spacer
home > ebr > Spring 2015
PUBLICATIONS

European Biopharmaceutical Review

ebr
Spring 2015

   
Text
PDF
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.
 
view
download pdf
bullet
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.
 
view
download pdf
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.
 
view
download pdf
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.
 
view
download pdf
bullet
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.
 
view
download pdf
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.
 
view
download pdf
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.
 
view
download pdf
bullet
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.
 
view
download pdf
bullet
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.



 
view
download pdf
bullet
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.
 
view
download pdf
bullet
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.
 
view
download pdf
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.
 
view
download pdf
bullet
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.
 
view
download pdf
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.
 
view
download pdf
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.

 
 
view
download pdf
   
spacer
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

Merck to Provide Provantage® End-to-End Development and Manufacturing Services to Y-mAbs for Lead Antibody Compound


More info >>

White Papers

New Temperature Profiles from a Global Study

Laminar Medica

Recently there has been an influx of temperature mapping studies to collect sufficient ambient data to develop temperature profiles.  Solid temperature profiles on specific shipping routes are required to ensure streamlined packaging and robust lane qualification. The most reliable method to develop temperature profiles is to capture the actual reading from shipments, as well as using the historical and meteorological data to increase the confidence level.
More info >>

Industry Events

PREP 2018: 31st International Symposium and Exhibit on Preparative and Process Chromatography

8-11 July 2018, Hyatt Regency in the Baltimore Inner Harbor, MD, USA

The PREP series of symposia is the most recognized international conference devoted to advances in separation technologies in the field of preparative and process chromatography. Join us for a dynamic and innovative program where experts from around the world will address the latest developments and hottest topics in preparative and process chromatography.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement