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.