Advancing trauma and hemorrhage care through bespoke research

Andrew (Andre) Cap, MD, PhD, is an internationally respected clinician-scientist in the field of trauma and critical care hematology with over 315 peer-reviewed articles and over 12,800 citations (h-index 60). Colonel Cap recently retired from the U.S. Army Medical Corps, where he served as Director of Research, U.S. Army Institute of Surgical Research (USAISR). In that capacity, he managed over 350 personnel and a budget of over $55M in executing the DoD’s primary intramural research program in combat casualty care.

Prior to this role, he led the U.S. Army’s Blood Research Program, and served as the Brooke Army Medical Center Program Director, Clinical Research Fellowship, and Associate Director, Hematology and Medical Oncology Fellowship. He also served as Chief of Medicine, 47th Combat Support Hospital, and as CENTCOM Theater Hematology Consultant.

He has worked extensively with the Armed Services Blood Program, Special Operations Command and Joint Trauma System (JTS) on a variety of blood and combat casualty care challenges. He served as Consultant to the U.S. Army Surgeon General on Hematology and Oncology, as Co-Chairman of the NATO Blood Panel and as a contributor to the NATO Prehospital Care Improvement Initiative.  He is a Professor of Medicine at the Uniformed Services University. As Board Director, Colonel Cap, Ret., will develop existing and new relationships and military projects in the field of spray dried plasma production and novel blood technologies.

Colonel Cap, Ret., earned a BA cum laude from Harvard University and an MS in Technology and Policy from MIT, and worked in management and policy consulting before attending medical school. He earned an MD magna cum laude and a PhD in Pathology from the Boston University School of Medicine, where he was also elected to the Alpha Omega Alpha Honor Medical Society. He completed residency in Internal Medicine and fellowship in Hematology and Medical Oncology at Walter Reed Army Medical Center, and training in hematopoietic stem cell transplantation at NIH.

Bettina (Tina) Bockelmann, TRI Secretary, TRI Co-Director Tina has worked in clinical research for over twenty years. Ms. Tina Bockelmann brings over 23 years of experience in clinical and pharmaceutical research. She currently serves as the Blinded CRA Manager for a global, phase 3 clinical trial involving more than 25 sites and enrolling up to 1,000 participants. In this role, she is responsible for optimizing trial operations, ensuring timely execution, and upholding high standards in Clinical Research Associate (CRA) training and oversight.

Her responsibilities also include ensuring adequate source data verification to maintain data integrity throughout the trial. In addition, Ms. Bockelmann serves as the program manager for a separate phase 3 trial, comprising 24 sites and also enrolling up to 1,000 participants. Her role involves comprehensive regulatory oversight, contributing to the successful management and compliance of the study.

Ms. Bockelmann has also consulted for academic programs funded by the U.S. Department of Defense (DoD) and the Biomedical Advanced Research and Development Authority (BARDA). Her consulting focus includes clinical trial and program management, encompassing contracting, protocol development, budget oversight, site monitoring, and regulatory file maintenance, including the Trial Master File (TMF), Institutional Review Board (IRB) submissions, and Essential Documents.

She has also served in several roles at leading Contract Research Organizations, overseeing a diverse portfolio across multiple therapeutic areas, including phase 1 studies, vaccines and immune therapies, respiratory, immunology, autoimmune diseases, and First-in-Human trials. She also managed global phase 2/3 oncology trials. In her leadership role, Ms. Bockelmann’s responsibilities include:

The strategic planning and execution of clinical trials, ensuring regulatory compliance, managing budgets and timelines, and leading cross-functional teams to meet project goals.

Ms. Sullivan has over 25 years of pharmaceutical development experience. Currently she is the program manager for an international phase 3 clinical trial with over 25 sites that enrolled 1,000 subjects where her efforts include contracting, quality management, and regulatory oversight, and management of investigational product supplies. She has been a consultant for small, start-up companies and academic programs whose primary funding comes from the US National Institutes of Health (NIH), US National Heart, Lung, and Blood Institute (NHLBI), or US Department of Defense.

She focuses on clinical trial management, including contracting, protocol development, budget oversight, and site monitoring as well as maintaining regulatory files (Trial Master File [TMF], Institutional Review Board [IRB], and Essential Documents). Previously, Ms. Sullivan was part of a small biotech company where the project team consisted of 15 people at its largest and 3 at its smallest. It was her responsibility to be the point person for external contract manufacturing organizations and release product for use in clinical trial.

Tangential to overseeing the CMOs, she implemented a right-sized quality system for the company and used quality agreements to ensure clear communication and delineation of quality responsibilities between the company and the CMOs. Throughout her career, Ms. Sullivan has been a leader for authoring and compiling CMC, nonclinical, and clinical sections of INDs, ANDAs, and NDAs.

Additional FDA interactions include authoring and submitting meeting requests, authoring and submitting briefing packages, and preparing the team for meetings with the Agency.