Rapid progress in neuroimaging technologies fuels central nervous system translational medicine.

Central nervous system (CNS) drug discovery suffers from high attrition rates; translational neuroscience approaches aiming to reduce these high rates include the use of brain imaging technologies. However, there is a need to better understand what methods are being used and for what diseases and purposes. Our analysis of the literature found that magnetic resonance imaging (MRI), positron emission tomography (PET), and single-photon emission computed tomography (SPECT) were the neuroimaging techniques used most often in clinical trials for the most prevalent CNS diseases: Alzheimer's disease (AD), Parkinson's disease (PD), depression, and schizophrenia.

State of the industry for drug-diagnostic development: challenge and change on the path to precision medicine.

Four challenges to the adoption of personalized medicine were identified in the mid-2000s - adherence to the blockbuster model, the lack of a supportive regulatory environment, the dysfunctional payment system and physician barriers. In this article, we report on our study findings based on interviews with 24 senior executives from leading drug and diagnostics companies to assess progress made in addressing those challenges over the last decade. Overall, we found that even with payer pushback and adjusting to new business models, the majority of developers expected their business to increase over the next 5 years.

An Examination of eClinical Technology Usage and CDISC Standards Adoption.

Background: The Tufts Center for the Study of Drug Development (Tufts CSDD) collaborated with the Clinical Data Interchange Standards Consortium (CDISC) on a joint working group study with 10 participating companies including biopharmaceutical, CROs, and eClinical technology vendors. The objective of the study was to examine current and projected use of eClinical technology and standards across respondent organizations and in clinical studies and to gather perceptions and attitudes about technology and standards adoption.

Methods: The Tufts CSDD study examined the use of eClinical technology and CDISC standards through a comprehensive survey combined with analyses of clinical study data among biopharmaceutical companies and contract research organizations.

Complementary versus companion diagnostics: apples and oranges?

There have been several major problems that have plagued biopharmaceutical development since the end of the 1990s, but two in particular have reached the point where they are impacting the economic viability of the industry: the lack of efficacy of new drugs and increasing competition among therapeutics that broadly attack certain common diseases and disease areas. The US FDA has noted that the era of one-size-fits-all treatment may well be reaching its end days as companies increasingly adopt approaches that involve biomarkers (there are now commercial databases that purport to track over 11,000 of them). Pharmacogenomic biomarkers in particular are used to create diagnostics that help to differentiate or stratify the likely outcomes a patient will experience with a drug, which can now be said to be targeted or tailored to patients with particular traits (i.

New challenges to medicare beneficiary access to mAbs.

Precision binding of monoclonal antibodies (mAbs) to biological targets, their relative clinical success, and expansion of indications following initial approval, are distinctive clinical features. The relatively high cost of mAbs, together with the absence of a regulatory pathway to generics, stand out as distinctive economic features. Based on both literature review and primary data collection we enumerated mAb original approvals, supplemental indications and off-label uses, assessed payer formulary management of mAbs, and determined new challenges to Medicare beneficiary access to mAbs.