Naresh Sethi

A big thank you to HBA NY Tri-State region's Central NJ chapter and Sanofi for hosting an exceptional event on market access in the pharmaceutical industry. The panel did an outstanding job educating attendees on the crucial role market access plays within pharma organizations. 📝 Key takeaways⭐️: 📓Commit to learning: If you're considering market access as part of your career path, don't just dip your toes in. Dedicate 2-3 or more years or more to truly understand the field's complexities. ❓Cultivate curiosity: Success in market access hinges on asking the right questions. Develop a mindset of continuous inquiry to excel in this role. 🏃‍♂️‍➡️Stay adaptable: The market access landscape evolves rapidly. Be prepared to keep learning and adjusting your strategies as the field changes. This event reinforced the importance of market access in shaping the future of pharmaceutical companies and patient care. Negelle Morris Nazanin Mehin Olivier Bogillot Garrett Ingram Lalitha P. Chandrashekhar #MarketAccess #Pharma #ProfessionalDevelopment #HBACentralNJ #Sanofi

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Over my 20+ years in the pharmaceutical industry, I’ve seen many trends come and go, but today’s shift stands out as one of the most profound: moving from stand-alone service providers and equipment suppliers to integrated solutions that truly serve the customer. At Ellab, we’re not just adapting to this shift—we’re driving it. By combining cutting-edge equipment with deep expertise, we are creating solutions that reduce complexity and build trust. This isn’t just about providing products; it’s about taking responsibility for validation and compliance, so our customers can focus on what they do best: delivering safe, effective products to patients. This shift has made me reflect on how much progress we’ve made as an industry—and the challenges we still face. Simplifying processes and aligning diverse teams and technologies is no easy feat. But every time we help a customer work more confidently and efficiently, it reaffirms why this transformation matters. How is your industry tackling complexity, building trust, or driving meaningful transformations? I’d love to hear your insights. #Ellab #IntegratedSolutions #CompliancePartner #PharmaValidation #LifeSciencesLeadership #CustomerSuccess #PharmaInnovation

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In the latest issue of IBI Journal, Sarah McAliskey from Almac Clinical Services shares invaluable insights on leveraging technology and expertise to protect clinical trial supply. Her expertise highlights the critical impact of these practices on the pharmaceutical industry. Don't miss her feature on pages 56-58! Read more here:https://hubs.li/Q031G_0N0

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Our team at UPMC Enterprises recently brought together an exceptional group of industry leaders from health care, biotechnology, policy, pharma, and life sciences for the second annual Top of Mind Summit: Life Sciences.  This year’s Summit fostered transformative discussions and meaningful collaboration on technological innovation, life-changing health care models, patient-centered care, and strategic partnerships. We invited forward-thinking professionals to address the pressing challenges and emerging opportunities shaping the future of health care. Key topics included how real-world data and AI are reshaping therapeutic development, what is needed to optimize clinical trials, and how we can enhance equitable access to cutting-edge treatments. Panels also highlighted the essential role of partnerships across health care systems, academia, and industry, with a special pre-summit on women’s health that built crucial networks to advance the health of women. At the Summit, we showcased UPMC’s distinctive approach to innovation and the unique UPMC Enterprises model, which merges clinical and scientific insights with investment discipline and industry knowledge to drive progress. I was honored to help lead the event and two of the discussions. We’re excited to share highlights and impactful moments from the Summit with you in the recap report. Let’s continue building on these conversations and partnerships to create a stronger, more innovative health care ecosystem. https://lnkd.in/eHnmaAAq

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In an article on AstraZeneca’s Farxiga blockbuster drug, PharmaVoice quotes Daniel Chancellor, Director of Thought Leadership at Norstella, Citeline's parent company: https://ow.ly/qmv650TMSa6. The article also references Citeline’s “Billion Dollar Blueprint: The Journey to Blockbuster Status” report: https://ow.ly/hJPB50TMSa5. #BlockBusterDrugs #PharmaTrends #DrugDevelopment

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Our President and CEO, Michael Stubblefield, recently spoke with the Philadelphia Business Journal about the opening of our new Bridgewater Innovation Center and solving the toughest challenges in biopharma research, discovery, and production. From faster scale-ups and streamlined workflows to direct collaboration with our scientists, our network of 13 innovation centers across the globe help scientists innovate, improve efficiency, and bring life-changing therapies to market faster. Follow Michael Stubblefield for more insights and read the full article here: https://bizj.us/1qmila  #Biopharma #Research #Discovery #Bioproduction 

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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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In an article on AstraZeneca’s Farxiga blockbuster drug, PharmaVoice quotes Daniel Chancellor, Director of Thought Leadership at Norstella, Citeline's parent company: https://ow.ly/sCkr50TMSAl. The article also references Citeline’s “Billion Dollar Blueprint: The Journey to Blockbuster Status” report: https://ow.ly/RvuY50TMSAm. #BlockBusterDrugs #PharmaTrends #DrugDevelopment

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Looking forward to bringing together Senior Regulatory Leaders Victoria Tu, Ph.D., MBA, DABT, Teginder S., Greg Adamson, Lisa Pankiewicz and Barry Ritz at the Veeva Consumer Products Summit next week to discuss how they are successfully leading their organisations through the tsunami of change in regulation, technology and consumer expectation. These are challenging and exciting times in Regulatory Affairs and fortune truly favors the brave. #productstewardship, #regulatory.

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Our President and CEO Michael Stubblefield recently shared insights with the Philadelphia Business Journal about our new Bridgewater Innovation Center and its role in advancing biopharma research, discovery, and production. With 13 innovation centers worldwide, Avantor is empowering scientists to streamline workflows, scale up faster, and collaborate directly with our experts—helping bring life-changing therapies to market more efficiently. Follow Michael Stubblefield on LinkedIn for more insights and read the full article here: https://bizj.us/1qmila

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What is culture, and what do we mean by it? Culture means different things to different people, and means different things in different companies. I know what I strive for, though and what I respect. Recently, I had the privilege of witnessing how Dr. Hatti captures and relays culture at Suburban Research Associates an Atlas Clinical Research site. Over many years, Dr Hatti has built and then evolved what his vision of shared stand on how we treat patients, each other, and our partners. I've never seen anything quite like it. It's rare to see someone codify with such clarity, and such love what their work means. Dr. Hatti took the time—really took the time—so that everyone who works there understands how their contributions make a difference. Seeing this has reaffirmed my belief in the power of culture. When done right, it can inspire, motivate, and bring a sense of collective ownership. I love my job... #Leadership #Culture #Inspiration #Teamwork

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9 days to go! Want to get a solid understanding of the challenges clinical sites experience when using IRT systems and how to mitigate for these when selecting your system? Join us next week in Boston where Joe Lisi, Senior Manager, Clinical Information Operations, IRT Lead at Takeda will be moderating a discussion with Igor Druker, Director, IRT & Clinical Supply Systems at Biohaven Pharmaceuticals and Jimmy Bechtel, MBA, Vice President, Site Engagement at Society for Clinical Research Sites (SCRS), diving into “Pain Points for Sites when Using IRT Systems" addressing these big questions: - What in IRT systems is redundant from a site perspective? - What processes are helping or hindering them? - What is IRT’s role in making things easier for sites? - What are support sites wants and needs from sponsors and vendors? - What are the wants and needs with regards to data exchange? Join them to understand the various challenges and implement your learnings to ensure you're supply strategy is running as quickly and effectively as possible from the get-go! 👉 Register now: https://lnkd.in/ecrmZS8z 📑 Download the agenda to learn more: https://lnkd.in/eTbas2UG #IRT2024 #IRT #InteractiveResponseTechnologies #ClinicalSite #ClinicalResearchSite #ClinicalSupply #ClinicalSystems #ClinicalTechnology #ClinicalResearch #Pharmaceuticals #Biotech

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Discover strategies for overcoming the specific obstacles associated with launching your cell and gene therapies (CGTs) into the marketplace. Dive into our newest blog post! https://gag.gl/NJNQ1Q and make sure to explore the accompanying white paper that you can find linked within our blog. #cellandgenetherepy #CGT #CMC #biopharma #drugdevelopment #regulatoryaffairs #pharma

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Project Optimus is revolutionizing early oncology trials, aiming to ensure more effective and safer cancer drugs and improve patients' quality of life. Parexel experts have identified three strategies to help sponsors overcome challenges in achieving dose-optimization requirements. Here’s what we know works: 1️⃣ Design an integrated first-in-human study 2️⃣ Reach agreement with FDA at each step 3️⃣ Challenge guidelines with a compelling rationale Let me know your thoughts below and read more in our New Medicines, Novel Insights report! https://lnkd.in/dmYADu-n #ProjectOptimus #Oncology #NovelInsights

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Exciting times in the world of innovative ADCs! Check out Differentia's Integrative ADC platform for drug discovery and development, as highlighted by CEO Kas Subramanian and others in a recent publication by Scheuher, Ghusinga, McGirr, et al. "Towards a platform quantitative systems pharmacology (QSP) model for preclinical to clinical translation of antibody drug conjugates (ADCs)." J Pharmacokinet Pharmacodyn (2023) Differentia's ADC platform offers a range of capabilities, including identifying optimal target combinations for bispecific ADCs, estimating antibody properties, selecting payloads, and predicting doses for First-in-Human studies. It also supports various regulatory submissions like INDs, NDAs, and BLAs. This platform, calibrated against two HER2 targeting ADCs, T-DM1 and T-DXd, leverages preclinical data to aid in making clinical predictions. Notably, it can be tailored to represent any other ADC, making it a versatile tool for drug development. Learn more about recent innovative ADC approaches here: [Link to the article] #ADCs #DrugDiscovery #PharmaInnovation #ClinicalPredictions

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Attention Life Science Professionals! 🔥 ANOTHER HOT TOPIC ALERT! 🧪🔬 Some More Good News in the Life Sciences! Check out the summary below regarding the 3,000 jobs created in Boston area in 2024. Share your thoughts in the comments! And if you are looking for folks, please let us know! hashtag #lifesciences #biotech #pharma #medicaldevice #diagnostics #hiring2024 #boston The Richmond Group USA

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Sema's Founder and CEO Matt Van Itallie joined a recent Pistoia Alliance event in Philadelphia for a presentation and lively discussion on managing the risks of GenAI in Biopharma. Beyond the nearly universal consensus that AI's benefits greatly outweigh the risks, there is also significant uncertainty on which risks matter most and how to tackle them. The presentation and session teased out some of those specifics. Key points: 1-The five major AI Risks for Biopharma come from Inaccuracy, Explainability, Data Privacy and Security, an uncertain Regulatory Environment, and Intellectual Property (IP). 2-On IP Risk, copyright and trade secret risks are the most pertinent but can be managed with the right safeguards. 3-As regulations evolve, biopharma companies should prepare for potential traceability requirements, similar to 21 CFR Part 11 and drug supply chain traceability (DSCSA). GenAI presents immense opportunities for innovation and efficiency in drug discovery, development, and patient care. By proactively addressing these risks, biopharma companies can confidently leverage AI to drive progress and improve health outcomes worldwide. If you'd like to get a copy of the presentation, contact [email protected].

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We started out Q1 with cautious optimism and the numbers continue to show the confidence was warranted. Biopharma M&A activity more than doubled nationally during the year’s first three months, coinciding with a rebound in venture capital deals as well as a flurry of IPOs. These are all good signs that the drug development cycle is normalizing and should translate into additional funding being available at the seed and Series A stages. Certain to be on the minds of funders and startups attending #AlignSummit24 on Thursday! https://lnkd.in/erEiJm6S  

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