Kathleen AGAF's Email Addresses & Phone Numbers

📖 Summary

I am a US trained, board-certified pediatric gastroenterologist with a Master's from Columbia University in Biostatistics focused on clinical research. I have worked in the pharmaceutical industry since 2002 in medical affairs, research and development (Phase 2-3), and have done some safety work. Specialties: pediatrics, gastroenterology, inflammatory bowel disease, acid-related disease, endocrinology, pediatric rheumatology, pharmaceutical research, clinical trials, outcomes research, medical review of promotional pieces /promotional material, medical review of training material, conducting training, pharmacovigilance role via safety assessment of single-case causality and creating company analyses for patients in clinical trials; safety work as medical monitor on 5000 patient global trial; US & Irish citizenships; active medical license.Lead Medical Director, Ilaris (canakinumab) @ From July 2014 to Present (1 year 6 months) Acting/Interim Co-Head of Medical Affairs and Commercial Regulatory-North America @ From February 2014 to July 2014 (6 months) Senior Medical Director, Medical Affairs, Endocrinology @ From February 2012 to July 2014 (2 years 6 months) Medical Director in Global Medical Affairs, Immunology (GI indications of Humira) @ • Clinical Trials (including medical monitoring and safety assessment for 5000 patient global trial, assessing/approving investigator-initiated grant studies, interacting with development team). • Sale Force/Marketing/Commercial Support (including developing and reviewing sales and promotional pieces, and developing and presenting data at advisory boards). • Training internal colleagues (medical and commercial) • Publications • Liaison with Health Economics/ Outcomes Research group, helping craft analyses of data for scientific publications, for internal use and for submission to national review groups (for example, NICE in the UK; OHSU; AMCP, CDR in Canada). • Key Opinion Leader liaison (US and international) • Review and Report on select In-licensing candidates for business development and venture capital investments (including conducting on-site due diligence) From 2005 to 2012 (7 years) Medical Director @ Aciphex (rabeprazole) •Clinical Trials -Involved in designing/approving company-sponsored Phase IV studies. Study director for Phase IV Pharmacodynamic study; involved in approving Outcomes Research study designs. -Involved in approving investigator-initiated grant studies and CME programs -Involved in Phase I-III development work for Aciphex. •Sale Force/Marketing Support -Created explanatory training pieces for sales force •On Legal-Medical-Regulatory Promotional Review committee, reviewed all documents/promotional items targeted at sales representatives, consumers, and MDs to ensure medical accuracy. •Co-Chair of Global Medical Team, responsible for ensuring Phase IV studies from global affiliates were consistent with brand strategy. •On US & Global Publication Teams. •On Global Lifecycle Team, project lead for 1 initiative From June 2004 to October 2005 (1 year 5 months) Associate Medical Director @ Projects, roles, and responsibilities at Eisai Medical Research Inc (in GI R&D): Aciphex •Worked with team to write clinical development plan for pediatric program. Assisted in developing protocol for pediatric PK study; medical monitor on study. •Assisted in updating Aciphex Investigator Brochure. •Involved in Phase I-III work with Aciphex (new formulation Phase I trial planning, helped formulate pediatric development plan including 1st pediatric phase II study protocol with Aciphex). Compound D: compound in late preclinical stage of development for Irritable Bowel Syndrome •Coordinated development of the compound between Japan and US. Involved in developing clinical development plan for bringing compound from Phase I through Phase III in the US. Compound M: compound studied up to Phase II in Japan for Irritable Bowel Syndrome •Wrote development plan document; helped draft clinical portions of Pre-IND meeting request document; primarily responsible for clinical sections of IB. •Involved in developing clinical development plan. •Facilitated Ad Board with key US opinion leaders From September 2002 to June 2004 (1 year 10 months) MS, Biostatistics, Patient-Oriented Research @ Columbia University in the City of New York From 2000 to 2002 Fellowship, Pediatric Gastroenterology and Nutrition @ Children's Hospital of Philadelphia From 1997 to 2000 Residency, Pediatrics @ University of Colorado Health Sciences Center From 1994 to 1997 MD @ The University of Texas Southwestern Medical Center at Dallas From 1990 to 1994 BS, Biology @ University of Notre Dame From 1986 to 1990 Kathleen AGAF is skilled in: Pharmaceutical Industry, Medical Affairs, Clinical Development, Medicine, Oncology, Pharmacovigilance, Clinical Research, Clinical Trials, Immunology, Endocrinology, Gastroenterology, Health Economics, Outcomes Research, Protocol, Biostatistics