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Volume 4 Issue 4

How Involved Should Biopharma CEOs Be In Outsourcing Activities?

When outsourcing drug development and manufacturing, how involved should the CEOs of emerging biopharma be in the requisite day-to-day activities and processes? Louis...
9 December 2021 Volume 4 Issue 4 Aristea Therapeutics | biopharma
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Volume 4 Issue 4

5 Drugs Facing Key Patent Expirations and Potential Generic Entry from December 2021 – February 2022

A challenge in anticipating generic entry is elucidating which patents and regulatory protections constrain generic entry. Yali Friedman at DrugPatentWatch, presents ...
9 December 2021 Volume 4 Issue 4 aspirin | FDA
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Volume 4 Issue 4

Contamination Control Strategy

Regulatory bodies expect that pharmaceutical companies have a Contamination Control Strategy (CCS) in place that outlines the control of contamination of utilities, m...
9 December 2021 Volume 4 Issue 4 CCS | Contamination Control Strategy
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Volume 4 Issue 4

Digitisation versus Digitalisation – Understanding the Difference and the Role of LIMS in Achieving Both

The system infrastructure for the creation, storage and management of electronic data has to be in place. If this isn’t the case, then completing a digitisation proje...
9 December 2021 Volume 4 Issue 4 creation | Digitalisation
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Volume 4 Issue 4

Predicting Drug Bioavailability with the Modern-day Toolkit

Bioavailability is defined as the fraction of drug reaching systemic circulation following absorption in the gut and first-pass metabolism in the liver. Accurately pr...
9 December 2021 Volume 4 Issue 4 Bioavailability | Drug Bioavailability
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Volume 4 Issue 4

SLIM: A Gateway to the Adoption of High-Resolution Ion Mobility for Biotherapeutic Peptide Mapping

The demand for protein therapeutics, such as recombinant human proteins, monoclonal antibodies (mAbs), and fusion proteins, has grown significantly over the past deca...
9 December 2021 Volume 4 Issue 4 Biotherapeutic | fusion proteins
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Volume 4 Issue 4

An End-to-End Solution to Accelerate CAR-T Cell Development from Concept to Clinic

CAR-T cell therapies have demonstrated tremendous success in relapsed or refractory haematological malignancies. Now therapeutics companies and academics alike are ra...
9 December 2021 Volume 4 Issue 4 cancer | CAR-T cell
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Volume 4 Issue 4

Benefits & Key Considerations of Using Human iPSC-Derived Disease Models in Drug Discovery

The process of drug discovery, development and commercialisation is long and associated with high costs. In addition, it is estimated that only 1% of the initially te...
9 December 2021 Volume 4 Issue 4 Disease Models | Drug Discovery
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Volume 4 Issue 4

Could Standardised Metadata be the Key to Optimising and Expediting Clinical Trials?

Clinical trials still offer the most effective way of testing the safety and efficacy of new drug treatments, and as more drugs are brought through development each y...
9 December 2021 Volume 4 Issue 4 clinical metadata repositories | cloud-based
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Volume 4 Issue 4

CGT CDMO Partnering: More than just Manufacturing

The biotech footprint has been exponentially expanding around the globe and no division has increased more feverishly in recent years than the Cell and Gene Therapy (...
9 December 2021 Volume 4 Issue 4 Biotech | CDMO
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