Richard C Yocum, MD

Chief Medical Officer

Dr. Yocum draws on extensive life science/healthcare experience. He has more than 24 years of biopharmaceutical industry experience in clinical drug development combined with 11 years of clinical practice of Internal Medicine. He has long provided high quality consulting for the biopharmaceutical industry to expedite clinical drug development, minimize risk, optimize results, and assess the probability of successful new product approvals.

His areas of expertise include:
 

  • Strategic clinical & regulatory guidance for drug development

  • Clinical development plans, protocols, study reports, sections of INDs/NDAs and annual reports, etc.

  • Manuscripts, abstracts, & other medical writing

  • Program management

  • Due diligence for in-licensing & partnership opportunities

  • Medical monitoring & pharmacovigilance
     

Dr. Yocum possesses a proven track record of success in seven new product approvals, with diverse experience comprising small molecule drugs, large molecule biologics, and device clinical development. He brings direct hands-on experience in all phases of clinical development, including SPA, Scientific Advice, multiple IND submissions; Phase I, II, III, & IV trials, investigator-initiated studies, lifecycle management, NDA and MAA submissions, and post-marketing pharmacovigilance.

Dr. Yocum has been an integral participant in dozens of successful face-to-face FDA & EMEA/CHMP meetings across a range of therapeutic areas, including pre-IND, pre-IDE, end-of-Phase II, and pre-NDA meetings, SPA and has defended registration dossiers at two FDA advisory panel meetings and one CHMP Oral Hearing. He was the principal author of numerous clinical development plans, protocols, study reports, PSURs, DSURs, integrated summaries of safety and efficacy, and clinical sections of FDA briefing books, new INDs, IND and NDA annual reports, and successful NDA, NDS, and MAA submissions.

Dr. Yocum is board-certified in general internal medicine and has authored/co-authored 58 publications/abstracts.

6076 Corte Del Cedro Carlsbad, CA 92011 USA

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