Carolina Correa

#PatientEngagement : From Nice-to-Have to Must-Have at #ReutersPharma 2024 At #ReutersPharma 2024 in Barcelona, I had the opportunity to attend, with my colleagues, Marta Garcia Manrique and Alexandre Jaegly,   key discussions surrounding the crucial topic of #PatientEngagement. Key Takeaways : -> #Patientengagement is no longer a "nice-to-have" but a "must-have" for pharmaceutical companies. The industry is moving beyond simply checking a box to demonstrating the strategic value and commercial benefits of patient engagement initiatives. -> Measuring and proving the impact of #patientengagement efforts is essential. Companies need to establish clear metrics and frameworks to track the effectiveness of their programs and showcase their contribution to improved patient outcomes and business objectives. ->Building impactful #patientengagement capabilities requires a cross-functional approach. Collaboration between departments such as commercial, marketing, medical affairs, and R&D is crucial for developing and executing successful patient engagement strategies. Overall, #ReutersPharma 2024 reinforced the notion that #patientengagement is not just a buzzword but a critical component of the pharmaceutical industry's future success. By embracing patient-centricity, companies can build stronger relationships with patients, improve health outcomes, and drive business growth. #pharma #healthcare #patientcentricity #WeAreServier #MovedByYou

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𝐑𝐄𝐆𝐔𝐋𝐀𝐓𝐎𝐑𝐘 𝐑𝐎𝐔𝐍𝐃𝐔𝐏 ⚛️ The FDA has released new draft guidance recommending best practices for multi-regional clinical trials (MRCTs) in oncology. Sponsors are encouraged to ensure that the outcomes of global oncology clinical development programs are understandable for US patients in support of marketing applications. 🌐 The FDA's final guidance on decentralized clinical trials (DCTs) clarifies several concerns raised by clinical experts and industry stakeholders regarding the earlier draft. This includes detailed requirements for maintaining a task log for healthcare providers, guidelines for physical inspections, and addressing challenges related to data variability in DCTs. 🤖 As the use of artificial intelligence (AI) tools, particularly generative AI, expands, experts remind regulatory professionals to prioritize the human aspect. Although these tools offer significant benefits, they necessitate human oversight and interpretation to be fully effective. During the opening plenary session, experts discussed how AI can be utilized across various sectors, the potential of this technology, and the hurdles in achieving its full benefits. Panelists included Ryan Kurtzman from the City of Long Beach, Bradley Thompson of Epstein Becker Green, Michelle Jump from MedSec, and Jay Mashburn from Recursion Pharmaceuticals, with moderation by Megha Iyer of Thermo Fisher Scientific. 🧬 As biosimilars gain market presence, they are generating competition with original products. However, patient adoption of biosimilars varies based on demographics, location, care setting, prescriber specialties, and types of insurance, according to two recent studies in Health Affairs. 🌐 The FDA has observed a rise in complete response letters (CRLs) issued to sponsors of biologics license applications (BLAs) over the last decade, with facility deficiencies being the most common reason cited, according to Leslie Rivera Rosado, a supervisory interdisciplinary scientist at the agency's Center for Drug Evaluation and Research (CDER). #Pharmaceuticals #Biotechnology #LifeSciences #PharmaNews #Biotech #HealthcareInnovation #DrugDevelopment #ClinicalResearch #Biopharma #PharmaTech #MedicalResearch #Healthcare #BioPharmaceuticals #PharmaIndustry #BiotechIndustry #PharmaCareers #MedicalInnovation #NewDrugs #Genomics #BiotechNews

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Colleagues! Our very own Sandra Lourenço will be leading the discussion on Scientific Advice at the 2024 Symposium of TOPRA - The Organisation for Professionals in Regulatory Affairs What makes #Arriello different is our unique çombined experience in Quality & Compliance, Regulatory and Pharmacovigilance. We have guided so many clients in this area and it can make or break an application. So here's another example: Watch Sandra's video below to get a flavor & to find out more about how we can help you make it, contact solutions@arriello.com ⬇⬇⬇ #TOPRASymposium #TOPRASym24 #Pharmaceuticals #ScientificAdvice #RegulatoryAffairs

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Colleagues! Our very own Sandra Lourenço will be leading the discussion on Scientific Advice at the 2024 Symposium of TOPRA - The Organisation for Professionals in Regulatory Affairs. What makes Arriello different is our unique çombined experience in Quality & Compliance, Regulatory and Pharmacovigilance. We have guided so many clients in this area and it can make or break an application. So here's another example: Watch Sandra's video below to get a flavor & to find out more about how we can help you make it, contact solutions@arriello.com ⬇⬇⬇ #TOPRASymposium #TOPRASym24 #Pharmaceuticals #ScientificAdvice

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The newly issued guidelines from SFDA propose a gradual implementation of general requirements and economic studies as part of a new dossier submission. Our pharma experts dive into the impact on the P&MA landscape, the challenges, opportunities, and strategies for a successful market entry. skp.link/d5sl #BetterMarketAccess #SFDA #Vision2030 #SaudiArabia #Pharma #SimonKucher

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CEO Bill Anderson is bringing major changes to the German company’s pharma commercial team, shaking up its structure, personnel and operations. Christine Roth, head of global commercialization at Bayer’s pharmaceutical division, stated in a recent interview: “We are transforming from a company that has been largely focused on hierarchy within functions to an organization—and supporting design—that really focuses on customers and products.” While layoffs across Bayer are not expected to finish until 2025, Roth said headcount reductions in the pharma commercialization unit will largely be done at the beginning of the fourth quarter. "Hats Off to Christine Roth" for moving fast on the restructuring. Speed is of the essence. During the merger of Astra and Zeneca, a guru we worked with preached that speed is of the essence and that it is "better to be roughly right than precisely wrong". However, the journey ahead is long and fraught with risks. Last year, Bayer laid out an ambition to reach $10 billion in revenue from cancer drugs by 2030 and to become a top 10 oncology player. It’s a bold target, considering none of the pharma division’s top 3 products last year were in oncology! Both the revenue target and the goal of being a top 10 oncology player are extremely ambitious. Given my experience in oncology, 51% of me says they won't deliver this. But I could be wrong. I hope they have culled much of the organisation's surplus fat of middle and senior managers. Their organisation just grew and grew without the supporting growth in revenue. But they are not alone. I know of several large pharmaceutical companies that have grown out of proportion to the size of their business—if not globally, certainly in regions such as MEA and especially Africa within that Middle East Region. As many of these begin their five-year planning around now, I would not be surprised if, after several years of failing to deliver the numbers, senior executives decide that a cull is in order to save funds and divert investment to other regions where there is likely to be more bang for their buck. Right now, I'm keen to watch how the new model evolves at Bayer and see if it can make a tangible difference in the numbers to hit their ambitious goals. #bayer #restructure #ssa

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Bayer got a lot of things wrong in Africa over many years. Earlier this year, they surrendered, threw in the towel and pulled out of Africa in a commercial equivalent of coitus interruptus. Several months later from that surrender, I have to give credit to the CEO Bill Anderson and his Chief Commercial Officer Christine Roth for (a) taking the bold decision to take an axe and cleaver to the organisation and (b) acting with speed. Speed is a critical success factor. Big Pharma lacks agility. Like a huge ocean-going tanker it takes a long time to change direction. Christine Roth has culled much of the surplus fat of junior, middle and senior managers in moving to a new DSO operating model. Only time will tell if the new model works and delivers Bayer's ambition to be a top 10 player in oncology. Reorganisations are rarely carried out well or effectively implemented to create the change that is required. The same applies for mergers and acquisitions. At the merger of Astra with Zeneca back in 1999, we worked with a guru who preached: "Move FAST! Speed is key. Don't deliberate and procrastinate. Focus on getting it 90%. Better to be roughly right than precisely wrong!" I never forgot these teachings. I preach the same to clients - they just procrastinate and worry about being wrong. They freeze with fear! Fight the fear and move fast!

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Executive skills are the result of practice and preparation. If you're looking for an example of communicating a complicated message to a global audience, look at this master class by Jennifer Zinn. bioMérieux is on a good path and is creating impact! Jennifer conveys this message perfectly. #Leadership #ExecutivePresence #BeRelevant

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Hi dear Network, Let me confess that this week I felt like an alien... I joined the WebSummit in Lisbon together with a few colleagues from #ViatrisPortugal. Walking into this tech-driven space, with only a few pharma representatives around, I got a lot of raised eyebrows when I introduced myself as a pharma sector professional. But that’s exactly what we came for—to dive into an environment outside our usual field and explore how the latest tech and innovation might translate into new opportunities for pharma. Our goals were clear: gain exposure to fresh ideas, discover tools to bring back to my "natural" sector, and explore potential partnerships. WebSummit LLC didn’t disappoint! I had the chance to hear from incredible speakers like Lidiane Jones, Pharrell Williams, Brad Smith, Naeem Ishaq or Cecilia Oliveira, as well as engage with big players like IBM, Adobe, Huawei, Meta or Alibaba. I also connected with impressive Alpha Startups, including Sabina Baitemirova from ESG FaceBody or Marcella Hall from MascotYou or Inês Castro de Lima, Leonor de Oliveira Pires, Mariana de Oliveira and Raquel Sales Rebordão from IMAGI Health, a solution for improving children's quality of life through pain management. One session that stood out to me was “DEI cuts + AI Boom = Recipe for Bias?” led by Nyanchama Okemwa, Joyann Boyce, Moojan Asghari, and Muhammad Lila. Conversations like these are so relevant as AI matures—not only advancing automation but supporting decision-making by integrating diverse data sources and perspectives. My main takeaway? There’s a massive opportunity for the pharma industry to leverage AI. The potential is huge, but it’s essential to keep our path transparent, compliant, and aligned with industry regulations—yes, even if it feels like we’re a bit late to the game. Now, over to you—have you ever felt like an alien in your professional life? How has exploring inspiration outside your “normal” environment helped you? Let’s discuss! #WebSummit2024 #PharmaAI #Diversity #DEI #StrongerTogether #Inspiration #Collaboration #Compliance Note: The image has been created using Chat GPT4o Enterprise

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AbbVie today announced the European Commission (EC) granted marketing authorization for ELAHERE® (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatment regimens. 👉 ELAHERE is the first and only folate receptor alpha (FRɑ)-directed antibody drug conjugate (ADC) medicine approved in the European Union (EU), as well as Iceland, Liechtenstein, Norway, and Northern Ireland. "It's been 10 years since a new treatment for platinum-resistant ovarian cancer was approved in the EU, and now oncologists have an effective, new, targeted treatment option for these patients," said Toon Van Gorp, Professor of Gynaecological Oncology at the University of Leuven. Ovarian cancer is one of the leading causes of death from gynecological cancers worldwide. Most patients present with late-stage disease and will typically undergo surgery followed by platinum-based chemotherapy. Unfortunately, most patients eventually develop platinum-resistant disease. Historically, treatment options for patients with platinum-resistant ovarian cancer (PROC) have been limited, and those available often result in adverse events which can negatively impact quality of life. "Ovarian cancer can be devastating, taking women away from precious moments with their family, disrupting careers and the many other important contributions that women make to society," said Clara MacKay, CEO, World Ovarian Cancer Coalition. "In Europe, ovarian cancer is three times more deadly than breast cancer, and having new innovative options allows us to work toward a world where everyone living with ovarian cancer has the best chance of survival and the best quality of life possible, no matter where they live." In approximately one third of people living with ovarian cancer, the folate-receptor alpha (FRα) biomarker is highly expressediv (≥75% of tumor cells with ≥2+ membrane staining intensity). To determine biomarker status, patients can be tested with Roche's VENTANA® FOLR1 (FOLR1-2.1) RxDx Assay at diagnosis or at the first sign of resistance to platinum-based chemotherapy. AbbVie collaborated with Roche Diagnostics on the newly approved immunohistochemistry (IHC) companion diagnostic test to identify patients who may be eligible for ELAHERE. "The approval of ELAHERE by the European Commission provides a much needed clinically meaningful option for patients who receive the heartbreaking news their ovarian cancer has returned, fearing what's next in their treatment journey after they've developed platinum-resistance," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. #oncology #gynecologicalcancers #ovariancancer #ELAHERE #ADC #AbbVie 

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What if I told you that inclusive teams can boost performance by as much as 30%? This transformative effect is rooted in neuroscience 🧠: When we step out of our comfort zone, and our brains are exposed to – and challenged by – diverse perspectives, we often experience that “aha!” moment that sparks creative thinking. For Global Diversity Awareness Month, Dr. Eran Harary, MD, a psychiatrist and SVP, Global Early Clinical Development at Teva, and Irit Hovic, our Global Inclusion and Diversity Lead, share how diverse minds fuel creativity and innovation: https://lnkd.in/g9ij66GQ Watch the video for more insightful "aha!" moments! 👇 #Diversity #Inclusion #Creativity #HigherPerformance #DiversityAwarenessMonth

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Another EHA congress in Madrid! A great opportunity for the Physicians to share practices and Pharma industry to present best approaches against hematologic challenges for the optimal disease management and best patient outcome! Bringing hope through science! In a Challenging Landscape find power! #Oncopeptides #Ariti New insights in Multiple Myeloma treatment

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European regulatory authority adopts a positive opinion for an update of the Wegovy® label to reflect risk reduction of major adverse cardiovascular events Bagsværd, Denmark, 25 July 2024 – Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Wegovy® (semaglutide 2.4 mg) label to reflect data from the SELECT cardiovascular outcomes trial, demonstrating a risk reduction of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack (myocardial infarction) or non-fatal stroke in adults with established cardiovascular disease (CVD) and either overweight or obesity (initial BMI ≥27 kg/m2) without diabetes.

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Led by Markus Renschler, MD, Light Horse Therapeutics has made significant progress in the oncology space with a $62M #SeriesA funding round led by MPM BioImpact and Omega Funds, alongside Novartis Venture Fund. This marks a big step for their work in developing LHT-001, a promising candidate targeting critical cancer pathways. In parallel, their partnership with Novartis could be worth up to $1B, combining Light Horse's innovative pipeline with Novartis' expertise in oncology drug development and commercialization. This collaboration has the potential to address unmet needs in cancer treatment and accelerate progress in this critical field. #Biotech #Oncology #Immunology #Innovation #LightHorseTherapeutics #Novartis #MPMBioImpact #OmegaFunds

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Check out AUX-001 Phase 1a results presented at European Society of Cardiology annual meeting in London by Uwe Tigör, MD, our Chief Medical Officer at Auxilius Pharma. Phase 1a study explored the safety, tolerability, and pharmacokinetics of our compound, which is promising new medication for chronic stable angina. Now that the meeting’s embargo has lifted, we’re thrilled to share these results with you! Check out the attached presentation for more details. If you’d like the full version of the deck, feel free to reach out directly to @Uwe Tigör, MD or to me #cardiology #CSAP #AUX001 #ESC #newmedication #biotech #news

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💡Insights from the bio.be Annual Event!  This afternoon, I attended the Bio.Be Annual Event, which focused on next-gen vaccines and our local footprint and position in the value chain. 👉 Here are my key takeaways: 1️⃣ 𝐁𝐞𝐥𝐠𝐢𝐮𝐦’𝐬 𝐁𝐢𝐨𝐦𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐢𝐧𝐠 𝐋𝐞𝐚𝐝𝐞𝐫𝐬𝐡𝐢𝐩: Belgium ranks first globally in vaccine exports, even after the pandemic! 2️⃣ 𝐂𝐚𝐥𝐥 𝐟𝐨𝐫 𝐕𝐨𝐥𝐮𝐧𝐭𝐞𝐞𝐫𝐬: To continue facilitating clinical studies for vaccine development, we need more volunteers, especially to test prophylactic vaccines. 3️⃣ 𝐈𝐦𝐩𝐨𝐫𝐭𝐚𝐧𝐜𝐞 𝐨𝐟 𝐏𝐚𝐫𝐭𝐧𝐞𝐫𝐬𝐡𝐢𝐩𝐬: During crises or pandemics, we need to act 10x faster... and with 10x higher volumes. Preparation is crucial, but true readiness comes from strong partnerships. Trust is essential. 4️⃣ 𝐂𝐨𝐧𝐭𝐢𝐧𝐮𝐨𝐮𝐬 𝐄𝐟𝐟𝐨𝐫𝐭: As ecosystems and governments evolve, maintaining our role in the value chain requires a clear path forward that supports R&D. A big thank you to bio.be, Frédéric Druck, Tineke Van hooland, and Geoffrey Pot for the excellent organisation! #BioTech #Vaccines #Innovation

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« In a world with increasing geopolitical tensions, we need to make sure that patients can get access to the treatments they need » one of the many reflections shared by our CEO Christophe Weber during his interview in « Les Echos ». He outlines the need for pharmaceutical companies to have scale and be global, how he transformed Takeda over the last decade, how exciting scientific and digital progress will impact health care systems. Health care systems in which Takeda wants to partner with all parties involved to ensure they stay sustainable. An ambition everyone in Takeda contributes to, to ensure a better health and a brighter future.

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