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.
Success Factors for NDA/BLA Preparation
The process by which the NDA/BLA is prepared, submitted, and supported throughout its evaluation is a key component of the timely approval and launch of a new drug or biologic product. Numerous important process issues and considerations must be addressed to maximize success, starting with early planning. Planning begins with a ...
IND Toxicology Study Report and SEND Dataset Requirements
Drug development is a stepwise evaluation process on both animal and human efficacy and safety information. Nonclinical toxicology studies play pivotal roles in estimating an initial safe starting dose and dose range for the human clinical trials and in identifying parameters for clinical monitoring for potential adverse effects. For an IND application, ideally ...
Cell and Gene Therapy from Preclinical Program to IND
The evolution of drug development from small molecules and proteins to the next generation of cell and gene therapy (CGT) provide tremendous promise for patients. CGT products involve complex and diverse chemistry and biological mechanisms aided by rapidly evolving scientific research. The intrinsic material composition and putative MOA(s) of CGT products differ from conventional ...
Fast Track Designation: How Aleon Can Help Sponsors Speed Up Their Drug Development to Serve the Underserved
From bench to bedside, drug development takes an average of more than ten years. Traditionally, drug development exposes thousands of patients in clinical trials to establish safety and efficacy before reaching the market. In recent years, advancements in drug development, such as targeted therapies in oncology, have shown exceptional and significant efficacy at ...
Breakthrough Therapy Designation
Breakthrough therapy designation is a US Food and Drug Administration (FDA) program to expedite the development and review of urgently needed investigational products (including biologics) for serious or life-threatening conditions. To receive a breakthrough therapy designation grant, the preliminary clinical evidence must suggest substantial improvement over available therapy on a clinically significant endpoint. 1 Drugs ...
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