Problem Solver

Dino Manca

Dino Manca

Areas Dino Manca is Knowledgeable in:

Non-clinical drug development, IND, NDA, BLA, FDA, EMA, Phase I, Phase II, regulatory sciences, derisking strategies, problem-solving, good and robust science

Techniques Dino Manca Uses:

Knowledge, expertise, passion

Dino Manca's Problem Solving Skills:

  1. Experienced in: CNS, cardiovascular, metabolic, dermal, hematology, ophthalmics, and oncology lines
  2. Program/Portfolio Support & Management
  3. Regulatory Sciences
  4. Discovery Research
  5. Non-Clinical Development

Dino Manca's Problem Solving Experience:

  1. Assisted pharma start-ups on portfolio management and compound progression to clinical milestones
    Managed professional personnel (BSc to PhD level) encompassing up to 15 headcounts/unit
    Managed R&D budgets in excess of CAN$5M/fiscal year
  2. Conducted, monitored or managed ca. 500 non GLP and GLP-compliant pharmacology, toxicology, safety pharmacology, ADME, and bioanalytical studies encompassing various in vitro test systems, animal models, dosing regimens/vehicles, routes of administration, and efficacy/therapeutic end-points
  3. Directly managed or contributed to the non-clinical design, execution, and filing of ca. 20 Investigational New Drug (IND) or Clinical Trial Application (CTA)
  4. Contributed to the non-clinical development, filing, and/or maintenance of 4 New Drug Applications (NDA) for atorvastatin (Lipitor®), pregabalin (Lyrica®), apomorphine hydrochloride (Apokyn®), and deferiprone (Ferriprox®); and one New Drug Submission (NDS): deferiprone (Ferriprox®)