Scarcely a day goes by that the Clinuvel team is not contacted regarding the latest conference: everything from monitoring to manufacturing to marketing is analysed, discussed and disputed across the globe in conference form. It’s impossible – and unwise – for small companies to try to attend all these forums, but it is equally impossible to work in the space without looking outside the office door: there is much to be learned from what others have done or not done to succeed in an industry fraught with failure.
And indeed there was much to take on at the recent World Orphan Drug Summit, held in Frankfurt last week. (more…)
Drug development is time consuming, expensive and fraught with risk. Setting aside commercial considerations, the scientific rational for the use of a drug and its introduction into the clinic requires a deep level of scientific and medical understanding in an environment which is continuously changing. The less common the drug class or clinical indication, the less likely one is to find individual experts who have the capacity to properly evaluate whether a drug is safe and effective for use in a clinical setting. Here one needs to learn while progressing, learning on the job due to lack of precedent.
As many of you may know, this week saw Clinuvel hold its Annual General Meeting in the Melbourne Town Hall. As managing director I welcome these opportunities where I am able to meet and talk to the people whom Clinuvel considers integral to the company and its existence; the Board of Directors sees Clinuvel’s investors as unique. In Clinuvel, an investor has to fundamentally believe in the premise of offering pharmaceutical photoprotection, a novel option, an innovative approach to skin disorders.
In January 1983 the United States government passed an Act that has had a profound impact on pharmaceutical development and the individuals whom it was intended to benefit. The Orphan Drug Act (ODA) was lobbied for successfully by the National Organisation for Rare Disorders (NORD) and provides incentives for researching and developing treatments for rare or ‘orphan’ diseases.
Allergan’s lawsuit filed against the FDA presents a relatively novel case in addressing the requirements of drug developers in relation to off-label use of drugs by physicians.
Following on from 
Today, and in the coming weeks I shall review the increasingly complex phenomenon in the pharmaceutical industry called off-label drug use. 
While we firmly believe at Clinuvel that communication and online dialogue is a most valuable tool to inform shareholders, prospective patients and physicians, the boundaries of drug promotion are being drawn as we speak.
Manufacturing drugs for human use is a complicated process frequently involving compounds and materials that, if used incorrectly, can be hazardous to people’s health. Highly regulated nations (such as the US, EU, Australia and Canada) have long realised the necessity that they develop strict guidelines governing these processes to protect patients and ensure product safety, quality and efficacy. Poor quality drugs, manufacturing processes or conditions can have extreme and dire consequences for patients. In countries that enforce Good Manufacturing Practice (GMP) the penalties for non-adherence reflect its importance and can include forcing worldwide product recalls, seizure of property, large fines, even imprisonment.
The millisecond transfer of data packs has changed medicine for good. When it comes to gaining online information about our health the pros outweigh the cons. We are seeing in modern medicine that patients are well prepared when seeking health consultation. Sites such as 
