Business Objectives: <TOP>

To be a premier provider of...

• practical, highly customized statistical analysis and data management services for discerning clients in the pharmaceutical and medical device industries;

• statistical analysis and reporting services for independent data monitoring committees in the pharmaceutical industry.

Core Business Strategies <TOP>

Provide portable solutions using the SAS® software system. Provide a highly skilled core of employees, augmented by retaining the services of independent consultants.

Experience <TOP>

The principal has worked in the pharmaceutical industry for well over 20 years, beginning as a Senior Biostatistician with Adria Laboratories in 1978. His last position before starting his own company was Director of Statistical Services at Harris Laboratories, Inc. During his career, he has conducted or supervised statistical analyses of all phases of clinical studies for CNS, gastrointestinal, cardiovascular, and cancer pain products. The work included protocol development and report writing for U.S. and European companies.

Recent Projects <TOP>

Pat O’Meara Associates, Inc. has served as the independent data management and statistical analysis organization supporting a data monitoring committee established to review safety and efficacy for the following international multi-center trials:

(2001- ) Currently serving as the unblinded data analysis center (DAC) for a 10,000+ patient study of postmenopausal women with mortality one of several primary endpoints. When we assumed DAC responsibility the study had been running for 2 years, the DSMB had lost confidence in the original DAC, and the Sponsor had begun to transfer data management activities to an in-house team. The DSMB was on the verge of terminating the study because it believed that patient safety could not be adequately monitored. In less than 7 months we validated the randomization schedule against original medication kit numbers, obtained and met the DSMB’s reporting requirements, completely revised the safety report with consistent reporting across tables, and prepared a draft interim efficacy report. Along the way, we merged 4 overlapping adverse event data streams, converted adverse event tables from COSTART to MedDRA, and convinced the sponsor to develop special search categories of MedDRA terms targeting adverse events of interest for this class of drug and indication.

Our revised expanded interim safety report convinced the DSMB that patients were not being placed at increased risk and regained the DSMB’s confidence in the sponsor’s data management plan.

We produce quarterly safety updates, arrange and conduct face-to-face meetings at 6-month intervals with the sponsor and the data monitoring committee. As secretary to the DSMB, we prepare and circulate the meeting minutes and file all DSMB related documents until the end of the study.

(2000-2001) Served as the independent unblinded data analysis center (DAC) for the data and safety monitoring board (DSMB) of an ischemia prevention trial with 2200 planned patients. The responsibilities included generating a randomization schedule, 24-hour turn around of monthly safety reports, and producing efficacy interim analyses for DSMB. In this project, we also served as secretary to DSMB, scheduling tele-conferences, recording and circulating minutes and filing all DSMB related documents until the completion of the study. In addition, data validation and decoding of biomarker data, and Monte Carlo simulation were performed at the sponsor's request.

Due to highly effective and real time analysis support, the DSMB was able to provide a timely study termination recommendation for the safety reason just after 350 patients enrolled.

(1999-2000) Served as the independent unblinded DAC for a 2300 patient study in sepsis. We produced and validated SAS programs to sponsor specifications. We assisted the sponsor in database validation and prepared unblinded two interim statistical analyses. We assisted the sponsor in verifying treatment assignments while the sponsor was blinded to treatment.

(1998-2000) 700 patient study of a novel intraocular lens. We advised the client on the best method of obtaining information from a legacy database, developed and assisted in the implementation of a data management plan, provided a statistical analysis of the validated database, and served as the statistical member of a team presenting results to a medical devices panel at the Food and Drug Administration.

Recently the owner served as a consultant to Restoragen, a biotech company located in Lincoln. He provided regulatory affairs support, retained and supervised study monitors, assisted with protocol writing and study design, developed randomization schedules, designed and supervised the production of case report forms, audited CRO performance, computed sample size estimates, performed statistical analysis, and reviewed reports.

The company has performed the data management for two integrated summaries of safety. Both products, Actiqä and Kadian, are on the market. For Anesta Corporation, the makers of Actiqä, we provided advice on the format and content of tables in the integrated summary of safety. We also created a standardized safety database from the legacy data. For the Kadian submission, we prepared standardized SAS datasets that were then used to create a standardized safety database. We also helped write the final draft of the integrated summary of safety.

Systems <TOP>

Software: The SAS System Version 8.2
SAS/STAT, GRAPH, IML, ETS, AF, EIS, SCL, ACCESS
SAS Enterprise Miner, SAS Warehouse Administrator

Other: LogExact, StatExact, SPlus, NQuery
MS Office 2000/Professional

Network: Microsoft Small Business Server

Internet:VPN service capable.