Christine Senn, PhD

How can sponsors prioritize diversity and inclusion of underrepresented populations in clinical trials and adhere to new guidelines from the U.S. Food and Drug Administration? Learn about strategies and recommendations for success in our latest publication: https://lnkd.in/egiDZtEg #ClinicalTrialInclusion #ClinicalTrialDiversity #ClinicalTrials

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Rho's latest blog post, by Kimberly Koehn, PhD, features recommendations on how to present a product's benefit-risk assessment within FDA's own structured benefit-risk format as part of your marketing application. Have you thought about this for your product(s) in development? Check it out here: https://bit.ly/3yD9V8y

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Using #geneticengineering in decentralized trials adds complications to IRB risk evaluations and overall participant safety efforts. Learn ways to approach these challenges in our September 17 webinar:

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📚 Congratulations to Elsevier Senior Acquisitions Editor Linda Buschman and book editors Batoul Farran (Albert Einstein College of Medicine) and Ganji Purnachandra Nagaraju (The University of Alabama) for the release of "Immune Landscape of Pancreatic Cancer Development and Drug Resistance". This important reference book covers immune-based therapies for pancreatic cancer. It explores the latest advances in rewiring tumor microenvironments and targeting pancreatic cells to improve survival rates. With a focus on therapeutic methods and immune targeted approaches, this book is a must-read for health professionals, scientists, researchers, and students interested in immunotherapy for pancreatic cancer. Key Features: 🔍 Summarizes combination strategies and clinical trials in pancreatic cancer 🔍 Provides an in-depth overview of pancreatic cancer development and immune features 🔍 Explores new immune-based therapies for targeting pancreatic cancer 🔍 Covers tumor microenvironments and immunotherapy strategies in pancreatic cancer progression This book is perfect for Graduate students and Researchers in cancer research, Oncologists, and Clinicians. #PancreaticCancer #Immunotherapy #Research #BookRelease

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Discover the latest enhancements to Labcorp Global Trial Connect, designed to streamline site workflows and boost clinical trial efficiency. These updates, driven by insights from collaboration with sponsors and sites, aim to empower investigator sites to focus more on what truly matters, patient care. Your commitment to patient care is why we’re committed to redefining clinical trial delivery. Learn more: https://lnkd.in/eavYncMz #ClinicalTrials #GlobalTrialConnect

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In #NeurodegenerativeDisease news, specifically on an experimental treatment for #ALS, with this new #strategic partnership is penned between Dewpoint Therapeutics and Mitsubishi Tanabe Pharma America. ⚛️ The asset is the former's drug, designed "to address the accumulation of a protein into toxic structures that lead to neuronal dysfunction in people with ALS." 🤝 The alliance would grant MTP exclusive rights to license, upon achieving certain developmental milestones. ⚕️ This would add to MTP's existing US-marketed ALS treatment, #Radicava https://lnkd.in/evayrVv4' #Dewpoint #Mitsubishi #Pharma #Biopharma #Healthcare

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#CDER’s Emerging Drug Safety Technology Meeting Program (EDSTM) -- in this conversation, Robert Ball, M.D., M.P.H., ScM, Deputy Director of CDER’s Office of Surveillance and Epidemiology, explains the EDSTM program and the application of #AI in #Pharmacovigilance based on his experience of more than a decade researching and developing AI systems in PV. https://lnkd.in/eRg7K7GB #FDA #DrugSafety #PV

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WEBINAR TOMORROW! Register here today: https://lnkd.in/eDG5Ba98 Bridging the gap between RWD and clinical trials In this #webinar from The Evidence Base®, Bruce Feinberg, DO, Richard Scott Swain, PhD, MPH and Tammy Schuler, Ph.D. of Cardinal Health will explore the critical limitations of #clinicaltrials and discuss how robust methods can bridge the gap between real-world and clinical trial data. #heor #healtheconomics #outcomesresearch #rwe #rwd #realworldevidence #realworlddata #marketaccess #pharma #biopharma #medicalaffairs #regulation #regulatoryaffairs #hta #healthtechnologyassessment #healthdata

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In this episode of the #ParexelBiotech podcast series, "De-Risking Drug Development," we focus on the pre-approval phase of drug development, where commercial launch planning should be started 2 - 3 years before marketing authorization. Learn why it's critical to start early and approaches biotechs should be implementing, especially those with a first-time launch. Listen now: https://lnkd.in/gCjE2KAy #DrugDevelopment #Biotech #LaunchExcellence #ClinicalDevelopment

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Oncology clinical trials are crucial for advancing cancer treatment and can help patients get access to cutting-edge therapies. Yet, the latest data show that the clinical trial enrollment rate for patients with cancer in the U.S. is just 7%. At Private Health Management, we understand the clinical and scientific complexity of identifying and prioritizing appropriate trials, as well as other barriers to access. In PHM’s new whitepaper, “The Importance of Clinical Trials in Cancer Care,” my colleagues, Natalya Gertsik, PhD, Tommy Axford, and I discuss how PHM’s approach to clinical trials can help to ensure access for all patients and present an analysis of clinical trial enrollment for our cancer patients over the last decade. Remarkably, the enrollment rate for PHM patients with cancer is 25% — nearly four times the rate of the general population. Patients across all cancer stages and over 20 cancer types enrolled in trials, demonstrating PHM’s commitment to ensuring access for all patients, even when few trials are available. By identifying suitable trials, supporting logistical needs of providers and patients, and educating patients about clinical trials, PHM helps overcome obstacles surrounding clinical trial access. Learn more here: https://lnkd.in/gz-3gaVP #clinicaltrials #employeehealth #cancer #oncology #healthequity #clinicalresearch #cancercare #employerbenefits #employerhealthplans

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“An Influential Drug Industry Expert”? So 340B Report described me in discussing my remarks at the Association for #ValueBased #Cancer Care on whether the rebate model is “dead”—or just headed to litigation. Bella Czajkowski’s provocative article is in the comments. (And Bella, your check is in the mail for that description of me—ha!) I don’t have any inside info on Johnson & Johnson’s plans, but I just have to imagine, as I read their response to the Health Resources and Services Administration (HRSAgov), HHS that it sounds like a strategic pause to provide enough time to draft and file a compliant. And, even if #JNJ wouldn’t push the button on a litigation salvo, why wouldn’t others? It’s a litigation no brainer given the scope of #340B expansion, the inability of contract #pharmacy policies to stem the tide, the creep of “#patient definition”, the emergence of triple and quadruple “discounts”, and the risk this all gets that much worse as soon as #Medicare “fair price” duplicates get dialed into this already unbalanced equation. Win or lose, how is this a case someone (or many someones) doesn’t file? I want to emphasize 2 points from the article: 1) “Sarraille argued that in the debate around cashflow, the rebate model could potentially be more beneficial to #coveredentities that would not have to use a certain quantity of drugs to submit a chargeback. ‘The covered entity doesn’t have to wait to accumulate a big enough package of drugs in order to submit a chargeback, as they do under the current system. Under a rebate system, they can get their money without accumulation on every individual unit as soon as it’s used,’ he said.” In the right hands, payment can come in just 7 days. We can make this work. 2) I’m willing to put my litigation prediction to the steak dinner test: “‘Anyone who wants to pay for a steak dinner for me sometime next month, you feel free to come up here. I’m going to take your money, and I’ll take your steak,” he said.’” Text me. BTW, my fav is a 10 inch filet mignon, butterfly cut, lots of butter. Association for Value-Based Cancer Care

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Recent news about counterfeit HIV medications highlights a persistent danger in our pharmaceutical supply chains. This issue goes beyond brand protection - it's a direct threat to consumer health and safety. Key challenges: 1. Consumers, the end-users, are disconnected from the supply chain. 2. There's no reliable way for consumers to verify a product's authenticity. 3. Current systems lack a secure, tamper-proof link between physical items and digital verification services. The root of the problem? The absence of a non-mutable, tamper-proof hyperlink connecting the physical product to the manufacturer's digital verification services. A potential solution: Hmidtags.com has developed technology to address this critical gap. Their system creates a secure bridge between physical products and digital verification, empowering consumers to authenticate their medications. As we move forward, it's crucial that we explore and implement innovative solutions to protect public health and maintain trust in our pharmaceutical supply chains. What are your thoughts on this issue? How can we better involve consumers in the verification process? #PharmaceuticalSafety #SupplyChainSecurity #ConsumerProtection #HealthTech #Gilead https://lnkd.in/e7DMd-X3

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In today's edition of the NPC Healthbiz Weekly newsletter from the National Pharmaceutical Congress: The #pharmaceutical industry faces a critical challenge: delivering medicines to the world's poorest populations. While successful in many areas, our current approaches fall short in addressing global health disparities. Some key considerations: 1. Rethink global access strategies 2. Invest in infrastructure in developing regions 3. Apply lessons from Covid-19 vaccine distribution So, here's a question: Looking at the challenges of 2025, isn't it time the industry innovated its approach to ensure life-saving therapies reach those who need them most, regardless of geography or economic status? NPC Healthbiz Weekly is created by Chronicle Companies. Let us know what you think. https://lnkd.in/g-CQaGNb #lifesciences #leadership #pharmainnovation #globalhealth

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The Innovation and Value Initiative has rebranded as the Center for Innovation & Value Research, reflecting a renewed commitment to patient-centered #HTA and equitable health care. Read at The Evidence Base® #heor #healtheconomics #outcomesresearch #rwe #rwd #realworldevidence #realworlddata #marketaccess #healthtechnologyassessment #healthdata #healthequity #healthpolicy

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Exciting news! Our Site Network is expanding and we're thrilled to welcome new members! Join our dynamic and collaborative network of research sites and unlock a world of opportunities. Our Site Network is growing since Q1 2024 and we now have locations in 📍Atlanta (Marietta), 📍Atlanta Metro, and 📍Memphis (Tri-state area). Collaboration within our site network allows for resource sharing and expertise in several ways. 📌 Site Network Consultation Fee 📌 First study within first 90 Days 📌 PI/Sub-I/CRC training By joining our site network, you gain access to a multitude of benefits: 1. Resource Sharing: Tap into a vast pool of shared resources, including state-of-the-art equipment, facilities, and technology platforms. Say goodbye to the burden of investing in costly infrastructure as you leverage the collective strength of the network. 2. Expertise Amplification: Connect and collaborate with a diverse group of experienced research professionals. Benefit from the exchange of knowledge, best practices, and innovative ideas. Expand your expertise through shared training sessions and workshops, ensuring you stay at the forefront of clinical research. 3. Streamlined Processes: Leverage standardized processes and SOPs developed collectively by the network. This promotes consistency, quality, and efficiency across research activities. Say goodbye to reinventing the wheel and embrace streamlined operations. 4. Data Powerhouse: Unlock the potential of data sharing and analysis. Pool your data with other sites to conduct comprehensive analyses and generate robust findings. Discover trends, patterns, and safety signals across diverse patient populations, contributing to advancements in medical knowledge. 5. Collaborative Growth: Join a community that fosters collaboration, growth, and continuous improvement. Together, we elevate the standards of clinical research and enhance patient care. Benefit from networking opportunities, mentorship, and professional development programs tailored to your needs. Don't miss out on the chance to be part of a vibrant and supportive clinical research site network. Join us today contact [email protected]

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The the US FDA has just released a new draft guidance on multi-regional clinical trials and how to ensure their representativeness to the US population.   Key takeaways: ✅ Single-country or single-region data no longer sufficient to support a marketing application ✅ Increased focus on U.S. population representation ✅ Emphasis on diverse study sites ✅ Comprehensive evaluation of regional differences Want to know how this affects your oncology clinical trials? Read the below Parexel Regulatory Navigator Blog post from my colleagues Mwango Kashoki MD MPH and Sinan B. Sarac (MD, MSc, PhD) for a deep dive into the new guidance and its implications for oncology drug development. #ClinicalTrials #Oncology #FDA #WithHeart

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If you work in the life sciences industry, you should know EXACTLY what statistical calculations are doing for the clinical trial. I want to help you understand this at its most basic level: Clinical Trials are tools used to show that a new drug is efficacious and safe. Statistics is the tool within the clinical trial that allows us to make these claims objectively. Specifically, statistics is used in a Proof By Contradiction where we first assume something to be true, and we then use data to show that the assumption we made cannot be true. We are using statistics to answer this question: - If there is no difference between two populations, what this the probability of randomly selecting samples with a difference as large or larger than actually observed? Braking this question out in simple steps: 1. Assume no difference between the two treatment samples 2. Collect data on the two treatment samples 3. Calculate the actual difference between the two treated samples 4. Use statistics to calculate how likely we are to get the result we actually got in step 3 if the assumption in step 1 is true (if there truly was no difference between the two groups - what is the chance we randomly sampled and got the difference we got) 5. If the probability is low enough (meaning there is a very low chance we would have been able to get the result we got if the assumption in step 1 was true) we can reject the assumption made in Step 1 and say there is a difference between the two treatment populations If that is not super clear (I don't blame you), here is a more detailed example: 1. I assume the population I give my drug to and the population I give placebo to will have the same systolic blood pressure result at week 2 of the trial 2. I treat the two populations accordingly and I measure the systolic blood pressure at week 2 and I calculate the average blood pressure at that time 3. My calculations of the average systolic blood pressure at week 2 is DIFFERENT at week 2 4. I USE STATISTICS TO CALCULATE THE PROBABILITY OF GETTING THE RESULT I GOT IN STEP 3 ASSUMING THERE ACTUALLY IS NO DIFFERENCE BETWEEN THE TWO POPULATIONS 5. If the calculated probability (also known as a P Value) in step 4 is less than 5% (typically) I can claim that my assumption in step 1 is NOT TRUE It's step 4 where statistics is applied and I have a course coming out in the near(ish) 😎 future that will break down how you actually do step 4 in concert with all the other steps. Until then, I recommend you check out my website (link in Bio) for a ton of free material around biostatistics, statistical programming, and how these two functions work in the regulated industry of the life sciences. Happy Reading and Happy Tuesday.

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In this edition of the New Medicines, Novel Insights newsletter, Stacy Hurt, M.H.A., M.B.A., Chief Patient Officer, Kristina Reeder, Director, Patient Insights, and Nichola Gokool, Vice President, Customer Strategy and Innovation, Medical Communications, review the critical importance of the patient's voice throughout clinical development. Learn why this is so important in oncology trials, steps for understanding and amplifying patient perspectives, and how Parexel experts are tailoring research processes to the people the therapies are intended to serve. Read the full article and subscribe to receive the latest #NovelInsights each week! https://lnkd.in/dS3cti6f #Oncology #PatientsFirst #PatientPerspectives #PatientVoice

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