About

 

INPERNUM PHARMA CONSULTING

Inpernum works with small and emerging biopharma clients to reduce development program variability
as well as providing an optimal regulatory strategy combined with a realistic assessment of
the constantly evolving clinical development landscape.

Steven Castillo is both Chief Executive Officer and Founder of Inpernum Pharma Consulting since February, 2016. Mr. Castillo has over 26 years of experience in Clinical Development and Regulatory Affairs that extends across academia, small biotech, large pharma, global CROs, and niche consulting. From October 2014 to January 2016, Mr. Castillo served as Vice President, Product and Clinical Development at Camargo Pharmaceutical Services, LLC, prior to that he was the Global Project Head III, Retina Drugs and Biologics, at Alcon, a Novartis, Co. from 2012 to 2014. From 2007 to 2012, Mr. Castillo was Director of Clinical Development at Argos Therapeutics then at the Global CRO PPD as Director of Global Product Development in the Regulatory Affairs Dept.

From 1996 to 2006, Mr. Castillo held various positions of increasing responsibility at Glaxo Wellcome and GlaxoSmithKline in the Infectious Disease group leading clinical development teams. Career accomplishments have been noted by the global approvals of once-daily lamivudine, once-daily abacavir, once-daily abacavir/lamivudine combination, and ocriplasmin. In addition, Mr. Castillo has led and/or participated in numerous FDA Pre-IND, Type B, EOP2, and Pre-NDA meetings across many divisions of the FDA. Mr. Castillo received his Master of Science degree from University of Washington – Seattle, in Molecular and Cellular Biology under a Pre-Doctoral NIH fellowship grant and a baccalaureate degree from the University of Colorado – Boulder, in Biology.

More than 20 years experience in Quality and Regulatory experience with GMP manufacturing of biologics and cell therapy products, including primary hepatocytes and individualized immunotherapy for oncology and infectious diseases.

Ms. Terry has prepared CMC regulatory documents for FDA, Health Canada, EMA and MHRA across multiple divisions for emerging technologies, as well as drafted CMC questions and background information for briefing documents to support Agency meetings.

Additionally Ms. Terry has been the Quality Project Manager for multiple site expansions and renovations, leading the effort to a qualified and fully GMP facilities. These facilities were determined to be GMP compliant by EMA and Health Canada. She has successfully completed technical transfers between Quality Control labs both internal company transfers and with external contract labs.