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European Biopharmaceutical Review

ebr
Summer 2011

   
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BioBusiness, Finance & Communication
IP Strategies

License to Thrill

In the increasingly competitive world of biotechnology, a robust R&D plan needs to have an equally strong IP strategy in place to succeed. With this in mind, Haydn Evans of CPA Global explains the importance of in-licensing.
 
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Drug Repositioning: Small Biotech

An Alternative Path to Drug Discovery

Núria Gavaldà, Núria Reig and Marc Centellas of SOM BIOTECH draw comparisons between multiple drug repurposing case studies, while evaluating the technology platforms and partnering opportunities that could potentially aid these strategies.
 
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Early Stage Drug Discovery

Behind the Screens

Early stage screening offers an affordable way to minimise the possibility of late stage failures. Sandhya Vellore of GBI Research looks at the technologies available for screening potential molecules as well as the latest trends in this market.
 
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BioResearch and Innovation
Adult Stem Cells

Life and Limb

Bone marrow has been shown to not only be the origin of blood cells, but other types of cells that participate in tissue remodelling and angiogenesis. Ronnda L Bartel, Sharon Watling and Eric Kaldjian at Aastrom Biosciences focus on how bone marrow-derived therapies are being adapted for the lab.
 
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Vaccine Innovation

Implementing Immunostimulants

Frédéric Durmont and Maxence de Villemeur of Lallemand Pharma discuss polyvalent chemical and mechanical bacterial lysates to show how their application affects the oral vaccines market.
 
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Discovery Technology
Industry Insight: Cell Therapeutics

Finding the Right Place

More sophisticated tools for molecular characterisation and the ability to link this back to the biology involved will be instrumental in delivering full characterisation of the cell, the process and consequently the product, reports Verna McErlane of Sistemic.


 
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BioDiscovery
Therapeutic Antibodies

Novel Libraries

Markus Enzelberger of MorphoSys discusses the impact combinatorial antibody libraries have had on drug discovery and development, and makes predictions about where this technology is going
 
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BioDevelopment
System Control: Data Analysis

Tools of the Trade

Carl-Johan Ivarsson of Qlucore looks at how tools such as principal component analysis and heat maps have provided a powerful way of identifying important structures and patterns, allowing for better comparison of data.
 
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First-in-Man Clinical Trials

Best Laid Plans

Paul
Titley of Aesica, R5 Formulation Development offers tips on reducing the cost of expensive first-time-in-man trials, focusing on the management and evaluation techniques that can help to avoid future wastage.
 
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BioDevelopment and Regulatory
Non-Clinical Safety Testing

Species Selection

In order to test the safety of new therapeutic mAbs, non-clinical studies have to be carried out using pharmacologically relevant species. Lolke de Haan, Simon Henderson,Mary McFarlane, Alison Scott and Jacintha Shenton of MedImmune analyse the factors involved in determining a species’ relevance to a study.
 
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Assessing Biosimilars

Spot the Difference

With specific reference to international regulations for categorising biosimilars, Shein-Chung Chow of Duke University School of Medicine discusses the fundamentals of biosimilarity and interchangeability.
 
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BioFormulation and Manufacturing
Phage Production

The Age of Phage

Despite a relative lack of interest in phage biology in the past, researchers are now tapping into the potential of this niche research area.Marcin Los of Phage Consultants considers what we can expect to see from biophages in the future.
 
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Therapeutic Proteins in Plants

Turning a New Leaf

The field of plant-made pharmaceutical therapeutics is hitting a critical point as developers begin looking for regulatory approval. Qiang Shawn Chen of Arizona State University suggests how the future production of biobetters and biosimilars is set to change under the increasing pressure of public perceptions of environmental risk.
 
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Liquid Handling Techniques

Fluid Thinking

Joby Jenkins of TTP LabTech runs a cost:benefit assessment of various liquid handling technologies and runs through methods of minimising the cost of screening through higher throughputs, miniaturising assay formats and streamlining the assay process.
 
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INTERVIEW
Q&A: Industry Advisors

Biopharm: Past, Present and Future

EBR’s new Industry Advisory Board give their opinions on the current shape of the biotechnology market and how they anticipate it changing in the years to come.
 
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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

Clinical and Regulatory Operational Excellence Forum

1. Innovative technologies are expected to take clinical development, licensing, and other regulatory processes to the next level in the future. What do you see are the biggest challenges facing companies when trying to cope with continued data growth in a fast changing environment? Pharmaceutical companies are heavily regulated and introducing change needs proof of acceptance by the authorities. The chance that authorities do not agree with that change makes the industry risk averse. Changes in a stable GxP environment are almost by default seen as a risk, however, not adapting to new technologies should also be seen as a risk! Therefore, ICH developed the ICH Q8, Q9, Q10, Q11, and Q12 guidelines, to anticipate change and implement changes much faster, with less of a regulatory burden. Nevertheless, industry is not picking up with the desired pace. Why not?
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White Papers

Key to Outsourcing Method Development and Validation: A Pragmatic Approach

RSSL

In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developer’s mind set and a regulatory background in validation. As companies are focussing on achieving ever shorter times of drug to market, it is vital that a tailored, pragmatic approach is adopted when engaging in both method development and validation activities for an Active Pharmaceutical Ingredient (API) or drug product (DP). Although methods still require a high degree of robustness, the overall strategy should encompass a full evaluation of the regulatory requirements applicable to the particular phase of the drug life-cycle; this is pivotal in Key to Outsourcing Method Development and Validation A Pragmatic Approach order to ensure a successful regulatory submission, where the applicant must demonstrate suitable validation of all methods used to support the filing.
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Industry Events

PDA Parenteral Packaging 2019

19-20 March 2019, Hilton Molino Stucky, Venice, Italy

PDA Europe’s Conference has become a must-attend event for all professionals in the Parenteral Packaging arena. Join us in Venice in March 2019 to continue and further deepen scientific advancements and our ongoing professional discourse of latest on primary packaging technologies and business trends. This conference and the accompanying exhibition address quality of components and cont­ainers, container closure development and integrity testing as well as aspects of processing, product distribution and storage.
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