November 28, 2022

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GSK, here are the three pillars of innovation in research and development

Three multipliers: science, technology and patient participation. To introduce a new treatment to the clinic, for the benefit of a person suffering from hematology or gynecology, today can not miss an overview that uses scientific and technological knowledge and close cooperation with patients. “The third factor, the person or the patient, is key,” says Barbara Grassi, M.D., medical director of GSK Italia. “If the third element in the equation is zero, all efforts will be in vain. It is essential that people act in agreement by following certain cultural rules and principles.” First of all, science, or understanding of what happens in the body of a person diagnosed with cancer. Barbara Grassi explains, “By science, we mean the focus on the immune system, moving beyond the specific research paradigm into therapeutic areas. We focus on an atheistic system centered on the immune system that is involved in all physiological and pathological mechanisms. Furthermore, when choosing a drug target or research target What, it is important to validate it through human genetics studies. It is about associating genetic and DNA abnormalities with the phenotype, that is, the disease itself. In this way, we double the chances of success of the drugs in preparation and we can deliver them to the patient. The current probability today is about 10% And it doubles if we link the genotype with the phenotype.”

Focus on technology

The second factor, technology. “By this – continues Barbara Grassi – we primarily mean functional genomics. We are talking about different technologies, but we are investing above all in genome editing (CRISPR) associated with artificial intelligence and machine learning. Today it is possible to transform a huge database into knowledge by simulating the behavior of The protein is defective in the body. This technology allows us to turn a large amount of data into usable knowledge. By technology we also mean the modalities, that is, methods for producing drugs or vaccines. We are working on mRNA, cell therapy and gene therapy platforms.”

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Research and development and cooperation

The third factor: the patient. “GSK also engages patients in planning research, listening to requests and unmet needs, and directing our research and development projects in order to find an answer to patients’ expectations,” emphasizes Barbara Grassi. It’s all part of a real ecosystem: “GSK does not operate in isolated systems but promotes collaboration with academia and universities,” Grassi explains. “All our R&D operations are always associated with large Italian and international research centers and GSK Italy is a key country: we are well represented and determined to maximize the efficiency level of the national centers. We also cultivate cooperation in research and discovery, in the very early stages of the R&D path , even if it’s clear that clinical trials are still ahead of the curve for us.”

Research in Oncology: Pillars

The main lines of research in oncology develop along four axes. “The first addresses the structural lethal mechanisms that cause cancer cell death,” explains GSK’s medical and scientific director. “Example: PARP (poly (ADP-ribose)-polymerase) inhibitors that we see are in the field of gynecological oncology. The second pillar is immuno-oncology, in this case it comes to strengthening the immune system in its defense capacity and eliminating cancer cells. Before fifty In general, the immune system was supposed to play an important role in tumor formation and monitoring.Another pillar is cell therapy for solid tumors, such as CAR-T: we have a molecule in research and development that we care about a lot, and preliminary data is very promising.Category IV is targeting cancer cells, That is, going to the molecular target of the tumor. Of course, we have promoted a massive development program in multiple myeloma, through the DREAMM studies. We aimed to verify the efficacy of bilantamab mavudotin even in the early stages of the disease, as a single and combined therapy. Part of the future of oncology will come from uses In addition, we have just acquired Sierra Oncology, a biopharmaceutical company that specializes in research and treatment of rare cancers.In particular, GSK has invested in a drug from Sierra, already in Phase 3 clinical development of a treatment for myelofibrosis (bone marrow fibrosis).

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Listening to the patient and their needs

“Patient’s voice and perspective are integrated from start to finish in our supply chain,” stresses Barbara Grassi, who heads up scientific research at GSK. The first step is planning clinical development programs to understand the real needs. We also ask for input into the feasibility of clinical trials, if the procedures are too cumbersome, if the end points are truly relevant to patients. Once a drug is available, we ask for insights into real-life disease management up to the PSP (Patient Support Program). For us, from a holistic perspective, it is important to involve the patient’s perspective in all the really relevant elements: every step should be informed from the patient’s point of view. Companies have arrived late in these aspects, and tend to stop at the clinical step, without moving forward.”

“Our Priorities: To be at the forefront of care and value chain management”

Written by Fabio Landazabal, President and General Manager of GSK Italy

GlaxoSmithKline is about to experience a moment of great change, the most important for us in the past 20 years. We have decided to separate our “Consumer” business unit to increase focus on medicines and vaccines, with the goal of strengthening our role and investments in the life sciences. We combine science, technology, and talent to be at the forefront in the treatment and prevention of disease, specializing even more in the pharmaceutical sector to make a critical contribution to the therapeutic areas with the highest unmet needs. Among them there are certainly blood diseases. Currently, we have two therapeutic opportunities of enormous value in treating ovarian cancer and multiple myeloma. After the summer, approval will come for another antibody prescribed to treat endometrial cancer. And many other molecules are under development, especially for rare cancers, solid tumors where today there is none or what is available is insufficient. Managing and changing the pharmaceutical value chain will be another of our priorities. The criteria for competitiveness, safety and sustainability on the basis of which new investments will be determined in the world are changing and will continue to change. It is a new and wonderful opportunity for Italy, but in order to be able to take advantage of it, it will be necessary to be quick and to be able to recognize the value of innovation at different levels, not only at the disruptive level but also at the structural level. In the same way, access must be managed, to ensure that innovation reaches all patients who need it in a fair and sustainable manner. To do this, the correct and rapid digitization of all systems in the supply chain, from prevention to treatment, is essential, ensuring that they do not become relevant to new inequalities between regions faster than others.

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