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Insights - Product Development, Clinical & Regulatory

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Articles, Blogs, Videos and items of interest relating to Pharma development, clinical and regulatory work


Target Product Profiles in Drug Research and Development

TPPs are descriptions of key features needed in a new treatment for a disease and are used to guide and drive drug research and development. They can save time and aid communication with regulatory agencies, they can provide direction for drug development programmes, they can help to stop inappropriate drug development and save resources, they can point the way to the critical experiments, and they can summarize drug profiles to varying stakeholders. Click to open

Double-Edged Sword

Consequences for Medical Devices in case of a no deal Brexit. Click to read more

Is Orphan Drug Status the answer to everyone’s prayers?

Developing orphan drugs is a risky business. Small numbers of patients, despite high prices, may not lead to high revenue and there is a high risk of failure to reach the market.

But there are advantages. There may be grants available; regulatory processes are simpler. patients and physicians are very eager to try new treatments. Also, small companies may be attracted by the smaller size of clinical trials and shorter development times. There are an estimated 7000 rare diseases, affecting 350 million people globally - and this paper described the landscape of this work in detail. Read More

The Benefits and Pitfalls of Repurposing Drugs

The interest in drug repurposing has grown, as the effort required to bring new drugs to market has increased. When the cost of failed projects is taken into account, it costs c. $2.6bn and 10 years for each new marketed product and these estimates are increasing. Historically, new used for some drug molecules have been found by accident. But in this era, a deep understanding of biological disease processes enables a rational investigation process, to develop an 'on target' repurpose (based on the same biological mechanism) or an 'off target' one (based on the API acting on a different mechanism). This paper discusses the screening of molecules that have failed during development; shorter development paths for repurposed use and the regulatory and IP opportunities. Read More