“Gerri is the ideal of what a senior manager should be: easy-going, but intense which allows creativity and brings out the best effort in those she manages. In the ad hoc matrix management approach to advisory projects at Nerac she lead the efforts to change the Nerac approach to client engagements and showed true bottom line leadership in getting things done. The energy level Gerri brought to the organization was contagious which made those who worked with her more productive. I'd would work with Gerri anytime, anywhere.”
Gerri Potash
Greater Philadelphia
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Paul Fehlner
Irrationally undermining patents does not solve the problem, though it raises unanswerable questions. What is the right number of patents for a biopharmaceutical product? Would they fit on the head of a pin? The Senate bill has that level of logic in the context of a patent system designed to incentivize, not limit, innovation. The system should encourage improvements to features like bioavailability, stability, safety, side effect profiles, and even convenience, not to mention repurposing drugs. Also, one good patent is enough to substantially extend exclusivity, so what happens then? Instead of playing games with patents, payers, including the biggest payer of all, the US Government, should condition adding a product to its formulary on the manufacturer's commitment to surrender exclusivity after a defined period (10 years?) by waiving injunctive relief for patent infringement after that time. That's a free-market, agreement-based solution with predictable effect. Competitors can license downstream development patents for royalties, rewarding unpredictable innovation that may occur during development. Or competitors can accept the risk and cost of designing around such patents. Either way, competitors can come to market. FRAND-like licensing programs would facilitate post-exclusivity licensing, and innovators would be assured of financial benefit for improving biopharmaceutical products after initial development.
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Luis Charles Chavarría
https://lnkd.in/ggRMWiJi Gross microbiological contamination but we wait almost a year to warn you? What happened to all those drugs made before, during and after the inspection that captured the evidence of gross contamination? These and many more questions paint a picture of why the agency even bothers to issue Warning Letters almost a year after the inspection that show significant risk to the consumer. This Warning Letter belongs to the latest batch just released by the agency, so it shows the current state of risk monitoring and mitigation. Not much urgency and not much mitigation, but much exposure. The best we can hope for, the gross current FDA recall process to kick in.
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Brennan Torregrossa
What do you have in common with David Schwimmer from Friends? Like actors, lawyers can be typecast. You have to prove that you can do more than what you currently do. If you can break your mold, you will go far. That is what my latest article and #5 on the list of top habits of successful corporate counsel examines. I know this is easier said than done. As we gain more experience in an area, it is harder to leave to do something else. Everything is so complicated and regulated that experience seems like it matters more than anything else. But that is dangerous thinking for your career. If you push yourself outside your area of comfort, you will get more comfortable about where your career is going. - Brennan PS Who are most typecast actors that come to mind for you? #acc #accfamily #generalcounsel
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Diluks De Silva
✨ Exciting Opportunity! ✨ Take advantage of an hour with a seasoned expert to tackle any challenges you might be facing. The Compliance Architects® team consists of industry-leading experts who can provide top-notch guidance and innovative solutions. Don’t miss this opportunity to benefit from our expertise! Don't Miss Out! Sign up below ⬇ #ProfessionalDevelopment #ExpertAdvice #CAExperts #ProblemSolving #15years #QualityCompliance #RegulatoryCompliance #QualityAssurance #ComplianceExperts #ConsultingServices #RegulatoryConsulting #QualityManagement #ComplianceSolutions #RiskManagement #IndustryStandards #AuditPreparation #ComplianceStrategy #QualityConsulting #RegulatoryAffairs #ProcessImprovement #ComplianceSupport
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Kristin Labate
What if the intensity of your desire could determine the height of your achievements? 🌟🔝 Napoleon Hill famously stated, “Desire is the starting point of all achievement, not a hope, not a wish, but a keen pulsating desire which transcends everything.” This powerful assertion lays the foundation for his first principle: Definite Purpose. Understanding and applying this can transform mere dreams into attainable realities. Defining Definite Purpose: ⭐️Clarity: Clearly articulate what you want to achieve. This isn’t just a general wish; it’s a specific, vivid and compelling vision of your outcome. ⭐️Conviction: Your purpose must be backed by a strong desire that feels almost tangible—a force so strong that it overcomes all obstacles. ⭐️Commitment: Devote yourself wholly to your purpose. This isn’t a half-hearted attempt but a full commitment to seeing it through. How to Harness a Definite Purpose: ✅Write it Down: Make your purpose tangible by documenting it. ✅Visualize Success: Regularly visualize achieving your purpose to reinforce your resolve. ✅Action Steps: Break down your big purpose into actionable and manageable steps. The journey to achievement starts with a deep, resolute desire that nothing can dim. Your purpose is not just what you wish to achieve; it’s the core of your drive, your actions, and ultimately, your success. 👉 Have you defined your purpose? How has it propelled you towards your goals? Share your experience in the comments or inspire others by tagging them! Let’s ignite our desires and pursue our purposes with passion! #NapoleonHill #DefinitePurpose #AchievementMindset #LeadershipGoals #SuccessDriven
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