Doug Fulling

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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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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What an interesting read on the shift from traditional patient recruitment methods in rare disease! Learn more about how to optimize patient-driven site engagement in my team member’s blog: https://bit.ly/4eHoBn4

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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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When evaluating eIRB systems, be sure to consider the needs of ALL institutional stakeholders - not just the IRB users. Read our blog from Advarra expert Faith Bertrand, CIP for advice bon assessing and implementing these technologies.

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Partnerships start with collaboration and an understanding of client culture. It is important to understand if a potential vendor shares the same values through a comprehensive RFP that also measures problem solving and personality traits. It is not about what you have....It is how you are going to customize an approach that best serves the client.

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Discover how Advanced Clinical is redefining FSP solutions! In this exclusive pharmaphorum video, our experts Lori Fletcher and Amber Beimer, MBA share insights on building flexible and innovative partnerships to accelerate clinical trials. 📈 Learn about our approach to delivering tailored Functional Service Provider (FSP) solutions that empower biotech and pharma companies to achieve their goals. 👉 Watch the full video here: https://hubs.la/Q02_k8kf0 #ClinicalTrials #Innovation #FSP #PharmaPhorum #HealthInnovators

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𝐑𝐄𝐆𝐔𝐋𝐀𝐓𝐎𝐑𝐘 𝐑𝐎𝐔𝐍𝐃𝐔𝐏 ⚛️ The FDA has released new draft guidance recommending best practices for multi-regional clinical trials (MRCTs) in oncology. Sponsors are encouraged to ensure that the outcomes of global oncology clinical development programs are understandable for US patients in support of marketing applications. 🌐 The FDA's final guidance on decentralized clinical trials (DCTs) clarifies several concerns raised by clinical experts and industry stakeholders regarding the earlier draft. This includes detailed requirements for maintaining a task log for healthcare providers, guidelines for physical inspections, and addressing challenges related to data variability in DCTs. 🤖 As the use of artificial intelligence (AI) tools, particularly generative AI, expands, experts remind regulatory professionals to prioritize the human aspect. Although these tools offer significant benefits, they necessitate human oversight and interpretation to be fully effective. During the opening plenary session, experts discussed how AI can be utilized across various sectors, the potential of this technology, and the hurdles in achieving its full benefits. Panelists included Ryan Kurtzman from the City of Long Beach, Bradley Thompson of Epstein Becker Green, Michelle Jump from MedSec, and Jay Mashburn from Recursion Pharmaceuticals, with moderation by Megha Iyer of Thermo Fisher Scientific. 🧬 As biosimilars gain market presence, they are generating competition with original products. However, patient adoption of biosimilars varies based on demographics, location, care setting, prescriber specialties, and types of insurance, according to two recent studies in Health Affairs. 🌐 The FDA has observed a rise in complete response letters (CRLs) issued to sponsors of biologics license applications (BLAs) over the last decade, with facility deficiencies being the most common reason cited, according to Leslie Rivera Rosado, a supervisory interdisciplinary scientist at the agency's Center for Drug Evaluation and Research (CDER). #Pharmaceuticals #Biotechnology #LifeSciences #PharmaNews #Biotech #HealthcareInnovation #DrugDevelopment #ClinicalResearch #Biopharma #PharmaTech #MedicalResearch #Healthcare #BioPharmaceuticals #PharmaIndustry #BiotechIndustry #PharmaCareers #MedicalInnovation #NewDrugs #Genomics #BiotechNews

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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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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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💥 SUPER MSL: The Quest to Become the TOP MSL on Your Team💥 Don't miss this weeks MSL Talk podcast with Daniel Snyder, Ph.D., Senior Medical Affairs & HEOR Leader who discusses the differentiators for MSLs that will make you stand out and become the top MSL on your team. Learn more about….   👉 The qualities and differentiators of a “Super MSL” 👉 The skills and attributes that make MSLs stand out relative to their peers 👉 What common mistakes do MSLs need to avoid to 👉 What MSL Team leader should do to encourage and entice ideal MSL skills The MSL Talk Podcast is available on all podcast platforms and the MSL Talk YouTube Channel.     MSL Talk is a podcast that features helpful information for current Medical Science Liaisons, Medical Affairs leaders, job seekers looking to break into the pharmaceutical industry in their first MSL role as well as anyone interested in hearing good industry conversations and medical affairs discussions.   #msl #medicalaffairs #medicalscienceliaison #MSLtalk #careers  

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💥 SUPER MSL: The Quest to Become the TOP MSL on Your Team💥 Don't miss this weeks MSL Talk podcast with Daniel Snyder, Ph.D., Senior Medical Affairs & HEOR Leader who discusses the differentiators for MSLs that will make you stand out and become the top MSL on your team. Learn more about…. 👉 The qualities and differentiators of a “Super MSL” 👉 The skills and attributes that make MSLs stand out relative to their peers 👉 What common mistakes do MSLs need to avoid to 👉 What MSL Team leader should do to encourage and entice ideal MSL skills The MSL Talk Podcast is available on all podcast platforms and the MSL Talk YouTube Channel. MSL Talk is a podcast that features helpful information for current Medical Science Liaisons, Medical Affairs leaders, job seekers looking to break into the pharmaceutical industry in their first MSL role as well as anyone interested in hearing good industry conversations and medical affairs discussions. #msl #medicalaffairs #medicalscienceliaison #MSLtalk #careers

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"How do we structure and strategize to bring successful products to market within the complexity that is oncology access? How much will the health system and payer access management change? What can manufacturers do to optimize success?   You are in luck as you can ask our experts at ASCO! They will be at Booth #35093 to answer any of your questions!    If you can't attend ASCO you can gain answers to these thought-provoking questions by tuning into their OnDemand webinar.    Watch now: https://lnkd.in/egRFWhxb"

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In this interview with Triangle Business Journal, CEO Peyton Howell shares her vision for how Parexel will tackle global challenges and leverage cutting-edge technology to reach more patients where they are. Read it: https://lnkd.in/gqS-FRmJ #PatientsFirst

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As part of AstraZeneca’s focus on sustainable science, we have set ourselves the ambitious goal to introduce electronic product information (ePI) across all medicines, while ensuring flexibility for patients to access product information through alternative ways if needed. The introduction of ePI brings with it a host of benefits for the planet, patients, and healthcare systems, including: 🌍 Improved accessibility to the most up-to-date information on medicines, available in multiple different languages. 💊 More efficient and wider availability of medicines through digitalisation of labels and quick implementation of label changes. 🍃 Lower environmental impact. If ePI was introduced across all AstraZeneca products, it could potentially save an average of 500,000 trees and 1.6bn litres of water each year. Learn more: https://lnkd.in/gJC-fwtd #WhatScienceCanDo

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🚀 Biopharma Market Expansion: Key Takeaways As biopharma companies explore new markets, it's crucial for leaders to tailor their approach to the unique nuances of each market. Here are some critical insights: 1️⃣ Revenue Potential: By 2028, markets outside the US are projected to generate US$120 billion in revenue, presenting substantial growth opportunities. 2️⃣ 2023 Revenues: Non-US markets accounted for 56% of global biopharma revenue in 2023, up from 52% in 2020. This trend underscores the growing importance of international markets. 3️⃣ Patent Cliff: The industry faces a $200 billion revenue risk from expiring patents by 2030, pushing companies to diversify globally. 4️⃣ Global Market Size: The global biopharma market was valued at US$1.4 trillion in 2023, highlighting the vast scale and potential of the industry. 5️⃣ Strategy Models: Large biopharmas (≥ US$20 billion annual revenue) prefer direct presence in significant markets, while smaller firms (≤ US$5 billion) often opt for distributor partnerships in complex regions. 6️⃣ Operational Challenges: Tailored entry strategies are essential due to varying regulatory, reimbursement, and tax considerations across different countries. 7️⃣ Strategic Focus: Companies should prioritize specific countries, develop tailored entry models, establish robust launch sequences, and build cross-functional capabilities to mitigate risks. Planning and executing a well-thought-out international expansion strategy can help biopharma companies maximize revenue potential and patient reach worldwide. 🌍💉 #Biopharma #MarketExpansion #GlobalGrowth #Biotech #Pharmaceuticals #Strategy #RevenueGrowth P.S. How is your company planning to navigate these market opportunities in 2024? Share your insights below.

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Stop by the Optum booth to meet our oncology RWE experts at #ASCO2024 and find out how Optum Life Sciences multi-modal real-world data, research and analytics can help advance cancer treatment and improve patient care and quality of life. See you there! #realworldevidence #realworlddata 

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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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