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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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Dempsey Demystifies Regulatory Cycle at DIA Europe
March 22, 2018 (Hartford, Conn.) – RWS Life Sciences Managing Director,
Sheena Dempsey, will present “Demystifying the Multilingual Complexities
in the Regulatory Cycle” at DIA Europe 2018, on April 17, at 3:30PM
(CET), in Basel, Switzerland.
More info >> |
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White Papers |
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The Role of the CRO in Effective Risk-Based Monitoring
Medpace
The clinical trial industry is evolving. In an effort to improve participant safety and data integrity, regulators are encouraging trial sponsors to transition from a focused on-site monitoring approach they have traditionally employed toward a risk-based approach that utilizes a combination of centralized and on-site monitoring techniques to ensure patient safety and data quality. The Risk-Based Monitoring (RBM) paradigm has many potential advantages over established monitoring practices including enhanced patient safety and data integrity, more efficient and effective protocol design, reduced costs, and the ability to strategically adjust oversight in keeping with changes in risk level.
More info >> |
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Industry Events |
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BioProcess International European Summit
23-25 April 2018, RAI, Amsterdam
Bringing together 900+ attendees from all major departments
in bioprocessing: Cell Culture, Downstream, Manufacturing, Vaccines, Viral
Safety and Cell Line Development this April in Amsterdam, Europe’s largest bioprocessing
event BPI Europe 2018 will provide you with the latest advice on how
optimise bioprocessing through connecting science, technology and business.
More info >> |
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