Dwayne Campell, President and Managing Member of DCC Pharma Consulting, LLC has over 30 years of experience in pharmaceutical product development in large and small organizations. Highlighted accomplishments include:
Reformulated commercialized modified release product to increase the shelf life while improving the manufacturing yield equivalent to approximately $2 million commercial sales per year.
Developed initial IND formulation and process for EGFR, HER2 inhibitor that progressed to commercialization. Formulation patent was granted.
Developed initial tablet formulation for an IND product at a dose of 0.1 mg/tablet that met all product specifications and requirements for content uniformity.
Formulated and validated a new IR tablet strength for a commercialized product and prepared CMC modules for sNDA submission and obtained regulatory approval.
Developed a combination product for hypertension with a partner company for distribution in emerging markets. EMA approval was achieved.
Scaled up a macrolide antibiotic capsule formulation and prepared CMC modules for NDA submission (CDMO project)
Converted a Phase I IND capsule formulation to an increased strength tablet formulation that was used for additional clinical studies (CDMO project).
Developed an increased tablet strength tablet for clinical studies of selective estrogen receptor degrader candidate (CDMO project).
Developed proprietary method for determination of drug substance particle size to ensure content uniformity requirements are consistently achieved.
Managed clinical supply packaging, labeling, and distribution for open label and blinded clinical studies.