The marketing model for US prescription pharmaceuticals is often debated for its direct-to-consumer (DTC) advertising as the United States is one of the few jurisdictions globally which allows this type of marketing. Yet equally debated is promotion directly to physicians, key decision makers in the prescription process. Physician promotion comes in many forms, ranging from one on one visits with sales representatives to educational sponsorship to the ubiquitous branded pen. (more…)
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…)
Use of drugs in patient populations for purposes which are not approved by the regulatory authorities is termed ‘off-label’ use. As the regulatory authorities do not have specific power over doctors’ prescribing habits (provided that the doctor assumes the medical risk), it is a common practice to prescribe drugs for purposes which have not been authorised by the regulators. While it is legal for doctors to prescribe off-label drugs, it is illegal for companies to market the use of these drugs. (more…)
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…)
Effective communication is demanded more than ever in present-day drug development. I’ve blogged before about the role of patients in this process and the importance of acknowledging patient driven drug development. In a time of advanced technologies and communications it is my intention that Clinuvel be at the forefront of any developments in this area and that the company seeks new ways to discuss our program, online and off.
We also work in a highly regulated environment: very little of what the company does is without scrutiny from this perspective, either from our own regulatory team or from external organizations established for this purpose. Despite the hightened reviews, there remains a discord in the communications realm, with a lack of regulation surrounding tools referred to broadly as ‘social media’. (more…)
This morning Clinuvel announced a significant milestone in its development program for SCENESSE®: the signing of the first manufacturing agreement for the final drug product with SurModics, Inc., a leading provider of drug delivery technologies to the healthcare industry. It has taken over eight years for Clinuvel to reach this milestone. In this time, the company has refined SCENESSE’s active ingredient – afamelanotide – and arrived at a final injectable drug product which controls its release to achieve an optimal photoprotective response in patients.
The human body functions and survives by maintaining a biological and physiological balance. Over tens of thousands of generations we have evolved numerous systems to care for and protect our health and well being at a cellular level.
As a response to damage, various cells are programmed to self-destruct. The process is known as apoptosis, and it works to ensure that defects to the nucleus of the cell arising from any damage are not replicated and passed on in subsequent generations of cells.
A second, and lesser known process, is the concept of senescence.
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.
Communication remains key, whereby content of news and material facts dominate over frequency of news flow. Here our adagium no news signifies focus and good news. A total devotion to this one project, and execution on clinical and regulatory development while finding a balance in available funds, are the core activities en route to commercialisation of afamelanotide.
The significance of communication is equally seen in the way regulators, patients and the medical community gain access to information, data and obtain feedback. Clinuvel is well aware of this and consistency in our operations helps to communicate its objectives.
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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