Antoniuk Consulting Services -- Quality Assurance Consulting for the Pharmaceutical and Biotechnology Industries

Background and Qualifications

Mr. Antoniuk graduated from the University of Massachusetts at Amherst in 1990 with a Bachelor of Science in Zoology; he has concentrations in both Microbiology and Chemistry.

Peter began his professional career at EcoScience Corporation, a company that develops biological pesticides, in 1990.  At EcoScience, Peter began as a lab technician and was promoted to supervisor of a quality control microbiology lab.  He was responsible for developing and writing procedures for laboratory techniques, assembling a GLP compliant testing laboratory, and training and supervising a staff of five employees.  Supervising this laboratory gave him practical microbiology experience, including a good working knowledge of mycology.  He held the title of Quality Assurance Officer, during which time he wrote the company's GLP compliance manual to satisfy EPA FIFRA and TSCA Regulations.  As QA Officer, Peter was responsible for administering EcoScience's quality program.

Peter came to Alkermes in 1993 as a QA Associate when the company was maturing from pre-clinical to clinical development.  Alkermes is a drug delivery company specializing in novel approaches in delivering fragile biotechnology products to patients.  He implemented a formal GLP program to support Alkermes' toxicology program while gaining experience in the cGMP Regulations.  While at Alkermes, Peter inspected nearly all of the major GLP testing facilities in the US.  He also was a principal data reviewer for a number of pharmacokinetics, toxicology, and clinical studies.  Peter also played a critical role in bringing Alkermes' Bioanalytical and QC labs into cGMP compliance.

When Alkermes acquired companies in 1993 and 1996, Peter was both times involved with the efforts of reintegrating their cGMP/GLP compliance programs.  Most noteworthy was the acquisition of MediSorb Technologies in 1996, where Peter spent approximately one year redesigning an existing cGMP program in order to accommodate Phase I clinical manufacturing with a corporate partner.  He demonstrated his experience with quality systems by effectivley leading management in the implementation of an efficient, total quality program in such a way that gave MediSorb personnel ownership of the program while, complying with cGMPs and their corporate partner's expectations.

As Alkermes began clinical manufacturing in its pilot facility, Peter played a crucial role in applying the cGMPs to support these efforts.  This entailed intimate involvement with such programs as vendor qualification, environmental monitoring, material control, validation, trending, and cleaning validation.  He also worked to establish an internal quality auditing program, stability program, and OOS procedure in Alkermes' QC Laboratory.  He helped to continuously refine Alkermes' quality systems up to the point of preparing for commercial manufacturing and successfully completing their PAI.  Peter also assisted in reviewing a number of regulatory submissions (annual reports, INDs) while at Alkermes.

Peter joined Peptide Therapeutics in 1998 as QA Manager with the challenge of recruiting a staff and rebuilding the company's quality programs.  Peptide Therapeutics is a company committed to developing vaccines.  He successfully hired a stafff and implemented the required GLP, cGMP, and GCP programs to support pre-clinical testing, clinical manufacturing, and clinical quality assurance.  At Peptide, he participated in several QA GCP audits of Phase III clinical sites in anticipation of FDA audits.  He also participated in a  number of contract manufacturing and testing facilities inspections, including a comprehensive mock PAI inspection, and assisted in the assembly of a BLA for a vaccine product.  His department provided critical regulatory support in the preparation of numerous annual reports and INDs as well.

Peter became an independent consultant and founded ACS in October 2000.  As a consultant, he has provided services for pharmaceutical, biologics, and vaccine development companies as well as clinical testing laboratories.  Since its inception, ACS has assisted over 20 companies with their quality and compliance programs.

Peter is an affiliate consultant with the Biologics Consulting Group LLC.

Since 1990, Mr. Antoniuk has demonstrated his strengths in evaluating, building, and redesigning quality systems, as well as conducting inspections.  He has been able to effectively apply his knowledge in this area to implement quality programs that are functional, efficient, and compliant, especially for startup companies, and he is committed to quality and the concept of continuous improvement.  He is a proficient data reviewer who has reviewed all types of data and documentation as related to pre-clinical and clinical development, as well as cGMP manufacturing.  Peter has robust technical writing skills and is comfortable with both MacIntosh and PC platforms.  He is adept at interacting in a positive and constructive manner with line employees, peers, and senior management.