Ms. Haynes was with Mallinckrodt Pharmaceuticals for over 28 years.  As VP of Alliance Management, she led the divestitures of Mallinckrodt’s contrast media and nuclear imaging businesses, delivering nearly $1 billion in total transaction value. Prior roles include Vice President & General Manager where she led teams in North and South America and Global Marketing, Marketing Director, Training Manager, and Pharmacist with Board Certification in Nuclear Pharmacy.

• Education: BS Pharmacy, St. Louis College of Pharmacy; MBA, Washington University
• Boards: Board of Trustees, University of Health Sciences and Pharmacy in St. Louis; ARTMS Products, Inc.

At UMB, he was also Director of the Nanofabrication and Imaging Core Labs at the Center for Blood Oxygen Transport and Hemostasis (CBOTH). Earlier he was a tenured Associate Professor of Bioengineering and Associate Head at University of Illinois at Urbana Champaign. He brings 20 years of experience in nanotechnology, chemistry, and bioengineering. He holds 8 granted U.S. patents, 31 U.S. patent applications, numerous high impact publications, and several ongoing clinical trials and is the founder of three University- based early start-ups including Vitruvian Bio dedicated to developing novel image-guided therapies, and InnSight Technologies dedicated to nanotechnology-based application for ocular diseases. He is an elected fellow of Royal Society of Chemistry, American Heart Association and American College of Cardiology.

• Education: MS, Vidyasagar University, India, PhD, Indian Institute of Technology (ITT) India
• Research: Postdoctoral Fellowships (Karen Wooley), Washington University, St. Louis

Prior to coming to Maryland, he was an Associate Professor in Bioengineering and Materials Science and Engineering and Institute of Sustainability in Energy and Environment at the University of Illinois, Urbana-Champaign. He held a faculty position in Beckman Institute for Advanced Science and Technology, University of Illinois Cancer Center and Carle-Illinois College of Medicine. Pan’s lab uniquely merges fundamental chemistry, biology, and engineering to bring a solution to today’s healthcare problems. His research is highly collaborative and interdisciplinary centering on the development of novel materials for biomedical applications, immune-nanomedicine and targeted therapies for stem-like cancer cell with phenotypically screened nanomedicine platforms.

He holds multiple patents (8 granted US patents), several ongoing clinical trials and is the founder of three University-based early start-ups. He is the CEO/President for a biotechnology start-up Vitruvian Biotech dedicated to developing novel image-guided therapies. He also co-founded InnSight Technologies dedicated to nanotechnology-based application for ocular diseases.

• Education: MS, Vidyasagar University, India, PhD, Indian Institute of Technology (ITT) India
• Research: Postdoctoral Research, Washington University, St. Louis

Dr. Spinella is a well-established clinical trialist, who has been funded by the US Department of Defense and the National Institutes of Health. He has published over 245 manuscripts and 21 chapters and is the editor for a textbook on the topic of trauma resuscitation. Dr. Spinella has also participated in, organized research symposia for, or provided external review of research programs for the FDA, NIH, DoD, Homeland Security, and the Department of Health and Human Services. He has also participated on a committee for the National Academy of Sciences to develop recommendations for a national trauma system in the US.

Dr. Spinella co-founded the THOR Network and has been its Co-Director since 2011. The THOR network has hosted training and educational programs in over 12 countries in 4 continents. The THOR Network has also performed groundbreaking research related to whole blood and platelet transfusion for traumatic bleeding.

George Allen Hides is the Regulatory Affairs Advisor​ at KaloCyte, where he advises on the company’s regulatory strategies and development activities.

Hides is Co-Founder of Geis-Hides Consulting LLC, a boutique consultancy that provides durable clinical and regulatory development solutions for translating emerging biologics and pharmaceutical compounds from discovery through clinical trials.

Prior to Geis-Hides Consulting, Mr. Hides spent 15 years at Northfield Laboratories Inc. as Vice President of Clinical Development and Regulatory Affairs where he was responsible for developing PolyHeme, a novel polymerized hemoglobin-based oxygen carrier for use as a blood substitute in patients in hemorrhagic shock where treatment began at the scene of injury. In addition, Mr. Hides conducted more than 50 Emergency Use INDs in patients with life-threatening anemia.

• Education: BA in Physics, DePauw University.

William D. McGhee, PhD. is Senior Director of Process Development at KaloCyte. Bill is highly experienced in the development of nanoparticles, Drug Substances and Drug Products within the pharmaceutical industry. He is responsible for the development of KC-1003, a novel lipid excipient and for a scalable process to produce ErythroMer.

Bill has worked in the Pharmaceutical Industry for over 25 years in both small startup and large companies. One of his focus areas involves the process development of Nanomedicines for intravenous use including nano-formulations for long circulating cancer drug candidates. Bill also maintains consultant status at Capella Imaging (St Louis, MO). He is an inventor/co-inventor on 33 U.S. patents. Bill carried out post-doctoral work at Oxford University while obtaining his Ph.D. at the University of California, Berkeley, and his B.S. in Chemistry at Kansas State University.

Esma Alp, PhD, is a formulation scientist at KaloCyte, where she performs pre-formulation and characterization studies of nanoparticulate systems in support of (pre)clinical and stability studies. Before she joined KaloCyte, her research focus was on developing and characterizing polymeric based nanoparticles for delivery of anti-cancer agents to enhance therapeutic efficiency of drugs.

From 2014-2019, Dr. Alp worked as research scholar at SUNY-Albany Cancer Research Center to develop biocompatible starch nanoparticle formulation of CG-1521, a histone deacetylase inhibitor in preclinical development for hard to-treat breast cancers, which improves its bioavailability and half-time. She published her doctoral study in International Journal of Nanomedicine. She also worked as visiting scholar to modify the nanoparticles with specific ligand to investigate the effect of modified nanoparticles for targeted nanoparticles.

Education:
MS: Hacettepe University,Turkey
PhD: Hacettepe University,Turkey

Research:
Pre-doctoral Training: State University of New York, Albany, NY
Visiting Scholar: State University of New York, Oswego, NY
Post-doctoral Training: Clark Atlanta University, Atlanta, GA

Shelby McCauley is the Laboratory Operations Manager with KaloCyte where she performs biological assays for the development and optimization of ErythroMer. She also monitors the project progress and productivity while maintaining the laboratory inventory.

After graduating with her master’s degree in biology, Shelby worked as a lab manager at Cincinnati Children’s Hospital Medical Center within the Oncology Department. Her research was focused on identifying specific biological responses of tumor and normal tissue following X-ray or proton irradiation and then subsequently investigating potential treatment adaptations and combinatory approaches. She then continued her research in the Radiation Oncology Department at the University of Cincinnati developing preclinical strategies for sensitizing tumors to improve treatment outcome before relocating to the Baltimore area.

Education:
BS, Biological Sciences, Youngstown State University; MS, Biology, Chatham University
Affiliations – Golden Key International Honour Society, Emerging Leaders Program

Stephen Reefe is responsible for managing KaloCyte’s business office operations and provides administrative oversight in the areas of human resources, finance, office services, and facilities.
Mr. Reefe has over 30 years of experience managing projects, people, and processes in corporate, non-profit, and small business environments across multiple industries.

Mr. Reefe began his career with Xerox Business Services, providing onsite support for a U.S.A.I.D. funded project focused on pediatric care in the developing world. Since then, he has worked for a broad range of organizations including the American Urological Association, Maritz Global Events, and others in the engineering, insurance, and service industries.