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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

CrystecPharma win CPhI Excellence in Pharma Award for Contract Services and Outsourcing

The award was presented for Crystec’s modified supercritical anti-solvent (mSAS) technology for accelerated product development, and chosen from shortlisted companies including 3M, Alcami, Catalent Pharma Services and Merck.
More info >>

White Papers

Clinical Trials in Russia Orange Paper: 2nd Quarter 2014

Synergy Research Group

The Ministry of Health of Russian Federation approved 194 new clinical trials of all types including local and bioequivalence studies during the 2nd Quarter of 2014 (3% less than at the same period of the last year). The main contribution to the total number of studies was made by multinational multi-center clinical trials (MMCT) and the number of these studies stayed the same as in Q2 2013 – 81 studies. The number of bioequivalence studies (BE) decreased from 76 studies in Q2 2013 to 59 in Q2 2014, a 22% decrease from last year’s figure. The number of local clinical trials (LCT) increased from 42 in Q2 2013 to 54 clinical trials in Q2 2014.
More info >>

Industry Events

12th Annual Parallel Trade

6-7 February 2018, Holiday Inn Kensington Forum, London, UK

SMi Group is proud to announce the return of Europe’s only Parallel Trade conference. Back for the 12thyear, Parallel Trade returns to London on 6th-7th February 2018.
More info >>

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