Allucent

As a rare disease CRO, Allucent understands that raising awareness and sharing knowledge is critical to driving research, support, and hope to the 300 million people worldwide living with a rare disease. Members of Allucent’s Center of Expertise (ACE) - Rare Diseases, Maria Cruz Morillo, Milan Marinkov, and Genevieve Wills are proud to stand with the rare disease community and just last week shared their valuable insights and expertise in how to accelerate the development of therapies for rare diseases through master protocol frameworks. Listen here: https://lnkd.in/eVWE_Xpu #RareDiseaseDay #NORD #ShowYourStripes #Allucent #BringingNewTherapiesToLight

🔶  𝙄𝙣𝙨𝙞𝙙𝙚 𝙩𝙝𝙚 𝙀𝙈𝘼: 𝙀𝙭𝙘𝙡𝙪𝙨𝙞𝙫𝙚 𝙄𝙣𝙨𝙞𝙜𝙝𝙩𝙨 𝙤𝙣 𝙄𝘾𝙃 𝙀𝟔(𝙍𝟑) 🔶 Allucent A-Team expert J Ernesto Vera-Sánchez, MD, PhD, MPH, was invited to attend an exclusive, in-person meeting at the European Medicines Agency (EMA) last week—the Accelerating Clinical Trials in the EU (ACT EU) Workshop—where a select group of regulators, industry leaders, and stakeholders gathered to discuss ICH E6(R3). What key priorities are driving the future of clinical trials? Dr. Vera Sanchez shares key insights in our latest blog, https://lnkd.in/e9tHjdu2, including: ✔️️ The importance of gap analysis and a risk-based approach ✔️️ How patient perspectives are shaping drug development ✔️️ The growing role of Quality by Design ✔️️ New expectations for data governance and EMR Read the blog to get the inside perspective from EMA! #Allucent #GxP #GCPCompliance #ClinicalTrials #BringingNewTherapiesToLight

We're excited to introduce you to James Clary, Associate Director, Pharmacometrics!   James is an essential member of our Pharmacometrics A-Team, bringing deep expertise to help our drug development teams translate complex data into actionable insights. By employing advanced quantitative approaches, our Pharmacometrics experts help mitigate risks, enhance decision-making, and ultimately deliver essential medicines to patients who need them.   Connect with James and visit our website to learn more about our Clinical Pharmacology services: Clinical Pharmacology | Allucent   #Allucent #BringNewTherapiesToLight #ClinicalPharmacology #DrugDevelopment #ClinicalTrials

Conducting clinical trials for rare diseases presents unique challenges -- small patient populations, recruitment hurdles, and regulatory complexities. But with the right strategies, innovation can pave the way for life-changing treatments. A-Team expert Milan Marinkov, Executive Medical Director, Rare Disease Medical Lead, explores key challenges and proven approaches to accelerate rare disease research while ensuring patient-centric solutions in his latest blog, ‘Rare Disease Clinical Trials: Challenges, Strategies, and Solutions for Success’. Click here to read: https://lnkd.in/eEyaeHgf #Allucent #RareDiseases #ClinicalTrials #BringingNewTherapiesToLight

Explore the latest issue of Allucent's Industry Spotlight newsletter: https://lnkd.in/eF35dHip Our Rare Diseases Special Edition includes these key highlights: ▪️ RNA Editing Hits the Clinic, Fueling New Hope for Rare and Common Diseases ▪️ Rare Disease Clinical Trials: Challenges, Strategies for Success ▪️ FDA Clears First Therapy for Rare Disease CTX from Mirum ▪️ Regeneron's Drug Restores Hearing in Patients with Rare Genetic Deafness ▪️ Solid Says Early Data Suggest 'Differentiated' Duchenne Gene Therapy #Allucent #IndustrySpotlight #Biotech #RareDiseases #RareDiseaseResearch

Allucent is proud to sponsor the upcoming PBSS Workshop Clinical Trial Planning and Conduct in San Francisco. Schedule a meeting with Katy Moore, PharmD, RPh and Chris Durham to learn how Allucent’s diverse team of experts partner with biotech companies to deliver comprehensive study, dose optimization, and drug development strategy and services:  https://lnkd.in/eQJUKsBv #Allucent #BringingNewTherapiesToLight #Pharmacometrics #ClinicalPharmacology #PBSS.

We're thrilled to introduce you to Michelle Fickes, Allucent Associate Director, Submissions! Michelle is an integral asset to our regulatory submissions and project management team. As a regulatory submissions specialist with deep expertise in FDA regulations and guidelines for drugs, devices, and biologics, she plays a critical role in ensuring high-quality, on-time eCTD submissions. She has experience preparing, publishing, and submitting FDA applications at all stages, from pre-IND through post-approval, including a broad range of marketing applications. Connect with Michelle and visit our website to learn more about Allucent's regulatory submissions services:  https://lnkd.in/es8nRBsV   #Allucent #BringNewTherapiesToLight #RegulatorySubmissions #FDAApproval #DrugDiscovery

World Day of Social Justice underscores the need for equity and inclusion across all fields—including clinical research. Diverse, representative trials are essential to ensuring medical advancements benefit all populations. Without inclusivity, we risk overlooking critical differences in treatment efficacy and safety. At Allucent, we help our clients design streamlined, scientifically rigorous, and inclusive clinical studies. Prioritizing diversity strengthens research reliability and improves patient outcomes. To learn more about fostering inclusion in clinical trials, read our blog: https://lnkd.in/g8MMDH-8 #WorldDayofSocialJustice #ClinicalTrials #BringingNewTherapiesToLight #RepresentationMatters #Allucent

We are proud to partner with COG UK, as it brings together clinical research experts from across the UK's biopharma industry. Join us there and schedule a meeting with our A-Team, John Taylor and Tim Koopman: https://lnkd.in/eNa7uC5W. Discover how our experts can partner with you to provide strategic guidance and creative solutions at every stage of your clinical development journey.   #ClinicalTrials #ClinicalResearch #COGUK #Allucent #BringingNewTherapiesToLight

Pediatric drug development can be challenging and thus takes precise analysis and innovative approaches to conduct. Check out our infographic where Allucent expert Jessica K. Roberts, PhD, MSCI (Senior Director, Pharmacometrics) discusses the transformative role of pharmacokinetic (PK) and pharmacodynamic (PD) modeling and simulation in overcoming challenges in pediatric drug development: https://lnkd.in/gkeNyqee   This infographic covers topics including: - Leveraging adult clinical trial data - Modeling and simulation of adult data for pediatric use - Predicting successful doses in pediatric patients   #Allucent #BringNewTherapiesToLight #PediatricDrugDevelopment #PBPK #Pharmacokinetics