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| home > ebr > Autumn 2013 |
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 PUBLICATIONS |
European Biopharmaceutical Review |
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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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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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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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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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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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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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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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News and Press Releases |
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ROUSSELOT INTRODUCES X-PURE® GelMA FOR TRANSLATIONAL MEDICINE
Irving, United States [03 June 2020] — Rousselot, a Darling Ingredients brand and the global leader of collagen-based solutions, takes on the digital challenge and introduces X-Pure® GelMA at Bio Digital 2020. The first GMP-ready range of gelatin methacryloyl (GelMA) biomaterials suitable for preclinical and clinical applications, X-Pure® GelMA is part of the X-Pure portfolio of ultra-pure gelatins and collagens, suitable for use as biomaterials in 3D bioprinting, tissue engineering, and regenerative medicine.
More info >> |
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White Papers |
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Device Develop for Combo Products
Phillips-Medisize
Combination products are defined as therapeutics combining two or more products (drug/device, biologics/device, biologics/drugs or drug/device/biologics), regulated and sold as a single unit. As these pharmaceutical and biological therapies and treatments have evolved, so has the need to develop appropriate delivery mechanisms for these applications. When developing a combination product, there are many things that need to be considered – the critical relationships between device development and the pharmaceutical or biologic, early establishment of regulatory and clinical strategies, understanding ‘user’ needs, determining product requirements, as well as, device manufacturing variation.
More info >> |
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Industry Events |
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CPhI Festival of Pharma
5-16 October 2020, Virtual
A virtual gathering for the pharmaceutical industry, the CPhI
Festival of Pharma has been created to fill the gap left by in-person events at
a time when travel and gatherings are off the cards.
More info >> |
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