Pharmaceutical development blog posts

03 October, 2018

How to get the most out of your non-clinical CRO

By Freddie Campbell

Many industry observers have said there's no such thing as a straightforward pharmaceutical development program anymore. Rising costs, high competition, novel therapeutic targets with complex biology and an increase in regulations are all factors that contribute to the challenges of progressing drugs to the market. 

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14 September, 2018

Anti-cancer evaluations with ICH S9 Guideline Q&A: what you need to know

By Robert Turcan

The ICH S9 Guideline Q&A document was recently published in June 2018, designed to clarify some of the most common challenges experienced across industry when implementing ICH S9. Here, we highlight a few key areas selected on the basis of the advice sought by our customers during development of their anticancer pharmaceutical.

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03 August, 2018

Did you know the EMA has simplified the orphan drug designation application process?

By Andrea Sisneros

Every month, Envigo’s pharmaceutical regulatory team keeps track of the key changes, influences and opinions that impact the drug development process around the globe.  This month, the team discuss recent changes to the way in which the European Medicines Agency (EMA) has simplified the submission of applications for orphan drug designation.

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03 August, 2018

Regulatory trends: your list of pharmaceutical regulatory affairs changes

By Andrea Sisneros

Each month, Envigo's pharmaceutical regulatory experts review the changes and influences affecting drug development around the world. Dive into some useful resources to ensure you stay in the know about regulatory affairs.

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01 August, 2018

6 take home messages from our Modern Drug Development Roadshow

By Freddie Campbell

Panel-and-speakers at Modern Drug Development RoadshowBringing a drug from discovery to market is an expensive and time-consuming business. Every drug that fails comes with a cost which could be both reputational and financial. Keeping your development program on track is therefore critical to success.

We recently held a roadshow in Cambridge and London, UK, to discuss the challenges in designing and executing a non-clinical development program, as well as how to effectively overcome these challenges. At 'Modern Drug Development - keeping your non-clinical program on track', delegates heard from:

- Dr. Robert Turcan, Head of Regulatory Affairs and Program Management, Envigo, on: "Drug Development - expect the best, plan for the worst, and prepare to be surprised!", which focused on the development of small molecules

- Dr. Kirsty Harper, Head of Biologics, Envigo, on: "Identifying, addressing and smoothing the bumps in the road to successful non-clinical development", relating to the development of biologics.

There was also a panel of experts who co-presented and answered questions from delegates.

In this post, you'll discover the six main take home messages from the roadshow.

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04 June, 2018

5 things we learned about biological product development at ABS 2018

By Freddie Campbell

We recently hosted The Eighth Annual Biologics Symposium (ABS) in New Jersey, where experts shared groundbreaking advancements in biotherapeutics over the last year. It was great to have a dedicated forum where scientists could share ideas and explore practical ways to progress their drug development goals.

The symposium highlighted areas such as immunological assessment, species selection, drug delivery, efficacy and safety and clinical aspects. Here are five things we learned about biological product development at ABS 2018.

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30 May, 2018

Joining forces to drive breakthroughs in the treatment of cancer

By Freddie Campbell

Cancer continues to be one of the main areas of focus in drug development. Unmet patient needs and advances in the understanding of cancer biology is resulting in exciting development in cancer treatments. We recently partnered with the National Foundation for Cancer Research at the American Association for Cancer Research (AACR) Annual Meeting where we explored groundbreaking advancements in cancer research and helped attendees recognize the power of their donations to build a healthier and safer world.

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29 March, 2018

Non-clinical drug development trends that will get you to market sooner

By Freddie Campbell

Two scientists working on nonclinical drug development projects

The pressure of looming patent expirations and the need for strengthened clinical development pipelines is driving the growth to address the demand of new medicines. In response to this pressure, the total number of molecules in development has grown consistently in recent years, with the largest growth seen in non-clinical drug development. 

Here we talk to four Envigo scientists, all working in different areas of the non-clinical setting, to get their take on the current trends of drug development and how these strategies and technologies can help you get to market sooner.

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06 March, 2018

10 scientific research trends in biological product development

By Freddie Campbell

Biological product developmentIn 2016, one third of all new Food and Drug Administration (FDA) approvals were classed as a new biological entity. In the same year, European Medicines Agency (EMA) authorized 27 new active substances with 12 (44%) being a biopharmaceutical.

Undoubtedly, one of the key growth areas in pharmaceutical research is in the study of biologics, designed to meet unmet clinical needs. In fact, according to EvaluatePharma, biologics are set to contribute 52% of the top 100 product sales by 2022. 

Here we look at the contributing factors of growth and speak to industry expert, Dr Kirsty Harper who explains her work in biological product development and bringing the wider scientific community together.

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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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