Alfred Kutor

🚨 **Job Seekers Beware** 🚨 There has been an alarming increase in scams where unscrupulous individuals send text messages or emails advertising fake job positions. These fraudsters often request sensitive personal information such as social security numbers under the guise of job application requirements. Always verify the legitimacy of the job offer and the company before sharing any personal details. Stay vigilant and protect your information! #JobSearch #JobScamAlert #StaySafe

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If I gave the kind of excuses the FDA recently presented to Congress during my performance review, I’d likely be fired—and rightly so. The FDA’s new report to Congress defends its increased reliance on non-binding guidance documents rather than legally enforceable regulations, claiming that this approach “keeps pace with the latest science.” While guidance documents may have some utility, their overuse and inconsistent implementation create confusion and stifle innovation. For a billion-dollar taxpayer-funded agency, this performance leaves much to be desired. Here’s the problem: In the private sector, where accountability is non-negotiable, vague answers, unfulfilled promises, and reliance on decades-old frameworks simply don’t cut it. Imagine telling your boss that you’ll “update a 20-year-old guidance system eventually” or failing to provide clear, actionable changes after stakeholder feedback. That’s a fast track to unemployment, not to mention loss of trust. Contrast this with the FDA’s self-assessment. They tout the “significant increase” in guidance documents published annually but fail to address the crux of industry criticism—guidances are not legally binding but function as de facto rules. This leaves companies, especially smaller innovators, navigating a minefield of uncertainty. The FDA claims this benefits smaller players, yet the reality is that these companies often lack the resources to interpret inconsistent guidance. Even more frustrating is the lack of public input in some cases, with the FDA citing “public health reasons” or “immediate implementation” as justifications. While urgency is understandable during crises like the pandemic, this pattern of bypassing input undermines transparency and trust. The FDA acknowledges that its Good Guidance Practices (GGP) regulation hasn’t been updated in over 20 years—an admission that should alarm all of us. Imagine if a private company relied on processes from 2003 in today’s dynamic environment. That’s not “keeping pace”; that’s stagnation. The FDA plays a critical role in safeguarding public health and enabling innovation in pharma and biotech. However, its current trajectory feels more like a bureaucratic stranglehold than a partner in progress. If we in the private sector are expected to operate with efficiency, accountability, and adaptability, why is it acceptable for a taxpayer-funded agency to fall so far short? It’s time for the FDA to hold itself to the standards it expects from the industry it regulates. Innovation in biopharma depends on a regulatory partner, not an overlord. Let’s call for accountability, transparency, and modernization—before the FDA becomes a roadblock to the very progress it’s supposed to support. What do you think? How can we balance regulation and innovation to better serve patients and the industry? Share your thoughts below.

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I am a first generation American. I am a woman. I am a single mother. I am neurodivergent. I have multiple conditions that are considered disabilities by the ADA. I am many things that are supposed to prevent me from being successful. More importantly, I am driven. I am determined. I am strong. I am fierce. I am unyielding. I am tenacious. I am goal oriented. I am ambitious. I am a collaborator. I am a leader. I am creative. I am a critical thinker. I am a life-long leaner. I am the first person in my family to earn a college degree. I am all the things that enable me to overcome all the things that I have been told are obstacles. I set a goal for myself at the start of the pandemic. I would finally pursue an educational goal set by a younger, more idealistic, and more energetic version of myself. I was going to invest in myself and earn my Master of Science. It was difficult to keep my very busy brain focused on the content sometimes. Oftentimes, it was challenging to carve out the time to complete graduate coursework, but this was important. I needed to remind the present me that the goals set by the younger me were important because I am important. It wasn’t easy at any step along the journey, but it wouldn’t be a goal if it were. Challenge is good. I did it. I achieved my goal. I earned an MS in Health Information Management (HIM). I am here to tell everyone who has ever been told, “You’re lazy.”; “You’re stupid.”; “You’re never going to amount to anything.”; “You’re too much.”; “You’re not enough.”; these are lies spoken by external voices. They are irrelevant and meaningless. Your internal dialogue with yourself should be filled with all the reasons you are amazing and important. Set your goals and start on your path to achieving them. Life isn’t a race or a straight line. Life is a journey, and you need to take that first step. You set the pace, and you choose the course. You may need to make a few adjustments when life presents challenges but reset your path and get back on track. You are important. You are everything. You are amazing. You are worth it. (Picture was taken at graduation with one of my greatest sources of inspiration, my oldest daughter)

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💥 Enough is Enough! 💥 The FTC is finally taking action against Pharmacy Benefit Managers (PBMs) who have profited off of the suffering of millions of patients. These PBMs have played games with insulin rebates, driving up the cost of this life-saving drug while patients struggle to afford it. It’s time for accountability. This lawsuit could finally bring justice for those who have been exploited by this broken system. PBMs should not be allowed to cause more suffering for patients. #HoldPBMsAccountable #HealthcareGreed #InsulinCostCrisis #PatientExploitation #PharmacyBenefitManagers #DrugPricingReform #JusticeForPatients https://lnkd.in/ew2Z5dbZ

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With what feels like constant change in Pharma/Biotech, it’s not uncommon to get in a situation where the company’s direction and your desires for your career become mis-matched. Whether you find yourself in the middle of company layoffs that are forcing you to pivot or you’re wondering if you should stick it out, here are 3 steps to keep your career path on track while your company is having layoffs. I hope these 3 steps helped you see how you can keep your career on path during layoffs.  Tune in to the Your Worthy Career podcast for more support or send me a message to inquire how I can support you directly. #careerchange #pharma #biotech #lifesciences #careertips

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With what feels like constant change in Pharma/Biotech, it’s not uncommon to get in a situation where the company’s direction and your desires for your career become mis-matched.😫 Whether you find yourself in the middle of company layoffs that are forcing you to pivot or you’re wondering if you should stick it out, here are 3 steps to keep your career path on track while your company is having layoffs. P.S. if you've been trying to get a new job or promotion and it feels like a dead-end, take my quiz to diagnose the problem and get the fix you need. 🤩 #careerchange #pharma #biotech #lifesciences #careertips

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CRAs Looking for tips on what to include on your resume? I've got you covered The clinical research associate job market is about as competitive as it can get. As a former Life Science recruiter let me share the key details employers wanted to have answered via applicant's resumes - How many studies do you typically have at one time - How many sites do you typically manage at one time - What systems CTMS or ADC's have you worked with - Which therapeutic area do you feel strongest in as a travelling CRA - What other therapeutic areas would you note as strengths - What phases have you monitored as a travelling CRA - How much risk-based monitoring experience do you have - Have you worked within an FSP model - How many years of on-site monitoring do you have - How many years of specific "Industry" (CRO, Pharma, Biotech) experience do you have You don't need me to tell you that it's tough getting a call back these days. So... The more of these questions you can answer using your resume the better. (P.s You can download my resume template via the comments - it's free) ♻ Do feel free to share with your CRA network #jobseekers #jobsearch #clinicalresearch

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Treatment-resistant depression (TRD) is a genuine condition.   📢 It is estimated that at least 30% of individuals with depression qualify as having TRD. In the US, 30.9% of adults receiving medication for major depressive disorder have TRD. 📢 TRD contributes to 47.2% of the total annual burden associated with medication-treated MDD in the US. 📢 Patients with TRD are more prone to experiencing anxiety, substance use disorders, cardiovascular disease, chronic pain, primary insomnia, obesity, and Type II diabetes. 🔔Learn about our innovative treatment option for patients with TRD: https://cnn.it/3CZ1W8g #whywework #jnjneuroscience #jointheteam

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"I'll never work in quality....."     That's what Andrea Goddard said to her boss one day. Fast-forward a few years, and she would become Chief Quality Officer for Genentech!   This is Andrea's story about her career at Genentech which spanned nearly 30 years. Starting in manufacturing and eventually becoming the CQO. Andrea’s boss encouraged her to step into quality because of her technical expertise and her leadership skills. It's these skills - collaboration, inclusive decision-making, and the ability to communicate with diverse teams - that helped her get to where she is now. We talk about: - Building strong relationships with other departments. - The challenges and rewards of working in a global role. - Managing different time zones and cultures. - Making informed decisions using data and facts. - Putting yourself out of your comfort zone. And more! You can watch YouTube or listen on Apple/Spotify.

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Just a friendly reminder I’m still #OpenToWork I have experience in #RegulatoryAffairs and #Labeling. Labeling really highlighted how well I do at #CompetitiveIntelligence, #MedicalWriting, and #TeamNegotiation. I have vast and in-depth #ScientificResearch skills. I mean how many folks do you know with a PhD in #Neuroscience AND #Immunology?? I’ve started and governed businesses and non-profits. Put #Entrepreneur and #BusinessAcumen at the top of the list. #Management and #EventPlanning experience in the bag. #TimeManagement and #ProjectManagement I excel at. Because time is one of our most precious gifts. And I hate wasting anyone’s. I have been missing working with data. #ClinicalScience seems like a great segue back to that. Until then, I’ll continue to build up my #DataScience skills. #RealWorldEvidence will have great clinical meaning, and I’m not missing this train combined with #MachineLearning and #ArtificialIntelligence. I have #Mentorship and #Teaching skills. #ContentCreation is a breeze. I make a great #Storyteller from science to patient advocacy with an audience of elementary schoolers to the life learner. Unfortunately, my disabilities preclude me from physical lab work (for now). But who knows… maybe someone already has a lab with wheelchair and mobility accessibility already in place?? I’m confident in my abilities and how I would be a great fit for your team! I love a good challenge! Let’s connect! #OpenToWork

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Over 700 of you voted and it's an even split! The question- for #pharma and #biotech roles, "Would you rather interview virtually or in-person?" 50% of you opted for virtual and 50% opted for in-person A few considerations: --It depends on the stage --It depends on the company's location --It depends on the role Theme: "it depends" However, we also have uncovered that personal preference is huge here and it's an even split! Are you surprised? #careerdevelopment #recruiterlife #interviewtips #virtualinterview

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Vaccine development requires clinical trials to generate the necessary safety, quality and efficacy data needed for licensure. The process takes on average 10–15 years and costs at least $500M, with probability of success estimated to be as low as 10%.

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I have few new connections so I wanted to introduce myself. My name is Maria Kane and I specialize in Lifestyle medicine coaching and social prescribing. I am currently working with people with chronic illnesses including IBD and mental health challenges. Many patients with chronic illnesses can benefit from additional support to navigate their health journey more effectively. How My Coaching Services help. Improved Patient Compliance: Help patients follow treatment plans, adhere to medication schedules, and make lifestyle changes recommended by their medical team. Chronic Disease Management: Provide patients with tools and strategies to better manage chronic conditions such as diabetes, hypertension, and cardiovascular diseases. Behavioral Health Support: Assist patients in managing stress, anxiety, and other mental health challenges, complementing the care they receive at your clinic. Personalized Health Coaching: Offer one-on-one coaching to empower patients to take charge of their health, resulting in better outcomes and higher satisfaction. How I Can Work Together with Medical clinics; Partnership Approach: I collaborate closely with medical practices to provide seamless, complementary support for your patients. My coaching services can be integrated into your existing patient care programs or offered as a standalone service to those who may need extra guidance. Customized Plans: Every patient is unique, so I tailor my coaching to fit their specific needs and your clinic’s objectives. This personalized approach ensures that patients receive the best possible support on their health journey. Easy Referral Process: Referring patients to my coaching services is straightforward. I can provide brochures, referral forms, or digital resources to make the process smooth and efficient for your team. If you be open to a learning more and discuss how we can work together to enhance patient outcomes and satisfaction? See link below. I love supporting my clients on their path to better health. Maria Kane Cork Lifestyle Medicine Coaching and Social prescribing services. [email protected] Follow me on LinkedIn; https://lnkd.in/eiq5NeWH Book a Free discovery call online here. https://lnkd.in/ewU-5-AQ Please let me know if you have any questions below in the chat or send me a message.

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Interested in learning about the trends and disruptions that will shape the future of drug development and the pharmaceutical industry. Check out this article!

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🌟 Brilliant Job Search Hack! 🌟 This post breaks down how to maximize Google for job hunting. From precise search queries to leveraging ATS platforms like Greenhouse, this guide has it all. 🚀 🔍 Favorite takeaway? "site .com" for company-specific results—such a game-changer!As someone navigating the job market, I find this approach not only saves time but also delivers highly targeted opportunities. If you're actively searching or know someone who is, this is a must-read. Let's work smarter, not harder. 💼 ♻ Reposting to help my network find their next big opportunity. Let’s make job hunting easier for everyone! 💡

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🏆 𝙲𝚕𝚒𝚗𝚒𝚌𝚊𝚕 𝚁𝚎𝚜𝚎𝚊𝚛𝚌𝚑 𝙲𝚑𝚊𝚖𝚙𝚒𝚘𝚗𝚜🏅: 𝚁𝚎𝚌𝚘𝚐𝚗𝚒𝚣𝚒𝚗𝚐 𝙸𝚗𝚍𝚞𝚜𝚝𝚛𝚢 𝙻𝚎𝚊𝚍𝚎𝚛𝚜 📚𝚊𝚗𝚍 𝚅𝚊𝚕𝚞𝚊𝚋𝚕𝚎 𝚁𝚎𝚜𝚘𝚞𝚛𝚌𝚎𝚜🛠️ 𝚒𝚗 𝚝𝚑𝚎 🧬 𝙲𝚕𝚒𝚗𝚒𝚌𝚊𝚕 𝚁𝚎𝚜𝚎𝚊𝚛𝚌𝚑 𝙲𝚘𝚖𝚖𝚞𝚗𝚒𝚝𝚢. 🌍 👋Hello, My Clinical Research Network!👇 If you are looking for clinical research information, support, and guidance, you should give 𝐑𝐮𝐝𝐲 𝐌𝐚𝐥𝐥𝐞 a follow. 𝐑𝐮𝐝𝐲 𝐌𝐚𝐥𝐥𝐞 is a thought leader in clinical research, and you're gaining access to first-rate insights and a wealth of knowledge. With over a decade of experience in oncology, cardiology, and beyond, Rudy's dedication to supporting and advancing clinical research is evident in his background, experiences, and the content he shares daily. His passion for mentorship and leadership is inspiring, and his ability to excel speaks volumes. Rudy is a true asset to our industry, and I'm excited to see the impact he continues to make. Connect with 𝐑𝐮𝐝𝐲 𝐌𝐚𝐥𝐥𝐞 for insights on clinical research and beyond! Rudy Malle💯 #ClinicalResearchLeader #MentorshipMatters #WorkLifeBalance #InspiringExcellence

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🔬 Groundbreaking news in the realm of vaccine development! Moderna is poised to enter the respiratory syncytial virus (RSV) fight, armed with its innovative mRNA-1345 vaccine candidate. Despite the market seeing some action from competitors like GSK and Pfizer, Moderna's unique offering might just change the game. 💉 The shot, currently awaiting regulatory nods, could arrive as soon as this fall, targeting the elderly - among the most vulnerable - along with the young and immunocompromised. What makes mRNA-1345 stand out? It's the promise of a pre-filled syringe, eliminating the need for vaccine reconstitution - a move set to streamline vaccination processes by saving invaluable time for both healthcare workers and patients. ⏱️ While we await the CDC's Advisory Committee on Immunization Practices (ACIP) post-approval recommendation, the company's engagement with pharmacists and hospitals nationwide underscores a commitment to bolstering public health infrastructure. 🏥 Despite a sharp first-quarter dip in COVID-19 vaccine sales within an endemic market, Moderna's strategic manoeuvres see them playing the long game. With RSV vaccine sales yet to be projected, the firm appears to be focusing on solidifying its stance as a major player in vaccine innovation and delivery. 🌍 Partnerships are key, and with efforts to integrate closely with healthcare providers and public health officials, Moderna seeks to up vaccination rates effectively. As the world adjusts to the realities of endemic living, vaccines like mRNA-1345 offer hope and convenience that could well shape tomorrow's vaccination landscape. 💡 #HealthcareInnovation #VaccineDevelopment #EndemicEra

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If there's one thing I hear all the time about clinical trials, it's that they’re "only for severely ill patients" or that they’re "too risky." But here's the thing, that’s just not true. To me, the biggest myth is that if you're healthy, clinical trials aren’t for you. But the reality is that many trials include healthy volunteers, and in fact, they play a crucial role. Trials cover everything from testing the effectiveness of new medications to studying disease prevention, early detection, and quality of life improvements. Healthy volunteers are needed to help researchers understand how a treatment works in people without a specific disease. Then there’s the idea that trials are “unsafe.” While every medical procedure or treatment has risks, clinical trials are held to incredibly high standards with rigorous oversight to protect participants' safety. Ethical guidelines, review boards, and regular monitoring all come together to ensure trials are conducted safely. And here’s one more myth I hear: “Clinical trials are for Western countries, they’re not relevant for us.” Actually, trials are crucial worldwide, because every population reacts differently. So, they’re just as essential here as anywhere else. So, let’s break these myths together! Clinical trials are not just for the sick, not overly risky, and definitely not just for certain countries. Have you ever had a misconception about clinical trials? What would make you consider participating in one? (image taken from Google)

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