Walid Saad

I recently had the opportunity to sit down with Deloitte’s Erik Smith to discuss the transformative potential of AI and emerging technologies on the biotechnology industry. At Amgen, we are leveraging AI, machine learning, and big data to enhance drug discovery, shorten development timelines, and improve patient access to medicines. These technologies are reshaping not only how we work but also how we serve patients, from discovery to delivery.  https://lnkd.in/gcPKHgpF

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Great insights about rapid sterility testing brought to you by Rapid Micro Biosystems! #automation #microbiology #sterilitytesting

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What an interesting read on the shift from traditional patient recruitment methods in rare disease! Learn more about how to optimize patient-driven site engagement in my team member’s blog: https://bit.ly/4eHoBn4

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Have you thought about health equity and gene therapy? Gene therapies are expensive! Pfizer’s newest hemophilia gene therapy is peaking at 3.5 million dollars a treatment. Talk about sticker shock. This is not accessible for many and for the “traditionally underserved and marginalized groups” this is nearly impossible. Mary A. Majumder and Titilope Fasipe write a cogent and timely essay in Ethics and Human Research Vol. 46, Issue 3 based on the National Academies of Science, Engineering, and Medicine report, on achieving fair and equal health innovations for everyone, titled “Toward Equitable Innovation in Health and Medicine: A Framework.” Majumder and Fasipe focused on two key areas of that report in their essay: First, input equity - making sure the voices of communities impacted by health issues are included in the research and development process. No more excluding the people it aims to help. Second, deployment equity - ensuring these new innovations actually benefit diverse populations, especially groups that are underserved or marginalized. Not just advantages for the usual populations. The report uses the approval of two new gene therapies for sickle cell disease in December 2023 as an example. While these therapies are major breakthroughs, they are very expensive ($2.2-$3.1 million per patient) and complex to administer. This raises concerns that they may not be equally accessible, especially for underserved populations most impacted by sickle cell disease. The government tried providing incentives like extended patents to get private companies to invest in developing the therapies. But there weren't any requirements around pricing to promote affordability. Some efforts were made to gather community perspectives and analyze costs to keep things equitable, but obstacles remain. Issues like lack of insurance coverage, doctor shortages, and mistrust in the healthcare system stand in the way of these new gene therapies reaching many sickle cell patients, at least in the short term. This example shows how important research funders are for promoting fairness, and the need for a comprehensive approach that considers real-world healthcare experiences and costs. The key lesson is that research funders have a crucial role to play in promoting true equity. And we need a comprehensive approach that deeply understands the real-world healthcare experiences and economic challenges people face. Cracking this is vital for ensuring all groups benefit from major health innovations. #HealthEquity #SickleCellDisease #GeneTherapy #HealthPolicy Links in the comments.

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Looking forward to attending #ASH2024 this year. Let's connect and I can share with you how TD2 can support your next trial. 🔗https://hubs.li/Q02YXgqv0 #HematologyOncology #ClinicalTrials #OncologyCRO #BloodCancerResearch #DrugDevelopment #PrecisionOncology #ClinicalTrialSolutions

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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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When the stakes are high, compliance isn’t just a goal—it’s a necessity. A leading biotech needed a clear path forward for their Computer System Validation (CSV) program to ensure they stayed compliant while managing their evolving project needs. The dedicated team at Advanced Clinical conducted a thorough gap analysis, deployed seasoned experts, and delivered results on time and under budget. This is what partnering for success looks like. Curious about how we did it? Dive into our latest case study: https://bit.ly/4gnTEpa #CSV #Validation #ClinicalResearch #ClinicalTrials

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Join me with Christine Senn from Advarra as we discuss the power of moving from siloed processes to integrated collaboration between sponsors, CROs, and sites. Christine shares how this approach is driving results in research — accelerating timelines, reducing costs, and ultimately improving patient access to trials. Join us to dive into the challenges of study startup and the risks posed by working in isolation ⇢ https://lnkd.in/ggS_98cP

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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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https://lnkd.in/gcXUGg6e I had the chance to speak on Monday with Max Gelman of Endpoints News regarding potential Trump administration picks for key leadership positions at HHS and FDA. I have no problem with people pointing out that we should eat healthier, avoid highly processed foods, exercise more, and be aware of and do our best to reduce environmental toxins, etc. And there is growing evidence that improving metabolic health can in many cases positively impact a number of other areas of health. That is all common sense and should be supported. I DO however, have a big problem with pseudo-science, baseless claims about correlation and causation, and a general anti-science sentiment that is concerning and may be embraced by people in positions of authority of the new administration. Rolling back long proven products and practices that have had enormous positive impact on human health (e.g, vaccines, fluoridation of drinking water) could be devastating. Whether it’s the HHS, EPA, FDA, USDA. etc. - these agencies have historically relied upon and should continue to rely on evidenced-based science to make decisions that affect public policy as well as commercialization of drugs, foods, chemicals, agricultural products and more.   It is critical for our industry (and for human and planetary health, for that matter) that whoever is appointed in key positions in these areas should not interfere with these science-based, well established regulatory processes. Not only have these processes evolved to balance risk benefit for consumers and patients, but the industries involved have relied on these to make portfolio and investment decisions. Last year we were very concerned that the courts, for political reasons, might subvert the authority of the FDA as the scientific arbiter of approval of new drugs and restrictions on their distribution.  If a new administration were to go even further and actually appoint individuals in positions of influence who may directly subvert the role of science and evidence base to make decisions, this is highly troubling. It could, ultimately, have devastating effects on public health, health care costs, and future innovation. #patientsfirst #sciencefirst #evidencebasedmedicine #KeepPoliticsOutOfMedicine

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At BlueGene Search, we don’t just recruit talent—we build the teams that bring #biotech innovations to life. Whether you're launching a new therapy, scaling operations, or filling key gaps in your organization, our specialized expertise delivers solutions tailored to the unique challenges of life sciences. Here’s how we make an impact: ✅ Launch Team Builds: We craft launch-ready teams, sourcing the best talent to hit the ground running in fast-paced biotech environments. Your innovation deserves a flawless rollout, and we’re here to assemble the team that makes it happen. ✅ Fractional Talent Acquisition: Need expert support without the full-time commitment? Our fractional talent acquisition services provide you with on-demand recruitment expertise, scaling your team at the right pace for your growth. ✅ Life Science Recruiting: We live and breathe biotech and pharma. With years of experience and deep networks, we connect you to candidates who have the skills and passion to drive your mission forward. ✅ Full-Service Agency: From sourcing to onboarding, we’re your end-to-end talent solution. BlueGene Search takes the guesswork out of hiring, allowing you to focus on what matters most—transforming lives through science. The right team isn’t a luxury—it’s a necessity. Let us help you find yours. 👉 Interested in learning more? Let’s connect to discuss how BlueGene Search can support your talent needs. #Biotech #LifeSciences #Recruiting #TalentAcquisition #FractionalRecruiting #LaunchTeam #BlueGeneSearch

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Over my 20+ years in the pharmaceutical industry, I’ve seen many trends come and go, but today’s shift stands out as one of the most profound: moving from stand-alone service providers and equipment suppliers to integrated solutions that truly serve the customer. At Ellab, we’re not just adapting to this shift—we’re driving it. By combining cutting-edge equipment with deep expertise, we are creating solutions that reduce complexity and build trust. This isn’t just about providing products; it’s about taking responsibility for validation and compliance, so our customers can focus on what they do best: delivering safe, effective products to patients. This shift has made me reflect on how much progress we’ve made as an industry—and the challenges we still face. Simplifying processes and aligning diverse teams and technologies is no easy feat. But every time we help a customer work more confidently and efficiently, it reaffirms why this transformation matters. How is your industry tackling complexity, building trust, or driving meaningful transformations? I’d love to hear your insights. #Ellab #IntegratedSolutions #CompliancePartner #PharmaValidation #LifeSciencesLeadership #CustomerSuccess #PharmaInnovation

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Exciting new updates coming from ADC Therapeutics: 🔬 For Zynlonta, reporting 'encouraging early data' from a Phase II study of Zynlonta (loncastuximab tesirine-lpyl). The therapy demonstrated a high response rate among patients with relapsed/refractory marginal zone lymphoma (MZL). 📈 Follow-On Offering and Stock Movement: Riding these positive clinical results, ADC announced a $105-million follow-on offering. 🌐 Zynlonta is already US/EU approved for r/r large B-cell lymphoma (LBCL), with net sales of $17.8M according to the company’s first-quarter earnings report. #Oncology #Zynlonta #Biotech #Innovation #Pharma #Healthcare https://lnkd.in/e46JN72A

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#AI is the talk everywhere, but to make AI work you need structured, harmonized data, and use a standardized terminology. This is also true for #lifescience process data analytics projects. Only a #datacentric approach ensures that the data is fit for purpose and aligned to standard terminology via an ontology-backed approach. #Ontologies make a difference in #therapeutics drug discovery, development, and manufacturing. Come learn more in tomorrow’s webinar, Wednesday at 9.00AM ET, which details how the L7 and SciBite partnership achieves this. #datastrategy #processorchestration #LLM #artificalintelligence #L7ESP #CENtree

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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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Embracing automation in clinical laboratories will bring multiple benefits to the lab and help pave the way for delivering personalized medicine and transforming patient care. To find out more about the benefits of automation, check out this recent LabLeaders article. http://spkl.io/6043fBodh #automation #laboratory #lab #roche #healthcare

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This week at #ASGCT2024 Creyon Bio’s CMO, David Dimmock, MD, will present clinical data showing how we used our AI- and data-driven platform to rapidly engineer an antisense oligonucleotide investigational therapy for treatment of an ultra-rare disease. This underscores the potential of AI to create new safe and active oligonucleotide therapeutic candidates with significantly improved efficiency for common and rare diseases targeting the genetic underpinning of disease. https://lnkd.in/dezfE_V9 American Society of Gene & Cell Therapy TNPO2 Foundation

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