Wyatt Gotbetter

To continue to the discussions from the American Society of Gene & Cell Therapy conference, check out CTI's Podcast "Moving Medicine Forward," highlighting the work we conduct in Cell and Gene Therapy: 1. Bret Marshall discusses CTI's involvement in Cardiac gene therapy trials, exploring our impact, goals, and industry trends 2. Michael Schmidt and Nicole Sparshott discuss Chain of Custody best practices 3. Joana Lancastre discusses feasibility considerations for Cell and Gene Therapy Trials 4. Jaclyn Guillory shares CTI's experience with enrolling patients to trials with targeted therapies #CTIPodcast #MovingMedicineForward #CRO #ASGCT24 #CellTherapy #GeneTherapy

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Learn the three key takeaways from the Becker's Healthcare CEO + CFO Roundtable discussion on social determinants of health. In the conversation, stakeholders from across the care continuum emphasized the importance of collaboration to scale and implement population health initiatives. Together, we can address social factors that impact care outcomes. #MyCompany #HealthEquity #AmgenSupported

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One of my favorite #digitalhealth monthly wrap-ups is from The Heart of Healthcare with Halle Tecco, MPH, MBA and Steve Kraus. In the latest episode 👇, which dropped yesterday, they discuss: -> The Peterson Institute's new report on #digitaltreatments for musculoskeletal conditions (spoiler: this one was much more favorable than their last report on diabetes digital health solutions). (https://lnkd.in/ddk3h-V2) -> The new FDA guidance on diversity in clinical trials, and they touch on a cool initiative that I hadn't heard of from Mural Health aiming to change legislation making clinical trial payments exempt from taxable income. (https://lnkd.in/dtQkpr7Z) -> Goldman Sachs' report that the use of GLP-1 drugs for obesity in the U.S. could result in a whopping 1% increase in GDP. -> Walgreens closing of of a quarter of its stores across the country, raising questions about the sustainability of the traditional pharmacy model in the current market. Lots more in the episode to make this an #interestinglisten for those who are in the #digitalhealth space. 👇 https://lnkd.in/dPWv_57h

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Exciting news in biotech - Q1 2024 saw a 46% surge in venture funding, signaling a strong recovery. Late-stage clinical developments and innovative therapies like ADCs and radiopharmaceuticals received significant investments. The important question is what does this mean for the future of biotech? How will these trends impact the development of new therapies? And how is investor confidence changing as the IPO market sort of re-opens? Interesting thoughts to consider. You can read more on our blog: https://ow.ly/bpCF50S2iY6 #Biotech #VentureCapital #HealthcareInvestments

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How do we minimize the number of protocol amendments and increase the operational feasibility of our clinical trials? This article below points out the benefits of using data, conversations and real world data to enhance the feasibility of the protocol design and inclusion/exclusion criteria: 1) Are we being too strict on our criteria in order to "control" for data variability? 2) Do are criteria allow for the intended patient population in the real world (if not, they need to) 3) How realistic is your design in how the study sites actually work? How they see and treat patients? How is your company ensuring the design meets these requirements? https://lnkd.in/gzJzFd-3

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It’s undeniable that the current health disparities at the local levels are increasing, and more individuals are falling through the cracks. Now, more than ever, we must harness innovation and collaboration to address these health disparities and improve equitable access to care for everyone. In my recent interview with Michael Gibney from PharmaVoice, we explored how AI is becoming a game-changer in tackling health disparities in cancer care. From pioneering screening initiatives to data-driven insights, the opportunities in leveraging AI to bridge the gap in health outcomes is endless. Innovation isn't just about developing ground-breaking treatments; it's about making sure those breakthroughs reach all populations who needs them. Everyone, regardless of their ZIP code, deserves access to cutting-edge cancer treatments. AI presents a tremendous opportunity to address these disparities head-on. Collaborating with diagnostic companies and AI innovators, we're using data to expose the disparities in care and address screening and access issues head-on. Our goal is steadfast: to leave no one behind in the battle against cancer. Together, we can eliminate the ZIP code lottery in cancer care and pave the way for a more equitable healthcare system. Read more from my recent interview here: https://lnkd.in/eEg5h_pv #HealthEqutiy #AI #Innovation #Leadership

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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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Today's episode of GCP features a fantastic discussion between Dr. Tala Fakhouri (FDA) and Stephen Pyke (Parexel) on the current and future state of AI in clinical research. Huge thanks to Tala and Stephen for joining me for such an enlightening conversation!!!

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When conducting a clinical trial, you must ensure that you maximize your chances of success. Identifying the best sites and recruiting the right participants are two of the most crucial steps - failing at this stage means your trial won't even get off the ground. Join WCG for our upcoming webinar where we discuss how these aspects of a clinical trial must continually evolve, and learn best practices of how to set yourself, and your trial, up for success!

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I'm so proud to share that I wrote this year's CEO Pay Gap article for BioSpace. We found that despite the strong headwinds that battered the industry last year, CEOs were still often paid hundreds of times more than their median employees. A couple of standouts: 1 - Pfizer head Albert Bourla took a 35% pay cut, but remains one of the highest-paid CEOs across the industry. He takes home nearly 300 times more than the median employee. 2 - J&J CEO Joaquin Duato had the largest pay jump in BioSpace's list, increasing from $13.1 million to $28.4 million. He makes 338 times more than the median J&J employee. 3 - Topping this year's list is Israeli multinational Teva, whose CEO Richard Francis made nearly 400 times more than the median employee. There are more great insights in the article, and I invite you to dive into our analysis. Great work from Jennifer "Jef" Akst, Shawna Williams, and Tyler Patchen, and of course incredible graphics from Nicole Bean and Taylor Tieden. #biotech #biopharma #pharma #PayGap #CEO

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Rare disease drug development is thriving – thanks to promising gene therapies, advances in AI and a supportive regulatory environment, among other influences. But more work needs to be done, urgently. 🎙 Listen to the latest episode of our podcast series "Preparing for a Cell and Gene Future," as Jamie Pierson and Kim MacDonnell address the use and regulatory acceptance of surrogate endpoints to demonstrate clinical benefit:

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Our Senior Managing Director, Jason Shafrin is shaping the conversation in healthcare! His recent STAT article delves into the vital role of societal perspectives in drug pricing policy. By quantifying costs and benefits through this lens, we can optimize value for money while still driving innovation. Don't miss his insights on this crucial topic below. #HealthcareInnovation #DrugPricing #SocietalPerspectives #InnovationLeadership

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What an honor to speak with Stoller James, MD, and MinhTri Nguyen, MD (https://lnkd.in/eGngb_kY) of The Cleveland Clinic! We explored ways to think about developing leaders in the context of healthcare, and these two have some wonderful insights. Enjoy! International Leadership Association #leadershippodcast #leadershipskills #leadershipdevelopement #leadershipinaction #leadershipcoaching #leadershiptraining #leadership #leadershiplessons #leadershiptips #leaders #leadershipjourney #healthcare

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Oncology reimbursement has been challenging and eroding over the last several years even while patient numbers are increasing and biomedical innovations are accelerating. Pending CMS proposals for 2025 may increase these challenges, limit provider investments and capabilities, and constrain patient access. Please read our perspective. #concertai #ASCO #oncology https://lnkd.in/eJ6t-GUe

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Takeda's CEO's annual letter hits on some key themes that many biopharma CEO's are converging on: value-based care, price transparency, breaking up the middlemen, and driving healthcare access and equity. "For several years I have been outlining Takeda’s thinking on health equity—including advocating for a transition to value-based health care that pays for outcomes and care quality, emphasizing the need to prepare for the next pandemic by ensuring global vaccine equity and explaining how the protection of intellectual property rights is essential to incentivize investment in R&D. One area where we would like to see greater progress this year is pharmacy benefit managers reform. We support efforts in Congress to delink rebates from list prices or wholesale acquisition cost. It is a complex system, but the bottom line is that the current system creates misaligned incentives that ultimately result in higher costs for the system and higher out-of-pocket costs for patients. One potential way to address these challenges is through greater transparency. Transparency at the point of purchase for patients would empower them to make decisions knowing exactly what their costs will be. This could lower costs for the entire system by building in greater pricing accountability along the chain so that no stakeholder can benefit from the inefficiencies that result in the prices that patients pay today." At COEUS, we are working with the world's leading biopharma companies to help transition them from a broken FFS model towards value-based care. We have built the world's leading platform that hosts the biggest CGT commercial launches, and rapidly moving into Oncology, Obesity/ Diabetes, and beyond. 1. Enabling Value-Based Healthcare: Our solution facilitates the transition to value-based healthcare by providing a powerful tool for creating and managing contracts that pay for outcomes and care quality. 2. Enhancing Transparency: By aggregating disparate healthcare data from various sources, our platform provides unprecedented transparency into the entire healthcare ecosystem. This empowers payers, providers, and patients to make informed decisions and helps stakeholders across the value-chain to tie price and value to therapeutic outcomes. 3. Driving Innovation: Our platform's ability to evaluate complex rules for value-based contracts, real-world evidence studies, and health equity measurements fosters innovation in the pharmaceutical industry. By providing a tool to measure the impact of new solutions, we help companies drive medical advancements while ensuring equitable access. 4. Improving Access and Affordability: Our solution helps identify areas where access and affordability can be improved without compromising innovation. By providing data-driven insights into the effectiveness of various interventions, we enable stakeholders to make informed decisions that benefit patients and the healthcare system as a whole. Visit https://coebra.ai/.

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How CliniLink is Reshaping Clinical Trials with Salesforce Join us this Wednesday, June 26, at 10:00 AM EST for an exclusive webinar! Discover how CliniLink Health's platform is transforming patient connections and clinical trials. Learn about our approach to FDA DEI requirements and improving patient engagement. Hosted by Shahzad Khokhar, Global Head of Platforms at Accelirate Inc. What to Expect: 1. How CliniLink improves patient outcomes. 2. Benefits and future of using Salesforce. 3. Insights into CliniLink's data challenges. 4. How Accelirate's expertise solves these issues. 5. Best practices for managing patient data. Don't miss this chance to explore the future of healthcare tech! Register now: https://lnkd.in/eRgdbR6f. #salesforce #clinilinkhealth #CliniLink #HealthcareInnovation #clinicaltrials #clinicalresearch

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Why are Americans paying so much for #prescription medicines? According to the FTC, it’s because the biggest #PBMs -- all owned by health insurers -- are using their market power to drive up costs, pocket #rebate dollars, and force patients to use pharmacies that the PBMs own. At the same time, they’re providing independent pharmacists with “untenably low” reimbursement, undermining the care ecosystem even as costs increase. The scathing new #PBM report from the FTC makes clear that PBMs are often a shell game, using vertical integration and convoluted corporate structures to hide the fact that PBM "benefits" are often just a way to steer dollars to the PBM's other businesses. Patients suffer the most, first paying higher prices than they should be paying at the pharmacy, and later as they will have access to fewer new treatments because #biotech innovation suffers due to PBM greed, unless we call attention to this egregious behavior. #patientsfirst #innovation #biotech Biotechnology Innovation Organization https://lnkd.in/gK2A2zFh

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#representationmatters. Cheers to each of those recognized for putting themselves out there -- and showing the next generation there is a seat for them at the table. Check out the article to learn more about the #Biopharma #leaders charting a path for the industry's #LGBTQ+ community: Endpoints News

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