|
|
|
| home > ebr > Summer 2011 |
|
|
 PUBLICATIONS |
European Biopharmaceutical Review |
|
|
|
|
|
 |
| |
|
|
|
|
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.
|
|
|
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.
|
|
|
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.
|
|
|
|
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.
|
|
|
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.
|
|
|
|
|
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.
|
|
|
|
|
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
|
|
|
|
|
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.
|
|
|
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.
|
|
|
|
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.
|
|
|
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.
|
|
|
|
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.
|
|
|
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.
|
|
|
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.
|
|
|
|
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.
|
|
|
|
|
|
 |
|
|
 |
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?
More info >> |
|
 |
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.
More info >> |
|
 |
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.
More info >> |
|
|
