The drug development process begins with the expeditions (F.1) that PharmaMar conducts around the world to gather samples of marine organisms. The samples form the basis of a process of research to discover new compounds with antitumour properties, under the Company’s standards and complying with very strict quality criteria. At this stage, it is very important to ensure traceability of the samples from their origin to final analysis (F.2), by managing all the information associated with each organism in the sample library, which contains both macro-organisms and micro-organisms (F.3). Extracts prepared from the samples are screened against a panel of tumour cells on the next step to determine their antitumour activity.
With the purpose of determine the antitumour activity from the extracts prepared from the samples, these are screened against a panel of tumour cells (F.4 and 5). Extracts that exhibit antitumour activity (F.6) are fractionated and purified so as to isolate the active compound responsible of that activity.
To avoid depending on natural sources, we design chemical processes to produce the compounds (F.7) in sufficient quantities in order to pursue the research process. While developing these processes, we also initiate medical chemistry programmes to obtain analogues (F.8) of the original compound with a view to selecting the best candidate for pre-clinical and clinical trials. Once the active compound has been synthesised, we consider possible formulations, and define the presentation (F.9) to be assessed in animal models (F.10) in order to determine its activity against various tumours and its safety profile. We also study the mechanism by which the chosen compound kills tumour cells, ascertain whether it is specific to certain tumour types, and determine whether it is more effective in combination with other drugs. The purpose of the entire pre-clinical phase is to generate information on which to base clinical research.
It is very important for biopharmaceutical firms to protect the inventions arising from their research by applying for patents (F.11). It is also important to register trademarks that may be used for commercialising medicines in the future. For this purpose, Industrial Property works closely with other departments of the company to identify or detect new inventions so as to ensure the utmost protection for development projects.
This stage begins with the industrial development, when a sound process is defined (F.12) that ensures supplies of the product for clinical and commercial purposes, enabling a registration dossier to be developed for an application for authorisation to market our drugs. Once the processes are defined, the Production Department is responsible for producing the active principles (F.13) required to manufacture the medicine. Production is also responsible for packing the drugs for worldwide distribution.
PharmaMar’s production facilities meet the highest standards of quality (as certified by the European and US health authorities), safety (OHSAS 18001 certification) and environmental preservation
(ISO 14001 certification)
Since laboratory animals are not a valid in vivo model for determining unequivocally whether a efficacy and safety features in humans, it is necessary to conduct trials (F.14) in humans before approval; this process consists of three phases, plus a fourth phase of study and followup after commercialisation commences. The various phases of clinical trials in patients try to establish a drug’s efficacy against various tumour pathologies and determine its main side effects. Before a doctor can prescribe a drug to patients, all countries’ competent authorities require that drug companies first prove that the drug has the necessary quality, safety and efficacy before giving authorisation to commercialise it (F.15). Once authorisation has been obtained, the drug company must contact the competent authorities to negotiate the price and reimbursement for the drug. The Regulatory Affairs area provides advice and supervises implementation at PharmaMar of the legal and regulatory requirements that apply to development, authorisation for commercialisation, and subsequent pricing and reimbursement of new drugs. This area also handles applications and negotiations with the competent authorities and institutions while the drug is commercially available.
Approved for commercialisation by the authorities, it is launched on the market. This involves coordinating a number of activities, such as identifying and establishing the product’s profile, positioning it in the market, and distinguishing it from the competition. Promotional and educational activities are also carried out to optimise the drug’s sales potential. Relationships are established with medical associations, opinion leaders and patient associations, and the company plans, organises and coordinates its presence in national and international scientific meetings and other events. Doctor’s prescription (F.16).