Michael Nessly

Background

About Michael Nessly

Comprehensive experience in collaborating with Sponsors and CRO’s in flexible resourcing models. Wide ranging involvement across a variety of clinical therapeutic areas: antivirals, infectious disease, cardiovascular, ophthalmology, psychiatry, neurology, clinical pharmacology, imaging/diagnostic devices. Extensive experience with regulatory agencies worldwide and frequent direct interactions with FDA, EMEA/CPMP/EMA, MPH, Japanese, Australian, Brazilian, Swiss, Canadian and other regulatory agencies. Worldwide submissions, requests for information, advisory committee meetings, post-approval commitments/follow-up measures, pediatric initiatives, label discussions, safety update reports, statistical documentation supporting worldwide marketing applications and pricing and re-imbursement. Product development team chairperson for one development compound candidate with multiple indications. Participated in multiple FDA Advisory Committee meetings including primary statistical respondent, preparer of presentations and expert trainer. Collaborated on multidisciplinary collaborative efforts: InterCompany Collaboration for AIDS Research, HIV Surrogate Markers Working Group, Intercompany Response to EMEA regarding metabolic adverse experiences and protease inhibitors, Clinical and Data Interchange Standards Consortium, Inc.(CDISC) Led the Analysis Dataset Management Working Group (ADaM). Has lead end to end implementation of CDISC standards at two companies. Lansdale, PA 19446 | 215.527.5011 | mnessly@gmail.com |