Integrated Product Development

Why your regulatory strategy needs a Trusted Regulatory Adviser
Category: Insights Integrated Product Development

Imagine you are a small biotech with an exciting asset with promising early phase clinical results. This bodes well for […]

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Driving an innovation culture – when elks are not enough?
Category: Insights Integrated Product Development

“All improvement happens project by project and in no other way” – Joseph M Juran There is something in that, […]

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Increasing patient recruitment through enhanced visibility – Just like a well-run supply chain
Category: Insights Integrated Product Development

Effective patient recruitment can accelerate the commercialization of new medicines more than any other single optimization. Unfortunately, patient recruitment is […]

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Target Product Profiles in Drug R&D – Regulatory Profiles
Category: Insights Integrated Product Development Project and Portfolio management

Regulatory Target Product Profiles (RTPPs)  RTPPs describe the aims of a drug development programme in terms of labelling concepts. They can be used […]

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Target Product Profiles in Drug R&D – Emerging profiles
Category: Insights Integrated Product Development Project and Portfolio management

Emerging TPPs  As a drug moves through development its properties, activity and effect on disease are revealed. ETPPs are used […]

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Target Product Profiles in Drug R&D – Aspirational profiles
Category: Insights Integrated Product Development Project and Portfolio management

Aspirational Target Product Profiles (ATPPs)  ATPPs provide the context for and set targets along a range of key criteria that are required to […]

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Target Product Profiles in Drug R&D – Introduction
Category: Insights Integrated Product Development Project and Portfolio management

Target Product Profiles (TPPs) are descriptions of key features needed in a new treatment for a disease and are used to […]

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The Benefits and Pitfalls of Repurposing Drugs
Category: Integrated Product Development

The interest in drug repurposing has grown, as the effort required to bring new drugs to market has increased. When […]

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Is Orphan Drug Status the answer to everyone’s prayers?
Category: Integrated Product Development

Developing orphan drugs is a risky business. Small numbers of patients, despite high prices, may not lead to high revenue […]

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Double-Edged Sword
Category: Integrated Product Development

Consequences for Medical Devices in case of a no deal Brexit. Over the Counter (OTC) remedies may not seem like […]

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