During the first and the start of the second decade of the 21st century it has become clear that the pharmaceutical industry is faced with a true paradigm shift. The era of the block buster drugs, the “one size fits all” type of medicines is over.
Technological advances in the pharmaceutical field
With the advent of biotechnology, which leads to an ever increasing pace knowledge accumulation, it has become clear that no two patients are perfectly alike. Many syndromes, once thought of as being one disease, turn out to be a large number of closely resembling but on a molecular level clearly distinct entities. It is therefore hardly surprising that drugs which are designed to bind to one specific molecular target do not work equally well in every patient.
Advances in medical science are currently leading to revolutionary changes in the use of medicines. The classic medicinal treatment is gradually being replaced by Health Technology. The selection of the right drug is done more and more on the basis of genetic analysis, often assisted by advanced in vitro diagnostic tests or by means of hi-tec medical imaging with or without the use of the newest generation of in vivo diagnostic agents, contrast media or radiopharmaceuticals. Efficacy is also monitored using laboratory assessments or medical imaging. For the pharmaceutical industry, data mining is a domain which is as yet almost entirely unexplored but new developments in IT may soon change this. The value of all therapeutic interventions is relative and current treatment modalities may be rendered obsolete at any time by new developments. Continuous Health Technology (re-)Assessment certainly will be a major challenge for years to come.
Focus on the patient
Patients have the right to be treated with efficacious and safe medicines. No new drug is put on the market without a systematic investigation of its safety and efficacy in in vitro systems, in animal models and last but not least, for those compounds that make it through the entire elimination process, in man. Human studies are essential to document the clinical properties and efficacy of the new drug, Many candidates with undesirable properties or an unfavorable benefit / risk balance are eliminated at this stage. Whereas limited efficacy and safety data in well-defined populations are collected during clinical trials organised for regulatory approval, Post-Approval Safety Studies in real-world settings (i.e. in patients with various co-morbidities, receiving other drug treatments concomitantly and presenting various other risk factors) have the potential to demonstrate the safety of any drug product.
Eye for quality
Ensuring that the finished drug product meets the highest qualitative standard possible is another approach to minimize the risk of side effects. Good Manufacturing Practices require an integral approach. Not only is it necessary to work with starting materials of certified sources, also the methods for analyzing these substances as well as the finished product need the most careful qualification. It goes without saying that the manufacturing methods are the result of systematic design, testing and redesigning by highly qualified and experienced professionals.
It is evident that all of these factors render the development of new drugs very expensive and this has important consequences for the patient, the payer and the pharmaceutical industry. The patient is much better informed now than was the case only a decade ago. The payer is confronted with an enormous choice of complex therapeutic alternatives which almost invariably have numerous short and long-term effects. As every Euro can only be spent once, difficult choices will have to be made. Health Technologies have to be Assessed taking into account the pharmaco-economic consequences of the various options. Pharmaco-economic data are not always available and may require the organization of Post-Approval Efficacy Studies (often observational trials) conducted under real-life circumstances. From the point of view of the industry, even with the most modern approaches for drug discovery, it is still impossible to exclude rare side effects. These factors, together with the focus on smaller and well-defined patient populations make drug discovery and development a high-risk venture.
Drug development is a lengthy process and industry’s return on investment is to a large extent determined by the period during which a new drug can be marketed at a premium price. The duration of patent protection is shortened by the time it takes for the Regulators to evaluate the application for marketing authorization.
Ensuring the availability of new medicines
Regulators and health insurance organisms generally acknowledge the efforts done by the pharmaceutical industry. It is also evident that without sufficient financial incentive, further drug developments by the pharmaceutical industry would grind to a standstill. In Europe this acknowledgement has led to the Early Temporary Marketing Authorization (ETMA) scheme. Under the ETMA scheme, an innovative new medicine is allowed to come on the market at a stage when the clinical development is in an advanced stage but not yet completely finished and not all actual or potential risks have been identified. The main condition of any ETMA is ongoing clinical development often as observational trials under conditions which closely resemble the usage of the medicine in real-life. The future Early Temporary Reimbursement (ETR) scheme in Belgium is also a step in the same direction. The conditions are more or less comparable to those of the ETMA. An ETR requires an agreement on price and volume and from the side of the applicant a commitment for further data collection. It should be stressed that market access, fast, under conditions that are attractive to the pharmaceutical company and at a price which is acceptable for all parties, requires strategic input from the Market Access Department during the late phases of clinical development. Unfortunately, it is still uncommon that the Market Access specialists are given the opportunity to provide advice at the stage where it would be most useful.
We bring your medicines and healthcare products to the market and keep them there.
To accomplish this mission, Archemin supports the Market Access and Medical Department of Pharmaceutical Companies who face the future challenges of servicing smaller patient groups under increased safety scrutiny.
These Innovating Pharmaceutical Companies typically have a viable business model that involves market access specialists at an early stage, during clinical development when strategic choices have to be made.
Today’s organisations need more diversified skills and expertise to keep abreast of the ever increasing complexity of legislation and policies. Currently the most successful pharmaceutcal companies must rely on multidisciplinary teams to deliver the best solutions possible. Archemin aims to meet this need by providing professional services in a number of subjects based around Regulatory Affairs, Market Access for healthcare products, Pharmacovigilance, Clinical Research, Medical Information, the development of Quality Systems and Training. Thanks to its innovative structure, Archemin is able to provide clients with exclusively tailored consulting services that either freelancers or large consultancies find impossible to supply.
Our added value is generated through a unique combination of
- strategic thinking in line with your marketing and sales strategy;
- commitment to excellence;
- scientific know how;
- organizational skills;
- extensive field experience;
- a hands-on can-do attitude;
- high motivation;
- networking within the pharmaceutical industry, distributors, contract manufacturers, certified laboratories, CRO's;
- excellent contacts with the Competent Authorities and with University Experts;