Following much hype and fanfare at the Olympics, news reports have begun to trickle out on the costs of the Games and the longer term impact they might have on the British economy. While not immune to Europe’s economic spluttering across the Channel, many of the issues facing Britain’s bottom line are unique, and they may have broader implications for drug development, more specifically for drug pricing and reimbursement. (more…)
Inside Clinuvel: NICE, QALYs and the UK’s reimbursement landscape
Wednesday, August 29th, 2012Inside Clinuvel: effective drug development
Tuesday, July 31st, 2012
Take ten years, half a billion dollars and countless man hours from some of the most highly trained, intelligent individuals on the globe. You still stand a 90% chance of failure, some of which is totally out of your control. This is the apparent reality of modern drug development.
With the odds so stacked against it, it’s little wonder that the drug development sector is one requiring constant evolution in rethinking how to survive. In addition to the ‘regular’ risks of drug development, turmoil in global markets since 2007 has seen risk adverse investors shun drug development and biotechnology stocks for blue chip companies which are perceived as safer. The pressure to perform has increased for those companies who continue to work in the space.
In short, it’s forced even greater creativity to ensure survival and prosperity. (more…)
Inside Clinuvel
Tuesday, July 31st, 2012The 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
MAA: a moment in Clinuvel’s EPP story
Thursday, February 9th, 2012
Those who have taken an interest in Clinuvel will have learned with joy that, on Monday February 6th, the company announced its first official filing for SCENESSE® (afamelanotide) with the European Medicines Agency. It has taken our teams around six years to arrive at this point. Benchmarked against peer companies, it is a relatively swift development path for a first-in-class drug; we first publicly announced our erythropoietic protoporphyria (EPP) program in September 2006. It is an opportune moment to reflect briefly on how we reached this milestone and then discuss the steps that must be taken from here. (more…)
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…)
A coffee a day keeps skin cancer at bay? Look a little deeper…
Thursday, August 18th, 2011
We tweeted it earlier this week and it’s been run across numerous news sites: new research has suggested that coffee – or more specifically caffeine – can help reduce the risk of skin cancer. It’s a fascinating story and one which deserves further review.
The research, conducted across multiple US sites and supported by National Institutes of Health grants, sought to expand upon an existing understanding of the correlation between the intake of caffeinated beverages and a decrease in the incidence of non-melanoma skin cancers. (more…)
The importance of clinical relevance
Tuesday, August 2nd, 2011
Development of novel drugs is truly like no other business: one attempts to address questions that may have never been previously posed – let alone answered – in the pursuit of improving the lives and quality of life of patients. As I eluded to in my recent letter to shareholders, the team is now well into the analysis of results from our erythropoietic protoporphyria (EPP) program; two studies from the US and Europe. This is a complex and time consuming task that requires one to collate and make sense of thousands of data points to answer a seemingly straight forward question: does this trial show that the drug is safe and effective?
Obtaining an answer needs to be understood from the concept of clinical relevance. Put simply, results don’t just need to show that a treatment or intervention has an effect on a disease. Rather, they need to indicate that that effect is relevant to the current clinical understanding, treatment and care for the disease or indication. They need to show that the drug’s effect is having a positive, meaningful impact upon a patient’s prognosis and care. This is a crucial point to consider in the development of protocols and in the careful analysis of results, as it is how regulators will review the results. (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, 2011When 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…)
FDA Basics website reworks new drug approvals data
Friday, March 18th, 2011We’ve spoken often about drug approvals by regulatory agencies, particularly approvals for new drugs, or new molecular entities (NMEs). A quick – and useful – data update on this front has just been posted by the FDA to their FDA Basics website (a project we blogged about in 2010).
The FDA has posed itself two questions which it seeks to answer, head over the their website to see the results:
Is it true FDA is approving fewer new drugs lately?
Is the U.S. really slower than Europe in approving new drugs?
