Company profile

Velleja Research (registered offices in Milan, Viale Lunigiana 23, and in Pontenure, PC, Via Natta 28) was established on May 4, 2006, through the merger of the (scientific-industrial, marketing & communication and business development) experiences of its three founders.

Its name, Velleja Research, was "borrowed" from Veleia (or Velleia or Veleja), an ancient Roman town (now a UNESCO World Heritage site) located in the province of Piacenza, not far from the present offices of one of the two locations. Ancient Veleia, flourished between the first century BC and the second century AD, declined around the third century and eventually disappeared in the fourth due to a series of landslides and landslips. It was discovered by chance in 1747, excavations began immediately and the old town was brought to light. The reason for this 'appropriation' lies in the fact that a famous bronze find ? the so-called 'Etruscan liver' ? was also discovered in the same area. According to recent interpretations, this object served as a practical guide for divination on the basis of the signs observed in the entrails of animals. The object is a bronze model of a sheep's liver and was probably an instrument, also of a medical nature, used by Etruscan haruspices.

Thanks to a passion for pharmacological, phytotherapeutic and nutritional sciences shared by its 3 founders, Velleja Research has been created to meet the need for rational ideation and scientific development of new products/preparations for the pharmaceutical, nutraceutical and cosmetic sectors, as well as of medical devices with particular regard to the branch of dietary supplements and phytotherapeutic remedies.

Thanks in particular to the legislation on food supplements, nutraceuticals and phytotherapeutic remedies have broken into the practice of both the general practitioner and the specialist over the last five to ten years . This entry has long obliged the physicians to deepen their knowledge and keep informed.

While a "medicinal product" is defined as any substance or combination of substances presented as having properties for treating or preventing disease and capable of exerting pharmacological, immunological or metabolic activities, any preparations intended to be integrated into the everyday diet and formulated to include a concentrated source of nutrients (vitamins, minerals, amino acids, fatty acids), or substances with physiological effect (fibres, herbal extracts), as pre-dosed mono-component or multicomponent preparations, are on the other hand called "supplements".

In case of phytotherapeutic supplements, it should be pointed out that they must be formulated according to the "Positive Lists", constantly updated by the Ministry of Health; they must take account of the medicinal plant parts indicated in the "lists", and the extractive preparations thus obtained must have been industrially processed according to the legislation on solvents. Whenever possible, the phytotherapeutic derivative, intended as raw material, will have to be standardized, preferably in terms of its chemical profile, rather than in terms of its titer, which is often counterfeited, misleading or useless inasmuch as it is a mere expression of an identification marker of the botanical species. And its chemical profile will have to be as much as possible the same, preparation after preparation. Only this standardization of this undoubtedly complex and expensive procedure will enable the resulting clinical, pharmacological or toxicological information to be repeatable and, therefore, allow the preparation to be used in medical practice. These standardization procedures are followed almost exclusively for preparations that are 'medicines' according to the laws in force in other EU Countries (in particular Germany, France and Great Britain), as well as in non-EU Countries. Ginseng, ginkgo biloba, as well as hawthorn or valerian and many more, are actually prescription drugs or, more frequently, OTC products and, therefore, registered as drugs in a number of foreign countries, quite often not including Italy. This means that in the preparation of a phytotherapeutic supplement, it will be useful to make use of these raw materials whenever possible.

Once the correct raw material has been chosen in terms of actual standardization, the formulation under trial must also take account of any pharmacokinetic and pharmacodynamic data available in literature on the pure extraction derivative that is to be used. In the case of a phytotherapeutic product this data often provide only the description of a poor, if any, oral bioavailability. The reasons for this low kinetic profile must be investigated and somehow corrected. Quite frequently a phytotherapeutic product is not absorbed because of poor gastric stability (need for gastric protection); or due to problems of a physicochemical nature (the active fractions of the extract are hydrophilic, and the lack of specific intestinal carriers makes it necessary to resort to phytosome carriers or co-grinding or ter-clatration techniques); or also because the active fractions are re-extruded by ABC protein systems in the enterocytes (the formulation requires specific antagonists of P-glycoprotein); or finally the active ingredients carried to the liver are promptly glucuronidated or sulfated and then eliminated in urine or the bile (this requires use of alimentary grade antagonists of liver phase II enzymes).

The preparation must be then investigated in terms of release curves in relation with "time" and "pH" variables, which often affect active ingredient release and absorption. Once the oral bioavailability issue has been solved, and the planned release profiles have been ensured through these and other approaches, the final formulation - and in particular multicomponent formulations - should be then investigated from the toxicological point of view according to the GHS legislation and analyzed in terms of its organoleptic and, whenever possible, chemical stability.

Finally - still more important for clinical practice - the formulation, exclusively and absolutely in its finished form as presented to the physician by the medical representative during his/her visit, will have to be investigated in clinical trials, which will guarantee its safety profile and provide guidance for its correct use in patients. The trial will have not only to highlight compliance, tolerability and the onset of possible unwanted side effects, but also to ensure and confirm the scientific rationale that prompted the formulators to finalize the preparation for the hypothesized clinical use.

The publication of the resulting clinical data and its constant verification in hospital practice or outpatient care will make physicians fully aware of the real use of the supplement and in the end, protect them from potential risks of product counterfeiting and/or adulteration. At the same time these actions will defend physicians from the "stolen science" deception, where the product is promoted with data obtained from formulations that are different from, and only similar to, the preparations advocated by the medical representative.

The above considerations expressly referred to phytotherapeutic derivatives (whether dietary supplements or traditional remedies) also apply to products containing vitamins, mineral salts, fatty acids, amino acids and the like. These substances, too, "suffer" from pharmacokinetic and/or pharmacodynamic problems that have to be investigated prior to their use.

The scientific issue becomes even more crucial in the probiosis field. In fact, use of enzymes is so widespread as to make it one of the most important sectors of pharmaceutics and modern nutraceutics. But probiotics are living forms and, consequently, quite "frail". This means that any relevant investigations, conducted with great scientific solidity, should cover stability aspects, possible interferences between strains and any potential interaction with all the ingredients (other active substances, excipients) used in the finished probiotic product, as they inadvertently yield water, thus limiting the strain survival. No less important is also the verification of the colonization aspects. In fact, a probiotic is aimed at generating a state of well-being deriving from an actual colonization and subsequent production of beneficial factors for the host organism - the user. Unfortunately, it often happens that the colonization aspects are instead totally neglected by the formulator because of their high costs.

Velleja Research obviously does not market any product as their exclusive mission lies in the study and development first of ideas and then of preparations according to the above methods and procedures. Then they sell these ideas/preparations to companies possessing a solid commercial structure and accompany the sale with all the required scientific aid (dossiers, reports, rationales, training, stability, PK and PD studies, clinical trials and data publication), also supporting any communication aspects whenever necessary.

Velleja Research is a company whose exclusive foundation lies in the value of their scientific data, and whose action moves from the initial analysis of the active ingredient to the subsequent assessment of its inclusion in the pharmaceutical form chosen and ends up with the assessment of the path followed by the ingredient in the organism to its excretion. For these reasons Velleja Research is a company whose aim is to provide the biopharmaceutical development of products, whether dietary supplements, medical devices, cosmetics or medicines.