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Office
1618 Winston Rd
Gladwyne, PA 19035Phone+1 610-896-1773Fax+1 610-896-1773
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
- The Ohio State UniversityB.S., Microbiology/Molecular Biology, 1968
Certifications & Licensure
- PA State Medical License 1976 - 2024
Awards, Honors, & Recognition
- Team Leadership Award PrepoPik Global Team, 2013
- True Grit Award Ferring Pharmaceuticals, 2011
- Multiple Impact Awards Strategic Therapy Team Shire Inc., 2006
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Publications & Presentations
PubMed
- 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 - 210 citationsEffect of once- or twice-daily MMX mesalamine (SPD476) for the induction of remission of mild to moderately active ulcerative colitis.Gary R. Lichtenstein, Michael A. Kamm, Prabhakar Boddu, Natalya Gubergrits, Andrew Lyne
Clinical Gastroenterology and Hepatology. 2007-01-01 - 263 citationsOnce-Daily, High-Concentration MMX Mesalamine in Active Ulcerative ColitisMichael A. Kamm, William J. Sandborn, Miguel A. Gassull, Stefan Schreiber, Lechoslaw Jackowski
Gastroenterology. 2007-01-01
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
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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
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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
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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 - Join now to see all
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