Marian Cutler

As a rare disease patient, post-trial access as a topic is close to my heart because we often have very limited treatment options. Losing access to a treatment which has been benefitting us as part of clinical trial could even be life threatening. I am proud of the fact that I am part of an organization that is among the first companies to guarantee continued access - called post-trial access - for participants of any clinical trial from the time each patient finishes the trial. If the results show superior efficacy, access is continued until the drug is on the market and reimbursed (where applicable). PS: When a clinical trial ends, it takes months or even years before a drug reaches the market. #inspired #curious #unbossed #access #novartis Paul Aliu Marion Dahlke Michael Steel Goran Mijuk Elizabeth Adamson Marjolein Willemen Neelesh Dongre Hanna Rueggeberg

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Diversity in clinical trials is important because it helps ensure that medical research represents everyone. Check out a candid conversation with a clinical trial participant and doctor below, where they share their perspectives on the importance of diversity in clinical trials. #MerckProud

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In this edition of the New Medicines, Novel Insights newsletter, Paul Bridges chats with clinical experts from Parexel and Health Advances about the critical decision points in the pre-clinical phase that can ultimately determine the success of your product. Learn how these experts are helping biotech companies reduce risk by advocating for better coordination among departments, with a clear patient focus, at the earliest stages. Create success by planning for it ✅ Read the full article below and subscribe for our latest #NovelInsights #ParexelBiotech #ClinicalDevelopment #EarlyPhase #DrugDevelopment

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Driven by a unified purpose to impact the lives of people living with advanced cancers, Novartis is working to create a future where every eligible patient can receive radioligand therapies (RLTs) not just today—but into the future.   Learn more about this commitment to RLT: https://lnkd.in/g8JcTs7A   #ASCO24 #NovartisTogether

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Louis Garguilo, editor, Outsourced Pharma, has published the latest part of his interview with Ali Pashazadeh, CEO, Treehill Partners where Ali details why he things why #biopharmas and #CDMOs need strategic help to focus more on profitability. Ali’s view is that Treehill is needed to provide “consultative, holistic view of #development and #commercialization”. Sponsors often fail to seek important advice from, or listen when formenting development and #manufacturing plans with #CDMOs, regarding the viability of targeting certain #molecules to specific #diseases. Louis asks his readers: 'Do you hold back strategic plans from your development and manufacturing contractors? Do you ask them to offer more strategic (life-cycle) insights?' Would love to know thoughts here, and I'm certain Louis and Ali would! https://lnkd.in/eg2AW7dX

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Excellent post, excellent read. The days of six generations in one workforce are finally here as they've been promising for years, and here's what to consider to build an inclusive culture for all groups.

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New data published last week showcased a major leap forward in cellular immunotherapy, a treatment that could change the way we approach immune-related diseases. Think of this therapy as a guided missile with a twist. It’s not just delivering a payload, it’s a living, adaptable system. These engineered cells are designed to sense disease signals in the body, target them with precision, and act locally to treat the problem without harming healthy tissues. In one study, researchers programmed T cells to calm overactive immune responses by releasing anti-inflammatory molecules exactly where they’re needed, potentially offering new solutions for autoimmune diseases and organ transplant rejection. Another study showed engineered T cells that target and kill brain cancer cells while sparing healthy tissues - a breakthrough for conditions that are notoriously hard to treat. Why does this matter? Unlike traditional therapies that can affect the whole body, cellular immunotherapy can be tailored to work where it’s needed most. This precision reduces side effects and enhances effectiveness, paving the way for safer, smarter treatments for some of the toughest diseases. Check out one of the original articles from Nature Portfolio here: https://lnkd.in/ea8-GEnq #TomorrowsHealthToday

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Excited to kick off preparations for #JPM2025! Don't miss this free webinar with top industry leaders sharing actionable insights to help you navigate the networking and partnering buzz during #JPMWeek. Whether you're a first-timer or a seasoned attendee, you'll walk away with strategies to make the most of your experience. Save your spot today! 📅✨ #Biotech #Networking #BIOatJPM25

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As we draw to the end of the year, the #lifescience, #biopharma, and #CGT industries are reviewing what happened in #2024, and looking forward to #2025. Here, Erin Harris, Chief Editor at Cell & Gene, the Life Science Connect publication, asks 3 KOLs about the outlook for 2025 in the #cellandgenetherapy sector. Miguel Forte, President, ISCT, International Society for Cell & Gene Therapy, and CEO, Kiji Therapeutics, and Vered Caplan, CEO, Orgenesis Inc. "As technology improves, and is doing so rather quickly, we will be better at accelerating the development and improving conditions of adoption and use, making the field delivering value to patients and stakeholders faster.” Miguel Forte, MD, Ph.D. Incorporating the advancements in automation, closed systems, quality control and IT solutions into a standard platform will make POC accessible for many institutes and enable a more efficient approach for the clinical development stage and will lay the basis for enhancing accessibility and reducing costs for commercial stage products.” Vered Caplan https://lnkd.in/eFWHqkpW

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Thank you Mary Lou Jepsen for a great article and also for the commitment to and leadership of open-source innovation with Openwater.health. Biopharma and biotechnology trailblazers, particularly those navigating mid-small-micro cap waters, face tremendous challenges across the board. And, not just in development. Certainly in development stages, the FDA is trying to keep pace with completely new frameworks they must consider and review. Developers must adapt to these learning curves and survive the process. If they do, the challenges often continue after approval. With desperately needed rare disease innovations, such as gene therapies, we are seeing business model issues hit developers and patient access. As the industry turns its attention to the Holy Grail of mass market ultra blockbusters, it's possible, if not probable, that more and more rare disease development programs will get shelved due to seemingly insurmountable challenges. "Go it alone" or waiting for the lucrative deal isn't a realistic option for too many developers. For many of us who care deeply about these underserved populations, throwing up our hands and giving up simply isn't an acceptable option. Patients and their families with few to no options are waiting for their miracle. #raredisease #biotech #innovation

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"How do you act as a good corporate citizen and disclose, without jeopardizing the unknown?" As the closing keynote speaker for the first day of Citeline’s two-day TrialScope EXTRA event, Ali Pashazadeh, CEO, Treehill Partners, discussed a topic frowned upon by the #disclosure experts in the room: #noncompliance. He shared candid insights on #clinicaltrial #disclosure #compliance and its relation to #intellectualproperty (#IP) and #patents. Here's the details published in Citeline.  https://lnkd.in/evcyUc4w

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Clinical research and therapeutic development are moving forward at a lighting fast pace. Among the many advancements, randomization and trial supply management (RTSM) stands out as a critical innovation, fundamentally reshaping how clinical trials are designed, executed, and managed globally. 👀 Read how Oracle is pioneering global RTSM solutions in the latest article by Wissam Kazan, VP of Product and Engineering for Clinical Research. https://lnkd.in/e8xjBPrw #clinicalresearch #clinicaltrials #lifesciences #drugdevelopment

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MLR reviews have to strike a delicate balance between speed and risk. How can you get it right? Leaders from Johnson & Johnson, UCB and Takeda Takeda Oncology deliberated on the topic, the lessons summarized for both Pink Sheet and Scrip CitelineCiteline Regulatory - from the Indegene digital summit. #pharmaceutical #marketing #regulatory #biotech

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What's great about this 500-strong Forbes Diversity list is that it's "based in part on survey results from 170,000 people working for organizations with at least 1,000 employees within the U.S." It's not something companies have to pay to be listed or have to fill out a lengthy survey form to get ranked. Employees know and see the work if the comms are good. But they can *feel* the commitment. Or lack thereof. https://lnkd.in/emqpXTQV

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Great article with long-standing CPHI contributor, and all round pharma legend, Bikash Chatterjee. With more than 40 years of industry experience, it's always fascinating to get Bikash's perspective on market trends and developments. Read on to see how a typical day shapes up for the President and CSO of Pharmatech Associates, a USP company

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Every election cycle, we find the biopharmaceutical industry squarely in the political maelstrom with tens of millions of dollars spent on political ads negatively focused on our industry and what elected officials are going to do about it. Affordability of healthcare broadly, and prescription medicines particularly, is rightly an important topic for voters. However, unlike the fair balance claims that our industry must put in our advertisements, political ads don't come with warnings about the "side effects" of soundbite policy making. I recently shared my thoughts with STAT, offering a perspective on why it’s critical as we head into this year’s election to stay focused on solutions that both lower patient out of pocket costs AND preserve our industry’s ability to significantly invest in new, lifesaving medicines. At Genentech, we have long collaborated with legislators, healthcare leaders and other stakeholders to help address the most difficult health challenges faced by patients today. You can read more about why I believe it’s ineffective to be distracted by political soundbites and what Genentech is doing to advance proactive policy solutions and uphold our commitment to building a healthcare system that works for all Americans. if you are interested to read more, click the link below. 

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