National Cancer Institute - NCI Division of Cancer Treatment and ...
National Cancer Institute - NCI Division of Cancer Treatment and ... National Cancer Institute - NCI Division of Cancer Treatment and ...
- Molecules entering the pipeline will be managed by teams with members from both DCTD and CCR - Joint drug development teams will be guided by a new DCTD Developmental Therapeutics Project Management Office, bringing a business-focused approach to tracking the progress of agents from discovery through earlyphase clinical trial ● Together, DCTD and CCR investigators will utilize the recently announced Food and Drug Administration exploratory IND guidance to facilitate testing of targeted therapies in patients earlier in the drug development process so that informed decisions to proceed with or stop development can be made before expensive bulk drug formulation occurs. These studies will also take advantage of new advances in molecular imaging, which can help detect whether an agent being tested is reaching its target and having the desired effect. - Extramural drug developers, for the first time, will be offered opportunities to utilize CCR resources for clinical trial support. This mechanism will be employed for novel molecules or high-priority targets. D I V I S I O N O F C A N C E R T R E A T M E N T A N D D I A G N O S I S ■ 9
■ The DCTD Developmental Therapeutics Project Management Office will also lend project management assistance to advance the evaluation of targeted therapies being studied jointly by the DCTD Developmental Therapeutics and Cancer Therapy Evaluation Programs ■ DCTD has initiated a new molecular toxicology laboratory that will develop novel approaches to toxicologic prediction using normal human tissues. This is concurrent with the new commitment by DCTD and CCR to combine resources to focus on developing predictive, preclinical molecular pharmacodynamic assays. These assays will support the clinical development of agents for which NCI holds the IND. 10 ■ P R O G R A M A C C O M P L I S H M E N T S 2 0 0 6 ■ ■ ■ The National Clinical Target Validation Laboratory will develop and authenticate pharmacodynamic assays well in advance of human studies, so that they can be used in early phase trials to provide information about the safety and efficacy of the entities being tested. ■ The division has also expanded its capabilities to develop and standardize diagnostic imaging biomarkers in addition to pharmacodynamic assays. These processes will be aided by the development of new imaging tools and agents that can track molecular events in tumors and normal tissues. Once completed, the portfolio of biomarkers and assays will be made available to all interested cancer researchers. DCTD has identified several resources to help achieve this goal. Chief among them is the establishment by DCTD and CCR of a new National Clinical Target Validation Laboratory (NCTVL). This laboratory will develop and authenticate pharmacodynamic assays well in advance of human studies, so that they can be used in early phase trials to provide information about the safety and efficacy of the entities being tested.
- Page 1 and 2: National Cancer Institute U.S. DEPA
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- Page 5 and 6: Clinical trials performed using an
- Page 7 and 8: Dr. James H. Doroshow, Director Jam
- Page 9 and 10: Cancer Diagnosis Program Dr. Sheila
- Page 11 and 12: DCTD Research Grants 6 ■ P R O G
- Page 13: disease-specific steering committee
- Page 17 and 18: P A R T N E R S H I P S A N D C O L
- Page 19 and 20: laboratories. Dr. Kevin Dobbin, BRB
- Page 21 and 22: ■ Gene expression patterns and pr
- Page 23 and 24: Simon R. DNA microarrays for diagno
- Page 25 and 26: Microarray Myths and Truths Myths
- Page 27 and 28: target, is sensitive to the agent.
- Page 29 and 30: O T H E R B I O S T A T I S T I C A
- Page 31 and 32: almost inevitably leads to an invas
- Page 33 and 34: Software and Technical Report Archi
- Page 35 and 36: Biomarker Development Process Marke
- Page 37 and 38: Strategic Partnering to Evaluate Ca
- Page 39 and 40: C U R R E N T F U N D I N G O P P O
- Page 41 and 42: P A R T N E R S H I P S A N D C O L
- Page 43 and 44: several types of cancer TMAs have b
- Page 45 and 46: Courtesy of NCI Visuals Online, Bil
- Page 47 and 48: ■ Cooperative Human Tissue Networ
- Page 49 and 50: Progress in many areas of cancer re
- Page 51 and 52: Diagnostic Imaging Program in 1996,
- Page 53 and 54: NCI Visuals Online, Terese Winslow,
- Page 55 and 56: ■ Support development and deliver
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- Page 61 and 62: Quick-Trials for Imaging and Image-
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- Molecules entering the pipeline will<br />
be managed by teams with members<br />
from both DCTD <strong>and</strong> CCR<br />
- Joint drug development teams will<br />
be guided by a new DCTD Developmental<br />
Therapeutics Project<br />
Management Office, bringing<br />
a business-focused approach to<br />
tracking the progress <strong>of</strong> agents<br />
from discovery through earlyphase<br />
clinical trial<br />
● Together, DCTD <strong>and</strong> CCR investigators<br />
will utilize the recently announced<br />
Food <strong>and</strong> Drug Administration exploratory<br />
IND guidance to facilitate testing<br />
<strong>of</strong> targeted therapies in patients<br />
earlier in the drug development<br />
process so that informed decisions<br />
to proceed with or stop development<br />
can be made before expensive bulk<br />
drug formulation occurs. These studies<br />
will also take advantage <strong>of</strong> new<br />
advances in molecular imaging, which<br />
can help detect whether an agent<br />
being tested is reaching its target<br />
<strong>and</strong> having the desired effect.<br />
- Extramural drug developers, for<br />
the first time, will be <strong>of</strong>fered opportunities<br />
to utilize CCR resources for<br />
clinical trial support. This mechanism<br />
will be employed for novel<br />
molecules or high-priority targets.<br />
D I V I S I O N O F C A N C E R T R E A T M E N T A N D D I A G N O S I S ■ 9
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