Pharmaceutical development blog posts

06 December, 2017

6 regulatory questions you should ask when developing CATMPs

By Sanjay Jain

The recent development in cellular and molecular biotechnology, has resulted in the growth of a new segment of biological medicinal products and paved the way for Combined Advanced Therapy Medicinal Products (CATMPs). These products are regulated in the EU under the Advanced Therapy Medicinal Product (ATMP) Regulation and are defined as containing one or more medical devices as an integral part of the product. They offer ground-breaking new treatment and prevention opportunities for many diseases, dysfunctions and injuries to the various parts of the human body. 

Nevertheless, the development of these products also presents challenges in the form of precise requirements, regulations and associated guidelines. Here are 6 regulatory related questions you should ask when developing CATMPs. 

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22 November, 2017

Best practices for bridging studies to generate data and validate a new strain

By Travis Rothrock

In this final blog on bridging studies, we provide general best-practices relevant to oncology bridging studies, including basic study design considerations and insights that are the culmination of many years of hands-on experience by Envigo experts.

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22 November, 2017

The importance of bridging studies when switching strains

By Travis Rothrock

Bridging studies play an important role in drug development, both in the clinical and preclinical stages. These studies provide important information that can circumvent the repetition of entire programs. Understanding the considerations and steps in switching rodent strains and the importance of bridging studies, is critical. In this post we outline the best practices on bridging studies.

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03 November, 2017

Metabolites in safety testing - the ultimate guide

By Guy Webber

Over the past two decades considerable industry and regulatory discussion has focused around the importance of drug metabolites as potential sources of drug toxicity.

The issue of metabolite-mediated toxicity, and when it should be assessed, has become known as metabolites in safety testing (MIST). Essentially, it tackles the following question: When does a human metabolite become important? It is crucial to MIST to identify the major circulating human metabolites and ensure the species used in safety assessment are exposed to the same metabolites, at similar levels of exposure.

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03 November, 2017

6 crucial facts about DILI you ought to know

By Guy Webber

Drug induced liver injury (DILI) is a major cause of safety-related drug withdrawal and black box warnings post-market. It is also a major cause of drug attrition during development. One of the main concerns about DILI is that it is often undetected until clinical development and/or post-market approval, when the molecule is exposed to larger populations. 

So what do you need to know about DILI that will help you to reduce the risk of hepatotoxicity in humans?  Here are six facts to keep in mind.

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04 October, 2017

Shining the light on drug-drug interactions (DDI)

By Guy Webber

Advancements in in vitro technologies and analytical instrumentation over the past decade allows scientists to apply a variety of in vitro based assays designed to rapidly assess risk-liability, such as drug-drug interactions (DDI), one of the factors contributing to both current high attrition rates and delays in development.

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04 October, 2017

How in vitro assays and drug metabolism are being used to de-risk drug development

By Guy Webber

If all molecules in discovery and development were added together over recent years and compared to the number of successful drug approvals each year, the ratio is (approximately) 10,000:1. In other words, for every 10,000 molecules entering drug discovery, 9,999 will fail during some stage of the development process. Evidently, developing a molecule that has a desired, efficacious yet safe effect in humans is a remarkable achievement considering the lengthy, complex and expensive process.

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04 October, 2017

Diabetes type 2: Developing a new potential treatment

By George Kerrick

Wouldn’t it be great to have a medication for diabetes which lasted longer than current treatments on the market?

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11 September, 2017

Why are biomarkers for non-clinical infusion reactions so critical?

By Kirsten Mease

It’s no secret that biomarkers for non-clinical infusion reactions (IRs) have become an important aspect of biotherapeutic development research. But why exactly is this topic so vital? And what are some of the main challenges it offers scientists?

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11 September, 2017

Did you know the EMA guideline on first-in-human trials is changing?

By Sarah Johnson

The EMA has revised its guidance on first in-human clinical trials; the revision comes in to effect on February 1, 2018 and extends the existing EU guidance to address first in-human (FIH) and early phase clinical trials with integrated protocols. Be sure to understand what these changes mean for you.

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