Product Development Project Manager

Brian Grabowski *****************@*****.***

*** ****** *****, *********, ******** 60102 C 224-***-**** SUMMARY

Project Manager in Pharmaceutical Product launch and dossier maintenance for the last 8 years. Results oriented product development professional for commercial products in aseptic manufacturing. Ten years of Clinical development for multiple therapeutic NDA submissions. Eighteen years of non-clinical and clinical Pharmacology studies on drug absorption and elimination. EDUCATION AND TRAINING

Bachelor of Arts: Major Biology, Minor Education, North Central College, Naperville, IL Associate of Science: Elgin Community College, Elgin, IL

• EMT training

• Laboratory Safety training

Drug Product Development studies, University of Wisconsin, Madison, WI

• Certification Coursework: Preclinical and Drug Product Design Strategies, Pharsight PK/PD Training, Basic Pharmacology, Practical Biostatistics, Pharmacokinetics, Bioavailability and Bioequivalence. Systemation: Fast start® in Project Management

EXPERIENCE

AbbVie Inc., North Chicago, IL

Project Manager-Dossier Management, Regulatory Affairs CMC (Oct 2020- Apr 2023) Commercial Product Dossier management for global Health authorities.

• Develop timelines for eCTD submission documents

• Manage and moderate team meetings for document authoring

• Manage/prepare filing sections for publication group

• Support for follow up from Health Authorities

Catalent Pharma Solutions, Inc. Woodstock, IL.

Project Coordinator II/ Technology Transfer Specialist (Mar 2015- Feb 2020) Managed Aseptic product development from feasibility through commercial launch.

• Five new product launches in concert with functional teams

• Managed timelines for project scope and completion dates

• Coordinate Operations, Engineering, Validations, Supply Chain, Quality and finance

• Technology Transfer documentation for Quality/Compliance

• Maintain Compliance utilizing TrackWise, Documentum and SharePoint for archiving

• Support for GMP Batch Record documentation

• Competence in FDA 21 CFR/820s and Critical Quality Attributes and Process Parameters Consultant for Development Strategy/Certified Coach (July 2011-Mar 2015) Scientific support for product development; publications, strategy and vendor selection. Targacept, Inc. Winston-Salem, NC (January-July 2011) Sr. Staff Scientist, Translational Medicine

Managed clinical phase I/II support for three business development programs.

• Vendor technical audit and oversight

• Responsible for the vendor bioanalytical sample analyses

• Managed pharmacokinetic analysis process

Takeda Global Research and Development (US), Deerfield, IL (2008-2010) Clinical Pharmacologist, Clinical Pharmacology Department. Product Launch Development, supporting 5 Phase I-IV NDA programs.

• Provide scientific leadership in the preparation, conduct and reporting of clinical pharmacology studies

• Conduct PK/PD analyses as required by the program to aid in data interpretation, dose selection, trial design and/or program decision-making

• Participate in writing publications and making scientific presentations consistent with development strategies and publication plan

• Approves routine data analyses and study reports conducted/written by external vendors

• Integrate and interpret clinical pharmacology data and quantitative translational knowledge to prepare the clinical pharmacology section of regulatory documents (IND, IMPD, IB, NDA CTD) TAP (Takeda/Abbott) Pharmaceutical Products Inc., Lake Forest, IL, (1999-2008) Sr. Research Scientist, Drug Metabolism and Pharmacokinetics Department

• President’s Award for successful product launch

• Bioanalytical vendor management for clinical development programs Abbott Laboratories PPD, Abbott Park, Illinois (1990-1999) Associate Pharmacologist, Drug Safety and Metabolism

• Development support for seven therapeutic areas in drug safety and metabolism CLINICAL PUBLICATIONS

Brian Grabowski and Ronald D. Lee. Absorption, Distribution, Metabolism and Excretion of

[14C]Dexlansoprazole in Healthy Male Subjects. Clinical Drug Investigation May 1, 2012; 32(5):319-332. Brian A. Grabowski, Reza Khosravan, Jingtao Wu, Laurent Vernillet and Christopher Lademacher. Effect of Hydrochlorothiazide on Pharmacokinetics and Pharmacodynamics of Febuxostat, a Non-Purine Selective Inhibitor of Xanthine Oxidase. Brit J Clinical Pharmacol 2010; 65(3):355-365. Brian A. Grabowski, Reza Khosravan, Laurent Vernillet, Darcy J. Mulford. Metabolism and Excretion of [14C] Febuxostat, A Novel Non-Purine Selective Inhibitor of Xanthine Oxidase, in Healthy Male Subjects. J Clinical Pharmacol March 2010.

Khosravan R, Grabowski BA, Wu JT, Joseph-Ridge N, Vernillet L. Pharmacokinetics, pharmacodynamics and safety of febuxostat, a non-purine selective inhibitor of xanthine oxidase, in a dose escalation study in healthy subjects. Clin Pharmacokinet 2006; 45:821-841.

Reza Khosravan, Michael Mayer, Brian Grabowski, Laurent Vernillet, Jing-Tao Wu, and Nancy Joseph-Ridge. TAP Pharmaceutical Products Inc. Lake Forest, IL. – The Effect of Mild and Moderate Hepatic Impairment on Pharmacokinetics, Pharmacodynamics, and Safety of Febuxostat, A Novel Non-Purine Selective Inhibitor of Xanthine Oxidase. J Clinical Pharmacol 2006; 46:88-102. Carr R.A., Andre A.K., Chen P., Grabowski B.A., Chang M.S., Locke C.S., Williams L.A., Chojkier M. The Effect of Hepatic Insufficiency on the Safety and Pharmacokinetics of Paricalcitol (ZemplarTM). Nephron Clinical Practice 2006.

CONFERENCE PRESENTATIONS

Brian Grabowski, Ronald Lee, Richard Czerniak

Takeda Global Research and Development Department of Drug Clinical Pharmacology, 675 N. Field Drive, Lake Forest, Illinois. Metabolism And Excretion Of [14C]TAK-390 In Healthy Male Subjects. ISSX Conference 2008. Ronald Lee, Brian Grabowski, Darcy Mulford, Neal Castagnoli, Antje Rottmann and Kristof Chwalisz. TAP Pharmaceutical Products Inc., Lake Forest, Illinois. Metabolism and Excretion of Asoprisnil, a Novel Selective Progesterone Receptor Modulator, in Healthy Female Subjects. ISSX Conference 2006 Brian A. Grabowski, Laurent Vernillet, Reza Khosravan, Jing-Tao Wu, Nancy Joseph-Ridge, Darcy J. Mulford. TAP Pharmaceutical Products Inc., Lake Forest, Illinois. Metabolism and Excretion of [14C] Febuxostat, A Novel Non-Purine Selective Inhibitor of Xanthine Oxidase, in Healthy Male Subjects. ISSX/JSSX Conference 2005.

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