RaymondEdwardJosephMD

Gastroenterology • Gladwyne, PA

Inflammatory Bowel Disease

Physician

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Office
1618 Winston Rd
Gladwyne, PA 19035
Phone+1 610-896-1773

Fax+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
Recognizing Excellence Impact Award R&D Leadership Team, 2006
Total Recognizing Excellence Awards (9 Awards) Shire Pharmaceuticals, 2005
Honored Member America's Registry of Outstanding Professionals, 2002
Special Service Award Department of Health and Human Services (CDER), 2001
"Commissioned" - Charitable Service Governor of the commonwealth of Kentucky -(Gov. Patton)/Colonel Army of Kentucky, 1997
Philadelphia Freedom Medal 1995
Knighthood- "Knight of Goodness Award" 13th Century Italian Knighthood; Italian American Press Association, 1993
Distinguished Professor Teaching Award Methodist-Jefferson, 1993-1994
Citation from General Assembly-Community Service Pennsylvania House of Representatives, 1992
Applied Pharmacology Teaching Award Thomas Jefferson Medical College, 1987
2nd Place for Original GI Research (Komarov Competition) Philadelphia GI Research Forum, 1979
Fellowship (FACP) American College of Physicians
Fellowship (FACG) American College of Gastroenterology
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Publications & Presentations

PubMed

17 citations
Expanding 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 citations
MMX 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 citations
Effect 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 Study
Katz 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 Disease
Tursi, A., Joseph, R.E., Streck, P., Dig Dis Sci, 1/1/2011
MMX Mesalamine for Induction and Maintenance Therapy in Mild-to-Moderate Ulcerative Colitis
Hanauer 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
Randomised trial of once- or twice-daily MMX�mesalazine for maintenance of remission in ulcerative colitis
Kamm MA, Lichtenstein GR, Sandborn WJ, Schreiber S, Lees KH, Barrett K, Joseph RE, Gut, 1/13/2008
Maintenance of remission in patients with ulcerative colitis with once- or twice-daily MMX�mesalazine: results of an international multicenter randomized trial
Schreiber S, Barrett K, Lees K, Joseph RE, J Crohns Colitis, 1/1/2008
Prolonged therapy with MMX�mesalazine for the induction of remission of active, mild-to-moderate ulcerative colitis (UC)
Sandborn W, Barrett K, Lees K, Joseph RE, Canadian Journal of Gastroenterology, 1/1/2008
Patients (PTS) with quiescent mild-to-moderate ulcerative colitis (UC) receiving a multiple-daily dose mesalamine formulation can change to once- or twice-daily MMX�me...
Sandborn WJ, Karlstadt R, Barrett K, Joseph RE, Canadian Journal of Gastroenterology, 1/1/2008
MMX�mesalazine as the sole medication for the induction of remission and prevention of relapse in mild-to-moderate ulcerative colitis (UC)
Panaccione R, Diebold R, Barrett K, Karlstadt R, Joseph RE, Canadian Journal of Gastroenterology, 1/1/2008
Prolonged therapy with MMX�mesalazine in patients with acute, mild-to-moderate ulcerative colitis who fail initial mesalazine treatment may avoid the need for therapeu...
Kamm MA, Panaccione R, Barrett K, Lees K, Joseph RE, J Crohns Colitis, 1/1/2008
Once- or twice-daily MMX�mesalazine (24G/day) is effective for the maintenance of remission to mild-to-moderate ulcerative colitis regardless of the mesalazine dose or...
Colombel JF, Diebold R, Karlstadt R, Barrett K, Joseph RE, J Crohns Colitis, 1/1/2008
MMX Multi Matrix System�mesalazine for the induction of remission in patients with mild-to-moderate ulcerative colitis: a combined analysis of two randomized double-bl...
Sandborn WJ, Kamm MA, Lichtenstein GR, Lyne A, Butler T, Joseph RE, Alimentary Pharmacology and Therapeutics, 1/30/2007
Long-Term Remission Rates in Patients with Mild-to-Moderate Ulcerative Colitis Who Require an MMX�Mesalazine Dose Increase To Induce Initial Remission
Hanauer SB, Kamm MA, Diebold R, Barrett K, Joseph R, American Journal of Gastroenterology, 1/1/2007
The effect of prolonged therapy with MMX � mesalamine in patients with acute, mild-to-moderate ulcerative colitis
Lichtenstein GR, Kamm MA, Panaccione R, Barrett K, Lees K, Joseph RE, American Journal of Gastroenterology, 1/1/2007
MMX�mesalazine induces complete mucosal healing in patients with mild-to-moderate ulcerative colitis
Sandborn WJ, Lichtenstein GR, Kamm MA, Barrett K, Joseph RE, Canadian Journal of Gastroenterology, 1/1/2007
MMX�mesalazine effectively induces remission of mild-to-moderate ulcerative colitis regardless of age
Sandborn WJ, Lichtenstein GR, Kamm MA, Barrett K, Joseph RE, Canadian Journal of Gastroenterology, 1/1/2007
MMX�mesalazine for the Treatment of Active Mild-to-Moderate Ulcerative Colitis: An Evidence-Based Medicine Analysis
Sandborn WJ, Lichtenstein GR, Kamm MA, Barrett K, Joseph RE, American Journal of Gastroenterology, 1/1/2007
Once- or Twice-Daily MMX�mesalazine for the Maintenance of Remission of Mild or moderate Ulcerative Colitis
Panaccione R, Kamm MA, Karlstadt R, Diebold R, Barrett K, Joseph RE, American Journal of Gastroenterology, 1/1/2007
Patients with Quiescent Mild-to-Moderate Ulcerative Colitis Receiving a Multiple-Daily Dose 5-Aminosalicylic Acid Formulation Can Maintain Remission with Once- or Twic...
Lichtenstein GR, Diebold R, Karlstadt RG, Barrett K, Joseph RE, Gastroenterology, 1/1/2007
The Effect of Sigmoidoscopy Score at the Start of 5-Aminosalicylic Acid Therapy on Long Term Remission Rates in Patients with Mild-to-Moderate Ulcerative Colitis
Lichtenstein GR, Diebold R, Karlstadt RG, Barrett K, Joseph RE, Gastroenterology, 1/1/2007
MMX�mesalazine Is Effective for the Maintenance of Ulcerative Colitis Remission in Both Left-Sided and Extensive Disease
Lichtenstein GR, Kamm MA, Karlstadt R, Diebold R, Barrett K, Joseph RE, American Journal of Gastroenterology, 1/1/2007
MMX�mesalazine is Effective for the Maintenance of Remission of Mild-to-Moderate Ulcerative colitis Irrespective of Patients Previous Relapse History
Sandborn WJ, Karlstadt R, Barrett K, Joseph RE, American Journal of Gastroenterology, 1/1/2007
MMX � mesalamine is effective for the maintenance of ulcerative colitis remission in both left-sided and extensive disease
Lichtenstein GR, Kamm MA, Karlstadt R, Diebold R, Barrett K, Joseph RE, American Journal of Gastroenterology, 1/1/2007
Time to initial symptom resolution with MMX � mesalamine therapy for active, mild-to-moderate ulcerative colitis
Sandborn WJ, Karlstadt R, Barrett K, Joseph RE, American Journal of Gastroenterology, 1/1/2007
MMX mesalamine for the treatment of active mild-to-moderate ulcerative colitis: An evidence-based medicine analysis
Sandborn WJ, Lichtenstein GR, Kamm MA, Barrett K, Joseph RE, American Journal of Gastroenterology, 1/1/2006
Once daily MMX mesalazine for the treatment of mild-to-moderate ulcerative colitis; a phase II, dose-ranging study
D'Haens G, Hommes D, Engels L, Baert F, Van der Waaij L, Connor P, Ramage J, Dewit O, Palmen M, Stephenson D, Joseph R, Alimentary Pharmacology and Therapeutics, 1/1/2006
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Books/Book Chapters

Progress with Domperidone, A Gastro kinetic and Antiemetic Agent: Royal Society of Medicine International Congress and Symposium Series No. 36
Chapter: Domperidone in Patients with Postprandial Upper Gastrointestinal Distress
Gordon SJ and Joseph REAcademic Press Inc. (London) Ltd., and the Royal Society of Medicine, London1981

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 preparation
Bertiger 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
Colon cleansing in the SEE CLEAR I study: an analysis by sex, race, and poverty level.
Katz PO, Rex DK, Clift S, Joseph R, 2013 Digestive Diseases Week Annual Meeting, Orlando, FL, 1/21/2013
Colon cleansing in patients with a predictor of a poor preparation: an analysis of the SEE CLEAR I study.
Bertiger G, Clift S, Krause R, Rex DK, Katz PO, Joseph R, 2013 Digestive Diseases Week Annual Meeting, Orlando, FL, 1/21/2013
Patient-Reported Tolerability in the SEE CLEAR Studies: An Analysis of Current and Previous Bowel Preparations in Patients with a Prior Colonoscopy.
Epstein M, Krause R, Katz PO, Rex DK, and Joseph RE, 2013 Society of Gastroenterology Nurses and Associates, Inc. Annual Course, Austin, TX, 1/17/2013
Efficacy and safety of a split-dose dual-action, low-volume bowel preparation for colonoscopy: the SEE CLEAR I study.
Rex D, Katz P, Bertiger G, Masure J, Joseph R, 8th Congress of the European Crohn's and Colitis Organization, Vienna, Austria, 1/15/2013
Efficacy and safety of day-before dosing of a dual-action, low-volume bowel preparation for colonoscopy: The SEE CLEAR II study.
Katz P, Rex D, Epstein M, Masure J, Joseph R, European Crohn's and Colitis Organization Congress, 1/14/2013
Efficacy and safety of a split-dose dual-action, low-volume bowel preparation for colonoscopy: The SEE CLEAR I study.
Rex D, Katz P, Bertiger G, Masure J, Joseph R, European Crohn's and Colitis Organization Congress, 1/14/2013
Use of split-dose sodium picosulfate/magnesium citrate (P/MC) bowel preparation for colonoscopy in patients with comorbid diabetes, controlled hypertension, and/or obe...
Bertiger G, Clift S, Krause R, Joseph R, American College of Gastroenterology 2013, San Diego, CA, 1/13/2013
Use of split-dose sodium picosulfate/magnesium citrate (P/MC) bowel preparation for colonoscopy in patients with comorbid diabetes, controlled hypertension, and/or obe...
Bertiger G, Clift S, Krause R, Joseph R, Am J Gastroenterol, 1/1/2013
Colon cleansing in patients with predictors of a poor preparation: an analysis of the SEE CLEAR I study.
Bertiger G, Clift S, Krause R, Rex DK, Katz PO, Joseph RE, Gastrointest Endosc, 1/1/2013
Colon cleansing in the SEE CLEAR I study: an analysis by sex, race, and poverty level.
Katz PO, Rex DK, Clift S, Joseph RE, Gastrointest Endosc, 1/1/2013
Efficacy and safety of a split-dose dual-action, low-volume bowel preparation for colonoscopy: the SEE CLEAR I study.
Rex D, Katz P, Bertiger G, Masure J, Joseph R, J Crohn's Colitis, 1/1/2013
Split-dose administration of a novel, dual-action low-volume bowel cleanser for colonoscopy: efficacy and safety results from the SEE CLEAR I Study.
Rex DK, Katz P, Bertiger G, Alderfer V, Joseph R, American College of Gastroenterology 2012 Annual Meeting, Las Vegas, NV, 1/23/2012
Split-Dose Administration of a Novel, Dual-Action, Low-Volume Bowel Cleanser for Colonoscopy: Efficacy and Safety Results from the SEE CLEAR I Study.
Rex DK, Katz PO, Bertiger G, Alderfer V, Joseph RE, ACG (American College of Gastroenterology) Annual Meeting, Las Vegas, NV, 1/23/2012
Day-Before Administration of a Novel, Dual-Action, Low-volume Bowel Cleanser for Colonoscopy: Efficacy and Safety Results from the SEE CLEAR II Study.
Katz PO, Rex DK, Epstein M, Grandhi N, Alderfer V, Joseph RE, ACG (American College of Gastroenterology) Annual Meeting, Las Vegas, NV, 1/23/2012
Tolerability and Patient Questionnaire Results from Split-Dose Administration of Picoprep for Colonoscopy: The SEE CLEAR I Study.
Rex D, Katz P, Bertiger G, Joseph R, Digestive Disease Week Congress, 1/19/2012
Day-Before Administration of Picoprep for Colonoscopy: Tolerability and Patient Questionnaire Results from the SEE CLEAR II Study.
Katz P, Rex D, Epstein M, Grandhi N, Joseph R, Digestive Disease Week Congress, 1/19/2012
Split-Dose Administration of a Novel, Dual-Action, Low-Volume Bowel Cleanser for Colonoscopy: Efficacy and Safety Results from the SEE CLEAR I Study.
Rex D, Katz P, Bertiger G, Alderfer V, Joseph R, American College of Gastroenterology Congress, 1/19/2012
Day-Before Administration of a Novel, Dual-Action, Low-Volume Bowel Cleanser for Colonoscopy: Efficacy and Safety Results from the SEE CLEAR II Study.
Katz P, Rex D, Epstein M, Grandhi N, Alderfer V, Joseph R, American College of Gastroenterology Congress, 1/19/2012
Patient-Reported Tolerability in the SEE CLEAR I Study: An Analysis of Current and Previous Preparations in Patients with a Prior Colonoscopy.
Epstein M, Krause R, Katz P, Rex D, Joseph R, Society of Gastroenterology Nurses & Associates Congress, 1/17/2012
Split-dose administration of a novel, dual-action low-volume bowel cleanser for colonoscopy: efficacy and safety results from the SEE CLEAR I Study.
Rex DK, Katz P, Bertiger G, Alderfer V, Joseph R, Am J Gastroenterol, 1/1/2012
Tolerability and patient questionnaire results from split-dose administration of Picoprep for colonoscopy: the SEE CLEAR I study.
Rex DK, Katz PO, Bertiger G, Joseph RE, Gastroenterology, 1/1/2012
MMX�mesalazine therapy for active, mild-to-moderate ulcerative colitis: time to initial symptom resolution.
Schreiber S, Karlstadt R, Barrett K, Joseph RE, Gut, 15th United European Gastroenterology Week, Paris, 1/29/2007
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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 Colitis
Phoenix, AZ; Miami, FL - 1/25/2006
TARGET study (lumiracoxib) review and perspective with CLASS and VIGOR.
Blue Bell, PA - 1/27/2004
"Effectiveness Evidence to Support Long-term Use"
FDA Parklawn Conference Rooms D and E, Rockville, MD - 1/28/2001
Ischemic colitis - (Drug Induced)
Rockville, MD - 1/1/2001
Gastroenterology-Brain-Gut Axis - Effect of Stress -Gastrointestinal Motility.
New Brunswick, NJ - 1/1/1997
Transporter and Enzymatic Changes in Neonates and Pediatrics: Challenges developing Drugs for Pediatric population.
San Antonio, TX
"Inflammatory Bowel Disease"
Multiple locations
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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
New Drug Application 21-252 Medical Officer's Review (Canasa®).
Joseph RE, Food and Drug Administration
Rockville, MD - 1/5/2002
Professional development- priority initiatives for CDER Medical Officers CDER News Along the Pike.
Raymond E. Joseph, M.D., FACP, FACG, Scheldon Kress, M.D., Markham Luke, M.D., Ph.D., and James Witter, M.D., Ph.D., Center for Drug Evaluation and Research, Volume 8, Issue 1
1/4/2002
�Written Request' IND 20987/20-988 Protonix.
Joseph RE
1/19/2001
�Written Request' IND 53, 733 Nexium.
Joseph RE
1/15/2001
New Drug Application 21-252 Medical Officer's Review CANASA (mesalamine) suppositories.
Joseph RE, Food and Drug Administration
Rockville, MD - 1/9/2001
Supplemental New Drug Applications 20-007/S-031, 20-781/S-002, 20-103/S-018, 20�403/S-O10, 20-605/S-005 Medical Reviews (Zofran)
Joseph RE, Food and Drug Administration
Rockville, MD - 1/29/2000
New Drug Application 21-200 Medical Officer's Review (Zelnorm)
Joseph RE, Food and Drug Administration
Rockville, MD - 1/8/2000
New Drug Application 21-121 Medical Consult Review (Concerta)
Joseph RE, Food and Drug Administration
Rockville, MD - 1/1/2000
Current Therapy for Ulcer Disease
Joseph RE, Audio-Digest Internal Medicine, Vol. 32, Number 9
1/8/1985
Gastric Ulcer.
Joseph RE, Audio-Digest International Medicine
1/16/1983
Final Autopsy Reports and Three Johns Hopkin's CPC's
RE Joseph, M.D., Johns Hopkins Press (1973-1975)
1/1/1975
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