Joanne Monahan

AbbVie today announced the U.S. Food and Drug Administration (FDA) has approved SKYRIZI® (risankizumab-rzaa) for adults with moderately to severely active ulcerative colitis, making it the first IL-23 specific inhibitor approved for both moderate to severe ulcerative colitis and moderate to severe Crohn's disease. SKYRIZI is now approved for four indications across immune-mediated inflammatory diseases. "When treating patients with ulcerative colitis, it's important to prioritize both early and sustained clinical remission as well as endoscopic improvement," said Edward Loftus, Jr., M.D., Maxine and Jack Zarrow Family Professor of Gastroenterology in the division of gastroenterology and hepatology at Mayo Clinic in Rochester, Minnesota. "This approval for SKYRIZI is an important step toward addressing these treatment goals." With over 1 million people living with ulcerative colitis, the United States has one of the largest populations affected by this disease and the numbers are continuing to rise. Ulcerative colitis is a form of inflammatory bowel disease (IBD) that causes inflammation in the digestive tract and can result in damage to the colon lining. Patients often experience a range of unpredictable symptoms that impact their daily lives, such as abdominal pain, bloody stool and urgency to use the bathroom. The disease course of ulcerative colitis varies between patients, and in some cases can lead to surgery or complications, including cancer or death. "Today's approval of SKYRIZI for ulcerative colitis expands our IBD portfolio and demonstrates our commitment to helping address ongoing needs of patients," said Roopal Thakkar, M.D., senior vice president, chief medical officer, global therapeutics, AbbVie. "We will continue to invest in transforming the treatment landscape and the lives of people suffering from lBD." Dosing of SKYRIZI for this indication includes a 12-week induction period with three 1200 mg doses delivered every four weeks, followed by maintenance therapy of either 180 mg or 360 mg delivered every eight weeks. Following the induction period, SKYRIZI treatment can be maintained at home using an on-body injector (OBI). The OBI is a hands-free device designed with patients in mind that adheres to the body and takes about five minutes to deliver the medication following preparation steps. #gastroenterology #immunology #ulcerativecolitis #CrohnsDisease  #IBD #SKYRIZI #AbbVie

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Top questions we hope to answer- How do you get on a board? Does being on a non-profit board help? Where and when to start?

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Approximately 5% of U.S. adults in any given year have #PTSD, with over 80% of those with PTSD not having served in the military. However, knowledge about the journey from a traumatic event to diagnosis and treatment is limited. Otsuka continues to invest in treatments for mental illnesses and brain diseases to meet the unmet needs of our patients, their caregivers, and the communities we serve. Through products, programs, policies, and advocacy, Otsuka-people will defy any limitation that stands in their way until every mind is valued. Discover our commitment to health for every mind: https://bit.ly/44Okime #PTSDAwarenessMonth #DefyLimitation

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Because the health of our planet matters

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#MensHealthMonth is a time to reflect on the importance of regular screenings, especially when it comes to prostate cancer – the fifth leading cause of cancer deaths among men globally. The AstraZeneca GU/GYN Oncology team is dedicated to providing resources and educating men who are at a higher risk for prostate cancer due to factors such as age, exposure, or family history. Discussing the potential benefits of prostate cancer screening can empower informed decisions, and potentially save lives.   I encourage you to take the opportunity this Men’s Health Month to learn more about what regular screenings are appropriate for yourself or a loved one, including those for prostate cancer. If you’ve been diagnosed with prostate cancer, I urge you to talk to your healthcare team about BRCA mutation testing, which can open doors to potential treatment options. Information on the importance of BRCA testing in prostate cancer can be found here: https://lnkd.in/eAXbrp8g

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"IQVIA estimates that the dearth of a Humira (adalimumab) biosimilars last year cost patients and employers cumulatively $6 billion." #Biosimilars #Adalimumab like #Hulio from #BioconBiologics can provide #affordable #access to #patients and save billions for the Government. #Biosimilars are the way forward for affordable biologics therapy. Read the article: US Specific "The biosimilar Hulio was offered last year at a WAC of $498 for a month's supply, versus $3,461 for Humira, according to a Samsung Bioepis biosimilar report. Still, the vast majority of prescriptions filled in 2023 were for the Humira originator product, prompting market research group IQVIA to conclude that “maintaining patients on Humira comes at a cost of up to about $6 billion per year for patients and employers, compared to a full transition to adalimumab biosimilars.�� Biocon Biologics Matt Erick Joshua Salsi https://lnkd.in/gN74FShF

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🔍 Today, on US National Women’s Checkup Day, let's stress the importance of regular screenings for women's health. Early detection is crucial, let’s prioritize our health daily. 🩺 #WomensCheckupDay #TakeTimeToCare #Median #eyonis #LungCancer

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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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LinkedIn Fam -- I don't know how we got this lucky, but we are EXTREMELY fortunate that Steven Moore has joined the HELIO team!! Those of you who know Steve will vouch that he brings an unbelievable energy and positivity to every relationship that he has. Steve will (obviously) help us with growing the Government Pricing practice, but he's a triple threat in that he can also assist us with our current suite of Compliance Consulting services AND -- what we think the future of Consulting will entail -- tech-enabled services across ALL areas. As I mentioned earlier this week, our plan is to tech-enable all areas of the Life Sciences industry. Steve will be crucial to continuing making that happen (check out our website for case studies of previous and current projects!). Ping one of us on the HELIO side if you want to understand how to apply GenAI technology to your current processes and operations to become more EFFICIENT and optimize your resources / team. I hope everyone has a great Holiday coming up and an amazing summer! #techenabledservices #genai

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We are a week away from the World Orphan Drug Congress (WODC) in Boston. I look forward to seeing several of my current contacts and meeting some new ones. Stop by to see me and the Halloran team to learn about how we support clients developing products for rare and orphan diseases. Set up a meeting with us or visit us at Booth 424 #WODC2024 #regulatory #clinicaldevelopment #quality #compliance #programmanagement

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Have you ever crossed a finish line and felt, wow that was amazing, I am so proud of myself? I recently felt that way after embarking on a journey, something I had been thinking about and finally turned that thought into action. My mentor once said, you can either make things happen or watch things happen. I chose to make the best investment- in myself. During the past year I have earned a Certificate of Specialization in Leadership & Management from Harvard Business School Online. I completed 3 certifications and over 180 hours of learning! Success doesn’t discriminate against those with a smooth experience vs those who don’t. I had to get disciplined and figure this out during work travel 🛩️, dealing with the loss of a loved one, toddler sleep regressions 😵‍💫, religious holidays 🪔, very productive times at work ✅✅✅, and even during a work fitness challenge 💪🏽. The result? I feel stretched, incredibly grateful, with an expanded thought process. Thanks to #HBSonline for creating an enriching, flexible program that I could take at my pace, with the ability to select dynamic courses based on my needs- Strategy Execution, Organizational Development, and Leadership Principles. I have been able to immediately leverage concepts from the lessons and case studies to drive positive change. Thanks to my family, my colleagues and peers, who helped along the way. #leadershipdevelopment #personalinvestment #hbs #hbsonline

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Every effort should be made to ensure Women's health is at the front and centre of all key discussions focused on the economic, investment, policy & political agenda and critical reforms. The progress of any country, the world and society can not be attained when over half of the population is not optimally catered for and included. Make women's health a priority. Make girls and women a priority. #GenderEquity #GenderEquality #WomensHealth #hereforherhealth

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Reflecting on a Quarter Century of Impact in Healthcare - We have dedicated ourselves to tackling significant health issues with enduring effects on society and the environment. Learn about our mission and achievements: https://lnkd.in/eE3FDmc4 #WhatScienceCanDo

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Here is some great info regarding Caregiving. Worth the check in

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Great article describing what is necessary to make in-roads for value-based care. It is not just about one engagement, or one aspect of the costs incurred in treating a disease. This explores how all stakeholders (Payers, Providers and Pharmacists) have to be vested in the concept of value for the patient throughout their journey! #VBC #specialtypharmacy #asembia #revhealth

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April is Parkinson’s Disease Awareness Month. As we draw to the end of April, it’s important for all of us to remember that awareness of Parkinson’s disease goes well beyond this month. There are nearly one million Americans living with Parkinson's Disease, a number expected to rise to 1.2 million by 2030. This is a disease with no boundaries in terms of age, gender, race, or geography. We must increase awareness about the symptoms of Parkinson’s disease to ensure timely accurate diagnosis, management and support. An estimated 4% of people with Parkinson’s disease are diagnosed before the age of 50 years and their symptoms can start to appear even in their 20s or 30s. Without awareness of young-onset Parkinson's disease, the diagnosis may be missed or delayed. Women are more often misdiagnosed or diagnosed late, and they can sometimes experience symptoms differently from men, which can be influenced by hormonal status, pre- and post-menopause. Now, more than ever before, awareness, education, connection and community are essential. Reach out your hands and let’s make a difference together. 

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📰 A potential new competitor in the #AtopicDermatitis space is on the developmental horizon, with this news from J&J regarding its new acquisition, gaining a key bispecific: Johnson & Johnson (J&J) enters a definitive agreement with Swiss biotech Numab Therapeutics AG to acquire global rights to NM26, a phase II-ready bispecific antibody for atopic dermatitis (AD). ✴ To facilitate the deal, Numab Therapeutics will spin off its wholly-owned subsidiary, Yellow Jersey Therapeutics, which holds NM26 rights, to its shareholders. ✴J&J will purchase Yellow Jersey Therapeutics from Numab’s shareholders for $1.25B. 🔬 NM26 targets two clinically proven disease-driving pathways in AD: IL-4R alpha subunit and IL-31. J&J believes NM26 has the potential to transform the standard of care for AD. ⚙ Additionally, J&J sees NM26 as a potential treatment for other inflammatory skin diseases involving Th2 inflammation and itch. The drug was discovered and engineered by Numab using its proprietary MATCH technology platform. The transaction is expected to close 2H24. https://lnkd.in/evV65_RZ #JnJ #bispecifics #AD #NumabTherapeutics #YellowJerseyTherapeutics #Pharma #Healthcare

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Last week, i’m excited to say, I completed the Artificial Intelligence in Health Care program at MIT Sloan School of Management. I learned a ton, was out over my skis in many of the assignments, and was introduced to some truly inspiring individuals. In the final assignment, I was asked to apply the AI decision framework we learned throughout the course for a specific use case in health care. My use case was “The Role of Machine Learning in Enhancing Patient Care and Reducing Administrative Burden With Utilization Management Policies”. If you are bored enough to keep reading (bless you), here are some of my initial takeaways: 1. A successful AI model in this use case would need to be limited to a narrow network due to the expansive amount of variable data and interoperability policies currently in place. 2. True stakeholder input would be needed throughout the process of AI model development and must include patients, providers, and payers at every level. 3. Explainability (understanding how the AI model arrived at its conclusion) of this AI model is paramount in development, as certain stakeholder motivations could incentivize a more complex machine learning model that could obscure transparency. 4. Policy making in machine learning in the health care delivery space must start with the ultimate goal of patient-centricity and demand transparency at every level. Overall, I’m encouraged and excited about what the future may hold in regard to health care delivery and machine learning, but policies must be put in place to ensure patient protections as we walk the fine line of encouraging innovation and creating safe guards for our future.

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