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European Biopharmaceutical Review

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Autumn 2013
   
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STRATEGY AND FINANCE
Regulatory

Long-Term Data Storage


The rapid data growth in biopharmaceutical and life sciences companies is far outweighing their IT budgets. Jim Cook at Arkivum suggests some likely strategies to address this issue.
 
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Strategy and Finance

Rising Up: Part 1

Mounting healthcare costs in the US are prompting a change from free-pricing to value-based pricing of pharmaceuticals, as Graham Scholefield and Markus Thunecke at Catenion demonstrate.

 
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BioBusiness Development

Data Analysis

New Generation

The industry has taken a bold step in regards to allergen testing. A sector that once relied heavily on animal testing is now using data analysis tools to move away from this controversial area, says Carl-Johan Ivarsson at Qlucore.

 
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Research and Development

Collaboration Schemes

The diminishing number of new drugs reaching the market, combined with decreasing R&D productivity and a low return on investment, makes Big Pharma an uncertain environment. Nicolas Carboni at SATT Conectus Alsace highlights a key factor in steering the industry back on track.

 
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Business Development

Global Challenges

Chris McCourt at TransPerfect reviews the approaches that the biopharma industry can use to tackle worldwide growth challenges.

 
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Medicinal Regulations

Cellular Therapy

Julian R De Havilland
, Anne Black and Anne Dickinson at Newcastle University reveal why advanced therapy medicinal products are rapidly coming to the forefront of commercialisation.
 
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BioDiscovery

Antibody Drug Conjugates

Characterisation Challenges

There are two classes of compounds that arise when considering anticancer medications – monoclonal antibodies and potent, cytotoxic drugs. Ashleigh Wake at Intertek takes a look at each.

 
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Therapy Engineering

Self Healing

Autologous and allogeneic cells can assist the body in restoring tissue and treating diseases, explain Eytan Abraham, Ayelet Chajut and Lena Pinzur at Pluristem Therapeutics.

 
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Legal, Regulatory and Public Policy

Falsified Drugs

Counterfeit Chain: A Global but Local Effort

Fake medicines not only cost the industry millions in revenue, they are also dangerous for patients’ health. Inass Hassan at Deallus Consulting suggests how government bodies, regulators and Big Pharma can tackle this issue together.

 
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BioFormulation and Manufacturing

Analytical Development

Ensuring Success

Riet Dams and Chris Bland at Aptuit discuss how a controlled approach for validation methods indicating high-performance liquid chromatography in substances can allow for more effective results.

 
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Market Authorisation

Gaining Approval


Thilo Kaltenbach at Arthur D. Little Healthcare assesses how Big Pharma can implement specific policies to ensure that a new drug is successfully authorised.
 
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INTERVIEW

Industry Interview

Staying Focused

Jerry Boxall, Managing Director of ACM Global Central Laboratory, outlines his business philosophy, motivation and what he thinks the industry needs to focus on at the moment.

 
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Industry Interview

Moving Forward


Bill Newell, Chief Executive Officer of Sutro Biopharma, discusses which novel classes of therapeutics we should keep our eyes on, as well as revealing the secrets of his success.
 
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DEVELOPMENT AND PRODUCTION

Peptides

Best in Class

Archana Gangakhedkar at American Peptide Company illustrates how an emerging branch of peptide molecules with favourable properties could target diseases.

 
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Bioimaging

Double Act


When trying to understand dosage form performance in compounds, gamma scintigraphy and pharmacoscintigraphy are opening the door for larger formulation studies. Fiona McInnes, Lee Ann Hodges and Howard Stevens at Bio-Images Group explain why.
 
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Biopharma Developments

Ultra Culture

The measurement of viscosity during the early development of pharmaceuticals is an essential stage of the drug process. Lisa Newey-Keane at Malvern Instruments considers the advantages of ultraviolet area imaging with microcapillary viscometry.

 

 
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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

World-leading cancer stem cell expert joins Avacta Scientific Advisory Board

Developer of biotherapeutics and research reagents announces the appointment of Professor Gerard Evan to its Scientific Advisory Board
More info >>

White Papers

Future-proofing serialization solutions: the importance of strong level 3 capabilities

Adents

The complexities surrounding product serialization for pharmaceutical and medical device companies are immense. While current serialization requirements are limited to marking the unit of sale with a unique data carrier, by 2023 the process will require a product to be traceable through the entirety of its journey - from the individual package through the carton/pallet to its final point of distribution. In the United States, the Healthcare Distribution Management Association (HDMA) is suggesting that pharmaceutical companies begin to support this level of serialization, called aggregation, now. Around the world – in Europe and Asia in particular – disparate track and trace practices are incrementally moving toward a global standard that will, undoubtedly, be more stringent than today’s differing benchmarks. How can companies manage this transformation with the greatest degree of success while also minimizing business disruption? The key to creating an optimal implementation strategy is to select a serialization solution that has strong capabilities at all levels of technology. It’s also important to choose a solution that enables multi-phase implementation
More info >>

Industry Events

BioPharm America™ 2017—10th Annual International Partnering Conference

26-27 September 2017, 39 Dalton Street, Boston, MA 02116

BioPharm America™ is a unique partnering event that forms the nexus of discovery and realization. Startup companies, established biotech and entrepreneurs from academia attend in search of finance, pharma and development partners.
More info >>

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