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PUBLICATIONS

European Biopharmaceutical Review

ebr
Spring 2015

   
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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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Legal, Regulatory and Public Policy
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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INTERVIEW
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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INDUSTRY DYNAMICS
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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BUSINESS STRATEGY
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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RESEARCH AND DEVELOPMENT
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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BIO-SECURITY
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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BIOIMAGING
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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Edited by
Dr Deborah O'Neil,
Chief Executive and Scientific Officer,
NovaBiotics Ltd
Published quarterly in
January, April,
July, and October

News and Press Releases

PCI Clinical Services Announces New Facility Dedicated to Clinical Trial Returns

Philadelphia, USA – October 15, 2018. Leading international pharmaceutical outsourcing services provider PCI Clinical Services (PCI) has announced the completion of a dedicated Returns Management facility at its Clinical Services Center of Excellence at Bridgend, UK. PCI provides a full service Returns Management service for clients, providing visibility and accountability in returning investigational drug product from investigational sites at the conclusion of a clinical study. Returning and reconciling Investigational Medicinal Product (IMP) on completion of a study is a critical part of a Clinical trial and can require complex reverse logistics. Trial outcomes can be impacted if Returns are not processed efficiently and precisely.
More info >>

White Papers

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 >>

Industry Events

CPhI & P-MEC India 2018

12-14 December 2018, India Expo Mart, New Delhi, India

CPhI & P-MEC India (December 12-14, 2018) – organised by UBM (part of Informa PLC) – announces that the 12th edition of Asia’s largest Pharma exhibition is moving to the India Expo Mart, New Delhi. The new venue will see the exhibition now hosted in a single venue, bringing it closer to the Indian regulatory and legislative capital. New Delhi is also the country’s main international transport hub and will encourage an increased international attendance. In total, more than 50,000 people from 122 countries are expected, along with nearly 1,500 exhibitors.
More info >>

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