Navigation Links
Workshop tackles challenges in biomarker and drug development

A commentary published online October 23 in the Journal of the National Cancer Institute summarizes a set of critical decision points in cancer biomarker and drug development. The points, which emerged from a workshop, include developing a clear understanding of the biology of the target and its interaction with the drug and the factors affecting the performance of the biomarker assay.

As described in the commentary by Sheila E. Taube, Ph.D., of ST-Consulting in Glen Echo, Md., and colleagues, workshop participants agreed that the more that is known about the biology and the stronger the association between the analytical signal of the biomarker assay and a clinical result, the less risky the development process will be. The workshop was co-sponsored by the National Cancer Institute and the U.S. Food and Drug Administration and held in October 2007.

According to the authors, a rigorous approach involving careful sample collection and standardized quality controlled data collection are critical for the rapid entry of predictive biomarkers and drug combinations into clinical practice. The attendees concluded that interaction with regulatory agencies early in the development process will ensure proper study design and performance characterization of biomarker assays.

"This articlepresents a set of issues for consideration and proposed development paths," the authors write. "We hope that this will serve as the beginning of a productive dialogue in the community."


Contact: Steve Graff
Journal of the National Cancer Institute

Page: 1

Related medicine news :

1. Perspectives Ltd and Chicagoland Chamber of Commerce Partner to Promote Drug-Free Workplaces. EAP Provider Offers Workshops to Help Businesses Understand Employee Substance Abuse and Its Impact
2. Global Regulators to Discuss Benefit-Risk Approaches of Medicinal Products at DIA Workshop
3. Workshop targets control-theoretic approaches for agent-based models
4. ColorAlchemy Hosts YouTube Mini-workshop Video About How Light and the Color Green Instantly Helps Balance Mind, Body, and Spirit
5. DIA/FDA/PhRMA to Host Progression-Free Survival Oncology Workshop
6. DIA 3rd Annual Clinical Trial Disclosure Workshop Offers Strategies for Creating Effective Registries and Results Databanks
7. LFAGW to Offer First Living with Lupus Baltimore Workshop on August 15
8. Renaissance Grants $3,000 to the Florida Dental Association to Present Oral Health Workshops for the Vulnerable Elderly
9. LFAGW to Run Could I Have Lupus? Workshop on July 26; Mystics Game Follows
10. DIA Workshop Features Industry and FDA for Discussion of Best Practices for Electronic Establishment Registration and Product Listing
11. Food crisis and global health workshop July 14-16
Post Your Comments:
(Date:11/24/2015)... ... ... Dr. Todd S. Afferica, a noted general dentist in Norcross, GA ... Afferica now uses the BIOLASE WaterLase iPlus 2.0™ in many of his dental procedures. ... traditional cutting tools, such as the scalpel and high-speed drill, which can both cause ...
(Date:11/24/2015)... ... November 24, 2015 , ... In an article published November ... determine which patients are or are not eligible for bariatric surgery. The article explains ... 40, are more than 100 pounds overweight, or have a BMI of 35 and ...
(Date:11/24/2015)... ... November 24, 2015 , ... It takes only three to five ... is critical that the first impression be positive and reflects business values. If a ... buy anything or want to return. They will also share their thoughts about a ...
(Date:11/24/2015)... ... 24, 2015 , ... Cancer patients, survivors, caregivers, family members ... live taping of the next CURE Connections® video series on Saturday, ... Symposium at Georgetown University Hotel & Conference Center in Washington, D.C. , CURE ...
(Date:11/24/2015)... ... November 24, 2015 , ... Aided by seed funding from the ... study designed to yield insights into how to detect and treat pancreatic cancer (PC). ... cancer from small, non-coding RNA molecules (ncRNA), genetic material that is present in the ...
Breaking Medicine News(10 mins):
(Date:11/24/2015)... 24, 2015 F1000Workspace - a ... since it was launched just six months ago. --> ... authoring platform for scientists - since it was launched just ... been loaded on to F1000Workspace - a research ... it was launched just six months ago. ...
(Date:11/24/2015)... st  Scientific Assembly and Annual Meeting of the Radiological ... in Chicago on Nov-29 th through ... st  Scientific Assembly and Annual Meeting of the Radiological Society of ... Chicago on Nov-29 th through Dec-4 th ... will present its revolutionary whole body CZT digital SPECT/CT solution at ...
(Date:11/24/2015)... , Nov. 24, 2015 Teledyne DALSA , ... image sensing technology, will introduce its CMOS X-Ray detector ... , November 29 to December 3, at McCormick Place in ... detectors for diagnostic and interventional imaging will be on display ... family of advanced CMOS X-Ray detectors is the industry ...
Breaking Medicine Technology: