Jo Anne Valentino

https://lnkd.in/gre8mUg8 If one is to look at a common denominator among these five FDA historical cases. We would see time, the time that transpired before the FDA system reacted to the risk. In the FDA business time is risk exposure and by default many times, loss of life. Fast forward to today and cases like the CPAP Phillips device and we see not much has changed in the agency’s timed reaction protecting the consumer to large scale risk. One can play the devils advocate and claim that many other cases were prevented to develop to this national impact. True, but if we are to apply the quality concepts the agency applies on its clients, validation, CAPA, and the rest of GMPs to lessons learned to its own operations what happens? What did the agency learned from all these historical cases that it applied to the Phillips case for example? This week we had one of the largest bottled water recalls in the history of bottled water. If you look at the causes of the recall it is time again. The conditions are time related negligence of company quality control and time related failure of the agency to inspect. Negligence, time after time in reacting to risk, much like most national cases. What are the primary factors that cause this reaction time issues? Maybe we need time to think about it?

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Harris vs. Trump: What the Presidential Election Could Mean for the Biopharma Industry As the 2024 election approaches, the close race between Vice President Kamala Harris and former President Donald Trump is sparking significant discussion about potential impacts on the biopharma sector. Analysts and industry stakeholders are weighing in on key issues like drug pricing reforms and regulatory policies that could shape biopharma's future under either administration. 🔴Potential Impacts Under a Trump Administration 🔴 Some believe a second Trump term could favor biopharma. According to BMO Capital Markets analysts Evan Seigerman and Kostas Biliouris, PhD, the industry might benefit from: 🔴Inflation Reduction Act Stability: The IRA may not expand and could be repealed. 🔴Less FTC Scrutiny: Potential decrease in Federal Trade Commission oversight on biopharma. 🔴Drug Pricing Reforms Targeting PBMs: Reforms may focus on pharmacy benefit managers (PBMs) over manufacturers. However, Trump's stance on drug pricing has been unpredictable. He has supported measures like price controls, not typically aligned with Republican positions, adding uncertainty for the industry. 🔵 Potential Impacts Under a Harris Administration 🔵 Vice President Harris's plan focuses on tackling high drug prices by addressing both PBMs and pharmaceutical companies. Key aspects include: 🔵 Cracking Down on Anti-Competitive Practices: Targeting practices that inflate drug prices. 🔵 Accelerating Medicare Negotiations: Speeding up talks to reduce medication costs faster. 🔵 Potential Use of "March-In Rights": Considering invoking Bayh-Dole Act provisions for reasonable pricing on federally funded drugs. While these measures aim to lower costs, some industry experts express concerns about unintended consequences. Invoking march-in rights could affect pharma-academic partnerships, potentially impacting innovation. The Industry at a Crossroads As election day nears, the biopharma industry is closely monitoring developments. The outcome could significantly influence regulatory policies, drug pricing reforms, and the business environment for pharmaceutical companies. Looking Ahead Regardless of the election outcome, biopharma will continue to face challenges in drug pricing, innovation, and regulation. Stakeholders are encouraged to engage in dialogue to find balanced solutions that promote both public health and industry growth. Join the Conversation What are your thoughts on how the election might impact biopharma? How do you see policies shaping the future of drug pricing and innovation? Share your perspectives below. Here a great article from BioSpace on this topic: https://lnkd.in/dv7dyphx

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https://lnkd.in/gjt4GJGf Take the F out of FDA, put the F back into FDA, but what happens if you make the F great again? The FDA stands at the great if not the greatest crossroads of that F future. Many uncertainties for sure, but one certainty is it’s lousy current performance. The agency’s solution under the current administration, -reorganization a favorite of bureaucratic bliss. If certain national political winds hit the battered sails of the agency, it might just knock down the mast period. Now I am not suggesting the agency’s food program will be or is a sail boat without a mast, I am saying it period. These are all opinions from a former FDA employee that did everything from collected melons in the field domestically and internationally to performed Low Acid Can food inspections of the big boys to import operations. So one can say I had my peek under the carpet as they say. Yes the real grass carpet. During the many years doing and supervising this program’s work, one common denominator was observed, barely making it, barely effective on every aspect of it. Now the BowTie announced they will cut the States contract work, the only part of the food inspection program that is actually inspecting, yep what a “F” mess. No doubt that F is on stage.

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Great opportunity in NYC

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🛑 The glass cliff theory holds that women are mostly likely to get a shot at a big job when a company is in crisis or turnaround. Beth Kowitt writes in Bloomberg “What’s now become apparent is that their rise had little to do with the pharmacy industry being particularly inclusive or intentional about fostering and promoting female talent. Instead, each company had an impossible job that needed to get done. And impossible jobs often go to women. It’s a classic glass cliff scenario.....In such cases, corporate boards are more willing to try a new kind of leader because the one they have (typically a white man) isn’t working out, or because likely male candidates see the job as a minefield they don’t want to touch. Women take the job because they know it may very well be their only chance to run a company.” https://lnkd.in/eKX4R7Mz https://lnkd.in/eWVr6xdY #equity #inclusion #leadership #glasscliff Jorge Herrera

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Crowell & Moring’s Helen Ogunyanwo discusses the impact of the Modernization of Cosmetics Regulation Act, which gave the FDA new regulatory powers over cosmetic products. Read more in Axios:

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We are just over 3 weeks away from the highlight US CI/MI event of the year! Join us in Newark, NJ at the Pharma CI Conference! I'll be speaking on Thursday morning during the event! Come say hello! I am looking forward to seeing and meeting you! 😊 #PharmaCI #CI #StrategicDecisionSupport #Strategy #Insights #ActionableIntelligence #CompetitiveIntelligence #MI #MarketIntelligence #Pharma

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On-shoring has been discussed for the last 4-5 years as a growing concern in biotech. The Biosecure Act is counting down the clock now for a big change in how we do business. https://lnkd.in/e8DJHVs4

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I had a fine experience recently chatting with John "Barr" Weiner about the evolution and current state of combination product development, definition, and related regulatory considerations. From his continued tenure at FDA, in which he has served in various leadership roles, Barr brought to the latest conversation in my Sit and Deliver videocast series on @Drug Delivery Leader many illuminating perspectives on how stakeholding organizations in biopharma may want to approach the global regulatory arena for combination products. #drugdelivery, #combinationproducts, #medicaldevices, #fda https://lnkd.in/ee6Qyypp

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So different; the #regulatory review process on both sides of the pond. 🛑 The CHMP states that the risks outweigh the benefits...so, it's a no go... https://shorturl.at/V022D #Biogen #Eisai #Leqembi #AlzheimersDisease #RegulatoryAffairs #Pharma #Healthcare

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💡 Check out this insightful whitepaper by my colleague, John Daley. Highly recommended for great insights!

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🌾 𝗪𝗵𝗲𝗮𝘁'𝘀 𝗪𝗲𝗲𝗸𝗹𝘆!! 🌾   #WheatsWeekly - August always feels quiet on LinkedIn, but we do have some exciting CDMO updates to share!   𝗕𝗿𝗲𝗮𝗸𝗶𝗻𝗴 𝗡𝗲𝘄𝘀   ✅ Eli Lilly and Company open their new 12-story innovation center in the Boston Seaport, occupying 346,000 square feet!   🔐 Ajinomoto Bio-Pharma Services lay off 71 staff members at California site after the Forge Biologics acquisition.   𝗠&𝗔 𝗼𝗳 𝘁𝗵𝗲 𝘄𝗲𝗲𝗸   🤝 Evotec and Bristol Myers Squibb further progress their strategic partnership, triggering a $75 million performance and program based milestone payment to Evotec.   🇫🇮 Nanoform and Takeda collaborate on on plasma-derived therapy development.   𝗘𝘅𝗽𝗮𝗻𝘀𝗶𝗼𝗻 𝗼𝗳 𝘁𝗵𝗲 𝘄𝗲𝗲𝗸   🏭 CiVentiChem has completed a new facility in Hyderabad, significantly expanding its manufacturing capacity by 300%.   🧬 Evonik expands formulation capabilities for lipid nanoparticles using KNAUER's scientific instruments. 𝗜𝗻𝘃𝗲𝘀𝘁𝗺𝗲𝗻𝘁 𝗼𝗳 𝘁𝗵𝗲 𝘄𝗲𝗲𝗸   💰Phosphorex receive new investment from NOF AMERICA CORPORATION to accelerate the establishment of their cGMP capabilities for enhanced collaboration and innovation in nanoparticle-based drug delivery.   𝗡𝗲𝘄 𝗟𝗲𝗮𝗱𝗲𝗿𝘀𝗵𝗶𝗽   🌟 Britton Jimenez is names the new SVP of Commercial Ops at Codexis, Inc.   👨‍🔬 Tanguy Le Talaer is named Head of CDMO Sales & Marketing at Sentiss Pharma Pvt. Ltd. 💫 Amit Thakkar, PhD, PMP is named VP of BD at Suven Pharmaceuticals.   Did I miss anything, let me know in the comments! 👇   #CDMO #pharma #biotech

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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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The recent removal of the 100% #AMPcap resulted in some interesting market dynamics. But what is AMP Cap, and why is it important to #plansponsors and manufacturers? When we chatted with Jessin Joseph, PharmD (Senior Director, PBA Services) he explained the history behind AMP Cap, new developments in the wake of the #InflationReductionAct, and how the market has reacted to those changes (among many other topics, like #M3P). Listen to the full episode here: https://okt.to/QOMlTa

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Interesting FDA panel discussion today on Strategies to increase clinical trial participation for diverse communities, featuring the OMHHE REACH Consortium. One of the key take-aways: many patients want to be invited to participate in clinical research; in fact, patients rarely say no when asked the right way. Many themes were mirrored across the different communities, settings, and geographies represented on the panel, and most of the conversation centered on building and maintaining trust. * This includes not 'parachuting' into communities, building trust takes time, active listening, repetition, education and co-creation, and a mindset of true partnership with community voices seen as equal partners. * The goal is community-based participatory research; come to the community offering what the community values and needs, not just wanting something; co-create and focus on research that has value to the community, not what happens to interest you. Meet the community where it is and be there when the community needs you. * Do not underestimate the importance of language and culture; we often go into communities with a language the communities have not heard before, and that does not honor or translate well to their culture, language, and lived experience. * Value cultural and geographic differences; for instance, not all Spanish-speaking communities speak the same Spanish; ensure you are communicating in a language that reflects what is spoken in the communities you are trying to reach. * People are not homogenous; for instance, not all Asian or Hispanic or Black communities share the same values, priories, cultures, traditions and languages; ensure you thoughtfully engage the communities you want to reach from the beginning. One solution will not fit all. * Leverage existing entry points to the community and be intentional; build a pipeline for future research, and intentionally expand the network of trusted advisors; it takes a lot of work to really be inclusive. For instance, working through primary care healthcare providers is key -- engage & educate primary care providers, mentor researchers and train frontline staff; share resources, and set up data systems to better understand who your community is. * Deliberately educate and train sponsors, researchers, and administrators to understand the community, its values and needs; increase research literacy in the community; co-train researchers and community to improve mutual understanding of values and norms. * Meet the community in person and allow ample opportunity to ask you questions. A few of the practical strategies for building trust: 1. Return research findings to the patients and the community(!!!) 2. Think about and discuss steps after the study is over (e.g., how to connect patients and communities with continued care) - being in clinical trials often offers the highest quality clinical care. 3. Help patients understand exactly how FDA is elevating the patient voice

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🚨 10 Key Takeaways from "Behind Big Pharma's layoffs — is there an end in sight?" 🚨 1️⃣ Massive Job Losses: In 2023, the biopharma industry saw around 14,000 job losses due to layoffs. 2️⃣ Bristol Myers Squibb Cuts: The company plans to eliminate 2,200 jobs by 2025, including 860 in New Jersey. 3️⃣ Bayer Restructuring: Bayer has already reduced its workforce by 1,500, with more layoffs possible. 4️⃣ Expense Trends: Pharma companies' selling, general, and administrative expenses have stayed at 29% for decades, while R&D spending has risen from 12% to nearly 18% of revenue since 2000. 5️⃣ Funding Worries: An EY Biotech report reveals that 31% of biotechs may run out of funds within a year. 6️⃣ High-Demand Skills: Digital technology, AI, and market access skills are currently in high demand. 7️⃣ AI's Impact: An EY-Parthenon report suggests AI could drive future hiring in biopharma as it becomes crucial in drug development. 8️⃣ Economic Shifts: The European Central Bank has cut interest rates from a high of 4% as inflation decreases, while the Federal Reserve has yet to follow suit. 9️⃣ Political Uncertainty: The November 2024 election is unpredictable and could impact the industry, though effects will only be known post-election. 🔟 Future Outlook: Arda Ural of EY predicts a potential return to normalcy by 2025, with the worst of the layoffs possibly over by then. Stay tuned for more insights and trends from the biopharma industry! 💡✨ #Pharma #Biotech #Layoffs #JobMarket #AI #Innovation #Healthcare #Economy #FutureTrends

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https://lnkd.in/gRmmHkjs FDA does/does not expect you to follow cGMP completely on an investigational drug pertaining to parts 210 and 211 in phase 1? Yes the official gab is that this is to streamline and help drug development. The devil resides in "completely”, what does this mean in government FDA terms? Was this really done to aid good drug development or aid the agency’s inspection burden? These and many more questions swirled around FDA real intentions when it does something like this. So in saying it doesn’t have to meet "all” the cGMPs of approval/commercial, the questions are really pertain to which ones must it meet? The answers, are really not given. Classic FDA moves, we will let you know which ones when we have a problem you caused. As to the boiler plate clarification sessions the agency promotes they are nothing more than clarification of it’s side steps it all ways takes to leave wiggle room for its enforcement policy. Yes of course we define the wiggle. Yes we don’t mean you can just mix the stuff in the vat without "any” cGMPs, just not all. Kinda reminds me of you of your golf posse is telling you, you can have some of the beer. You end up drinking one too many and they quickly yell they didn’t tell you you could that many. Disclaimer, this commentary is not meant to imply all FDA guidance is bad, just the ones I pick.

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🤔 Pharma professionals: What if your company's next breakthrough isn't in the lab, but in how you communicate? Sound far-fetched? Let's think critically about this for a moment. Consider these common scenarios in pharma: 💊 A promising drug faces delays in regulatory approval (Who knew the FDA wasn't a fan of interpretive dance as a data presentation method?) 🧪 Manufacturing deviations occur due to misinterpreted SOPs (Because "mix thoroughly" is clearly open to artistic interpretation) 📧 Cross-functional projects stall because of communication breakdowns (Ah, the joy of interdepartmental email tennis) What if these aren't just "communication issues," but symptoms of a deeper problem - a lack of critical thinking in how we write and share information? The most successful pharma companies don't just write well; they think differently about writing. (And no, thinking differently doesn't mean channeling your inner James Joyce for that next regulatory submission.) So, what does critical thinking in pharma writing look like? 1️⃣ Analyze root causes systematically: Identify underlying factors in deviations or quality issues. 2️⃣ Evaluate evidence objectively: Distinguish between facts and assumptions in investigation reports. 3️⃣ Consider multiple perspectives: Examine issues from various angles to develop comprehensive solutions. 4️⃣ Challenge status quo processes: Identify potential improvements or hidden risks. 5️⃣ Synthesize complex information: Connect data points across departments for meaningful conclusions. By applying these principles, you're not just writing: you're solving problems before they start. Imagine: 📋✅ Regulatory submissions sailing through approvals 📘👍 SOPs that are actually followed 🤝🚀 Cross-functional projects moving smoothly It's not a pipe dream. It's what happens when you apply critical thinking to writing. So, pharma folks, I challenge you: Take a hard look at your next document. Are you just writing, or are you thinking critically about how you're communicating? Your next breakthrough might not be in a test tube. It might be in a well-crafted email, a clear SOP, or a compelling regulatory submission. What's your take? Share your stories (or horror stories) in the comments ⤵️ P.S. Need help with this? That's our thing at Hurley Write, Inc.. Just saying. 😉

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Great article summarizing a fascinating and very timely #MedPAC conversation last week. If nothing else, the article puts some of FDA's proposals around #biosimilars and #interchangable #biosimilars into context and reinforces how complex #drugpricing policy really is. One grim reality for many #raredisease patients: list prices have little correlation with actual #out-of-pocket costs for our patients, many of whom rely on #medicalproducts on #specialtytiers of the formularies. For background, MedPac is the #Medicare Payment Advisory Commission, an independent legislative branch set up to advise #Congress on the Centers for Medicare & Medicaid Services #Medicare program, and a key voice in the #drugpricing and #pbm #pharmacybenefitmanager reform debates.

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