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| home > ebr > Spring 2015 |
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 PUBLICATIONS |
European Biopharmaceutical Review |
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Editor’s Letter
Deborah O’Neil comments on the ever-changing regulatory landscape, reminding us how quickly the industry moves, as well as highlighting a number of this edition’s features.
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Clinical Trial Agreements
Standard Practice
As overheads rise, Richard Dickinson, Blaine Templeman and Jackie Mulryne from Arnold & Porter LLP propose implementing more simplistic and standardised approaches to documentation, which will improve the cost and timing of clinical trial contracting.
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Patent Cancellation
On the Attack
Olga Partington and Paul Calvo of Sterne, Kessler, Goldstein and Fox discuss the similarities and differences between US post-grant proceedings and European oppositions when it comes to challenging a patent.
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America Invents Act
Patents Overhauled
Tom Scourfield and Andrew Payne at CMS review the America Invents Act, noting that, although its requirements have gone some way towards harmonising regulation with the rest of the world, some provisions remain unique to the US.
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Q&A: Epidemics
Expect the Unexpected
Peter Openshaw from Imperial College London advises on what steps pharma and governments can take to manage the widescale threats from communicable diseases.
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Q&A: Nanomedicine
Small and Mighty
Nanobiotix’s Laurent Lévy tells EBR about the many applications of nanomedicine in healthcare, and what this could mean for the sector over the next decade.
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Industry Interview
Beating Cancer
EBR quizzes Hamish Ryder about the projects he is working on at Cancer Research Technology’s Discovery Laboratories, and how they could benefit patients.
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In Brief
The Weakest Link
Emile Bellott reflects on current approaches to precision medicine, and suggests how the industry can make the most of research funding.
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Clinical and Regulatory Strategies
Biosimilars Go Global
Kinesys Consulting’s Gerry McGettigan and Elizabeth Yamashita at Oncobiologics observe how commercial drivers are gradually pushing companies to produce biosimilars that meet the technical standards and regulatory requirements of all major international markets.
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Advanced Therapy Medicinal Products
Coming of Age
Despite slow progress, Gopalan Narayanan of the NDA Group believes the future is bright for cell- and gene-based therapies. Due to their potential in curing or correcting disease pathology, the industry should see increased uptake across the field, with more products gaining approval.
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Bioterrorism
The Lone Wolf
Miri Halperin Wernli at Actelion Pharmaceuticals and Boaz Ganor at the International Institute for Counter-Terrorism urge biopharma firms to remain vigilant against potential intrusions. With employee and patient safety at stake, companies cannot afford to neglect any data access gaps or security deficiencies.
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Cyber Security
Identity Fraud
SAFE-BioPharma’s Jon Weisberg encourages the industry to make the most of the tools at hand when it comes to deploying strategies to defend against cyber criminality and terrorism. He recommends putting standardised identity trust at the forefront of any agenda.
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Medical Imaging
Imaging the Future
State-of-the-art imaging is enabling the discovery and optimisation of tomorrow’s therapeutics. Patrick McConville of Molecular Imaging Inc explains how careful integration of technologies can help to quantify the critical properties and effects of new medicines.
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Confocal Microscopy
Diabetes Focus
Olympus’s Helge Schmidt questions Professor Simone Baltrusch at the University of Rostock about her investigation into the role of the mitochondrial network in diabetes and how confocal microscopy is advancing academic research in the field.
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Preclinical Imaging
A View to Succeed
David Taylor at MR Solutions reflects on the transformation of the preclinical imaging market, and how new, compact scanning systems are allowing ease of use, smoothness of workflow and seamless integration of imaging modalities.
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News and Press Releases |
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Save The Date: Bormioli Pharma Envision Press Conference
Bormioli Pharma Envision is a milestone, the first digital event for the
company. As part of this important moment, Bormioli Pharma has decided
to dedicate a unique presentation to the press. The conference, in
virtual mode and by invitation only, will give you the opportunity to
learn about the company’s strategies for the future. Andrea Lodetti, CEO
of Bormioli Pharma and Andrea Sentimenti, Marketing & Innovation
Director, will present a preview of the new organization of the
company’s product range, involving participants in the company’s
innovation process. Bormioli Pharma’s top management will also show the
latest products and new prototypes.
More info >> |
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White Papers |
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Working Towards a Standardised Identification Solution
PCI Pharma Services
The security of the pharmaceutical supply chain is an issue of growing concern, with recent reports addressing its vulnerability to counterfeiting. The complexity of the European supply chain is one of the key factors of this counterfeiting pandemic, with millions of medicine packs being moved around the EU, annually. Aside from this, fragmentation has resulted in decreased transparency in the supply chain and increased difficulties to track and trace medicines, leading to significant threat from counterfeiting. As a key source of income for the European economy, it is essential that the supply chain remains safe and free of counterfeits. A significant stumbling block within the industry remains to be the lack of a unified, single‐source pan‐European or indeed global database where scanned bar codes on drug packaging can be verified at point of dispense. At some point in the future the pharmaceutical industry, regulatory bodies, clinicians and retailers will need to join forces to overcome this.
More info >> |
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