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

 

PERSONAL:

Date of Birth: November 6, 1957
Birthplace: Philadelphia, PA

RESEARCH FACILITY: South Florida Center of Gastroenterology, P.A. PRINCIPAL INVESTIGATOR d/b/a Hepatitis Treatment Institute of Florida
1447 Medical Park Boulevard, Suite #205
Wellington, Florida 33414

 

EMPLOYMENT:

Dec 2006 – Feb 2017 South Florida Center of Gastroenterology, LLC, a subsidiary of GastroCare, 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

 

EDUCATION CONT:

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 College of Gastroenterology
American Society for Gastroenterology Endoscopy
American College of Osteopathic Internists
American Osteopathic Association
Florida Osteopathic Medical Association
Lambda Omicron Gamma Medical Fraternity Member, American Association for the Study of Liver Diseases (AASLD)
Member, European Association for the
Study of the Liver (EASL)

 

HOSPITAL AFFILIATIONS:

Active Privileges Wellington Regional Medical Center
10101 Forest Hill Blvd
Wellington, FL 33414

Active Privileges Northpoint Surgery and Laser Center
200 Northpoint Parkway
West Palm Beach, FL 33407

 

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

TEACHING APPOINTMENTS:

Clinical Adjunct Professor of Gastroenterology
Lake Erie College of Osteopathic Medicine
10/96 to Present

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:
PRIMARY INVESTIGATOR

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

 

RESEARCH PROJECTS (Cont.)

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
RESEARCH PROJECTS (Cont.)

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
RESEARCH PROJECTS (Cont.)

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

 

RESEARCH PROJECTS (Cont.)

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 – Present

 

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.
PUBLICATIONS (Cont.)

“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.

 

PUBLICATIONS (Cont.)

“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.

 

______________________________________         ________________________
Mitchell N. Davis, DO, FACOI.                                                                      Dated: