Speed, Quality & Cost – Why You Should be Conducting Your Clinical Trials in Australia

An introduction to study designs for investigating the role of genes in disease will be provided, followed by an overview of statistical methods used to test hypotheses for each design. Examples of several designs will be discussed, as well as accompanying methods. Publications assessing the role of genetic variation in disease will be examined, and a critical critique of methods and results for each publication will be reviewed.

Formulators modify the release profiles of drugs for multiple reasons: to target delivery of the API, enhance bioavailability, provide dosage convenience, improve patient adherence, and extend the patentable life cycle of an existing drug.Whether the desired profile is for immediate or modified release, formulators must overcome the development hurdles of poorly soluble APIs. Modified-release drugs may require more excipients and more complex formulations and manufacturing steps, resulting in longer, and more expensive, development processes. Proven formulation methods and careful excipient selection, however, can be employed to develop formulations for modified release drugs that offer value to the patient.

The pharmaceutical industry has experienced a trend in the number of accelerated approval designations for drugs (e.g. orphan drugs, breakthrough therapies, accelerated approvals, and FDA priority reviews) being developed. These designations are given shortened timelines for product development, product assessment and commercial scale-up (typically between 3-5 years) and come with several development and manufacturing challenges. In this webinar, you will hear from industry experts on overcoming scale-up challenges and fit-for-purpose manufacturing strategies.

When it comes to the Pharma supply chain, problems can occur at any part of the process, including non-standardized bills of material, translation mistakes, typos and poor proofreading, missed annotations, unclear briefs, artwork problems, expired digital assets, third-party artwork suppliers and printing shops. Consumer and pharma companies must also deal with a very strict regulatory environment. Each time there is a problem, the manufacturer risks having to issue a (potentially major) recall.