implementation of the ras program - nci dea...2013 what “national missions” at fnlcr? ras...
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The Frederick National Laboratory is a federally funded research and development center operated by SAIC-Frederick, Inc., for the National Cancer Institute DEPARTMENT OF HEALTH AND HUMAN SERVICES • National Institutes of Health • National Cancer Institute
Implementation of the RAS Program David C. Heimbrook, Ph.D. CEO, SAIC-Frederick
Presentation to Joint BSA / NCAB Meeting June 24, 2013
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Frederick National Laboratory Missions What is RAS, and why is it so important?
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RAS stands for Rat Sarcoma viral oncogene homolog, and is a protein which is a key regulator of signal transduction in normal and cancerous cells • Four flavors : Harvey, Kirsten (A & B), and Neuroblastoma
HRAS (Wikimedia commons)
Growth factor receptors
Cell growth, survival, stability
Mutated RAS is found in ~33% of human cancers, is currently undruggable, and enables resistance to many existing cancer therapies
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Etiology of the RAS Program at FNLCR
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2012 2013
What “National Missions” at
FNLCR?
RAS Proposal
Communicate to BSA &
NCAB
RAS Workshop San Francisco
Workshop T/C Follow-up
F. McCormick joins program
Joint BSA / NCAB
Presentation
RAS Pivot
Programs rolling
Develop Budget and Operational Plan
Develop Scientific Plan
Feb
May Nov
Sept
Feb Jun
Jun Summer
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Full-Spectrum Research & Development at FNLCR
Research & Development • Basic Research: New knowledge about AIDS and cancer • Applied R&D: New diagnostics and therapeutics • Clinical Research: Clinical trials and laboratory analysis • cGMP manufacturing: Biologicals and vaccine production
Specialties • Genomics, proteomics, and metabolomics • Bioinformatics and imaging • Nanotechnology • Animal models • Tumor cell biology and virology • Immunology and inflammation
Customers • NCI, NIH, and external academic and commercial biomedical scientists
All FNLCR assets and expertise are available to the RAS program 4
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Implementing “National Missions” at FNLCR The RAS Hub
Essential capabilities….
Genetics and Genomics
Proteins and Proteomics
Imaging and Nanotechnology
Advanced Biomedical Computing
Cell Biology
…integrated into a brand new state-of-the-art Research Facility
Advanced Technology Research Facility Opened June 2012
Integrated in vivo support at Frederick & Bethesda
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Operationalizing the RAS Program Hub and Spoke model
FNLCR – The Hub
Extramural NCI-Supported Labs Intramural Labs
Contract Research Pharma
Biotechs 6
http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&docid=U7wIHyW3GndlYM&tbnid=JW47KsYlu-1ijM:&ved=0CAUQjRw&url=http://ncas.edu.in/department/department-of-biotechnology/breakthrough-in-biotechnology/&ei=mTmyUd_LJ4XG4AOE14HgBg&bvm=bv.47534661,d.dmg&psig=AFQjCNHuKbnoTQdLnedvcV9IkpFccId7Rw&ust=1370721022873707
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Hub Partnerships Facilitated through NCI and Contractor Mechanisms
Cooperative Research & Development Agreement (CRADA)
Collaboration Agreement • Research materials transferred (in or out); • Research plan developed • Both contribute intellectually; no $$ to NCI
Technical Services Agreement
Material Transfer Agreement (MTA)
• Research materials transferred (in or out); research plan • No fees; No joint IP
• Purchase of contractor-developed assays or reagents • Minimal paperwork; Assay list online • Cost recovery only
• R&D collaboration both partners contribute intellectually • Both contribute resources; can include $$ to NCI • Both NCI and Contractor mechanisms
http://frederick.cancer.gov/
http://frederick.cancer.gov/
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The RAS Program Funding Model
• Funding for FNLCR RAS Hub – Approximately $10 M / yr from NCI-directed re-prioritization of ongoing activities
within the existing FFRDC contract - No new money
• The Advanced Technology Program “Pivot” re-orients a predominantly intramural effort towards driving the RAS Hub
• Additional “one-time” funds from within the existing contract facilitate start-up activities
– This funding supports ongoing research activities within the Hub, as well as initial phase of subcontracts between the Hub and external laboratories
• Funding for RAS Spokes – Contract Research Organization – subcontracts from FNLCR RAS Hub
– Pharma, Biotech – Self-funded
– Academic : Some subcontracts from FNLCR RAS Hub;
• Existing and future grantees working on RAS will have the opportunity to participate in RAS program 8
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• Oversight – An NCI-Frederick Advisory Committee (NFAC) subgroup will be formed
• Will include NFAC members and representatives from academia and industry (TBD)
• Research Program Prioritization
– Joint recommendations by RAS Program leadership (Frank McCormick and SAIC-F leadership) and RAS Program oversight group, with concurrence by NCI Leadership (Drs. Varmus and Lowy)
The RAS Program Oversight and Governance
Implementation of the RAS ProgramFrederick National Laboratory Missions�What is RAS, and why is it so important?Etiology of the RAS Program at FNLCRFull-Spectrum Research & Development at FNLCRImplementing “National Missions” at FNLCR The RAS HubOperationalizing the RAS Program�Hub and Spoke modelHub Partnerships Facilitated through�NCI and Contractor MechanismsThe RAS Program�Funding ModelThe RAS Program�Oversight and Governance