Are you on the Blue Line?

Are you on the Blue Line?

Depending on your organisation’s size and the number of development projects that you have running right now, there is a level of capability that is right for you. We represent this by the blue line in this diagram:   An organisation on this line is in perfect balance - where the capabilities have developed to best facilitate delivery of any project or a portfolio of projects. These capabilities need to change as the size of the organisation changes as well as with evolving context.   However, we’ve seen many companies that don’t have this balance right. Small organisations may struggle if they don’t evolve to stay on the line. Equally, others may set over-ambitious goals for sophistication, when ‘good’ is perfectly adequate.  You may not be able to judge if you are on the blue line. We can help you to assess your current position and if required, build a roadmap to get you there.      AN OVER-THE-TOP INSTALLATION OF PROCESSES, STRUCTURES AND TECHNOLOGIES Typically a biotech starts with simple tools such as homebuilt spreadsheets - but these become increasingly unwieldy and only understood by few in the organisation - so to solve that problem, they buy...
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Target Product Profiles in Drug R&D – Regulatory Profiles

Target Product Profiles in Drug R&D – Regulatory Profiles

Regulatory Target Product Profiles (RTPPs)  RTPPs describe the aims of a drug development programme in terms of labelling concepts. They can be used by regulatory agencies to quickly see the claims the developer is aiming for with a new drug and therefore the data, experimentation and clinical trials needed to support these claims from the regulatory perspective.    An RTPP is a valuable reference document that helps the drug developer and regulatory agency understand the entire drug development process, from pre-investigational new drug application (pre-IND) through post-approval programs to pursue new labeling claims or indications. An RTPP is not a necessarily a fixed description of the aims of drug development but may change as more becomes known about the nature of the drug under development.   Possible sections of an RTPP could include:   Therapeutic area   Indications and usage   Patient population   Dosage, dosage form and administration   Claims and labelling   Clinical pharmacology   Proposed clinical programme and data to be provided   Toxicology programme and data to be provided   Contraindications and drug interactions   Adverse reactions   Warnings and...
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Target Product Profiles in Drug R&D – Introduction

Target Product Profiles in Drug R&D – Introduction

Target Product Profiles (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. As we shall see, TPPs have different meaning and structure dependent on usage. Here we intend to explore and clarify.    TPPs can be broadly divided into 3 related forms:   Aspirational (ATPP). A fixed description of the essential attributes of a treatment for a disease, derived from a wide ranging understanding of the disease in question, the medical and commercial opportunity, the regulatory hurdles, any real or potential competitors, the access and re-imbursement environment, and the goals of the developing organization.   Emerging (ETPP). As the drug undergoes trials its properties are revealed. This...
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