Charles Schmidt

The power to think globally and act locally! How a global strategy and project can be activated locally in different ways to move the needle for patients in different healthcare systems. Also, but definately not less important, patients leading a multistakeholder discussion to raise their voices about their unmet needs and being able to “co-create” solutions or next steps with health authorities. #globalhearthub #institutoladoalado #patientledresearch #patientengagement #advocacy #multistakeholderdiscussion

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The FDA - La Administración de Alimentos y Medicamentos has authorized almost 1000 #AI enabled #medicaldevices and has received hundreds of regulatory submissions for #drugs that used AI in their discovery and development. The evaluation and regulatory system will need to focus on #patient #health outcomes to balance the use of AI for financial optimization for developers, payers, and #healthsystems

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The Brazilian Congress of Clinical Oncology is taking place in Rio de Janerio from November 7-9, 2024, and we are thrilled to be an exhibitor at this prestigious event. Organized by the Brazilian Society of Clinical Oncology, the congress brings together over 4,000 healthcare professionals, including oncologists, researchers, and industry experts. It provides a unique opportunity for us to strengthen relationships with healthcare professionals and showcase our company and our recently launched brands. The event aims to foster collaboration and knowledge exchange among professionals dedicated to improving cancer care. It features a variety of sessions, including keynote speeches, panel discussions, and poster presentations, covering the latest advancements in oncology research and treatment. Marcelo Holanda, Head, LATAM, Jacqueline Paiva, Marketing Manager, Fernando de Souza Marcos, Access Manager, Rodrigo Araujo, Access Manager, and Marcelo Fernandes, Governmental Account Manager, are representing Biocon Biologics at the congress. Brazil faces a significant cancer burden, with breast cancer being the leading cause of cancer death among women, accounting for more than 57,000 new cases annually, highlighting the urgent need for effective and accessible treatment options. The healthcare system is challenged by inefficiencies and resource allocation issues, impacting the quality of cancer care. Biocon Biologics is dedicated to broadening access to biosimilars that can significantly enhance patient outcomes and alleviate the financial burden on Brazil's healthcare system through our self-led and partner-led commercial models. We currently have 5 commercialized biosimilars for treating cancer in Brazil, ensuring cancer patients receive the treatment they need. We look forward to engaging with healthcare professionals at the congress, share insights, and explore new strategies to combat cancer effectively. Join us at the Brazilian Congress of Oncology to learn more about our company and how we are working to transform cancer care in Brazil. #HealthcareInnovation #BrazilianHealthcare #Oncology #HealthTech #BioconBiologics

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It is very important the actions that have been taken for training all stakeholders on the new regulatory procedures according to the recently approved law (14.784/2024) for Clinical Trials in Brazil. The new law will provide more protection for participants, predictable regulatory timeline approvals and less bureaucratic procedures.

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I am very excited to share our latest article. In this study we have made a incredible overview on cancer's mortality in Brazil from 1979-2021, and compared with US and China to better understand the mains trends considering the population growth, politics and impacts. I know, my field of expertise is radiopharmacy. But the lack of accurate data from Brazil in cancer lead me to deeply study, understand and publish this study, which I am quite sure will help many authors around the globe to have a clear scenario in cancer in Brazil. https://lnkd.in/d6g9iPss.

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🔵 What Is the True Reality of [177Lu]PSMA Treatments Between the USA and Brazil? At LA Analítica, we’re exploring the realities of nuclear medicine access in Latin America. This time, we’re exploring the use of [177Lu]PSMA for treating prostate cancer. According to the recent Lancet Oncology Commission report (https://lnkd.in/gk5KF6fc), the data suggests that the number of treatments per million inhabitants in the USA and Brazil might appear similar. But is this really the case? The numbers tell a different story. As reported by Novartis, Pluvicto ([177Lu]PSMA) sales reached $655 million in the first half of 2024, with $522 million from the US alone (https://lnkd.in/e6hCzK_2). With these figures, over 6,000 patients (4 doses/patient) in the USA could be treated this year.  Meanwhile, Brazil, with a population of 215 million, treated only about 120 patients with the generic version of this radiopharmaceutical in 2023. Until 2023, Brazilian patients had to pay for [177Lu]PSMA out of pocket. Although it is now covered by private health insurance, only 25% of the population has private insurance, leaving many patients without access. This stark difference highlights how access is shaped by economic factors, where only those who can afford private options benefit.  🟢 How can we turn this disparity into a more equitable landscape across the Americas, where innovative treatments like [177Lu]PSMA are more accessible? #LAAnalitica #NuclearMedicineAnalysis

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The challenges of access to innovative medicines in Brazil—and what lessons can be learned from other countries—was the focus of a session in which I participated at Johnson & Johnson’s first access conference in Brazil on 7th December 2024. It was an honour to share the stage with Camila Pepe and Felipe Roitberg (see accompanying photo). Conversations with other attendees at the event were also enlightening.   The primacy of cost-effectiveness in Brazilian HTA perhaps reflects the strong influence of NICE. In 2022, the standard QALY threshold was set at R$40,000 ($6,579), which was roughly equivalent to GDP per capita at the time. Unlike NICE, which has had a static QALY threshold of £20-30,000 since its inception in 1999, Brazil’s threshold is meant to change annually in line with growth in GDP per capita. However, these adjustments have not been happening.   Notwithstanding the importance of cost-effectiveness, it should be possible for technologies that exceed the QALY threshold to receive a favourable recommendation for reimbursement based on other criteria. The industry questions, however, whether this flexibility is being applied.   I shared with the audience findings from a report from the Office of Health Economics on the use of modifiers (tinyurl.com/2yspm4se), surrogate endpoints (tinyurl.com/2nyj79ae) and RWE (tinyurl.com/593cthua) by leading HTA agencies. Brazil’s CONITEC has discretion to increase the threshold up to threefold in four circumstances to promote innovation and equity in health for the SUS, but observers once again cast doubt on the use of this provision in practice.   One of the fundamental obstacles to achieving uniform access to new medicines in Brazil is the dispersion of healthcare across the public system and a multitude of private insurers. The government is seeking to promote a convergence of the public and private sectors, but reform is likely to be a lengthy process. In the meantime, the fragmentation of the Brazilian healthcare system, as well as the lack of a coherent health data infrastructure, would make it difficult to adopt some of the innovative contracting approaches being explored in Europe.   In August 2024, the government allocated R$2.9mn (US$472,000) to two new research projects on improving the use of #HTA in #Brazil. The first will focus on innovative methods, the second on ultra-rare diseases, including best practices in other countries. Areas of investigation could include the use of clinical or economic evidence in decision making on the reimbursement of treatments for ultra-rare diseases, as well as real-world monitoring of such products that have previously been evaluated and reimbursed (tinyurl.com/bdfhekaa). It will be interesting to see what impact these projects have (tinyurl.com/bdfhekaa). I look forward to learning more about the Brazilian #access environment—and the particular challenges facing rare disease therapies—in conversation with Claudio Cordovil Oliveira this week.

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Building leadership in any particular area is akin to building muscle! As I return from SBOC conference I reflect on our Oncology journey in Brazil has been exactly that - Focus on getting fundamentals right and continously strengthen them Nourish with right nutrition (resources) Be Consistent Prep for long term gains ( instead of short term shortcuts ) SBOC Annual congress is the flagship Oncology conference of Brazil that gives us an opportunity to meet our customers, seek their valuable inputs and also showcase our rich pipeline, as we foray from branded generics to innovative assets in difficult to treat tumor types. With focus on excellence in Portfolio, People, Processes, we continue to stay committed to bringing access to affordable medicines to Brazilian patients! #drreddys #goodhealthcantwait #oncology #Brasil #latam #pharma #leadership #healthcare #sboc

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After reflecting on my recent visit to Lima, it's clear that Patients play a pivotal role in shaping healthcare ecosystems in LATAM and APAC regions. Supporting the development and integration of Patient Organizations into Regulatory and market access dialogues is crucial for progress. The Pharmaceutical and Medical Devices industries share the same purpose - to reshape ecosystems and provide better and faster access to medicines, ultimately benefiting patients. It's inspiring to see the progress made by WHO in promoting diversity and inclusivity within the healthcare sector. Embracing these values is key to fostering a more inclusive and effective healthcare environment. This will mean more funding from government agencies to make this happen... Stay tuned for more updates on Patient organizations in LATAM and APAC. Contact us at www.socratescompliance.com #Healthcare #Patients #Regulatory #Diversity #Inclusivity #LATAM #APAC #WHO

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For IBP Care Access Brazil and for any Clinical research center - 3 KEY points: “consistent care with protocols avoiding errors, efficient results and good medical assistance ”! #careaccess #clinicresearch #clinicaltrial #innovation #newmedicines

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🌟 Chagas disease (CD) Chagas disease (CD) is a parasitic disease caused by the protozoan Trypanosoma cruzi; it affects more than 5.7 million people worldwide, claims 12,000 lives annually, and causes the greatest burden of disability-adjusted life years of any parasitic disease in Latin America. Approximately 1.2 million of those affected are women of childbearing age. Chagas disease is present in rural areas in endemic countries, and due to migration of infected individuals from rural to urban areas in Latin America #LatinAmerica and international migration from endemic to non-endemic countries, CD has #CD emerged as a public health concern in non-endemic countries, including the United States.  Approximately 23 million people living in the United States were born in CD-endemic countries, and an estimated > 300,000 people living in the United States are infected with CD.  Most individuals infected are asymptomatic and unaware, making CD challenging to diagnose and treat. For patients with chronic, untreated CD, 20–30% will ultimately progress to the “determinate” disease form, characterized by irreversible heart and/or gastrointestinal disease with high morbidity and mortality. Diagnosis in the asymptomatic phase is essential to avoid long-term consequences. #Colombia #ElSalvador #Guatemala #Chagas Screening for CD in the United States in at-risk reproductive-aged women is currently recommended by the CDC but is not routinely performed because of lack of physician and patient knowledge and dearth of healthcare resources in the at-risk population. There are insufficient data in the United States regarding the prevalence of CD; thus, the public health burden remains unclear. Source: https://lnkd.in/dEFHj_ak SR Bioera Manufacturing ➡ CD Ab ➡CD Ab Rapid Test Strips- Uncut Sheet ➡CD Ab Rapid Test for more information visit : www.srbioera.com #srbioera contact with your sales consultant from [email protected] for assistance.

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Gene Therapy in Brazil

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Excited to announce my participation in the IPCAA Annual Seminar on Compliance; join us for insightful discussions: we will explore recent hot topics around medical congress compliance & the evolving role of congresses in omnichannel world; for more information and registration please visit: ipcaa.org #IPCAA #complianceseminar #medicalcongress #pharmaindustry #IPCAAseminar2025

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🌟 **The Importance of Real-World Evidence in Oncology in Brazil** 🌟 The oncology sector in Brazil faces significant challenges, from unequal access to healthcare services to inadequate infrastructure and high treatment costs. In this context, Real-World Evidence (RWE) studies emerge as a crucial tool to overcome these barriers. 🔍 **Why are RWE studies essential?** 1. **Evaluation in Diverse Populations**: Unlike traditional clinical trials, RWE studies use data from patients treated in real-world settings, allowing for the assessment of treatment efficacy and safety in a more representative population. 2. **Identification of Treatment Gaps**: Real-world data reveal regional variations in access to treatments and quality of care, helping to develop more effective public policies. 3. **Enhancement of Clinical Guidelines**: RWE evidence complements clinical trial data, refining and updating clinical guidelines to make them more applicable to daily practice. 4. **Long-Term Monitoring**: RWE studies enable long-term patient follow-up, observing late adverse effects and evaluating the long-term efficacy of treatments. 5. **Support for Decision-Making**: Healthcare professionals can use RWE data to make more informed treatment decisions, based on evidence that reflects real clinical practice. 6. **Cost Reduction**: By identifying the most effective and safe treatments, RWE studies help optimize healthcare resources, reducing costs and improving system efficiency. 7. **Development of New Therapies**: Real-world data can identify new treatment opportunities and evaluate the effectiveness of emerging therapies in a broader population. 8. **Implementation of Public Policies**: RWE supports the implementation of more effective public policies, based on concrete data on treatment efficacy and safety in different contexts and populations. These studies are essential for adapting oncology practices to the real needs of patients and promoting a more equitable and efficient healthcare system. Let's work together to transform oncology in Brazil! 💪 #Oncology #Healthcare #RealWorldEvidence #RWE #PublicPolicy #PharmaceuticalInnovation

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Recently, we successfully hosted a Basic Hematology Training in #PanamaCity, an initiative led by HUMAN Diagnostics Latin America. 🌎🩸 This intensive five-day program was designed to deepen participants' expertise in #hematology — a cornerstone of diagnosing and treating blood-related conditions. With hands-on sessions and interactive discussions, attendees explored key topics, including #bloodtesting, hematologic disorders, and the use of HUMAN's #laboratory equipment. Special thanks to our expert trainers, Ricardo Carrera Diez and Isaela Markelys Rodriguez Guerrero, and to Verenice Castellanos from our partner #AgenciaArde, Honduras, for her valuable participation. Together, we combined theory with real-world application, empowering #healthcare professionals to tackle challenges with confidence. ➡️ Check out our heme portfolio: https://lnkd.in/e5U_EEYQ

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https://lnkd.in/dtJWE7xh Chapter 9: Post-COVID-19 Advancing Targeted Drug Delivery (TDD) Literature Insights and Market Dynamics Fucà, R., Cubico, S., Leitão, J., Favretto, G., & Ardolino, P. (2024). Post-COVID-19 Advancing Targeted Drug Delivery (TDD) Literature Insights and Market Dynamics. In Emerging Social Issues on Targeted Drug Delivery (pp. 255–312). Scientific Research Publishing. https://lnkd.in/dSpJBU7s

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This study aimed to evaluate the impact of secukinumab and ustekinumab against moderate-to-severe plaque psoriasis in a Brazilian pediatric population with access to public healthcare. Check it out at https://lnkd.in/d6Zs7vFs   #visualabstract #journaleinstein #publishedineinstein #psoriasis #pediatricpsoriasis #secukinumab #ustekinumab #immunologicaltherapy

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ANVISA decision to rely on #EDQM certification (#CEP) is a game-changer for #IndianPharma, bolstering Export potential, advancing regulatory alignment, and solidifying India’s position in global healthcare. #EnhancedMarketAccess: With 2,371 CEPs, Indian pharma companies can seamlessly enter the Brazilian market, overcoming regulatory hurdles. #APIExportsBoost: As a top global API supplier, India is poised to benefit from increased demand for CEP-certified ingredients in Brazil. #CostEfficiency: CEP recognition streamlines approval processes, saving time and resources, especially for #SMEs. #GlobalHarmonisation: This fosters deeper regulatory collaborations, enhancing India’s credibility as a global pharmaceutical leader. European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe Ana Carolina Moreira Marino Araujo Indian Pharmaceutical Alliance Indian Pharmacopoeia Commission Indian Drug Manufacturers' Association Bulk Drug Manufacturers Association US Pharmacopeia

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