Pete Makowenskyj

🗞 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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Did you know that facility maintenance at your CDMO could impact your drug development? Charlie Hoff, JLL Life Sciences Contract Organizations Leader, emphasizes the crucial role of integrated facility maintenance in ensuring efficient operations and cost savings at CDMOs. From HVAC systems to pest control, proper maintenance is vital for regulatory compliance and product quality. Some CDMOs now outsource maintenance to specialized firms, potentially improving coordination and cost-effectiveness across sites. Read more in Outsourced Pharma: #JLLFacilitiesManagement #IFM #CDMO #FM #DrugDevelopment

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Regeneron builds new venture arm with $500M commitment to invest in biotech and beyond Regeneron is joining its pharma peers in the venture investing sector, committing up to $500 million over the next five years for its new private financing arm. The New York pharma unveiled Regeneron Ventures on Monday with Jay Markowitz, M.D., and Michael Aberman, M.D., at the helm, both of whom were previously executives at Regeneron. Markowitz said in a release that the outfit would be “agnostic to therapeutic area, technology and stage of development.” That wide-ranging view includes companies beyond drug development, including “devices, tools and enabling technologies.” Markowitz joins from Arch Venture Partners, where he was a senior partner and helped launch three companies. He was a senior vice president at Regeneron from 2017 to 2020 after more than 16 years in public investing roles, including eight at T. Rowe Price. Aberman spent seven years at Regeneron, including as the senior vice president of investor relations and strategy. He went on to lead a couple of biotechs: Quentis Therapeutics and XenImmune Therapeutics. “Our goal is to cultivate an ecosystem where the next generation of biotech companies can thrive, drawing on the lessons learned and successes achieved at Regeneron and throughout our careers,” Aberman said in the release. “Together, we will strive to identify and support groundbreaking advancements that push the boundaries of what's possible in science and medicine.” Regeneron joins nearly all of its Big Pharma peers in having a venture capital wing. Sanofi, Ei Lilly, Bristol Myers Squibb, Astellas and Novartis were some of the largest corporate investors in 2023, according to a tally by HSBC. Not only do the firms act as run-of-the-mill venture investors, but they can also serve as the eyes and ears of their respective pharma companies in the hunt for potential partnerships or deals.

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The roll out of MoCRA continues. Mandatory facility registration and product listings under the Modernization of Cosmetics Regulations Act went into effect today, July 1. Also noted that while the FDA hasn't yet provided detailed guidance related to MoCRA's safety substantiation requirements, the essence of this requirement is already in effect and fully enforceable by the FDA. Affected cosmetic companies are advised to be able to provide safety data for their products "derived from scientifically robust methods." Being able to demonstrate that your cosmetic-related facility is in a state of control has always made good business sense; now it's a regulatory requirement.

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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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Regeneron confirms FDA won’t approve myeloma drug over manufacturing issues The company expects a reinspection in the ‘coming months’ for a facility run by third-party manufacturer. After warning investors earlier this month of a possible delay, Regeneron Pharmaceuticals on Tuesday confirmed that U.S. regulators will not approve its experimental multiple myeloma drug at this time. The Food and Drug Administration previously identified flaws at a third-party fill/finish manufacturing facility. And while the manufacturer believes the issues have been resolved, a new inspection must take place before Regeneron can win approval of its medicine. The inspection is likely to happen in “coming months,” the company said. Regeneron emphasized the manufacturing issue was the only one related to approvability of its drug, called linvoseltamab. Executives told investors during an Aug. 1 conference call that they have not been informed by the FDA of any safety or efficacy concerns. While not unexpected, the FDA’s complete response letter represents a delay for Regeneron, which is vying to enter an already competitive market for a type of cancer treatment known as a bispecific antibody. Johnson & Johnson won FDA approval to sell its option, Tecvayli, for multiple myeloma in October 2022. And Pfizer in August 2023 got clearance to enter the market with a treatment called Elrexfio. The drugs work by targeting both diseased cells and the T cells that spur an immune response. Regeneron is hoping to distinguish linvoseltamab from already approved medicines by showcasing an administration schedule that requires less time in the hospital. And while it’s difficult to compare clinical trials run by different companies, Regeneron may have a slightly stronger data set to show doctors, according to a company presentation. https://lnkd.in/e9icn4Nu

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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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"The U.S. House of Representatives on Monday overwhelmingly passed the bipartisan bill, which targets WuXi AppTec, WuXi Biologics and other Chinese biotech companies as potential national security risks." While the bill still needs to go through the Senate, it looks likely that it will get passed. If you are looking to re-evaluate your #API #GMP manufacturing for a US based company with almost 40 years of experience, look no further than Ascensus Specialties. From small molecule synthesis, organometallic compound synthesis, high purity metals for cell culture media, and water soluble phosphines, we have a great reputation in support of pharma and biotech in the US. https://lnkd.in/exkt_w8V

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Check out Horst Ruppach's insights on navigating the revised ICH Q5A(R2) guidelines for biologics viral safety thorough documentation and proactive engagement with regulatory bodies. For the full article: https://okt.to/nRu86y

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The NC pharmaceutical industry #growth and #innovation has been nothing but astonishing since I moved here. While this is not a comprehensive list, I wanted to highlight some of the major expansions and builds in just the last few years for my friends who may have missed them (Note: Some information in this post may be out of date - information sourced from Fierce Pharma and respective company websites). Novo Nordisk: $𝟐𝐁 investment to build an Active Pharmaceutical Ingredient (API) facility. This facility aimed to increase production capacity for diabetes treatments. + Novo Nordisk: Additional $𝟒.𝟏𝐁 investment to build a second fill-finish manufacturing plant, doubling the combined footprint of Novo Nordisk's existing facilities in the state (~3,500 𝑗𝑜𝑏𝑠 𝑖𝑛 𝑁𝐶 𝑡𝑜𝑡𝑎𝑙). Eli Lilly and Company: over $𝟏𝐁 investment in a new injectable product and device manufacturing facility in Concord, North Carolina. (~600 𝑛𝑒𝑤 𝑗𝑜𝑏𝑠). + Eli Lilly and Company: $𝟒𝟓𝟎𝐌 investment in its manufacturing site in Research Triangle Park (~100 𝑛𝑒𝑤 𝑗𝑜𝑏𝑠). FUJIFILM Diosynth Biotechnologies: $𝟏.𝟐𝐁 in expansion of its end-to-end biomanufacturing facility in Holly Springs. This brought the total investment in the plant to more than $𝟑.𝟐𝐁 (~680 𝑛𝑒𝑤 𝑗𝑜𝑏𝑠). Amgen: $𝟓𝟓𝟎𝐌 investment in a greenfield manufacturing facility in Holly Springs for biologics and other medicine production. Resilience: $𝟐𝟐𝟓𝐌 aimed at scaling up production capacity. SCHOTT Pharma: $𝟑𝟕𝟏𝐌 in a new prefilled syringe manufacturing facility in Wilson, North Carolina (~400 𝑛𝑒𝑤 𝑗𝑜𝑏𝑠). Fresenius Kabi: $𝟏𝟎𝟎𝐌 expansion of its pharmaceutical manufacturing facility in Wilson, increasing production capacity for generic drugs in prefilled syringes (~450 𝑛𝑒𝑤 𝑗𝑜𝑏𝑠). Pfizer: $𝟔𝟎𝟎𝐌 investment in expanding its gene therapy manufacturing facility at its Sanford campus to improve clinical and commercial-scale manufacturing capabilities. Kyowa Kirin International plc. Kirin: $𝟓𝟑𝟎𝐌 to establish a biologics manufacturing facility in Sanford (~100 𝑛𝑒𝑤 𝑗𝑜𝑏𝑠). These significant investments in North Carolina foreshadow its growing role as a hub for biotech manufacturing and innovation. I'm glad I get to be a part of it, and I'm equally excited to see what comes next! #NC #Biotech #PharmaceuticalManufacturing

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Join the Alcami experts to hear them speak about critical GMP materials storage and management.

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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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Having mentors and advocates throughout my career have been a key element to my professional success. In this article, I talk about the elements and behaviors that lead to lasting, authentic, and beneficial mentor relationships. Please share your own experiences with mentors and advocates from your career journey! A special shout-out to Matthew Snyder for sharing his photo from the event for use in the article (and for being my mentor when we were at CRB)! #haskellaec #lifesciences #mentorship

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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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Johnson & Johnson to pour $2B into North Carolina biologics plant, add 420 jobs On the same day that Johnson & Johnson confirmed layoffs at its home base in New Jersey, the company made waves with a major manufacturing announcement in Wilson, North Carolina.  J&J is planning to build a state-of-the-art biologics plant to provide supplies for treatments across the oncology, immunology and neuroscience treatment areas, J&J said in a Tuesday press release. Construction is slated to begin in the first half of 2025, and the site will have a workforce of 420 once fully operational.  The company's total investment in the site is expected to reach "more than $2 billion," according to J&J's release. "We are investing in capacity and new technologies to enhance our industry leading capabilities and ensure a resilient supply chain for the future," Dapo Ajayi, J&J's vice president of innovative medicine supply chain, explained in the release. "North Carolina is an important hub for biopharmaceutical manufacturing and talent, and we are pleased to join this thriving life sciences ecosystem and become part of the Wilson community.” At a Tuesday meeting of the state's Economic Investment Committee, officials approved a 12-year reimbursement grant worth nearly $13.7 million, according to a press release from North Carolina Gov. Roy Cooper. The money is contingent on J&J meeting certain job creation and investment targets. Over the 12-year span, the manufacturing site is expected to grow the state's economy by $2.3 billion, according to the release. https://lnkd.in/eU9Cc97k

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Register to learn proactive clinical quality assurance measures that can be taken to prevent errors, protect patient data, and ensure data integrity as the core of running clinical trials. The webinar will also cover effective strategies to secure executive buy-in, creating a company-wide commitment to quality.

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oops! Gene editing needs to be undone, pronto...You can't make this up. DARPA on X: "We are soliciting innovative proposals to develop and demonstrate rapid methods to identify and optimize #novelmolecules that counteract gene editing technologies. To learn more, visit https://t.co/3L2HAUQgFy #BiotechInnovation #InnovationInScience https://t.co/or9N5S5aD6" / X

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Preparing for a pre-IND meeting with the FDA? It’s such an exciting milestone, but it’s important to ensure the timing is right. Over the past few months, I’ve connected with prospective clients who each have their "own" timeline for this step. While those timelines are unique to every program, the key to a successful pre-IND meeting lies in understanding what’s needed to get there, and unfortunately, that process can't be rushed. At Radyus Research, we’re here to guide you. Through thoughtful technical assessments and gap analyses, we can help you identify what’s missing and guide you toward a clear, actionable plan so your Facetime with the FDA is truly worthwhile. Our goal is to make sure your meeting is as productive as possible so you can feel confident about the road ahead. Let’s work together to turn your timeline into a success story! #DrugDevelopment #PreIND #FDA #Biotech #Collaboration #RadyusResearch #Preclinical

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