Kathleen Wisemandle, MSLOC, DOEC 🌿

This content is intended for U.S. audiences only. The countdown to Chicago is on, as we gear up for #ASCO24 in less than two weeks! For the first time, @AstraZeneca will headline not one, but TWO back-to-back plenary sessions in LUNG as well as a late-breaking study in BREAST. Our team is focused on treating cancers at earlier stages and across subtypes while advancing medicines and combination therapies that attack the disease from all angles, evidenced by our strong, diverse research to be presented in Chicago. Behind every data point is a patient, who deserves a personalised therapy that will give them a longer and healthier life. For each one, we’re pushing the boundaries of science, and I can’t wait to highlight our research advances in the coming weeks. Stay tuned! 🔬 For a more detailed preview of our #ASCO24 data presentations, please see our press release https://lnkd.in/ehH7tqFc #CancerResearch #oncology #MedicalAdvancements

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As the healthcare industry continues to evolve, one of the most promising areas of innovation is the development of GLP-1-based therapies. These treatments, crucial for addressing conditions such as obesity, type 2 diabetes, and high cholesterol, are currently experiencing a rapid expansion in clinical trials, indicating a robust future pipeline. A standout in this space is Real Chemistry and its Iris platform, which illuminates the significant progress being made across more than 110 active GLP-1 agonist clinical trials. With 53 of these trials in advanced phases, the potential for new therapeutic options is immense, covering over 60 disease states. This progress underscores the need for strong commercial readiness as companies prepare to bring these innovative solutions to market. At Rockland Immunochemicals, Inc. Immunochemicals, and through our brand antibodies-online.com, we are committed to supporting this exciting field. Our teams are actively expanding antibodies and assays that are integral for studying GLP-1 pathways and designing more effective treatments. These tools are not only pivotal for understanding the basic physiology of GLP-1 and its receptors but are also essential in our race to enhance efficacy and minimize side effects. I am enthusiastic about the potential of our GLP-1 antibodies to contribute to improved patient outcomes and am keen to explore how we can leverage these innovations to support the healthcare community further. Discover more about our GLP-1 research tools here:  https://lnkd.in/eUHwvxuU #GLP1 #DiabetesTreatment #ObesityManagement #HealthcareInnovation #ClinicalTrials #RocklandImmunochemicals #AntibodiesOnline

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📨 Potential implications exist in regard to #LCM and #strategies regarding market exclusivity, see below, the latest from the FTC, sending warning letters to ten major pharma companies in an attempt to continue challenging and cracking down on #JunkPatents. 📂 The claims are around 'inaccurate or improper' patents in place which essentially block competition and keep drug prices high. Many big-name prescription brands are included in this round of probes. 2️⃣ 0️⃣ : "The FTC is challenging the patents of 20 different brand name products, claiming that their listings in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations—more commonly known as the Orange Book—are improper or inaccurate." 🤔 Are your brands affected? ❓ How might actions against you or your competitors affect your LCM strategy? https://lnkd.in/eVuapvWJ #LifeCycleManagement #RegulatoryAffairs #Policy #FTC #FederalTradeCommission #OrangeBook #PharmaPatents #AntiTrust #Pharma

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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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For newcomers to clinical research, it can be difficult to break into specialties like CNS or neurodegenerative clinical trials.  Kelley Yokum MD describes how it takes time and perseverance to establish (and invent!) your role. As an industry, welcoming new talent will bring fresh perspectives and new approaches. We need to open our eyes and consider training (and accepting) newcomers in order to solve some of the problems we are facing. ➡️Dr. Kelley Yokum is the Principal Investigator and Co-Owner of K2 Medical Research in Tampa, Florida. Dr. Yokum is a board-certified psychiatrist who oversees clinical trials in schizophrenia, Alzheimer’s disease, anxiety, depression, and memory loss, among others. #clinicaltrials #entrepreneur #clinicalresearch #ichorclinical #perseverance #womeninresearch

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What kinds of study changes and amendments need @IRB review? Check out Advarra's most recent #blog to get a refresher on the basics of what to send for review by the IRB.

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🔍 Companies to Watch for Potential M&As in 2024 🔍 📈 The biopharma sector has witnessed substantial merger and acquisition activity, with six deals exceeding $1 billion so far this year. This trend is expected to continue due to: - Significant revenue loss anticipated from loss of exclusivity (LOE) on major drugs. - Successful biotechs now have the financial capacity to make acquisitions. 🗝️Key Players to Watch: 💼 Vertex Pharmaceuticals ❇️ Financial Strength: Over $114 billion in revenue, $10 billion in cash. ❇️ Recent Acquisition: Completed a $4.9 billion acquisition of Alpine and its lead asset, povetacicept. ❇️ Strategy: Enhance development capabilities in autoimmune and inflammatory diseases. 💼 Regeneron ❇️ Financial Strength: Market cap of $109 billion, $17 billion in cash, $2.7 billion in debt. ❇️ Comparison: Larger market cap than Bristol-Myers Squibb and GSK. ❇️ Recent Acquisitions: Acquired 2seventy Bio and Decibel Therapeutics, expanding oncology and gene therapy pipelines. ❇️ Focus: Investing in innovative solutions for serious diseases. 💼 Biogen ❇️ Financial Strength: $33 billion market cap, strong cash flow. ❇️ Strategy: Primarily focused on neurology but expanding into immunology. ❇️ Recent Acquisition: Purchased HI-Bio for $1.15 billion, adding felzartamab, an anti-CD38 monoclonal antibody, to the pipeline. ❇️ Expansion: Augmenting expertise in immunology. 💼 Moderna ❇️ Financial Strength: $55 billion market cap, over $8 billion in cash from COVID-19 vaccine success. ❇️ Opportunities: Potential to diversify, particularly in new mRNA technologies and cancer vaccines. ❇️ Focus: Growth in mRNA vaccine applications beyond COVID-19. Stay tuned as these companies leverage their financial resources and strategic acquisitions to shape the future of biopharma in 2024! 🚀💊 #Biopharma #MergersAndAcquisitions #Innovation #BiotechFinance

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Being touted as 'practice-changing' and likely a new SOC, AstraZeneca shared data from PIII 'LAURA' in this week's ASCO plenary sessions, showing that #Tagrisso provides an 84% lower risk of tumor progression or death in unresectable EGFRm #NSCLC. How will other drugs fare in this shifting treatment landscape, given AZ's remarkable results? #LungCancer #2024ASCO #Oncology #MedicalAffairs #ClinicalStudies #Pharma #Healthcare

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The FDA has updated its draft guidance, emphasizing the crucial role of Data Monitoring Committees (DMC) in enhancing trial safety and efficacy. This step marks a significant development in ensuring independent and objective review processes, safeguarding participant wellbeing, and maintaining the integrity of clinical trials. Understanding these guidelines is essential for anyone involved in clinical research - from sponsors to trial investigators. #FDADraftGuidance #ClinicalTrials  

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💥Finally! FDA Guidance Provides New Details on Diversity Action Plans This is a major step towards ensuring that studies include participants from historically underrepresented populations. Here's why this matters: ➡️More generalizable results: Diverse trials lead to findings applicable to a wider range of patients. ➡️Deeper understanding: Studying a broader population provides valuable insights into the disease or treatment. ➡️Safer & more effective treatments: Data from diverse populations helps ensure safe and effective use for everyone. The draft guidance outlines: ▪️What a Diversity Action Plan should include ▪️When and how to submit it ▪️How the FDA will evaluate waiver requests This is just one of many efforts to improve diversity in clinical trials. Let's work together to ensure everyone benefits from medical advancements! 📢Want a quick breakdown of the FDA's Diversity Action Plans? I've created a summary to help you navigate the key points. Check it out here: https://lnkd.in/g945QzUv Ina Burgstaller #diversityactionplan #clinicaltrials #healthequity

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Stop what you are doing and watch this episode of Pathfinder with Gopinath Jaganmohan from ConverSight at 16 Tech Innovation District. Gopi's team at ConverSight is developing solutions to address inefficiencies in business intelligence systems. The future of AI, according to Gopi, involves creating intelligent agents that can autonomously perform tasks and make decisions within specified parameters. WATCH NOW 👇

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Totally agree with Josh Bernoff here about naming your book. Catchy (title) plus briefly explanatory (subtitle) is the way to go. https://lnkd.in/gbxU7e7r Grab attention and memory. Then address understanding. Make both intriguing.

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An important update on the #BiosecuresAct, which includes a grandfather clause on existing contracts thru 2032, but this new draft prohibits setting up new agreements or extending existing ones. While balancing national security, also to ponder is "the potential fallout could have negative impacts on the supply chains of several drugmakers." https://lnkd.in/ebcE6x4w #Policy #Biotech #Innovation #GovernmentalAffairs #Pharma #Healthcare

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Safety. This, to me, is the most important question to be addressed today by the FDA advisory committee on Lykos’s NDA for MDMA. Based on the data they’ve presented - and what they’ve failed to present- they are likely to fare poorly on this area Discussion can be followed live here https://lnkd.in/gdv3ezgp

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Success in a global clinical trial relies heavily on compliance-focused yet collaborative, strategic partners. The key ingredient to groundbreaking treatments truly begins with Advanced Clinical! Mai Mishir and David Turner share expert insights on how to prioritize safety and remain compliant during a clinical trial: https://bit.ly/3yHnDHQ #ClinicalResearch

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FDA’s Endorsement: The Marvel of MRD Minimal Residual Disease (MRD) “Elevating MRD to the Forefront” and Revolutionizing Cancer Treatment Approaches The FDA’s Oncologic Drugs Advisory Committee’s recent meeting in April 2024 has cast a spotlight on Minimal Residual Disease (MRD), underscoring its critical role in the advancement of cancer therapies. Here’s how the FDA’s recognition is reshaping the future: 1. Multiple Myeloma: The FDA’s committee has officially recognized MRD as a valid endpoint for accelerated drug approvals. This pivotal decision by the FDA is a testament to MRD’s potential in changing the treatment paradigm for multiple myeloma. 2. Acute Lymphocytic Leukemia (ALL): MRD serves as a vital prognostic indicator, and the FDA’s stance influences treatment choices and regulatory approvals of new medications. It’s a significant step forward, with the FDA’s backing enhancing the credibility of MRD in clinical settings. 3. Chronic Lymphocytic Leukemia (CLL): The MRD status is integral to treatment planning, and the FDA’s consideration is crucial during the approval process of new treatments. The FDA’s involvement ensures that MRD remains a key factor in CLL therapy strategies. 4. Acute Myeloid Leukemia (AML): MRD is being considered by the FDA as a potential surrogate endpoint in trials, which could expedite the approval of innovative AML therapies. The FDA’s support could pave the way for quicker access to new treatments. These examples underscore the vital role of MRD as a clinical endpoint across various cancer types. It’s not just a measure; it’s a movement towards enhancing patient care and fast-tracking the introduction of innovative treatments. The FDA’s Oncologic Drugs Advisory Committee’s discussions and decisions highlight the indispensable role of MRD, now backed by the FDA’s authoritative support. It’s a monumental stride in enhancing patient care and introducing cutting-edge treatments more swiftly, all through the FDA’s visionary lens. For more details, please contact, sales@oliveridleyadvisory.com #oncology #oncolotrials #clinicaltrials #pharma #drugapproval #FDA #minimalresidualdisease #cancer #approval #aacr #esmo #ash Dr. Simone SeiterMoussa Ahmed AmerMou ChatterjeeAnshu Mittal Roy PhD (She/Her)Reena KhuranaKarnik RampalKriti ArnejaMolekule Consulting LLCDavid AldermanAmaninder Singh DhillonVikas SarangalRicha S.Nidhi DhingraYogesh VadepalliBruno LarvolAmit GuptaDr.Hamid Hasan Faridi, MD MBAMichele SpinettaRobert F. Siegmund, PhD MBASabih BeckDr. Timos PapagatsiasSalvador CarlucciDIWAKAR JHA, M.PHARM, M.B.A

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Exciting times ahead in gene therapy! 🧬✨ Regeneron has just announced a colossal partnership with Mammoth Biosciences, spotlighting a promising future for CRISPR-based in vivo gene editing treatments. This dynamic duo is bringing together Regeneron's state-of-the-art viral vectors and Mammoth's cutting-edge compact nucleases to forge treatments with precision targeting. The deal includes a whopping $100 million upfront with an additional $370 million for milestones, plus royalties. That's a serious investment in next-gen healthcare. Dr. Christos Kyratsous from Regeneron cites years of groundwork laying the foundation for this collaboration, set to align the delivery systems with specific diseases for optimal outcomes. With equity involved and the option for Mammoth to co-fund and profit-share, the deal embodies a true symbiotic spirit. As the second major gene editing stride for Regeneron, after its ongoing work with Intellia Therapeutics, we're witnessing an exhilarating era where the potential for breakthrough therapies is skyrocketing. This is game-changing science with patient lives ready to be profoundly impacted! #GeneTherapy #CRISPR #Innovation #Healthcare

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One for my Diagnostic network - I'm interested to hear thoughts on the FDA's plan to bring LDTs into its regulatory fold over the next 4 years? What impact is this going to have on the market? 👇 ✏ #FDA #IVD #diagnostics #LDTs #labdevelopedtests #IVDS

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Based on strong OS and PFS data in its Phase III confirmatory study, Pfizer and Genmab’s ADC Tivdak on Monday secured the FDA’s full approval for recurrent or metastatic cervical cancer that had progressed on or after chemotherapy. In the Phase III innovaTV 301 study, Tivdak cut the risk of death by 30% and the risk of disease progression or death by 33%, as compared with chemotherapy. Tivdak comes with a boxed warning for ocular toxicity, notifying prescribers of its risk of inducing changes in the corneal epithelium and conjunctiva, which has the potential to lead to loss of vision. Patients should undergo ophthalmic evaluation at baseline and before each dose, according to the label. #biotech #biopharma #Tivdak #CervicalCancer

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