Laura A. Thoma, Pharm.D., is Professor of Pharmaceutical Sciences and Director of the Plough Center for Sterile Drug Delivery Systems (formally known as the Parenteral Medication Laboratories), University of Tennessee Health Science Center.
Dr. Thoma is responsible for the University’s sterile product manufacturing facility and for its related training programs. She has over 20 years experience in training pharmaceutical and biotechnology industry personnel in the procedures and methods used in the aseptic preparation and quality control of sterile products. She is a member of the Parenteral Drug Association (PDA), recently completing her 6th year on the PDA Board of Directors. Dr. Thoma has been an active member of the PDA serving on several program committees, the Program Advisory Board, and was a member of the Task Forces developing a technical report on “Validation of Manual Aseptic Processing” and another involved in the revision of Technical Report 22, “Process Simulation Testing for the Aseptically Filled Products.” She is also heavily involved in the compounding of sterile preparations and served from 2005 to 2010 on the USP Sterile Product Compounding Committee. She is a member of the American Association of Pharmaceutical Scientists, International Society of Pharmaceutical Engineers, American Pharmacists Association, and the American Society of Health-System Pharmacists.
Frank P. Horton II
Mr. Horton has extensive experience in the development and validation of steam sterilization and dry heat processes as well as the validation of lyophilization processes. He has more than 20 years’ experience in training personnel in aseptic processing of parenteral dosage forms in both industry as well as academia. He is a validated fill team member and is involved in all aspects of contract manufacturing for Phase I clinical trials. He is also involved in educating pharmacy students in aseptic technique and processing. He is a lab instructor in the Comprehensive Industrial Course in the Preparation of Parenteral Products teaching steam sterilization cycle development and validation. Additionally, Mr. Horton is responsible for all the day to day operations of the Plough Center for Sterile Drug Delivery Systems and his previous industry experience makes him a valued member of the PCSDDS team.
Pavan Balabathula, M.S.
Senior Research Specialist, Plough Center for Sterile Drug Delivery Systems
Mr. Balabathula has more than 5 years of experience in research, training and manufacturing of sterile dosage forms. He conducts research and analytical studies for development of novel drug products according to federal guidelines which includes pre-formulation studies and formulation development of sterile dosage forms for new chemical entities for pre-clinical & Phase I studies. He develops & validates HPLC assays for drug product testing & stability testing. He is a validated team member for sterile manufacturing of parenteral products under cGMP for pre-clinical and Phase I & Phase II clinical studies. He is involved in proper documentation of Batch Production Record’s for finished products. He trains professionals from pharmaceutical industry & regulatory agencies in the Comprehensive Industrial Course in the Preparation of Parenteral Products. He is also a lab instructor for Pharm.D. students and trains them in aseptic techniques.
George C. Wood, Ph.D.
Emeritus Professor, UT Department of Pharmaceutical Sciences
Dr. Wood has been actively involved in dosage form development and evaluation for over 30 years. His research interests include nanomedicine (nanoparticle targeted drug delivery), the application of lyophilization technology to parenteral dosage forms and development, as well as validation of HPLC assays for stability studies of formulations.
Senior Research Assistant, Plough Center for Sterile Drug Delivery Systems
Ms. Stornes has over 30 years of experience at the University of Tennessee Health Science Center with 24 of those years in the former Parenteral Medications Laboratory, now Plough Center for Sterile Drug Delivery Systems. She is a validated member of the drug manufacturing team. In addition she is a lab instructor in the Comprehensive Industrial Course in the Preparation of Parenteral Products where she instructs in the product equipment and supply preparations lab and instructor for the aseptic sterile drug processing lab. She is responsible for environmental monitoring and all other routine monitoring and testing required for the operation of the Plough Center for Sterile Drug Delivery Systems cleanroom facility. She also has the role of research support in the Plough Center and training support for UT pharmacy students on campus and for some offsite training classes.
Mr. Nguyen has over 15 years of technical experience in a pharmaceutical and manufacturing environment with an emphasis on research & development, laboratory facility space and requirements, quality control, and production. At GTx Inc., he has maintained and overseen assigned laboratory equipment and facilities in compliance with all applicable regulatory requirements (EPA, OSHA, and FDA) which include equipment calibration and maintenance and environmental monitoring. He has extensive knowledge in qualification and validation, industry specific laboratory software & hardware, and GxPs regulatory safety measures. He also provided technical guidance in area of expertise as well as drafting and review of technical GxPs documentation such as investigations and SOPs. He brings a wealth of knowledge and experience on regulatory requirements to the GMP facility at UTHSC.