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European Biopharmaceutical Review

ebr
Summer 2020
   
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Features
Surfacing Missed Opportunities

David Gwyn at Amplexor

There are five areas in which richer, more holistic product information could shine a light into the life science industryís blind spots and help transform business outcomes
 
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Base Editing and Its Application to Cell and Gene Therapy

Dr Ceri Wiggins at Horizon Discovery

CRISPR-Cas gene editing has been a force to be reckoned with in gene engineering for years, and it doesnít seem likely this is going to change anytime soon
 
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Nova Biomedical FLEXģ2

With over 1,300 employees and manufacturing facilities in Waltham and Billerica, Massachusetts, and Taipei, Taiwan, Nova Biomedical is one of the 25 largest in vitro diagnostic companies in the world and the largest privately owned in vitro diagnostic company in the US
 
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Analytical Methods
Risk Management for Analytical Method Development

Madalena R Testas, Daniela B Santos, and Josť C Menezes at 4Tune Engineering

In the biopharmaceutical industry, analytical methods are among the most critical elements for process monitoring and product release
 
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Beyond Big Data

Joern Klinger at biotx.ai

We canít always rely on Big Data to be available; therefore, itís worth suggesting ways of still effectively applying machine learning when thatís the case
 
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Genotoxic Impurities in Drug Products: Review of Nitrosamine Assays

Elodie Barrau, Emmanuel Desmartin, Valentina Paschetta, Davide Tartaglione, MÚnica Coll Furest, and Ana Novak at Eurofins

In the past couple of years, the prevalence of nitrosamines in drug substances has made them a hot topic of conversation in the medical industry
 
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R&D on COVID-19
The Quest for a Cure

David Wilson at Avacta

It's of little doubt that there is a great need for the development of rapid diagnostic tests to tackle the COVID-19 pandemic
 
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Leveraging Health Data to Support Patient Care

Gilles Paubert at Cegedim Health Data

There are some key areas where current real-world data can add immediate value to patients, the healthcare system, and our economies



 
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Would Greater Diversity and Inclusion Improve Innovation?


Stephen Frost at Frost Included

The pharma industry is responsible for great strides in world health, yet itís undeniable that there are still many more goals to accomplish, and a lack of diversity may be holding it back

 
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A Conversation with an Expert in Drug Development

As the world grapples with the impact of the COVID-19 pandemic, the life science industry and regulators are racing to find an effective treatment. We spoke with Colin Orford, Senior Vice President of Drug Development services at ICON plc about the direction that this work is taking
 
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Improving Drug Discovery Models
The Promise of Drug Discovery

The past few decades have seen large strides in the medical industry, but there are still many patients suffering with unmet medical needs that could benefit from further innovation, especially in drug discovery. EBR spoke to Dr Craig Fox, CSO at C4X Discovery, to ask about his thoughts on the subject

 
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Microphysiological Systems Emerging as Powerful Tools for Drug Discovery

Dr Audrey Dubourg at CN Bio

A new class of in vitro model is expected to assist drug discovery by providing robust physiologically relevant data at critical stages of R&D
 
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Published quarterly in
January, April,
July, and October

News and Press Releases

Lynparza recommended for approval in EU by CHMP for BRCA-mutated metastatic pancreatic cancer

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced that Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) for the 1st-line maintenance treatment of patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the Phase III POLO trial, which were published in The New England Journal of Medicine.
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White Papers

Pharmaceutical Companies: Outsourcing Combination Product Manufacturing

Phillips-Medisize

Combination products are therapeutics that combine two or more products (drug/device, biologics/device, biologics/drugs, or drug/device/biologics), regulated and sold as a single unit. Examples of combination products include drug-coated implantable devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
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Industry Events

12th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology

8-11 February 2021, Vienna, Austria

In continuation of the very successful scientific meetings in Budapest, Paris, Berlin, Florence, Geneva, Barcelona, Malta, Istanbul, Lisbon, Glasgow and Granada, the 12th PBP World will be held in Vienna from 8-11 Feb 2021. This every two year held conference has gained an ever increasing impact among the pharmaceutical scientists: With up to 1000 submitted abstracts and about 1300 participants it has become a well-established major meeting, attracting scientists from all over the world.
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