Many Unknowns Surround Novel Trial Designs
By Deborah Borfitz

The vast majority of adaptive clinical trials (ACTs) that have been done to date appear to involve sample size re-estimation, says Jay Herson, PhD, senior associate in biostatistics at Johns Hopkins University. The "adaptive" methodology, which Herson helped develop in the mid-1990s, requires neither Bayesian analysis nor special accommodating software. It is well understood and no longer incites controversy within the industry or red flags at the FDA.

Regulatory acceptance of a seamlessly combined Phase IIB/III trial may be quite another matter, says Herson. "The big problem is that companies aren't getting the dose right even when they do many Phase II trials in the traditional fashion. Now they want to learn a lot in one trial and there's a lot of room for error and a lot of room for the FDA to not approve a drug because [of recent product recalls and public safety concerns]."

At Wyeth, a champion of the adaptive "Learn and Confirm" model of drug development, six adaptive dose-ranging studies involving "dynamic termination rules" were started in 2007 and another eight are expected to begin this year, according to Michael Krams, MD, assistant vice president, adaptive trials, clinical development. "If we decide not to go ahead with an adaptive design, it's mostly an internal [rather than an FDA-imposed] decision." Read more.

ClinPhone Combines Three Tools in One
By Ann Neuer

ClinPhone recently launched a combined EDC-IVR/IWR solution to bring much-needed efficiency to the process of data collection and management. "When electronic data capture (EDC) and interactive voice response (IVR) or Web response (IWR) systems are not linked together, you are asking sites or clinical research associates (CRAs) to enter data twice. This is painful from the work point of view," says Bill Byrom, VP of product strategy and marketing.

When data are entered into two different systems, invariably, there are issues around data reconciliation, and much time is wasted determining which system houses the correct information. Byrom explains, "Before integration, we used to spend a lot of time with clients cleaning and reconciling data at the end of the study when things weren't matching up among various datasets." Read more.

Provisio Moves into the Business of Protocol Feasibility Assessment
By Deborah Borfitz

Patient recruitment and site selection expert Provisio Inc. has a new service to help trial-sponsoring companies better assess protocol feasibility -- line by line and patient by patient.

The company's mammoth iTrials Data Universe contains information from more than 500,000 physicians with unique diagnoses/treatment histories on roughly 60 million patients. "Our data sources include EMR [electronic medical records], claims data, prescription and lab information, 1572 records, and other descriptive information such as physician profiles and referral patterns," says Mike Hassell, CEO of Provisio. Read more.

LIFE SCIENCE JOBS

Lilly Singapore Center for Drug Discovery (LSCDD) - Associate Director of Informatics,
Lead and mentor a strong team for the Bioinformatics group at the Integrative Computational Sciences (ICS) department at LSCDD towards the development of novel algorithms, data analysis methods and software tools for drug discovery. Work closely with the Software Engineering group at ICS, and collaborate with the Discovery IT organization in Europe and USA. For additional information, or to apply visit: LSCDD


Lilly Singapore Center for Drug Discovery (LSCDD)- Senior Bioinformatics Scientist,Contribute to the development of novel algorithms, data analysis methods and software tools for drug discovery as part of the Integrative Computational Sciences (ICS) department at LSCDD. Work closely with informatics and software engineering peers at ICS, and collaborate with the Discovery IT organization in Europe and USA. The successful candidate will offer hands-on insight and expertise in tailored therapeutic informatics and statistical analyses at the post-genomic era. For additional information, or to apply visit: LSCDD


Lilly Singapore Center for Drug Discovery(LSCDD) -Senior Software Engineer,
Join a strong team of software engineers in our Integrative Computational Sciences (ICS) at LSCDD. Collaborate with, and help develop integrated applications to process and visualize data from cutting-edge technologies used by scientists at Lilly Research Labs (LRL) and the Drug Discovery Research (DDR) teams. The Software Engineering team provides computational tools and tailored software solutions that enable the global effort of Tailored Therapeutics; ‘The Right Drug, at The Right Dose for The Right Patient at The Right Time'. For additional information, or to apply visit: LSCDD

Agilent Technologies-Asia Pacific - Job Requisition: 2021927
Job Title : Application Engineer and Implementation Specialist for Lab Informatics Platform
Location(s) : Bangalore, India. Project management: small to large scale implementations, including integration/ validation of Agilent’s software platform. Manage assigned customer account relationship, customer satisfaction and education of future Agilent plans. On time and on budget implementation, focus Pharma, Petro and Chemical markets. Qualifications: BS/’MS Degree in Computer Engineering, or other related discipline or equivalent. Apply

Agilent Technologies-Asia Pacific - Job Requisition:2021658, Job Title : Product Specialist – Laboratory Informatics Location(s) : Bangalore, India. Proactively understand customer needs and identify solutions to actively create business opportunities. Manage a complex, enterprise solution sale with long sales cycle. Develop approaches to achieve quota strategies. Lead coordinated projects across organizations. Solve complex broad range of problems. Qualifications: BS/MS Degree in Sciences, Engineering, Computer or equivalent plus 5 to 8 years work experience. Apply

GNS Biotech - Computational Scientist, Discovery Biology
Candidate will reverse engineer models from large coherent data sets. In addition, candidate will complete genome-wide association analysis of disease and drug-response and develop methods to deal with population genetic structure, pedigrees, missing data and computational scaling. http://www.gnsbiotech.com/careers/openings/

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IIR - 12th Annual EDC & Beyond, April 14-16, 2008, Las Vegas, NV

InforSense Translational Research Symposium, May 2,2008, Boston, MA

The First International Workshop on Label-free biosensing April 8-9, 2008, Enschede, The Netherlands

BioInformatics Asia 2008, April 14-17, Singapore

The Post-Approval Summit May 14-15, 2008, The Conference Center, Harvard Medical School, Boston, MA

The 1st Symposium on Protein Tomography -- May 1, 2008, Boston, MA

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TEPR 2008 -- May 17-21, 2008 Ft. Lauderdale,FL

Laboratory Informatics -- March 25-April 3, 2008, San Francisco CA.

Lean Six Sigma for Pharmaceutical, Biotech, and Medical Device Excellence -- February 25-27, 2008, Philadelphia, PA.

Best Practices Awards Program -- April 29, 2008, Boston, MA

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