Clinical development plans require efficiency, expertise and agility in a rapidly changing regulatory and treatment environment. Meghann Smith and Kathy Burruss of Ockham explain the major points of consideration regarding the ability to strategically guide compounds through the clinical development process in a cost-effective manner by utilisation of a niche oncology CRO.
The cost of patient enrolment is now the single largest part of the total trial budget, representing 32% of the cost. Among CROs and sponsors, this expense has been accepted as the inevitable cost of trial management, but it no longer should be. Richard Malcolm of Acurian considers what impact the emerging CRO/sponsor strategic partnerships that represent the latest trend in the CRO industry will have on patient enrolment.
Optimised Commissioning of Control systems Pre-Parameterisation of Control Systems Facilitates their Planning and Commissioning
In the commissioning of control systems, coordination problems between the selected individual components occur quite frequently. Dr Egon Huefner, of Bürkert Fluid Control Systems, discusses a new, integrated controller concept with pre-parameterised control systems and defined components that prevents these problems and ensures fast, trouble-free commissioning.
Traditional high-throughput screening (HTS) strategies searching for single targets have not led to a high number of promising leads for new drugs. Hence pharmaceutical companies are now increasingly looking for multi-target drugs to investigate. Dr E J Dell of BMG LABTECH explains how a next-generation photomultiplier- (PMT-) based instrument was compared to a high-performance charged coupled device (CCD), and how a next-generation HTS microplate reader provides a new more economical tool for finding lower affinity drug discovery compounds via traditional HTS bioassays.
The ever ageing global population has led to an increasing prevalence of protein misfolding diseases, which underlie a number of serious and chronic degenerative conditions. The misshapen structures of these abnormal proteins make them aggregation-prone, leading to the formation of toxic aggregates that underlie various disease pathologies. As the details of the science of this process continue to unfold, new therapeutic approaches to combat this fundamental mechanism of senescence are now emerging. Dr Mark Treherne, Chief Executive at Senexis, explains that as our understanding of the science underlying this fundamental pathological process continues to evolve, we will come ever closer to unfolding the fascinating science of protein senescence.
Drug Discovery: Reversed-Phase High Pressure Liquid Chromatography for Protein/Peptide Identification
Scientists typically perform unbiased protein identification by directly coupling reversed-phase high pressure liquid chromatography (HPLC) via electrospray ionisation to a mass spectrometer. Unlike innovations in mass spectrometric instrumentation, cutting-edge technology in reserved-phase HPLC has generally not been well adopted in drug discovery. Remco Swart at Thermo Fisher Scientific describes the effects of increased peak capacities on the number of identified proteins and peptides in complex mixtures utilising an RSLCnano LC system, providing a rationale for using advanced reversed-phase HPLC technology coupled with tandem mass spectrometry (HPLC-MS/MS).
Drug development is a lengthy process; development durations of 10–15 years are commonplace when following the established paradigms. Zheng Jim Wang and Mark R. Lane of MPI Research explain that a recent shift in drug discovery efforts, utilising novel biomarkers against specific molecular targets highlights, has seen the need for robust molecular imaging platforms to provide specific endpoints.
The New Life Science Solution and its Implications on Document Management for Pharmaceutical Companies
The European Medicines Agency (EMA) recently announced new pharmacovigilance legislation, more commonly known as “the pharmaceutical package”. In this package the EMA describes how to modernise its pharmacovigilance system, how to improve patient safety and how to supply health information to patients. Olaf Schoepke and Gerhard Neurauter at EXTEDO explain how agencies and pharmaceutical companies can address this new legislation, along with the respective consequences for their data management.
The NCD epidemic is hitting vulnerable, socially and economically disadvantaged people the hardest. The World Economic Forum’s 2010 Global Risk Report lists NCDs as the second-greatest risk to global economic growth. One half of those who die from NCDs are in their productive years, making the social costs and economic consequences in terms of lost productivity considerable. Rebecca MORTON DOHERTY of Union for International Cancer Control (UICC) discusses that, by having the UN Summit and agreement on a political declaration on NCDs, the process of addressing NCDs globally has been set in motion in the most powerful way.
Healthcare in the developed world is on the edge of a precipice. Populations are aging and healthcare costs are rising against the backdrop of uncertain economic times. Consulting the latest OECD figures shows the cost of healthcare as a percentage of GDP rising from 13.6% to 17.4%. Nick Rollings of Sagentia explores how the pharma industry itself is undergoing a period of intense change.