Faraz Siddiqui

Excited to share the latest feature in our "Partnering Spotlight" series, where we share some of the connections we are building to foster scientific innovation in healthcare. In this edition, our very own Neha Kaushal sits down with Daniel Anderson, Professor of Chemical Engineering at MIT, to discuss the potential of innovative #mRNA applications in vaccines and novel treatments for genetic diseases. Check out the video to learn more about our collaboration! https://lnkd.in/eHwpyjeY #vaccines #immunoscience

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America’s drug shortages are a growing crisis that demand bold and immediate action. Addressing this dilemma requires a multifaceted approach: boosting domestic manufacturing, diversifying supply chains, and leveraging innovation to streamline production and distribution. Collaboration between the government, healthcare providers, pharmaceutical industry and the logistics services providers, is crucial to ensure consistent availability of critical medications. Advanced technologies, such as AI and predictive analytics, can help identify and prevent supply disruptions before they escalate. Solving drug shortages isn’t just about logistics—it’s about saving lives. Globyz can help you solve your healthcare logistics challenges and help you build a more resilient & integrated pharmaceutical supply chain to meet your healthcare needs today and in the future. Please contact us for details. [email protected] www.globyz.com

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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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📨 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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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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Robert Battista has some great insights on the unique #transportvalidation challenges for pre-filled syringes. Check it out at Modality Solutions today!

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https://lnkd.in/gKzw332q Biotechnology Big Pharmaceutical Industry: In the July 11 report, the analysts calculate that products #losing #exclusivity through 2030 are generating a combined $183.5 billion in annual sales, with #Amgen, #BristolMyersSquibb and #Merck facing the most #exposure of their revenue. Per Morgan Stanley’s metrics, #JJ is in excellent shape as just 33% of its revenue is exposed to patent expirations through 2030, compared to an industry average of 38%. Other #biopharma companies in good positions regarding their #patentcliffs are #Vertex (6%), #Gilead (24%), #AbbVie (29%), #EliLilly (31%) and #Pfizer (33%).

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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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As we celebrate Aryastha Life Sciences First Anniversary, this past year has been incredibly inspiring. Since our inception, we've maintained a unique position, securing Series A funding and establishing India's leading CRDMO. This milestone has empowered us to pursue our mission and vision with confidence, supported by state-of-the-art infrastructure and top-tier talent, allowing us to deliver unparalleled services. Our robust scientific expertise has attracted strategic clients from the US, Canada, Europe, and India, nurturing enduring business relationships. We extend our sincere thanks to our dedicated team and strategic clients worldwide for their trust in our scientific credibility. This trust enables us to make informed, strategic decisions to achieve project goals and ensure shared success. We deeply appreciate all who have supported us and those seeking to collaborate with Aryastha Life Sciences as essential resources and strategic partners. Together, we are poised to achieve significant success in advancing global healthcare for patients. #AryasthaLifeSciences #Anniversary #LifeSciences #CRDMO #SeriesAFunding #Innovation #Healthcare #AryasthaLifeSciencesAnniversary #GlobalImpact #ScientificExcellence #StrategicPartnerships #Teamwork #ClientSuccess #CuttingEdgeResearch #HealthcareAdvancement #Milestone #Inspiration #GlobalHealthcare #IndiaInnovates #Biotech #PharmaInnovation

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Regulations are always evolving, opening new opportunities to interact with FDA. The Inflation Reduction Act (IRA) of 2022 had an appreciable impact on the pharmaceutical industry in authorizing Medicare to negotiate drug prices starting in 2025 for the 10 most costly drugs in Part D. Review the attached slides for an update on the status of IRA in the pharma world. #BostonBiotechnologySummit #InflationReductionAct

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The adoption curve for AI based Pharmaceutical Research and Development continues to advance. Some of the leaders in the space led a fascinating and informative conversation at the JP Morgan Healthcare Conference today.

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How do you quantify and analyze in a rare matrix? I am proud to share that Dr. Prajita Pandey, Assistant Director of Chemistry at Emery Pharma, has developed an LC-MS/MS method for quantitating a small molecule in vitreous humor using human plasma as a surrogate matrix. This approach, aligned with ICH M10 guidelines, addresses bioanalytical challenges such as matrix interference and analyte instability. The method’s robust validation includes specificity, recovery, carryover, stability studies, and parallelism to ensure accurate and precise results. By employing a surrogate matrix, this strategy enhances detection limits and method reliability, offering a cost-effective solution for bioanalysis in challenging matrices.. #LCMS #bioanalysis Moji Bonakdar Ryan Cheu, Ph.D. Hui Zhao Emmett Cunningham Bill Galush Adrienne Graves Eric Donnenfeld https://lnkd.in/grHCyTz4

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Anyone who knows me knows that my commitment to diversity, equity and inclusion in science runs deep. I have seen through my own experience that prioritizing equity and representation within an organization is not just a moral imperative, but also a strategic asset. And as a business leader, people manager and scientific head, I’m proud of what I’ve seen in Sanofi's Diversity, Equity & Inclusion Report for 2023. 44% of our senior leaders are women. 100% of our clinical trials in the US have diversity targets. And the gender pay gap is less than 5% in most of our countries. To be clear, we aren’t there yet against all of our 2025 Global DE&I ambitions. Even when we do reach the numbers we’ve set for ourselves, we’ll still have improvements to make. But our commitment is real, and so is the progress. This progress is especially critical – and I would argue maybe more than anywhere else – in R&D. Clinical research requires embracing the diversity of perspectives, backgrounds and experiences that reflect the patients we are serving. Game-changing medicine doesn’t come from a single group of like minds. If everyone in the room looks and sounds the same, I know from experience that we aren’t going to succeed. I believe Sanofi can be a force for positive change in the world, and I plan to make R&D an example. Read more about all of the incredible work my colleagues across Sanofi are already doing here: https://lnkd.in/efar2sQU #DiversityEquityInclusion #AllIn #SanofiDEIReport2023

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I had the great privilege to speak to our early career employee resource group today, AZ Inspire, about how to navigate their career development. During the talk, I had the opportunity to share my own journey during my 16+ years with the company in 9 different roles spanning many functions. Below are a few of my reflections: - Color outside the lines of your job description: be open to opportunities to expand your responsibilities beyond the scope of your role (within reason, of course). Some of my greatest learning and capability has come from things that weren't "my job." -Have active and ongoing development conversations: Having regular "small" development conversations is much easier than waiting for a "big" conversation, i.e. having to tell your manager that you're leaving for a new role. -Build your network: Look for opportunities to make connections outside of your immediate department and find people with job titles or in functions that interest you. Reach out for an informal discussion, informational interview or potential mentorship. -Focus on skills, not job titles: Often we limit ourselves with labels (i.e. job titles or specific functions) rather than focusing on the skills requirements of a role. When you consider your strengths and experience, try to take the specifics of your role/expertise and take it one level higher to make it more general. -Demonstrate learning & change agility: Learning agility will help you make the case for a cross-functional move or a move with a notable development area. Don’t be afraid to acknowledge the development gap but focus your energy on demonstrating how you will bridge it. Share specific examples of where you have overcome similar gaps or displayed learning agility in the past. What would you add to this list?

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Life Science Business: $300B 𝐌𝐚𝐫𝐤𝐞𝐭 𝐎𝐩𝐩𝐨𝐫𝐭𝐮𝐧𝐢𝐭𝐲! The pharmaceutical landscape is evolving as nearly 200 drugs, including 69 blockbusters (annual sales >$1B), approach patent expiration. While this "patent cliff" poses challenges, it also unlocks a $300B market opportunity for those ready to innovate and adapt. 𝐓𝐡𝐞 𝐑𝐨𝐚𝐝 𝐀𝐡𝐞𝐚𝐝 1:- 2025-2029: Blockbusters like Perjeta, Blincyto, Keytruda, and Darzalex will see biosimilar entries, paving the way for increased access and competition. 𝐇𝐨𝐰 𝐂𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬 𝐂𝐚𝐧 𝐒𝐮𝐜𝐜𝐞𝐞𝐝 Digital Innovate: Develop cutting-edge therapies and expand into new markets through digital transformation. Collaborate: Partner strategically for biosimilar launches and market entry. Diversify: Broaden portfolios to create growth opportunities. 𝐏𝐨𝐬𝐢𝐭𝐢𝐯𝐞 𝐈𝐦𝐩𝐚𝐜𝐭 𝐟𝐨𝐫 𝐀𝐥𝐥 Patients and providers can benefit from greater treatment options at more affordable prices, while biosimilar manufacturers and innovators can redefine therapeutic landscapes. The future is bright for those who embrace the digital transformation. Let’s shape it together and reach us for AI solutions demonstrations on #clinicaltrialsautomation, #DataHarmonization, #RealworldEvidence #LiteratureReviews etc. Source: Joanna Sadowska

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Hello Everyone, I will be delivering the first of these sessions on 29th Apr. Through practical examples, I will be sharing my knowledge and experience on how compliance & quality management go hand in hand to achieve operational excellence. #pharmaceuticalmanufacturing #medicaldevices #biotech #clinicaltrials #GMP #compliance #qualityassurance #qualitymanagement

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We know that delays, bottlenecks, and rising costs can really slow down the drug development process. These are major challenges that biotech and pharma companies face, but there are ways to tackle them head-on. Leading CROs navigate these obstacles with innovative strategies to keep programs moving forward. My colleague, Vimal Patel, recently recorded a great on-demand webinar walking you through the cutting-edge bioanalytical strategies – including automation solutions – that help clients make smarter, faster decisions and accelerate their development timelines. Click this link to watch: https://okt.to/pzfWy0

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#factfriday 👨‍🌾 My Name is Bryan Boomer the owner of Boomspharm a Genetic Consulting company based in Los Angeles, CA. 🪴Ive been growing for 20+ years primarily specializing in indoor cultivation. 📖 Educational background: Business Management & Marketing Degree ⏰20+ Years Commercial HVAC and Electrical Experience (Family Biz) 💪 The collective experiences above have given me a unique skillset able to assess, design, build, commission, hire, train, direct, market, and sell any facility/product in the cultivation space. ✅ My emphasis on quality assurance with due diligence checks inspecting raw materials and equipment suppliers has enabled me to better mitigate common issues seen in the grow by short cuts taken and not truly understanding the inputs needed for outputs desired. 🧬 Moreso recently I have focused on genetics for input; starting with tissue cultured generation zero plantlets with partnered labs, we provide clean elite mom stock for my verified and partnered nurseries that in turn produce generation one clones for bloom clients needing production ready clones & ready to flip teen plants. The SOPs ive drafted include random HLV sampling to also help QC along the propagation process. 🚛 I visit each nursery partner weekly to assess the health and provide solutions to enhance the propgation department while mutually benefiting my bloom clients who receive premium clones and teens to start their production off right. 🙏 We savvy ourselves as cultivators veg partners, encouraging them to visit us for due diligence and Ill show you how much more revenue youll make by shutting down your mom and clone rooms, contracting with us for your bloom cycles, we can offset pest pathogen and production risks, and offer you a premium product at a cost less than most would be able to achieve internally at such a small scale for veg. 📲 Reach out to me directly to learn more about the equipment trials for products I see doing well in nursery and bloom spaces. Follow @boomspharm & @clone2u for more and websites www.boomspharm.com & new genetics marketplace www.clone2u.com (both getting updated this Aug2024!) #Adaptandgrow

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Leaders of San Diego, come and join me at the Alzheimer's Association® San Diego Annual Business Breakfast to learn how you can best support those affected by Alzheimer's in your teams. Details below:

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