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Damos un paso gigante en Farmacias Peruanas: Nuestro nuevo Centro de Distribución de Punta Negra ya inició operaciones. Tras dos años de trabajo, hacemos realidad uno de los centros más modernos y automatizados de Latinoamérica, con la capacidad de preparar más de 1 millón de unidades al día y respaldar una red que cada año recorre el equivalente a 142 vueltas al mundo para llevar salud y bienestar a todas las familias peruanas. Para mí, liderar esta operación junto a un equipo de altísimo nivel es un desafío que marca un antes y un después en mi carrera. La magnitud tecnológica, la complejidad operativa y el impacto que tendrá en millones de peruanos lo convierten en un reto tan grande como inspirador. A partir de ahora inicia una etapa clave: la consolidación de una operación altamente automatizada y orientada a la excelencia operacional. Esto implica integrar talento, procesos, analítica, tecnología y gestión del cambio para asegurar una curva de aprendizaje sólida y un desempeño sostenible desde el día uno. Agradezco profundamente al equipo que ha trabajado durante estos dos años para hacer realidad este proyecto. Continuaremos construyendo una cadena de suministro robusta, moderna y preparada para el futuro. #CDPuntaNegra #EmbajadoresFarmaciasPeruanas #Supplychain Jose Carlos Risco Calle Heidy Santillan Coral Karen Rubio

Hace poco más de 2 años Edmundo Yañez, Juan Carlos Vallejo me invitaron a sumarme a un proyecto ambicioso, que iba a ser un referente en la región. Así fue que con Paula Yanina Soto y nuestra hija, emprendimos viaje. En este tiempo, armamos un equipo de proyecto, que realmente la rompió, que piensa todo el tiempo en como se pueden hacer mejor las cosas y al cual le agradezco enormemente porque sin ellos no lo podríamos haber conseguido: Andrea Cama Pabón, Christian Robles Barrón, JOSE ANDRES ARISPE SEVILLA, Man Sam Leung Wong, Henry Abanto Medina Tatiana Milagros Barrutia Novoa Zulema Pilar Castañeda Rodriguez Jorge Cárdenas Díaz Antonio Stefano Palmisano Patron Ian Roberto Villacorta Carbajal y los equipos que lideran. ¡Hoy podemos decir que Inauguramos el nuevo Centro de Distribución de Farmacias Peruanas!, uno de los más modernos y automatizados de Latinoamérica. Este proyecto combina dos grandes apuestas: sistemas de alta precisión que nos brindan una eficiencia operativa de mas de un 30% y trabajo más seguro para nuestros colaboradores, y un proceso de transferencia de conocimiento donde nuestro equipo trabajó con expertos de varios países, fortaleciendo sus capacidades y dejando conocimiento que se queda aquí para siempre. Lo que logramos demuestra que en el Perú sí podemos competir al máximo nivel. Gracias por las largas jornadas, la resiliencia y el compromiso. Hoy, podemos sentirnos orgullosos y decir “esto funciona gracias al trabajo que hicimos”. ¡Celebramos este paso enorme para la logística y la tecnología del país! #EmbajadoresFarmaciasPeruanas #CDPuntaNegra

Spreadsheets are NOT a Quality Management System (QMS). They were not built to manage deviations, guide CAPAs, or prove compliance in an audit. But too many teams are still relying on them to do exactly that, copying data between tabs, chasing version control, and hoping nothing gets missed. Ennov QMS was built to solve that. It’s purpose-built for life sciences, with connected workflows, real-time visibility, and audit-ready records. It helps you focus on quality, not file management. The difference is more than just efficiency: it’s confidence in your process and compliance as a result. Discover what Ennov can mean on your Quality Processes: https://lnkd.in/eA-jRCRj

Your regulatory, quality, and clinical docs should always be in a row. Not scattered. Not siloed. Not slowing you down. When documents live in disconnected systems, you end up with duplicate records, version control headaches and audit delays. That’s why we built Ennov: the only AI-powered unified platform designed for life sciences from day one. One place where all your documents work together, not against you. What does that mean for your teams? ✅ Find the right document in seconds ✅ Respond to audits with confidence ✅ Eliminate duplicate work ✅ Collaborate seamlessly across departments ✅ Keep data consistent across the entire product lifecycle Simple on the surface. Powerful under the hood. Discover what we do and why more than 450 life sciences companies around the world trust Ennov: https://en.ennov.com/

Do you want to uplift your portal and add a personalization engine to it, but don't know where to start? I wrote a new article about the 3 levels of personalization and how to implement it. Enjoy the reading and if you want to learn more on how to implement it on your portal, DM me and I can give you a blueprint.

Your Senior QP’s calendar is full. Not with impact. With paperwork. Minor 📃 documentation errors. Low-risk deviations. Things that should take minutes. But somehow consume weeks. That’s what happens when #QualityManagement systems grow old. They stop enabling people. They start controlling them. That’s the silent cost of a bad QMS. Not compliance risk. Decision debt. With Docuply, QPs get their time back. AI-suggested SOP questionnaires. Instant CAPA plan proposals. Clean audit trails by default. The system does the busywork. The QP does what only humans can do. 🟢 Judgement. 🟢 Prioritization. 🟢 Quality culture. Tools should support expertise. Not bury it. See how we can support you and accelerate your daily QM tasks: ➡️ https://docuply.io/en/demo

Hiring Great Quality Managers is an 8.5/10 Difficulty. Is That Your Only Scaling Strategy? When we interviewed pharma industry CEOs and Quality Leaders in 2021, I'll never forget what a QM director told me: "Every 15 employees, I need to hire a new Quality Manager. That's just how it works here." I asked if the CEO and family owners were okay with that. He hesitated. Then: "Yes... 𝘵𝘩𝘦𝘺’𝘷𝘦 𝘢𝘤𝘤𝘦𝘱𝘵𝘦𝘥 𝘵𝘩𝘦 𝘣𝘶𝘳𝘥𝘦𝘯." Then I asked the hardest question: "On a scale from 1 to 10, how hard is it to find good QMs?" His answer: "8.5 to 9" Think about that. Quality measured in people. Every hire adding cost. Every process waits on someone else. And are you able to attract the talent without a matching eQMS? Docuply changes the game: ✅ Lean quality teams. ✅ Decisions over admin. ✅ Daily QM tasks automated. Quality scales when systems do the heavy lifting. Your team focuses on people and decisions. Not chasing signatures. Not firefighting Excel files. Lean. Smart. Scalable. Without adding unnecessary headcount. 𝐓𝐡𝐚𝐭’𝐬 𝐡𝐨𝐰 𝐪𝐮𝐚𝐥𝐢𝐭𝐲 𝐠𝐫𝐨𝐰𝐬. See how we can help keeping your quality team lean: ➡️ https://docuply.io/en/demo

In case you are thinking of adding a personalization layer on top of your portal or website, I think this article might be useful for you. Enjoy the reading

𝐖𝐚𝐭 𝐡𝐨𝐮𝐝𝐭 𝐞𝐞𝐧 𝐳𝐢𝐞𝐤𝐞𝐧𝐡𝐮𝐢𝐬𝐚𝐩𝐨𝐭𝐡𝐞𝐞𝐤 é𝐜𝐡𝐭 𝐝𝐫𝐚𝐚𝐢𝐞𝐧𝐝𝐞? Niet het gebouw of de apparatuur, maar de mensen die zich elke dag inzetten om het verschil te maken. Juist bij personeelstekorten en hoge werkdruk verdienen zij oplossingen die hen ondersteunen, niet systemen die extra werk opleveren. Bij Dyzle begrijpen we dat. Daarom werken wij niet als leverancier, maar als partner. We denken mee, ook over zaken als kalibratiestrategie en validatie, zodat uw team zich kan blijven richten op wat écht telt: de patiënt. Inmiddels werken meer dan 15 Nederlandse ziekenhuizen met onze gevalideerde oplossing voor temperatuurbewaking, volledig compliant met GxP richtlijnen. De oplossing werkt volledig cloud-based en is bereikbaar via elke browser of de gratis Dyzle-app. Wij nemen de volledige verantwoordelijkheid voor alle verbindingen, zodat uw IT-afdeling zich kan richten op andere prioriteiten. Benieuwd naar wat Dyzle voor uw ziekenhuis kan betekenen, of wat u kunt besparen ten opzichte van uw huidige leverancier? Stuurt u mij vooral een berichtje op LinkedIn, ik adviseer u graag. #ziekenhuisapotheek #temperatuurbewaking #ziekenhuis #gezondheidszorg #NVZA

Unser Leiter Marketing geht für 5 Monate in Elternzeit. Und ich bin ehrlich: Ich bin zwiegespalten. Auf der einen Seite – und das ist mir fachlich und persönlich extrem wichtig – brauchen wir genau das: Mehr Männer in Elternzeit. Mit mehr als den üblichen zwei Monaten. Mehr echte Aufteilung von Care-Arbeit. Mehr Übernahme von Verantwortung für die Familie. Mehr strukturelle Gleichberechtigung, damit Frauen in Führung nicht dauerhaft den Preis zahlen. Leider habe und hatte ich trotzdem ein unternehmerisches ABER, bei dem ich mich selbst sehr hinterfragen und challengen musste: Wir sind ein wachsendes Unternehmen in der Aufbauphase. Keine Position ist „einfach ersetzbar“. Schon gar nicht eine Schlüsselrolle wie die Führungsposition im Marketing mit Verantwortung für Markenaufbau und Vertriebsthemen. Und genau hier entsteht dieses unangenehme Spannungsfeld: Zwischen dem, was gesellschaftlich richtig ist und ich aus weiblicher Sicht mit der Erfahrung von zwei Elternzeiten und dem Spannungsfeld Familie und Karriere und dem, was unternehmerisch einfach gerade echt weh tut. Natürlich haben wir es möglich gemacht. Wir haben früh und ehrlich kommuniziert, alles strategisch geplant und.. Gott sei Dank... wir haben eine tolle Vertretung gefunden. Aber: Das war auch Glück. Es hat uns gefordert. Organisatorisch, emotional und strategisch. Was mich daran am meisten beschäftigt? Meine Ambivalenz. Dass ich gleichzeitig voll dahinter stehe(n) will – und mich trotzdem dabei ertappe, wie ich mir denke: „Warum ausgerechnet jetzt? Muss das sein?“ Das ist genau der Punkt, über den wir ehrlicher sprechen sollten: Gleichberechtigung ist nicht nur ein Wert. Sie ist im Alltag manchmal verdammt unbequem, sogar für Feministinnen. Und genau deshalb braucht sie mehr als schöne Worte. Sie braucht Klarheit, Offenheit, Organisation, Struktur und Mut. Wie geht ihr in euren Unternehmen mit genau solchen Spannungsfeldern um? #elternzeit #carearbeit #femaleleadership #drvn #newworkinhealthcare #gleichberechtigung

Männer bringen ihr Auto zur Inspektion. Ihren Körper nicht. Ich habe das Gefühl, viele Männer kümmern sich besser um ihren Wagen als um ihre Gesundheit. Ölwechsel? Natürlich. TÜV? Selbstverständlich. Regelmäßige Wartung? Keine Diskussion. Aber Vorsorgeuntersuchung? „Brauche ich nicht.“ Blutwerte? „Mir geht's doch gut.“ Schlechter Schlaf? Mehr Kaffee. Stress? Augen zu und weiter. Und zum Arzt gehen viele Männer erst, wenn gar nichts mehr geht. Ich übrigens früher auch. Bis mir klar geworden ist: Gesundheit ist kein Zeichen von Schwäche. Sondern Verantwortung. Vor allem, wenn man Familie hat, Mitarbeiter führt oder Leistung bringen möchte. Wir Männer reden gerne über Performance. Aber echte Performance beginnt nicht im Gym. Sondern mit Prävention. Deshalb bin ich überzeugt: Check-ups und Gesundheitsvorsorge sollten für Männer genauso selbstverständlich sein wie die Hauptuntersuchung beim Auto. Oder wie seht ihr das? #Männergesundheit #Longevity #Prävention #DRVN

𝐃𝐮𝐫𝐟𝐭 𝐮𝐰 𝐳𝐢𝐞𝐤𝐞𝐧𝐡𝐮𝐢𝐬 𝐧𝐢𝐞𝐭 𝐨𝐯𝐞𝐫 𝐭𝐞 𝐬𝐭𝐚𝐩𝐩𝐞𝐧 𝐧𝐚𝐚𝐫 𝐞𝐞𝐧 𝐦𝐨𝐝𝐞𝐫𝐧𝐞 𝐨𝐩𝐥𝐨𝐬𝐬𝐢𝐧𝐠 𝐯𝐨𝐨𝐫 𝐭𝐞𝐦𝐩𝐞𝐫𝐚𝐭𝐮𝐮𝐫𝐛𝐞𝐰𝐚𝐤𝐢𝐧𝐠? 𝐃𝐢𝐭 𝐳𝐢𝐣𝐧 𝐝𝐞 𝐫𝐢𝐬𝐢𝐜𝐨'𝐬. Veel ziekenhuizen werken al jaren met hetzelfde systeem. Het systeem doet in principe wat het moet doen en modernisering staat niet op de agenda. Maar onder de oppervlakte speelt er vaak iets anders. Medewerkers weten dat het beter kan. Dataverlies is geen uitzondering, alarmen zijn niet in te richten in lijn met de eigen werkprocessen en de validatie van het systeem is niet aantoonbaar geborgd. De onvrede is er, maar de drempel om te veranderen lijkt groter dan de problemen zelf. De urgentie om te handelen ontbreekt nog. Wat wij in de praktijk zien, is dat verouderde systemen op meerdere fronten kwetsbaar worden. Onderdelen zijn niet meer leverbaar en vervanging wordt kostbaar. Functionaliteiten die jarenlang voldeden, sluiten niet meer aan op de huidige regelgeving. De validatiestatus is steeds moeilijker aantoonbaar te houden. En de mensen met kennis van zowel de hardware als de software zijn mogelijk al lang niet meer betrokken bij de ontwikkeling en het onderhoud van dat systeem. Dan is niets doen geen optie meer. 𝐖𝐚𝐭 𝐚𝐥𝐬 𝐝𝐞 𝐨𝐯𝐞𝐫𝐬𝐭𝐚𝐩 𝐦𝐢𝐧𝐝𝐞𝐫 𝐢𝐧𝐠𝐫𝐢𝐣𝐩𝐞𝐧𝐝 𝐢𝐬 𝐝𝐚𝐧 𝐯𝐞𝐫𝐰𝐚𝐜𝐡𝐭? Dyzle begeleidt ziekenhuizen van de eerste schouw tot aan de uiteindelijke validatie. Compleet met alle validatie documentatie die u nodig heeft en onboarding met certificering voor uw personeel. Waar het oude systeem werd ervaren als een last en een risico, is onze oplossing gebouwd om het ziekenhuispersoneel te ondersteunen en werk uit handen te nemen. Zodat uw mensen meer tijd hebben voor waar het echt om gaat: de patiënt. #ziekenhuisapotheek #ziekenhuis #temperatuurbewaking #gezondheidszorg #NVZA

𝗪𝗵𝘆 𝗛𝗼𝗺𝗲 𝗖𝗮𝗿𝗲 𝘀𝗵𝗼𝘂𝗹𝗱 𝗺𝗮𝘁𝗰𝗵 𝘁𝗵𝗲 𝗴𝗿𝗼𝘂𝗻𝗱 𝗯𝗲𝗻𝗲𝗮𝘁𝗵 𝗶𝘁 We all read the same aging maps with the percentage 65+, growth curves, dependency ratios. Useful, but incomplete. As Alfred Korzybski warned, 𝘵𝘩𝘦 𝘮𝘢𝘱 𝘪𝘴 𝘯𝘰𝘵 𝘵𝘩𝘦 𝘵𝘦𝘳𝘳𝘪𝘵𝘰𝘳𝘺: what wins in home-based care is how aging shows up block by block. In some cities it stacks vertically, in others it sprawls horizontally, or clusters, or climbs stairs. When you match your model to the territory, it unlocks local connection that allows for trusting relationships to be the force multiplier for scaling care. Aging percentages tell you 𝘸𝘩𝘰; city geometry helps tell you 𝘩𝘰𝘸 𝘵𝘰 𝘳𝘦𝘢𝘤𝘩 𝘵𝘩𝘦𝘮. When your ops mirror the territory’s structure, the “map error” shrinks, and conversion speed, starts of care, and family trust rise. The way people age is shaped by the city itself, different geometries, same reality: aging isn’t uniform, and care models that ignore geography face challenges in adapting their operations. • In 𝗧𝗼𝗿𝗼𝗻𝘁𝗼, it stacks vertically, as the population and immigration boom was largely built on post-war planning, which led to “tower-in-the-park” apartment blocks across the inner suburbs and now has 489 high-rise retirement community buildings housing ~70,000 older adults. By 2041, ~42% of older adults in Toronto are projected to live in “vertical communities.” • In 𝗝𝗮𝗰𝗸𝘀𝗼𝗻𝘃𝗶𝗹𝗹𝗲, it sprawls horizontally, at ~874 sq mi with relatively low density, the city spreads need across distance. One of the largest U.S. cities by land area, its auto-first infrastructure (I-95, I-10, I-295) led to its aging population being dispersed across ever-expanding subdivisions. • In 𝗦𝘆𝗱𝗻𝗲𝘆, it follows rail corridors. The city’s ring of national parks, ridges, and waterways limits outward sprawl, so the city expanded homes and services along existing rail corridors. Older residents concentrate along these train corridors and inner bayside suburbs. • In 𝗔𝗺𝘀𝘁𝗲𝗿𝗱𝗮𝗺, it’s about climbing stairs, as centuries of narrow canal houses, taxed by frontage, left Amsterdam with steep, space-saving stairs. Aging residents are forced to deal with most homes having walk-ups and stairs throughout. To reach people where they are, operations need to mirror the terrain: • Tune your teams to the shape of the city, not just the size of demand. • Build connection systems, not templates; local trust scales faster than distance. • Keep updating your map, because the territory is always changing. At Dovida, our 𝗖𝗶𝗿𝗰𝗹𝗲 𝗼𝗳 𝗖𝗮𝗿𝗲 connects families, healthcare professionals, caregivers, and our local office support teams so we can tune the connection pattern to each city’s shape. Same service quality, different routes to reach people fast. Care doesn’t scale by ignoring the local community; it scales by fitting the ground beneath it. Read more about our Circle of Care here: https://lnkd.in/ebrZFWgZ

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𝗪𝗵𝘆 𝗱𝗼𝗲𝘀 𝗘𝘂𝗿𝗼𝗽𝗲'𝘀 𝗰𝗼𝗺𝗽𝗲𝘁𝗶𝘁𝗶𝘃𝗲𝗻𝗲𝘀𝘀 𝗺𝗮𝘁𝘁𝗲𝗿 𝘁𝗼 𝗺𝗲? Not because of rankings. Not because of economic indicators. But because of people. One of the most rewarding aspects of leadership is 𝘀𝗲𝗲𝗶𝗻𝗴 𝗽𝗲𝗼𝗽𝗹𝗲 𝗴𝗿𝗼𝘄. Whether it's a young scientist taking on their first project, an experienced colleague mentoring others, or teams solving complex challenges together – innovation has always been driven by people. As leaders, we often talk about strategy, performance and results. But I believe our responsibility goes further. It is about creating an environment where people can develop, collaborate, and make a meaningful contribution. Europe has much to build on: world-class science, outstanding universities and highly skilled professionals. Today, the research-based pharmaceutical industry supports more than 𝟮.𝟯 𝗺𝗶𝗹𝗹𝗶𝗼𝗻 𝗷𝗼𝗯𝘀 across Europe.* Behind these numbers are colleagues working across research, manufacturing, supply chain, medical, commercial and many other functions – all united by one common purpose: improving patients' lives. This is why Europe's competitiveness matters to me: Because a competitive Europe creates opportunities. ◾ Opportunities for scientists to pursue breakthrough research. ◾ For young professionals to build meaningful careers. ◾ For experienced colleagues to mentor the next generation. And ultimately, 𝗼𝗽𝗽𝗼𝗿𝘁𝘂𝗻𝗶𝘁𝗶𝗲𝘀 𝗳𝗼𝗿 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀 𝘁𝗼 𝗯𝗲𝗻𝗲𝗳𝗶𝘁 𝗳𝗿𝗼𝗺 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻. That is why we need to continue creating the conditions that allow great people to do great work: investing in research, fostering collaboration, and reducing unnecessary bureaucracy. 𝗜𝗻 𝘁𝗵𝗲 𝗲𝗻𝗱, 𝗶𝘁 𝗶𝘀 𝗽𝗲𝗼𝗽𝗹𝗲 𝘄𝗵𝗼 𝗶𝗺𝗽𝗿𝗼𝘃𝗲 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀' 𝗹𝗶𝘃𝗲𝘀. 𝗢𝘂𝗿 𝗿𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗶𝘀 𝘁𝗼 𝗰𝗿𝗲𝗮𝘁𝗲 𝘁𝗵𝗲 𝗰𝗼𝗻𝗱𝗶𝘁𝗶𝗼𝗻𝘀 𝘁𝗵𝗮𝘁 𝗮𝗹𝗹𝗼𝘄 𝘁𝗵𝗲𝗺 𝘁𝗼 𝗱𝗼 𝘁𝗵𝗲𝗶𝗿 𝗯𝗲𝘀𝘁 𝘄𝗼𝗿𝗸. *EFPIA, source in comments

𝗩𝗲𝗿𝗸𝗹𝗲𝘂𝗿𝗶𝗻𝗴𝗲𝗻 𝘁𝗶𝗷𝗱𝗲𝗻𝘀 𝗲𝗲𝗻 𝗯𝗲𝗵𝗮𝗻𝗱𝗲𝗹𝗶𝗻𝗴 𝗺𝗲𝘁 𝗰𝗵𝗹𝗼𝗼𝗿𝗵𝗲𝘅𝗶𝗱𝗶𝗻𝗲 𝘇𝗶𝗷𝗻 𝗲𝗲𝗻 𝘃𝗲𝗲𝗹𝗯𝗲𝘀𝗽𝗿𝗼𝗸𝗲𝗻 𝗼𝗻𝗱𝗲𝗿𝘄𝗲𝗿𝗽 𝗶𝗻 𝗱𝗲 𝗱𝗮𝗴𝗲𝗹𝗶𝗷𝗸𝘀𝗲 𝗽𝗿𝗮𝗸𝘁𝗶𝗷𝗸. 𝗠𝗮𝗮𝗿 𝘄𝗲𝗹𝗸𝗲 𝗳𝗮𝗰𝘁𝗼𝗿𝗲𝗻 𝘀𝗽𝗲𝗹𝗲𝗻 𝗱𝗮𝗮𝗿𝗯𝗶𝗷 𝗲𝗶𝗴𝗲𝗻𝗹𝗶𝗷𝗸 𝗲𝗲𝗻 𝗿𝗼𝗹, 𝗲𝗻 𝗵𝗼𝗲 𝗸𝘂𝗻 𝗷𝗲 𝗽𝗮𝘁𝗶𝐞̈𝗻𝘁𝗲𝗻 𝗵𝗶𝗲𝗿𝗶𝗻 𝘇𝗼 𝗴𝗼𝗲𝗱 𝗺𝗼𝗴𝗲𝗹𝗶𝗷𝗸 𝗯𝗲𝗴𝗲𝗹𝗲𝗶𝗱𝗲𝗻? Vanuit die vraag werkte ik recent een clinical case uit tijdens de initiële therapie (parodontale behandeling) met Perio•Aid en de inzet van VITIS Anti-stain. Deze casus laat zien: - Hoe mondhygiëne, patiëntgedrag (zelfzorg) en de gekozen mondverzorgingsroutine elkaar gedurende het behandeltraject beïnvloeden. - Dat veranderingen in één van deze factoren impact kunnen hebben op het behandelresultaat. - Dat behaalde resultaten altijd binnen de juiste context moeten worden geïnterpreteerd. Een belangrijke nuance is dat de patiënt gedurende de behandeling een goede mondhygiëne handhaafde. De verkleuringen bleven beperkt, waardoor geen uitspraken kunnen worden gedaan over het effect van VITIS Anti-stain als afzonderlijke factor. Binnen deze casus maakte VITIS Anti-stain deel uit van de mondverzorgingsroutine waarbij de patiënt weinig last had van verkleuringen en het product positief beoordeelde. Benieuwd naar de volledige bevindingen en de praktijkoverwegingen? Download de clinical case hier: https://lnkd.in/euQc2yxx

Tumor response endpoints influence some of the most critical decisions in oncology clinical development. They inform go/no-go decisions, anchor regulatory submissions, and, ultimately, can decide how quickly patients gain access to promising therapies. But while RECIST 1.1 gives us a clear framework for assessing tumor response, real-world data rarely follows its tidy timelines. In my latest white paper with Cytel, co-authored with guillaume HERVE and Ophélie Calas-Zeroug, we explore the nuances behind how confirmed best overall response (BOR) is derived in practice. We look into where RECIST 1.1 leaves room for interpretation, the programming and interpretation challenges sponsors face, and why documenting assumptions early can ensure consistency, traceability, and regulatory confidence. Read the full white paper now via the link below 👇 https://lnkd.in/e7hJDBMx

Our positive Phase 3 Emerge results are an important milestone for Definium, but they also hold the potential to stand for something much bigger. In my latest edition of Forward Focus, I ask whether the standards we've long used to measure success in psychiatry are ambitious enough—and whether the field is ready to aim higher than incremental gains. Read more about the inflection point we’re standing within here: https://bit.ly/4vj7WOv #MentalHealth #DefiniumTherapeutics #Psychedelics #HealthcareInnovation #MDD #Depression

Data Monitoring Committees (DMCs) are an essential safeguard for patients in drug development — but they’re rarely discussed as a financial decision. They should be. A DMC costs a fraction of a study’s budget, yet a well-designed one can cut months from a development timeline, and redirect key resources away from a trial whose answer is already clear. Design one poorly, however, and it’s money wasted on an insurance you won’t use. So what does a successful, cost-effective DMC look like? In my article with Cytel, I set out the ten components of the cost-effective DMC. You can read it now via the link below 👇 https://lnkd.in/gv5PQAFR If you want to learn more, you can also watch my webinar, “Maximizing the Value of the DMC: A Cost-Effective Approach to Safeguarding Clinical Development”, on-demand via the link at the bottom of the article.

💡#Causation is better than correlation! Join me and Lexogen's Filippo Passardi for a deep dive into #LiveSeq in practice. With the #FluidFM OMNIUM we collect a tiny cytoplasmic #biopsy while keeping cells alive, then profile ultra-low RNA inputs with #LUTHORHD. Result: same cell, time-resolved trajectories instead of snapshots. ⏳When? Oct 29th (3 PM CET / 10 AM ET). Can’t attend live? Register anyway to get the recording. 👉 https://lnkd.in/dxSnDXjE #SingleCell #RNAseq #SameCell #Webinar

🔬 Precision medicine is advancing rapidly, bringing transformative therapies to market that can dramatically improve patient outcomes. NTRK therapies show up to a 75% overall response rate in NTRK fusion-positive tumors, with a duration of response up to 35 months and progression-free survival of 28 months. So why are patients still missing out on these therapies? The problem isn’t the science. 📙Precision Medicine Needs a New Commercial Playbook At a very basic level, success in precision medicine depends on the coordinated efforts of three key stakeholders each with their own focus: 1. Biopharma: Drives innovation by developing and launching new therapies. 2. Labs: Advance diagnostic capabilities and efficiency. 3. Physicians: Diagnose and treat patients. To realize precision medicine’s potential, we must boost testing, raise biomarker awareness, and connect therapies to eligible patients. This demands coordinated effort & behavioral change – which is often under-resourced and hard to incentivize. ⚠️ Without early alignment, testing lags - and patients miss out. 📩Innovation Overload: The Engagement Challenge Physicians face a constant influx of new therapies, protocols, and guidelines – all while staying focused on patient care. Static, generic education often gets ignored. To truly engage, education must be timely, relevant, and actionable. 🎯The Ideal Precision Commercialization Model Launching targeted therapies presents unique challenges, but also unique opportunities. 🧠 Imagine a world where you have testing data at your fingertips. You have a clear strategic roadmap and a partner to help you execute your tactics. You know where eligible patients are being treated and who they’re being treated by. You can engage pathologists, labs, and physicians on who, how, and when to test. Better yet, you can provide them with peer-to-peer support to further drive awareness. That’s the goal. 💡 A new commercialization model for precision medicine must: - Engage all key stakeholders to accelerate test readiness and biomarker awareness before launch. - Apply a precision lens to commercialization - focusing on both the testing and the treatment. - Use real-world data (RWD) to identify eligible patients and guide engagement: tailored, timely, data-driven digital with complementary personal engagement. - Track the success of tactics across engagement, testing rates, conversion, and adjust accordingly. 💸 And ideally a new model needs to achieve all this for a fraction of the cost required by traditional models! Great medicines aren’t reaching their true potential. This isn’t just a commercial imperative, it’s critical for patients. Every missed test is a potential missed patient. 🚀Let’s build the future of precision medicine together! 💬 Share your thoughts, experiences, or perspectives in the comments. #PrecisionMedicine #RealWorldData #PatientImpact #Diaceutics

🚦How do we turn budget roadblocks into commercialization green lights? As the industry moves toward increasingly tailored treatments, it’s clear that traditional commercialization models aren’t necessarily suitable to support precision medicines. To truly unlock the potential of precision medicine, we must apply a precision lens to commercialization itself. If the patient population is more specific, shouldn’t the commercial strategy and tactics be too? 💰Traditional Commercialization is too expensive Traditional commercialization relies on broad campaigns, large sales teams, and extensive infrastructure, often costing up to and over $1 billion annually, especially in launch years. While this may work for blockbuster drugs, it’s misaligned with the needs of precision therapies targeting narrower populations. For biotechs and smaller pharma, these costs can be prohibitive but by leveraging the right data, strategies, and targeted engagement capabilities, it doesn’t have to be. 💸 Targeted Commercialization Is More Effective and Cost-Efficient Targeted commercialization uses real-world data and analytics to understand, engage and prepare the market for testing, finding patients and engaging physicians and labs in a relevant, timely and tailored way. This means resources are focused where they have the greatest impact, reducing spend on low-yield activities. ⌛Targeted commercialization enables “just-in-time” engagement - reaching stakeholders at the exact moment they are making testing or treatment decisions. This increases the likelihood of therapy adoption and ensures that educational resources are delivered when most relevant. Instead of front-loading costs, targeted commercialization aligns investment with product milestones and commercial success. When you partner you can pay for results, not just for tactics. This approach is especially valuable for smaller biotechs and pharma where preserving the cash runway is critical and where every dollar counts. 🧠 A Smarter Path Forward: Precision Commercialization At Diaceutics, we advocate for an approach that is: Data-driven: Leveraging real-world data to identify eligible patients, guide engagement, and track adoption. Targeted: Reaching the right physicians, pathologists, and labs at the right time, with the right message through digital and personal peer-to-peer channels. Cost-effective: Delivering measurable impact at a fraction of traditional costs. With room for alternative commercial models e.g. milestone/success based pricing. Diaceutics has developed a commercialization model designed to drive testing, promote biomarker awareness, accelerate therapy adoption, and deliver impact - without the blockbuster price tag. Because every missed test could mean a missed patient. And every missed patient is a missed opportunity to improve a life. 🚀Let’s build the future of precision medicine together! #PrecisionMedicine #RealWorldData #PatientImpact #Diaceutics

Today we’re celebrating an important step forward! CEA has officially become Decera Clinical (deh-SAIR-uh), The Scientific Activation™ Company. This new identity reflects the organization we’ve grown into over the past 25 years — one that unites accredited education, actionable insights, and medical communications to help move healthcare professionals from evidence to action. By decoding complex science, Decera Clinical supports better decisions, stronger partnerships, and improved patient care. Our aligned expertise comes to life through three divisions: ✅ Decera Clinical Education, accredited CME and CE ✅ Decera Clinical Insights HCP insights and scientific exchange ✅ Decera Clinical Communications, medical communications and scientific engagement I’m grateful to work alongside such dedicated colleagues, faculty, and partners who make this mission real every day. I'm excited about the impact we’ll make together. Learn more: https://lnkd.in/e9j825Dp

Today the company I was fortunate enough to join just a few weeks ago is celebrating an important step forward! CEA has officially become Decera Clinical (deh-SAIR-uh), The Scientific Activation™ Company. I could not be more proud to have joined such a smart, enthusiastic and motivated group of professionals. Our new identity reflects how the organization has grown over the past 25 years — one that unites the expanding use of Artificial Intelligence, Accredited education, Actionable insights, and Medical communications to help move healthcare professionals from evidence to action. By decoding complex science, Decera Clinical truly supports better decisions, stronger partnerships, and improved patient care. Our aligned expertise comes to life through three divisions: ✅ Decera Clinical Education, accredited CME and CE ✅ Decera Clinical Insights HCP insights and scientific exchange ✅ Decera Clinical Communications, medical communications and scientific engagement I’m grateful to work alongside such awesome colleagues, faculty, and partners who make this mission real every day. I'm am really excited about the impact we’ll make together. Learn more: https://lnkd.in/eVVeXay9