Nada Mitic

Managing pediatric formulation development and manufacturing optimization activities through CDMO.

CMC leader, ensuring CMC team delivers against accountabilities and key deliverables, identifies, and mitigate the risks. Member of Portfolio Leadership Team, responsible for developing integrated product plan related to CMC and overall product strategy. Managing formulation development and manufacturing optimization activities through CMOs leading to the identification and selection of robust dosage forms capable of supporting nonclinical and clinical studies (Phase I through Phase III).

Managing formulation development and manufacturing optimization activities through CMOs leading to the identification and selection of robust dosage forms capable of supporting nonclinical and clinical studies (Phase I through Phase III).

Technical leader of several manufacturing campaigns of clinical trial materials (CTM) for phase I and Phase II clinical trials. Managed development of formulation and manufacturing process for compound in phase II clinical trial and manufacturing process transfer, scale-up, and validation for commercial product.

Responsible for designing formulation and manufacturing process for the lead compound. Investigated and identified the critical factors affecting manufacturing process and product stability study. Successfully scaled up manufacturing process. Involved in commissioning of manufacturing equipment for production of CTM. Responsible for CTM manufacturing of film-coated tablets for phase II clinical trials. Responsible for CTM manufacturing of powder in capsule for phase I FIM clinical trials, using Xcelodose and CFS 1500, automated capsule fillers. Supervisor of one employee in formulation development. Authored and reviewed master batch records for CTM manufacturing of solid oral dosage forms. Authored IND and NDA sections. Authored numerous manufacturing protocols and development reports.

Supported FDA Pre-approval inspection (PAI) of manufacturing facility resulted in No 483 observation. Selected by management to over see process development of drug candidate at pilot scale and commercial scale at contract manufacturing facility. Investigated and identified the critical factors affecting product stability study. Contributed to manufacturing development section in NDA. Authored numerous manufacturing protocols and development reports.

Conducted process optimization using DOE at pilot scale to establish process control of critical manufacturing steps. Successfully developed extended release tablets. Involved in capsule formulation development for phase I, using Xcelodose, automated capsule filler. Support liquid capsule formulation of poorly soluble drug candidate. Authored numerous manufacturing protocols and development reports.

Support manufacturing process of several drug candidates at laboratory scale consisting of blending, roller compaction/wet granulation, compression, and coating. Conducted numerous experiments to support formulation development studies, such as disintegration testing, friability testing, hardness test, and dissolution. Authored numerous manufacturing protocols and development reports.

Synthesis of Novel Anti – tumor agents: Sansalvamide A Derivatives