Robert is an expert in US regulatory affairs with focus on the clinical development of new drugs from IND through to NDA/BLA filings. He has extensive experience supporting a wide array of therapeutic areas and classes of drugs. In addition, Robert is highly experienced with the regulations governing nonclinical testing and manufacturing of drugs.
Key Areas Of Expertise
- US FDA and Health Canada regulations
- Small molecules, large molecules, cell therapy
- IND and 505(b)(1) and 505(b)(2) NDAs
- Orphan drug/rare disease, paediatric development plan, breakthrough therapy, regenerative medicine advanced therapy
- IND and post-marking safety reporting (pharmacovigilance)
- Product labelling and proprietary names
- Formal FDA meetings (Types A, B, and C): pre-IND, EOP1, EOP2, pre-NDA
Before NDA
Robert has worked in the regulatory affairs arena continuously since 2000 at several different drug companies and in supportive roles as an outside consultant. He has been responsible for leading the regulatory affairs efforts at start-up and mid-size drug companies, both domestic and foreign.
