International Pharmaceutical Industry ‘Supporting the industry through communication’
Designing Biobetter Monoclonal Antibody Therapeutics By Glycoengineering IPI - International Pharmaceutical Industry
Leveraging Today’s Technology for Clinical Trials Imaging
New Models for Cost Coverage of Drugs call for Improved Patient Compliance
Managing Pharmaceutical Globalization: A Work in Progress
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2 INTERNATIONAL PHARMACEUTICAL INDUSTRY
Managing and Assuring Safety and Quality Throughout the Pharmaceutical, Biopharm, Medical Device and Healthcare Provider organisations, safety and quality remain at the top of the agenda driven by adverse events and the responses to them, especially when they are well covered in the media. The industry has come a long way over the past 20 years. Improvements have been driven by, for example the development and application of standards for pharmaceuticals and medical devices such as ISO 15378 and ISO 14971, and the creation of standards by regulators such as the NHSLA standards and Standards for Better in England. Mark Boult of DNV explains how the overall performance against the standards by the healthcare organisations has improved over the years. Göteborg – World Leader in Biomaterials Göteborg, on the west coast of Sweden, is the site of numerous breakthroughs in research and development within medicine, and the city is today a leading cluster in biomaterials and cell therapy. (IPI Market Review 2009) DRUG DISCOVERY, DEVELOPMENT & DELIVERY
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Molecular Modelling for Optimization of Stabilized Therapeutic D-Peptides Peptides have become an important class of active therapeutic agents. In the last decade, a lot of synthetic peptide-based drugs entered the market as therapeutic agents. Dr. Udo Haberl & Prof. Dr. Hans-Georg Frank of Aplagen discusses Isosteric transformation which is a new and fast molecular modelling procedure enabling structure-based design of D-amino acid based peptides. It generates D-peptide based drug candidates in very short time. Biobridge-event 2009 Geneva: The Regenerative Medicine Conference Monday, 26th of October 2009 at the United Nations Office Geneva (UNOG), Palais des Nations, Switzerland, the Biobridge Foundation and its Scientific Committee will once again create a stimulating environment for debate and discussion on the topic of regenerative medicine, in which officials, scientific researchers, professionals and specialized scholars are invited to participate. It will take place under the Conseil d’Etat de la Republique et Canton de Genève high patronage. Big Pharma R&D—thinking big, acting small In order to mitigate the considerable risks in developing drugs, the pharmaceutical industry is going through an extended phase of consolidation to try to realise economies of scale. In this paper James Man & Andy Black of Kinapse outlines critical success factors for making disintegration work. This includes having talent management with a clear focus on leadership development, structuring operating units around clear areas of competence and performance, having clear divisions of accountabilities and transparent cost accounting between operating units.
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Designing Biobetter Monoclonal Antibody Therapeutics By Glycoengineering Monoclonal antibodies (MAbs) currently comprise the fastest growing class of protein therapeutics - primarily for the treatment of cancers and autoimmune, infectious and inflammatory diseases. One area of great interest to developers, copiers and improvers of therapeutic antibodies is glycosylation since it can significantly influence the safety and efficacy profiles of the drug in this article, By Dr. Claire Morgan and Dr. Daryl Fernandes of Ludger shows how both the original drug manufacturers and the designers of follow-on biologics could produce biobetter antibodies through glycoengineering. In vitro alternatives to reduce animal use and to decrease drug development costs In preclinical drug development in vitro studies have obtained a more prominent position. Because of ethical considerations an increasing number of in vivo tests have been replaced by in vitro experiments. These tests are recommended by many organizations. The National Institutes of Health (NIH) and other federal agencies are committed to the welfare of research animals. These animals are protected by law, regulations and policies to ensure use in the smallest number possible and with the greatest commitment to their comfort. By: Ida A.J. Verbaan-Giebelen of NOTOX B.V. High-Throughput Antioxidant Determination – The ORAC Assay performed on Multidetection Microplate Readers Antioxidants, present in fruits, vegetables and whole grains, act as free radical scavengers and thus are thought to protect living cells from being damaged by reactive oxygen species (ROS). In this article Franka Ganske, Marjan Orban, and Michael Fejtl, of BMG LABTECH, presents s the ORAC assay as a tool to measure antioxidant capacity in fruit juices in a highthroughput microplate format.
Leveraging Today’s Technology for Clinical Trial Imaging Over the last decade, medical imaging has been playing a greater role in the diagnosis of disease and, logically, there has been an analogous increase in the use of imaging in all phases of clinical trials to evaluate new drug candidates. Leveraging telecommunication tools for file transfer and integrating imaging with electronic data capture (EDC) has the potential to transform the manner in which imaging is used in clinical trials. Abraham Gutman of AG Mednet & Robert Quinn of Phase Forward analyses new tools that are now available that make this integration a reality and could provide better transparency for sponsors, improve data quality, reduce costs, give more de-identification options, and even reduce a firm’s carbon footprint.
Central Component of Drug Development Contemporary lifecycle drug development encompasses in silico computer simulation modeling of drug molecule binding to both target and off-target receptors, nonclinical investigation, preapproval clinical studies, and postmarketing surveillance.1 Since cardiac and cardiovascular adverse drug reactions are serious and potentially lethal, their lifecycle assessment is critical.2 While assessment in all of these four phases is important, this paper focuses registration studies. J. Rick Turner, Senior Director, Cardiac Safety of Quintiles ECG Services has provided a sample of cardiac and cardiovascular safety assessments during contemporary drug development. An Interview with Kenneth G. Faulkner and James Paskavitz of Perceptive Informatics on a robust medical imaging methodology for Central Nervous System (CNS) clinical trials involving Alzheimer’s disease India – Worlds best choice for clinical trials India has the potential to attract 5-10% of the global contract research outsourced market (all services including chemistry, toxicology and clinical research) over the next 5 years. The Indian government has recognized that India can become a hub for conducting global clinical trials. The Planning Commission’s Report of the High Level Group on Services Sector highlights the opportunities and identifies the gaps that need to be addressed by the government for this sector. Dr. Rajam Jaishanker of Quest Life Sciences discusses the factors contributing to a gradual but steady growth. Ethics Committees in India- An insight Ethics Committee (EC(s)) constitutes the third arm of the research triangle and it can make significant contribution towards the ethical conduct of clinical trials. Post 2005, i.e. after schedule Y has been amended, obtaining ethics committee approval is one of the mandatory step towards conduct of the trial. While amended Schedule Y1, ICHGCP Guidelines2, Indian GCP3 specifies standards to be maintained by ECs, the majority of institutions in India still lack compliance with the applicable standards in a true sense. Deepti Goel of Cliniminds takes a look at major areas that require immediate attention and correction. LABS & LOGISTICS
Successfully involving central laboratories: How to avoid fundamental errors No doubt, central laboratory services are complex, particularly due to the logistical tasks involved. One aspect renders central lab services different to almost any other service outsourced by Pharma or Biotech companies during a clinical trial: biological samples have a limited stability and if the lab provider does not take this into account in many cases the samples may
Cardiac and Cardiovascular Safety Assessment: A 4 INTERNATIONAL PHARMACEUTICAL INDUSTRY
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