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1618 Winston RdGladwyne, PA 19035
Phone+1 610-896-1773
Fax+1 610-896-1773
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Summary
- Profile:
Board certified in Internal Medicine, Gastroenterology, Hepatology & Board eligible in Anatomical Pathology (Ford Foundation Fellow in hepatic biopsy pathology & GI surg. path)
Latest title – Associate Vice President at Ferring Global Pharmaceutical Company. Greater than 15 years’ experience leading global drug development progressing through Phase I-III clinical development to launch to successful commercialization and Phase-IV.
Marked experience with regulatory meetings with FDA, MAA, Health Canada, etc.
Co-Chair of (2) global drug safety teams. Co-chair with VP of Pharmacovigilance - Lialda™/Mesavant™/MesavantXL™; Pentasa® Core Team in charge of clinical data use in all promotional publications and medical global safety lead. Member of ‘Open session’ of External Safety Monitoring Board (Merck) orchestrating the compilation of ‘data packages’ for adjudication of selected adverse experiences (MIs, CVAs and peptic ulcer disease).
Leadership roles in global inflammatory diseases especially ulcerative colitis and Crohn’s disease. Evaluated Elobixibat (A3309) P-I &II. Elobixibat is an ileal bile transport inhibitor that increases bile acid delivery to the colon with effects on the inhibition of BA absorption with reduced activation of the Farnesoid X Receptor leading to increased bile acid synthesis culminating in increased bile acids in the bowel, and designed the global P-III clinical trials.
Empowered global, highly matrixed clinical teams that led to commercialization of: Lialda, Mesavant®, Mesavant XL®, Quintasa, PrepoPic & ClenPiQ. Additionally, a team member for FDA approval of - EMEND® and Zetia® (contributed to Integrated Summary of Safety).
Investigator in global somatostatin for variceal bleeding trial, several GI P-III and IV studies and others in sub-investigator roles
Key Areas of Expertise Include:
• Three years’ experience at FDA Senior Specialist at both CDER and CBER) Prepared analyses for
Education & Training
Sidney Kimmel Medical College at Thomas Jefferson University/TJUHFellowship, Gastroenterology, 1977 - 1979
Sidney Kimmel Medical College at Thomas Jefferson University/TJUHResidency, Internal Medicine, 1975 - 1977
Johns Hopkins UniversityResidency, Pathology-Anatomic and Clinical, 1973 - 1975
Ohio State University HospitalInternship, Transitional Year, 1972 - 1973
George Washington University School of Medicine and Health SciencesClass of 1972
Certifications & Licensure
PA State Medical License 1976 - 2026
Awards, Honors, & Recognition
- Team Leadership Award PrepoPik Global Team, 2013
- True Grit Award Ferring Pharmaceuticals, 2011
- Recognizing Excellence Impact Award R&D Leadership Team, 2006
Publications & Presentations
PubMed
- 17 citationsExpanding applications: the potential usage of 5-aminosalicylic acid in diverticular disease.Antonio Tursi, R Joseph, Paul Streck
Digestive Diseases and Sciences. 2011-05-13 - 3 citationsMMX Mesalamine for Induction and Maintenance Therapy in Mild-to-Moderate Ulcerative Colitis.Stephen B Hanauer, Gary R Lichtenstein, Michael A Kamm, William J Sandborn, Kirstin H Lees
Gastroenterology & Hepatology. 2009-07-01 - 68 citationsEffect of extended MMX mesalamine therapy for acute, mild-to-moderate ulcerative colitis.Michael A. Kamm, Gary R. Lichtenstein, William J. Sandborn, Stefan Schreiber, Kirstin Lees
Inflammatory Bowel Diseases. 2009-01-01
Journal Articles
- A Dual-Action, Low-Volume Bowel Cleanser Administered the Day Before Colonoscopy: Results from the SEE CLEAR II StudyKatz P, Rex D, Epstein M, Grandhi N, Vanner S, Hookey L, Alderfer V, Joseph R, American Journal of Gastroenterology, 1/1/2013
- Expanded Applications: The Potential usage of Mesalamine in Diverticular DiseaseTursi, A., Joseph, R.E., Streck, P., Dig Dis Sci, 1/1/2011
- MMX Mesalamine for Induction and Maintenance Therapy in Mild-to-Moderate Ulcerative ColitisHanauer SB, Lichtenstein GR, Kamm MA, Sandborn WJ, Lees KH, Barrett K, Karlstadt RG, Diebold R, and Joseph R, Gastroenterol Hepatol (N Y), 1/1/2009
Books/Book Chapters
Abstracts/Posters
- Serum magnesium levels are not affected by renal function in patients receiving split-dose, low-volume sodium picosulfate and magnesium citrate bowel preparation.Bertiger G, Jones E, Dahdal D, Joseph RE, 2014 Digestive Diseases Week Annual Meeting, Chicago, IL, 1/4/2014
- Serum magnesium levels are not affected by renal function in patients receiving split-dose low-volume sodium picosulfate and magnesium citrate bowel preparationBertiger G, Jones E, Dahdal D, Joseph RE, Gastrointest Endosc, 1/1/2014
- Serum magnesium levels are not affected by renal function in patients receiving split-dose low-volume sodium picosulfate and magnesium citrate bowel preparation.Bertiger G, Jones E, Dahdal D, Joseph RE, Gastrointest Endosc, 1/1/2014
Lectures
- Patients with quiescent mild-to-moderate ulcerative colitis receiving a multiple-daily dose mesalazine formulation can change to once-or twice-daily MMX�mesalazine and...Montreal, Canada - 1/1/2008
- Advances In Ulcerative ColitisPhoenix, AZ; Miami, FL - 1/25/2006
- TARGET study (lumiracoxib) review and perspective with CLASS and VIGOR.Blue Bell, PA - 1/27/2004
Other
- Once-Or Twice-Daily MMX Mesalazine (2.4g/Day) Is Effective for The Maintenance Of Remission of Mild-To-Moderate Ulcerative Colitis Regardless of The Mesalazine Dose Or...Colombel JF, Diebold R, Karlstadt R, Barrett K, Joseph R, Shire Pharmaceuticals Inc., Vol. 2, No. 1, pp. 17-17
Basingstoke, United Kingdom - 1/1/2008 - MMX Mesalazine is an effective treatment for active, mild-to-moderate UC regardless of prior 5-ASA use: a pooled analysis of two placebo-controlled, Phase III Trials, ...Kamm M, Lichtenstein G, Sandborn W, Barrett K, Joseph R, Shire Pharmaceuticals Inc., Vol. 1, No. 1, Pages 18-18
Wayne, PA - 1/1/2007 - Biologic License Application (BLA) Medical Officer's Review (Remicade®)Joseph RE, Food and Drug Administration
Rockville, MD - 1/26/2003
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