Empowering Cell & Gene Therapy Analytics
Cellanalytics Consulting
About
I founded Cellanalytics Consulting, a firm recognized for its expertise in cell and gene therapy advisory services. My specialization in CMC analytical development has honed my ability to optimize IND-enabling assays specifically tailored to the unique demands of cell and gene therapies. Known for developing detailed CMC roadmaps, I prioritize regulatory compliance and superior product quality. My expertise also includes crafting comprehensive IND packages and managing effective regulatory interactions. As a strategic thinker, I collaborate with teams to align product strategies with business goals, focusing on key milestones and risk assessments. My dedication to quality is evident in my emphasis on GMP compliance and stringent quality control, ensuring the safety and efficacy of products.
Throughout my tenure as a Subject Matter Expert (SME) and program director in cell and gene therapy development, I identified a critical knowledge gap in scientific and analytical development, Target Product Profile (TPP), Critical Quality Attribute (CQA) generation, and the challenges of technology transfer across academic and collaborative laboratory sites. Recognizing that these gaps could delay essential therapeutics, I aim to bridge these divides and expedite drug development processes, ensuring life-saving drugs reach patients promptly.
I have offered my services to cell and gene therapy startups, CDMOs, CROs, medical devices, and large pharmaceutical companies. My contributions span CMC analytical development, qualification, validation, strategic planning, tech transfer, BLA filing, IND preparation, FDA interactions, risk assessment, GMP-compliant laboratory establishment, interim technical/operational leadership, and comparability testing.
Specialized roadmap creation, ensuring regulatory compliance and quality.
CMC Analytical Development
Tailored optimization for cell and gene therapies' unique needs.
IND-Enabling Assay Development
High-quality authoring, organization, and compliance for regulatory submissions
IND Package Preparation
Collaborative product planning aligned with business objectives and risk assessments
Product Strategy Development
Services We Provide
Upholding GMP standards, implementing robust quality control, and ensuring product safety and efficacy
Quality Assurance and Compliance
Expertise in communication and strategy development with regulatory agency's therapies' unique needs.
Regulatory Engagement
Comprehensive evaluation to navigate challenges and ensure successful product development.
Risk Assessment
Expert oversight and direction to ensure timely and efficient project completion.
Project Management
At Cellanalytics Consulting, our mission is rooted in pioneering excellence in IND-enabling assay development for cell and gene therapies, ensuring unparalleled precision. We pride ourselves on crafting comprehensive strategies for analytical CMC programs and leading tech transfers while spearheading optimizations in assays ranging from cell cytotoxicity to advanced flow cytometry applications. Our team is adept at conducting thorough program risk assessments, ensuring proactive mitigation and streamlined solutions. Central to our mission is our commitment to streamlining the drug development process, aiming to swiftly bring innovative treatments to patients in need. Furthermore, our proficiency in IND preparations and regulatory submissions complements our dedication to collaboration, bridging academic and industry knowledge to advance therapeutic innovations.
Testimonials
From developing IND-enabling assays to the final submission to the FDA, Jim Shaw, Ph.D, stood by us at every step. His comprehensive understanding and proactive approach significantly streamlined our journey to IND submission. Jim will be at the top of your choice list for anyone navigating the FDA IND process.
Li R., Ph.D. Chief Technology Officer, Cell & Gene Therapy
I wholeheartedly endorse Jim's consulting firm in the field of CMC cell and gene therapy analytical services. Their expertise in CMC development, regulatory compliance, and analytical methods is top-notch. They excel in designing and implementing robust analytical strategies, ensuring quality, and facilitating seamless collaborations. I highly recommend their firm for anyone seeking excellence in this industry.
Jennifer M., Ph.D. Principal Scientist, Analytical Development
Jim’s capability in engaging with the FDA is remarkable. He not only prepared the potential queries and strategized communications with the agency as an analytical development and CMC expert, making the entire IND submission process efficient. Their insights into the regulatory landscape are invaluable.
Lance Z., Senior Clinical Trials Manager
From initial assay development to flow cytometry’s intricacies for potency and immunophenotyping, Jim Shaw’s approach is holistic and thorough. His dedication to providing reliable and robust analytical solutions has been invaluable.
Oscar O., Ph.D. Director, Analytical and Process Development
I've had the honor of collaborating with Jim in an academic setting. His expertise in IND-enabling assay development stands out remarkably. His acumen in strategizing and executing tech transfers, combined with his leadership in optimizing assays, especially cell cytotoxicity and identity flow cytometry assays, is commendable. Jim comes highly recommended for organizations or individuals looking to streamline their IND preparation and submission. His blend of academic rigor and practical application is unparalleled in the field.
Jay Fang, Ph.D. Director of Technology Development
I've had the honor of collaborating with Jim in an academic setting. His expertise in IND-enabling assay development stands out remarkably. His acumen in strategizing and executing tech transfers, combined with his leadership in optimizing assays, especially cell cytotoxicity and identity flow cytometry assays, is commendable. Jim is highly recommended for organizations or individuals who streamline their IND preparation and submission. His blend of academic rigor and practical application is unparalleled in the field.
Elizabeth T., Senior Director Program Management
