Daniel Valentino

As NAMs are becoming more relevant and accessible in today’s chemical product development, Labcorp is innovating in vitro alternatives so clients around the globe can leverage these new assays. From standard techniques to novel solutions, we can identify an approach that fits your product’s specific regulatory requirements. Discover your NAM options today. #CropProtection #ChemicalDevelopment #InVitroStudyAlternatives NewApproachMethodologies #NAMs

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Dear Friends, while we are all looking deeply and more deeply into the Revision 2 of the FDA’s Guidance for Industry, “Control of Nitrosamine Impurities in Human Drugs”, a significant change in the content of the website (https://lnkd.in/eYXSx-Gu) in the section, “Recommended Safety Testing Methods for Nitrosamine Impurities” of the website, an update that may merit looking with new eyes. This section says, “In addition to the enhanced Ames test, the Agency is currently requesting a second in vitro mammalian cell mutation assay and in vitro metabolism data (including human hepatocyte or microsome) to support an AI limit of 1500 ng/day." Scary, isn't it!! Chuck Lambert of Intrinsik and I put some thought into this and came up with some ideas of what may be needed in the form of in vitro testing beyond the modified Ames Test to derisk a nitrosamine. Please visit the BLOG at my Raaha LLC website. Just to let you know, this is "food for thought" as we wait for more clarification from FDA and should be taken only as a possibility. https://lnkd.in/eh5Y6kjW #nitrosamines, #pharmaceuticals, #carcinogenic, #genotoxic, #impurities, #FDA, #FDAguidances, #API, #drug

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Sharing a fascinating episode on the science and psychology of humility from Hidden Brain, one of my favorite podcasts. https://lnkd.in/gepbc9Xy A few insights: ✔ Humility plays a crucial role in our personal relationships, society, and workplace. ✔ Humble leaders have teams with higher productivity and satisfaction, more employee engagement, and they are more creative.  ✔ Intellectual humility - a key tenant of scientific inquiry is openness to uncertainty. In a society that values confidence and certainty, this openness can be viewed as a weakness, when it is really a strength. ✔ "Even if something doesn't make sense to us, cultural humility asks us to accept that it can be a real concern to someone else" #leadership #hiddenbrain #pharmacy

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Let your values drive how you do business and how you treat your team.

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In #NeurodegenerativeDisease news, specifically on an experimental treatment for #ALS, with this new #strategic partnership is penned between Dewpoint Therapeutics and Mitsubishi Tanabe Pharma America. ⚛️ The asset is the former's drug, designed "to address the accumulation of a protein into toxic structures that lead to neuronal dysfunction in people with ALS." 🤝 The alliance would grant MTP exclusive rights to license, upon achieving certain developmental milestones. ⚕️ This would add to MTP's existing US-marketed ALS treatment, #Radicava https://lnkd.in/evayrVv4' #Dewpoint #Mitsubishi #Pharma #Biopharma #Healthcare

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#Certara #CoAuthor webinar happening June 25th. Join us to see how CoAuthor will be transforming regulatory writing and bringing many efficiencies to your writing process. #regulatorywriting #AI

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Summer is here and many of us are more than ready to take a well-deserved break, myself included. As I gear up for my trip, I'm reminded of the importance of preparation—especially when it comes to traveling. One essential item I never leave home without is a well-stocked pharmacy kit. Whether you're planning an adventurous vacation or a relaxing one at the beach, having a pharmacy kit can make a world of difference. It typically includes over-the-counter medications for common ailments like pain relief, allergies, indigestion, motion sickness etc. Teva's over-the-counter (OTC) products portfolio includes a range of consumer healthcare treatments available that help relieve and prevent a variety of these conditions. If you are not certain what to bring with you, remember to consult a pharmacist or healthcare professional that can advise you. Don’t forget to enjoy your time off as well 😉 #tevapharm #tevapharmaceuticals #tevaotc #otc #vacation #vacanze #vacaciones #SummerSafety #CorporateWellness #HealthAndSafety #WellBeingAtWork #travel #traveling

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Energy is never created or destroyed; it only changes form. Just like energy, challenges in life don't vanish - they transform into opportunities for growth, resilience, and innovation. The question is: what will you transform yours into today?

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🗞 Breaking news 🤩 Genezen acquire uniQure's commercial GT manufacturing ops in Lexington!! This strategic acquisition will enable Genezen to deliver late-phase and commercial gene therapy development and manufacturing services to customers around the world. Check out full article below👇 #CDMO #Genezen #GeneTherapy

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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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We often read about and are inspired by unique leadership achievements, organizational excellence, and flawless operational execution. All things to strive for, but not always the reality. Life in business, as in general, is not paved with easy solutions and one recipe for success. Hard choices are often required, dilemmas constantly surfacing, and difficult conversations necessary. So, despite all good intentions, with investment in strategic plans and strong organizational support, positive outcomes are not guaranteed and do not come without sacrifices. Six months ago, I took over as the head of our newly established service center in Mexico City. A truly exciting challenge to support further globalization and sustainable growth of Novo Nordisk. It offers endless opportunities to drive operational excellence, talent development, and global business integration. Today we are more than 100 employees, with great energy and high ambitions. But I cannot claim that we got here without challenges. Starting a new business is not a simple effort, even in a company that recently celebrated its 100th anniversary. Many things were implemented too fast, too fragile and without full understanding of the context. Perhaps we didn’t ask a simple question often enough— “are we ready to move to the next stage”? Ultimately, we found a need to hit pause and revisit the basics, to build a foundation that can support long-term success. Revisiting the basics led to changes, some of which negatively impacted internal and external first-movers. While this is regrettable, we also need to recognize that sub-optimal decisions do not age well. Mistakes are painful, but learnings are precious, especially when rooted in collaboration, patience, understanding, and transparency. On the back of this, I’d be remiss to not recognize all who have contributed to this project, from our first employees to our first internal customers. This is what encourages me most – our people. To do what we do, we rely on the talent, passion, and diversity of our employees. We depend on the multitude of personal experiences, perspective, and backgrounds, that show up to work every day. In the end, I am very encouraged about our future and believe that together we will create something lasting and meaningful. Something that contributes to Novo Nordisk driving change to defeat serious chronic diseases. And I hope many more people will join us on this endeavor. From personal experience, I can attest that Novo Nordisk offers life-changing opportunities, within and through the organization. Our Mexico City service center is here to stay, and we look forward to the next chapter of the project, to be written by our wonderful team, rooted in our strong company values.

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Congrats to Christine Juday and the Real Chemistry Market Access team for our first-ever guest blog with Drug Channels Institute, an HMP Global Company. Chris makes a compelling case for how patients' perceptions of what "counts" as an out-of-pocket cost are more expansive than manufacturers may think. Read the full article to learn more about the implications for biopharma manufacturers' strategies to improve access and affordability. https://lnkd.in/eWcxGTx4

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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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As NAMs are becoming more relevant and accessible in today’s chemical product development, Labcorp is innovating in vitro alternatives so clients around the globe can leverage these new assays. From standard techniques to novel solutions, we can identify an approach that fits your product’s specific regulatory requirements. Discover your NAM options today: https://lnkd.in/ed_27CNQ #CropProtection #ChemicalDevelopment #InVitroStudyAlternatives NewApproachMethodologies #NAMs

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Amgen is committing $1 billion to establish a second drug substance facility in Holly Springs. This new project, combined with a previous investment of $550 million, raises Amgen's total planned investment in the area to over $1.5 billion. The new plant will feature advanced technology and sustainable practices. Alongside the existing facility, Amgen's developments in Holly Springs are expected to generate 370 new jobs.

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The Food and Drug Administration has a busy fourth quarter of approval decisions ahead. Dive in to learn more: https://ow.ly/uzgM30sIcsC

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