical and industrial leaders; standardize biomarker validation criteria; develop a quality assurance program; and bring biomarkers to clinical use.  The EDRN has a need for tissue storage and specimen processing for extramural investigators.  http://edrn.nci.nih.gov/ http://edrn.nci.nih.gov/ Major DCP Programs That Use FNLCR Resources (2)

6. 6 Major DCP Programs That Use FNLCR Resources (3)  PREVENT supports the development of potential cancer prevention agents using mechanism-based assays in vitro and in vivo, as well as defining efficacy, including pharmacodynamics or surrogate endpoint biomarkers of validated, or yet to be studied, chemopreventive agents and vaccines.  The main objectives of these studies are to prioritize and validate potential chemopreventive agents and surrogate endpoints for toxicological/pharmacokinetics/pharmacodynamics evaluation and ultimately for their use in clinical prevention trials. Support is also provided for drug or vaccine synthesis, formulation, and stability studies.  http://prevention.cancer.gov/major-programs/prevent-cancer-preclinical http://prevention.cancer.gov/major-programs/prevent-cancer-preclinical

7. 7 Major DCP Programs That Use FNLCR Resources (4)  The Nutritional Sciences Research Group promotes and supports studies establishing a comprehensive understanding of the precise role of diet and food components in modulating cancer risk and tumor cell behavior. Basic, translational and clinical studies are supported to understand the interplay between nutrition and the microbiome, the underlying mechanisms implicated in cancer prevention, as well as the interplay between genetics, gene expression and dietary intake.

8. 8 Overview of Scientific Work

9. 9 Overview of Scientific Work Biorepositories/ Specimen Storage  Specimen storage and processing are required for several major programs.  Specimen processing storage and access by extramural investigators continues beyond the life of the grant or contract which funded the original study and specimen collection.

10. 10 Overview of Scientific Work Biorepositories/ Specimen Storage Specimen Processing & Distribution  The ability to process the specimens requires seamless collaboration and coordination with the extramural data centers for the identification and processing of the specimens for each individual proposal.  The ability to be flexible in interactions with the investigators who have requested the specimens as each proposal may require thousands of specimens to be processed and distributed to investigators worldwide.  For example, SELECT had 35,533 participants  The processing includes, but is not limited to DNA extraction and plating specimens in different schemas.

11. 11 Overview of Scientific Work Biorepositories/ Specimen Storage Early Detection Research Network  Receiving samples for specimen reference sets, aliquotting them to smaller sizes, maintaining them in freezers, and shipping out to investigators who obtain approval to test their biomarkers.  Sets are used only for pre-validation or validation studies of markers, one of the chief purposes of EDRN.  Currently, the repository is in the process of transferring specimens from an extramural investigator to the FNLCR.

12. 12 Overview of Scientific Work PREVENT Cancer Preclinical Drug Development Program Preclinical Model Development  Genetically engineered mice (GEM) for cancer prevention studies, such as BRCA-driven models of ovarian and mammary cancer. Cancer Immunoprevention  Support for next generation HPV vaccine development, including assays and animal studies.

13. 13 Overview of Scientific Work Nutritional Sciences Research Group  Samples (preclinical and clinical) provided to the transcriptomic laboratory for micro-RNA analyses and initial characterization of the pathways most influenced by food components.

14. www.cancer.gov www.cancer.gov/espanol