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Anthony Qu, Ph.D.Vice President Scientific AffairsHalo Pharmaceutical

Title: Fixed Dose Combination (FDC) –A cost effective approach for simplified dosingFixed-dose combination products (FDCs) are the drug products containing multiple active ingredients. FDCs offer several advantages to pharmaceutical companies and patients which includes better patient compliance, more convenient dosing associated with improved clinical performance, reduce side effects, cost savings for both patients (fewer co-pays) and drug manufacturers (reduced production and testing costs), and extended patent protection. 505(b) (2) pathway is commonly used for these approvals as most of the FDCs usually consist of previously approved drugs, which leads to smaller development programs. Producing safe and effective FDC products requires thoughtfulproduct design, access to state-of-the-art manufacturing technology, and advanced analytical tools. Several case studies of FDCs will be discussed in the presentations to cover adult and pediatric formulation development and innovations. Additionally, theprocessing challenges associated with development of FDCs will be outlined and scientific approach to overcome those challenges will be discussed.5-6 Bullet points on what the take away would be /he value of attending the session:▪FDCs are normallycomposed of previously approved molecules.505(b)(2) pathway is commonly used for these approvals (shorter development program). Additional IP protection and extended market shares.▪Normally Low therapeutic dose of 2 drugs andmore effective than higherdose of single drug.▪Simplified treatment regimen: better adherence and compliance.▪Health care costs will be reduced,fewer copayments and fewer refills.▪Manufacturing and testing cost could be lower: one drug product vs. two or three separate drug products.My Bio and head shot:Dr. Anthony Qu who is currently the Vice President of Scientific Affairs at Halo Pharmaceuticals in Whippany, NJ. Anthony has been in pharmaceutical industry more than 28 years and got his PhD in Pharmacology from Universityof Toronto, Canada.Anthony published more than dozen scientific papers, two patents and three books.