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| home > ebr > Summer 2002 |
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 PUBLICATIONS |
European Biopharmaceutical Review |
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| At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. EBR provides a unique platform of communication for the market across Europe, North America and the rest of the developed world. To find out what's hot in the world of of biopharmaceuticals, take a look below at the range of articles featured in this issue of EBR. |
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| In her Editor's Letter, Dr Helen Abbott gives us a brief synopsis of the range and content of this issue |
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| What are the driving factors and the change in management approach needed to negotiate the risk transfer issues the industry is facing? Howard Pearson, a Director and Head of the Science and Technology Team at The Miller Insurance Group, presents some of the answers in Preventing Risk Becoming a Crisis |
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| Dr Benjamin Jones, Business Development Manager at Huntingdon Life Sciences Ltd, comments on the value of contract research organisations and the growth of contract research in the context of the biopharmaceutical industry, in his article Contract Development - Industry Spend and Value |
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| In the current climate of consolidation within the biomedical sector, many companies may find that they need adopt a flexible approach to their business strategy or face losing their investments. Martin Austin, Director of European Operations, Paul Royalty Funds, at Paul Capital Partners, presents A Case for Alternative Financing in Biomedical Companies INDUSTRY DYNAMICS |
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| The success of large pharmaceutical companies primarily reflects their development and marketing of blockbuster drugs, but Where is the Blockbuster Market Heading? Dr Linda McNamara, Healthcare Strategy Analyst at Datamonitor provides a must read analysis of the current and future blockbuster market |
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| Dr Helen Abbott, Senior Consultant at Technomark Consulting Services, reviews Beyond Borders - Ernst & Young's Global Biotechnology Report 2002 |
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| Dr Abbott's been busy this month! Read her review of the 2nd European C21 BioInvestor Conference (EC21), Munich, 2002 |
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| Dr Andreas Rьhlmann, European Bioinformatics and Microarray Specialist at Agilent Technologies, examines current therapeutic developments for the treatment of central nervous system defects, in Gene Therapy for Damaged Nerves |
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| If the dream of proteomics is the identification and characterisation of all proteins, then the nightmare is the number of unique functional protein structures. Dr Lucio van Rooijen, Vice President Business Development, and Dr Josef Schwarz, Director of Protein Profiling at Xzillion, examine the Ongoing Challenges in Proteomics |
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| Keith Chidwick, Consultant at Technomark Consulting Services, reviews Shayla Walmsley's Scrip report in Delivering Gene Therapy - A Review |
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| Dr Frank Kooy of the Mental Retardation Research Group, Department of Medical Genetics, University of Antwerp in Belgium, explores the Genetic Aspects of Mental Retardation, explaining why a better insight into the molecular causes of retardation could lead to realistic therapies for the mentally handicapped |
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In Proteolytic Enzymes as Therapeutic Targets, Dr Urs Lüthi, Senior Scientist at ESBATech, reviews a number of methods that have allowed molecular cloning of secretases and discusses various approaches to discovering specific secretase inhibitors
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| Screening, production and test systems are crucial for the survival of drugs through the development process, making careful selection of these systems vital. Michael Zang-Gandor, CEO of Eugenex Biotechnologies GmbH, explores these selection processes in Finding the Meaning of the Gene |
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| The debate about the safety and ethics of gene therapy has always been controversial. Daniel Gooch, Jayne Spink and John Connolly at the Department of Health in London, examine The Role of the Gene Therapy Advisory Committee in the Ethical and Regulatory Oversight of UK Gene Therapy |
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| The UK Government has demonstrated a determination to increase the level of R&D investment by UK industry. Dawn Primarolo MP, Paymaster General for HM Treasury, explains Why R&D Matters |
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| EBR's Editor, Helen Abbott, takes an in-depth look at the key lessons to be learnt from the review process for b-IFN treatment of multiple sclerosis patients in the UK, in her interview with two of the three product manufacturers (Serono and Schering), and the UK Multiple Sclerosis Society |
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| Anne-Toni Rodgers, Communications Director of the National Institute for Clinical Excellence (NICE), outlines NICE and the Technology Appraisal Process and presents the facts behind the NICE appraisal of beta-interferon |
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| EBR's Editor reviews BIO 2002, Toronto and the launch of CORDIA, Vienna |
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| Is Data-Mining - The Magic Eye of Informatics? ask Dr Jonathan Heal, Director of Informatics, and Dr Jonathan Swinton, Senior Computational Biologist at Proteom Ltd |
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| Dr Jцrg Sprengel, Executive Project Director i-biology® at LION bioscience AG, examines The Pivotal Role of IT Systems in Drug Delivery and Innovation |
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In Singapore - A World Class Hub for Biomedical Sciences, Tan Hsueh Mei at the Singapore Economic Development Board, introduces the 'Biopolis of Asia'
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| Daniel Pavin, a Solicitor Specialising in Intellectual Property and Information Technology Law with Taylor Joynson Garrett, is the bearer of Good News for European Bioinformatics - The Database Right |
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| In Effective Gene Transfer in Neurobiology, Professor Alan Kingsman, Chief Executive Officer and Co-Founder of Oxford BioMedica plc, reviews the vectors available for gene therapy in neurobiological applications and examines potential gene therapy approaches for neurodegenerative disease and nerve regeneration |
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| Dr Salvatore Febbraro, Medical Director at Simbec Research Ltd, looks at Early Phase Clinical Trials of Biopharmaceuticals |
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| The issues involved in Post-Translational Modifications of Biopharmaceuticals - A Challenge for Analytical Characterisation are outlined by Dr Fiona Greer, Dr Andrew Reason and Dr Mark Rogers of M-Scan |
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| Dr Mark Bodmer, Chief Executive of Lorantis Ltd, examines the quest for the 'holy grail' of immunotherapy in Immunotherapy - From Suppression to Tolerance |
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News and Press Releases |
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3P Biopharmaceuticals receives FDA approval
[Pamplona, September 16th, 2019] 3P Biopharmaceuticals (3P), a leading Contract Development and Manufacturing Organisation (CDMO) specialized in process development and GMP manufacturing of biologics, receives FDA approval after completing the Pre-Approval Inspection (PAI) conducted at the 3P drug substance manufacturing facility.
More info >> |
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White Papers |
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Extractables and Leachables Testing: A Risk Based Approach
RSSL
Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime.
Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance.
Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure.
This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
More info >> |
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Industry Events |
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BioTrinity 2020
28-29 April 2020, Digitally delivered
BioTrinity is a long-running and highly regarded two day life sciences conference that takes place in Central London from 28-29 April. BioTrinity focuses on partnering, investment and collaboration and aims to inspire growth and create opportunities for all who attend. The core delegate mix includes early-stage and emerging biotech, medtech and digital health companies, big pharma executives and life sciences investors.
More info >> |
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