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Clinical Research Medical

Location:
Portland, OR
Posted:
December 22, 2020

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Resume:

Peter Donald O’Hanley, Ph.D., M.D., M.P.H.

Contact Coordinates

Home Address **** ** ******* ******

Portland, OR 97213

Telephone Number 1-541-***-****

Email adiwbr@r.postjobfree.com

Educational History

Aug 1995 – May 1996

University of California

Berkeley, CA

MPH, Epidemiology

Mar 1978 - Jun 1979

Medical University of South Carolina

Charleston, SC

MD, Medicine

Sept 1973 - Jun 1978

Medical University of South Carolina

Charleston, SC

PhD, Anatomy/Immunology-minor

Graduate Advisor: J. Robert Cantey, MD;

Albert Sabin, MD, served on Advisory Committee

Jan 1970 - Jun 1972

Pomona College

Claremont, CA

BA, Zoology

Post-Doctoral Training

Aug 1995 – May 1996

Masters in Public Health Program

Department of Epidemiology and Biostatistics

University of California, School of Public Health

Berkeley, CA

Advisor: Arthur Ringold, MD

Jul 1984 – Jun 1985

Chief Resident

Department of Medicine

Stanford University School of Medicine

Stanford, CA

Chairmen: Rex Jamison, MD and

Ferid Murad, MD, PhD (1998 Medicine- Nobel Prize)

Jul 1981 - Jun 1984

Post-doctoral Fellow

Department of Medical Microbiology

Stanford University School of Medicine

Stanford, CA

Directors: Gary Schoolnik,MD and Stanley Falkow, PhD (2008–Lasker Award)

Jul 1981 – Jun 1984

Infectious Disease Fellow

Division of Infectious Disease

Department of Medicine

Stanford University School of Medicine

Stanford, CA

Director: Thomas Merigan, MD

Jul 1979 – Jul 1981

Internal Medicine Intern PGY 1 and Resident PGY 2

Providence Medical Center, Portland, OR

Director: David Gilbert, MD

Academic Appointments

Jul 2005 - May 2015

Affiliate Professor

Oregon Health Sciences University & Portland State University School of Public Health and Preventive Medicine

Portland, OR

May 1992 – Jan 1998

Associate Professor (tenured)

Department of Medicine (Infectious Diseases & Geographic Medicine) and Department of Medical Microbiology

Stanford University School of Medicine

Stanford, CA

Jul 1985 – Apr1992

Assistant Professor (tenured track)

Department of Medicine, (Division of Infectious

Diseases) and Department of Medical Microbiology

Stanford University School of Medicine

Stanford, CA

Sept 1980 – May 1981

Instructor

Portland State University

Portland, OR

(Taught courses to undergraduates in Pathobiology and Human Toxicology from Environmental Exposures for two semesters)

Medical Licenses/Board Certification

Oregon MD 12380 (Active)

California MD (retired from active service in this state since 2004)

Board Certified (lifetime) by the American Board of Internal Medicine 1986

Board Certified Infectious Diseases Subspecialty 2002-2012; scheduled for Infectious Disease recertification in Spring 2021

Current/Recent or Primary Hospital Privileges

Jul 2015 – present Portland Veterans Administration Hospital

Staff Physician- Nocturnal Hospitalist

Portland, Oregon

Nov 2003 –May 2017 Providence Hospital System in Oregon

Portland Providence Medical Center

Willamette Falls Medical Center

(Staff physician- part-time: usually 1 shift per

week during this interval)

Jul 1985 – Jan 1998 Stanford University Medical Center and

Palo Alto Veterans Affairs Hospital Palo Alto, California

Overview of Clinical Experience: I have more than 29 years as a clinician providing primary internal medicine care, primarily as a hospitalist, and infectious disease subspecialist. As well, I was a tenure-tracked academic physician from 1985-1998 at Stanford University interested in a variety of infectious disease problems. Between 1985 and 1998, I had considerable international health clinical experiences in Mexico, Nepal, and Indonesia related to my research interests in gastrointestinal parasitology, trachoma, and in vaccinology for prevention of infectious diseases and development of molecular-based diagnostics (e.g., trachoma and ascariasis). I was also the Director of Antimicrobial Stewardship and Infectious Disease Director of Adult Leukemia Patients at Stanford University Hospital between 1985 and 1986. As Chief of the Division of Infectious Diseases at the Palo Alto Veterans Affairs Hospital, I was responsible for 1,500 institutionalized geriatric patients for infection control between 1986 and 1989. I served as the first Director of the HIV/AIDS Clinic for over 500 HIV-infected patients at the Palo Alto Veterans Affairs Hospital from 1986 to 1989 at the height of the HIV/AIDS epidemic in the US without any anti-retroviral drugs and again returning to the HIV/AIDS clinic in 1995 until 1998 in a support role. From 1985 to 1990, I worked intensely on trachoma projects in western Nepal and ascariasis projects in Mexico. From 1991 to 1994, I had extensive clinical experiences in a variety of tropical diseases as the Head of Tropical Medicine Department at NAMRU-2 in Jakarta, Indonesia via a US government IPA with Stanford University and the VA. Via my work in Indonesia, I had extensive clinical experience with a variety of infectious diseases hyper-endemic in Indonesia: cholera, bacterial and parasitic diarrheal diseases, hepatitis B, typhoid fever, dengue viral syndromes, Japanese encephalitis, malaria, and a variety of systemic parasitic infections. Furthermore, I had considerable experience with sexually transmitted diseases and HIV/AIDS among sex workers in Jakarta during my stay in Indonesia. Furthermore, I was a co-medical Director for homeless veterans in the San Francisco Bay Area cared at the Menlo Park Campus within the Palo Alto Veterans Affairs Hospital from 1995 to 1998. On average, I was responsible for the daily medical care of 75 to 100 homeless patients involved in intensity recovery. The majority of medical issues for the homeless included: alcoholism, illicit drug abuse, tuberculosis, HIV/ AIDS, hepatitis C virus infection, infectious dermatological conditions, and chronic active hepatitis B infection---in addition to routine management of diabetes mellitus, coronary artery disease, cerebral vascular insufficiency/ infarcts, malnutrition, and chronic obstructive pulmonary disease. In view of 12 years of NIH support for vaccine development and bacterial pathogenesis of urinary tract infections, I and my research team worked closely with medical staff at Stanford University Cowell Student Health and the Spinal Cord Injury Unit at the Palo Alto Veterans Affairs Hospital between 1986 and 1998. I have extensive practical expertise in the management of spinal cord injury patients, pressure ulcers and chronic ventilation.

Over the last 16 years as a non-academic physician working in Oregon, I continue to be interested and work in primary care. I have served as a part-time or full-time hospitalist working between 48 to 150 hours per month since 2003 to the present: admitting and caring for hospitalized patients with acute medical issues during 12 hour night shifts (e.g., strokes, altered mentation, myocardial infarcts, diabetic ketoacidosis, hyperosmolar glycemia, infections, endocrinopathies, neoplastic diseases, abdominal pain, nausea and vomiting, diarrhea, constipation, vascular insufficiency, chronic and acute pulmonary conditions, rheumatologic disorders, renal failure, and hepatic failure).

Primary Professional Industry Experience

May 2017 – present Karius, Inc.

Redwood City, CA

Medical Consultant

Apr 2019 – present Colorado BioReg International, Corp.

Boulder, CO

Expert Clinical Consultant

Sept 2017- Oct 2018 Collidion, Inc.

Petaluma, CA

Medical Consultant via Nopras

Jul 2009 - May 2017; Exoxemis, Inc.

Mar 2020 – May 2020 Little Rock, AR

(consultant) Executive Vice President of Clinical

Development and Regulatory Affairs

Jan 2004 – Jan 2009 AVI BioPharma, Inc. (currently named

Sarpeta Therapeutics, Inc.)

Portland, OR

Senior Vice President of Clinical Development

and Regulatory Affairs

Jan 2002 – Nov 2003 Maxygen, Inc.

Redwood City, CA

Vice President Clinical Development

Mar 2000 – Dec 2001 Preventis, Inc.

Washington, D.C.

President and Chief Scientific Officer

Jan 1998 – Mar 2000 Quintiles Transnational, Inc.

Arlington, VA

Oct 1999 – Mar 2000 Vice President and Chief Scientific Officer,

Anti-Infective Therapeutic & Immunology

Therapeutic Groups

Jan 1998 – Oct 1999 Executive Director/Vice President,

Anti-Infective Therapeutic & Immunology

Therapeutic Groups (AMERICAS)

Sept 1996 – Aug 1997 Shaman Pharmaceuticals, Inc.

South San Francisco, CA

Visiting Clinical Scientist

(while on sabbatical leave from Stanford University)

CAREER DETAILS

Summary: I have focused most of my time in the last 35 years in independent biomedical-clinical research, primarily in the discovery and clinical development of novel vaccines, antiseptics, diagnostics, and drugs, as well as clinical practice. My range of biomedical involvement has involved primarily infectious disease (emphasis in soft tissue infections, diarrheal diseases, urinary tract infections, vaccine development and trials, and antimicrobial drug trials) but also includes discovery and development projects in rheumatology, metabolic modulation, muscular dystrophy, and coronary artery re-stenosis. I have had pivotal roles (especially in design, protocol/document preparation, regulatory filings, and clinical trial logistics) in over 140 clinical protocols that have included Phase 1 through Phase 4 studies under ICH/GCP that were conducted in the United States, Mexico, Venezuela, European Union, Poland, Ukraine, South Africa, Israel, Indonesia, and India. These studies have enrolled over 120,000 volunteers. These studies have been conducted in full compliance with all local and international governing regulatory agencies. I have also served as a senior consultant in clinical development, regulatory affairs, and business development for several companies over the last 20 years. I have experience in Fast Track, Orphan Drug Applications, Animal Rule, and Breakthrough Therapy programs with the FDA. I have an extensive network of professional colleagues in a number of fields including biostatistics, data management, preclinical and clinical development, quality, and regulatory affairs to assure that I can provide comprehensive consultant advice for development programs in vaccinology, drug development, biological development, and diagnostics. From 1985 to 1998, I was actively engaged as an academic investigator in conventional biomedical molecular research focused on infectious disease topics with a major interest in international health and tropical medicine. Over the course of the last 20 years as an industry professional, I have played pivotal roles in basic research and clinical development on dengue, Ebola Zaire, Marburg viruses, West Nile virus, hepatitis C, influenza, cholera, HIV-1 and HIV-2 vaccine/products and antiseptic drug development, as well as, Duchene muscular dystrophy utilizing antisense-mediated dystrophin exon skipping strategies. The Phase 1 clinical study that I designed for dystrophin exon skipping was the first-ever to demonstrate that antisense RNA oligonucleotide administration could result in de novo truncated dystrophin in boys with a particular genetic mutation in the United Kingdom via the Medicines and Healthcare products Regulatory Agency (MHRA) and Gene Therapy Advisory Committee (GTAC). I have regulatory experiences in many countries in Asia, Latin America, European Union, United Kingdom, Israel, and South Africa-- besides the United States. In view of my expertise in tropical infectious diseases, I was contacted in the summer of 2015 to serve as Chairman of a Data Monitoring Safety Board for an experimental dengue vaccine program sponsored by the US government (via WRAIR) and Glaxo-Smith-Kline.

SPECIFIC ROLES IN CLINICAL DEVELOPMENT:

May 2017 – present

Karius, Inc., Redwood City, CA

Medical Consultant responsible for analyzing next-generating sequencing clinical trial data for publication and drafting an interventional clinical trial protocol to demonstrate the clinical utility of the Karius Digital Cell Test to detect cell free DNA for H. pylori so as improve peptic ulcer disease diagnosis. In addition, I have worked extensively on identifying invasive fungal disease in a variety of patient populations by the Karius Digital Cell Test.

Apr 2019 – present

Colorado BioReg International, Corp., Boulder, CO

Expert Clinical Consultant responsible for strategic clinical development and regulatory affairs for several industry clients in the fields of infectious diseases, rheumatology, neoplastic diseases, and metabolic disorders in compliance with FDA and EU regulations. This includes drafting of clinical trial manuals, documents, and Phase 1-2 protocols, pre-clinical protocols, as well as regulatory IND application filings and correspondence.

Sept 2017 – Oct 2018

Collidion, Inc., Petaluma, CA

Medical and Regulatory Consultant via Nopras Technologies, Inc., responsible for clinical development of a hypochlorous-based antiseptic for a pre-surgical scrub indication in compliance with FDA regulations. Ceased efforts because company hired a full-time VP of regulatory affairs.

Jul 2009 – May 2017: full-time EVP Position

Mar 2020-May 2020: short term Consultant Position

Exoxemis, Inc., Little Rock, AR

Executive Vice President of Clinical Development and Regulatory Affairs (2009-2017 prior to cessation of operations in 2017) responsible for clinical development strategy and regulatory affairs of this privately-owned company’s lead myeloperoxidase product (E-101 Solution) for the prevention of surgical site infections among elective colorectal surgery patients and open wound antisepsis. I lead a multinational Phase 3 clinical trial for E-101 Solution to prevent surgical site infections under an IND with the FDA at the Center for Biological Evaluation and Research (CBER). I had responsibility for its design and execution. Due to the unique regulatory challenges for open wound antiseptics, I had extensive interaction/discussions with senior management in the Office of Antimicrobial Products (OAP) and Division of Anti-Infective Products (DAIP). I have also engaged in advanced interactions/filings for alternative protocols for open wound antisepsis with the European Medicines Agency (EMA), especially with Germany’s Federal Institute for Drugs and Medical Devices (BfArM) and Sweden’s Medical Products Agency (MPA), and India with the Drugs Controller General of India (DCGI). Also, I am fully aware of the regulatory risks/process for clinical trial applications (CTAs) in Indonesia, Philippines, Malaysia, Australia, Thailand, Venezuela, Peru, Brazil, and South Africa. Asked to serve for a short-term consultant position between March 2020 and May 2020 for the prevention of COVID-19 transmission and other viral and bacterial respiratory pathogens.

Apr 2004 – Jan 2009

AVI BioPharma, Inc. (now called Sarpeta Therapeutics, Inc.), Portland, OR

Senior Vice President of Clinical Development and Regulatory Affairs responsible for overseeing all facets of clinical development and regulatory affairs for the company exploiting its phosphorodiamidate morpholino oligomer (PMO) antisense technology. I was responsible for the completion of 18 clinical protocols (including Phase 1, Phase 1b, and Phase 2 clinical studies) using antisense PMO product concepts. The projects were focused on cardiovascular in-stent restenosis (i.e., CABG saphenous vein graft failure), muscular dystrophy, corneal transplant rejection, and infectious diseases (e.g., HCV, West Nile virus, Ebola Zaire, Marburg virus, dengue, and influenza), metabolic modulation, and Duchene muscular dystrophy (MD). Multiple INDs and CTAs for new product concepts in these fields were obtained via my work products from the FDA. Under my leadership, our group was responsible the first-ever in demonstrating that intramuscular administration of an antisense cassette could lead to targeted exon-skipping to produce a truncated dystrophin in MD boys. I also designed non-human primate studies that supported subsequent Phase 1 testing in humans at Fort Detrick, MD, evaluating antisense drugs against Ebola and Marburg viruses. I have working knowledge of the FDA animal efficacy rule and biodefense products. In addition, 3 orphan approvals were obtained under my leadership.

Jan 2002 – Nov 2003

Maxygen, Inc., Redwood City, CA

Vice President Clinical Development responsible for all facets of clinical development and regulatory affairs/filing for the company to exploit its proprietary recombination-based technologies for creating genetic diversity, known as its molecular breeding directed evolution platform. In particular, I was responsible for pre-clinical development of lead product concepts, clinical trial design, strategic regulatory affairs, and implementation of infectious disease (HIV and dengue vaccines) and oncology (colorectal) vaccine development programs. I relied on considerable first-hand experiences in these broad areas of development and had numerous interactions with key academic investigators, thought leaders in infectious diseases and oncology, clinical trial experts, regulatory affairs experts in the United States and abroad, as well as business experts in marketing. I interacted on an on-going basis with corporate scientists, attorneys, and business developers for the success of pre-clinical development of dengue fever and colorectal vaccines, as well as, manufacturing and pre-clinical testing in laboratory animals and non-human primates according to GLP standards for these product concepts. This biotechnology company has ceased to operate. However, my non-human primate pre-clinical development work on the dengue vaccine project was eventually bought by Sanofi Pasteur in 2005.

Feb 2000 – Nov 2003

Preventis Inc., Washington D.C.

President and Chief Scientific Officer responsible for a virtual, start-up company that has raised $4 million for an international vaccine program in Brazil, South Africa, and Poland to develop a synthetic therapeutic R7V HIV vaccine based on the discovery of the co-discoverer of HIV and its causation with AIDS (viz., Professor Jean-Claude Chermann). I was responsible for pre-clinical development, manufacturing GMP products, successful GLP animal safety studies, and successful regulatory approvals of clinical trial projects in designated countries abroad. I was successful in establishing and organizing a therapeutic HIV vaccine testing Phase 1 site in Brazil for a prototype synthetic HIV vaccine. This biotechnology company has ceased to operate.

Jan 1998 – Mar 2000

Quintiles Transnational, Inc., Arlington, VA

Oct 1999 – Mar 2000

Vice President and Chief Scientific Officer,

Anti-Infective Therapeutic & Immunology Therapeutic Groups (Americas)

&

Jan 1998 – Oct 1999

Executive Director/Vice President,

Anti-Infective Therapeutic & Immunology Therapeutic Groups (Americas)

responsible for establishing, implementing, and maintaining standard operating procedures and guidelines to assure proper management of clinical trials contracted with Quintiles to meet FDA regulatory approval of diagnostic test/drug/vaccine development. I actively participated in problem-solving issues relevant to diagnostic test/drug/vaccine development with clients, including protocol design; drafting protocols and case reports; written or oral presentations at regulatory, investor, scientific or client company meetings; and representation at selected scientific, regulatory, and business meetings. I also actively participated in field operations to ensure proper implementation and compliance of protocol requirements, as needed. I also served senior management at Quintiles in organizing selected clinical trials in South Africa and India in compliance with their national and local regulatory guidelines.

Major accomplishments included:

Responsible for growing the therapeutic infectious disease and clinical immunology group from 30 to more than 260 individuals (clinical research associates [CRAs], medical writers, business developers, and physicians).

Business sales increased to over $90 million over a 20-month period.

Recognized as one of four top employees of the year for this 28,000 company in 1999.

Sept 1996 – Aug 1997

Shaman Pharmaceuticals, Inc., South San Francisco, CA

Visiting Clinical Scientist (sabbatical leave from Stanford University) As a Visiting Clinical Scientist, I was responsible for scientific and clinical trial direction for an experimental drug (SP-303) that was being considered as a therapeutic for the symptomatic relief of diarrhea in selected target populations (e.g. travelers and AIDS patients) that has only recently been approved for the market. I had extensive interaction with financial analysts, venture capitalists, bankers, private investors, and scientific community relevant to role as de facto medical director for this start-up biotech company. I had also extensive regulatory interaction with foreign health ministries and drug control (viz., Indonesia, Vietnam, Bangladesh, Thailand, Philippines, Mexico, Jamaica, and Venezuela) for this company. This biotechnology company has ceased to operate.

Sept 1986 – Jan 1998

Palo Alto Veterans Healthcare System, Palo Alto, CA

Chief of Infectious Diseases

Received national recognition in infection control and antibiotic utilization for the largest Veterans Affairs Hospital in the United States. Specific accomplishments included:

Documented leadership in maintenance of prudent antibiotic usage in subsequent years.

Established the first HIV/AIDS and Infectious Disease Clinic at PAVAH in 1986 and was Supervisor of 12 professionals from multiple disciplines in to care for HIV/AIDS patients.

Primary care provider for ~500 HIV-infected patients between 1986 and 1991.

Jul 1985 – Aug 1991

Stanford University Hospital, Stanford, CA

Jan 1989 – Aug 1991

Director of Antibiotic Utilization and Evaluation Program

Major accomplishments in this role included:

Responsible for 30% reduction in antibiotic costs or $4.5 million at Stanford University Hospital in the first year of leadership.

Documented leadership in maintaining prudent antibiotic usage in the subsequent year of leadership.

Hospital recognition that appropriate antibiotic usage was associated with cost savings and improved patient outcome compared to indiscriminate and costly antibiotic prescribing practices.

Jul 1985 – Sept 1987

Infectious Disease Director of Compromised Host Unit

Recognized as clinical leader at the hospital for this well-renown medical unit, specifically for his infectious disease management and infection control for this medically complex target population. Published a manuscript on its infectious disease outcomes.

AWARDS AND HONORS:

Diplomat of Infectious Diseases, American Board of Internal Medicine, 2002-2012

U.S. Public Health Services Fellowship Award, 1995 - 1996

American Society of Clinical Investigation - “Young Turk”, 1992

Western Society of Clinical Investigation - Member, 1989

Mellon Foundation Fellow, 1988 - 1989

Infectious Diseases Society of America - Fellow, 1988

NATO - Scholar, 1986 - 1991

SmithKline & French Investigator Award of Infectious Disease Society of America, 1986-1988

American Board of Internal Medicine - Diplomat, 1986 (lifetime)

Chief Resident, Department of Medicine, Stanford University, 1984 - 1985

Peter Beckett Chief Resident Exchange, Stanford University with Massachusetts General Hospital, 1985

American Gastroenterological Association (AGA) - Student Research Award, 1977

American Gastroenterological Association (AGA) - Student Fellowship, 1976

PROFESSIONAL AFFILIATIONS:

Organizations

Surgical Infection Society

American Society of Clinical Investigation

American Society of Tropical Medicine

Infectious Disease Society of America

American Society of Microbiology

American Federation of Clinical Research

American Association of Anatomists

Electron Microscopy Society of America

Consultant/Advisor

Shaman Pharmaceuticals, Inc., South San Francisco, CA 1995 - 1997

Redcell, South San Francisco, CA 1994 - 1997

Alza Research Corporation, Palo Alto, CA 1988 - 1991

Alza Corporation, Palo Alto, CA 1994 - 1996

Schering-Plough, Bloomfield, NJ 1986 - 1990

John Snow Incorporated, Boston, MA 1988 - 2002

Cetus Corporation, Emeryville, CA 1985 - 1988

Quintiles Strategic Drug Development and Regulatory Affairs 2000 - 2002

United Therapeutics, Scientific Consultant 2000 - 2002

Cytovax, Scientific Advisory Board 2001 – 2002

US Department of Health and Human Services

(Vaccine & Treatment Evaluation Units-Special Emphasis Panel) 2007

USAMMDA, Experimental dengue vaccine program, Chairman-

Data Safety Monitoring Board 2015- 2019

PATENTS:

Issued a sub-unit pilus human vaccine for the prevention of Escherichia coli pyelonephritis, issued April, 1987.

Issued a synthetic pilus peptide vaccine for the prevention of Escherichia coli pyelonephritis, issued July, 1988.

PUBLICATIONS:

Abstracts 80

Journal or Original Texts 74

Book Chapters, Monographs, Clinical Reports 31

PUBLICATIONS:

Abstracts

1. O’Hanley PD, Callaway ST, Daniel RS. Three-dimensional reconstruction of bat liver cell organelles by serial section cinematography. Program and Abstracts of South Carolina Academy of Science, Greenville, South Carolina, March 1974.

2. O’Hanley PD, Cantey JR, Blake RK. Study of virulence factors of enteropathic Escherichia coli. Program and Abstracts of the 16th Annual Meeting of Southern Association of Anatomists in Journal of the Southern Medical Society, Atlanta, Georgia, October 1976.

3. O’Hanley PD, Cantey JR, Blake RK. Rabbit model for human invasive Escherichia coli (HInvEC) diarrheal disease. Program and Abstracts of the 16th Interscience Conference on Antimicrobial Agents and Chemotherapy, Chicago, Illinois, October 1976.

4. Cantey JR, O’Hanley PD, Blake RK. Prevention of Escherichia coli colonization and diarrhea by immune secretory immunoglobulin A (SlgA). Program of the AGA-NIH Workshop on Immunology of the Gastrointestinal Tract, Aspen, Colorado, October 1976.

5. Cantey JR, O’Hanley PD, Blake RK. Prevention of Escherichia coli colonization and diarrhea by immune secretory immunoglobulin A (SlgA). Program and Abstracts of the Southern Society of the American Federation of Clinical Research, New Orleans, Louisiana, January 1977. Clinical Research 25:27A, 1977.

6. O’Hanley PD, Cantey JR, Lushbaugh WB, Inman L, Takeuchi A. Scanning (SEM) and transmission (TEM) electron microscopic observations of diarrheal disease produced by an enteropathic Escherichia coli strain (RDEC). Program and Abstracts of the AGA Annual Meeting, Toronto, Ontario, May 1977. Gastroenterology 72:1109A, 1977.

7. O‘Hanley PD. Ileal Immunoglobulin (Ig) synthesis and secretion after human invasive Escherichia coli (HIEC) diarrheal disease in the rabbit model. Program and Abstracts of the AGA Annual Meeting, Toronto, Ontario, May 1977.

8. Takeuchi A, Inman LR, O’Hanley PD, Lushbaugh WB, Cantey JR. Morphologic studies on enteric infection in rabbits with Escherichia coli 015 (RDEC-1). Proceedings of the 13th NIH US-Japan Joint Conference on Cholera, Atlanta, Georgia, September 1977.

9. O’Hanley PD, Cantey JR. Local immune response to invasive Escherichia coli. Program and Abstracts of the 17th Interscience Conference on Antimicrobial Agents and Chemotherapy, New York, New York, October 1977.

10. Cantey JR, O’Hanley PD. Virulence factors of enteropathic Escherichia coli. Program and Abstracts of the 17th Interscience Conference on Antimicrobial Agents and Chemotherapy, New York, New York, October 1977.

11. O’Hanley PD, Callaway ST, Daniel RS. Serial section cinematography at the electron microscope level of resolution. Program and Abstracts Annual Meeting of the American Association of Anatomists, Vancouver, British Columbia, April 1978.

12. O’Hanley PD. Systemic and ileal immunoglobulin response following human invasive Escherichia coli diarrhea in a rabbit model. Program and Abstracts of the Eastern Student Research Forum, Miami, Florida, May 1978.

13. Waldman SA, O’Hanley PD, Falkow S, Schoolnik GK, Murad F. A simple, sensitive and quantitative in vitro assay for the detection of heat-stable enterotoxin (ST) produced by Escherichia coli. Program and Abstracts Western Meeting of American Federation of Clinical Research, Carmel, California, February 1983. Clinical Research 31:50A, 1983.

14. O’Hanley PD, Lark D, Falkow S, Schoolnik GK. A globoside binding Escherichia coli pilus vaccine prevents pyelonephritis. Program and Abstracts National Meeting of American Federation of Clinical Research, Washington, D.C., April 1983. Clinical Research 31:372A, 1983.

15. O’Hanley PD, Lark D, Clegg S, Schoolnik G. Functional and chemical aspects of X pili from a recombinant Escherichia coli strain SC802. Program and Abstracts of the 23rd Interscience Conference on Antimicrobial Agents and Chemotherapy, Las Vegas, Nevada, October 1983.

16. Lark DL, O’Hanley P, Weinstein WM, Schoolnik G. Human uroepithelia: The distribution and density of receptor analogues for pyelonephritic Escherichia coli pili. Program and Abstracts National Meeting of American Federation of Clinical Research, Washington, D.C., May 1984. Clinical Research 32:374A, 1984.

17. Lark DL, O’Hanley P, Romero I, Low D, Lark D, Falkow S, Vosti K, Schoolnik G. Virulence factors of uropathogenic Escherichia coli: First epidemiological study in adult females, Program and Abstracts National Meeting of American Federation of Clinical Research, Washington, D.C., May 1984. Clinical Research 32:377A, 1984.

18. O’Hanley P, Watt K, Romero I, Lark D, Schoolnik G. Primary structure of globoside-binding pili (G-Pili): Antigenic determinants. Program and Abstracts National Meeting of American Federation of



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