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European Biopharmaceutical Review

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Summer 2021

   
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Biomarkers
Spearheading the Fight Against Infectious Diseases and Emerging Outbreaks

Anup Madan, Tina Green, Palanikumar Manoharan, and Abigail Cross at PPD

High throughput molecular technologies combined with bioinformatics are helping public health and diagnostic laboratories across the globe to monitor rising trends in drug resistance, detect emerging outbreaks faster, and stop outbreaks more effectively.
 
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Reconsidering the Future of Precision Medicine

Jonathan Lawson at Owlstone Medical

The study of the metabolome provides a comprehensive and current snapshot of what’s happening in the body, and offers a host of advantages in applications such as asthma, COPD, gut health, and cancer.
 
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Innovation in Oncology Clinical Trials

Brian Huber at ICON

Advances in genomics have ushered in a new era of precision medicine and the discovery that cancer cells can harbour specific genetic lesions, encouraging the emergence of therapies that selectivity target these lesions.
 
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The Power of Our DNA – Paving the Way for Precision Cancer Care

Isabelle Ray-Coquard at Centre Leon Bérard, Claude Bernard University Lyon I

By enhancing our understanding of tumour development and the biological processes responsible, optimal disease management and treatment strategies that are based on a patient’s precise genetic profile can be successfully formulated.
 
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Immuno-oncology
Are We Nearly There Yet? The Ongoing Journey of CAR T Cell Therapies

Sophie Lutter at OXGENE

Allogeneic T cell therapies are set to be game changers, improving the accessibility of CAR T cell therapies in terms of reduced cost of goods, manufacturing scalability, and improving patient eligibility.
 
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Accelerating OV Immunotherapeutic Innovation to Market

Kai Lipinski at Vibalogics

The combination of oncolytic viruses with immune checkpoint inhibitors and other therapies have the potential to transform the field of immuno-oncology and the way we approach cancer treatment.
 
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Alternative Therapies to Reverse Resistance to Checkpoint Inhibitors

Marisol Quintero at Hightlight Therapeutics

Identifying therapeutic approaches that enable the body’s immune system to recognise and kill tumour cells could be the key to extending the benefits of immunotherapy beyond use as a single line of treatment.
 
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Monoclonal Antibodies
The Vital Role of Transient Antibody Expression During Pandemics

Michael Fiebig at Absolute Antibody

Despite recent advances in large-scale transient expression, barriers must be overcome before it can be used to help produce the diagnostics, therapeutics, and vaccines needed during a pandemic.
 
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Streamlining Affinity Analysis for Accelerated Lead Screening, Characterisation, Optimisation, and Final Selection

Sartorius details its Octet® BLI systems, which offer a fluidics-free approach for the kinetic characterisation of binding interactions.
 
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In Vivo and Ex Vivo Gene Editing
The New Renaissance in Functional Genomics Screening

Benjamin Borgo at Merck

The functional genomics revolution has been led by the advancement of genome editing-based screening tools. This expanding technology offers endless possibilities, and has the potential to reveal the underlying biological networks for just about any phenotype.
 
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CRISPR: The Jump From Bench to Clinic

Cosimo Ducani at Moligo Technologies

A number of barriers stand in the way of CRISPR becoming a real possibility for patients. To address these problems, biopharma must consider how large quantities of DNA can be safely produced and distributed for scaled-up treatments.
 
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Discovery Technology
New Applications of Picodroplet Technology for Drug Discovery and Development

Olivia Hughes at Sphere Fluidics

High throughput picodroplet technologies play a vital role in drug discovery by accelerating research in areas such as bispecific antibody development, cell line engineering, and cell therapy.
 
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Human Fresh Tissues vs Clinical Attrition

Graeme Macluskie and Zara Puckrin at REPROCELL

With a multitude of groundbreaking advances in technology, such as molecular biology, cell and material engineering, AI, and machine learning, now is the time to embrace human complexity in drug development.
 
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In Brief
A Walk in the Cloud

EBR Industry Advisor, Emile Bellott, explores how AI and Big Data in biopharma promise to transform drug development from target identification through to post-market surveillance.
 
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Features
BIO-Europe® 2021 Digital

EBR speaks to Pam Putz, Managing Director of EBD Group, in anticipation of the BIO-Europe 2021 event and the vital role it plays in building partnerships between global biopharma and investment leaders.
 
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Richter-Helm Triples Production Capacity at Bovenau Site to Meet Global Demand for Biopharma Production

In the continuously growing pharmaceutical biotechnology market, Richter-Helm BioLogics discusses how the expansion of its Bovenau, Germany, site will help them meet the increased demand for production capacities.
 
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Driving Dendritic Cells to Induce Immunity Against the World’s Deadliest Diseases

Christian Brechot at TheraVectys

Used in combination with next-generation gene editing and transduction techniques, lentiviral vectors have the potential to deliver non-replicative, non-cytopathic transduction of the non-dividing dendritic cells that drive cell-mediated responses.
 
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Published quarterly in
January, April,
July, and October

News and Press Releases

Cumulus Neuroscience Commences Clinical Studies of Digital Biomarker Platform in Degenerative Neurological Diseases

Belfast, UK – 25 May 2022. Cumulus Neuroscience, a global digital health company, announces the start of two validation trials – CNS-101 and CNS-102 – supported by a group of leading global pharma companies and Innovate UK. The studies will investigate the potential benefits of Cumulus’ integrated physiological and digital biomarker platform in quantifying cognitive decline over time in patients with dementia, across AD, ALS and FTD.
More info >>

White Papers

The Role of the CRO in Effective Risk-Based Monitoring

Medpace

The clinical trial industry is evolving. In an effort to improve participant safety and data integrity, regulators are encouraging trial sponsors to transition from a focused on-site monitoring approach they have traditionally employed toward a risk-based approach that utilizes a combination of centralized and on-site monitoring techniques to ensure patient safety and data quality. The Risk-Based Monitoring (RBM) paradigm has many potential advantages over established monitoring practices including enhanced patient safety and data integrity, more efficient and effective protocol design, reduced costs, and the ability to strategically adjust oversight in keeping with changes in risk level.
More info >>

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