A Journey of Collaboration and Future Transformations in Biotech Space

In an exclusive interview with Life Sciences Review, Marcus Delatte, PhD, Vice President, Regulatory Strategy, Allucent, shared his valuable insights on the challenges and trends of the industry. He also talked about how technology is shaping the future of the biotech marketplace. Click below to read the full article. Read here

Patient-Centric Approach To Accelerating Clinical Trials

In an interview with Life Sciences Review, Anita Nelsen, senior vice president, clinical trial operations, Allucent, provides a general outlook on the current clinical trial landscape and highlights the value of a patient-centric approach. Click below to read the full article. Read here

Inroads To Approval: Navigating Formal FDA Meetings to Optimize Your Drug Development Program

Matthew Hight, PhD, RAC, Associate Director, Regulatory Affairs, AllucentJoshua Taylor, PhD, RAC, Senior Director, Regulatory Affairs and Head of Clinical Strategy, Allucent Marcus Delatte, PhD, Vice President, Regulatory and Drug Development Consulting, Allucent Welcome to our comprehensive five-part blog series where we will seek to guide you through the intricate world of formal meetings between the […]

Exosomes: Unveiling Their Potential in Cell and Gene Therapy

By Marites T. Woon (Associate Director, Nonclinical), Mialy Ramaroson (Director, CMC), Jessica Lee (Principal, Global Head Cell & Gene Therapy), William Lee (Vice President, Regulatory Affairs), and Richard Stewart (Vice President, Nonclinical)   Welcome to our three-part blog series on exosomes, the fascinating messengers of the cellular world. In this captivating exploration, we delve into the […]

Technical Writing Services with a Clinical Pharmacology Focus

Allucent has extensive experience with clinical pharmacology studies and analyses needed to support drug development programs and messaging of key data to support the product label. Our authoring tasks span the entire process from drafting, reviewing, and updating to full writing of regulatory documents, supporting clients with documents that meet industry standards in an efficient […]

Study Design and Conduct Leveraging Allucent’s Clinical Pharmacology Expertise

Allucent has extensive experience with designing, conducting, analyzing, and interpreting of data from each type of Phase 1 clinical pharmacology study needed for an individual drug development program. While we can conduct any Phase 1 study, our focus and expertise in clinical pharmacology is our differentiator. This is about much more than just conducting one […]

Population Modeling Capabilities

Population pharmacokinetic, PK/PD, and exposure-response modeling are the industry standard approaches for modeling clinical, and increasingly non-clinical, pharmacological and safety and efficacy data to inform clinical trial program design and data analysis and interpretation. This meets regulatory requirements and expectations through all drug development phases to submission and beyond. Population PK, or PK/PD modeling uses […]

Model-Informed Drug Development

Let your data be your guide. With model-informed drug development (MIDD), you can leverage your existing data and others to optimize your pre-clinical and clinical studies and development programs. Allucent has an expert team of pharmacometricians and modelers with state-of-the-art high-performance computing (AWS) to help you design, simulate and analyze your drug development studies and […]