Page 1 of 21
`
`CURRICULUM VITAE
`Michael S. Epstein, M.D., F.A.C.G., A.G.A.F., A.M.E.
`
`Investigative Clinical Research
`621 Ridgely Avenue, Suite 403
`Annapolis, MD 21401
`
`Digestive Disorders Associates
`621 Ridgely Avenue, Suite 201
`Annapolis, MD 21401
`
`Maryland Diagnostic & Therapeutic
`Endoscopy Center
`621 Ridgely Avenue, Suite 101
`Annapolis, MD 21401
`
`Office: (410) 224-4887 ext. 444
`Fax: (410) 266-7144
`
`
` michael@icrmd.com
`
`EDUCATION AND TRAINING
`
`1984 – 1986
`
`1981-1984
`
`1977-1981
`
`1973-1977
`
`
`
`
`
`
`
`
`
`Fellowship in Gastroenterology and Hepatology
`Veterans Administration Medical Center
`
`Director: Leonard B. Seef, M.D.
`
`Washington, D.C.
`
`Internship and Residency Program
`Washington, D.C.
`George Washington University Hospital and School of Medicine
`Director: Gorge G. Rios, M.D.
`
`Doctor of Medicine
`Newark, NJ
`Robert Wood Johnson School of Medicine, New Jersey College of
`Medicine and Dentistry
`
`Bachelor of Arts with Distinction
`University of Colorado
`Molecular, Cellular, Developmental Biology
`
`
`
`Boulder, CO
`
`CURRENT STATUS
`
`2010-Present
`2009-Present
`2007-Present
`2006-Present
`
`2006-Present
`1995-Present
`1994-Present
`1993-Present
`
`1990-Present
`1990-Present
`1986-Present
`
`Founder and President, Investigative Clinical Research, Annapolis, MD
`Member, IRB Company
`Aviation Medical Examiner, FAA
`Special Government Employee and Consultant, Gastrointestinal Drugs
`Advisory Committee
`Fellow, American Gastroenterology Association
`Fellow, American College of Gastroenterology
`Staff Gastroenterologist, Baltimore Washington Medical Center
`Founder and President, Maryland Diagnostic & Therapeutic Endo
`Center (MDTEC), Annapolis, MD
`Principal Physician, Digestive Disorders Associates, Annapolis, MD
`Staff Gastroenterologist, Anne Arundel Medical Center, Annapolis, MD
`Assistant Professor of Medicine, Uniformed Services of Health Science,
`Bethesda, MD
`
`MYLAN EXHIBIT - 1071
`Mylan Pharmaceuticals, Inc. v. Bausch Health Ireland, Ltd.
`IPR2022-00722
`
`

`

`Page 2 of 21
`
`CURRENT LICENSURE
`
`Maryland license number D0034426, September 1986
`
`BOARDS CERTIFICATION
`
`1987
`1984
`
`
`American Board of Internal Medicine, subspecialty of Gastroenterology
`American Board of Internal Medicine
`
`PREVIOUS PROFESSIONAL POSITIONS
`
`
`
`
`
`
`
`
`
`2006-2009
`1988-2007
`1996-2007
`2003-2006
`2000-2004
`2002-2004
`2000-2002
`1999-2001
`1998-2000
`
`Member, Gastrointestinal Drugs Advisory Committee of the FDA
`Member, American Gastroenterology Association
`Vice President and Medical Director, AmeriTrial OTC Research Inc.
`Acting Medical Director, First Circle Medical
`Member, Board of Trustees, Anne Arundel Medical Center
`Member, FDA Gastrointestinal and Urologic Device Panel
`President, Medical Staff of Anne Arundel Medical Center
`President, Medical Board Executive Committee, AAMC, Annapolis, MD
`Vice President, Medical Board Executive Committee, Anne Arundel
`Medical Center Annapolis, MD
`Vice President, Anne Arundel County Medical Society
`
`1998-2000
`1997-1999 Secretary/Treasurer, Medical Board Executive Committee, AAMC
`Secretary, Anne Arundel County Medical Society
`1997-1998
`
`President, Maryland Ambulatory Surgery Association
`1995-1998
`
`Chairman, Anne Arundel Medical Center Institutional Review Board
`1995-1999
`
`Member, American College of Gastroenterology
`1988-1995
`
` Member at Large, Medical Executive Board, AAMC, Annapolis, MD
`1994-1995
`Board Member, Anne Arundel Medical Center, Annapolis, MD
`1990-1992
`
`President, Medical Staff, Anne Arundel Medical Center, Annapolis, MD
`1990-1992
`
`IRB Chair, Anne Arundel Medical Center, Annapolis, MD
`1989-1990
`
`Staff Gastroenterologist, Malcolm Grow USAF Medical Center,
`1986-1990
`Andrews Air Force Base, Largo, MD
`
`AWARDS
`
`2009
`1992
`1992
`
`
`US FDA Advisory Committee Service Award
`Meritorious Service Medal USAF
`AMA Physicians Recognition Award
`
`

`

`Page 3 of 21
`
`CONSULTING CLIENTS (Partial List)
`
`Pharmaceutical Corporations
`
`Proctor and Gamble Pharmaceutical
`
` Given Imaging
` Anesta Corporation
` McNeil Pharmaceutical
` Merck and Co. Inc.
` Roche Pharmaceutical
`Sucampo
`
` Allergan
` Abbott (Abbvie) Pharmacheticals
` Zx Pharmaceuticals
` Eli Lilly
` Vertice Pharmaceuticals
`Ferring Pharmaceuticals
`
` Otsuka America Pharmaceuticals
` Knsyl Pharmaceuticals
`
`Device Manufacturers
`
`Proteus Biomedical
`
` Ethicon Endosurgical
` Medigus
` Betastim Ltd. Life Sciences
` GI View Ltd.
` EVASC Medical Systems
`Precision Endoscopic Therapeutics
`
`
`Legal Firms
`
` Baker, Donelson, Bearman, Caldwell, & Berkowitz, PC, Jackson, MS
` Nutter, McClennen, & Fish, LLP, Boston, MA
` Lisa S. Levine, P.A., Weston, FL
`Frommer Lawrence & Huang, LLP, New York, NY
`
` Dickstein Shapiro, New York, NY
` Hogan & Harston, Washington, D.C.
` Keating Jones Hughes, PA, Portland, OR
` Latham Watkins, LLP, Washington D.C. & San Francisco, CA
`
`

`

`Page 4 of 21
`
`PERSONAL DATA
`
`Born:
`Children:
`
`Hobbies:
`
`December 30, 1955, Ft. Meade, Maryland
`Lauren J. Epstein, October 17, 1986
`Stephen D. Epstein, October 1, 1989
`Rachelle A. Epstein, August, 9, 1991
`Water skiing, skiing, aviation
`
`PUBLICATIONS
`
`1. Cash, B.D., Moncrief, M.B.C., Epstein, M.S. et al. Patient experience with NER1006 as
`a bowel preparation for colonoscopy: a prospective, multicenter US survey. BMC
`Gastroenterol 21, 70 (2021).
`
`2. Epstein, M., Johnson, D., Hawes, R., Schmulewitz, N., Vanagunas, A., Gossen, R.,
`Eaton, S., Robieson, W., Dubow, J., Chatamra, K., & Benesh, J. Gastrointestinal safety of
`levodopa-carbidopa intestinal gel system in advanced Parkinson’s Disease. Movement
`Disorders. (in press)
`3. Cash, B. D., Epstein, M. S., & Shah, S. M. (2016). A novel delivery system of
`peppermint oil is an effective therapy for irritable bowel syndrome symptoms. Digestive
`Diseases and Sciences, 61(2), 560-571.
`4. Cash, B. D., Epstein, M. S., & Shah, S. M. (2016). Patient Satisfaction with IBS
`Symptom Relief Using a Novel Peppermint Oil Delivery System in a Randomized
`Clinical Trial and in the General Population. International Journal of Digestive Diseases,
`2(2), 227.
`5. Epstein, M., Johnson, D. A., Hawes, R., Schmulewitz, N., Vanagunas, A. D., Gossen, E.
`R., Robieson, W.Z., Eaton, S., Dubow, J., Chatamra, K., & Benesh, J. (2016). Long-term
`PEG-J Tube safety in patients with advanced Parkinson's disease. Clinical and
`Translational Gastroenterology, 7(3), e159.
`6. Epstein, M.S., Ehrenpreis, E.D., & Kulkarni, P.M. (2014). Biosimilars: the need, the
`challenge, the future: the FDA perspective. The American Journal of
`Gastroenterology, 109(12), 1856-1859.
`7. McLemore, E.C., Rai, R., Siddiqui, J., Basu, P., Tabbba, M., & Epstein M.S. (2012).
`Novel endoscopic delivery modality of infrared coagulation therapy for internal
`hemorrhoids. Surgical Endoscopy, 26(11), 3082-3087.
`8. Au-Yeung, K.Y., Moon, G.D., Robertson, T., DiCarlo, L.A., Epstein, M.S., Weis, S.E.,
`Reves, R.R., & Engel, G. (2011). Early clinical experience with networked system for
`promoting patient self-management. American Journal of Managed Care, 17(7), e277-
`e287.
`9. Jacobson, I. M., Brown, R. S., Freilich, B., Afdhal, N., Kwo, P. Y., Santoro, J., Becker,
`S., Wakil, A.E., Pound, D., Godofsky, E. Strauss, R., Bernstein, D., Flamm, S., Pauly,
`
`M.P., Mukhopadhyay, P., Griffel, L.H., & Brass, C.A. (2007). Peginterferon alfa‐2b and
`weight‐based or flat‐dose ribavirin in chronic hepatitis C patients: A randomized
`
`trial. Hepatology, 46(4), 971-981.
`10. Epstein, M.S. (1995). Munchausen syndrome: Case reports and literature overview.
`Maryland Medical Journal, 44(1), 39-43.
`
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`

`Page 5 of 21
`
`11. Devaney, K., Goodman, Z.D., Epstein, M.S., Zimmerman, H.J, & Ishak, K.G. (1993).
`Hepatic sarcoidosis: clinicopathologic features in 100 patients. The American Journal of
`Surgical Pathology, 17(12), 1272-1280.
`12. Epstein, M.S., Ingram, C.W., Borts, F.W., Korman, L.Y., & Seef, L.B. (1986).
`Retrospective and prospective analysis of focal defects demonstrated by computerized
`tomography. Gastroenterology, 90(5), 1724.
`
`ABSTRACTS
`
`1. Bertiger, G., Epstein, M., Marshall, D., & Dahdal, D. (2016). A low-volume sodium
`picosulfate and magnesium citrate bowel preparation has no effect on cardiovascular
`parameters in patients preparing for colonoscopy. Seattle, WA.
`2. Draganov, P., Epstein, M., Hawes, R. Johnson, D., Vanagunas, A., Robieson, W.Z.,
`Chatamra, K., Benesh, J.A., & Eaton, S. (2016). Short- and long-term safety of PEG-J
`used for continuous infusions of levodopa-carbidopa intestinal gel. Vancouver, BC,
`Canada.
`3. Epstein, M.S., Clayton, L., Ng, R., & DeMicco, M. (2016). Efficacy and safety of the
`novel 1L PEG and ascorbate bowel preparation NER1006 versus standard 2L PEG with
`ascorbate in overnight or morning split-dosing administration: results from the phase 3
`study. San Diego, CA.
`4. Epstein, M., Willey, R., Almansa, C., & Dahdal, D. Efficacy, safety and patient-reported
`tolerability of sodium picosulfate plus magnesium citrate in patients with previous bowel
`preparation experience. San Antonio, TX.
`5. Epstein, M.S., Clayton, L., Ng, R., & DeMicco, M. (2016). Efficacy and safety of the
`novel 1L PEG and ascorbate bowel prearation NER1006 versus trisulfate solution in
`overnight split-dosing administration: results from the phase 3 study NOCT. Vienna,
`Austria.
`6. Poordad, F., Sedghi, S., Pockros, P.J., Ravendrhan, N., Reindollar, R, Lucey, M.R.,
`Epstein, M., Bank, L., Bernstein, D., Trinh, R., Krishnan, P., Piolot-Matias, T.,
`Polepally, A.R., Pothacamury, R.K., Rajvineeth, K., Martinez, M., & Nelson, D.R.
`(2016). GEODE-II: Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir
`with low-dose ribavirin QD in patient with genotype 1a chronic hepatitis C virus
`infection without cirrhosis. Paris, France.
`7. Poordad, F., Sedghi, S., Pockros, P.J., Ravendrhan, N., Reindollar, R, Lucey, M.R.,
`Epstein, M., Bank, L., Bernstein, D., Trinh, R., Krishnan, P., Piolot-Matias, T.,
`Polepally, A.R., Pothacamury, R.K., Rajvineeth, K., Martinez, M., & Nelson, D.R.
`(2016). GEODE-II: Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir
`with low-dose ribavirin QD in patient with genotype 1a chronic hepatitis C virus
`infection without cirrhosis. Boston, MA.
`8. Bertiger, G., Epstein, M., Hutson-Walker, A., Almansa, C., & Dahdal, D.N. (2016).
`Comparison of bowel preparation quality scales used in randomized controlled trials of
`patients undergoing colonoscopy. Las Vegas, NV.
`9. Vanagunas, A., Draganov, P., Schmulewitz, N., Epstein, M., Hawes, R., Johnson, D.,
`Benesh, J.A., Chatamra, K., Easton, S., Facheris, M.F., Hall, C.M., & Robieson, W.Z.
`(2016). Multi-year safety and durability of PEG-J used for continuous infusion of
`
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`

`Page 6 of 21
`
`levodopa-carbidopa intestinal gel in ambulatory Parkinson’s disease patients: year 2 and
`beyond. Las Vegas, NV.
`10. Epstein, M.S., Cash, B.D., & Shah, S.M. (2015). Targeted delivery of peppermint oil to
`the small intestine provide significant improvement in the syndrome of symptoms
`associates with irritable bowel syndrome. Presented at Digestive Disorders Week,
`Washington, D.C.
`11. Cash, B.D., Epstein, M.S., & Shah, S.M. (2015). IBgard®, a novel targeted delivery
`system of peppermint oil, results in significant improvement in the Total IBS Symptom
`Score and individual IBS symptoms. Results from the US based, 4-week, randomized,
`placebo controlled, multi-center IBSREST™ trial. Presented at Digestive Disorders
`Week, Washington, D.C.
`12. Epstein, M.S., Cash, B. D., & Shah, S. M. (2015). 24-Hour Results From a Placebo-
`Controlled Trial, to Evaluate a Novel Peppermint Oil Delivery System, Targeting Release
`in the Small Intestine. Results From the US Based, 4-Week, Randomized, Placebo
`Controlled, Multi-Centered IBREST™ Trial. Gastroenterology, 148(4), S-69.
`13. Epstein, M.S., Cash, B.D., & Shah, S.M. (2015). 24 hour results form a US based,
`randomized, placebo-controlled, multi-centered trial, to evaluate a novel peppermint oil
`delivery system: Results from the IBREST™ Trial. Presented at Digestive Disorders
`Week, Washington, DC.
`14. Epstein, M., & Shah, S. (2015). A novel formulation containing a L-Menthol and
`peppermint oil blend (LPB) reduces symptom intensity and frequency in Irritable Bowel
`Syndrome (IBS). Presented at James W. Freston Conference, AGA Institute, Chicago, IL.
`15. Dragov, P., Epstein, M., Robieson, W.Z., Chatamra, K., Benesh, J.A., & Easton, S.
`(2015). Short- and long-term safety of PEG-J used for continuous infusion of levodopa-
`carbidopa intestinal gel. Presented at ACG, Honolulu, HI.
`16. Johnson, D., Epstein, M., Hawes, R., Draganov, P., Schmulewitz, N., Vanaguna, A.,
`Hall, C.M., Robieson, W.Z., Chatamra, K., Benesh, J.A., & Eaton, S. (2015). Devices
`complaints and longevity of PEG-J used for continuous infusion of levodopa-carbidopa
`intestingal gel in ambulatory patients with Parkinson’s disease. Presented at ACG,
`Honolulu, HI.
`17. Epstein, M., Cash, B., & Shah, S. (2015). Rapid relief of Irritable Bowel Syndrome
`(IBS) symptoms with targeted delivery of L-Menthol to the small intestine: results form 2
`clinical trials and a patient survey. Presented at ACG, Honolulu, HI.
`18. Epstein, M., Cash, B., & Shah, S. (2015). Patient satisfaction with IBS symptom relief
`using a novel peppermint oil delivery system in a randomized clinical trial and by the
`general patient population. Presented at ACG, Honolulu, HI.
`19. Cash, B.D., Epstein, M., & Shah, S. (2015). Successful management viscerosensory
`symptoms in patients with IBS-M and IBS-D using a targeted delivery system of
`peppermint oil (PO-SST). Presented at ACG, Honolulu, HI.
`20. Epstein, M., Johnson, D., Hawes, R., Schmulewitz, N., Vanagunas, A., Gossen, R.,
`Widnell, K.L., Eaton, S., Robieson, W.Z., Chatamra, K., & Benesh, J. (2014).
`Gastrointestinal safety of the levodopa-carbidopa intestinal gel delivery system in treating
`advanced Parkinson’s patients (MDS Encore). Presented at American Academy of
`Neurology Annual Meeting, Philadelphia, PA.
`21. Epstein, M., Johnson, D., Hawes, R., Schmulewitz, N., Vanagunas, A., Gossen, R.,
`Widnell, K.L., Eaton, S., Robieson, W.Z., Chatamra, K., & Benesh, J. (2013).
`
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`

`Page 7 of 21
`
`Gastrointestinal safety of the levodopa-carbidopa intestinal gel delivery system in treating
`advanced Parkinson’s patients. Sydney, Australia.
`22. Epstein, M., Johnson, D., Hawes, R., Schmulewitz, N., Vanagunas, A., Gossen, R.,
`Eaton, S., Robieson, W.Z., Chatamra, K., & Benesh, J. (2013). Gastrointestinal safety of
`the long-term PEG-J used for continuous infusion of levodopa-carbidopa intestinal gel.
`Berlin, Germany.
`23. Epstein, M., Johnson, D., Hawes, R., Schmulewitz, N., Vanagunas, A., Zadikoff, C.,
`Gossen, R., Eaton, S., Robieson, W.Z., Chatamra, K., & Benesh, J. (2013). PEG-J
`administration of therapeutic agents for neurological disorders: levodopa-carbidopa
`intestinal gel for advanced Parkinson’s disease. San Diego, CA.
`24. Johnson, D., Epstein, M., Hawes, R., Schmulewitz, N., Vanaguna, A., Gossen, R., Eaton,
`S., Robieson, W.Z., Chatamra, K., & Benesh, J. Durability of the PEG-J system in long-
`term studies of levodopa-carbidopa intestinal gel infusion in advanced Parkinson’s
`disease patients. San Diego, CA.
`25. Epstein, M., Grandhi, N., Katz, P, & Joseph, R. (2013). Diabetes controlled hypertension
`and obesity have little effect on the safety and tolerability of day before sodium
`picosulfate and magnesium citrate bowel preparation. American Journal of
`Gastroenterology, 108, S581.
`26. Epstein, M., Grandhi, N.K., Katz, P.O., & Rex, D.K. (2013). Colon cleansing in patients
`with predictors of a poor bowel preparation: an analysis of the See Clear II study. Society
`of American Gastrointestinal and Endoscopic Surgeons Annual Meeting, Baltimore, MD.
`27. Bertiger, G., Clift, S., Krause, R., Rex, D., Katz, P., & Joseph, R. (2013). Colon cleansing
`in patients with predictors of a poor preparation: an analysis of the SEE CLEAR I
`study. Gastrointestinal Endoscopy, 77(5), AB514-AB515.
`28. Katz, P., Rex, D., Clift, S., & Joseph, R. (2013, May 19). Colon Cleansing in the SEE
`CLEAR I Study: an analysis by sex, race, and poverty level. Gastrointestinal
`Endoscopy, 77(5), AB515.
`29. Epstein, M., Krause, R., Katz, P.O., Rex, D., & Joseph, R. (2013). Patient-reported
`tolerability in the SEE CLEAR I study: an analysis of current and previous preparations
`in patients with a prior colonoscopy.
`30. Rex, D.K., Katz, P.O., Bertiger, G., Masure, J., & Joseph, R. (2013). Efficacy and safety
`of a split-dose dual-action, low-volume bowel preparation for colonoscopy. Journal of
`Crohn’s and Colitis, 7, Suppl.1, S110-S111.
`31. Katz, P.O., Rex, D.K., Epstein, M., Masure, J., & Joseph, R. (2013) Efficacy and safety
`of day-before dosing of a dual-action, low-volume bowel preparation for colonoscopy:
`the SEE CLEAR II study. Journal of Crohn’s and Colitis, 7, Suppl.1, S110.
`32. Rex, D.K., Katz, P.O., Bertiger, G., & Joseph, R. (2012). Tolerability and patient
`questionnaire results from split-dose administration of Picoprep for colonoscopy: the SEE
`CLEAR I study. Gastroenterology, 142(5), S-738.
`33. (2012, May 22). Day-before administration of a dual-action, low-volume preparation for
`colonoscopy: tolerability and patient questionnaire results from the SEE CLEAR II study
`34. Rex, D.K., Katz, P.O., Bertiger, G., & Joseph, R. (2012). Tolerability and patient
`questionnaire results from split-dose administration of a dual-action, low-volume
`preparation for colonoscopy: the SEE CLEAR I study.
`35. Rex, D.K., Katz, P.O., Bertiger, G., Alderfer, V., & Joseph, R. (2012). Split-dose
`administration of a novel, dual-action, low-volume bowel cleanser for colonoscopy:
`
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`Page 8 of 21
`
`efficacy and safety results from the SEE CLEAR I study. American Journal of
`Gastroenterology, 107, S746.
`36. Katz, P.O., Rex, D.K., Epstein, M., Grandhi, N.K., Alderfer, V., & Joseph, R. (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. American
`Journal of Gastroenterology, 107, S746-S747.
`37. Rex, D.K., Epstein, M.S., Katz, P.O., Bertiger, G., & Joseph, R.E. (2012). Tu1070
`tolerability and patient questionnaire results from split-dose administration of Picoprep
`for colonoscopy: SEE CLEAR I study. Gastroenterology, 142(5), Suppl. 1, S-738.
`38. Epstein, M.S., & Katz, P.O. (2012). Day-before administration of Picoprep for
`colonoscopy: tolerability and patient questionnaire results from the SEE CLEAR II study.
`Gastroenterology, 142(1), S.
`39. Katz, P.O., Rex, D.K., Epstein, M.¸ Grandhi, N.K., & Joseph, R. (2012). Day before
`dose (study 2009-02) tolerability and patient questionnaire. Digestive Disease Week, San
`Diego, CA.
`40. Epstein, M.S. (2009). Ingestible event marker system – a novel physiologically-sized
`device platform for frequent, repeated use. Gastrointestinal endoscopy, 69(5), AB106.
`41. Lewis, J.H., Collier, K.P., Epstein, M.S., Howell, C.D., Laurin, J., Thuluvath, P.J…&
`Lobis, I.F. (2000). Intron-A plus ribavirin (Rebetron) for the treatment of chronic
`hepatitis C in prior interferon monotherapy non-responders (NRs): final results of the
`Washington, DC metropolitan area hepatitis C investigators study. Gastroenterology,
`118(4), A1464.
`42. Epstein M.S. (1999). Pilot study of the safety and activity of interleukin-10 (rHulL-10)
`in the prevention of acute pancreatitis following endoscopic retrograde
`cholangiopancreotography (ECRP).
`43. Lewis, J.H., Gallagher, J.E., Gibbs, L., & Epstein, M.S. (1998). Interferon-2b plus
`ribavirin for the treatment of chronic hepatitis C in prior interferon non-responders:
`interim results of a community trial. Gastroenterology, 114(Suppl. 1), A1288.
`44. Epstein, M.S. (1998). Treatment of chronic hepatitis C with a combination of interferon
`plus ribavirin.
`45. Epstein, M.S. & Zobrist, R.H. (1998). Oral transmucosal etomidate in patients
`undergoing diagnostic sigmoidoscopy. Arundel Ambulatory Surgery Center, Annapolis,
`MD.
`46. Epstein, M.S. (1990). Screening for colon cancer, prospective study of fecal occult blood
`testing. Society of Air Force Journal.
`47. Epstein, M.S., Devaney, K.O., Goodman, Z.D., Zimmerman, H.J., & Ishak, K.G. (1990).
`Liver disease in sarcoidosis. Hepatology, 12(4), 839.
`
`CLINICAL RESEARCH STUDIES
`
`1.
`
`Inventiva Clinical Study Protocol 337HNAS20011 (NATiV3). A randomized, double-
`blind, placebo-controlled, multicenter Phase 3 study evaluating long-term efficacy and
`safety of Lanifibranaor in adult patients with non-cirrhotic non-alcoholic steatohepatitis
`(NASH) and fibrosis 2 (F2)/Fibrosis 3 (F3) state of liver fibrosis.
`
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`Page 9 of 21
`
`2.
`
`4.
`
`5.
`
`Phathom Pharmaceuticals Clinical Study Protocol NERD-301. A phase 3, randomized,
`double-blind, multicenter study to evaluate the efficacy and safety of Vonoprazan 10mg,
`20 mg, compared to placebo for relief of episodic heartburn in subjects with symptomatic
`Non-Erosive Gastroesophagal Reflux Disease (NERD) after 4 weeks and to evaluate the
`efficacy and safety of Vonoprazan 10mg, 20 mg for relief of heartburn in subjects with
`NERD after 6 months.
`3. Abbvie Clinical Study Protocol M14-327 OLE A phase 2, multicenter, Open Label
`Extension study to observe the long-term efficacy, safety and tolerability of repeated
`administration of Upadacitinib (ABT-494) in subjects with Crohn’s Disease.
`9 Meters Biopharma Clinical Study Protocol Ced-LA-3001 a Phase 3 randomized,
`double-blind, placebo-controlled study to evaluate the efficacy and safety of Larazotide
`for relief of persistent symptoms in patients with celiac disease on a gluten free diet.
`Phathom Pharmaceuticals Clinical Study Protocol NERD-201. A phase 2, randomized,
`double-blind, multicenter study to evaluate the efficacy and safety of Vonoprazan 10mg,
`20 mg, and 40 mg compared to placebo for relief of episodic heartburn in subjects with
`symptomatic Non-Erosive Gastroesophagal Reflux Disease (GERD).
`6. Clinical Validation of An Optimized Multi-Target Stool DNA (mt-sDNA 2.0) Test, for
`Colorectal Cancer Screening “Blue-C” 2019-01. Principal Investigator, 2020
`7. BLOOD COLLECTION SUB-STUDY OF EXACT SCIENCES PROTOCOL 2019-01:
`“CLINICAL VALIDATION OF AN OPTIMIZED MULTI-TARGET STOOL DNA (mt-
`sDNA 2.0) TEST, FOR COLORECTAL CANCER SCREENING BLUE-C” 2019-01B.
`Principal Invesitgator, 2020
`Ironwood, Protocol C3718-302: A Phase 3, Randomized, Double-blind, Placebo-
`controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients
`with Gastroesophageal Reflux Disease while receiving Proton Pump Inhibitors. Principal
`Investigator, 2019.
`9. Exact Sciences, Protocol 2018-10B: Blood Collection Sub-Study of Exact Sciences
`Protocol 2018-10: “An Evaluation of a Multi-target Stool DNA (mt-sDNA) Test,
`Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average Risk for
`Development of Colorectal Cancer: Act Now”. Principal Investigator, 2019.
`10. Exact Sciences, Protocol 2018-10: An Evaluation of a Multi-target Stool DNA (mt-
`sDNA) Test, Cologuard, for CRC Screening in Individuals Aged 45-49 and at Average
`Risk for Development of Colorectal Cancer. Principal Investigator, 2019.
`11. Gilead, Protocol GS-US-418-4279: A Randomized, Double-blind, Placebo-controlled
`Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with
`Moderately to Severely Active Ulcerative Colitis. Principal Investigator, 2018.
`12. Sebela, Protocol SEB-ECP-202: A Randomized, Investigator- and Colonoscopist-
`blinded, Phase 2 Study of the Efficacy and Safety of ECP (polyethylene glycol 3350
`[PEG 3350]) Colon Prep Kit Compared with MoviPrep® Split-dose for Colonoscopy
`Preparation. Principal Investigator, 2017.
`13. Allergan, Protocol CMO-US-GI-0429: A Phase 4 Multicenter, Multinational,
`Prospective, Randomized, Placebo-Controlled, Double-Blinded Parallel Group Study to
`Assess Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome with
`Diarrhea (IBS-D) in Patients Who Report Inadequate Control of IBS-D Symptoms with
`Prior Loperamide Use (RELIEF). Principal Investigator, 2017
`
`8.
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`20.
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`14. Gilead, Protocol GS-US-419-3895: Combined Phase 3, Double-blind, Randomized,
`Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the
`Induction and Maintenance of Remission in Subjects with Moderately to Severely Active
`Crohn’s Disease. Principal Investigator, 2017
`15. Gilead, Protocol GS-US-419-3896: A Long Term Extension Study to Evaluate the Safety
`of Filgotinib in Subjects with Crohn’s Disease. Principal Investigator, 2017
`16. Gilead, Protocol GS-US-418-3898: Combined Phase 2b/3, Double-Blind, Randomized,
`Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the
`Induction and Maintenance of Remission in Subjects with Moderately to Severely Active
`Ulcerative Colitis. Principal Investigator, 2017
`17. Gilead, Protocol GS-US-418-3899: A Long-Term Extension Study to Evaluate the Safety
`of Filgotinib in Subjects with Ulcerative Colitis. Principal Investigator, 2017
`18. AbbVie Clinical Study Protocol M14-327: A Phase 2, Multicenter, Open-Label
`Extension (OLE) Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of
`Repeated Administration of ABT-494 in Subjects with Crohn's Disease. Principal
`Investigator, 2016
`19. Colonary Concepts, Protocol: C Bar 001 An Exploratory Study Evaluating the use of C-
`Bar in the Treatment of Chronic Idiopathic Constipation Principal Investigator, 2016
`Intercept, Protocol 747-303: A Phase 3, Double-Blind, Randomized, Long-Term,
`Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic
`Acid in Subjects with Nonalcoholic Steatohepatitis. Principal Investigator, 2016
`21. Synergy, Protocol SP304203-05 Second Phase 3 Randomized, 12-Week, Double-Blind,
`Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients with
`Irritable Bowel Syndrome with Constipation (IBS-C). Principal Investigator, 2016
`22. AbbVie, Clinical Study Protocol M14-172: A Single Arm, Open-label Study to Evaluate
`the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus
`Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis (EXPEDITION-1).
`Principal Investigator, 2016
`Ironwood, Protocol ICP-3718-202: A Phase 2b, Randomized, Double-blind, Placebo-
`controlled, Parallel-group, Dose-range-finding Trial of IW-3718 Administered Orally for
`8 Weeks to Patients with Symptomatic Gastroesophageal Reflux Disease Not Completely
`Responsive to Proton Pump Inhibitors. Principal Investigator, 2015
`24. Ardelyx, Protocol TEN-01-302: A 26-Week, Randomized, Double-Blind, Placebo-
`Controlled Study to Evaluate the Efficacy and Safety of Tenapanor for the Treatment of
`Constipation-Predominant Irritable Bowel Syndrome (IBS-C). Principal Investigator,
`2015
`25. AbbVie, Clinical Study Protocol M15-582: An Open-Label, Multicenter Study to
`Evaluate the Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
`with Low-Dose Ribavirin QD in Subjects with Genotype 1a Chronic Hepatitis C Virus
`Infection (GEODE II). Principal Investigator, 2015
`26. Biomecite, LLC, Protocol BM-1001: Metagenomic Signature Discovery. Principal
`Investigator, 2015
`27. Synergy, Protocol SP304203-05: Second Phase 3 Randomized, 12-Week, Double-Blind,
`Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients with
`Irritable Bowel Syndrome with Constipation (IBS-C). Principal Investigator, 2015
`
`23.
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`28. AbbVie, Clinical Study Protocol M13-740: A Multicenter, Randomized, Double-Blind,
`Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic
`Remission in Subjects with Moderately to Severely Active Crohn's Disease who have
`Inadequately Responded to or are Intolerant to Anti-TNF Therapy. Principal Investigator,
`2014
`29. Norgine, Protocol NER1006-01/2014 (NOCT): A Multicenter Randomized Parallel
`Group Phase III Study Comparing the Bowel Cleansing Efficacy, Safety and Tolerability
`of NER 1006 (a Low Volume Bowel Cleansing Solution using a 2-Day Split-Dosing
`Regime in Adults. Principal Investigator, 2014
`30. Hologic, Protocol P10433-HCVQPS-CSP-01: Collection of Plasma and Serum Samples
`From Individuals Initiating Therapy With Sofosbuvir for Chronic Hepatitis C Virus
`Infection for the Clinical Evaluation of the Aptima HCV Quant DX Assay. Principal
`Investigator, 2014
`31. Redhill, Protocol RHB-105-01: A Randomized Placebo-controlled Phase III Study to
`Assess the Safety and Efficacy of RHB-105 in the Treatment of Confirmed Helicobacter
`pylori (H. pylori) Infection in Dyspepsia Patients. Principal Investigator, 2014
`32. Robarts, Clinical Trials Inc. Protocol No. RP1202: A Cluster Randomized Controlled
`Trial of an Enhanced Treatment Algorithm for the Management of Crohn’s Disease.
`Principal Investigator, 2014
`33. AbbVie, Clinical Study Protocol F12-119: A Multicenter Study Evaluating a PRactical
`IndEx Score for Subjects with Crohn's DIsease Assessing the Absence of Mucosal
`UlCeraTion (PREDICT). Principal Investigator, 2014
`34. AbbVie, Clinical Study Protocol M14-347 A Multicenter, Open-Label Study to Evaluate
`the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of
`Adalimumab in Subjects with Crohn's Disease. Principal Investigator, 2014
`35. AbbVie, Clinical Study Protocol M14-115 A Multicenter, Randomized, Double-Blind
`Study to Evaluate the Efficacy and Safety of Two Adalimumab Induction Regimens in
`Subjects with Moderately to Severely Active Crohn's Disease and Evidence of Mucosal
`Ulceration. Principal Investigator, 2014
`36. Takeda, Protocol ROF-NASH-205: A Randomized, Double-Blind, Controlled, Multi-
`Center Phase 2 Study to Evaluate the Effect of Roflumilast Plus Pioglitazone on Liver
`Enzymes and Liver Fat Content in Subjects with Nonalcoholic Steatohepatitis A Phase 2
`Study of Roflumilast plus Pioglitazone in Subjects with Nonalcoholic Steatohepatitis.
`Principal Investigator, 2013
`37. Ventrus, Protocol VEN307-AF-001: A Phase 3B, Randomized, Double-Blind, Placebo
`Controlled, Parallel-Treatment Group, Multicenter Efficacy and Safety Study of Topical
`Diltiazem Hydrochloride 2% Cream in Subjects with Anal Fissure. Principal Investigator,
`2013
`38. Salix, Protocol RNLC 2131: A Randomized, Double-Blind, Placebo-Controlled, Dose-
`Ranging, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid
`Dispersion (SSD) Tablets for the Prevention of Complications in Subjects with Early
`Decompensated Liver Cirrhosis. Principal Investigator, 2013
`39. AbbVie, Registry Protocol P11-282: A Long-Term Non-Interventional Registry to Assess
`Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to
`Severely Active Ulcerative Colitis (UC). Principal Investigator, 2013
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`46.
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`40. Redhill, Protocol RHB-104: A Phase III Randomized, Double Blind, Placebo-controlled,
`Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose
`Combination RHB-104 in Subjects with Moderately to Severely Active Crohn’s Disease.
`Principal Investigator, 2013
`41. Ardelyx, Protocol No. D5612C00001: A Randomized, Double-Blind, Placebo-Controlled
`Study to Assess the Safety and Efficacy of AZD1722 for the Treatment of Constipation-
`Predominant Irritable Bowel Syndrome (IBS-C). Principal Investigator, 2013
`42. AbbVie, Clinical Study Protocol M13-102: A Follow-up Study to Assess Resistance and
`Durability of Response to AbbVie Direct-Acting Antiviral Agent (DAA) Therapy in
`Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic
`Hepatitis C Virus (HCV) Infection. Principal Investigator, 2013
`43. AbbVie, Clinical Study Protocol M13-098: A Randomized, Double-blind, Placebo-
`controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267
`(ABT-450/r/ABT-267) and ABT-333 Co-administered with Ribavirin (RBV) in
`Treatment-Experienced Adults with Genotype 1 Chronic Hepatitis C Virus (HCV)
`Infection (SAPPHIRE-II). Principal Investigator, 2013
`44. Ferring Pharmaceuticals, Protocol 000110: Renal Function Assessment in Subjects
`Undergoing Colon Cleansing with Prepopik™ or HalfLytely® in Preparation for
`Colonoscopy: A Retrospective Analysis. Principal Investigator, 2013
`45. Salix, Protocol RFIB3053: A Study