Navigation Links
SNM's Clinical Trials Network expands European membership of PET biomarker manufacturers
Date:7/23/2009

Reston, Va.SNM's Clinical Trials Network today announced that several leading commercial providers of PET radiopharmaceuticals in Europe have registered their manufacturing sites with the network. SNM's Clinical Trials Network is an initiative designed to address the need for streamlined drug discovery through the integration of imaging biomarkers into multi-center clinical trials.

According to Michael M. Graham, M.D., Ph.D., SNM President and co-chair of the Clinical Trials Network, "SNM is very pleased to have the support of Advanced Accelerator Applications, Erigal Limited and IBA Molecular. Their participation in the network will afford European clinical trial sites the option to obtain investigational imaging agents like FLT from a commercial provider instead of having to produce it themselves." These commercial manufacturers represent 27 PET manufacturing sites in Europe.

The SNM Clinical Trials Network has received investigational new drug (IND) status for the use of FLT in multicenter studies. The goal of the network is to receive multicenter IND status for additional imaging biomarkers over time. Each imaging site that participates in a study using an SNM multicenter IND will need to demonstrate that the biomarker for the study is manufactured in a manner consistent with FDA standards. Now, in place of submitting detailed information about in-house production methods, sites will have the option to purchase investigational biomarkers from a commercial manufacturer with a drug master file (DMF) on file with the FDA. Advanced Accelerator Applications, Erigal Limited and IBA Molecular have all expressed interest in participating in future multicenter clinical trials under SNM INDs. Participation in any specific trial will require that these manufacturers have chemistry, manufacturing and control (CMC) information on file with the FDA for the investigational imaging biomarker being used in that trial.

"We hope that having commerci
'/>"/>

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

0

GOOD

Page: 1 2

Related medicine news :

1. Radiologists encouraged to look beyond cancer for clinically unseen diseases
2. Clinical depression linked to abnormal emotional brain circuits
3. Preclinical study suggests organ-transplant drug may aid in lupus fight
4. Provectus Pharmaceuticals, Inc. Begins Phase 2 Clinical Trial for Metastatic Melanoma
5. Good Clinical Practice Journal Awards: Winners Announced
6. Microsoft Helps Developers of Clinical User Interfaces Improve Efficiency, Patient Safety With Free Toolkit
7. Study Questions Dead-End Cancer Clinical Trials
8. Genomic Health Announces Multiple Studies on Oncotype DX(TM) Presented at 2007 American Society of Clinical Oncology (ASCO) Breast Cancer Symposium
9. Clinical trials present better alternatives for dialysis patients
10. Mirixa Debuts New Clinical Technology Solutions for Enhancing Patient Care
11. IMPACT initiative looks to improve patient participation in clinical trials
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2013)... measuring fractional flow reserve (FFR) using pressure wire ... pain leads to significant changes in the management ... from a study reported at EuroPCR 2013. , ... management strategy at coronary angiography for diagnosis of ... routine assessment of FFR in all the main ...
(Date:5/24/2013)... Beach Gardens, FL (PRWEB) May 24, 2013 ... surgeons jealous, Dr. Greg DeLange of the Estetica ... of the hosts of KOOL 105.5 FM’s popular morning show, ... the air about their experiences and their satisfaction with the ... Institute, a cutting-edge facility located in Palm Beach Gardens, very ...
(Date:5/24/2013)... (PRWEB) May 24, 2013 Electric™ Energy Straws, ... fueling IndyCar Rookie Carlos Munoz and will be the lead ... 500 at the Indianapolis Motor Speedway. Munoz, who is part ... speed of 228.342 mph in race, qualifying to be named ... the first row in Sunday’s race. , While Munoz ...
(Date:5/24/2013)... OH (PRWEB) May 24, 2013 ... provider of barcode identification, tracking and data management ... acquired Triangle Biomedical Sciences Inc., (TBS) of Durham, ... instrumentation, reagents and consumables for the clinical and ... of General Data Healthcare, which provides specialty products ...
(Date:5/24/2013)... New research presented today shows that formation of new ... for its importance in learning and remembering - could ... of existing brain circuits. Drs. Paul Frankland and ... in Toronto, argue this reorganization could have the positive ... increasing capacity for new learning. These results were ...
Breaking Medicine News(10 mins):Health News:Diagnostic coronary angiography: Functional flow reserve changes decisions in 25 percent of cases 2Health News:Dr. Greg DeLange of the Estetica Institute Recently Performed Eye Surgery on Both Members of Popular Morning Radio Team 2Health News:Unistraw Electric™ Energy Straw Chevy Car Powers Indianapolis 500 Rookie Driver Carlos Munoz 2Health News:Unistraw Electric™ Energy Straw Chevy Car Powers Indianapolis 500 Rookie Driver Carlos Munoz 3Health News:General Data Acquires Triangle Biomedical Sciences 2Health News:General Data Acquires Triangle Biomedical Sciences 3Health News:New neuron formation could increase capacity for new learning, at the expense of old memories 2
... , ... products and services provider DHS Technologies LLC recently revealed its newest shelter system – ... ... Technologies LLC recently revealed its newest shelter system – the Reeves Mobile Vaccination System., ...
... ... income in the current economy, and who are looking to better their health, too, can ... enlisting interested business leaders nationwide., , ... (PRWEB) March 16, 2010 -- Independent businessman Brad Aspin and leading health and wellness ...
... Large amounts of frozen plasma are being used inappropriately, ... Medical Association Journal ) (pre-embargo link only) http://www.cmaj.ca/embargo/cmaj081933.pdf ... the clinical use of red blood cells and platelets ... of frozen plasma. "Two recent studies in Canada ...
... ... ... SAN RAFAEL, Calif. , March 15 The following was released today by the Marin Institute: , ... , , ...
... March 15 Spotlighting the importance of oral health care for expectant mothers, the California Dental Association (CDA) Foundation has released new guidelines designed to emphasize the safety of ... ... ... ...
... , March 15 The Board of Directors of Healthcare Trust of America, Inc. ("HTA"), ... June 2010 .  These distributions will be calculated based on the stockholders of record each day ... $10.00 . , ... ...
Cached Medicine News:Health News:DHS Technologies Unveils New Mobile Vaccination System 2Health News:Brad Aspin and Health and Wellness Company GBG Now Looking for Leaders Nationwide 2Health News:Advocates Rally Southland Assembly Health Committee Members to Pass AB 1694 2Health News:Advocates Rally Southland Assembly Health Committee Members to Pass AB 1694 3Health News:Advocates Rally Southland Assembly Health Committee Members to Pass AB 1694 4Health News:California Dental Association Foundation Releases New Oral Health Guidelines for Pregnant Women 2Health News:California Dental Association Foundation Releases New Oral Health Guidelines for Pregnant Women 3Health News:California Dental Association Foundation Releases New Oral Health Guidelines for Pregnant Women 4Health News:Healthcare Trust of America Board of Directors Declares Distributions 2Health News:Healthcare Trust of America Board of Directors Declares Distributions 3
(Date:5/23/2013)... -- Hearing health affects a man,s lifestyle, and if he ... professionally engaged, he should address any hearing loss he may ... Better Hearing Institute (BHI) is delivering to men around ... , which leads up to and includes Father,s Day. This ... June 16. To help men address their ...
(Date:5/23/2013)... , May 23, 2013  TeamHealth Medical ... nurse triage and nurse advice lines, announces its ... comprising physician, nursing and administrative leaders, provides clinical ... quality and cost-effective services for hospital clients, physician ... national healthcare system evolves, it,s imperative to continuously ...
(Date:5/23/2013)... DIEGO , May 23, 2013  The ... prostate cancer treatment continuum was highlighted prominently at ... American Urological Association (AUA), in San Diego.  According ... high intensity focused ultrasound (HIFU) technology, the need ... disease, and for urologists to consider minimally invasive ...
Breaking Medicine Technology:Men Who Want to Stay Active, Feel Younger, and Remain Socially and Professionally Engaged Should Address Hearing Loss, BHI Advises 2Men Who Want to Stay Active, Feel Younger, and Remain Socially and Professionally Engaged Should Address Hearing Loss, BHI Advises 3Men Who Want to Stay Active, Feel Younger, and Remain Socially and Professionally Engaged Should Address Hearing Loss, BHI Advises 4TeamHealth Medical Call Center Forms Clinical Advisory Committee 2Need for Image Guided Minimally Invasive Ablative Treatments Featured Prominently at American Urological Association (AUA) Annual Meeting 2Need for Image Guided Minimally Invasive Ablative Treatments Featured Prominently at American Urological Association (AUA) Annual Meeting 3Need for Image Guided Minimally Invasive Ablative Treatments Featured Prominently at American Urological Association (AUA) Annual Meeting 4Need for Image Guided Minimally Invasive Ablative Treatments Featured Prominently at American Urological Association (AUA) Annual Meeting 5Need for Image Guided Minimally Invasive Ablative Treatments Featured Prominently at American Urological Association (AUA) Annual Meeting 6
... Access Pharmaceuticals, Inc.,(OTC Bulletin Board: ACCP) ... using the company,s proprietary Cobalamin(TM) technology, to,significantly ... of diabetes, through,its oral insulin product candidate. ... the body,s natural absorption of vitamin B12 ...
... Some 5,000 COPD patients will be tested,to ... in,a study marking a major cooperative effort between ... Care (AARC)., The principal investigator is Robert ... Medicine, National Jewish Medical and Research Center,in Denver. ...
Cached Medicine Technology:Access Pharmaceuticals Demonstrates Ability to Significantly Reduce Glucose Levels in Pre-clinical Testing of Cobalamin(TM) Oral Insulin 2Access Pharmaceuticals Demonstrates Ability to Significantly Reduce Glucose Levels in Pre-clinical Testing of Cobalamin(TM) Oral Insulin 3Alpha-1 Foundation, AARC Cooperate on Study to Test 5,000 COPD Patients for Alpha-1 2Alpha-1 Foundation, AARC Cooperate on Study to Test 5,000 COPD Patients for Alpha-1 3
Indications For Usage: ,Airway management during anesthesia or short-term surgical procedures....
Indications For Usage: , Airway management during surgical procedures. , Long-term ventilatory management. ...
Indications For Usage: , Nasal surgery. , Ophthalmic surgery. , Facial surgery. , T&A surgery. ...
Indications For Usage: ,Airway management during pediatric surgical procedures and intensive care....
Medicine Products: