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Our Team

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.

Senior Management

Cornelia KampCornelia Kamp, MBA
Executive Director Strategic Initiatives
Phone: (585) 355-5341
Fax: (508-355-5349)
Email: cornelia.kamp@cmsu.rochester.edu

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.

 

AhmedAhmed Fetouh, PharmD, MBA

Director, Clinical and Business Affairs
Phone: (585) 758-0506
Fax: (585) 272-8307
Email: ahmed.fetouh@cmsu.rochester.edu

As part of succession planning for Pat Bolger’s (current Director, Clinical and Business Affairs) planned retirement in June 2021, Ahmed is shadowing all aspects of this position over the next 6 months.  This will allow for a smooth and seamless transition on all projects for our valued clients.  As Director, Clinical and Business Affairs at the Clinical Materials Services Unit, Ahmed 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. Ahmed previously served as a clinical pharmacist in the areas on critical care, oncology, and allergy/immunology/rheumatology at Strong Memorial Hospital, the University of Rochester Medical Center’s teaching hospital. He received a Doctorate of Pharmacy in 2009 from the Massachusetts College of Pharmacy and Health Sciences and a MBA in 2020 from the Simon Business School at the University of Rochester. He has more than 10 years of experience in pharmacy operations.

 

Joan WoodcookJoan Woodcook, BS
Director, Quality Assurance
Phone: (585) 758-0499
Fax: (585) 272-8307
Email: Joan.Woodcook@cmsu.rochester.edu

Joan joined the CMSU in 2010 and serves as the 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 Operations Technicians

EllenEllen Weinberger
Clinical Supplies Package/Label and Site Support Coordinator
Phone: (585) 758-0503
Email: Ellen.Weinberger@cmsu.rochester.edu

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 13 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.

 

Arian HorbovetzArian Horbovetz
Associate Project Manager
Phone: (585) 758-0516
Email: Arian.Horbovetz@cmsu.rochester.edu

As a packaging technician for twelve 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.

 

Mike DonnerMike Donner
Clinical Supplies Operations Technician
Phone: (585) 758-0515
Email: Mike.Donner@cmsu.rochester.edu

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.

 

KatieKatie Colbert
Clinical Supplies Operations Technician
Phone: (585) 758-0488
Email: Katherine.Colbert@cmsu.rochester.edu

Katie came to the CMSU in 2020, bringing with her a diverse skillset as a Quality Analyst and an Operations Technician.  Her experience with clean room environments, quality inspection, warehouse management, employee training and advanced Excel template creation have quickly made her a key component to the CMSU team.  While wearing many “hats” at the CMSU, Katie has become the point person with regard to order fulfillment, working directly with clinical trial site coordinators to ensure accurate distribution. 

 

LuisLuis Ramos
Clinical Supplies Operations Technician
Phone: (585) 758-0557
Email: Luis.Ramos@cmsu.rochester.edu

Luis joined CMSU in 2021. Having been in the operations field for over 6 years, Luis comes to CMSU with experience in manufacturing, including a knowledge of cGMPs, packaging and paperwork review. With a diverse work history in cleanroom assembly and a versatile skillset, Luis brings a tremendous amount of knowledge and experience to the CMSU team.

 

 

Quality Assurance Technicians

Jessica LarsenJessica Larsen
Clinical Supplies Quality Assurance Technician
Phone (585) 758-0502
Email: Jessica.Larsen@cmsu.rochester.edu

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.

 

 

Maricruz VazquezMaricruz Vazquez
Clinical Supplies Quality Assurance Technician
Phone (585) 758-0507
Email: Maricruz.Vazquez@cmsu.rochester.edu

Maricruz (Mari) joined the CMSU in Dec. 2019. Mari brings a wealth of experience from 13 years in the medical device industry (Ortho Clinical Diagnostics and LSI Solutions). In her 12 years at Ortho Clinical Diagnostics she supported the research and development of new diagnostic assays, as well as the validation of the final products. In addition to her analytical skills she brings knowledge and experience in biologic specimen handling and management, data management, document management, cold chain shipping, quality systems and auditing. Mari’s knowledge of GMP and GCP regulations & compliance and her understanding of customer needs and expectations through the life cycle of a product make her a valuable member of the CMSU team.

 

Maybeth SotoMaybeth Soto
Clinical Supplies Quality Assurance Technician
Phone (585) 758-0558
Email: Maybeth.Soto@cmsu.rochester.edu

Maybeth comes to the CMSU from a larger industry where she held down diverse roles in the Quality and Operation departments. During her six years at LSI, she was responsible for the inspection and testing of manufacturing processes and products, as well as ensuring product quality and adherence to established company standards. She also helped generate reports of daily activities for executive evaluations. Her knowledge of quality policies, conducting inspections and presenting solutions makes Maybeth a welcomed asset to the CMSU team.