SciPro’s Post

🚀 Join Syneos Health for an insightful webinar shedding light on the pivotal role of Medical Science Liaisons (#MSLs) in pharmaceutical companies. These professionals operate in a realm of scientific exchange and real-world insights, crucial for guiding strategic development and brand decisions. 📊💡 As the MSL role expands across pharmaceutical development stages and audiences, industry faces challenges in measuring its impact. How effective are different engagement strategies? Where should resources be allocated for optimal results? The value delivered remains elusive without quantifiable metrics. In this webinar, the expert speakers will delve into the innovative approaches for measuring value beyond mere output and learn how data-driven AI/tech solutions empower MSLs. REGISTER HERE: https://buff.ly/44EFPxD 🌟 Expert speakers: Angela W. Michael DeGeorge Jr Mayank Pandita Celeste Mosby #RealWorldData #PatientOutcomes #RealWorldEvidence #MedicalAffairs #Marketing #MedicalScienceLiaison #AI #RWE #Commercialization #HEOR #MarketAccess #OtherResearch #RWD

OUTSOURCING INCREASING; SUCCESS DECREASING? Imagine you had a very valuable piece of Art or a precious heirloom to put into the safe keeping of a Company - would you choose the cheapest or the best? Would you check them out beforehand or trust what was on their website? The Company products ARE those valuable items, whether in clinical development or post-marketing. They need to be managed effectively and compliantly. This requires you to understand what was being done, that it was done properly, and compliantly to keep everyone safe. This starts by understanding the capabilities (people and processes), the Quality (Having their own QMS); and capacity (personnel and geographic coverage) to engage with you now and in the future rather than making multiple changes. This talk looks at some of the considerations to have in place to ensure that any outsourcing activity is a successful, long term, compliant relationship. 😀

"Thrilled to announce the successful completion of my Clinical Research Certification Course! 🎓🌐 Excited to apply this knowledge in advancing healthcare and contributing to cutting-edge research. Topics covered:: -Introduction to Clinical research -Drug Discovery & Development -Investigational New Drug Application (INDA) -Clinical Trials -Stakeholders -Pharmacokinetics & Pharmacodynamics -Pharmacovigilance -International Council for Harmonisation (ICH) Guidelines -Good Clinical Practices (GCP) Guidelines -Ethical Guidelines -Clinical Data Management #BioGrademy #ClinicalResearch #CertificationComplete #HealthcareAdvancement"

Nonclinical experts function in many ways on drug development teams. I view this discipline as a key ingredient needed to keep the teams connected and focused. My success in this discipline has been based on many lessons learned such as those below here. * Identifying and managing regulatory and safety risks typically involves the nonclinical expert and another discipline (e.g., CMC, Clinical Pharmacology, and Clinical) * Serving as an effective nonclinical expert involves actively listening and learning from other disciplines * Leveraging my institutional knowledge from the FDA uniquely positions me to use my insights to help inform the team’s work and to anticipate and solve potential concerns from regulatory authorities prior to engaging them For more insights on the multifaceted role of the nonclinical expert see the blog that I co-authored below here. #Allucent #BringNewTherapiesToLight #NonClinical #RegulatoryAffairs #DrugDevelopment #ClinicalTrial

🔔 Exciting News from Aurora Analytica! We are thrilled to announce the launch of our bespoke consulting services, designed to revolutionize the way clinical trials are planned, designed, and executed. At Aurora Analytica, we believe in the power of data-driven decisions and methodologically sound approaches to steer your projects towards success. Our services are tailored to support the critical phases of your clinical trials, offering flexible, affordable, and robust solutions. With a decade of healthcare industry experience, our seasoned consultants specialize in: - Market Access Strategies - Competitive Landscape Assessments - Enrolment Benchmarking - Simulation and Forecasting Our approach is centered on leveraging robust, relevant, and credible data to answer your key questions, such as: - Where are the best sites for my study? - Who has the most experience with this indication? - What will my study timelines look like? - When can I expect to reach Last Patient In (LPI)? - What is the cost of care for this indication in Europe? - What enrolment rate can we expect for our study? We're not just about collecting data; we're about synthesizing information from a variety of sources to provide actionable insights that drive success. Let Aurora Analytica be your partner in navigating the complexities of clinical trials with confidence. Contact us to learn how we can support your next project and drive it towards success. https://lnkd.in/dNw25d7V #clinicaltrials  #datadrivendecisions  #healthcareconsulting  #clinicalresearch  #biotech  #pharmaceutical  #feasibility

🌟 New McKinsey article says clinical trials need to improve: “Biopharmaceutical (biopharma) R&D stands at an inflection point, with the limiting factor for innovation no longer science or funding but the speed at which clinical trials can be completed because of a shortage of study participants and clinical site professionals such as principal investigators (PIs), site coordinators, and nurses.” Despite increased R&D investment, productivity is declining in drug approval. To address this, we need to accelerate clinical trials to reduce costs, improve patient recruitment, and bring drugs to market faster. Key strategies involve data analytics, streamlined operations, and digital tech. Collaboration and regulatory changes will drive this acceleration! Let's work together to advance healthcare and bring life-changing drugs to market faster. #BiopharmaInnovation #drugdevelopment #drugdiscovery #regulatoryaffairs #ClinicalTrials #HealthcareAdvancement #innovation #nursesonlinkedin 🚀 Read the whole article: https://lnkd.in/eCHBnG3A

🌟 As we stand on the precipice of a new era in pharmacovigilance, I am thrilled to announce our participation in the upcoming 9th Annual European Drug Safety Pharma & Biotech Conference, taking place on November 29-30, 2023. 🔍 Joining me in a pioneering panel discussion on the "Future of Collaboration Between Drug Safety & Medical Department" are esteemed thought leaders: Branka Stojanovic of Pfizer, Lisa Stagi of Roche, and Sibel Guerler of Bristol Myers Squibb. Together, we will explore how integrated strategies can enhance patient safety, adherence, and satisfaction through data. 💡 As the CEO of DrugCards, I am passionate about the transformative power of AI in drug safety. This panel is a testament to our commitment to innovation and excellence. We are at the forefront of a visionary journey to redefine industry standards and ensure that patient well-being remains the heart of pharmaceutical advancement. 🙏 I extend my deepest gratitude to my fellow panelists for their dedication to this cause and to you, our community, for your unwavering support. Let's lead the charge in creating a safer, more efficient future for all. #DrugSafety #Pharmacovigilance #PatientCare #Innovation #DrugCards #Collaboration #AI

Delighted to talk on April 18th at 1ST AMERICAN PHARMA AND BIOTECH PROJECT, PROGRAM AND PORTFOLIO MANAGEMENT CONFERENCE on "Medical Affairs Strategy: Successful Navigation of Phase III Clinical Development, Regulatory Pathway, Medical Communication and Market Access Needs". Topic should stimulate lively discussion around very current issues of very large influx of novel drugs across therapeutic areas that is projected to persist in the next 5 years with key elements that need optimal planing and decision making. https://lnkd.in/e8_vZbkf #Clinical development #market access #Pharmaceuticals #Medical affairs #Oncology #Biotech #Strategic planing Why Summits

In 2023, the CDER's first-cycle approval rate of 84% for novel drugs underscored the pivotal role of detailed, supportive clinical documentation.*  It highlighted the challenges faced when initial submissions lack the necessary information for approval, prompting a resubmission and potentially delaying market entry. Intego Clinical's expertise in medical writing is crucial in this context. The process of ensuring regulatory compliance through documentation is akin to programming an advanced security system, where precision and clarity are paramount. Collaboration is key, with regulatory experts, statisticians, and clinical data managers working together to refine documentation. This collective effort aims to exceed the expectations of regulatory bodies like the EMA and FDA, facilitating a more streamlined approval process. Intego Clinical offers a comprehensive suite of services, from protocol development to regulatory submission documents, all designed to address the nuances of the regulatory approval process. For organizations aiming to expedite their innovative treatments to market, leveraging Intego Clinical's medical writing services is a strategic move. Explore the benefits and connect with Intego Clinical to be sure your clinical documentation is in capable hands, freeing you to focus on the core mission of driving the industry forward every day ▶️ https://lnkd.in/dMhJFU4f _______________________________________________________________ *New Drug Therapy Approvals Report 2023 by the Center For Drug Evaluation And Research of the US Food & Drug Administration #integogroup #integoclinical

Tomorrow, our Chief Medical Officer, Dr. Ulrike Lorch, will join the Medicines and Healthcare products Regulatory Agency (MHRA) Early Phase Community Meeting. Dr. Lorch will present insights on "Developing a state-of-the-art scoring system and algorithm to determine the overall risk category of a trial." Her expertise in this area is pivotal in advancing the landscape of clinical trials. Her presentation focuses on the crucial aspects of rigorously assessing the overall risk classical of trials. This innovative approach promises to enhance decision-making processes, ensuring more efficient and informed trial management. This endeavour aligns perfectly with Richmond Pharmacology's commitment to pioneering advancements in clinical research, aiming for the highest quality and safety standards. Dr. Ulrike Lorch's participation in such forums further solidifies our dedication to innovation and excellence in the field. Stay tuned for more updates as we continue to drive progress in early-phase research and redefine the future of clinical trials! #ClinicalResearch #MHRA #EarlyPhase #Innovation #ClinicalTrials #RichmondPharmacology #Healthcare #MedicalResearch #Science #Pharmaceuticals #FasterAnswers