Navigation Links
Annual SNM MI summit introduces the clinical trials network
Date:1/13/2009

RESTON, Va.SNM will devote its annual Molecular Imaging Summit to introducing the new SNM Clinical Trials Network, Feb. 8𔃇, 2009, at the Hilton Clearwater Hotel, Clearwater, Fl. In part, the program will explain requirements of participation in the Clinical Trials Network, which was designed to facilitate cost-effective drug development through the integration of imaging biomarkers into Phase 1, 2, 3 and 4 therapeutics clinical trials. In addition, the workshop will explore key issues involved with imaging participation in multi-center trials.

"Attendance at this workshop is a must for imaging centers, pharmaceutical manufacturers and others who wish to be involved with the SNM's Clinical Trials Network," said Robert W. Atcher, Ph.D., M.B.A, president of SNM. "This intensive two-day program will outline the nuts and bolts of the network and requirements for participation."

The goal of SNM's Clinical Trials Network is to bring together the pharmaceutical industry, the imaging community, biomarker manufacturers and regulatory agencies and provide them with processes, standards and protocols to streamline the use of imaging in the development and testing processes for new pharmaceuticals. The use of imaging in clinical trials can help pharmaceutical developers determine earlier in the development process whether a new product is clinically promisingaccelerating the development of these promising drugs and eliminating those without apparent patient benefit. However, including these investigational imaging biomarkers in clinical trials for investigational therapeutics poses challenges for a drug development company, including a lack of standardized imaging methods and challenging regulatory approval or paperwork requirements for the imaging biomarker.

Several discussions between FDA and SNM have surfaced on this issue of limited harmonization of imaging protocols between multiple imaging centers. The use of a consistent methodology and protocol is key to quality data generation and ultimate FDA approval of investigational therapeutics.

"It is important that interested imaging centers, drug manufacturers and other facilities get involved at this time as there are steps to be taken to ensure imaging standardization and to maintain imaging quality control across multiple sites," added Atcher. "This workshop will give members of the molecular imaging community an overview of the network and specific steps that participating imaging sites can take to ensure that they are qualified for participation in therapeutic clinical trialsand remain qualified over time. Speakers from the Food and Drug Administration, National Cancer Institute, pharmaceutical development industry and the imaging community will share their thoughts on specific needs for imaging biomarkers in drug development and the unique issues involved with incorporating imaging into multi-center clinical trials.

This comprehensive workshop will be held immediately after SNM's Mid-Winter Educational Symposium. It is slated to include presentations and discussions about: methods and short-comings of current drug development practices; the potential for imaging biomarkers in multi-center clinical trials; the role of the Clinical Trials Network in drug development; and fundamentals of participation in this network. SNM will discuss the specific goals and detailed plans of the Clinical Trials Network, including the roles and responsibilities of participation in network imaging and manufacturing registries, the phantom program and the 2009 F-18-fluorothymidine (FLT) demonstration project. Representatives from drug trial sponsors will discuss the specific needs for imaging in multi-center clinical trials.


'/>"/>

Contact: Amy Shaw
ashaw@snm.org
703-652-6773
Society of Nuclear Medicine
Source:Eurekalert

Related medicine news :

1. Covance to Present at the 27th Annual J.P. Morgan Healthcare Conference
2. Agito Networks Earns INTERNET TELEPHONY Magazines 11th Annual Product of the Year Award
3. Abaxis, Inc. to Present at Sidoti & Companys Sixth Annual Palm Beach Emerging Growth Institutional Investor Forum
4. WebMD to Present at the 27th Annual J.P. Morgan Healthcare Conference
5. drugstore.com to Present at the 11th Annual ICR XChange Conference
6. Hop the Trolley for DNAs 27th Annual Conference
7. Almost Family to Present at 27th Annual J.P. Morgan Healthcare Conference
8. Society of Gynecologic Oncologists to Host 40th Annual Meeting on Womens Cancer
9. Hanger Orthopedic Group, Inc. Announces Six Acquisitions Totaling $8.9 Million of Annual Net Revenue
10. Medivation Announces Participation in 27th Annual J.P. Morgan Healthcare Conference
11. VNUS Medical Technologies to Present at 27th Annual J.P. Morgan Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published June ... with. The article goes on to state that individuals are now more comfortable seeking ... common operations such as calf and cheek reduction. The Los Angeles area medical group, ...
(Date:6/24/2016)... ... 2016 , ... June 19, 2016 is World Sickle Cell Observance Day. In ... benefits of holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued ... Sickle Cell Disease (SCD) is a disorder of the red blood cells, which can ...
(Date:6/24/2016)... ... 2016 , ... The Pulmonary Hypertension Association (PHA) learned during ... two significant new grants to support its work to advance research and patient ... recognizing patients, medical professionals and scientists for their work in fighting pulmonary hypertension ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all areas of ... AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to ...
(Date:6/24/2016)... ... ... BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a ... an hour by 2020 and then adjusting it yearly to increase at the same rate ... assure the wage floor does not erode again, and make future increases more predictable. , ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... BEIJING , June 24, 2016 Dehaier ... or the "Company"), which develops, markets and sells medical ... China , signed a strategic cooperation agreement with ... as "Hongyuan Supply Chain") on June 20, 2016, to ... Under the strategic cooperation agreement, Dehaier will leverage Hongyuan ...
(Date:6/24/2016)... 24, 2016 Research and Markets has ... Companion Diagnostic Tests" report to their offering. ... Diagnostics The World Market for Companion Diagnostics ... diagnostics. Market analysis in the report includes the following: ... Vitro Diagnostic Kits) by Region (N. America, EU, ROW), 2015-2020 ...
(Date:6/24/2016)... LEXINGTON, Mass. , June 24, 2016   ... specialty pharmaceutical company developing innovative inhaled drugs, announced today ... when Russell Investments reconstituted its comprehensive set ... 2016. "This is an important milestone for ... "It will increase shareholder awareness of our progress in ...
Breaking Medicine Technology: