Dr. Gabach, our director & manager of New Projects, analyzes the present and gives us a preview of the future of Amarin and the transdermal market.
Dr. Roberto Gabach has been working in the pharmaceutical industry for almost 40 years. With his experience and valuable information about the transdermal sector, he demystifies the rumours that this market niche is in decline.
Here we share with you a clear and detailed summary of the current situation and the future of this sector.
Dr. Roberto Gabach is the first member of his family to graduate as a physician. He confesses that he wanted to become a commercial pilot when he finished high school. However, unable to do so, months later he started his career at the School of Medicine of the University of Buenos Aires, where he obtained his medical degree.
During his time as a student, he worked to support his career, that is how he began his work in the pharmaceutical industry in his third year of medical school. Dr. Gabach recalls that, around 1978, his mother found an advertisement in a newspaper offering jobs to medical students to work as medical promotion agents. Thus, he had the first contact with the pharmaceutical industry, being part of a special team along with other medical students within a national laboratory.
After graduation and through the years he held different positions in companies such as Szabo & Kessler and Roemmers Laboratories, in the International Area.
He then joined Laboratorios Beta S.A. where he reached the position of Medical Director. Dr. Gabach confesses that the moment before joining this company was crucial in his life since he had to choose between the job offers he had, at the same time, from two solid and growing national companies. He chose Laboratorios Beta, which allowed him to get to know the transdermal development division of that company, which was the basis for the creation of Amarin Technologies.
He was a staff physician at the Toxicology Service, Department of Internal Medicine, Hospital de Clínicas “José de San Martín”. He also taught at the School of Medicine of the University of Buenos Aires and at the School of Medicine of the Universidad del Salvador, where he became a Professor of Toxicology. Dr. Gabach emphasizes that he always enjoyed his career as a physician, both in his work in the health care area and during his long career as a teacher at undergraduate and postgraduate levels.
There are rumours that the transdermal market is in a slow decline. When we asked Dr. Gabach about how he sees the future of the transdermal industry, he affirms: “I see it with a sustained growth”. In this sense, he comments that “there are different technologies that are being developed to increase the number of molecules administered through the skin. This will lead to a growth in the transdermal sector due to the progressive incorporation of different therapeutic agents”.
However, “the market launch of transdermal products is slower than what is happening with the rest of the pharmaceutical industry,” Gabach points out. This is because “patches are complex products. (…) Not all therapeutically available drugs can be administered transdermally. The development of these systems, known as patches, requires more time, greater investment and must meet more requirements to be approved than other pharmaceutical forms”.
In general, the development of any transdermal system presents three challenges:
That is to say, to ensure that it penetrates the skin and maintains stable concentrations in the blood and therapeutic usefulness for the product to be effective.
In this sense, he explains that “the great challenge of this technology is to use indicated permeation enhancers. The purpose is to achieve adequate penetration, especially at the level of the stratum corneum, that is, the most superficial layer of the skin. Transdermal technology tries to overcome this barrier using different types of enhancers, which are selected taking into account, among other things, the characteristics of the active ingredient being worked with. The appearance of new permeation enhancers, and especially the combination of these in the same formulation, makes it possible to increase the number of drugs that can be administered transdermally and thus the number of products available”.
Another major requirement of transdermal systems is to remain fixed to the skin for the time necessary to achieve a stable drug concentration in the blood. The duration of the application will depend on the characteristics of the patch, “there are daily replacement patches, others that are replaced every 3 or 4 days and those that reach maximum duration in 7 days, at least as far as commercial products are concerned”. When generic transdermal systems are developed, the objective is that the adhesiveness of the copy should not be inferior to that of the original patch.
This is another sine qua non-requirement for the approval of these dosage forms. The transdermal system must not only be effective and have adequate adhesiveness, but also good local tolerance, in other words, it must not irritate the site of application.
For example, to develop a generic development, at least these three requirements must be met since it must be shown to be “no different from the original patch”. Meeting all these requirements in itself makes the development of a transdermal more complex than, for example, an orally administered dosage form.
As we can see, permeation enhancers play a crucial role in the topical or systemic therapeutic activity of a transdermal system. When asked about the type of enhancers used in Amarin, he comments: “We work with chemical enhancers. That is, with substances that are added to the adhesives to facilitate the passage of the drug through the skin”.
He also points out that several technologies are currently being developed to improve the efficiency of the patches. “We are interested in studying and advancing on new lines of development,” he expands.
Dr. Gabach mentions the technologies that could revolutionize the transdermal market:
But a technology that is advancing and being perfected is the use of microneedles. These are tens or hundreds of micrometer needles that are on the surface of the patch that comes into contact with the skin and which contain or are coated with the active ingredient, in other words, the therapeutic agent. In this sense, he confesses, “although this description may give a certain idea of pain in the application, the patches with microneedles do not cause discomfort because, being so small, they do not reach the nerve structures responsible for the perception of the painful stimulus”.
He also clarifies that this is not a new technology, since “the first patent for a microneedle patch dates back to 1976”. Gabach affirms that “the evolution of these devices was very slow, but of sustained improvement and maybe very soon a common form of drug administration. Different molecules are being studied for administration through dissolvable or biodegradable microneedle patches. This technology has a high chance of becoming a form of vaccine administration due to its notable advantages over traditional injectable application. One of the main ones is that they would not need a cold chain”.
As we commented in the review of his story, Dr. Gabach joined Laboratorios Beta where the first lines of Amarin’s history began to be written.
“It was there that I first met Dr. Francisco Stefano, who led the transdermal development team, and then the accountant Sergio Lucero, who was in charge of international affairs within the company. With them we forged a relationship that was consolidated through the years of working together at Amarin,” he sums up.
Today Amarin is a solid company that Gabach defines in three words:
In this sense, he emphasizes: “Due to the need to be in the international market with our developments, the different areas of the company have improved and acquired the necessary knowledge to be competitive with other companies abroad. I do not think it is wrong to say that Amarin’s work team is at the same level as their colleagues in any other international company”.
In this respect, he stresses that “Amarin is a small company that is competing in a market where there are very important and outstanding companies in transdermal technology.”
“We have to provide something more than what the larger companies offer: a fluid relationship with the client, direct treatment, adequate costs, and optimized development times.”
Dr. Roberto Gabach
Gabach clarifies “Amarin is a company with a development capacity limited to the human and financial resources at its disposal”. At the same time, he remarks that: “the strategy is to be very cautious in the selection of new projects, to be able to put all our intellectual, operative and financial capacity in developments that are feasible and attractive to potential partners”. In this way, we will be able to achieve our objectives, which are: “to win new customers and introduce new products at an international level”.
In his almost 40 years in the pharmaceutical industry, Gabach has worked for several companies and interacted with different areas of them. Here he shares with us what he considers to be three main lessons learned.
He confesses that although he does not agree with the habit of excessive meetings, he clarifies that “well-organized meetings allow a fruitful interaction between the different areas and an exchange of thoughts, views, and points of view that can be very enriching”. He also stresses that “interaction between areas is very important for the creation of new projects and the introduction of new ideas in an organization”.
He explains that “perseverance in the objectives and the sustained follow-up of projects is fundamental in any company. On the other hand, when you are convinced that an idea can be useful and you think you are on the right track, you don’t have to abandon it. An idea may not be well received by an organization at one moment and become brilliant at another. How it is presented is essential.”
In this regard, he explains, “there is a renowned company whose motto is ‘Think different’, which seeks to break with the tendency to think conventionally. It is convenient to try to analyze an idea or a project from different perspectives. The idea is: not to be tied to preconceptions and to challenge our ideas before the eyes and judgment of others when we firmly believe that these ideas are useful for the company. Imagination can be more important than knowledge”.
Dr. Roberto Gabach is one of the key players in the generation of new Amarin projects. His message is of self-improvement and perseverance when it comes to pursuing the objectives proposed in each project. “The difficult is planned, the impossible is attempted”, he says is one of his favorite phrases (not his own).
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