Contract research organisation Nutrasource Pharmaceutical and Nutraceutical Services has announced US FDA approval of three investigator-initiated applications on behalf of the n-Lorem Foundation.
In order to authorise a treatment or trial for humans, the FDA requires sufficient information to assess the safety of the intended drug and research study.
Notably, these IND applications leveraged the FDA’s recent 2021 Draft Guidance for Industry, Investigational New Drug Submissions for Individualised Antisense Oligonucleotide Drug Products for Severe Debilitating or Life-Threatening Diseases, to achieve successful outcomes.
n-Lorem is primarily focused on creating individual treatments for patients in the United States with nano-rare diseases caused by genetic mutations that affect approximately 30 patients in the world. These INDs allow for individualised treatment of such patients for which no other approved treatment option is available worldwide.
Sarah Glass, PhD, Chief Operating Officer at n-Loren Foundation, said: “Each patient is treated under an investigator-held research IND guided by the regulatory framework described in the four 2021 FDA guidance documents on antisense oligonucleotides. Nutrasource’s experts have become integral members of the n-Lorem team by providing technical and experience-driven regulatory expertise that has enabled n-Lorem to accelerate its ability to meet the regulatory needs for each patient with high quality in an efficient fashion.”
Due to the novelty of individualised drug treatments, each IND submission presents a unique challenge. At the same time, given the nature of ALS (Amyotrophic Lateral Sclerosis) and its rapid progression, every IND file and subsequent authorisation is distinctly rewarding
Glass continued: “Not only is the work done by the Nutrasource team members meticulous, but they are also generally exceptional individuals with whom to work. We look forward to partnering with Nutrasource to support our ability to help many more nano-rare patients.”
William Rowe, Nutrasource President and CEO, said: “We are delighted to be entrusted with such meaningful work supporting the mission of the n-Lorem foundation.Typically, our work is tied to servicing clients with commercial launch pressure.”
Paula Guerra, PhD, Senior Regulatory Affairs Associate at Nutrasource, said: “Working with the n-Lorem team has been an exceptional experience because of their commitment to patients and their overall drug development program.”
Guerra continued: “Due to the novelty of individualised drug treatments, each IND submission presents a unique challenge. At the same time, given the nature of ALS (Amyotrophic Lateral Sclerosis) and its rapid progression, every IND file and subsequent authorisation is distinctly rewarding.”