“Not all patients respond the same to the same medication”

The global medical director of Bristol-Myers Squibb points out that “we have to understand the relevance of translational medicine and the use of biomarkers”

Only through exposure to necessity can we better appreciate the existence of certain details that comfort us. While here in Spain, Europe, we enjoy the advantages of a Healthcare that covers all citizens, in other countries it is desired. Samit Hirawat He wanted to study medicine because “I’ve seen the deficiency of medical care in a country that now has the largest population, but not everyone there can get the medical care they need.”

Hirawat graduated in Medicine and Surgery from the Sawai Man Singh Medical College in India. To complete her training, she made the jump to the United States and completed her residency in Internal Medicine and Medical Oncology at North Shore University Hospital in New York. «My experience as a doctor shapes the way I think, live, and approach drug development.». And this brief description on LinkedIn is evident throughout the interview he held with El MUNDO while passing through Madrid at an international meeting held by Bristol-Myers Squibb with the main officials of the pharmaceutical laboratory.

Hirawat covers the present and future of the new therapies launched by the American company. As medical director of Drug Development he is able to summarize in about 20 minutes what is in the development phase and even venture that «we have the potential to offer 16 new medicines by the end of the decade».

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This is not just an advertisement. Behind it there is a whole range of molecules for different pathologies almost at the finish line. A long-distance race that comes from the «transformation we have made at Bristol-Myers Squibb in the last five years». In order to get to that point, he highlights that “in recent decades, we have understood the biology, mechanisms and signaling pathways of diseases. We have to turn those scientific efforts into real medicinesand then think about being able to make them available to patients as quickly as possible.

A vocation in finding solutions for their patients

His training as a doctor makes him think first about knowing the enemy, the disease, and then seeing how to end it, the therapeutic strategies. After his training in the US he crossed to the other side: to the world of pharmaceutical companies. He was first at Pfizer and later, until five years ago, at the Swiss company, Novartis. In both he led medical divisions in which he launched ambitious projects in the field of Oncology.

In reality, his passion, as he acknowledges, “is drug development.” And how does a surgeon end up investigating? Out of curiosity. «In medical school I did part of my surgical residency, but I felt the need to get closer to the solution. Surgical cases often addressed issues that, as a physician, I would try to avoid in the first place. I switched to internal medicine and I fell in love with Oncology and clinical research».

The clinical practice and facing as a doctor on the front line makes him more aware of the real needs of patients. On some occasions he has told how some of them still occupy a place in his memory. «A young man with anaplastic thyroid carcinoma, whose probability of survival was quite low, asked us to help him live another three or four months so that he could resolve his issues. At that time, we didn’t have genetic testing or any major targeted therapies. In the end he survived another 11 months.

That is why when he goes back to the advances in Oncology almost 15 years ago, there is palpable emotion in his words. “If we think about immuno-oncology for a second, going back to 2011 when patients were diagnosed with melanoma, the life expectancy of the patients was very short.” And he values ​​the development efforts of a whole range of molecules that help our defense system recognize the tumor and eliminate it. First, “through the CTLA-4 protein inhibitor, ipilimumab, and later with, a PD-L1 protein inhibitor, nivolumab, and then the combination of the two.”

At the same time, he highlights that these molecules have not only brought good news for those diagnosed with melanoma, “but for multiple diseases where they have had surprising transformations for all these patients.

In this review of the present and future of advances against cancer, Hirawat does not hesitate to point out therapies aimed at precision medicine. Not only looking for targets in each tumor and new ways to reach them. The new division of radiopharmaceuticals thanks to the acquisition ofRayzeBio opens a new window of opportunity: “In which we have developed actinium, which is an alpha inhibitor, radio radiation emitter combined through a linker with a peptide that is then directed to the organism.”

New indications and targets are the oncological maxims, “but our journey does not stop there because tumors are always intelligent and, therefore, we have to continue being smarter than them, even if it is difficult,” he emphasizes.

Although Bristol-Myers Squibb has stood out in the last decade for anti-cancer advances, the current pipeline is more ambitious. With new generations of antithrombotic or anticoagulant drugs in development. Apixaban led the way almost a decade ago and now comes milvexian, “a factor [una enzima de la coagulación que provoca peligrosas trombosis, coágulos de sangre]». Also within the field of Cardiology «andWe are focusing our attention on the treatment of hypertrophic obstructive cardiomyopathy».

They do not forget the importance of addressing brain pathologies, such as dementia and psychiatric disorders. “We look at neurology to address two basic aspects, such as neuroinflammation and neurodegeneration.” In order to carry out this roadmap forward, the American company has acquired Karuna. «We hope to give good news to patients with schizophrenia, since it is an area without disruptive advances in the last two decades. Also in the field of Alzheimer’s disease, where he points out the two possible forms of approach: the treatment of the pathology and the treatment of related symptoms. «We have a phase 2 trial with an anti-MTBR-Tau molecule. “We still have two years left to have results, but we hope for effective development.”

Being a trained doctor makes him meticulous and precise in the explanations of each essay. And it does not make you forget the sensitivity with which the entire therapeutic revolution must be transmitted to patients, specifying the time in which the results of each of them will be available. «Both from the point of view of research and clinical development, These scientific experiments must be translated into real medicines and those have to reach the patients. Otherwise, “our work is meaningless.”

TEST THERAPIES FOR EVERYONE

Within this area, it refers to the need for clinical trials to be carried out with real samples of the population that will be the target of these therapies. «Diversity in clinical trials is key. “We have to develop new drugs in such a way that they are not only made for certain people, but are applicable to many, all of them in the real world.” Here, Hirawat is shown proud to be a driving part of the spearheadof a new way of investigating that leaves no one out. “We have started in the US and now we are going to take it on a global scale, analyzing what the definition of diversity should be applied to various countries and regions.” This is a key step “to not leave anyone out,” she insists.

And he justifies with arguments that “there is a need to think about what clinical diversity is. What is the underserved community in Spain or in Europe or in Asia or in South America? I am very passionate about this topic because really when it comes to diseases, they do not differentiate between them, but people do. A new concept of approaching clinical trials that “means that we have to understand the Biology, the Physiology and the treatment landscape as a whole.”

With this step they are taking, they recognize the diversity of sex and race, which until now was overlooked in most clinical trials and is critical to understanding the unequal impact of the same molecule for a disease in people from different regions of the planet. “Because Not all diseases are present in all countries, but there are pathologies that are. Not all patients will respond in the same way to the same drug. So we have to understand that this is why translational medicine is important. “Biomarker exploration is important holistically to impact the general population as well.”

This kind of innovation that they have started in the US will be transferred to other countries where they are active. “Europe and Spain are absolutely fundamental for research, for innovation.”

Here in our country, Hirawat does not hesitate to wink at the trials they have underway in Salamanca and Barcelona in the Vall D’Hebron, where they have more than a hundred trials underway. “Multiple Bristol-Myers Squibb innovations have come from Spain,” he emphasizes.

 
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