MORRISVILLE, NC and NEWARK, NJ, January 8, 2024 – Premier Research, a preeminent global clinical research, product development, and consulting company, and BioCentriq, a renowned Contract Development and Manufacturing Organization (CDMO), have entered a strategic partnership to revolutionize the pre-Investigational New Drug (IND) process and accelerate the clinical translation of novel cell therapy products.
By leveraging Premier Research’s expertise in cell therapy product development and BioCentriq’s proficiency in developing and manufacturing and testing cell therapies, the partnership will streamline the process of bringing new products to patients. As partners, Premier and BioCentriq are well positioned to support sponsors seeking to expedite the transition of their innovative cell therapy candidates from research to clinical trials.
“Partnering with BioCentriq aligns with our commitment to expediting the development of transformative cell therapies,” stated Kenneth Ndugga-Kabuye, MD, FACMG, Vice President, Cell and Gene Therapy at Premier Research. “By merging our comprehensive product development expertise with BioCentriq’s specialized capabilities we will help sponsors simplify the development process from pre-IND through approval, ultimately accelerating the delivery of innovative therapies to patients in need.”
This collaboration will harness Premier Research’s comprehensive understanding of regulatory requirements, clinical trial design and study execution, alongside BioCentriq’s specialized capabilities in cell therapy development.
“Cell therapy development is extremely complex,” added Olu Aloba, PhD, Vice President, Chemical Manufacturing and Control (CMC) Services, Premier Consulting, a business unit of Premier Research, “Nonclinical and Clinical development, CMC, and the CDMO have to work hand in hand to address the scientific, logistical and regulatory demands that enable studies to generate high-quality results.”
“This collaboration marks a significant step in fostering a more streamlined pathway for groundbreaking cell therapies,” remarked Alex Klarer, Vice President, Business Strategy and Innovation at BioCentriq. “Combining Premier Research’s clinical insights with our CDMO expertise will empower us to expedite the translation of novel therapies from the lab to clinical reality, benefiting patients worldwide.”
About Premier Research
Premier Research, a global clinical research, product development, and consulting company, is dedicated to helping biotech, specialty pharma, and medtech innovators transform life-changing ideas and breakthrough science into new medical treatments.
Premier Research specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors.
Whether it’s developing product lifecycle strategies, reducing clinical development cycle timelines, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier Research is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions. Visit premier-research.com.
BioCentriq is a global cell therapy Contract Development and Manufacturing Organization (CDMO) successfully developing, manufacturing, and releasing GMP drug product for use in clinical trials since 2022.
With industry-recognized leadership, scientists, engineers, analysts, and manufacturing specialists, along with established quality systems and modern infrastructure, BioCentriq is a trusted strategic partner for the development and manufacture of both autologous and allogeneic cell therapies.
In June 2023, BioCentriq launched its LEAPTM Advanced Therapy Platform designed to help cell therapy developers move from contract to clinic in as little as six months. The company was purchased by GC Holdings Inc. of South Korea for $73 million in May 2022. Our newly constructed, modern facilities feature flexible GMP manufacturing suites and fully equipped process development, quality control and analytical method development laboratories.
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