DBJW Consulting

About

Consultant on CMC activities (analytical, preformulation, formulation development) for pipeline compounds and IND nominees at R1 universities, pharmaceutical consultancies, and early clinical stage startups.

- Develop and implement analytical elements (drug substance and product methods, specifications, batch release, stability programs) to derive phase appropriate control strategies to enable compound/modality progression through clinical development 

- Use expertise in the following areas in service of non-clinical and clinical development: material characterization (small molecules, biologics, excipients) and physical form selection; development and manufacture of stable amorphous dispersions as drug substance or drug product intermediates; formulation development activities of small molecules and biologics for sterile and oral administration (small molecule only) 

- Utilize the target product profile to enable patient-centric product design for clinical development with various delivery systems, including syringes, ocular pumps, and inhalation 

- Leverage experience with preparing technical regulatory packages for IND through NDA and MAA submissions