Kenneth Dorko

Areas of Expertise:

• Liver biology
• Human liver cell isolation (including GMP experience)
• Laboratory operations (Academic and industry)
• Staff management and training
• Clinical and R&D cell transplantation
• Development of R&D and clinical protocols, SOPs and batch records

Ken has over 25 years of experience in the isolation, characterization, transplantation and shipping of human primary liver cells. He also has extensive experience isolating cells from human kidney, intestine, umbilical cord and amnion.  He has an extensive research background that includes being a key member of the first FDA approved academic lab established for the isolation of human hepatocytes used for transplantation. He is an expert in cell transplantation and hepatocyte isolation from multiple animal species.

Ken has worked with multiple academic and clinical IRBs writing project proposals and patient consent forms. He has been a liaison between academic labs and the clinic as well as between commercial operations and academic partners.  He is an active member of the Cell Transplant and Regenerative Medicine Society and has a passion for the development of liver products and therapies for the clinic.

— • —

A full CV of Kenneth Dorko and participating project consultants and contractors will be available to clients in advance of project initiation.

Joel LeCluyse

Areas of Expertise:

• Human liver cell isolation
• Laboratory operations (inventory management, shipping/receiving, logistics)
• Freezerworks™ Inventory database management
• Initial laboratory design and set-up
• Training staff
• Establishing team and operating structures that work and building team rapport

Joel LeCluyse has over 13 years of primary human and animal cell isolation experience, from tissues including liver, kidney, and umbilical cord. He is extensive practical experience in cell culture, characterization, and cryopreservation, including the development of new methods that improve outcomes and/or reduce costs. Joel is an expert at logistics, lab design, and inventory database management. He has designed, set up, and established operations for start-up cell isolation labs in the US and EU, in both corporate and academic environments. Joel finds professional inspiration in training the next generation of isolationists and exchanging new ideas to drive the future of primary cell isolations. It is the partnerships and experiences provided by those opportunities that inspire him in his everyday life.

— • —

A full CV of Joel LeCluyse and participating project consultants and contractors will be available to clients in advance of project initiation.

Anna Waters

Areas of Expertise:

• Operations, manufacturing and supply chain
• Inventory control
• Product Lifecycle Management (PLM)
• New Product Introductions (NPI)
• Documentation
• Product development and scale up
• Technology Transfer
• Virology
• Cell Culture and characterization
• Team leadership and people development
• Acquisitions, integrations and manufacturing relocation
• Project Management
• Education/teaching

Anna Waters has over 20 years of experience in life science research and operations management. With experience in companies ranging in size from start up to global leaders, her wide range of expertise enables her to work cross functionally in all stages of a company’s growth.

— • —

A full CV of Anna Waters and participating project consultants and contractors will be available to clients in advance of project initiation.

Sharon Collins Presnell
Founder

Areas of Expertise:

• Mammalian cell biology
• Primary cell isolation, culture, and characterization strategies
• Getting started in the start-up environment
• R&D lab design & organizational structures that work
• Strategic design of cell-based programs, in vitro & in vivo
• Operationalizing biological processes

Sharon Collins Presnell founded CYTOStrategy consulting firm in 2018, and has over 30 years of experience in the isolation, characterization, and use of primary human cells from a wide variety of tissues, including liver, prostate, pancreas, bladder, intestine, kidney, skin, muscle, and vascular system. Her experience spans the academic, start-up, and Fortune 500 environments and includes the successful development of both technical and commercial strategies related to cell-based products.

She is an active board member of the North Carolina State University College of Life Sciences and serves on the Coulter Foundation Translational Research Partnership Board at the University of Virginia. She has served continuously as a scientific, technical, and translational reviewer for the NIH for over 20 years. Sharon’s specialty and passion is developing strategies for the successful development of nascent technologies, including considerations of science, organizational structure, and economic factors.

— • —

A full CV of Dr. Presnell and participating project consultants and contractors will be available to clients in advance of project initiation.