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Microsoft word - pieniaszek's cv 10-05.doc

CURRICULUM VITAE
Henry (Hank) J. Pieniaszek, Jr., Ph.D., FCP
PERSONAL INFORMATION

Business Mailing
Address:

EDUCATION

1978 - 1982
Major: Pharmacy (Pharmaceutical Sciences) Dissertation Topic: Pharmacokinetic Studies with Digitalis Glycosides and Propranolol Dissertation Committee: Department of Pharmaceutical Sciences 1. Donald G. Perrier, Ph.D., co-major advisor 2. Michael B. Mayersohn, Ph.D., co-major advisor Department of Pharmacology and Toxicology Curriculum Vitae
H. J. Pieniaszek, Jr.


CONTINUING EDUCATION
1.
Du Pont or DuPont Merck Sponsored Training/Symposia Programs: • Burger Course in Effective Writing (Wilmington, DE, 9/85). Business Excellence Workshop -- Project Team Building Skills (Great Oak Landing, MD, 9/86). Managers Workshop on Personal Safety (Newark, DE, 9/87). Customer Focus Workshop (Philadelphia, PA, 10/87). Substance Abuse Workshop for Supervision (Newark, DE, 2/88 and 2/89). A Matter of Respect -- Sex Discrimination and Sexual Harassment Prevention (Wilmington, DE, 6/88). Pharmacologic Management of Ventricular Arrhythmias (Scottsdale, AZ, 10/89). Medical Products Leadership Conference: "Winning Partners" (Nashville, TN, 5/90). Leadership of Continuous Improvement (Mendenhall, PA, 5/91). Ethmozine Advisory Board (Monte Carlo, Monaco, 6/91). Personal Charting Development (Mendenhall, PA, 8/91). Project Planning & Development (Baltimore, MD, 2/92). Managing Technical Professionals (Wilmington, DE, 10/93). Laboratory cGMP Training (Wilmington, DE, 2/96). Managing Conflict (Wilmington, DE, 6/96). Respect and Responsibility (Wilmington, DE, 6/97). SAS – Applied Statistics for Business Decisions (Wilmington, DE, 5/98). ACS short-course: Practice of Modern Liquid Chromatography (Wilmington, DE, 10/82). APS/APhA short-course: Bioanalytical Approaches and Pharmacokinetic Considerations in Pharmacokinetic and Drug Metabolism Studies (Minneapolis, MN, 10/85). Analytichem International Workshop: Sample Preparation and Isolation Using Bonded Silicas PhRMA/Drug Metabolism Subsection Workshops: • Food Effects in New Drug Development (Washington, DC, 3/87). Use of Animals as Substitutes for Humans in Oral Bioavailability Studies (Washington, DC, 6/89). Predicting Populations at Risk from Drug Interactions (Rockville, MD, 3/92). Blood Sampling Strategies in Support of Toxicology and Preclinical Pharmacokinetics -- participated as a Workshop Co-Moderator/Presenter “Preclinical Sparse Sampling: Reduction to Practice” (Rockville, MD, 10/96). Pharmacokinetics or Pharmacodynamics in Drug Development and Regulatory Decisions (Bethesda, MD, 6/98). Curriculum Vitae
H. J. Pieniaszek, Jr.

CONTINUING EDUCATION (Cont.)

6. AAPS/FDA
Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies (Arlington, VA, 12/90). Evaluation of Orally Administered Highly Variable Drugs and Drug Formulations (Arlington, VA, 3/95). Scientific and Regulatory Issues in Product Quality: Narrow Therapeutic Index Drugs and Individual Bioequivalence (Arlington, VA, 3/98). Bioanalytical Methods Validation – A Revisit with a Decade of Progress (Arlington, VA, 1/00). Bioanalytical Methods Validation for Macromolecules (Arlington, VA, 3/00). Bioanalytical Methods Validation for Macromolecules in Support of Pharmacokinetic Studies (Washington, DC, 5/03). 3rd Conference for the Mid-Atlantic Population Approach Methods Users Group (Collegeville, PA, 9/94). Fifth Mid-Atlantic Population Users Group Meeting (King of Prussia, PA, 10/95). Covey Leadership Time Management Seminar (“First Things First -- Life Leadership through Effective Time Management”, Philadelphia, PA, 5/95). Third International Workshop on Pharmacokinetic/Pharmacodynamic Relationships of Antineoplastic Agents (Arlington, VA, 9/95). 10. Pharmaceutical Education & Research Institute (PERI): Preparing for and Facilitating Key FDA Meeting Workshop (5/98). 11. University of Arizona sponsored at the University of Delaware (Drs. Michael Mayersohn and Harold Boxenbaum, Instructors) Course Entitled: “Selected Topics in Pharmacokinetics and Toxicokinetics” (7/98, 6/00, 6/01).
ACADEMIC AWARDS

1970
St. Mary’s Athletic Association (Albion, NY) College Scholarship
PROFESSIONAL EXPERIENCE
01/02 – present
CSO and President, HPP Consulting & Services, Inc. (Clinical Pharmacology, Pharmacokinetics, Pharmacodynamics, & Clinical and Pharmaceutical Development Company) Curriculum Vitae
H. J. Pieniaszek, Jr.

PROFESSIONAL EXPERIENCE (cont.)
1/04 – present
Collateral Agent, representing the former shareholders of Microconstants, Inc. in post-sale transactions. Chairman, Board of Directors MicroConstants, Inc. 10110 Sorrento Valley Road San Diego, CA 92121 Senior Director – Clinical Pharmacokinetics, Pharmacodynamics, and Biomarker Development Groups Drug Metabolism and Pharmacokinetics Section Stine-Haskell Research Center, Bldg. 112
12/00 – 9/01
Senior Director – Clinical Pharmacokinetics, Pharmacodynamics, and Biomarker Development Groups Drug Metabolism and Pharmacokinetics Section Stine-Haskell Research Center, Bldg. 112 Senior Director – Clinical Pharmacokinetics Group Drug Metabolism and Pharmacokinetics Section Director - Clinical Pharmacokinetics Group Drug Metabolism and Pharmacokinetics Section Director - Clinical Pharmacokinetics Group Drug Metabolism and Pharmacokinetics Section Drug Metabolism and Pharmacokinetics Section Associate Director - Clinical ADME and GLP Group Drug Metabolism and Pharmacokinetics Section Curriculum Vitae
H. J. Pieniaszek, Jr.


PROFESSIONAL EXPERIENCE (cont.)

10/89 - 12/90
Senior Research Supervisor - Clinical ADME and GLP Group E. I. du Pont de Nemours & Company, Inc. Pharmaceuticals & Biotechnology R&D Division
1/89 - 9/89
Research Supervisor - Clinical ADME and GLP Group E. I. du Pont de Nemours & Company, Inc. Group Leader - Clinical ADME and GLP Group E. I. du Pont de Nemours & Company, Inc. E. I. du Pont de Nemours & Company, Inc. E. I. du Pont de Nemours and Company, Inc.
1/78 - 8/82
Graduate Research and Teaching Assistant Department of Pharmaceutical Sciences, College of Pharmacy Department of Pharmaceutics, School of Pharmacy Senior Laboratory Technician, Grade SG-11 Department of Pharmaceutics, School of Pharmacy Department of Pharmaceutics, School of Pharmacy Curriculum Vitae
H. J. Pieniaszek, Jr.


INDUSTRIAL AWARDS
7/99
DuPont Pharmaceuticals Accomplishment Award for “Tremendous effort, commitment, and teamwork that resulted in the Innohep Full NDA”.
4/99 DuPont
1999 Corporate Summit Award for “Development of a drug dependent
antibody test for the GP IIb/IIIa antagonist, roxifiban, and implementation of this test in Phase II clinical trials”. 10/98 DuPont Pharmaceuticals Accomplishment Award for “Outstanding contribution and dedication to the 12/96 DuPont Merck Accomplishment Award for “Outstanding scientific contribution in clinically advancing the morphine sustained release dosage form project”.
11/95 DuPont Merck (first) Corporate Work/Life Award for “Continued support for employee work/life
issues by allowing flexible work practices to accommodate ever-changing real-life situations”. 12/90 Du Pont Medical Products Department Accomplishment Award for “Outstanding contribution in preparing the Ethmozine preclinical ADME and Clinical Pharmacology sections of the NDA and the Summary Basis of Approval”. 5/90 1990 Director's Corporate Recognition Award from Du Pont Medical Research for “High quality
and continuing commitment to the preclinical interface with Medical”. Du Pont Medical Products Department Accomplishment Award for “Outstanding contribution in preparing for the Ethmozine presentation to the FDA Cardio-Renal Advisory Committee on 1/27/89”.
11/86 Du Pont Biomedical Products Department Accomplishment Award for “Development of a quantitative
HPLC/MS assay for Ethmozine in human plasma”.
INDUSTRIAL COMMITTEE SERVICE
1/93 - 12/93
DuPont Merck R/D Report Standardization Committee Du Pont Medical Products Random Drug Screening Implementation Committee Du Pont Experimental Station Lavoisier Library Steering Committee Stine-Haskell Research Center Radiation Safety Committee (co-prepared/reviewed NRC license renewals for 1984, 1989, and 1994) Curriculum Vitae
H. J. Pieniaszek, Jr.


RESEARCH EXPERIENCE
During my 20-year tenure at DuPont (Medical Products, DuPont Merck, and DuPont Pharmaceuticals), I was
involved with numerous discovery and development projects in the areas of cancer, cardiovascular, CNS,
infectious diseases, metabolic diseases, transplantation, and drug delivery systems. My initial responsibilities
were as the Drug Metabolism and Pharmacokinetics (DM&PK) Department’s representative for various
research working groups and development project teams. During this time, I gained a working knowledge of
the development activities and regulatory requirements in all areas of pharmacokinetics and metabolism, and
also, in research areas outside my own direct areas of expertise, including Preclinical and Clinical
Pharmacology, Medical, Medical Affairs, Biometrics, Pharmacy&Analytical R/D, Toxicology, and Process
Chemistry. As my role evolved, my managerial responsibilities increased. I was at various times responsible
for the following functional Groups within our Department: Clinical PK (and PD), GLP toxicokinetics,
bioanalytical (both assay development and assay conduct of preclinical and clinical samples under GLP/GCP
guidelines), clinical metabolism, and QC support. My assigned headcount over this period ranged from 15 to
45 technical personnel. In addition to providing technical leadership, I also assisted, and for a number of years
was responsible for maintaining both the operating and capital budgets for the entire Department. I had primary
management-line responsibility for overseeing the construction of a 14,400-sq. ft. research building housing 12
DM&PK bioanalytical/pharmacokinetic laboratories. I maintained administrative oversight of this building (until
it was closed on 12/31/01) which housed the Clinical PK/PD, Biomarker Development, and the Development
Support Bioanalytical Groups.

In my role at Bristol-Myers Squibb, I managed the research activities of the Clinical Pharmacokinetics,
Pharmacodynamics and Biomarker Development Groups which (in the 4Q01) consisted of 4 Ph.D. scientists,
and 11 technical (A.A., B.S., and M.S. level) and non-technical support personnel. The Clinical PK/PD Group,
in collaboration with the Clinical Pharmacology Group in the Medical Research and Development Department,
conducted all human Phase I and IIa and special study research for the following therapeutic areas:
cardiovascular, metabolic diseases, and oncology. We also supported Phase IIb and III in conjunction with the
therapeutic area clinicians within Medical R/D. My Group was responsible for writing the PK and PD sections
of the clinical protocol; coordinating laboratory assays of the biological samples for both drug/metabolite
concentrations and biomarker (pharmacodynamic) endpoint measurements; performing PK/PD data analysis;
writing the PK/PD sections of the final Clinical Study Report; and providing the Human Pharmacokinetics and
Bioavailability (Section 6) and Clinical Pharmacology (Section 8) sections of the NDA (or equivalent sections
of other regulatory submissions). I also allocated resources to support clinical research on marketed products -
- providing laboratory research and telephone support to outside investigators and personnel to make
presentations to hospital and state formulary boards and at clinical pharmacy meetings. The newly formed
Biomarker Development Group was to ultimately partner with Discovery, Preclinical and Clinical to
recommend, analytically validate, and implement existing and new biomarkers into preclinical and clinical
development programs.
In addition to my management responsibilities, I maintained an active research role (25% of my time) and at
the end of my DuPont/BMS career, I was serving as the Department’s Project Team representative for one
high-profile Phase III program (roxifiban) and for the marketed product, Coumadin. My research interests and
those which I fostered within my Group included: the identification and use of pharmacological biomarkers and
surrogate endpoints to expedite clinical develop-ment; the rational development of objective compliance markers
to better assess clinical efficacy/safety in Phase III; the use of novel prodrugs and dosage forms to enhance a
drug's clinical utility (e.g., enhanced bioavailability, sustained efficacy, etc.); the rational development of
Curriculum Vitae
H. J. Pieniaszek, Jr.

RESEARCH EXPERIENCE (Cont.)
concentration-controlled (Bayesian forecasting) or effect-controlled clinical trials; and the use of population PK
approaches to define product labeling.

From a pharmaceutical development standpoint, the ultimate milestone is submission and approval of
regulatory documents to support marketing of new chemical entities. In this regard, I have either written or
have had first-line management responsibilities for the drug metabolism/pharmacokinetics sections for IND
and ERC (preclinical, seven drugs), 510K Investigational Plan (one device), NDA (four drugs), NDS (five
drugs), and MAA (three drugs) submissions. All of the NDA/NDS/MAA submissions ultimately were
approved for marketing of the drugs. I have extensive knowledge of the requirements involved in the
submission of documents to regulatory authorities and I personally have interacted on numerous occasions
with regulatory agencies, specifically the Clinical Pharmacology and Biopharmaceutics, Antiviral, Cardio-
Renal, Neuropharmacology, Oncology, Pulmonary, and Gastrointestinal and Coagulation Offices or Divisions;
the former Pilot Drug Division and the Office of Generic Drugs at CDER (drugs, FDA); CDRH (devices,
FDA); and various branches at the HPB; and also with representatives from NCI and NIDA. Finally, either I
or a principle investigator within my Group was usually asked to participate in the due-diligence process for
in- or out-licensing of drug candidates. I personally was involved in the in-licensing process for DuPont
Pharmaceutical’s most recent success, Innohep (Leo), which was ultimately approved for U.S. marketing in
2000.
Currently, I am a consultant and service provider to several large and small pharmaceutical companies and CROs
in the areas of preclinical and clinical pharmacology, pharmacokinetics, pharmacodynamics, metabolism, and
overall clinical and pharmaceutical development. Additionally, I have established a network of pharmaceutical
contractors and niche clinical and bioanalytical CROs to assist me as extended service providers to my clients.
My work is quite diverse and ranges from assisting in the completion of a pediatric trial with an anti-
thrombotic agent (my specific role was in the biomarker assay validations, the population PK/PD analysis, and
the CSR and manuscript preparations) to formulating Clinical Pharmacology development plans and protocols
for several potential CNS, Oncology, and Metabolic Disease drug candidates. Currently for four companies, I
function as a drug development specialist and I review and edit internally and externally generated protocols
and reports, work with management to assist in go/no go decisions, and in the case of a CRO, work directly
with their clients to provide solutions to their development issues. I have re-written a package insert for a
cardiovascular combination product that is being studied for a new indication and I have written a several
pharmacokinetic CSRs (anti-cancer and antibiotic), and a Section 6 of the NDA for an antimicrobial/anti-
inflammatory agent. I have performed due diligence on four in-licensing compounds and or drug delivery
systems for there different pharmaceutical companies. I have assisted another pharmaceutical group with the
start-up activities for an immunoassay/ biomarker/forensic toxicology facility (including evaluation and
purchase of existing companies). I recently negotiated the sale of a LC/MS-MS bioanalytical CRO for which I
was Chairman of the Board. I am currently serving on an external expert panel for a Citizen’s Petition
submitted to the FDA. Finally, I have served as the plaintiff’s expert witness for litigation involving a
proprietary drug company and a CRO and in another case, as the pharmaceutical expert in a Paragraph 4 patent
challenge.
Curriculum Vitae
H. J. Pieniaszek, Jr.

SIGNIFICANT INDUSTRIAL ACCOMPLISHMENTS
1)
Regulatory Approvals
NDA/MAA/NDS
Innohep (tinzaparin sodium, low molecular weight heparin): NDA (7/00).
Sustiva (efavirenz, anti-HIV agent): NDA (9/98), NDS (3/99), MAA (UK, 4/99).
Bianda (losoxantrone, anticancer): NDS (2/96).
ReVia (naltrexone•HCl): sNDA (alcohol indication, 12/94), NDS (opiate and alcohol
indications, 12/95), MAA (for either the combined or additional alcohol indication: Austria, 4/96; Pakistan, 8/96; France and Israel, 9/96; Denmark, 10/96; Finland, 11/96; Columbia, Eire and Ireland, 12/96); and 21 other worldwide approvals since 1996. − Ethmozine (moricizine•HCl, antiarrhythmic): NDA (6/90), MAA (UK and France, 12/91;
− selegiline (8/96, one of the first two initial FDA approvals). − captopril (2/96, one of many initial FDA approvals). − glipizide (11/94). − cimetidine (5/94, one of the ‘first’ three initial FDA approvals).
2)
Developed, negotiated, and implemented a very effective and novel research working relationship between
Clinical Pharmacokinetics and Medical Research at DuPont Pharmaceuticals. These efforts resulted in my 1990 Director’s Corporate Award.
3) Championed the initial implementation of laboratory automation (i.e., robotics) and automated information
management (i.e., PK-IMS and CDAS) within the Drug Metabolism and Pharmacokinetics Section.
4)
Championed the concept that research timeliness and quality are not incongruent. Responsibilities initially
included the conduct of all GLP and GCP studies within the Section; also provided resources to develop and write SOPs, to do periodic laboratory audits, and to audit all study data slated for regulatory submissions.
5) Championed the identification and use of pharmacological biomarkers and/or surrogate endpoints to
expedite clinical development. A project related to this concept resulted in my 1999 Corporate Summit Award. Curriculum Vitae
H. J. Pieniaszek, Jr.

PROFESSIONAL AND ACADEMIC AFFILIATIONS AND ACTIVITIES

Adjunct Professor, Department of Pharmacy Practice and Science, College of Pharmacy, University of Arizona, 1997-present Fellow, AAPS, American Association of Pharmaceutical Scientists (member since 1986; elected to
Fellow status, 1999)

Elected to serve as AAPS Vice-Chair, Clinical Sciences Section, 1999
Nominated as Chair-Elect, AAPS Fellows Final Selection Committee, 2005.
− Co-recipient of AAPS Special Recognition Award for Service to the Clinical Sciences Section, 2004.
− Past Chair, Clinical Sciences (CS) Section, 2003
Chair, CS Section, 2002
− Chair-Elect, Clinical Sciences Section, 2001
− AAPS Fellows Final Selection Committee, 2001, 2002, and 2003
− AAPS (PPDM Section/CS Section /Lilly sponsored) Graduate Student Symposium in PK, PD, and
Clinical Sciences, Award Selection Committee, 2001 and 2002 − Annual Meeting (Denver, 10/01) Program Steering Committee, 2000-2001 − AAPS New Investigator Grant In PK, PD, and Drug Metabolism, Selection Committee Chair, 2002 − CS Section sponsored AAPS Annual Meeting Graduate Travel Awards, Selection Committee Co- − AAPS Research Achievement Award in Clinical Sciences, Selection Committee Co-Chair, 2003 Member, ACS, American Chemical Society, since 1975 Fellow, ACCP, American College of Clinical Pharmacology (member since 1991; elected to Fellow,
1993)

Elected to serve on ACCP Board of Regents, 1999-2004.
Member of Editorial Board for Journal of Clinical Pharmacology, since 1997
− Annual Meeting (San Francisco, 9/01) Program Committee, 2001-2002 − Membership Retention Committee, member: 1999-present; Co-Chair: 2000-2004 − Publications Committee, member: 2003-present, Member, IATDM-CT, International Association of Therapeutic Drug Monitoring and Clinical Toxicology, since 1993 Member, ISSX, International Society for the Study of Xenobiotics, 1984-2001
JOURNAL REVIEWER/REFEREE


Journal of Pharmaceutical Sciences (1983 - present) Pharmaceutical Research (1984 - present) Journal of Clinical Pharmacology (1994 - present); Editorial Board member (since 8/97)
Journal of Pharmaceutical and Biomedical Analysis (1995 - present) Drug Metabolism and Disposition (1996 - present) Biopharmaceutics and Drug Disposition (1997 - present) Curriculum Vitae
H. J. Pieniaszek, Jr.

STUDENT INTERNS AND POST-DOCTORAL FELLOWS SPONSORED/MENTORED AT DUPONT
PHARMACEUTICALS (1983-1997)
Name Affiliation Dates

of Present Major
Projects
Internship Occupation

Kevin A. McNamara

Darlene M. Eberhardt
Curriculum Vitae
H. J. Pieniaszek, Jr.


INVITED PRESENTATIONS
“Principles of Pharmacokinetics and Toxicokinetics for the Industrial Scientist”, Course and Workshop Guest
Lecturer, Primary Instructors: Drs. Michael Mayersohn and Harold Boxenbaum, sponsored by The Univeristy of
Arizona College of Pharmacy, The Westin La Paloma Resort & Spa, Tucon, AZ, April 18-22, 2005.

“Utility of Biomarkers in Clinical Drug Development”, invited symposium speaker, American Association of
Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition, Salt Lake City, Utah, October 26-30, 2003;
also invited speaker at the Department of Pharmacy Practice and Science, College of Pharmacy, University of
Arizona, October 31, 2003.
“The Role and Impact of Clinical Pharmacokinetics and Pharmacodynamics in Drug Development”, Amgen, Inc.,
Thousand Oaks, CA, November 22, 2002; MicroConstants, Inc, San Diego, CA, February 6, 2003.
“CRO Partnerships with the Pharmaceutical Industry in Expediting Drug Development”, symposium organizer
and co-moderator, American College of Clinical Pharmacology (ACCP) 31st Annual Meeting, San Francisco, CA,
September 21-23, 2002.
“Utility of Various Commercial Software Packages to Expedite Clinical Drug Development”, symposium
organizer and co-moderator, American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and
Exposition, Denver, CO, October 21-25, 2001.
“Recent Clinical Experiences Using Biomarkers at DuPont Pharmaceuticals”, DuPont Pharmaceuticals
Surrogate Marker Forum, Pharmaceutical R&D Department, Wilmington, DE, April 24, 2000.

“The Impact of Clinical Pharmacokinetics on Drug Development”, DuPont Pharmaceuticals, Pharmaceutical
R&D Department, Wilmington, DE, February 14, 2000.

Analytical Method Validation and Transfer” Short Course, Co-instructor with Dr. Thomas Rosanske
(Quintiles), 10th International Symposium on Pharmaceutical and Biomedical Analysis, Washington, DC,
May 9, 1999.
“Analytical and Bioanalytical Method Validation” Short Course, Co-instructor with Dr. Thomas Rosanske
(Hoechst Marion Roussel), 8th International Symposium on Pharmaceutical and Biomedical Analysis,
Kissamee, FL, May 4, 1997.
“The Evolving Functional Role of Drug Metabolism and Pharmacokinetics in the Drug Development Process”,
Department of Pharmacy Practice and Science, College of Pharmacy, University of Arizona, Tucson, AZ,
April 3, 1997.

“Bioanalytical Method Development and Validation: An Evolutionary Process during Preclinical and Clinical
Drug Development”, Eastern Analytical Symposium and Exposition, Somerset, NJ, November 19, 1996.
“Bioanalytical Method Validation of Drugs and Metabolites in Biological Fluids”, Method Validation
Workshop, The DuPont Merck Pharmaceutical Company, Wilmington, DE, October 30, 1995.
Curriculum Vitae
H. J. Pieniaszek, Jr.

INVITED PRESENTATIONS (Cont.)
“Role of Drug Metabolism and Pharmacokinetics in Drug Development”, Delaware State College, Department
of Biological Sciences, Dover, DE, April 27, 1995.

"Industrial Approaches to Solving Pharmaceutical Problems", University of Georgia, College of Pharmacy,
Department of Pharmaceutics, Athens, GA, March 10, 1989.



Curriculum Vitae
H. J. Pieniaszek, Jr.


PUBLICATIONS (*senior and/or corresponding author)
Kuhle, S., Massicotte, P., Dinyari, M., Vegh, P., Mitchell, D., Marzinotto, V.,. Chan, A, Pieniaszk, H., Mitchell,
L.G.: Dose-finding, Pharmacokinetics and Safety of Therapeutic Doses of Tinzaparin in Pediatric Patients with
Thromboembolic Events, Submitted, Thrombosis and Haemostasis, in press.
Adams, M.; Pieniaszek, H. J., Jr, Gammaitoni, A.R., Ahdieh, H.: Oxymorphone Extended Release Does Not
Affect CYP2C9 or CYP3A4 Metabolic Pathways. J. Clin. Pharmacol., 45, 337-345 (2005).

Murphy, J., Wright, R. S., Gussak, I., Williams, B., Daly, R. N., Cain, V. A., Pieniaszek, H. J., Sy, S.K.B.,
Ebling, W., Simonson, K., Wilcox, R. A., and Kopecky, S. L.: The use of roxifiban (DMP 754), a novel oral
platelet glycoprotein IIb/IIIa receptor inhibitor, in patients with stable coronary artery disease. Am. J.
Cardiovasc. Drugs, 3(2), 101-112 (2003).
Shi, G., Lloyd, T. L., Sy, S. K. B., Jiao, Q., Wernicki, A., Mutlib, A., Emm, T. A., Unger, S. E., and Pieniaszek,
H. J., Jr.
: Simultaneous quantification of seven active metabolites of roxifiban in human plasma by LC/MS/MS
in the presence of an interfering displacer at millimolar concentrations . J. Pharm. Biomed. Anal., 31(5), 937-951
(2003)
Pieniaszek, H. J., Jr.*, Davidson, A. F., Walton, H. L., Pinto, D. J., Olson, R. E., Reilly, T.M., and Barrett, Y.
C.: A double antibody radioimmunoassay for the determination of XV459, the active hydrolysis metabolite of
roxifiban, in human plasma. J. Pharm. Biomed. Anal., 30(5), 1441-1449 (2003).
Seiffert, D., Stern, A. M., Ebling, W., Rossi, R. J., Barrett, Y. C., Wynn, R., Hollis, G. F., He, B., Kieras, C. J.,
Pedicord, D. L., Cromley, D. A., Hua, T. A., Stein, R. B., Daly, R. N., Sferruzza, A., Pieniaszek, H. J., and
Billheimer, J. T.: Prospective testing for drug-dependent antibodies reduces the incidence of
thrombocytopenia observed with the small molecule glycoprotein IIb/IIIa antagonist roxifiban: implications for
the etiology of thrombocytopenia. Blood, 101(1), 58-63 (2003) [pre-published online as Blood First Edition
paper, June 28, 2002; DOI 10.1182/blood-2002-02-0471].
Fossler, M. J., Ebling, W. F., Ma, S., Kornhauser, D., Mondick, J., Garner, D., Quon, C. Y., and Pieniaszek,
H. J., Jr.
: Pharmacokinetics and pharmacodynamics of XV459, a potent and specific GP IIb/IIIa inhibitor, in
healthy male volunteers. J. Clin. Pharmacol., 42(12), 1326-1334 (2002)
Barrett, J. S., Joshi, A. S., Chai, M., Ludden, T. M., Fiske, W. D., and Pieniaszek, H. J.: Population
pharmacokinetic meta-analysis with efavirenz. Inter. J. Clin. Pharmacol. Ther., 40(11), 507-519 (2002).
Pieniaszek, H. J., Jr.*, Sy, S. K. B., Ebling, W., Fossler, M .J., Cain, V. A., Mondick, J. T., Ma, S., and
Kornhauser, D. M.: Safety, tolerability, pharmacokinetics and time-course of pharmacologic response of the
active metabolite of roxifiban, XV459, a potent GP IIb/IIIa antagonist, following oral administration in healthy
volunteers. J. Clin. Pharmacol., 42(7), 738-753 (2002).

Pieniaszek, H. J.*
: Products approved in the United States for marketing during 2000 (invited editorial). J.
Clin. Pharmacol., 41(5), 479-481 (2001).
Curriculum Vitae
H. J. Pieniaszek, Jr.

PUBLICATIONS (cont.)
Barrett, J. S., Hainer, J. W., Kornhauser, D. M., Gaskill, J. L., Hua, T. A., Sprogel, P., Johansen, K., van Lier, J.
J., Knebel, W., Pieniaszek, H. J., Jr.: Anticoagulant pharmacodynamics of tinzaparin following 175 IU/Kg
subcutaneous administration to healthy volunteers. Throm. Res., 101(4), 243-254 (2001).

Joshi, A. S., Pieniaszek, H. J., Jr., Vokes, E. E., Vogelzang, N. J., Davidson, A. F., Richards, L. E., Chai, M.
F., Finizio, M., and Ratain, M. J.: Elimination pathways of [14C]losoxantrone in four cancer patients. Drug
Metab. Dispos., 29(2), 96-99 (2001).

Barrett, J. S., Yu, J., Kapil, R., Padovani, P., Brown, F., Ebling, W. F., Corjay, M. H., Reilly, T. M., Bozarth, J.
M., Mousa, S. A., and Pieniaszek, H. J., Jr.: Disposition and exposure of the fibrinogen receptor antagonist
XV459 on αЦ Ββ3 binding sites in the guinea pig. Biopharm. Drug Disposition, 20(6), 309-318 (1999).

Pieniaszek, H. J., Jr.*, Davidson, A. F., Chaney, J. E., Shum, L., Robinson, C. A., and Mayersohn, M.:
Human moricizine metabolism: II. Quantification and pharmacokinetics of plasma and urinary metabolites.
Xenobiotica, 29(9), 945-955 (1999).

Pieniaszek, H. J., Jr.*
, Mayersohn, M., Adams, M. P., Reinhart, R. J., and Barrett, J. S.: Moricizine
bioavailability via simultaneous, dual, stable isotope administration: Bioequivalence implications. J. Clin.
Pharmacol., 39(8), 817-825 (1999).
Lai, C.-M., Garner, D. M., Gray, J. E., Brogdon, B. L., Peterman, V. C., and Pieniaszek, H. J., Jr.*:
Determination of bisnafide, a novel bis-naphthalimide anticancer agent, in human plasma by high-performance
liquid chromatography with UV detection. J. Pharm. Biomed. Anal., 17(3), 427-434 (1998).

O’Reilly, S., Baker, S. D., Sartorius, S., Rowinsky, E. K., Finizio, M., Lubiniecki, G. M., Grochow, L. B.,
Gray, J. E., Pieniaszek, H. J., Jr., and Donehower, R. C.: A Phase I and pharmacologic study of DMP 840
administered by 24-hour infusion. Ann. Oncol., 9(1), 101-104 (1998).

Hainer, J. W., Hunninghake, D. B., Benedek, I. H., Broyles, F. E., Garner, D. M., Jenkins, R. M., McGinn, A.,
Pieniaszek, H. J., Jr., London, E., and Gillies, P. J.: DMP 504, a novel hydrogel bile acid sequestrant: III.
Safety, tolerability, and cholesterol-lowering in healthy hypercholesterolemic subjects. Drug Develop. Res.,
41(2), 76-84 (1997).
Richards, L. E., Pieniaszek, H. J., Jr.*, Shatzmiller, S., Page, G. O., Blom, K. F., Read, J. M., Davidson,
A. F., and Confalone, P. N.: Human moricizine metabolism: I. Isolation and identification of metabolites in
human urine. Xenobiotica, 27(2), 217-229 (1997).

Shum, L., Pieniaszek, H. J., Jr.*, Robinson, C. A., Davidson, A. F., Widner, P. J., Benedek, I. H., and
Flamenbaum, W.: Pharmacokinetic interactions of moricizine and diltiazem in healthy volunteers. J. Clin.
Pharmacol., 36(12), 1161-1168 (1996).
Davidson, A. F., Emm, T. A., and Pieniaszek, H. J., Jr.*: Determination of naltrexone and its major
metabolite, 6-β-naltrexol, in human plasma using liquid chromatography with electrochemical detection.
J. Pharm. Biomed. Anal., 14(12), 1717-1725 (1996).
Curriculum Vitae
H. J. Pieniaszek, Jr.

PUBLICATIONS (cont.)

Benedek, I. H., Joshi, A. S., Pieniaszek, H. J., Jr., King, S.-Y. P., and Kornhauser, D. M.: Variability in the
pharmacokinetics and pharmacodynamics of low dose aspirin in healthy male volunteers. J. Clin. Pharmacol.,
35(12), 1181-1186 (1995).

King, S-Y. P., Joslin, M. A., Raudibaugh, K., Pieniaszek, H. J., Jr., and Benedek, I. H.: Dose-dependent
pharmacokinetics of warfarin in healthy volunteers. Pharm. Res., 12(12), 1874-1877 (1995).
Pieniaszek, H. J., Jr.*, Fiske, W. D., Saxton, T. D., Kim, Y. S., Garner, D. M., Xilinas, M., and Martz, R.:
Single-dose pharmacokinetics, safety, and tolerance of linopirdine (DuP 996) in healthy young adults and
elderly volunteers. J. Clin. Pharmacol., 35(1), 22-30 (1995).
Gray, J. E., Noll, G. A., Davidson, A. F., Robinson, C. A., Peterman, V. C., Diamond, S., Pieniaszek, H. J.,
Jr.
, and Quon, C. Y.: The design, construction, testing, and implementation of a laboratory data management
system. In: Little, J. N., O’Neil, C., Strimaitis, J. R. eds. Proceedings of the International Symposium on
Laboratory Automation and Robotics 1994. Hopkinton: Zymark Corporation, 308-320 (1995).
King, S-Y. P., Agra, A. M., Shen, H-S. L., Chi, C. L., Adams, D. B., Currie, V. E., Bertino, J. R., Pieniaszek,
H. J., Jr.,
and Quon, C. Y.: Protein binding of brequinar in the plasma of healthy donors and cancer patients
and analysis of the relationship between protein binding and pharmacokinetics in cancer patients. Cancer
Chemother. Pharmacol., 35(2), 101-108 (1994).
Garner, D. M., Pieniaszek, H. J., Jr., Connell, J. M., and Fiske, W. D.: Determination of linopirdine and its
mono-N-oxide metabolite in human plasma and urine by high-performance liquid chromatography. J. Liquid
Chromatogr., 17(20), 4541-4555 (1994).

Lai, C. M., Brogdon, B., Quon, C. Y., and Pieniaszek, H. J., Jr.: Determination of DuP 128, an ACAT
inhibitor and its sulphoxide and sulphone metabolites in human plasma by liquid chromatography. J. Pharm.
Biomed. Anal., 12(9), 1163-1172 (1994).
Joshi, A. S., Pieniaszek, H. J., Jr., Quon, C. Y., and King, S-Y. P.: Plasma protein binding of highly bound
drugs: Implications of radiochemical impurities. J. Pharm. Sci., 83(8), 1187-1188 (1994).

Pieniaszek, H. J., Jr.*
, Davidson, A. F., Mc Entegart, C. M., Quon, C. Y., Sampliner, R. E., and Mayersohn,
M.: The effect of hepatic disease on the disposition of moricizine in humans. Biopharm. Drug Disposition,
15, 243-252 (1994).
Benedek, I. H., Davidson, A. F., and Pieniaszek, H. J., Jr.*: Enzyme induction by moricizine: Time course
and extent in healthy subjects. J. Clin. Pharmacol., 34(2), 167-175 (1994).
Gray, J. E., Peterman, V., Newton, R., King, S-Y. P., and Pieniaszek, H. J., Jr.: ELISA determination and
preliminary pharmacokinetics of modified human rIL-1 β in dogs. Res. Commun. Chem. Pathol. Pharmacol.,
81(2), 233-241 (1993).
Curriculum Vitae
H. J. Pieniaszek, Jr.

PUBLICATIONS (cont.)
Pieniaszek, H. J., Jr.*, Davidson, A. F., and Benedek, I. H.: Effect of moricizine on the pharmacokinetics of
single-dose theophylline in healthy subjects. Ther. Drug Monit., 15(3), 199-203 (1993).
Benedek, I. H., King, S-Y. P., Powel, R. J., Agra, A. M., Schary, W. L., and Pieniaszek, H. J., Jr.: Effect of
moricizine on the pharmacokinetics and pharmacodynamics of warfarin in healthy volunteers. J. Clin.
Pharmacol., 32(6), 558-563 (1992).
Pieniaszek, H. J., Jr.*, McEntegart, C. M., Mayersohn, M., and Michael, U. F.: Moricizine pharmacokinetics
in renal insufficiency: Reevaluation of elimination half-life. J. Clin. Pharmacol., 32(5), 412-414 (1992).
King, S-Y. P., Powel, R. J., Wong, Y. N., Davidson, A. F., Vincent, D. R., Quon, C. Y., and Pieniaszek, H. J.,
Jr.
: Effects of multiple doses of moricizine hydrochloride on its pharmacokinetics and hepatic microsomal
enzymes in rats. Res. Commun. Chem. Path. Pharmacol., 75(3), 259-274 (1992).

Pieniaszek, H. J., Jr.*, Rakestraw, D. C., Schary, W. L., and Williams, R. L.: Influence of food on the oral
absorption and bioavailability of moricizine. J. Clin. Pharmacol., 31(9), 792-795 (1991).
Benedek, I. H., Garner, D. M., and Pieniaszek, H. J., Jr.: Dose proportionality of moricizine after escalating
multiple doses in healthy volunteers. J. Clin. Pharmacol., 31(3), 229-232 (1991).

Pieniaszek, H. J., Jr.*
, Shen, H-S. L., Garner, D. M., Page, G. O., Shalaby, L. M., Isensee, R. K., and
Whitney, C. C., Jr.: Determination of unlabeled and 13C6-labeled moricizine in human plasma using
thermospray liquid chromatography-mass spectrometry. J. Chromatogr., 493, 79-92 (1989).
Howrie, D. L., Pieniaszek, H. J., Jr.*, Fogoros, R. N., Juhl, R. P., Schary, W. L., Whitney, C. C., Jr., and
Dittert, L. W.: Disposition of moracizine (Ethmozine) in healthy subjects after oral administration of
radiolabelled drug. Eur. J. Clin. Pharmacol., 32, 607-610 (1987).

MacFarland, R. T., Moeller, V. R., Pieniaszek, H. J., Jr., Whitney, C. C., Jr., and Marcus, F. I.: Assessment
of the potential pharmacokinetic interaction between digoxin and Ethmozine. J. Clin. Pharmacol., 25(2), 138-
143 (1985).

Goldman, S., Olajos, M., Pieniaszek, H., Perrier, D., Mayersohn, M., and Morkin, E.: Beta adrenergic
blockade with propranolol in conscious euthyroid and thyrotoxic calves: Dosage requirements and effects on
heart rate and left ventricular performance. J. Pharmacol. Exp. Ther., 219(2), 394-399 (1981).
Hager, W. D., Pieniaszek, H. J., Jr., Perrier, D., Mayersohn, M., and Goldberger, V.: Assessment of beta
blockade with propranolol. Clin. Pharmacol. Ther., 30(3), 283-290 (1981).

Pieniaszek, H. J., Jr.
and Bates, T. R.: Capacity-limited gut wall metabolism of 5-aminosalicylic acid, a
therapeutically active metabolite of sulfasalazine, in rats. J. Pharm. Sci., 68(10), 1323-1325 (1979)
Curriculum Vitae
H. J. Pieniaszek, Jr.

PUBLICATIONS (cont.)
Pieniaszek, H. J., Jr.
, Resetarits, D. E., Wilferth, W. W., Blumenthal, H. P., and Bates, T. R.: Relative
systemic availability of sulfapyridine from commercial enteric-coated and uncoated sulfasalazine tablets. J.
Clin. Pharmacol., 19(1), 39-45 (1979).
Bates, T. R. and Pieniaszek, H. J., Jr.: A modified colorimetric assay for free and N4-acetylated sulfapyridine
in serum and saliva after sulfasalazine administration. Anal. Letters, B11(9), 709-720 (1978).
Owerbach, J., Johnson, N. F., Bates, T. R., Pieniaszek, H. J., Jr., and Jusko, W. J.: High-performance liquid
chromatographic assay of sulfapyridine and acetylsulfapyridine in biological fluids. J. Pharm. Sci., 67(9),
1250-1253 (1978).
Bates, T. R., Blumenthal, H. P., and Pieniaszek, H. J., Jr.: Salivary excretion and pharmacokinetics of
sulfapyridine after sulfasalazine. Clin. Pharmacol. Ther., 22(6), 917-927 (1977).

Bates, T. R., Pieniaszek, H. J., Jr., Sequeira, J. A. L., and Rasmussen, J. E.: Gastrointestinal absorption of
griseofulvin from corn oil-in-water emulsions -- Effect of amount of corn oil ingested in man.
Arch. Dermatol., 113, 302-306 (1977).
Bates, T. R., Blumenthal, H. P., and Pieniaszek, H. J., Jr.: Time course of free and N4-acetylated
sulfapyridine concentrations in the plasma and saliva of man after sulfasalazine (salicylazosulfapyridine)
administration: preliminary findings. Res. Commun. Chem. Pathol. Pharmacol., 15(1), 183-189 (1976).
Pieniaszek, H. J., Jr. and Bates, T. R.: Cholestyramine-induced inhibition of salicylazosulfapyridine
(sulfasalazine) metabolism by rat intestinal microflora. J. Pharmacol. Exp. Ther., 198(1), 240-245 (1976).
Pieniaszek, H. J., Jr. and Bates, T. R.: Colorimetric determination of 5-aminosalicylic acid and its N-
acetylated metabolite in urine and feces. Res. Commun. Chem. Pathol. Pharmacol., 12(3), 571-581 (1975).
Joshi, A. S., Barrett, J. S., Chai, M., Brennan, J. M., White, S. J., Fiske, W. D., Ludden, T. M., and Pieniaszek, H.
J.
: Population pharmacokinetics of efavirenz in dose finding studies in HIV-infected patients. Submitted, Inter. J.
Clin. Pharmacol.
Pieniaszek, H. J., Jr.*, Davidson, A. F., Garner, D. M., Cox, D. S, Billheimer, J. T., Lam, G. N., and Hainer, J.
W.: The analytical validation and clinical evaluation of 7α-hydroxy-4-cholesten-3-one, a biomarker of LDL-
cholesterol lowering for bile acid sequestrants. In preparation.
Pieniaszek, H. J., Jr.*, Davidson, A. F., Labriola, D. F., Wroblewski, J. M., Barrett, J. S, and Croop, R. S.: The
clinical utility of an objective patient compliance measure in pivotal trials with naltrexone. In preparation.
Pieniaszek, H. J., Jr.*, Garner, D. M., Croop, R. S., Chien, B. M., Davidson, A. F., and Ebling, W. E.: Clinical
utility of a rapid, sensitive, and robust LC/MS/MS plasma assay method coupled with a Bayesian forecast model
to control DMP 543 plasma concentrations in Alzheimer’s patients during Phase IIa clinical trials. In preparation.
Curriculum Vitae
H. J. Pieniaszek, Jr.


PUBLICATIONS (cont.)

Pieniaszek, H. J., Jr.*, Davidson, A. F., and Aungst, B. J.: Interspecies differences in the disposition and oral
bioavailability of nalbuphine and its anthranilate ester prodrug in humans, dogs, and rats. In preparation.
Sy, S. K. B., Pieniaszek, H. J., Jr.*, Aungst, B. J., Ebling, W. E., and Kornhauser, D.M.: Possible role of the
peptide transporter in the roxifiban food interaction. In preparation.
Curriculum Vitae
H. J. Pieniaszek, Jr.

ABSTRACTS

Kuhle, S., Massicotte, M. P., Dinyari, M., Marzinotto, V., Mitchell, D., Pieniaszek, H., Andrew, M., Chan, A. K.
C., Vegh, P., Mitchell, L: A pharmacokinetic study of tinzaparin in pediatric patients. J. Thrombosis
Haemostasis, 1 Supplement 1, July (2003), abstract number P1886.

Goldberg, S., Kletzel, M., Pineiro, L., Pieniaszek, H.J. Pharmacokinetics and Tolerability of EN3247 0.1%
Triclosan Antimucositic Oral Solution in Patients with Mucositis. Phase 3 Results. Proc. Am. Soc. Hem., 102(11),
436b (2003), Abstract #5471.
Davidson, A. F., Pieniaszek, H. J., Jr., Brennan, J. M., Fiske, W. D., Richards, L. E., Du, Y. A., Benedek, I. H.,
and Kornhauser, D. M.: Disposition of efavirenz in healthy subjects following oral administration of radiolabeled
drug. 2001 AAPS Annual Meeting, AAPS PharmSci.; 3(4), (2001). Available from:
www.aapspharmaceutica.com/scientificjournals/.
Mondick, J. T., Fossler, M. J., Sy, S. K. B., Ebling, W. F., Garner, D. M., Kornhauser, D. M., Daly, R. N.,
Kopecky, S. L., Pieniaszek, H. J., Jr.: Comparative pharmacokinetics (PK) and pharmacodynamics (PD) of
roxifiban, a potent and specific platelet GPIIb/IIIa antagonist in patients with chronic stable coronary artery
disease (CAD) and in healthy subjects. J. Clin. Pharmacol., 41(9), 1023 (2001).
Pieniaszek, H. J., Jr., Davidson, A. F., Walton, H. L., Olson, R. E., Barrett, Y. C.: Validation and clinical utility
of a double antibody radioimmunoassay (RIA) for the determination of XV459, the active moiety of roxifiban
(DMP 754), a glycoprotein (GP) IIb/IIIa antagonist. J. Clin. Pharmacol., 41(9), 1023 (2001).
Barrett, J. S., Davidson, A. F., Jiao, Q. T., Mosqueda-Garcia R., Kornhauser, D. M., Gangrade, N. K., Jona, J. A.,
and Pieniaszek, H. J., Jr.: The effect of food, formulation, and dosing duration on the pharmacokinetics of
DPC 423, a potent Factor Xa Inhibitor. J. Clin. Pharmacol., 41(9), 1023 (2001).
Fossler, M. J., Ebling, W. F., Kornhauser, D., Ma, S., Mondick, J. T., Charnick, S. B., Barrett, J. S., Garner,
D. M., Koprowski, S. P., Quon, C. Y., and Pieniaszek, H. J., Jr.: Pharmacokinetics (PK) and pharmaco-
dynamics (PD) of roxifiban (DMP 754) in healthy male volunteers. J. Clin. Pharmacol., 40(9), 1059 (2000).
Barrett, J. S., Kornhauser, D. M., Hainer, J. W., Gaskill, J., Hua, T. A., Sprogel, P., Johansen, K., van Lier, J. J.,
Knebel, W., and Pieniaszek, H. J.: Anticoagulant pharmacodynamics of tinzaparin following 175 IU/kg
subcutaneous administration in healthy volunteers. Int. J. Hematol., 72(1), 147 (2000).
Barrett, J. S., Kornhauser, D. M., Hainer, J. W., Gaskill, J., Pieniaszek, H. J., Sprogel, P., Johansen, K., Knebel,
W., and Pentikis, H. S.: Effect of molecular weight distribution on the pharmacodynamics of tinzaparin healthy
volunteers. 1999 AAPS Annual Meeting, AAPS PharmSci.; 1(4), (1999). Available from:
www.aapspharmaceutica.com/scientificjournals/.
Curriculum Vitae
H. J. Pieniaszek, Jr.

ABSTRACTS (cont.)

Pieniaszek, H. J., Jr., Garner, D. M., Klingerman, C. A., Ebling, W. F., and Kornhauser, D. M.:
Pharmacokinetics (PK), safety, and tolerance of DMP 543, a potential cognitive enhancer, in older male
subjects after multiple oral doses. 1999 AAPS Annual Meeting, AAPS PharmSci.; 1(4), (1999). Available
from: www.aapspharmaceutica.com/scientificjournals/.
Garner, D. M., Pieniaszek, H. J., Jr., Croop, R. S., Chien, B. M., Davidson, A. F., and Ebling, W. F.: Clinical
utility of a rapid, sensitive, and robust LC-MS/MS plasma assay method coupled with a Bayesian forecast
model to control DMP 543 plasma concentrations in Alzheimer’s patients during phase IIa clinical trials. 1999
AAPS Annual Meeting, AAPS PharmSci.; 1(4), (1999). Available from:
www.aapspharmaceutica.com/scientificjournals/.
Barrett, J. S., Yu, J., Kapil, R., Padovani, P., Brown, F., Ebling, W. F., Corjay, M. H., Reilly, T. M., Bozarth,
J. M., Mousa, S. A., and Pieniaszek, H. J., Jr.: Disposition and exposure of GPIIb/IIIa antagonist, XV459, on
αΠВβ3 binding sites in the guinea pig. J. Clin. Pharmacol., 39(9), 983 (1999).

Ebling, W. F., Kornhauser, D. M., Ma, S., Oliver, J. S., and Pieniaszek, H. J., Jr.: The influence of food and
fasting duration on the pharmacokinetics and pharmacodynamics of roxifiban, a glycoprotein IIb/IIIa
antagonist. J. Clin. Pharmacol., 39(9), 983 (1999).

Joshi, A. S., Barrett, J. S., Fiske, W. D., Pieniaszek, H. J., Ludden, T. M., Bacheler, L. T., and Ruiz, N. M.:
Population pharmacokinetics of efavirenz in phase II studies and relationship with efficacy. Thirty-Ninth
Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), p 35 (#1201), San Francisco,
CA, September 26 – 29 (1999).
Daly, R., Ebling W., Pieniaszek, H., Cain, V., Kopecky, S., and Murphy, J.: Roxifiban, a new oral IIb/IIIa
glycoprotein receptor antagonist, in patients with coronary artery disease. The Lancet Conference, “The
Challenge of Acute Coronary Syndromes”, p 58 (#66), Copenhagen, Denmark, June 10 – 11 (1999).

Davidson, A. F., Ebling, W. F., Pieniaszek, H. J., Jr., Ma, S., Daly, R. N., Jennings, L. K., and Berkowitz,
S. D.: The design and utility of a pre-study proficiency kit for multi-center clinical trials performing platelet
aggregation. J. Clin. Pharmacol., 38(9), 871 (1998).
Morehead, W. T., Lewis, R. K., Buehler, J. D., Fiske, W. D., Pieniaszek, H. J., Jr., Finan, W. L., Hussain,
M. A., Rowe, S. M., and Maurin, M. B.: Effect of formulation on the oral bioavailability of DMP 266 in dogs.
Pharm. Res., 14(11), S-251 (1997).
Pieniaszek, H. J., Jr., Garner, D. M., Klingerman, C. A., and Kornhauser, D. M.: Pharmacokinetics, safety,
and tolerability of DMP 543, a potential cognitive enhancer, in young and elderly male subjects after single
oral doses. J. Clin. Pharmacol., 37(9), 867 (1997).
Curriculum Vitae
H. J. Pieniaszek, Jr.

ABSTRACTS (cont.)

Davidson, A. F., Ebling, W. F., and Pieniaszek, H. J., Jr.: Variability in ex vivo measurements of platelet
aggregation in the clinical development of glycoprotein IIb/IIIa antagonists. J. Clin. Pharmacol., 37(9), 868
(1997).
Joshi, A. S., Pieniaszek, H. J., Jr., Richards, L. E., Davidson, A. F., Ratain, M., Cooper, N., Finizio, M., and
Vokes, E.: Disposition of losoxantrone after intravenous administration of 14C-losoxantrone to cancer patients.
J. Clin. Pharmacol., 37(9), 868 (1997).

Pieniaszek, H. J., Jr.
: Bioanalytical method development and validation: an evolutionary process during
preclinical and clinical drug development. 1995 Eastern Analytical Symposium and Exposition, p 84 (#175),
Somerset, NJ, November 17-22 (1996).
Pieniaszek, H. J., Jr., Labriola, D. F., Davidson, A. F., Wroblewski, J. M., and Croop, R. S.: The clinical
utility of an objective patient compliance measure in pivotal trials with naltrexone. Pharm. Res., 13(9), S-123
(1996).

Pieniaszek, H. J., Jr
., Garner, D. M., Davidson, A. F., Gillies, P. J., Billheimer, J. T., Jenkins, R. M., Connell,
J. M., Hua, T. A., Kieras, C. J., Lam, G. N., Benedek, I. H., and Hainer, J. W.: Plasma 7α-hydroxy-4-
cholesten-3-one (7-AHC) as an early clinical surrogate marker for LDL-cholesterol reduction following bile
acid sequestrant (BAS) administration. J. Clin. Pharmacol., 36(9), 853 (1996).
Davidson, A. F., Emm, T. A., and Pieniaszek, H. J., Jr.: Determination of naltrexone and its major
metabolite, 6-β-naltrexol, in human plasma using liquid chromatography with electrochemical detection.
Pharm. Res., 12(9), S-50 (1995).

White, S. J., Robinson, C. A., Shum, L., Kornhauser, D. M., Carter, R. J., Quon, C. Y., Pieniaszek, H. J., Jr.,
Cohen, I., Riddell, J. G., and Winslow, D. L.: Pharmacokinetics, safety, and tolerance of DMP 450 single oral
doses in healthy male subjects. J. Clin. Pharmacol., 35(9), 933 (1995).

Pieniaszek, H. J., Jr.
, Davidson, A. F., Faulkner, E. B., and Benedek, I. H.: Comparative pharmacokinetics of
naltrexone and its major metabolite, 6-β-naltrexol, in alcoholics and healthy subjects. J. Clin. Pharmacol.,
35(9), 933 (1995).
Garner, D. M., Gray, J. E., White, S. J., and Pieniaszek, H. J., Jr.: Laboratory automation within drug
metabolism and pharmacokinetics at DuPont Merck. 1995 Eastern Analytical Symposium & Exposition, p 60
(#104), Somerset, NJ, November 12-17, (1995).
Gray, J. E., Noll, G. A., Robinson, C. A., Davidson, A. F., Peterman, V. C., Pieniaszek, H. J., Jr., and Quon,
C. Y.: Developing and using a custom laboratory data management system. 1995 Eastern Analytical
Symposium & Exposition, p 60 (#105), Somerset, NJ, November 12-17, (1995).


Curriculum Vitae
H. J. Pieniaszek, Jr.

ABSTRACTS (cont.)
O’Reilly S., Rowinsky, E. K., Grochow, L., Adjei, A., Bowling, K., Slichenmyer, W., Sartorius, S., Finizio,
M., Gray, J. E., Pieniaszek, H. J., Peterman, V. C., Mabring, D., and Donehower, R. C.: Phase I and
pharmacologic study of DMP 840 as a 24 hour infusion in patients with solid tumors. Proc. of ASCO, 14, 472
(1995).
Pieniaszek, H. J., Jr., Davidson, A. F., DiLuccio, R. C., Torosian G., and Hussain M. A.: Development of a
sustained release formulation for the antiarrhythmic moricizine. Pharm. Res., 11(10), S-446 (1994).
Joshi, A. S., King, S.-Y. P., Pieniaszek, H. J., Jr., Benedek, I. H., and Kornhauser, D. M.: Inter- and
intrasubject variability in the pharmacokinetics of low dose acetylsalicylic acid (ASA) in healthy volunteers.
Pharm. Res., 11(10), S-446 (1994).
Gray, J. E., Davidson, A. F., Robinson, C., Peterman, V., Diamond, S., Pieniaszek, H. J., Jr., and Quon, C.:
The design, construction, testing and implementation of a laboratory data management system. Proc. of
International Society of Laboratory Automation and Robotics (ISLAR ’94), 308-320, Boston, MA, October.
Garner, D. M., Davidson, A. F., and Pieniaszek, H. J., Jr.: Determination of 6-β-naltrexol, a major metabolite
of naltrexone, in human urine by robotic sample preparation and high-performance liquid chromatography.
Proc. of International Society of Laboratory Automation and Robotics (ISLAR ‘94), 154-167, Boston, MA,
October.
Lai, C.-M., Brogdon, B. L., Pieniaszek, H. J., Quon, C. Y., Zyruk, H., Connell, J. M., Benedek, I. H.,
Hainer, J. W., Terry, J. G., and Crouse, J. R., III: Pharmacokinetics and pharmacodynamics of the ACAT
inhibitor DuP 128 in man. Atherosclerosis, 109(1,2), 250 (1994).

Pieniaszek, H.,
Lai, C.-M., Slichenmyer, W., Maroun, J., Cobb, P., Davidson, A., Finizio, M., Brogdon, B.,
Bunitsky, K., Sun, J-H., Sartorius, S., Grochow, L., Stewart, D., Goel, R., Burris, H., Eckardt, J., Nibbelink,
D., Quon, C., Winslow, D., Donehower, R., and Von Hoff, D.: Clinical pharmacokinetics (PK) of DMP 840, a
novel bis-naphthalimide anticancer agent. J. Clin. Pharmacol., 34(10), 1017 (1994).

Cobb, P., Burris, H., Finizio, M., Lai, C., Eckardt, J., Fields, S., Kuhn, J., Nelson, J., Bunitsky, K.,
Pieniaszek, H., Brogdon, B., and Von Hoff, D.: Phase I trial and pharmacokinetic study of a new
bis-naphthalimide, DMP 840, given daily x 5. Proc. of ASCO, 13, 159 (1994).
Maroun, J., Stewart, D., Goel, R., Goss, G., Verma, S., Yau, J., Finizio, M., Lai, C.-M., Bunitsky, K.,
Pieniaszek, H., and Brogdon, B.: Phase I pharmacokinetic study of DMP 840 given in a 3 weekly dosage in a
5 weeks schedule. Proc. of ASCO, 13, 151 (1994).
Slichenmyer, W., Finizio, M., Sartorius, S., Rowinsky, E., Lai, C.-M., Grochow, L., Pieniaszek, H., O’Reilly
S., Bunitsky, K., Brogdon, B., Mabring, D., Shifflett, C., and Donehower, R.: Phase I and pharmacologic
study of DMP 840 as a single infusion every three weeks. Proc. of ASCO, 13, 142 (1994).
Davidson, A. F., Pieniaszek, H. J., Jr., Fiske, W. D., Joshi, A. S., Cox, C. C., and King, S. P.: Comparative
plasma protein binding of moricizine. J. Clin. Pharmacol., 33(10), 1005 (1993).
Curriculum Vitae
H. J. Pieniaszek, Jr.

ABSTRACTS (cont.)
Pieniaszek, H. J., Jr.
, Shum, L., Widner, P., Garner, D. M., and Benedek, I. H.: Pharmacokinetic interaction
of moricizine and captopril in healthy volunteers. J. Clin. Pharmacol., 33(10), 1005 (1993).

Richards, L. E., Blom, K. F., and Pieniaszek, H. J., Jr.: Species differentiation in linopirdine metabolism:
Formation of a dispicolyl-pyridinium-N-glucuronide metabolite in humans. ISSX Proceedings, 4, p. 252, Fifth
North American ISSX Meeting, Tucson, Arizona, October 17-21 (1993).

Garner, D. M., Pieniaszek, H. J., Jr., King, S. P, Gray, J. E., and Quon, C. Y.: Determination of racemic
warfarin in human plasma by robotic sample preparation and high-performance liquid chromatography. Proc.
of International Symposium on Laboratory Automation and Robotics (ISLAR '93), p. 706, Boston, MA,
October 17-20 (1993).
Shum, L., White, S. J., Robinson, C. A., and Pieniaszek, H. J., Jr.: Determination of DMP 323, an HIV
protease inhibitor, in plasma, by automated solid phase extraction and HPLC with UV detection. Pharm. Res.,
10(10), S-367 (1993).
Shum, L., Robinson, C. A., and Pieniaszek, H. J., Jr.: Protein binding of DMP 323 in human, monkey, dog,
rat, and mouse plasma. Pharm. Res., 10(10), S-366 (1993).
Joshi, A. S., Pieniaszek, H. J., Jr., Quon, C. Y., and King, S-Y. P.: Plasma protein binding of highly bound
drugs: Implications of radiochemical impurities. Pharm. Res., 10(10), S-48 (1993).

Lai, C. M., Brogdon, B. L., Pieniaszek, H. J., Jr., Quon, C. Y., Connell, J. M., Benedek, I. H., Kornhauser,
D. M., and Hainer, J. M.: Pharmacokinetics of DuP 128 in humans after single oral doses. Pharm. Res., 9(10),
S-308 (1992).
Richards, L. E. and Pieniaszek, H. J., Jr.: Molecular structure-based rationale of Class I antiarrhythmic
activity. Pharm. Res., 9(10), S-104 (1992).
Pieniaszek, H. J., Jr., Young, S. M., Davidson, A. F., and Benedek, I. H.: Moricizine pharmacokinetics in
young and elderly subjects. J. Clin. Pharmacol., 32(8), 755 (1992).
Davidson, A. F., Pieniaszek, H. J., Jr., Mc Entegart, C. M., Quon, C. Y., Michael, U. F., and Mayersohn, M.:
Moricizine pharmacokinetics in patients with renal disease. J. Clin. Pharmacol., 32(8), 749 (1992).

Davidson, A. F., Whitney, C. C., Jr., and Pieniaszek, H. J., Jr.: Comparative pharmacokinetics of moricizine
in dogs and humans. Pharm. Res., 8(10), S-281 (1991).
Gray, J. E., Peterman, V., Newton, R. C., King, S-Y. P., Quon, C. Y., and Pieniaszek, H. J., Jr.:
Pharmacokinetics of a modified human interleukin-1 beta, following intravenous bolus administration in dogs.
Pharm. Res., 8(10), S-55 (1991).
Frost, S. G, Byrum, S. J., Litt, G. J., Pieniaszek, H. J., Jr., and Fiske, W. D.: Quantitative ELISA (enzyme
linked immunosorbent assay) method for the analysis of DuP 996, a cognitive enhancer, in human plasma.
Pharm. Res., 8(10), S-44 (1991).


Curriculum Vitae
H. J. Pieniaszek, Jr.

ABSTRACTS (cont.)

Pieniaszek, H. J., Jr.
, McEntegart, C. M., Davidson, A. F., Quon, C. Y., Sampliner, R., and Mayersohn, M.:
Moricizine pharmacokinetics in patients with hepatic cirrhosis. J. Clin. Pharmacol., 31(9), 864 (1991).
Chow, M. S. S., Fan, C., Zhao, H., Whitney, C. C., and Pieniaszek, H.: Kinetics of moricizine in pigs --
comparison with other species. Sixth Southeast Asian/Western Pacific Regional Meeting of Pharmacologists,
"Pharmacology for Better Therapeutics", p169 (P-222), Hong Kong, June 30 - July 4 (1991).
Shum, L., Pieniaszek, H. J., Jr., Garner, D. M., Widner, P. J., and Flamenbaum, W.: Pharmacokinetic
interaction of moricizine and diltiazem in normal healthy volunteers. Third North American ISSX Meeting, p
18 (#42), San Diego, CA, October 21-25 (1990).

Pieniaszek, H. J., Jr.
, Chaney, J. E., Sigvardson, K. W., Davidson, A. F., Whitney, C. C., Jr., Gaylord, J. C.,
Zemaitis M. A., Rakestraw, D. C., and Quon, C. Y.: Qualitative and quantitative aspects of moricizine
metabolism. Third North American ISSX Meeting, p 37 (#153), San Diego, CA, October 21-25 (1990).
Benedek, I. H., Pieniaszek, H. J., Jr., and Davidson, A. F.: Effect of moricizine on the pharmacokinetics of
theophylline in healthy volunteers. Pharm. Res., 6(9), S-234 (1989).

King, S. P., Powel, R. J., Wong, Y. N., Davidson, A. F., Vincent, D. R., and Pieniaszek, H. J., Jr.: Effect of
chronic moricizine treatment on its pharmacokinetics and hepatic enzymes in rats. Pharm. Res., 6(9), S-202
(1989).
Pieniaszek, H. J., Jr., Xilinas, M., Fiske, W. D., Saxton, T. D., Garner, D. M., Kim, Y. S., Cook, L.,
Martz, R. C., Darragh, A., and Nibbelink, D. W.: Safety, tolerance, and pharmacokinetics of DuP 996, a
(potential) cognitive enhancer, in young and elderly male volunteers after single escalating doses. Pharm.
Res., 6(9), S-35 (1989).
Pieniaszek, H. J., Jr., Adams, M. P., Garner, D. M., Bliss, M., Reinhart, R. J., and Mayersohn, M.:
Moricizine bioavailability after simultaneous administration of a tablet and solution using stable isotopes and
quantitative thermospray liquid chromatography (LC/MS). J. Clin. Pharmacol., 29(9), 842 (1989).

Pieniaszek, H. J., Jr.
, Benedek, I. H., and Davidson, A. F.: Enzyme induction by moricizine: Time course
and extent in healthy volunteers. J. Clin. Pharmacol., 29(9), 842 (1989).
Benedek, I. H., Pieniaszek, H. J., Jr., and Garner, D. M.: Dose proportionality of moricizine after escalating
multiple doses in healthy volunteers. J. Clin. Pharmacol., 29(9), 838 (1989).
Pieniaszek, H. J., Jr., Aungst, B. J., Adams, M. P., Davidson, A. F., Whitney, C. C., Jr., Myers, M. J., and
Shefter, E.: Disposition and oral bioavailability of nalbuphine and its anthranilate ester prodrug in the rat, dog,
and human. J. Pharm. Sci., 76(11), S91 (1987).

Pieniaszek, H. J., Jr.
, Shen, H-S., Page, G. O., Shalaby, L. M., Garner, D. M., Isensee, R., and Whitney,
C. C., Jr.: Determination of 12C- and 13C-moricizine in human plasma using thermospray liquid
chromatography/mass spectrometry (LC/MS). J. Pharm. Sci., 76(11), S19 (1987).


Curriculum Vitae
H. J. Pieniaszek, Jr.

ABSTRACTS (cont.)

McFarland, R. T., Moeller, R. N., Pieniaszek, H. J., Jr., Whitney, C. C., Jr., and Marcus, F. I.: Assessment of
the potential pharmacokinetic interaction between digoxin and Ethmozine. Cardiovascular Pharmacology
International Symposium, Geneva, Switzerland, April 22-26 (1985).
Pieniaszek, H. J., Jr., Howrie, D. L., Fogoros, R., Juhl, R. P., Schary, W. L., and Whitney, C. C., Jr.:
Disposition of orally administered 14C-Ethmozine in healthy volunteers. APhA Academy of Pharmaceutical
Sciences, 14(2), 244 (1984).
DeYoung, D. W., Pieniaszek, H., and Wilcox, H. E.: Creation of a renally impaired canine model. Vet. Surg.,
13(1), 50 (1984).

Pieniaszek, H. J., Jr.
, Graves, P., Mayersohn, M., Marcus, F. I., and Perrier, D.: Pharmacokinetic studies of
digitalis glycosides. APhA Academy of Pharmaceutical Sciences, 12(1), 56 (1982).

Jung, D., Pieniaszek, H. J., Jr., Mayersohn, M., and Perrier, D.: Absolute bioavailability (F) determination by
simultaneous nonlinear regression fit of oral and intravenous data. APhA Academy of Pharmaceutical
Sciences, 12(1), 49 (1982).

Hager, W. D., Pieniaszek, H. J., Jr., Perrier, D., Mayersohn, M., and Goldberger, V.: Assessing beta-
blockade: Is there a universally applicable procedure? Modern Medicine, 50(3), 162 (1982).
Goldman, S., Olajos, M., Perrier, D., Pieniaszek, H., Mayersohn, M., and Morkin, E.: In vivo titration of
beta-adrenergic receptors in thyrotoxic calf heart. Clin. Res., 28(1), 469A (1980).
Hager W. D., Pieniaszek, H. J., Jr., Perrier, D., Goldberger, V., and Mayersohn, M.: Assessment of beta
blockage to propranolol. Clin. Res., 28(1), 18A (1980).

Bates, T. R., Wilkens, A. L., and Pieniaszek, H. J., Jr.: Pre-systemic metabolism of 17-beta estradiol after
oral administration to dogs. APhA Academy of Pharmaceutical Sciences, 9(2), 83 (1979).

Goldman, S., Perrier, D., Olajos, M., Pieniaszek, H. J., Jr., Mayersohn, M., and Morkin, E.: Beta-adrenergic
blockage and pharmacokinetics of propranolol in thyrotoxicosis. Circulation, 60(4), II-273 (1979).
Bates, T. R., Blumenthal, H. P., and Pieniaszek, H. J., Jr.: Salivary excretion and pharmacokinetics of
sulfapyridine after sulfasalazine administration. APhA Academy of Pharmaceutical Sciences, 7(2), 128
(1977).
Bates, T. R. and Pieniaszek, H. J., Jr.: Capacity-limited gut wall metabolism of 5-aminosalicylic acid (a
potential active metabolite of sulfasalazine) in rats. APhA Academy of Pharmaceutical Sciences, 6(2), 84
(1976).

Pieniaszek, H. J., Jr.
and Bates, T. R.: Cholestyramine-induced alterations in the metabolism of
salicylazosulfapyridine by rats and their intestinal microflora. APhA Academy of Pharmaceutical Sciences,
5(2), 124 (1975).

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