Under your skin: Sunscreen and skin cancer this summer

Thursday, June 24th, 2010

With the northern Hemisphere officially creeping into summer, the first arguments of this season’s sun and skin debate have arisen

Anti cancer councils and organisations akin to Australia’s Sunsmart are continuing their awareness-raising campaigns, educating the public about the issue, and most importantly the practice of sun protective behaviour; although significant investment and persistence are required, well executed and long running campaigns can make significant progress, albeit on a regional scale. But a vocal group of skeptics are continuing to question whether a central element, sunscreen, might just be part of the problem.

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Orphan drug development legislation and regulation landscape

Monday, May 17th, 2010

Previously we have discussed the shifts which take place in the regulatory centers of the world specifically London and Maryland, which present an opportunity to the industry to respond to expressed need.  Perhaps the greatest concern of every individual is access to health and quality of life.

This implies a strong directive for drug developers to respond to the identified needs of the patients and patient communities. But amongst those with therapeutic needs are some with more unaddressed medical requirements: patients with ‘orphan’ diseases.

Orphan diseases are rare and frequently untreated diseases. The previously referred shift towards patient driven drug development made a few voices heard and legislators in the European Community and United States started to act on behalf of the population. Here the legislators and regulators provided incentives to drug developers by reducing fees, providing exemptions and protection from competitors.

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Patient driven drug development

Monday, May 17th, 2010

Pharmaceutical development is undergoing a defining shift following the ever-increasing regulatory rigor in the process of evaluating a new product. Our recent announcement reflects the conservative view we hold on 21st century drug development.

During development the innovator often seeks to create a market for the new product, a common concept applicable to various industries. The same holds true for afamelanotide: we identified and developed our lead product in an under-served market of porphyria. Adaptation to chemistry and technology, novel communication platforms, deep knowledge and relationships with academia facilitated today’s entry to market.

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The Science of Sunburn

Tuesday, January 5th, 2010

UVindextodayIn Australia, Sunsmart and the state Cancer Councils work to educate and inform the public of the consequences of UV exposure and the protective and defensive measures that should be taken in order to avoid sunburn and to decrease the risk of skin cancer and melanoma developing later in life. An important part of changing behaviour in relation to UV exposure is to increase our understanding of the science of UV, sunburn and skin.

Comprehension of the changes skin undergoes when damaged by UV light and how UV impacts on skin (short and long term) serves as a reminder of the importance of sun protection. Understanding the physical processes and risks associated with damage makes the sun protection strategies and behaviour necessary relevant at this time of year in Australia. One only need look at today’s Australian UV forecast to understand the risks posed by the sun.

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The Clinuvel AGM

Tuesday, November 24th, 2009

melbournetownhallAs 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 a meeting that would be considered short by international standards I was both excited and proud to present some of the achievements and milestones our team has reached this year, and lay out our plans for the next 12 months.

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Talking off the label – part three

Friday, November 6th, 2009

offlabel_3Allergan’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.

Allergan may be one of the many companies to follow suit in time. Allergan’s concern is the FDA’s stance – prohibiting communication to the medical community in regards to the common off-label uses of Allergan’s lead product – poses a violation of the first amendment rights under the US constitution. A pharmaceutical company should be able to exercise its rights under freedom of speech to provide truthful and relevant information to its users: physicians.

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Talking off the label – part two

Friday, October 30th, 2009

offlabel_2Following on from last week’s conversation, I left off with the issues surrounding the off-label prescriptive habits by physicians and the implicit role of the sponsors. The Academy of Managed Care Pharmacy (AMCP) supports off-label use of FDA-approved drugs when medically appropriate and necessary, but opposes government-mandated coverage of specific pharmaceuticals, whether for FDA-approved or off-label uses.

Mentioned last week was the original definition of off-label use as the use of a drug for clinical indications other than those stated in the labelling approved by the US Food and Drug Administration (FDA) and other regulators. An example would be the use of a drug for oncological treatment (e.g. pancreatic), where the drug would originally have been approved for treating other maladies of the same class (e.g. ovarian, bladder and genitourinary cancer).

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GMP – Good Manufacturing Practice makes perfect

Wednesday, October 14th, 2009

beakersManufacturing 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.

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New media communication and the effects on pharmaceuticals

Friday, September 4th, 2009

Photoart_0117The 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 eMedicine, YahooHealth and the Dermdoctor contribute to our deeper understanding of medicine. The endless flow of free information will certainly have its effect on drug development too, but the lack of direct contact between the pharmaceutical company and its end-customers traditionally forces drug developers to primarily focus on the prescriptive behaviour and needs of physicians.

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The drug development process – Part 3

Tuesday, September 1st, 2009

Test Tubes 1This is a continuation of the post “The drug development process – Part 1” and “The drug development process – Part 2″

The 3 Phases of clinical trials are strictly monitored and controlled by different regulatory bodies such as the FDA (US), the TGA (Australia), the EMEA (EU) and SwissMedic.

All trials must undergo the same rigorous process as outlined in our previous post, but are quite distinctly different and influenced by a number of other factors.

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