Aleon Pharma
International
Our Work
With innovation, integrity, and continuous improvement as our anchors, we help clients achieve something remarkable - bringing life-saving drugs and treatments into the world that truly make a difference.
Aleon has authored several position papers to share our expertise and demonstrate the value we can bring to your project.
Regulatory Insights
Summary
In this position paper, you will learn (1). US FDA regulations and FDA/ICH guidance on the utilization of foreign clinical data (2). Recent FDA NDA/BLA approvals predominantly dependent on Asian clinical data (3). Key insights into FDA policies to effectively leverage Asian clinical study results
Success Factors for NDA/BLA Preparation
Summary
In this position paper, you will learn (1) How you should plan for an NDA / BLA, (2) How to execute your NDA / BLA plan, and (3) Less Tangible Factors that contribute to a successful NDA / BLA.
IND Toxicology Study Report and SEND Dataset Requirements
Summary
In this position paper, you will learn (1) The primary objectives of nonclinical safety evaluation for an IND, (2) The risks of submitting draft toxicology study reports at the time of IND submission, and (3) The requirements for SEND Datasets in an IND submission.
Cell and Gene Therapy from Preclinical Program to IND
Summary
In this position paper, you will learn (1) The unique characteristics of preclinical development for CGT products, (2) CGT specific considerations for preclinical programs, and (3) When to communicate with FDA Office of Tissues and Advanced Therapies (OTAT)
Fast Track Designation: How Aleon Can Help Sponsors Speed Up Their Drug Development to Serve the Underserved
Summary
In this position paper, you will learn about (1) The differences between Fast Track Designation, Breakthrough Therapy Designation, Accelerated Approval, and Priority Review Designation and (2) Aleon's tips for developing a high quality Fast Track Designation Application.
Please check back for new position papers authored by Aleon.