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CURRICULUM VITAE 

MITCHELL N. DAVIS, D.O, FACOI, FACG.

PERSONAL:


Date of Birth: November 6, 1957

Birthplace: Philadelphia, PA


RESEARCH FACILITY PRINCIPAL INVESTIGATOR:


South Florida Center of Gastroenterology, P.A. d/b/a Hepatitis Treatment Institute of Florida 1447 Medical Park Boulevard, Suite #205
Wellington, Florida 334141996-2018


EMPLOYMENT:


Dec 2006 – Feb 2017: South Florida Center of Gastroenterology, LLC, a subsidiary gastrulae, LLP d/b/a Digestive Care


Oct 1991 – Dec 2006: South Florida Center of Gastroenterology, PA


EDUCATION:


Aug 1975 – Jun 1979: Pennsylvania State University, University Park, PA. Bachelor of Science


Aug 1980 – Jun 1984: Philadelphia College of Osteopathic Medicine, Philadelphia, PA. Doctor of Osteopathy


July 1984 – Jun 1985: Metropolitan Hospital – Parkview Division, Philadelphia, PA. Rotating Internship


July 1985 – Jun 1988: UMDNJ-SOM/Kennedy Memorial Hospitals, Stanford, NJ Residency in Internal Medicine


July 1988 – Jun 1990: University of Medicine and Dentistry of New Jersey, School of Osteopathic Medicine, Stanford, NJ. Fellowship in Gastroenterology


BOARD CERTIFICATIONS:


1985: Diplomat, National Board of Examiners of Osteopathic Physicians and Surgeons


1991: Diplomat, American Osteopathic Board of Internal Medicine, Subsection of Gastroenterology


1998: Diplomat, American Osteopathic Board of Internal Medicine


2002: Fellow, American College of Osteopathic Internist


2012: Fellow, American College of Gastroenterology


PROFESSIONAL ORGANIZATIONS:


American Medical Marijuana Physicians Association

Society of Cannabis Clinicians American

Society of Cannabis Medicine American

College of Gastroenterology American

Society for Gastroenterology Endoscopy
American College of Osteopathic Internists

American Osteopathic Association
Florida Osteopathic Medical Association

Member, American Association for the Study of Liver Diseases (AASLD)
Member, European Association for the Study of Liver Diseases (EASL)


SPECIAL TRAINING:


Good Clinical Practice, Level 2,

GenED, Inc. 2007


National Institutes of Health (NIH) 

Protecting Human Research Participants

Certification Number: 721061. 25 July, 2011


GCP/ICH TRAINING

Abbvie, Inc. June 2014

Overcoming the Challenges to HCV Elimination Among Individuals Who Are Incarcerated.

October 2019


TEACHING APPOINTMENTS:


Clinical Adjunct Professor of Gastroenterology

Lake Erie College of Osteopathic Medicine

10/96 to 6/17


Clinical Instructor in Gastroenterology

NOVA-Southeastern University

Department of Internal Medicine

10/91 – 10/96


Clinical Instructor in Gastroenterology

Philadelphia College of Osteopathic Medicine

7/90 – 10/91


RESEARCH PROJECTS and PUBLICATIONS as PRIMARY INVESTIGATOR


Rebetron/Intron A – Protocol R 97-023, Phase In. 

September 1999 – June 2002


Infergen Protocol #980102, Phase IV

November 1999 – January 2001


Infergen Protocol #980170, Phase IV

November 1999 – January 2001


Rebetron Protocol #156-03-99, Phase III

December 1999 – December 2002


Rebetron Protocol #157-03-99, Phase III

June 2001 – June 2003


Peg-Intron/ribavirin Protocol #215-04-00, Phase III

June 2001 – June 2003


Peg-Intron/Rebetol Protocol #244-11-00, Phase III

July 2003 – October 2005

Peg-Intron/Rebetol Co-Infected Protocol #266-07-01, Phase III

April 2001 – May 2003


Hoffman La-Roche Protocol #NV17317, Phase IV

November 2003 – October 2005


Hoffman La-Roche Protocol #ML17756B, Phase IV

January 2004 – May 2006


Hoffman La-Roche Protocol #NV17318, Phase IV

April 2004 – February 2006


Hoffman La-Roche Protocol #NV17590, Phase IV

April 2005 – January 2007


Schering-Plough Ideal Protocol #P03471, Phase IV

April 2004 – February 2008


Schering-Plough Protocol #P03523, Phase II

November 2006 – December 2007


Schering-Plough Protocol #P05063, Phase III

August 2007 – October 2014


Schering-Plough Protocol #P05101, Phase III

July 2008 – July 2010


Schering-Plough Protocol #P05216, Phase III

July 2008 – August 2010


Vertex Protocol #VX08-950-111, Phase III

September 2008 – August 2010


Schering-Plough Protocol #P05685, Phase III

November 2008 – January 2011


Schering-Plough Protocol #P05514, Phase III

December 2008 – October 2014


Schering-Plough Protocol #P06086, Phase III

December 2009 – January 2012


Merck & Co. Protocol MK7009-009-04, Phase II

March 2010 – May 2013


Gilead, Inc. Protocol GS-US-196-0140, Phase II

February 2011 – Aug 2013


Pharmasset, Inc. Protocol P7977-0724,ATOMIC Phase II

March 2011 – Dec 2012


Gilead Inc. Protocol GS-US-256-0124, Phase IIb

August, 2011 – Dec 2012


Pharmasset, Inc. Protocol P7977-1231, FISSION Phase II

December 2011 – May 2013


Pharmasset, Inc. Protocol P2938-0721,QUANTUM Phase II

October 2011 – July 2013


Bristol-Myers Squibb, Inc. Protocol AI444-038 Phase III

December 2011- June 2014


Abbott Laboratories, Inc., Protocol M11-652, Phase III 

December 2011 – November 2013


Bristol-Myers Squibb, Inc. Protocol AI444-052, Phase III

February 2012- July 2012


Gilead Inc. Protocol GS-US-248-0122,  A Long Term Follow-up Registry – SVR

August, 2012 – Present


Gilead Inc. Protocol GS-US-248-0123, A Long Term Follow-up Registry – No SVR

August, 2012 – Present


Gilead Inc. Protocol GS-US-334-0107, Phase III

April, 2012 – July 2013


Gilead Inc. Protocol GS-US-334-0108, Phase III

April, 2012 – July 2013


Gilead Inc. Protocol GS-US-334-0109, Phase III

May, 2012 – July 2009


Gilead Inc. Protocol GS-US-334-0110, Phase III

May, 2012 – July 2013


Janssen Research & Development, Inc. TMC435HPC2002, Phase IIa

July 2012 – March 2014


Gilead Sciences, Inc. GS-US-337-0102, Phase III

Sept 2012- June 2014


Abbott Laboratories, Inc., M11-646, Phase III

Oct 2012- July 2014


Abbott Laboratories, Inc., M13-099, Phase III

January 2013 – August 2014


Abbott Laboratories, Inc., M14-002, Phase III

April, 2013 – July 2014


Gilead Inc. Protocol GS-US-337-0108, Phase III

April, 2013 – June 2014


Gilead Inc. Protocol GS-US-342-0102, Phase II

May, 2013 – July 2014


Gilead Inc. Protocol GS-US-342-0109, Phase II

May, 2013 – July 2014


Gilead Inc. Protocol GS-US-334-0153, Phase IIIb

December, 2013 – June 2015


Gilead Inc. Protocol GS-US-337-1118

November, 2013 – September 2014


Abbott Laboratories, Inc., M13-102, A Long Term Follow-up Registry – SVR

April 2014 – December 2014


Janssen Research & Development, Inc. TMC435HPC3017, Phase III

May 2014 – Present


Janssen Research & Development, Inc. TMC435HPC3018, Phase III

May 2014 – Present


Abbvie Inc., M14-222, Phase IIIb

June 2014 – Present


Gilead Inc. Protocol GS-US-342-1140, Phase III

July 2014 – Present


Gilead Inc. Protocol GS-US-342-1138, Phase III

August 2014 – Present


Gilead Inc. Protocol GS-US-342-1139, Phase III

October 2014 – Present


Gilead Inc. Protocol GS-US-342-1553

December 2014 – 2016


Gilead Inc. Protocol GS-US-367-1168, Phase II

January 2015- Present


Gilead Inc. Protocol GS-US-367-1169, Phase II

January 2015- Present


Gilead Inc. Protocol GS-US-342-1446

February 2015- 2016


Gilead Inc. Protocol GS-US-337-1431, A Long Term Follow-up Cirrhotic Registry – SVR

June 2015- Present


Gilead Inc. Protocol GS-US-367-1170, Phase III

January 2016 – Present


Gilead Inc. Protocol GS-US-367-1171, Phase III

January 2016 – Present


Gilead Inc. Protocol GS-US- 367-1172, Phase III

January 2016 – Present


Gilead Inc. Protocol GS-US-367-1173, Phase III

January 2016 – Present


Intercept Pharmaceuticals, Inc.

Protocol 747-303 REGENERATE, Phase III

January 2016 – Present


Intercept Pharmaceuticals, Inc. Protocol 747-209 CONTROL, Phase II

January 2016- Present


Shire Human Genetic Therapies, Inc. Protocol SHP 626-201, Phase II

June 2016 – Present


Octeta Therapeutics LLC,  Protocol MSDC-0602K-C009NASH, Phase II, EMMINENCE

August 2016 – March 2018


PUBLICATIONS:


“Chronic Lymphocyte Leukemia Presenting with Massive Chylous Ascites”

Davis, MN, Chiesa, JC, Alloy, AM, et al.

The American Journal of Gastroenterology, 1990; 8:593-596


“Low Dose Pegylated Interferon Alpha-2b is as Effective as the High Dose in HIV/HCV Coinfected Patients”

Hammon G, Li J, Vega K.

Hepatology, 2004; 40:4 Suppl. 1,520A


“Pharmacolkinetics and Pharmacodynamics of Pegylated Interferon Alpha-2a or Alpha-2b with Ribavirin in Treatment Naïve Patients with Genotype I Chronic Hepatitis C”

DiBisceglie AM, Rustgi VK, Thuluwath P, et al.

Hepatology, 2004; 40:4, Suppl. 1, LB18


“Weight-based Ribavirin Dosing (WBD) Increases Sustained Viral Response (SVR) in Patients with Chronic Hepatitis C )CHC): Final Results of the WIN-R Study, A US Community based Trial”

Jacobson IM, Brown RS, Freilich B, et al.

Hepatlogy, 2005; 42 (4 Suppl 1):LB03, P749A


“Prior HCV Treatment Expreience and Its Relationship to Sustained Virologic Response (SVR): An Analysis of the WIN-R Study Database, a US Academic Community Based Trial”

Kwo P, Jacobson IM, Brown RS, et al.

Gastroenterology, 2006; 130 (4), T1802, PA-836


“Peginterferon Alfa-2b or Alfa-2a with Ribavirin for treatment of Hepatitis C Infection”

McHutchinson JG, Lawitz EJ, Shiffman ML, et al.

N Engl J Med.2009 Aug 6;361(6):580-93. Epub 2009 Jul 22. N Engl J Med. 2009 Sep 3;361(10):1027


“Induction Pegylated Interferon Alfa-2b in Combination with Ribavirin in Patients with Genotype 1 and 4 Chronic Hepatitis C: A Prospective, Randomized, Multi-Center, Open-Label Study”

Brady DE, Torres DM, An JW, et al.

Clin Gastroenterol Hepatol. 2009 Sep 9 [Epub ahead of print]


“High Sustained Virologic Response (SVR) in Genotype 1 (G 1) Null Responders to Peg-Interferon Alfa-2B (P) Plus Ribavirin (R) when treated with Boceprevir (BOC) Combination Therapy.”

Kwo, P.Y., E. Lowitz, J. McCone, et al.

Hepatology, 50(4 Suppl):72A, 2009.


“Efficacy of Boceprevir, an NS3 Protease Inhibitor in combination with PegInterferon alfa-2b and Ribavirin in Treatment-Naïve Patients with Genotype 1 Hepatitis C Infection (SPRINT-1): An Open Label, Randomized, Multicentre Phase 2 Trial.”

Kwo PY, Lawitz EJ, McCone J, et al.

Lancet, 2010 Aug 28;376(9742):662-3.


“Hepatitis C virus treatment-related anemia is associated with higher sustained virologic response rate.”

Sulkowski MS, Shiffman ML, Afdhal NH, et al.

Gastroenterology. 2010 Nov;139(5):1602-11, 1611.e1. doi:10.1053/j.gastro.2010.07.059.


“Racial differences in hepatitis C treatment eligibility.”

Melia MT, Muir AJ, McCone J, et al.

Hepatology. 2011 Jul;54(1):70-8.


“Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomised, multicentre phase 2 trial.”

Lawitz E, Mangia A, Wyles D, et al.

N Engl J Med. 2013 May 16;368(20)


“Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomised, multicentre phase 2 trial.”

Kowdley KV, Lawitz E, Crespo I, et al.

Lancet. 2013 Jun 15;381(9883):2100-7.


“Resistance-associated amino acid variants associated with boceprevir plus pegylated interferon-α2b and ribavirin in patients with chronic hepatitis C in the SPRINT-1 trial.”

Ogert RA, Howe JA, Vierling JM, et al.

Antivir Ther. 2013;18(3):387-97


“Sofosbuvir for previously untreated chronic hepatitis C infection.”

Lawitz E, Mangia A, Wyles D, et al.

N Engl J Med. 2013 May 16;368(20):1878-87


“Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options.”

Jacobson IM, Gordon SC, Kowdley KV, et al.

N Engl J Med. 2013 May 16;368(20):1867-77.


“Overall safety profile of boceprevir plus peginterferon alfa-2b and ribavirin in patients with chronic hepatitis C genotype 1: a combined analysis of 3 phase 2/3 clinical trials.”

Manns MP, McCone J Jr, Davis MN, et al.

Liver Int. 2013 Aug 2.


“Boceprevir for Chronic HCV Genotype 1 Infection in Patients with Prior Treatment Failure to Peginterferon/Ribavirin, including Prior Null Response.”

Vierling JM, Davis M, Flamm S, et al.

J Hepatol. 2013 Dec 19. pii: S0168-8278(13)00881-7.


“Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis.”

Kowdley KV, Gordon SC, Reddy KR, et al.

N Engl J Med. 2014 May 15;370(20):1879-88. Epub 2014 Apr 10


“Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection.”

Afdhal N, Zeuzem S, Kwo P, Chojkier M, et al.

N Engl J Med. 2014 May 15;370(20):1889-98. Epub 2014 Apr 11.


“Sofosbuvir With Velpatasvir in Treatment-Naïve Noncirrhotic Patients with Genotype 1 to 6 Hepatitis C Virus infection: A Randomized Trial.”

Everson GT, Towner WJ, Davis MN, et al.

Ann intern Med. 2015 Dec 1;163(11):818-26.

Epub 2015 Nov 10.


“Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 3, 4, 5, and 6 Infection.”

Feld JJ, Jacobson IM, Hezode C, Asselah T, et al.

N Engl J Med. 2015 Dec 31;373(27):2599-607.

Epub 2015 Nov 16.


“Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection.”

Foster GR, Afdhal N, Roberts SK, Brau N, et al.

N Engl J Med. 2015 Dec 31;373(27):2608-17

Epub 2015 Nov 17.


“Simeprevir plus sofosbuvir (12 and 8 weeks) in hepatitis C virus genotype 1-infected patients without cirrhosis: OPTIMIST-1, a phase 3, randomized study.”

Kwo P, Gitlin N, Nahass R, Bernstein D, et al.

Hepatology. 2016 Aug;64(2):370-80.

Epub 2016 Mar 22.


“Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Hepatitis C Virus Genotype 2, 3, 4, or 6 infections in an Open-Label, Phase 2 Trial.”

Gane EJ, Kowdley KV, Pound D, et al.

Gastroenterology. 2016 Nov;151(5):902-909.

Epub 2016 Jul 30.

"Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients with Chronic HCV Infection: 2 Phase 3 Randomized Trials."

Jacobson IM, Lawitz E, Gane EJ, Willems BE, Ruane PJ, Nahass RG, Borgja SM, Shafran SD, Workowski KA, Pearlman B, Hyland RH, Stamm LM, Svarovskaia E, Dvory-Sobol H, Zhu Y, Subramanian GM, Brainard DM, McHutchison JG, Brau N, Berg T, Agarwal K, Bhandari BR, Davis  M, Feld JJ, Dore GJ, Stedman CAM, Thompson AJ, Asselah T, Roberts SK, Foster GR.

Gastroenterology. 2017 Jul;153(1):113-122. doi: 10. 1053/j.gastro.2017.03 .047.

Epub 2017 Apr 5.

"Sofosbuvir-velpatasvir with ribavirin for 24 weeks in hepatitis C virus patients previously treated with a direct-acting antiviral regimen."

Gane EJ, Shiffman ML, Etzkorn K, Morelli G, Stedman CAM, Davis MN, Hinestrosa F, Dvory­ Sobol H, Huang KC, Osinusi A, McNally J, Brainard DM, McHutchison JG, Thompson AJ, Sulkowski MS; GS-US-342-1553 Investigators.

Hepatology. 2017 Oct;66(4):1083-1089. doi: 10 .100 2/hep.292 56.

Epub 2017 Aug 26.

"Sofosbuvir, Velpatasvir, and Voxilaprevir for Previously Treated BCV Infection."
Bourliere M, Gordon SC, Flamm SL, Cooper CL, Ramji A, Tong M, Ravendhran N, Vierling JM, Tran TT, Pianko S, Bansal MB, de Ledinghen V, Hyland RH, Stamm LM, Dvory-Sobol H, Svarovskaia E, Zhang J, Huang KC, Subramanian GM, Brainard DM, McHutchison JG, Verna EC, Buggisch P, Landis CS, Younes ZH, Curry MP, Strasser SJ, Schiff ER, Reddy KR, Manns MP, Kowdley KV, Zeuzem S; POLARIS-I and POLARIS-4 Investigators.
N Engl J Med. 2017 Jun 1;376(22):2134-2146. doi:10.1056/NEJMoa1613512.

"Deferred treatment with a fixed-dose combination of sofosbuvir-velpatasvir for chronic hepatitis C virus genotype 12 22 4 and 6 infection."
Asselah T, Shafran SD, Bourgeois S, Lai CL, Mathurin P, Willems B, Nguyen MH, Davis MN, Huang KC, Svarovskaia E, Osinusi A, McNally J, Brainard DM, Shaikh OS, Tran TT. J Viral Hepat. 2019, Jun 19, doi: 10.1111 / jv h 13159 (Epub ahead of print)


______________________________________ ________________________

Mitchell N. Davis, DO, FACOI.       

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