Roberto Gonzalez Piqueras

Ascentage Pharma announced that updated results from three studies of olverembatinib, have been released in posters at the 2024 European Hematology Association Hybrid Congress, taking place in Madrid, Spain. Olverembatinib (HQP1351) is an oral, third-generation BCR-ABL1 tyrosine kinase inhibitor (TKI) developed by Ascentage Pharma for the treatment of chronic myeloid leukaemia (CML), acute myeloid leukaemia, acute lymphoblastic leukaemia (ALL) and solid tumours, including gastrointestinal stromal tumours (GIST). Olverembatinib is an ATP binding-site inhibitor of wild type BCR-ABL1 kinase and a broad spectrum of BCR-ABL1 mutants, including mutant T315I, which confers resistance against all first- and second-generation TKIs.  Chemenu has been working to develop more compounds for drug discovery. Here comes the building blocks we can provide: https://lnkd.in/gaVnBaRP #Olverembatinib #HQP1351 #GZD824 #TKI #CML #buildingblocks

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When patient drop-out continues to be a challenge in today's clinical trials, obtaining a 95% patient retention rate is such a huge success! We want to celebrate it by sharing with you how Almirall obtained 95% patient retention in the AKtive study, a Phase IV, three-year study in which patients were required to report outcomes periodically and avoid sunlight or UV light exposure. Read the case study by clicking here: https://lnkd.in/edUvVrFJ

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So excited to be part of this project... 😃 AEFI - Asociación Española de Farmacéuticos de la Industria has become a member of the #CriticalMedicinesAlliance of the #EuropeanCommission. Today, we have attended the #inaugural meeting, where the objectives of the Alliance, the challenges and the paths forward have been discussed. The Critical Medicines Alliance (CMA), set up in January 2024, is a consultative mechanism bringing together relevant stakeholders from #EU Member States, key industries, the civil society, and the scientific community. The Alliance aims to identify key areas and priorities for action, proposing solutions to strengthen the #supply of critical medicines in the EU, ultimately enhancing efforts to prevent and address #shortages effectively. From AEFI we are so proud to be part of this Alliance, and will work hard to contribute and to add value, on the interest of our members and of the whole healthcare industry in Spain. #biopharma #compliance #regulation #quality #supplychain #patients #future

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Key discussions emerged from the Veeva R&D Summit at the Marriott Madrid Auditorium, where Novo Nordisk's senior vice president, Thomas Senderovitz, emphasized the critical need for pharmaceutical companies to be involved in shaping AI regulations. Alongside James Weatherall from AstraZeneca, Senderovitz highlighted the necessity of harmonizing global AI regulations to facilitate uniform drug trials across different regions. Key Points: 🔹 Advocacy for increased pharma involvement in AI regulation 🔹 Challenges posed by disparate global regulatory systems 🔹 Anticipation of the FDA’s forthcoming AI guidance and the need for updates in Europe 🔹 Novo Nordisk’s advancements in AI, including the development of the AI super-computer Gefion Read more on this drive to establish unified global standards, ensuring more efficient and effective AI-driven research and innovation within the healthcare sector. https://lnkd.in/dffUNFcY #VeevaSummit #PharmaAI #NovoNordisk #AIRegulation #HealthcareInnovation #GlobalStandards

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Is CAR-T-cell therapy sustainable for Spain’s National Health System (SNS)? What can be done to enhance outcomes with these treatments? And what inequalities in access are emerging across the country? These questions have recently been addressed by specialists in the field (tinyurl.com/35packda).   Adrián Alegre, Director of the CAR-T programme at La Princesa University Hospital in Madrid, believes these treatments are sustainable: “First of all, they are administered only once, so they are finite therapies, in contrast to other expensive anti-tumour combination options that are maintained until relapse. Centralisation by an expert committee in the Ministry guarantees the indication for patients who meet the criteria. Moreover, the payment agreement is risk sharing, that is, payment for clinical results.” In his view, CAR-T-cell therapy has “cost-benefit advantages, although it would be useful to carry out pharmacoeconomic studies comparing it with prolonged therapies with new strategies, such as bispecific antibodies.”   Adrián Mosquera, a haematologist at the Santiago Health Research Institute (IDIS), sees a need to invest in research to distinguish patients who will respond to CAR-T-cell therapy from those who will require combination therapy to achieve complete remission: “There are patients who relapse, even with an initial response. If we can understand or anticipate this lack of optimal response, we can explore other strategies, such as the intensity with which conditioning is performed, other bridging therapy strategies or consider alternative maintenance, to increase the effectiveness of the CAR-T cells and improve response.”   Growing regional inequalities in access to CAR-T-cell therapies are a cause for concern. Manuel Muñoz, head of Haematology at the Regional University Hospital of Málaga, says: “Depending on the criteria of one regional sub-committee or another, a patient may or may not have access to CAR-T therapy. In some cases, approval varies depending on the community where you live, and that is becoming worrying. It is a situation that did not occur at the start of CAR-T and that we are now seeing and need to address.”   Variations can relate to bridging therapy: some autonomous communities allow the use of polatuzumab, whereas others restrict access. Muñoz says: “The Ministry should determine where these deviations are, to correct them. For a start, the guidelines could be updated. CAR-T therapy began in a particularly limited way with ministerial commissions, regional sub-committees, pharmaco-clinical guidelines. However, scientific evidence and experience move faster than regulations, so depending on how strict the interpretation is, there is a risk of deviating from scientific evidence and depriving a patient of therapy.” #Spain #marketaccess #cartcelltherapy

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🌟 Celebrating 15 Years of ViiV Healthcare's Impact on HIV Treatment 🌟 📢 This month marks the 15th anniversary of ViiV Healthcare, a groundbreaking collaboration between GSK, Pfizer, and Shionogi. Operating from GSK’s state-of-the-art production facility in Aranda de Duero (Burgos), Spain, ViiV is a global leader in the fight against HIV, producing 175+ million packs of life-saving antiretroviral medicines annually for distribution to over 100 countries. Key Highlights of ViiV Healthcare's Mission: 💊 Innovation: Pioneering new molecules, treatment strategies, and adaptive drug formulations. 🌍 Sustainability: GSK invests €20M annually to enhance facilities, integrate technologies like AI and robotics, and reduce its environmental footprint. 🧪 Research Excellence: Spain leads global clinical trials for ViiV, advancing HIV therapies with local researcher collaboration. 🤝 Social Impact: Funding 100+ NGO projects in Spain and providing voluntary licenses for generic manufacturing, ensuring accessibility in low-income regions. Read the complete news article ➡️ https://lnkd.in/dAYGrVVv

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Gilead Sciences’ recent acquisition of Barcelona-based AELIX Therapeutics shines a spotlight on Spain's growing influence in the global biotech industry, particularly in vaccine development. Aelix's HTI vaccine, designed to target specific regions of the HIV virus, has shown promising results in clinical trials, making it a strategic addition to Gilead’s HIV portfolio. Why Spain? The Spanish biotech sector is rapidly expanding, with impressive contributions to vaccine innovation: The industry generated €10.3 billion in 2020, accounting for 0.9% of Spain's GDP, and private investment has surged by 20% year-over-year. Leading Spanish biotech companies like Algenex, with its cutting-edge baculovirus-based technologies, and Reig Jofre, a pioneer in vaccine production, are shaping the global vaccine landscape. Spain is positioning itself as a key player in delivering high-quality, scalable solutions for complex diseases, including HIV and COVID-19. Aelix’s innovative HIV vaccine program, combined with Gilead’s expertise, demonstrates the value of cross-border collaborations in advancing life sciences. This acquisition is a testament to Spain’s thriving biotech ecosystem and its role in addressing some of the world’s most pressing health challenges. As Spain continues to attract global investments and foster innovation, it’s clear that the country is not only a hub for cutting-edge science but also a key contributor to improving global health. #Biotechnology #VaccineInnovation #SpainBiotech #CrossBorderCollaboration #HIVResearch #LifeSciencesLeadership #GlobalHealth https://lnkd.in/eJSmvz7b

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Cardiovascular problems affect individuals of all genders, and it’s crucial to understand the risk factors involved. Smoking, high cholesterol, hypertension, and being overweight significantly increase the likelihood of developing heart disease.​ ​ At ESTEVE, prevention is key, especially in alignment with our purpose of improving people’s lives. That’s why we encourage you to trust healthcare professionals and steer clear of common myths.​ ​  👉 In a recent video, Dr. Enrique Santas, a cardiology specialist at the Hospital Clínico Universitario de Valencia, shares verified insights on this critical topic.​ Watch the video to learn more and empower yourself with knowledge for better heart health!​ ❤️ https://lnkd.in/eaQ36fFG

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Today, the European Medicines Agency recommended not granting a marketing authorisation for Leqembi (lecanemab). The main reason for that decision was, according to the EMA statement, that "the observed effect of Leqembi on delaying cognitive decline does not counterbalance the risk of serious side events associated with the medicine, in particular the frequent occurrence of amyloid-related imaging abnormalities (ARIA), involving swelling and potential bleedings in the brain of patients who received Leqembi." You can see more details about the EMA statement at their website. At Ace Alzheimer Center Barcelona we believe this decision entails major concerns for the clinical, medical, and care community as well as for the field of research. First, the access of European patients to the same options and opportunities as the citizens from other countries. Secondly, the effect it can have in terms of research and investment in research. See more of our position in the open letter we sent to the EMA representatives: https://lnkd.in/d46T7fMt #Lecanemab #EMA #Leqembi #Alzheimers

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Yesterday, we concluded the 2nd Congress on Rare Diseases for Latin America and the Caribbean. The congress emphasized strategies to strengthen rare disease policy development and implementation, improve access to diagnostics and treatments, and fostering innovation. Experts discussed the importance of integrating rare diseases into national health agendas through stronger regional collaboration, political will, and patient advocacy. The event also highlighted the need for comprehensive policies, equitable access to care, and the role of reference centers in improving care. Let us continue to promote collaboration across sectors, countries, and regions to ensure better outcomes for people living with rare diseases, their families, and caregivers. Watch a brief recap of Day 2 here: https://lnkd.in/g_quAvaH #AHF #RareDiseases #AHFCongress #ERCAL

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Artificial intelligence (AI) will play a growing role in pharmaceutical P&R in Spain in the coming years. Analítica Farmacia (AF; Pharmacy Analytics), an AI-based tool to generate predictive models to support P&R procedures and supply management, has been in development by the Ministry of Health (MoH) for the last two years.   According to César Hernández, Director General of the Common Portfolio of SNS and Pharmacy Services (DGCCSF), the government wants to move towards a healthcare model based more on demand than supply, and AF “can be an enormously valuable resource to help manage this move to a strategic planning environment.” He believes AF could streamline the pharmaceutical P&R process in three ways: (1) an earlier start; (2) a shorter duration because of greater predictability; (3) managing decisions as a continuum rather than an “all-or-nothing” phenomenon.   Carlos Martín Saborido, an advisor to the DGCCSF, believes a key objective of AF is to facilitate “precision reimbursement” for the growing number of precision medicines. At a recent conference, he explained that AF uses information from a wide range of sources, including horizon scanning, medical literature databases, clinical trials, grey literature, conference presentations, press releases and media reports. The aim is to “combine clinical evidence and process it with economic information to obtain economic impact scenarios,” according to Martín Saborido. Information can be filtered and presented in lists with a traffic light rating of the quality of evidence, risk of bias and level of uncertainty. ChatGPT is then used to produce a draft summary.   Martín Saborido notes that the pharmaceutical industry has extensive experience in the use of long-term scenario models, so the healthcare system needs to “copy this use of predictive analytics for its decision-making, as this is what has allowed the industry to make strategic decisions.” Consumption data from Seguimed, expenditure data obtained by internal calculation or from the Ministry of Finance, and epidemiological data feed into budget impact scenarios and analyses by indication, disease area or therapeutic group. Where short-term analyses are required, data may be obtained from DARWIN EU or the European Health Data Space, in addition to consumption, expenditure and epidemiological data. Spain’s regional healthcare systems can thus be better prepared for the medium- and long-term costs of new medicines.   #Spain could learn from other countries' use of #AI to manage dedicated funds for new drugs. Martín Saborido cited the example of the Innovative Medicines Fund in England. AI can make it much easier to move drugs into and out of managed entry agreements. The practical challenge is the need for patient-level data, which Spain hopes to have in place “in the near future.”   Martín Saborido notes a need for metadata. Dashboards must be developed to provide “a granular level of data digitisation” for decision making. #drugpricing

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Exciting news from Ferrer, a B Corp-certified pharmaceutical company! They have launched the Phase II clinical trial, PROSPER, to evaluate FNP-223's safety and efficacy in slowing the progression of Progressive Supranuclear Palsy (PSP). PROSPER is a rigorous randomized, double-blind, placebo-controlled trial with up to 220 participants spanning sites in the US, UK, and the EU. PSP is a rare neurodegenerative disease with no known cure, characterized by speech difficulties, imbalance, cognitive impairments, and eye control issues. FNP-223 shows promise in halting the abnormal accumulation of tau protein in specific brain regions associated with PSP. Ferrer aims to prove the drug's safety and effectiveness in PSP patients to potentially decelerate the disease's advancement. Jorge Cúneo, Ferrer's Chief Medical Officer, underlines the company's dedication to enhancing the lives of individuals with rare diseases. Patient organizations like CurePSP and PSPA UK have been instrumental in shaping the PROSPER trial. Kristophe Diaz, Executive Director and Chief Science Officer of CurePSP, stresses the trial's significance in seeking treatments for PSP, an ailment currently without a cure. Stay informed about Ferrer's progress in the Phase II trial by visiting the link: https://lnkd.in/dfmZDDnn Tania Nadal Matthew Pepe SHRM-CP Alba Soler Conangla

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Why meet #IQVIA during #BioEquityEurope? 🤔 Check out my colleague Joe Hopcraft’s response below. I’ll be there with Anjna Rising Christopher Lech, PhD Etienne DROUET Michael Sanvoisin Pierre Antoine A. Massimiliano Rubin Michelle M. IQVIA…accelerating innovation for a healthier world 🌎 #Biotech #DrugDevelopment #TargetProductProfile #ClinicalDevelopmentPlan #StrategicCommercialAssessment #IndicationPrioritization #ValueCreation #OneIQVIA

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A new early access system, longer periods for instalment payments for gene therapies and greater use of centralised procurement—these are some of the ambitions of the Spanish government, according to César Hernández, the Director General of the Common Portfolio of SNS and Pharmacy Services.   Speaking at the Farmaforum 24, he disclosed that his primary objective is to “rebalance the pharmaceutical system” in three respects: improving access to innovations so that they make investment in drug development profitable, promoting the launch of generics and biosimilars after patent expiry and ensuring that medicines that have lost profitability but still have significant value remain available.   The Ministry of Health wants to adopt measures for early access. Spain currently has “access to medicines in special situations,” a system that covers four situations—compassionate use, drugs authorised elsewhere but not in Spain, off-label prescribing and the use of medicines from marketing authorisation to reimbursement—and benefits around 40,000 patients per year. The Ministry reportedly wants to create “an environment for certain products, an access route, when the negotiation with the pharmaceutical company and the decision of the General Directorate of Pharmacy are pending.”   Hernández also sees a need to alter the current regulatory framework for instalment payments—particularly to enable outcomes-based agreements for single-administration gene therapies to be extended. He said: “If we want to pay for a gene therapy at a high price, but it involves achieving certain outcomes or replaces alternatives at the same price that we already spend money on, the payments should be spread over more than 5 years, which is what is currently allowed by law.”   Greater use of centralised procurement—at both national and EU level—is of interest. However, an obstacle in Spain is that 98% of the country’s healthcare budget is currently spent by the autonomous communities.   Changes to the reimbursement system and the internal reference pricing system (RPS) will be included in the forthcoming update to the Guarantees Law. According to Hernández, “we have already raised prices for medications that were in the RPS, so the way is open; the problem is that this dynamic can be generated only when a reference price order (RPO) has already been published.”   Hernández indicated that he is “not saying that health spending or pharmaceutical spending has to fall, but it must be appropriate; there is a need for screenings that allow early diagnosis to avoid suffering for patients, but also unnecessary health costs.”   The government wants to ensure that Spain is a major centre of drug development and production in Europe: “If many countries are competing with us or want to have policies that promote it, it is because it is an important pillar of the health, well-being, productivity and quality of life of our citizens.” #Spain #earlyaccess #drugpricing

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During the AECIC Annual Meeting in Madrid, Mónica Bermejo, Senior Manager of Clinical Monitoring at Advanced Clinical, will be moderating panel discussions on DCTs and Artificial Intelligence in clinical trials. The conference will focus on the theme, "The Future Already Present in Clinical Trials: Update in Artificial Intelligence, Technology, and Regulation." Plan on attending to hear best practices and insights from a panel of industry experts. #clinicalresearch #clinicaltrials #AI #Regulation

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Today we want to share with you the interim results of an ongoing Phase IV clinical trial in which we partnered with Almirall. The study aims to evaluate the long-term safety of a topical treatment for patients with actinic keratosis. At the same time, the study requires patients to report outcomes periodically and avoid sunlight or UV light exposure. "We selected the Replior solution because integrating the UV sensor with the study ePRO app simplified access and supported participant retention and engagement, while streamlining UV exposure monitoring for our study team." Diego Herrera Egea, Director of Clinical Data & Digital Innovation at Almirall. Click here to read the case study and learn what results we have seen so far: https://lnkd.in/edUvVrFJ

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#EucrofWebinar Do you know that Spain is one of the world leading countries in #clinicalresearch and is #1 the EU with the highest participation in #clinicaltrials with Medicinal Products in 2023? We are delighted to present our next webinar in the “Clinical Trials in Europe” series where you can find out  what makes Spain so attractive to have been the EU country most chosen to conduct clinical trials in 2023. During the webinar you will learn: -The role that Spain plays in the clinical trials worldwide and in Europe -The patient recruitment potential -The Spanish infrastructure and capabilities -The regulatory and ethical processes for medicinal products and medical devices -The acceptability of decentralized trial methods -The Clinical Research Costs -Specifics of Spain The webinar will be presented by Dr. Elisa San Isidro, Manager, Clinical Operations and Global Talent Center, NAMSA  👉When? Thursday, June 12 | 11 - 12.30 am CEST Follow the link to register: https://lnkd.in/eX_sAtAF #ema #fda #clinicaltrialspain #clinicalresearcheurope #eucrof

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𝐆𝐢𝐠𝐚𝐆𝐞𝐧 𝐁𝐞𝐠𝐢𝐧𝐬 𝐏𝐡𝐚𝐬𝐞 𝟏 𝐓𝐫𝐢𝐚𝐥 𝐟𝐨𝐫 𝐀𝐧𝐭𝐢-𝐂𝐓𝐋𝐀-𝟒 𝐎𝐧𝐜𝐨𝐥𝐨𝐠𝐲 𝐃𝐫𝐮𝐠 𝐆𝐈𝐆𝐀-𝟓𝟔𝟒 GigaGen Inc. GigaGen Inc, a subsidiary of Grifols Grifols, announced the dosing of the first patient in a Phase 1 clinical trial for its anti-CTLA-4 oncology drug, GIGA-564, targeting metastatic or locally advanced solid tumors. “This Phase 1 trial with GIGA-564 marks a significant milestone as GigaGen’s first oncology asset to enter the clinic,” said Carter Keller Carter Keller, senior vice president of Grifols and head of GigaGen. “We hope to translate the superior anti-tumor performance and reduced immune-related toxicity observed in pre-clinical studies into clinical success. There is a pressing need for innovative solid tumor therapies, and we believe GIGA-564 can improve patient outcomes.” The trial is conducted in partnership with the National Cancer Institute (NCI), part of the NIH. #GigaGen #Grifols #Oncology #CancerResearch #ClinicalTrials #Immunotherapy #Phase1Trial #CancerTreatment #InnovativeTherapies #Biotechnology

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