LITE DEPALMA GREENBERG, LLC

Allyn Z. Lite 

Michael E. Patunas 

Mayra V. Tarantino 

Two Gateway Center, 12th Floor 

Newark, New Jersey 07102 

Telephone: (973) 623-3000 

Facsimile: (973) 877-3872 

alite@litedepalma.com 

mpatunas@litedepalma.com 

mtarantino@litedepalma.com 

Attorneys for Defendants Hanmi USA, Inc., 

Hanmi Pharmaceutical Co., Ltd., Hanmi Fine 

Chemical Co., Ltd., and Hanmi Holdings Co., 

Ltd.

UNITED STATES DISTRICT COURT 

DISTRICT OF NEW JERSEY 

ASTRAZENECA AB, AKTIEBOLAGET 

HÄSSLE, ASTRAZENECA LP, KBI INC., 

and KBI-E INC., 

 Plaintiffs and 

 Counterclaim Defendants, 

 v. 

HANMI USA, INC., HANMI 

PHARMACEUTICAL CO., LTD., HANMI 

FINE CHEMICAL CO., LTD, and HANMI 

HOLDINGS CO., LTD., 

 Defendants and 

 Counterclaim Plaintiffs. 

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Civil Action No. 3:11-CV-00760-JAP-TJB 

DECLARATION OF ROBERT HARDI, M.D. 

1. I, Robert Hardi, M.D. have been retained by Sughrue Mion, PLLC (counsel for 

Hanmi USA Inc., et al) to provide expert testimony in the above captioned action. I reserve the 

Case 3:11-cv-00760-JAP-TJB Document 132-1 Filed 11/07/11 Page 1 of 18 PageID: 4246
2 

right to supplement this declaration as additional information is made available to me, including 

information provided by AstraZeneca in the present action and evidence at trial. I may also 

provide testimony in response to any expert opinions offered by AstraZeneca. 

I. Background

2. I received a Medical Degree, Summa cum Laude, in 1972 from Semmelweis 

University Medical School, Budapest, Hungary. I did post graduate training in Biochemistry 

and Genetics and worked as Assistant Professor of Genetics at Eotvos Lorand University of 

Sciences in Budapest, Hungary. I also did a year of post doctoral Fellowship in the Department 

of Pharmacology of SUNY Buffalo, in conjunction with the Department of Virology of 

Roswell Park Memorial Institute. I did my training in Internal Medicine at Semmelweis 

University Medical School, ST. Bonifatius Hospital in Lingen, Germany, Hannover University 

Medical School in Germany and The University of New Mexico Medical School in 

Albuquerque, New Mexico. Following my residency, I completed a Hematology-Oncology 

Fellowship at the University of New Mexico Medical School, Albuquerque, New Mexico in 

1982 and a GI Fellowship at Cornell University Medical College, New York, New York in 

1984. 

3. I have been a Diplomate of the American Board of Internal Medicine since 1983, 

and specifically with the Gastroenterology division of American Board of Internal Medicine 

since 1985. I have been a Certified Physician Investigator since 2005. 

4. I have been in the private practice of Gastroenterology and Internal Medicine in 

Washington, DC since 1984. I joined Metropolitan Gastroenterology Group in early 1996. 

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5. I am currently the Medical Director and Principal Investigator of Chevy Chase 

Clinical Research as well as a treating physician with Metropolitan Gastroenterology Group, 

PC, and have been so since 1996. As Medical Director, my general responsibilities include 

oversight of all research activities of the group. 

6. I have been the Principal Investigator on more than 250 gastroenterology clinical 

trials encompassing all phases and all areas of Gastroenterology, including trials of acid 

reducing compounds. 

7. I treat patients having a variety of gastroenterological conditions and diseases 

including but not limited to, gastric ulcer, duodenal ulcer, reflux esophagitis and gastritis and 

duodenitis as well as non ulcer dyspepsia, adverse effects stemming from use of non-steroidal 

anti-inflammatory drugs (NSAIDs), gastro-esophageal reflux disease (GERD), gastrinomas, 

Zollinger-Ellison syndrome, upper gastrointestinal bleeding, and helicobacter infections. 

8. In addition to practicing with the Metropolitan Gastroenterology Group, I am a staff 

physician at Sibley Memorial in Washington D.C. and Suburban Hospital in Bethesda, 

Maryland. 

9. I am a Clinical Assistant Professor of Medicine at Georgetown University Medical 

School and Clinical Associate Professor of Medicine at George Washington University Medical 

School. 

10. I am a member of American Society of Gastrointestinal Endoscopy, American 

Gastroenterological Association- Fellow, American College of Gastroenterology, Academy of 

Pharmaceutical Physicians and Investigators, International Society for Travel Medicine and the 

Crohn’s and Colitis Foundation of America. 

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11. I have presented lectures on Inflammatory Bowel Diseases and speak on the 

management of acid related diseases as a member of Takeda Pharmaceuticals’ Speaker Bureau. 

I have co-authored 16 publications on Inflammatory Bowel Diseases, Pharmacology and 

procedural sedation. 

12. A copy of my curriculum vitae is attached as Exhibit A. 

13. Based on my experience and education as set above, including over 28 years in 

working in the field of gastroenterology, I provide the following views regarding U.S. Patent 

No. 5,714,504 and U.S. Patent No. 5,877,192. 

II. Scope of Review 

14. I have been asked to provide comments on specific claim terms in U.S. Patent No. 

5,714,504 and U.S. Patent No. 5,877,192, and have done so below. In particular, I have 

considered certain aspects of claims 6 and 7 of U.S. Patent No. 5,714,504, and I have 

considered certain aspects of claims 1 and 2 of U.S. Patent No. 5,877,192. My comments are 

below. 

15. I have not been asked to comment on any claim terms other than those discussed 

below, nor have I been asked to consider any other issues in this case. 

III. Discussion 

 A. Credentials of a Person Of Ordinary Skill In The Art 

16. I have reviewed U.S. Patent No. 5,714,504 (“the ‘504 Patent”) which is based on 

U.S. Patent Application No. 376,512 filed January 23, 1995 (“the ‘512 application”), and which 

references on the cover page two prior applications filed in 1994 and 1993. I have also 

reviewed the ‘512 application and Patent Office prosecution history of the ‘504 patent. I have 

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also reviewed U.S. Patent No. 5,877,192 (“the ‘192 Patent”) which is based on U.S. Patent 

Application No. 833,962 filed April 11, 1997, and which references on the cover page the prior 

‘504 patent and its predecessor applications. I have also reviewed the ‘962 application and the 

Patent Office prosecution history of the ‘192 patent. 

17. The ‘504 and ‘192 patents can be considered multi-disciplinary to some extent, 

because they discuss certain chemistry, synthetic process and stereochemistry concepts on the 

one hand, while also discussing the practical utilities of the formulations, modes of 

administration and biological effects on the other hand. Clearly, these patents are written not 

for just a single person, and describe concepts and technologies requiring knowledge of 

different professionals with largely non-overlapping backgrounds -- such as chemists and 

medical practitioners. I am providing views on the claim terms from the latter’s standpoint, and 

understand that other experts who may opine on chemistry issues (such as optical purity to name 

one example) would describe the qualifications and skill set of a person of ordinary skill in the 

art in a different but complementary way than I do here, based on the requirements of the 

patents. 

18. It is my opinion that, at the time of the patent filings in the 1993-1997 time frame, 

one of ordinary skill in the art of diagnosing and treating gastroenterological diseases and 

conditions discussed in the patents would be a physician, such as a gastroenterologist, with a 

degree in medicine and post-graduate clinical training and experience in examining patients and 

working knowledge of the etiology and pathology of the spectra of diseases and conditions 

affecting the gastrointestinal tract as well as a knowledge of available medications, treatment 

regimens, therapies and procedures. Another example would be a primary care physician or 

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internist, who would diagnose and treat routine gastrointestinal conditions but who would 

usually refer a patient to a gastroenterologist or other specialist in more complicated cases to 

obtain definite diagnosis, guidance in treatment and follow up. Such a person would typically 

have 3-5 years of working experience treating patients for gastrointestinal disorders. 

19. Based on my education and experience over the past 39 years, I am able to comment 

on the knowledge of such a person at the relevant time. The qualifications and skill set of such 

a person of ordinary skill in the art in 1993, 1995 or 1997 would have been the same. 

B. “Administration” And “Administering To A Mammal In Need Of Treatment” 

In The Context Of Practicing The Methods Of The ’504 And ’192 Patent 

 ’504 Patent – Claims 6 and 7 

20. Claim 6 of the ‘504 patent reads as follows: 

A method of inhibiting gastric acid secretion comprising the oral 

administration of a pharmaceutical formulation comprising a 

therapeutically effective amount of a pure solid state alkaline salt of the (-)-

enantiomer of 5-methoxy-2[[(4-methoxy-3,5-dimethyl-2-

pyridinyl)methyl]sulfinyl]-1H-benzimidazole and a pharmaceutically 

acceptable carrier. 

I have focused on the bold face language in my following comments. 

21. Claim 7 of the ‘504 patent reads as follows. 

 A method for the treatment of gastrointestinal inflammatory disease comprising the 

oral administration to a mammal including man in need of such treatment of a 

pharmaceutical formulation comprising a therapeutically effective amount of a pure 

solid state alkaline salt of the (-)-enantiomer of 5-methoxy-2[[(4-methoxy-3,5-

dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole and a pharmaceutically 

acceptable carrier. 

I have focused on the bold face language in my following comments. 

22. I have been asked to consider the meaning of “administration of” in claim 6 and 

“administration to” in claim 7, in the context of those claims from the standpoint of one of 

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ordinary skill in the art in the mid-1990’s. I am informed that Hanmi asserts that 

“administration” in each of these claims means: “the prescription by a physician or other 

licensed healthcare professional, dispensing and ingestion.” Given the precise context of these 

claims in light of the manner in which such methods are actually carried out in day-to-day 

practice, in my judgment Hanmi’s interpretation would be consistent with the views of a person 

of ordinary skill in the art in the mid-1990’s. The reasons in support of this conclusion are set 

forth below.

23. I have been asked to assume that AstraZeneca’s Nexium® is a pharmaceutical 

formulation within the scope of claims 6 and 7 (and also claims 1 and 2 of the ‘192 patent) and 

is the only commercially available product meeting that description. In the United States, 

Nexium® is available only by prescription. I often prescribe Nexium® in the course of my 

gastroenterology practice. 

24. The context of the claim language in which the “administration” term appears makes 

clear that the involvement of a physician or other licensed healthcare professional (I will use 

“physician” for short) is required. This is because the claims require administration of a 

therapeutically effective amount of the pharmaceutical formulation and because in practice 

Nexium® is available only by prescription. One of ordinary skill would also immediately 

appreciate that only a physician is capable of determining what amount would be therapeutically 

effective. 

25. Claim 7 additionally requires that the mammal that is the subject of administration 

be “in need of such treatment.” One of ordinary skill reading this language would immediately 

recognize that the diagnosis of a physician is required, since only those individuals can capably 

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determine that a subject 1) has gastrointestinal inflammatory disease (through diagnosis), and 2) 

requires treatment with the claimed formulation, in addition to determining the “therapeutically 

effective amount” as discussed above.

26. Although not explicitly stated in claims in 6 and 7, one of ordinary skill in the art in 

the mid-1990’s would have understood the term “administration” to also require the physician 

to prescribe the drug product to the subject being treated. In practice in the United States, such 

subjects are typically human patients and I will refer to patients for short. From the real world 

perspective of the person of ordinary skill in the art, prescription medications are federally 

regulated and can only be dispensed by entities licensed to do so, e.g., pharmacies, managed 

healthcare organizations, etc. On occasion physicians can and sometimes do prescribe and 

dispense “sample” prescription medications, that were provided by manufacturers’ drug 

representatives, directly to patients during an office visit. 

27. To complete the “administration” required by claims 6 and 7, the patient would need 

to orally ingest the prescribed drug product. 

28. The ’504 patent specification is consistent with my comments above concerning the 

meaning of “administration” in claims 6 and 7 and “mammal in need of treatment” in claim 7. 

For example, I have quoted below some relevant portions of the patent specification that 

support this conclusion. 

Typical daily dose of the active compound will depend on various factors ... 

such as ... individual requirement of each patient, the route of administration

and ... (column 6, lines 21-25); 

It is desirable to obtain compounds with ... which will give an improved 

therapeutic profile ... (column 1, lines 50-53); 

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The compounds of the invention may be used for inhibiting gastric acid 

secretion in mammals and man. In a more general sense, the compounds of the 

invention may be used for the treatment of gastric-acid related diseases and 

gastrointestinal inflammatory diseases in mammals and man ... (column 2, lines 

17-23); 

...compounds may be used for treatment of other gastrointestinal disorders 

where gastric antisecretory is desirable, e.g., patients on NSAID therapy, in 

patients with gastrinomas, and in patients with acute upper gastrointestinal 

bleeding ... (column 2, lines 23-27); 

They may also be used in patients in intensive care situations and pre- and 

post-operatively ... for treatment or prophylaxis of inflammatory conditions. 

Conditions that may be specifically mentioned for treatment are rheumatoid 

arthritis and gout ... also useful in the treatment of psoriasis as well as ... 

Helicobacter infections (column 2, lines 17-37.) (emphases added).

Based on these statements, one of ordinary skill would understand that the pharmaceutical 

formulations of the ’504 patent are intended for 1) clinical therapeutic use, 2) 

“administration” occurs in the context of methods where the need for inhibiting gastric acid 

secretion has been recognized, and 3) therapeutically effective amounts will vary from subject 

to subject based on multiple factors. 

29. In the context of claims 6 and 7, the physician’s determination of a therapeutically 

effective amount will vary patient by patient. This is made clear by the ’504 patent (column 6, 

lines 21-25). Such a determination cannot be made without an assessment as to whether a 

patient is in need of treatment as claimed. 

 The ’192 Patent – Claims 1 and 2 

30. Claim 1 reads as follows: 

A method for treatment of gastric acid related diseases by inhibition of gastric 

acid secretion comprising administering to a mammal in need of treatment a 

therapeutically effective amount of a proton pump inhibitor consisting essentially 

of the (-)-enantiomer of 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-

pyridinyl)methyl]sulfinyl]-1H-benzimidazole or a pharmaceutically acceptable 

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salt thereof, so as to effect decreased interindividual variation in plasma levels 

(AUC) during treatment of gastric acid related diseases. 

I have focused on the bold face language in my following comments. 

31. Claim 2 reads as follows: 

A method for treatment of gastric acid related diseases by inhibition of gastric 

acid secretion comprising administering to a mammal in need of treatment a 

therapeutically effective amount of a proton pump inhibitor consisting essentially 

of the (-)-enantiomer of 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-

pyridinyl)methyl]sulfinyl]-1H-benzimidazole or a pharmaceutically acceptable 

salt thereof, so as to effect an increased average plasma levels (AUC) per dosage 

unit. 

I have focused on the bold face language in my following comments. 

32. I have been asked to consider the meaning of “administering to a mammal in need of 

treatment” in the context of those claims from the standpoint of one of ordinary skill in the art in 

the mid-1990’s. I am informed that Hanmi asserts that “administering to a mammal in need of 

treatment” in each of these claims means: “the prescription by a physician or other licensed 

healthcare professional, dispensing and delivery by any suitable means.” Given the precise 

context of these claims in light of the manner in which such methods are actually carried out in 

day-to-day practice, in my judgment Hanmi’s interpretation would be consistent with the views 

of a person of ordinary skill in the art in the mid-1990’s. The reasons in support of this 

conclusion are set forth below.

33. The context of the claim language in which the “administering” phrase appears 

makes clear that the involvement of a physician is required. This is because the claims require 

administering a therapeutically effective amount of the pharmaceutical formulation to a 

mammal in need of treatment and because in practice Nexium® is available only by 

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11 

prescription. One of ordinary skill would also immediately appreciate that only a physician is 

capable of determining what amount would be therapeutically effective. 

34. Claims 1 and 2 require that the mammal is “in need of such treatment.” One of 

ordinary skill reading this language would immediately recognize that the diagnosis of a 

physician is required, since only those individuals can capably determine that a subject 1) has a 

“gastric acid related disease” (through diagnosis), and 2) requires treatment with the claimed 

formulation, in addition to determining the “therapeutically effective amount” as discussed 

above.

35. Although not explicitly stated in claims in 1 and 2, one of ordinary skill in the art in 

the mid-1990’s would have understood the term “administering ” to also require the physician 

to prescribe the drug product to the subject being treated. In practice in the United States, such 

subjects are typically human patients. As I discussed above, from the real world perspective of 

the person of ordinary skill in the art, prescription medications are federally regulated and can 

only be dispensed by entities licensed to do so, e.g., pharmacies, managed healthcare 

organizations, etc., but on occasion a physician will prescribe and dispense “sample” 

prescription medications directly to patients during an office visit. 

36. To complete the “administering to a mammal in need of treatment” required by 

claims 1 and 2, the patient could be delivered the drug product by any suitable means. While 

claims 6 and 7 of the ‘504 patent discussed above specifically require oral ingestion, claims 1 

and 2 of the ‘192 patent allow for oral ingestion, parenteral routes, etc. ( ‘192 patent, column 4, 

lines 19-24). 

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37. The "192 patent specification is consistent with my comments above concerning the 

meaning of "administering to a mammal in need of treatment" in claims 1 and 2. For example, 

Below, I refer to below some relevant portions of the patent specification that support this 

conclusion. The '192 patent specification statements confirm that 1) the methods and 

fonnulations are intended for clinical therapeutic use, 2) "administering" occurs in the context 

of methods where the need for inhibiting gastric acid secretion, or treatment of a 

disease/condition has been recognized, and 3) therapeutically effective amounts will vary from 

patient to patient based on multiple factors. For example, the '192 patent specification at 

column 4, lines 25-31: 

"The most suitable route of administration as well as the magnitude of a 

therapeutic dose of the (-)-enantiomer of omeprazole or a pharmaceutically 

acceptable salt thereof in any given case will depend on the nature and 

severity of the diseases to be treated. The dose, and dose frequency, may 

also vary according to age, body weight, and response of the individual 

patient. 

For further examples, refer to column 2, lines 13-63, column 3, lines 37- 60, column 4, line 60-

column 7, line 17, column 4, lines 31-44. 

38. In the context of claims 1 and 2, the physician's determination of a therapeutically 

effective amount will vary patient by patient. This is made clear by the' 192 patent (column 

4:25-44). Such a detennination cannot be made without an assessment as to whether a patient 

is in need of treatment as claimed. 

I declare under penalty of perjury that the foregoing is true and correct. 

Dated: November __!j__, 2011 j)6L or~· Robert Hardi, M.D. 

12 

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EXHIBIT A

Case 3:11-cv-00760-JAP-TJB Document 132-1 Filed 11/07/11 Page 13 of 18 PageID: 4258
Curriculum Vitae: 

Robert Hardi, M.D., CPI 

May 2011 

Page 1 of 5 

Robert Hardi, M.D., AGAF, CPI 

Metropolitan Gastroenterology Group, PC 

Chevy Chase Clinical Research 

5550 Friendship Blvd, Suite T-90 

Chevy Chase, MD 20815 

Phone: 301.652.5520 

Fax: 301.654.7961 

robert.hardi@capitaldigestivecare.com

SITE AFFILIATIONS 

Metropolitan Gastroenterology Group, PC 

Chevy Chase Clinical Research 

5550 Friendship Blvd, Suite T-90 

Chevy Chase, MD 20815 

Metropolitan Gastroenterology Group, PC 

2021 K Street NW, Suite T110 

Washington, DC 20006 

Chevy Chase Endoscopy Center 

5530 Wisconsin Ave, Suite 500 

Chevy Chase, MD 20815 

Endoscopy Center of Washington, DC 

2021 K Street NW, Suite T115 

Washington, DC 20006 

CREDENTIALS 

Medical License: D0030771 Maryland 

Medical License: MD14559 District of Columbia 

2010- Fellow- American Gastroenterological Association 

1985 – Present: Diplomate - American Board of Internal Medicine - Gastroenterology 

1983 – Present: Diplomate - American Board of Internal Medicine 

2005 Certified Physician Investigator 

EDUCATION 

1972 – 1974 Postdoctoral - Biochemistry,Genetics, Semmelweis University Medical 

 School, Budapest, Hungary 

1966 – 1972 MD - Semmelweis University Medical School, Budapest, Hungary 

1962 – 1966 Apaczai Gymnasium, Budapest, Hungary 

TRAINING 

1982 – 1984 GI Fellowship, Cornell University Medical College, New York, New York 

1982 – 1982 Senior Resident-Internal Medicine - University of New Mexico 

 Medical School, Albuquerque, New Mexico 

Case 3:11-cv-00760-JAP-TJB Document 132-1 Filed 11/07/11 Page 14 of 18 PageID: 4259
Curriculum Vitae: 

Robert Hardi, M.D., CPI 

May 2011 

Page 2 of 5 

1979 – 1982 Hematology-Oncology Fellowship, University of New Mexico Medical 

School, Albuquerque, New Mexico 

1978 – 1979 Residency, Internal Medicine: Medical University of Hannover, Hannover, 

West Germany 

1977 – 1978 Residency, Internal Medicine: St. Bonifatius Hospital, Lingen, West 

Germany 

1976 – 1977 Internship: First Medical Clinic, Semmelweis University Medical 

 School, Budapest, Hungary 

1975 – 1976 Post-doctoral Fellowship - State University of New York at Buffalo and 

 Roswell Park Memorial Institute; Department of Medical Viral 

 Oncology, Buffalo, New York 

WORK EXPERIENCE 

2004 – Present Physician – Lufthansa Airlines – Washington, DC 

1997 – Present Consultant, Gastroenterologist - World Bank, US Dept. of State 

1996 – Present Principal Investigator and Medical Director- Metropolitan Gastroenterology 

Group, P.C., Chevy Chase Clinical Research, Chevy Chase, Maryland 

1996 – Present Physician - Metropolitan Gastroenterology Group, P.C. (Private Practice, 

Gastroenterology & Internal Medicine), Chevy Chase, Maryland & 

Washington, DC 

1996 – Present Physician - Chevy Chase Endoscopy Center, Chevy Chase, MD 

1996 – Present Physician - Endoscopy Center of Washington, DC, Washington, DC 

1990 – Present Physician - Embassy of the Federal Republic of Germany, Washington, 

District of Columbia 

1984 – 1996 Physician - Private Practice of Gastroenterology, Washington, District of 

 Columbia 

ACADEMIC APPOINTMENTS 

1992 – Present Clinical Assistant Professor of Medicine, Georgetown University 

 Medical School, Washington, District of Columbia 

1984 – 2011 Assistant Clinical Professor of Medicine, George Washington 

 University Medical School, Washington, District of Columbia 

2011-Present Clinical Associate Professor of Medicine, George Washington University 

 Medical School, Washington,D.C. 

1973 – 1975 Assistant Professor of Genetics, Eotvos University of Sciences, Budapest, 

Hungary 

PROFESSIONAL APPOINTMENTS 

2011 – Present Chairman, Research Committee, Capital Digestive Care 

2011 – Present Member, APPI’s representative on the Professional Development 

 Committee of the ACRP 

1984 – Present Member, Medical Advisory Committee, CCFA, National Capital 

1990 – 2001 Chairman of Gastroenterology, Columbia Hospital for Women, 

 Washington, District of Columbia 

1995 – 1998 Board of Directors, Capitol Physicians Network 

1994 – 1998 Member, National Board of CCFA 

1994 – 1996 Judicial Council, Medical Society of the District of Columbia 

Case 3:11-cv-00760-JAP-TJB Document 132-1 Filed 11/07/11 Page 15 of 18 PageID: 4260
Curriculum Vitae: 

Robert Hardi, M.D., CPI 

May 2011 

Page 3 of 5 

1988 – 1994 Chairman, National Capital Area Medical Advisory Committee for CCFA, 

1993 – 1992 Vice Chairman, Utilization Review Committee, Sibley Memorial 

HOSPTIAL AFFILIATIONS 

1992 – Present Staff Physician, Georgetown University Hospital, Washington, 

 District of Columbia 

1984 – Present Staff Physician, Suburban Hospital, Bethesda, Maryland 

1984 – Present Staff Physician, Sibley Memorial Hospital, Washington, District of 

 Columbia 

1984 – Present Staff Physician, George Washington University Hospital, Washington, 

District of Columbia 

1984 – 2001 Staff Physician, Columbia Hospital for Women, Washington, District of 

Columbia 

MEMBERSHIPS 

 

American Society of Gastrointestinal Endoscopy 

American Gastroenterological Association- Fellow 

American College of Gastroenterology 

American College of Physicians 

Academy of Pharmaceutical Physicians and Investigators 

International Society for Travel Medicine 

Crohn’s and Colitis Foundation of America 

 

RESEARCH ACTIVITY 

Robert Hardi has been Principal Investigator on more than 250 gastroenterology clinical trials 

encompassing all phases and all areas of Gastroenterology including polyp prevention, sedation trials and 

therapeutic device trials. 

PUBLICATIONS 

1. Hardi R, Hughes RG, Ho YK, Chadha KC, Bardos TJ. Differential Effects of 5-

Methylmercapto-2’-Deoxyuridine on the Replication of Herpes Simplex Virus Type 1 in 2 

Cell Systems. Antimicrobial Agents and Chemotherapy, Oct 1976 p. 682-686. 

2. Balsalazide Is Superior to Mesalamine in the Time to Improvement of Signs and Symptoms 

of Acute Mild-to-Moderate Ulcerative Colitis; "The American Journal of Gastroenterology", 

Vol. 97, Number 12, Dec, 2002. 

3. Katz S., Novick, J., Hardi R., Rose M., Karlstadt R., Lottes S., Ettinger N. “Efficacy and 

Safety Profile of Older Patients Using Oral INKP-102 as a Bowel Purgative Prior to 

Colonoscopy Compared to Visicol”. Poster presented at ACG. 2005 

4. Hanauer S.B., Sandborn W.J., Kornbluth A., Hardi R., Regalli G., Yeh C. Delayed-release 

oral mesalamine 4.8 g/day (800mg tablet) versus 2.4 g/day (400mg tablet) for treatment of 

moderately active ulcerative colitis: combined analysis of two randomized, double-blind, 

controlled trials. Gastroenterology 2005 Apr; 128(4, Suppl 2): A-74. Abstract 492. 

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Curriculum Vitae: 

Robert Hardi, M.D., CPI 

May 2011 

Page 4 of 5 

5. Hanauer S.B., Sandborn W.J., Kornbluth A., Hardi R., Regalli G., Yeh C. Delayed-release 

oral mesalamine 4.8 g/day (800mg tablet) versus 2.4 g/day (400mg tablet) for treatment of 

moderately active ulcerative colitis: combined efficacy analysis of two randomized, doubleblind, controlled trials. Can J Gastroenterology 2005 Sept; 19 (Suppl C): Abstract R.0470. 

6. Hanauer S.B,. Sandborn W.J. Kornbluth A., Hardi R., Regalli G., Yeh C. Modified-release 

oral mesalazine 4.8 g/day (800mg tablet) versus 2.4 g/day (400mg tablet) for treatment of 

moderately active ulcerative colitis: combined analysis of two randomised, double-blind, 

controlled trials. Gut 2005 Oct; 54(Suppl VII): A56. Abstract OP-G-236. 

7. Hanauer S.B., Sandborn W.J., Kornbluth A., Hardi R., Regalli G., Yeh C. Modified-release 

oral mesalazine 4.8 g/day (800mg tablet) versus 2.4 g/day (400mg tablet) for treatment of 

moderately active ulcerative colitis: combined analysis of two randomized, double-blind, 

controlled trials. Colorectal Dis 2006 Jul; 8 (Suppl 2): Abstract O17. 

8. Aue, G., Carroll, N., Kressel, B. R., Hardi, R., Horne III, M. K. Disseminated Intravascular 

Couagulation in an Ambulatory Young Woman. Journal of Laboratory and Clinical 

Medicine, Vol.146 #3, Sept 2005 192-196. 

9. Gan T.G., Hardi R., Ekman E., Shore N. “Safety of Fospropofol for Minimal-to-Moderate 

Sedation in Patients Undergoing Minor Surgical Procedures”, Poster, Presented at the Society 

for Ambulatory Anesthesia 23rd Annual Meeting, Miami, May 2008. 

10. Pambianco, D., Bray, W., Hardi, R., Kodali, V., Pruitt, R., Shubert, T., Vargo, J., Weinstein, 

M. L. “A Computer- Assisted Personalized Sedation System To Administer Propofol Versus 

Standard Of Care Sedation For Colonoscopy And EGD: A 1000 Subject Randomized, 

Controlled, Multi-center, Pivotal Trial”. Presentation DDW 2008. 

11. Weinstein ML, Hardi R, Vargo J, Pambianco D: Psychomotor Recovery After Endoscopic 

Procedures Using a Computer-Assisted Personalized Sedation System to Administer Propofol 

or Standard of Care Sedation: Implications for Care Efficiency. Poster Abstract. Orlando, 

Florida. ACG Sept 2008. 

12. Abreu MT, von Tirpitz C, Hardi R, et al. “Extracorporeal photopheresis for the treatment of 

refractory Crohn's disease: results of an open-label pilot study”; Crohn's Disease 

Photopheresis Study Group. Inflamm Bowel Dis. 2009 Jun; 15(6):829-36 

13. Hardi R., Weinstein, M. L., Vargo, J., Pambianco, D. “Correlation of Hypoxia, Clinician 

Satisfaction (CSSI), Patient Satisfaction (PSSI) and Recovery Time (RT) with Level of 

Sedation”, Poster, Presented at the American Gastroenterology Association, Chicago, June 

2009. 

14. Daniel J. Pambianco, MD, John J. Vargo, MD, MPH, Ronald E. Pruitt, MD, Robert Hardi, 

MD, James F. Martin, PhD. “Computer-assisted personalized sedation for upper endoscopy 

and colonoscopy: a comparative, multicenter randomized study”, Gastrointestinal Endoscopy 

2010. 

15. Update on Colorectal Cancer Screening in the United States Gastro Update 2009. 

Case 3:11-cv-00760-JAP-TJB Document 132-1 Filed 11/07/11 Page 17 of 18 PageID: 4262
Curriculum Vitae: 

Robert Hardi, M.D., CPI 

May 2011 

Page 5 of 5 

16. The debate for nonanesthesiologist-administered propofol sedation in endoscopy 

rages on by Daniel J. Pambianco, Robert Hardi Gastrointestinal Endoscopy (Vol.74, 

Issue 2).

PRESENTATIONS: 

Hardi, R, Mayer, L., Targan, S., Yellin, M., Cardarelli, P., Witte, A., & Das, K. A Phase 1 Open–label, 

Single-dose, Dose-escalation Study of MDX-1100, a High-affinity, Neutralizing, Fully Human IgG1κ

anti-CXCL10 (IP-10) Monoclonal Antibody, in Ulcerative Colitis. DDW 2008, San Diego 

ASCEND: Assessing the Safety& Clinical Efficacy of a New Dose of 5-ASA (4.8 /day) (800 mg tablet) 

Association of ColoProctologists of Great Britain and Ireland; 2006, Newcastle 

Case 3:11-cv-00760-JAP-TJB Document 132-1 Filed 11/07/11 Page 18 of 18 PageID: 4263