Dr. DeShield, formerly Chief Legal and Operations Officer of Vivacelle Bio, Inc. for four years, is a pharmaceutical, biomedical, and life sciences intellectual property attorney with more than eleven years' experience. He has experience in fund raising, patent litigation and prosecution, intellectual property transactions encompassing licensing and assignments of patents and trademarks, due diligence with respect to mergers and acquisitions, FDA law, contracts and business agreements, research and joint development collaborative agreements, service, manufacturing and quality control agreements and confidentiality agreements.
Dr. DeShield is also a former Vice President, Commercialization and Business Development for a developmental stage medical device company. Dr. DeShield has a doctorate in Biochemistry from SUNY, Buffalo School of Medicine and Biomedical Sciences; a Masters in Biological Sciences from SUNY, Buffalo Department of Biological Sciences and a Juris Doctorate from SUNY, Buffalo Law School with a concentration in Intellectual Property and Technology Law. He also holds a Bachelor of Science in Biology with honors from Appalachian State University in Boone, NC.
Dr. Simpkins is the inventor of Vivacelle and the President of Vivacelle Bio Inc. He is a trauma surgeon and scientist. Dr. Simpkins has over thirty years of experience as a surgeon including serving as Director of the Trauma Program at LSU Health Sciences Center in Shreveport, LA. He finished his undergraduate studies at Amherst College with honors in Chemistry and graduated from Harvard Medical School in 1974.
Dr. Simpkins completed his surgical training in 1980 at St. Luke Hospital in New York City, and Downstate Medical Center in Brooklyn. He did research fellowships at Boston University School of Medicine and the Naval Medical Research Institute. He received the rank of Commander and received two commendations for excellence in research while serving in the U.S Navy which included several scientific discoveries and publications.
While at LSU Health Sciences Center of Shreveport, Dr. Simpkins led the program in regaining its previously- lost Level One verification by the American College of Surgeons in adult trauma and adding Level One verification in pediatric trauma, a designation that no LSUHSC facility in the state had before. Dr. Simpkins is a Fellow of the American College of Surgeons.
Dr. Talluri is the Chief Medical Officer for Vivacelle Bio. She is also the owner of Compass Consulting International. Dr. Taluri has over seventeen years of experience as a licensed physician and in drug development and medical affairs including stints at Johnson & Johnson, CATO, Lundbeck and Talecris Biotherapeutics.
Her specialties include safety and medical affairs, global clinical development from early stages/POC to pivotal studies in small molecules, biologics, devices, delivery systems, blood substitute (Hemopure) and medical devices.
Her experience includes successful IND's and NDA's in CNS, neuroimmunology, immunology, pulmonary, oncology and other indications. Dr. Talluri possesses the rare combination of experience at the CRO investigator and sponsor level. She has multiple publications in peer-reviewed journals. Dr. Talluri completed her residency at DukeUniversity.
Dr. Kumar is the Senior Vice President, Regulatory Affairs for Vivacelle Bio. Prior to his election to the Board of Directors of Vivacelle Bio and to his appointment to serve as Vivacelle Bio's Senior Vice President for Regulatory Affairs, Dr. Kumar provided services to Vivacelle Bio as our independent consultant with respect to regulatory affairs and in his capacity with a third-party FDA clinical and regulatory affairs company. Under Dr. Kumar's leadership Vivacelle Bio received its first clearance to proceed with its clinical trial of VBI-1 primarily-designed to treat the hypovolemia caused by blood loss. Dr. Kumar is an inventor and a former NIH Staff Scientist. His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has written more than 40 new INDs for FDA submission and reviewed more than 100 INDs. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has made regulatory submissions in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well-known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar has a PhD in Biochemistry and in addition to his work at the NIH, he has also worked as a research scientist at the Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA. Dr. Kumar is also CEO and Founder of FDAMap, a Washington DC-based firm helping manufacturers and developers of FDA-regulated products in regulatory affairs, quality assurance, clinical trials, and smart development strategies.
Thomas A. Fitzgerald, M.B.A.
Thomas A. Fitzgerald has served as Vice President and Chief Financial Officer for Velico Medical, Inc. since August 2006 and, for seven months in 2013, as Interim President and CEO. Mr. Fitzgerald has over 30 years of extensive financial management experience, including with life sciences companies both as an investment banker and chief financial officer, as well as a consultant to emerging growth companies. He was founding Managing Director for the healthcare investment banking firm of Leerink Swann, where he raised capital in both the private and public markets and completed mergers, acquisitions and other strategic transactions. As a chief financial officer, he has managed financial reporting, upgraded reporting systems and processes, improved working capital and cash flow, and led corporate financing as well as corporate governance activities.
Mr. Fitzgerald graduated with an M.B.A. from the Harvard University Graduate School of Business Administration and an A.B. in Economics from Stanford University. Mr. Fitzgerald served in the U.S. Army for nearly four years, initially as an enlisted man and, subsequently, an airborne-qualified infantry officer.
Ronald E. Damper, M.B.A.
Mr. Damper is the President & CEO of DAMRON Corporation which he founded in 1985. DAMRON Corporation manufactures and distributes a variety of private label and branded products for the food service and retail industry. DAMRON was McDonald's first national minority supplier. It continues to provide McDonald's tea products and the McFlurry plastic spoon. Mr. Damper is actively engaged in supporting VBI in the area of capital raising and general management. In fact, his generous efforts ensured a very successful conclusion to our Friends and Family round of financing. He is actively engaged as VBI’s Corporate Development Lead.
Stephen N. Keith, M.D., M.S.P.H.
Stephen N. Keith, M.D., M.S.P.H. is a business leader, pharmaceutical and a biotech executive, entrepreneur and clinician. Dr. Keith has been instrumental in launching VBI and is experienced in raising capital for public private life science companies, investment banking venture capital. He is a board -certified pediatrician with over 20 years of considerable clinical experience in academic,hospital and outpatient settings. Former Chief Executive Officer of Vivacelle Bio,Inc. Former President, Antex Biologies (Vaccines and Antibodies), now a wholly-owned subsidiary of Emergent BioSolutions (NYSE;2015: Total Revenue US$523 Million & EBITDA US$130 Million) and Panacea Pharmaceuticals (Cancer and Central Nervous System Drugs)(Series E 15 US$15 Million closed in December 2015.
Samuel Hill, M.D.
Dr. Hill has over fifteen years' experience as a licensed physician. He is a physician of otolaryngology, head and neck surgery. Dr. Hill has been involved in biomedical research and his efforts and contributions in both residency and fellowship have lead to multiple publications. He has helped VBI to focus on the safety profile of the active ingredients of Vivacelle in humans.
Nik Hurt, M.D.
Dr. Hurt has several years of experience as a licensed physician. She is an Anesthesiologist and Intensivist. She is the CEO and Founder of GM4L, LLC. Her firm brings medicine and entertainment together.
Scientific Advisory Board
Conrad Epting, M.D.
Dr. Epting is a physician - scientist at Northwestern University.He is an associate Professor of Pediatrics and Pathology, Northwestern University, and an attending Pediatric and Cardiac ICU physician at the Ann & Robert H. Lurie Childrens Hospital of Chicago. He is a founding member of Vivacelle Bio Team, sharing and appreciating the vision of the paradigm-shifting properties of micellar colloids, and has served as a contributing scientific consultant since April of 2013. Dr. Epting brings expertise in experimental design and interpretation , animal modeling and critical care physiologic principles underlying resuscitation.
Presently, he studies the epigenetic modifications regulating stem cell phenotype following exposure to end-stage heart failure. He has been the recipient of numerous awards and has received funding from the March of Dimes, the NICHD, the Children’s Heart and Mend A Heart Foundations, the Mathews Center for Cellular Therapy and from multiple other intramural sources.
Corydon W. Siffring, M.D.
Dr. Siffring is a Trauma, Critical Care, and General Surgeon who resides in Kingsport, Tennessee. From 2006 to 2016 he worked at the Level 1 Trauma Center at Holston Valley Medical Center and taught surgical residents as a Professor of Surgery at East Tennessee State University. He has over twenty-four years of experience as a surgeon and medical researcher focused on trauma care. He is currently serving in multiple understaffed Trauma Programs throughout the Midwest and East Coast as a Locum Tenens Surgeon with Weatherby Healthcare.
Dr. Siffring retired from the Army Reserves after 22 years of service, including three tours of active duty with Forward Surgical Teams in Operation Enduring Freedom in Afghanistan from 2003-2010.
Mallory Williams, M.D., M.P.H.
Dr. Williams is Professor of Surgery and Chief of the Division of Trauma, Critical Care, and Surgical Nutrition in the Department of Surgery at Howard University a Level I Trauma Center in Washington, D.C. He is an academic traumatologist with a very busy practice in all three components of acute care surgery including, trauma surgery, emergency general surgery and surgical critical care.
He has served our nation as a combat surgeon and the Chief of Surgery at the 345th Combat Support Hospital in Al Asad, Iraq during Operation Iraqi Freedom and as the senior officer of the Mobile Surgical Team of the Medical Element of Soto Cano Air Base in Honduras. He currently holds the rank of Lieutenant Colonel in the United States Army Medical Corps. As an academic trauma surgeon, he was previously the Associate Director of Trauma & Critical Care at the Louisiana State University Health Science Center in Shreveport where he helped train providers and built capacity at the trauma center level. He served on the Louisiana Emergency Response Network, a state commission with the mission of building an inclusive trauma system. He is also the former Chief of Trauma, Critical Care & Acute Care Surgery at the University of Toledo.
He is a member of several professional trauma societies. As a result of a wealth of clinical experience in busy urban and rural trauma centers, active duty service in the military and academic contributions, he is considered a subject matter expert in resuscitation of multisystem trauma.
Juan Rodriguez, Ph. D.
Dr. Rodriguez is a professor of physics at the University of Health Sciences and Pharmacy in St. Louis, where he divides his time between teaching physics and conducting biophysics research. His interest in biophysics was developed while a postdoctoral fellow at Washington University in St. Louis, where he investigated the optical properties of metalloporphyrins, a class of molecules that
includes the O2 carrying active site in hemoglobin known as heme. His work on metalloporphyrins continued at Centenary College of Louisiana where he investigated how light can be used to monitor brain oxygenation non-invasively. His research interests later expanded to nitric oxide (NO) biology, where his work shed light on the biological actions elicited by secondary products of NO synthesis. He also contributed to the development of NO assays, especially the one that was later used to characterize the NO and O2 carrying capacity of Vivacelle’s first products. His work has been funded by a variety of foundations, including the NSF. Dr. Rodriguez is also affiliated with the Vision Sciences and Mechanobiology centers at Washington University in St. Louis.
After graduating from the University of Maryland in College Park, Gerard Millán began his career in public relations at GMMB assisting the Robert Wood Johnson Foundation with their marketing efforts to educate parents on healthcare access for their children. After a few years at GMMB, he relocated to Los Angeles and accepted a sales and marketing position at Breville USA. During that time, he was promoted almost every year for the first six years managing sales, marketing and, eventually, sales operations in North America. While at Breville, he was responsible for developing forecasting tools and best practices, SOP and ERP implementation, inventory management, sales budgeting and other supply chain, financial and business operations processes and systems.
On August 2015, Gerard Millán left Breville to become an advisor to startups and small-to-mid-size companies. His focus is on helping young, fast-growing companies develop scalable business models that address HR and morale issues, internal and external communication, supply chain management, IT systems, business continuity planning, domestic and international sales strategies and ERP implementation.
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