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Inside Clinuvel

Tuesday, July 31st, 2012

The last five years have brought much change in the global pharmaceutical industry. As one of thousands of firms working in the space, we’ve taken a novel approach to try and overcome the challenges such change has presented.

This approach has taken us close to achieving what few of these firms will – proving that a new drug is safe and effective in its treatment of a disease and getting the product approved by the regulatory authorities. Every day the team and I have learnt something new that has helped us in this quest.

Over the next few months – coming from a different perspective as head of communications – I will try to share some of this knowledge with you via the blog; looking at how and why we do what we do, and trying to address some of the most common questions the company encounters on a day to day basis. I welcome your thoughts and feedback, either through comments on the blog, via Facebook, or directly via email to mail@clinuvel.com

- Lachlan Hay, Head of Global Network and Communications, Clinuvel

Clinical relevance – the value of patient experiences

Friday, September 30th, 2011

Since 2006 Clinuvel has trialed SCENESSE® in a truly unique group of individuals: patients living with erythropoietic protoporphyria (EPP), a rare genetic blood disorder which causes an absolute intolerance to light.

EPP prevents patients from leading ‘normal’ lives, especially outdoors. It is one of the few diseases that manifest clinically with initially invisible symptoms which cause severe dermal pain for several days. This not only presents a challenge for diagnosis and treatment, but also for generating meaningful clinical trial results – those which are measurable numerically and are used by regulatory authorities to evaluate the efficacy of a drug in a patient population. Here, real life patient experiences during a trial can play an important role in providing clinical relevance and analysing hard data. (more…)

Melanocyte stem cells

Friday, June 17th, 2011

Human skin consists of a number of different cells. The majority of the top layer of the skin is made up of keratinocytes which are produced constantly and migrate to the surface of the skin where they ‘slough off’ as dead skin.

Melanocytes, the cells which produce pigment in the skin, lie below the keratinocytes at the base of the epidermis (see the figure, click to enlarge). Melanocytes also exist at the root of the hair follicle, in the matrix of the inner root sheath or shaft, and are responsible for giving hair its colour. The dermis, the layer of the skin beneath the epidermis, consists mostly of collagen, elastic tissue and reticulum fibres, along with some specialised nerves and glands. The bases of hair follicles are also embedded in this middle layer of skin.

(more…)

The challenges of ‘orphan’: can drug development cope with rare diseases?

Thursday, June 9th, 2011

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…)

Small populations, big therapeutic potential

Monday, May 23rd, 2011

When Andrew Pollack of the New York Times declared that the “world’s largest drug company is thinking small”, he wasn’t referring to reductions in sales force.

Rather, Pollack was reporting on a licensing deal between Pfizer and Israeli biotech company Protalix which built upon a growing global trend: big pharmaceutical companies were making a move into treatments for rare diseases, otherwise known as ‘orphan’ therapies.

In the months that followed Pollack’s December 2009 article, both Pfizer and GSK (two of the world’s largest pharmaceutical companies) launched specific business units focused on R&D for orphan drugs. In their announcements, both companies highlighted the significant unmet medical needs that exist in rare diseases and the potential of therapies that were in development. (more…)

New drug approval rates

Friday, February 25th, 2011

Novel drug development is a business which is not well understood; perhaps one which is not well explained. To be able to launch a novel drug proposition, one needs tenacity, expertise and a talented team to succeed. Unlike a ‘follow-on’ product where an abundance of safety data on the molecule in one or other formulation or therapeutic application exists, those few companies working with new drugs must clear all the necessary stringent barriers from the outset.

This makes novel drug development a risky endeavour, amplified by a level of uncertainty even when it is believed that the necessary regulatory hurdles have been cleared and the drug development process seems complete. By looking at several new molecules being developed for obesity (Lorcaserin, Contrave and Qnexa particularly), one can see how uncertain the outcome remains, even when so much work and so many years have been invested; others have written extensively about these cases and I encourage avid readers to review the publications. (more…)

Further news from the AAD

Tuesday, February 15th, 2011

A week ago we saw the close of the American Academy of Dermatology’s 69th Annual Meeting in New Orleans. The conference is often the launching pad for many new and interesting scientific study results. This year was no exception, with some interesting findings being presented.

This is a follow up to an earlier post on AAD news which can be viewed here. (more…)

The evolution of human skin pigmentation: The delicate balance

Friday, July 16th, 2010

Skin colour is one of the most obvious and most variable traits humans possess. As visual creatures, people readily observe these differences in one another.  Anthropologist, Dr. Nina Jablonski, and colleague George Chaplin have unraveled the mystery behind the diversity of this distinguishing characteristic in their article, ‘Human skin pigmentation as an adaptation to UV radiation’. The pair have presented the first complete theory of skin colour as an evolutionary adaptation.

Paeleotologists have long known that human ancestors once had bodies covered with dense hair. Several theories on the evolution of the present ‘hairless condition’ exist. In this case, the authors suggest this was in response to hot conditions and the need to lose body heat upon physical activity. As naked beings, their once-protected skin became exposed to a multitude of environmental elements, including abrasion, infection, various chemicals and weather conditions. At the same time as the disappearance of the majority of body hair, humans evolved skin that was a more resilient barrier to such hazards and also contained the protective pigment eumelanin (melanin).

(more…)

Summary of today’s announcements

Wednesday, July 14th, 2010

Today’s announcement of the results of CUV017 has brought with it a stream of updates from Clinuvel, on the website, YouTube and beyond.

In this post we summarise the days releases and developments.

(more…)

What makes a ‘gold standard’ in cGMP? (plus a new webcast)

Monday, July 12th, 2010

As previously discussed on the blog, Good Manufacturing Practice, or GMP is a vital consideration for pharmaceutical manufacture and quality control. This means that the processes, equipment, active ingredients, documentation and training are controlled and of a high standard prior to a drug being approved. To be in compliance with GMP, regulations should ensure that the drug substance is of adequate quality, when used in humans and becomes available commercially.

Ultimately, quality protects the public and ensures that the reality of a drug sold or prescribed is an accurate reflection of the claims and ingredients made not only on the label, but also of the exact nature of the formulation that was approved through rigorous clinical trials and analysis.

(more…)

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