Sponsorship Support
The Global Health Institute offers the ability to serve as the regulatory sponsor for FDA IND submissions to clients that may not have the internal or external expertise to do so. Whether internally or through our preferred partners, we can provide all capabilities to be the regulatory sponsor or can supplement your internal capabilities, including but not limited to regulatory strategy, Pre-IND and IND preparation, representation during regulatory meetings, clinical protocol development, medical writing, database development, TMF maintenance, statistical analysis and TLF development, and eCTD submission.
Quality Affairs
We offer an internal Quality Affairs office providing expertise and oversight for both our clinical trials and laboratory-based research projects. Our QA team tracks staff compliance training, evaluates audit readiness, conducts risk assessments, and implements quality systems for GCP and GLP activities.
Contract and Financial Management
The Global Health Institute finance and administration team manages areas including strategic planning, project management, grant and contract submission and award management, financial reporting, A/P & A/R, human resources, payroll, and special projects.
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Lisa Ware, MS, RAC
Director, Regulatory Affairs
Lisa Ware is the Director of Regulatory Affairs and the Sponsor Representative for SUNY Upstate Medical University. She has over 40 years of experience in product development, with 20 of those in early phase regulatory submissions. She joined the Global Health Institute in 2013 and, as part of the team, she prepares Investigational New Drug (IND) Applications for submission to the FDA and works closely with internal or external clients to ensure that the clinical, laboratory, data and statistical teams are aligned to meet requirements of a regulated clinical trial.
Prior to joining Global Health, she worked at the Walter Reed Army Institute of Research in the Malaria Vaccine Development Branch. Here she was a bench scientist developing malaria vaccines, testing them in in vitro and in vivo experiments. As products showed promise, she helped develop protocols for cGMP production, GLP toxicology testing and GCP clinical trials and moved into the regulatory world of FDA IND Applications. While in the Translational Medicine Branch at Walter Reed, she supported both the Department of Clinical Trials and the Pilot Bioproduction Facility, taking products from an idea to manufacturing to people. She finds her work very rewarding with the knowledge that any little bit she can do to help get a new drug or vaccine to the market might make a difference to those help save lives.
She received her bachelor's in biology from St. Anselm College, her Master's in Genetics from George Washington University, and her Certificate in Regulatory Compliance from Hood College. Outside of work, she enjoys camping and traveling with her husband and pets, getting together with her three grown children, her extended family, and friends.