The CMSU’s senior management team is comprised exclusively of professionals, each of whom bring with them over 20 years of experience from diverse roles (e.g. operations, clinical trials, QA, packaging development, regulatory compliance, drug development and project management) within the pharmaceutical and medical device industries. Our extensive industry experience combined with the resources available within a world-class academic research institution allow us to provide our clients with a uniquely integrated approach to delivering clinical strategy, packaging, labeling and logistics solutions and support for clinical trial programs or stand-alone trials, from proof-of-concept through Phase IV. Our distribution capabilities and project management experience ensure products are of the highest quality, delivered on time and to our clients’ satisfaction.
Cornelia Kamp, MBA
Executive Director Strategic Initiatives
Phone: (585) 355-5341
Cornelia has served on the University of Rochester faculty for the past 20 years and has been the Executive Director of CMSU, in CHeT, since its inception in 2008. She received a Masters Degree in Business Administration (Operations Management and Finance) in 1994 from the William E. Simon School of Business Administration, at the University of Rochester. She has had more than 25 years experience in pharmaceutical-based research including: clinical drug/device supply services, project management, data management, operations, budgets, contracts, site management, and site activation. Cornelia has overseen the operations of more than 150 multi-center international clinical trials mostly in CNS and acute and chronic pain. She has managed over 23 INDs from initial submission through annual reporting and creation of the final Clinical Summary Reports (CSRs). She served as the Director of Clinical Research Operations at the Clinical Trials Coordination Center (CTCC) at the University of Rochester for more than 8 years and was formerly Vice President of Site Operations for SCIREX (now the Premier Research Group). She has served as a consultant to the Clintrex Research Corp, clinical research company that works with pharmaceutical organizations to operationalize development pathways for new treatments for CNS diseases, since its inception in 2010.
Director, Regulatory and Technical Affairs
Phone: (585) 758-0498
Fax: (585) 272-8307
Tim is the Director of Regulatory and Technical Affairs for Clinical Materials Services Unit. Tim is responsible for oversight of the Quality System at the CMSU as well as maintenance and management of the facility and infrastructure. In this role Tim utilizes his 30 plus years of experience in Quality Assurance support of pharmaceutical product development. Previous to this position, Tim was the Manager of Quality Assurance for the Office of Human Subject Protection at the University of Rochester. Tim also was an active consultant to both the Pharmaceutical Industry and Academic Medical Centers providing quality assurance and auditing services in the area of drug product development. These consulting activities focused on both regulatory compliance and process optimization, the latter of which identifies process vulnerabilities and develops practical business solutions towards process improvement. Previous to his employment with the University of Rochester, Tim was a Quality Assurance Professional for both Pennwalt Pharmaceuticals and Fisons Pharmaceutical Corporation’s where he supported numerous aspects of clinical research and development functions. In the pharmaceutical industry, Tim was part of an international team responsible for developing Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) standards in support of new product development, resulting in five New Drug Approvals in the United States. At the U of R Tim has authored numerous IND’s and his regulatory contributions to the Muscle Study Group have resulted in two Orphan Drug approvals in the US.
Patrick Bolger, R.Ph., MBA
Director, Clinical and Business Affairs
Phone: (585) 758-0508
Fax: (585) 272-8307
As Director, Clinical and Business Affairs at the Clinical Materials Services Unit, Pat provides tactical and strategic support for all stages of clinical trial supply, including project proposals, study kit design, supply chain management, distribution logistics, project management, and regulatory compliance. In addition to practicing hospital pharmacy early in his career, Pat spent over 20 years in the pharmaceutical industry (Pennwalt Corporation, Fisons Pharmaceuticals, Rhone-Poulenc Rorer, Medeva Pharmaceuticals, Celltech Pharmaceuticals and UCB, Inc.), the majority of which in involved developing and managing systems to comply with federal and state regulatory requirements. Pat also led cross-functional product development teams in the planning and execution of strategies to obtain regulatory approval for pharmaceutical products. Pat received a BS in Pharmacy from the University of Florida and a MBA in International Business from the Rochester Institute of Technology.
Joan Woodcook, BS
Associate Director, Quality Assurance
Phone: (585) 758-0499
Fax: (585) 272-8307
Joan joined the CMSU in 2010 and serves as the Associate Director of Quality. She is responsible for the management, continuous improvement of and compliance to the CMSU Quality System. She began her 30+ years of pharmaceutical and medical device experience at Pennwalt Pharmaceuticals in Quality. Management positions at Fisons Pharmaceuticals, Rhone-Poulenc Rorer, Medeva Pharmaceuticals, Celltech Pharmaceuticals and Bausch & Lomb, provided opportunities to develop a broad breadth of knowledge in regulatory affairs (drug and medical device), project management, supply chain management and medical device/pharmaceutical packaging development. Joan has led cross-functional teams for a wide variety of projects including product development, pharmaceutical facility renovation, new pharmaceutical and medical device packaging, supply chain efficiency and cost improvements and regulatory compliance initiatives for new regulations. She received a BS in Packaging Science with a focus on pharmaceutical packaging and a Certificate in Business Management from the Rochester Institute of Technology.
CMSU Supervisors and Technicians
Supervisor, Clinical Packaging/Labeling
Phone: (585) 758-0503
Ellen has been in the clinical trials industry for more than 25 years with experience at Pennwalt Pharmaceuticals, Fisons Pharmaceuticals and previously at the University of Rochester. For the last 11 years, she has served as the CMSU labeling supervisor, overseeing the production of all CMSU clinical labeling used to support drug and device packaging. Ellen has previously been a part of two clinical trial packaging start-up groups, in addition to coming in on the ground floor at the CMSU. Ellen was previously employed by The American Red Cross where she monitored hospital blood product inventory levels, ordering and shipping product when necessary.
Clinical Supply Operations Technician
Phone: (585) 758-0516
As a packaging technician for ten years, Arian has coordinated or participated in nearly every drug and device processing run in the CMSU’s history. Arian also has label production training and participates regularly in the facilitation of study drug receiving and distribution, as well as SOP writing. Arian came to the CMSU with experience as a photographer and a website developer, and has continued to utilize these skills to the benefit of the CMSU’s visual and digital presence.
Clinical Supply Quality Assurance Technician
Phone: (585) 758-0506
Patti has been with the CMSU for over 10 years, bringing 25 years of Quality and Audit experience from her positions at Coast to Coast Circuits and Applied Image Group Inc. Patti is responsible for the management of all documentation related to the CMSU Quality System. In addition, she is the primary quality inspector for clinical labeling, clinical material processing and incoming and outgoing CTM inspections. Patti’s experience in Optics manufacturing with an emphasis on ISO 9000 compliance, QMS and Internal Auditing, facilitated an easy transition to 21CFR Part 210 and 211 compliance (cGMP regulations).
Clinical Supply Operations Technician
Phone: (585) 758-0515
Mike has been in the clinical trials industry for more than 35 years, having worked in various cGMP positions during his tenure at Fisons Pharmaceuticals, Medeva Pharmaceuticals and UCB Pharmaceuticals. His knowledge and experience in Manufacturing, Packaging, Development, and Clinical Trials environments are invaluable and help to ensure cGMP compliance, operations safety and accurate inventory management. Mike has been involved in successful project outcomes in product launches in his days of drug development and in the numerous clinical trials he has been involved with at CMSU.
Clinical Supplies Operations Technician
Phone (585) 758-0502
Jessica joined the CMSU in 2017 and quickly became an integral part of the CMSU team. Her experience in audit and inventory control for a major jewelry retailer and her penchant for detail easily segued into the GMP regulated clinical trial supply environment. Jessica is proficient in many operations functions including distribution, packaging and communication with clinical sites.