Michal Nitka

The topic of Field Medical has always been my passion since I joined Pharma. Looking forward to this Medical Affairs Professional Society (MAPS) masterclass to share my experience and to discuss how this area will evolve in the future. #MAPS

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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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“Our hope is that with a validated device for use in narcolepsy, we can contribute to limiting the burden of traveling to a sleep center. Beyond the clinical trial setting, a validated Digital Health Tool could help to improve the diagnostic journey by allowing for a timely differential diagnosis for people living with narcolepsy.” So exciting to see this initiative to pair the development of a therapeutic innovation with digital innovation to add more value for patients living with narcolepsy.

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🌍✨ Today marks World Asthma Day 2024! ✨🌍 On this day, let's celebrate the remarkable resilience of individuals living with asthma. They defy the constraints of their condition, surpassing limits, and embracing life to the fullest. At Chiesi we are honored to share compelling stories of patients who have defied the limitations imposed by their condition. Today, we shine a spotlight on their inspirational journeys, highlighting their resilience and determination in overcoming the challenges of living with asthma. Behind these inspiring individuals lie stark statistics: Asthma is one of the most common chronic non-communicable diseases that affects over 260 million worldwide, leading to 450,000 annual deaths, many of which could have been prevented. Join us in honoring our patients and raising awareness about this respiratory disease. Happy World Asthma Day! 🌍 #Limitless #Sustainability #RespiratoryHealth

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Sustained market-beating growth for the Stada Consumer Healthcare business is driven by a differentiated strategy. Focusing on activating local jewel brands for local consumer needs in the UK and beyond is at the core of this success! Beyond Consumer Healthcare, as we build out our Specialty Pharmaceutical capability in the UK, we will deliver ever more against our purpose of caring for people’s health as a trusted partner. #onestadaforgrowth

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As 2024 comes to a close, we take a moment to reflect on a year of collaboration, growth, and progress in advancing Cell & Gene Therapies. This year, we strengthened and expanded our network with 15 partnerships, including UMC Utrecht, Pan Cancer T, bioMérieux, OogFarma, @Biotactical, Digi.Bio, IBSAL, RegMed XB, Aarhus University, Trince, Leiden University Medical Center and Leiden Bio Science Park. Key achievements through these collaborations include: - A €10 million grant awarded to NecstGen and partners to advance treatments for Duchenne Muscular Dystrophy and Diamond Blackfan Anemia. - A €2.5 million grant from the European Innovation Council for cell therapy advancements with Trince, IBSAL, and NecstGen. We also engaged with our community locally and globally through events such as the International Society for Stem Cell Research annual event, BIO International Convention 2024, ISCT, International Society for Cell & Gene Therapy 2024, and the European Society of Gene and Cell Therapy. Our reach has grown significantly, with over 7,000 LinkedIn followers, local events such as TechTalk XL on Cell & Gene Therapies and The CGT Circle, and webinars with over 1,000 registrations. On behalf of all of us at NecstGen, we wish you a happy holiday season and look forward to creating new memories and achievements together in 2025.

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𝐀𝐛𝐨𝐮𝐭 𝐭𝐡𝐞 𝐫𝐞𝐚𝐥𝐦 𝐨𝐟 𝐩𝐨𝐬𝐬𝐢𝐛𝐢𝐥𝐢𝐭𝐢𝐞𝐬 𝐚𝐧𝐝 𝐥𝐞𝐭𝐭𝐢𝐧𝐠 𝐭𝐡𝐢𝐧𝐠𝐬 𝐠𝐨! Sunday all are free, sun was shining, so we decided to do an excursion with the family.. We went with the bicycle to a restaurant some 10 kilometers away. The whole trip the kids were mourning that they don´t want to go by bike, are hungry, unmotivated etc… 😡 I strongly felt what we have initially planned will not move into the direction I have expected sitting in a nice restaurant after pleasant bicycle trip. When the mood was reaching its low point I decided to turn around and change the plans..! My kids were a bit astonished as the destination was 5-10 minutes away….However, I had the feeling that this mood will also be part of our lunch… My husband tried to find a middle way finding another place to eat, but for me it was clear that we turn around. We drove some half hour and were not talking. All have been reflecting… Finally, we made a stop as mood was not turning better and out of the nowhere around the corner turned my sister with her family on bicycles. They asked us what happened as they could feel the bad mood… Finally, they suggested to join them. It was a wonderful day as we went to a café, stayed some time at our home where the kids have been playing and went to dinner in the evening together.. 💓 “𝘞𝘩𝘦𝘯 𝘺𝘰𝘶 𝘵𝘩𝘪𝘯𝘬, 𝘵𝘩𝘪𝘯𝘨𝘴 𝘸𝘪𝘭𝘭 𝘤𝘰𝘮𝘦 𝘵𝘰 𝘢𝘯 𝘦𝘯𝘥, 𝘩𝘦𝘢𝘷𝘦𝘯 𝘢 𝘭𝘪𝘵𝘵𝘭𝘦 𝘭𝘪𝘨𝘩𝘵 𝘸𝘪𝘭𝘭 𝘴𝘦𝘯𝘥!” I know we all know such daily hurdles but how to apply to leadership? ✅ 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧 – before you start going to your goal, talk to your Team mates and make clear that all are picked up where they stand. ✅ 𝐂𝐥𝐚𝐫𝐢𝐭𝐲 & 𝐃𝐞𝐜𝐢𝐬𝐢𝐨𝐧 𝐦𝐚𝐤𝐢𝐧𝐠 – when you feel there is so much resistance, let things go and change  your plans and take a decision, reflection time will bring you & your Team to the next unexpected step. ✅ 𝐓𝐫𝐮𝐬𝐭 & 𝐎𝐩𝐭𝐢𝐦𝐢𝐬𝐦 – when you leave the old situation behind trust that something better will come by means a new room of possibilities, you are not expecting, is opening for you! If one door is closing another is opening! Believe that something great is waiting beyond your expectations! 💫 Have you experienced similar situations and how are you reacting? Which skills help you to turn around challenging situations? #leadership #clearity #decisionmaking #possibilities

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Report 1 Three reports published by the European Federation of Pharmaceutical Industries and Associations show that disparities in the time it takes for European patients to access new medicines persist. Across the region, the average time to patient access is 531 days. Ranging from 126 days in Germany to 804 days in neighbouring Poland. The data shines a light on the delays and barriers to access that European patients face. Ensuring that medicines reach citizens regardless of where they live in Europe, is not only a shared goal but a shared responsibility. The current situation, where patients in one European country can wait more than 6 times as long as patients in a neighbouring country for the same medicines must be addressed. The reasons for unavailability and delays, explored in the CRA Report are multifactorial, even before a medicine is approved in Europe, slow regulatory processes can lengthen the time it takes for new medicines to get to patients. Delays and barriers to access are often due to a combination of factors. For example, the speed of health technology assessments, different reimbursement processes or additional layers of regional and local decision making. Duplicative or inconsistent evidence requirements can also cause delay or a lack of availability. For example, different countries, HTA bodies and payers may require different endpoints, or some accept real world evidence where others do not. The use of external reference pricing (ERP) also causes delays and unavailability. Several countries don’t start their national pricing and reimbursement processes until they have access to the reimbursement decisions from several other European countries.

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https://lnkd.in/d9BMazVF Interesting article from IQVIA about a tendency of "Near Patient Care" The healthcare sector has increasingly moved towards treating patients at an individual level, both in terms of patient centricity and personalised medicine. As part of this phenomenon there is a growing focus on providing patients with greater flexibility with where and when they receive care. It is important to stress that this movement is not merely looking to increase at-home delivery of medicines, but instead to introduce structural changes to healthcare systems, focusing on treating patients outside of the hospital where feasible. A near-to-patient care system involves moving healthcare closer to the patient, bringing a range of benefits to stakeholders.

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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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At UCB, innovation drives us forward with a steadfast commitment to enhancing access to our solutions for patients in need. We've always held the belief that access to innovations is fundamentally anchored in strong partnerships and a supportive regulatory environment. As a company with large R&D and manufacturing capabilities in Belgium, staying competitive, leveraging state-of-the-art technologies and attracting the best talents are crucial for advancing our unwavering commitment to innovation. We stand united with the EFPIA - European Federation of Pharmaceutical Industries and Associations members, advocating for policies that support the competitiveness and resilience of our industry. Our dedication to a sustainable future is mirrored in our support of the Antwerp Declaration for a "European Industrial Deal" ➡️ https://lnkd.in/e-YnNFeV As we confront global challenges like the climate crisis and increasing social inequalities, the need for collective action to build a healthier and fairer world becomes ever more pressing. In this journey, we invite you to collaborate and explore together pathways and possibilities to harness innovation to not only advance healthcare but also address the broader societal challenges of our time. #AntwerpDeclaration #Innovation #Healthcare

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Thank you, Politico, for partnering on the awareness on a very important topic, a WHO goal - HCV elimination by 2030. As we are getting closer to the date, the target becomes tougher. However we have the tools to reach it. If we all focus on finding the patients, linking them to care and curing them, we can get there. At AbbVie, we are committed to this partnership. Some insights from the article why HCV matters: Currently, an estimated 58 million people around the world suffer from chronic hepatitis C, with over 12 million of them in Europe. Every year there are an estimated 300,000 new infections in the European Region. The consequences of leaving the disease untreated can be severe. As well as cirrhosis and liver failure, over 20 percent of liver cancers are caused by HCV. Liver cancer is the third most common cause of cancer deaths: it killed approximately 78,000 people in Europe and over 800,000 people globally in 2020 #hepatitisC #hcv #cancer #healthcare #cure #patients #policy #globalhealth #infectiousdiseases

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Interesting read from EFPIA - European Federation of Pharmaceutical Industries and Associations and PwC on the economic footprint of Europe’s pharma industry. While it’s encouraging that R&D investment is rising, these figures only tell part of the story.     R&D spending in both the US and China is outpacing Europe. At the same time, we’re seeing a decline in new molecular entities discovered here. This poses a real risk to the competitiveness of Europe’s pharma sector, the broader economy, and ultimately, patient care across the continent. Yet, the industry is among Europe’s most productive high-tech sectors, with every €1 invested generating €1.91 in economic returns across the EU27.   What matters now is to secure a forward-looking European life sciences strategy. We need a competitive environment where Europe can lead globally and bring transformative treatments to the people who need them most.

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Report 3 Three reports published by the European Federation of Pharmaceutical Industries and Associations show that disparities in the time it takes for European patients to access new medicines persist. Across the region, the average time to patient access is 531 days. Ranging from 126 days in Germany to 804 days in neighbouring Poland. The data shines a light on the delays and barriers to access that European patients face. Ensuring that medicines reach citizens regardless of where they live in Europe, is not only a shared goal but a shared responsibility. The current situation, where patients in one European country can wait more than 6 times as long as patients in a neighbouring country for the same medicines must be addressed. The Patient W.A.I.T. Indicator documents the time from EU marketing authorisation to the reimbursement of medicines in Member States, the portal allows us to look in greater detail at the timings of different steps in that process. The data shows that the majority (71%) of the time between EMA approval and reimbursement occur after a product has been filed for pricing and reimbursement (P&R). The remaining 29% happens prior to filing for P&R.

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In the last 10 years, 192 oncology novel active substances have launched globally, out of which 68 were indicated for hematological malignancies. However, the access to advanced therapies varies greatly not only globally, but also within the EU. We can see it especially in countries in Central and Eastern Europe which have lower utilization of innovative treatments.   A newly released report by IQVIA funded and consulted by AbbVie outlines the challenges leading to delays in patient access to efficacious therapies and highlights the importance of harmonizing regulatory processes.   Let´s use it as a tool to spark discussion on policy solutions that would enable equitable access to #BloodCancer treatments. Read the full report here: https://lnkd.in/eugriFaG   #BloodCancerAwarenessMonth #BCAM2024 #Innovation #Oncology

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Biosimilars are revolutionizing both patient care and health systems across Europe. Since their introduction, over 700 million patient treatment days have been recorded with biosimilars, demonstrating their critical role in improving access to life-saving treatments*. Their use spans across oncology, supportive care, and chronic disease management, offering patients safe and effective alternatives to biologics.   For patients, the benefits are clear—biosimilars provide broader access to high-quality, advanced therapies, often at a reduced cost. This translates into better health outcomes, particularly for those with chronic and severe conditions who require long-term treatment. The safety and efficacy of biosimilars are well-documented, with over a decade of clinical experience in Europe supporting their widespread adoption.   On the economic front, the European Commission estimates that biosimilars could save healthcare systems between €11.8 billion and €33.4 billion by 2025, allowing these funds to be reinvested in new innovations and expanded patient care**. These savings are vital for sustaining health care systems under the increasing pressure of rising drug costs and aging populations.   With over 90 approved biosimilars and 80% of European physicians expressing confidence in prescribing them, biosimilars are proving to be a reliable, safe, and cost-effective solution. However, there are still hurdles to overcome, including regulatory challenges and the need for greater education among both healthcare professionals and patients to fully unlock the potential of biosimilars.   At Teva, we are proud to be contributing to this transformative change. With 4 biosimilar products available in 16 countries, we are committed to ensuring that more patients have access to these vital treatments, helping to improve health outcomes and reduce healthcare disparities. #Teva #Tevapharmaceuticals #Tevapharm #GBW2024 #Biosimilars,#HealthcareInnovation #PatientCare #Sustainability #Biotech #Accesstomedicines #WeAreAllInForBetterHealth

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Curious about the trends in Nuclear Medicine for 2025? Discover the new series with Prof Dr Rudi Dierckx 🚀

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What have been the recent activities of The Beneluxa Initiative? The organisation’s website and the latest annual report of Belgium’s RIZIV-INAMI offer some insights.   In August, Beneluxa announced that Belgium and the Netherlands had completed a joint assessment of CSL Behring’s haemophilia B gene therapy Hemgenix (etranacogene dezaparvovec). Based on that evaluation, the Dutch National Health Care Institute (ZIN) recommended an outcomes-based agreement (OBA) of up to ten years’ duration  to the Minister of Health in the Netherlands (tinyurl.com/4nnwvews). More recently, Beneluxa has disclosed that, although joint pricing negotiations are “the preferred approach of both governments,” differences in healthcare systems can present challenges to this process. In the case of Hemgenix, “the financing of the current SoC, the factor IX products, is organised differently in both countries and therefore resulting in a different outcome of the recommendation for reimbursement. Therefore, the decision was made to proceed individually with the negotiations for Hemgenix.”   RIZIV-INAMI provides some detail on the general working of Beneluxa. The domain taskforces (DTFs) meet regularly—the one on HTA monthly, the one on pricing and reimbursement every six weeks—“to exchange information, share best practices and discuss strategies.” Twice yearly, the DTFs present the results of their work to the Beneluxa Initiative Steering Committee.   At the June 2023 Steering Committee meeting, representatives of the European Commission and Beneluxa’s Nordic counterparts were invited to attend. The DTF HTA drew up a list of four drugs that were considered to be potential candidates for joint evaluation.   The activities of the DTF Horizon Scanning have been temporarily scaled back because several members of Beneluxa are actively involved in the International Horizon Scanning Initiative. DTF Information Sharing has been working with PPRI on organising a joint webinar on pharmaceutical expectations in the field of Alzheimer's disease.   The Ministers of Health of member countries met at the EPSCO meeting in November 2023 to reaffirm the importance of Beneluxa. They also considered topics such as managed entry agreements, external reference pricing and collaboration with other stakeholders and partners.   At the December 2023 Steering Committee meeting, chairmanship of the organisation was transferred from Belgium to the Netherlands and Ireland was appointed as the first vice-chair. The meeting also discussed the creation of a Policy Working Group to maintain Beneluxa’s strategic position and explored opportunities such as (continued) cooperation in the field of Alzheimer's disease.   The June 2024 Steering Committee meeting included discussions on experiences with joint negotiations, strategic planning for Beneluxa’s future activities, and potential new collaborations. #Beneluxa #Belgium #Netherlands #drugpricing

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