We recently announced that Roldán Cortés, Director of Development and Marketing of our company, had granted a video interview to PM Farma magazine. For those of you who have not seen it, you can view it here (the audio is in Spanish, without subtitles).
A transcribed and translated version in English is posted below:
PM FARMA: When was MEDSIR born and why?
R. CORTÉS: MEDSIR was born in 2021, founded by experts in Oncology who specialized in independent clinical research. And it was born out of a necessity: there was no support structure that allowed Oncology researchers to take their ideas forward and turn them into clinical trials. We refer to management, planning ... issues that do not have to be the direct expertise of these researchers.
PM FARMA: MEDSIR is based on a collaborative research model, what does it mean?
R. CORTÉS: The world of independent research is sometimes purely academic, where an external idea is presented to the pharmaceutical industry, then assistance to finance that idea and/or use a specific drug owned by the company is requested to carry out the trial. The development and management of these academic trials usually ends up being completely independent, and the company supporting the trial has no voice whatsoever in the process. The collaborative model that we propose is precisely an intermediate model between the normal CRO-based, industry-sponsored research and the classic academic research.
We want to unite independent research with the strategic interests of the pharmaceutical industry. Without ever giving up the scientific relevance and the clinical needs of patients, of course. We also want to involve the pharmaceutical industry in the whole process, since we believe that if we are all aligned, these improvements will reach patients easier and benefit them faster.
PM FARMA: What is the differential value of MEDSIR with respect to the CRO (Contact Research Organization)?
R. CORTÉS: We do not like to define ourselves as a CRO, since our added value is in our scientific knowledge and in the generation of ideas. The differential value of MEDSIR is in the initial part of the project development, in the ability to generate an initial idea, transform it into a full proposal and put it into action. And this is something that CROs don't do.
PM FARMA: What benefit does MEDSIR bring to researchers? And the pharmaceutical companies?
R. CORTÉS: We provide the investigator with the benefit of knowing that, if he or she has an interesting idea for clinical research, we are going to give them the support they need to transform that idea into a real, fully funded and fully designed trial, which we can help manage from beginning to end. We always involve the researcher in all of the decision-making, and we help them with all medical-writing, management, and regulatory aspects; and, most importantly, we help them obtain financing to execute the study.
From the point of view of pharmaceutical companies, we provide a very novel research model because it combines the best of both worlds: the best of independent research, since we put them in contact with a network of researchers with ground-breaking ideas who are very committed to the projects they helped develop, together with the best of classic company-sponsored research, since we want to take into account the strategic interests of the companies themselves, involving them in the process and allowing their access to the database of the trial itself (as well as all intellectual property exploitation rights).
PM FARMA: Has the pandemic situation affected the development of your activity? How?
R. CORTÉS: As you can imagine, it has been a challenge for everyone, especially in a sector like ours in which we work hand in hand with hospitals. It has been quite an organizational challenge that has forced us to innovate very quickly and to consider new forms of follow-up during clinical trials and new recruitment strategies. But all of this has a very positive side, in that it has accelerated the clinical research innovation, allowing to implement many things that have to do with remote monitoring or testing of patients outside the hospital and the streamlining of bureaucracy. In the post-pandemic era this will be great improvements that we will continue to take advantage of.
PM FARMA: Recently, MEDSIR participated in SEOM with the presentation of the results of two studies; one on breast cancer (PARSIFAL), and the other on prostate cancer (EXCAAPE). What conclusions do you draw from them?
R. CORTÉS: The PARSIFAL study in breast cancer involved around 400 patients in more than 60 different centers across Europe. It aimed to demonstrate what is the best combination of drugs to use in the first line of treatment for a subtype of patients with metastatic breast cancer. We evaluated the effect of the combination of palbociclib and fulvestrant versus the combination of palbociclib and letrozole, and we saw that both treatment options achieved very similar results in terms of efficacy and safety, which will allow doctors to make an informed decision based on other aspects such as drug availability or planned subsequent lines of treatment.
For its part, the EXCAAPE study focused on prostate cancer patients with bone metastases, and the results indicated that Radium-223 dichloride is active and safe for thesecond-line treatment of asymptomatic patients with mCRPC and bone metastases, who have progressed to standard of care frontline treatment with hormonal regimens.
PM FARMA: What remains in MEDSIR's future? Where is cancer research going?
R. CORTÉS: Our model has worked very well so far and the challenge before us is to expand on it. We started by focusing on our greatest expertise, which was breast cancer, but since it has worked so well, we are already applying it to many other of solid tumors, and are expanding our network of collaborators to be able to boost independent and collaborative clinical research in any type of cancer.
And closely linked to this, we also engaged in an internationalization strategy for the company, involving working with international researchers from all over the world.
If we talk about the specific challenges in cancer research, I would focus on the increasingly specific personalization of treatment for each patient. We used to consider tumors as homogeneous diseases within each histology, and in recent years we have seen how all tumors have become many different, rarer diseases based on many patient-specific variables, such as their molecular profile. This is leading us to consider Oncology more and more as a field composed of many different rare tumors shared by smaller groups of patients. This allows us to give the ideal treatment to a very select group of patients with unique characteristics that ensure they will benefit from the intervention, but implies several challenges for clinical research and for the generation of robust data.
Finally, the potential of Artificial Intelligence will also change the future of clinical research. We are now able to easily acquire enormous amounts of data per patient. These data are increasingly easier to collect but, at the same time, its analyses is a great challenge. We must be able to develop Artificial Intelligence tools that help us process and interpret this gigantic quantity of data, in order to offer predictions that will allow oncologists to make the best decisions on the treatment of their patients.
PM FARMA: And finally, the million-dollar question: will we ever achieve a total victory against cancer?
R. CORTÉS: Without a doubt, we all work for that, but for the sake of realism we must say that completely eradicating the disease is not around the corner. This is also a disease that, on many occasions, has a lot to do with aging and with processes that stop working over time, so imagining a world without these processes, which in some way are consequence of a natural ‘degradation’, is a bit complicated.
But at the same time, it is true that we are experiencing a very interesting moment in the world of cancer research. Diseases that have not had substantial advances for decades have in recent years experienced real evolution; the arrival of new drugs, targeted therapies, immunotherapy ... are allowing us to control these diseases for a longer time. The real objective that we have within our reach is precisely this, to control tumors for as long as possible, achieving therapies that work for a long time and thus maintaining good quality of life for the patient.
In the end, the objective should be to ensure that having cancer is not a death sentence, but rather to assume that the patient can live with it, managing to maintain their quality of life for as long as possible, and even getting to eventually die “with” cancer, but not “from” cancer.
PM FARMA: If you want to add something else…
R. CORTÉS: Just to thank the pharmaceutical industry, as well as oncologists, researchers, patients, family members, etc... for their effort and work towards improving cancer research, and especially in difficult times such as these.
Link to the PM Farma magazine. Interview on page 94-96.