Proof-of-Concept Trial of an Amniotic Fluid-Derived Extracellular Vesicle Biologic for Treating High Risk Patients with Mild-to-Moderate Acute COVID-19 Infection
Organicell’s latest research publication is now available to read in Biomaterials and Biosystems Journal, “Proof-of-Concept Trial of an Amniotic Fluid-Derived Extracellular Vesicle Biologic for Treating High Risk Patients with Mild-to-Moderate Acute COVID-19 Infection”.
We have dedicated this to our Primary Investigator who didn’t have the chance to see it published. Thank you Dr. Friedewald, your career has greatly impacted us and has left us inspired to continue your legacy.
https://organicell.com/wp-content/uploads/2021/12/Biomaterials_WebBanner-scaled.jpg16002560ZEO ScientifiXhttps://organicell.com/wp-content/uploads/2024/01/Zeo-Logo@1500x-300x56.pngZEO ScientifiX2021-12-06 14:20:392021-12-07 12:08:52Proof-of-Concept Trial of an Amniotic Fluid-Derived Extracellular Vesicle Biologic for Treating High Risk Patients with Mild-to-Moderate Acute COVID-19 Infection
Dr. Shapiro has been a practicing physician for 30 years, specializing in Internal Medicine, Cardiovascular Disease and Age Management Medicine. His career in medicine began in 1988 when he graduated from New York Medical College. An internship and residency then followed at Albert Einstein College of Medicine, after which Dr. Shapiro completed a fellowship at Columbia University College of Physicians and Surgeons in 1994, focusing on Cardiovascular Disease Management, including Congestive Heart Failure and Heart Transplantation.
Dr. Shapiro was the recipient of the 10th Annual Alan P. Mintz, M.D. Award, for Clinical Excellence in Age Management Medicine, as he has become known nationwide as an expert in age management medicine, and leads one of the most prominent age management practices in the country as president of Cenegenics New York City.
Always challenged by the need for innovative medicine, Dr. Shapiro has patented medical devices as well as explored and innovated new medical protocols. He has long been known as one of New York’s foremost cardiologists, specializing in regenerative medicine and improving longevity, including the genomics of cardiovascular disease and congestive heart failure.
Dr. Shapiro is active in 13 medical societies, has been a speaker for the Age Management Medicine Group (AMMG) group for many years, and is a long-standing member of the AMMG Conference Planning Committee. Dr. Shapiro was named 2016-2020 Top Doctor in New York City.
Jackie Domenech
VP of Operations
Jackie Domenech manages operations, accounting, and financial reporting for ZEO ScientifiX™. Ms. Domenech has over 15 years of operations and accounting management experience with companies in healthcare, media, and technology. Prior to joining ZEO ScientifiX™, Ms. Domenech was the Controller of Equisolve, an award-winning digital agency tailored to enhance investor relations. During her tenure, she led a successful transition from an outsourced accounting provider to creating an internal accounting division.
She also served as Controller for various startups including MedicFP & MDLIVE. Most notable is MDLIVE, a telehealth company acquired by Cigna for $2 billion dollars in 2021. She is passionate about the art of entrepreneurship and has volunteered for an organization in South Florida that focuses on disrupting the market by assisting amateur entrepreneurs with developing proof of concepts and product development. Ms. Domenech received her BA in Accounting from the University of South Florida and plans to attain her CPA licensure in 2024.
Jill Swartz
Chief Product Officer
Jill Swartz is a seasoned executive with nearly two decades of executive leadership experience with highly successful healthcare businesses – specifically in the concierge medicine arena. Prior to joining ZEO ScientifiX™, in 2015, Jill founded both PRP Science and Specialty Med Training. These ventures provided comprehensive turn-key solutions for healthcare providers in the regenerative medicine field.
Previously, Jill co-founded BodyLogicMD, the nation’s largest medical franchise of anti-aging physicians. In her 10-year tenure with the organization, as the Senior Vice President of Sales and Marketing, Jill played a pivotal role in successfully transforming over 50 physician practices.
Recognized as a thought leader and influencer, Jill’s expertise extends beyond her corporate endeavors. She serves as a distinguished speaker for The Jim Moran Institute for Global Entrepreneurship College and is actively involved at the Adams Center for Entrepreneurship at Florida Atlantic University in Boca Raton, FL. By sharing her knowledge and experiences, she inspires aspiring entrepreneurs and contributes to the growth of the business community.
Jill’s remarkable career trajectory, marked by her exceptional leadership, strategic acumen, and deep industry insights, positions her as a visionary executive capable of driving transformative success in the functional, integrative, and regenerative medicine arena.
Harry Leider, MD, MBA
Harry Leider, MD, MBA joined ZEO ScientifiX™ as CEO in June of 2023. Dr. Leider, has over 25 years’ experience as a highly successful C-suite healthcare executive and serial entrepreneur in a variety of innovative high-growth companies.
From 2018 to 2022, Dr. Leider was the Chief Medical Officer and Executive Vice President of Gelesis – a biotech company that successfully developed an FDA-cleared therapy for obesity and went public in 2022. Prior to this, he served as the Chief Medical Officer and Group Vice President of Fortune 50 – Walgreens Boots Alliance. Earlier, he was Chief Medical Officer & SVP of Ameritox – a leading national specialty lab company. He has served on the Board of Directors of Alivio Therapeutics, TytoCare, and Mobile Help.
In addition, Dr. Leider has been on the faculty of Harvard Medical School and the John Hopkins Carey School of Business. He has published over 25 articles and book chapters on healthcare and leadership and holds 5 patents in laboratory medicine. He received his medical degree from the University of Pennsylvania, an MBA from the University of Washington where he was a Robert Wood Johnson Clinical Scholar, and his undergraduate degree from Pennsylvania State University where he received the most prestigious award at graduation for leadership, academics, and community service.
Cassie Bennett, Ph.D.
Dr. Cassie Bennett holds her doctorate in biomedical engineering. She focuses in research, development, and project management within biomedical environments. Her accomplished work has led her to author and co-author numerous peer-reviewed papers, as well as several poster conference presentations. Dr. Bennett received her doctorate from The University of Miami, during which time she worked as a research assistant and lab manager until her graduation. After graduating, she joined the ZEO ScientifiX™ team to oversee quality control, the development of standard operating procedures, and quality assurance at the biomedical level.
ADVANCED TRAINING INCLUDES:
Biomedical Engineering
Gene Expression
Immunochemistry
Tissue & Blood Processing
Cell Work
Lab Management
Research
Scientific Publication
Medical & Technical Writing
EDUCATION
Dr. Bennett received her Bachelor of Science in Biological Engineering from Mississippi State University in 2016. In 2021, she graduated with her doctorate in Biomedical Engineering from The University of Miami.
BOARD AFFILIATIONS AND CERTIFICATIONS
Society Of Neuroscience | Member
American Medical Writers Association | Member
Six Sigma | Green Belt Certified
Julian Milberg
Julian Milberg’s background and training are in the field of engineering, specifically Biomedical Engineering. His skill and expertise in highly evolved
equipment have proven to be a major asset to the industry. He has worked with the Leica Confocal and a Leica TCS SP8 Stimulated Emission Depletion (STED) imaging modality and has instructed engineering students on the proper use and maintenance of a scanning electron microscope. His current work with ZEO ScientifiX™ in the field of Nanotechnology, specifically with the
Nano Sight NS 300 is helping the industry in looking into the field of virus and vaccine development, gene therapy, and drug delivery systems. In addition to his instructional experience, Mr. Milberg has published technical articles concerning cancer treatment.
HIS ADVANCED TRAINING INCLUDES:
Analysis of Amniotic Fluid
Scanning Electron Microscopy
Robotics
Computer Systems
Testing of Biomedical Equipment
EDUCATION
Mr. Milberg graduated from The University of Miami, School of Engineering after obtaining a BS in Biomedical Engineering and then his Master’s Degree in the field.
BOARD AFFILIATIONS AND CERTIFICATIONS
Microsoft Office Suite Certified
CITI Animal Care and Use
Practical Radiologic Technologist
Basics of Extracellular Vesicles
Fluent in German and Conversant in Spanish
Zanub Abdullah
Zanub is a Cell Processing Specialist at ZEO ScientifiX™ and brings close to four years of professional experience in medical, manufacturing, quality assurance, regulatory and service environments. She is proficient in FDA rules, regulations, and current good manufacturing practices (cGMP) for research and clinical manufacturing.
RESPONSIBILITIES:
Process extracellular vesicles and perinatal-derived nanoparticles to create therapies for patients following strict FDA guidelines.
Write and revise Standard Operation Procedures (SOPs).
Responsible for laboratory maintenance, reagent receipt and inspection, data entry and analysis, stocking of supplies, and day to day functions of the laboratory.
Responsible for placing all laboratory orders and returns.
Process, store, and release therapies for clinical trails and emergency INDs.
Ivan Santos
Ivan Santos is the Biologics Manufacturing and Operations Manager at ZEO ScientifiX™. Experienced in regenerative medicine, Ivan has a strong ability to translate design requirements into actionable plans. He brings valuable experience in biotechnology and neuroscience research, and is a key contributor to the development of novel therapeutics at ZEO ScientifiX™.
Ivan is immensely adept with biologic quantification techniques such as ELISA assays, Bradford analysis, flow cytometry, Nano sight technology, and is skilled in biologic processing such as exosome isolation, and cell culturing and expansion.
He also has extensive experience with MATLAB/Simulink, Wolfram Mathematics, and Python, contributing qualitative analysis programing to biologic research and manufacturing.
SKILLS INCLUDE:
ELISA/Bradford/Flow Cytometry/Nano sight
MSCs Cell Culture/Exosomes Isolation
Quality Assurance/Validation
Extensive experience in MATLAB/Simulink, Wolfram Matematica, Python
Michael A. Bellio, Ph.D.
As the Laboratory Director at ZEO ScientifiX™, I have lead the research, development, and manufacturing of novel biological medicine for the treatment of pulmonary, cardiovascular, and orthopedic degenerative disease. Our teams mission is to advance biological medicine to offer safe and effective solutions to treat diseases. I received comprehensive training manufacturing, characterizing, and culturing primary stem cells and cell derived nanoparticles and exosomes for research, pre-clinical, and clinical regenerative medicine application at the University of Miami’s Interdisciplinary Stem Cell Institute (ISCI). This experience includes the translation of molecular biology techniques including, flow cytometry analysis, protein and RNA analysis, and fluorescence microscopy to the completion of research development and processing validation tasks required in an expanding cGMP production facility. My past research has focused on the develop of in vitro culture systems that modulate physiological levels of oxygen to better isolate and expand potent cell products for use in translational and clinical projects. More recently, I have developed a methodology for the large-scale manufacturing of exosome products from bioreactors for use in translational and pre-clinical research and presented the results at the 2019 International Society of Cell Therapy meeting as a young professional abstract awardee.
EDUCATION/TRAINING:
Sacred Heart University
B.S. – Biology
University of Miami- Miller School of Medicine
Ph.D. – Molecular and Cellular Pharmacology
University of Miami- Interdisciplinary Stem Cell Institute
Post-Doc – Clinical Cell Manufacturing
Ian T. Bothwell
From 2003 through November 2015, Mr. Bothwell served in various executive positions for Central Energy GP LLC, the general partner of Central Energy Partners LP, a publicly traded master limited partnership.
From July 2007 through November 2015, Mr. Bothwell served as President and a director of Regional Enterprises, Inc. Since April 2007, Mr. Bothwell has served as the President and controlling member of Rover Technologies, LLC, a company formed to provide management solutions to the public transportation industry. Since 2015, Mr. Bothwell has also served as the President and controlling member of CountOnMe Inc., a company that provides software solutions for the educational industry. Mr. Bothwell received his Bachelor of Science in Business Administration from Boston University in 1984.
Harry Leider, MD, MBA
Harry Leider, MD, MBA joined Organicell as CEO in June of 2023. Dr. Leider, has over 25 years’ experience as a highly successful C-suite healthcare executive and serial entrepreneur in a variety of innovative high-growth companies.
From 2018 to 2022, Dr. Leider was the Chief Medical Officer and Executive Vice President of Gelesis – a biotech company that successfully developed an FDA-cleared therapy for obesity and went public in 2022. Prior to this, he served as the Chief Medical Officer and Group Vice President of Fortune 50 – Walgreens Boots Alliance. Earlier, he was Chief Medical Officer & SVP of Ameritox – a leading national specialty lab company. He has served on the Board of Directors of Alivio Therapeutics, TytoCare, and Mobile Help.
In addition, Dr. Leider has been on the faculty of Harvard Medical School and the John Hopkins Carey School of Business. He has published over 25 articles and book chapters on healthcare and leadership and holds 5 patents in laboratory medicine. He received his medical degree from the University of Pennsylvania, an MBA from the University of Washington where he was a Robert Wood Johnson Clinical Scholar, and his undergraduate degree from Pennsylvania State University where he received the most prestigious award at graduation for leadership, academics, and community service.
Howard L. Golub, MD, Ph.D
Executive Vice President
Chief Science Officer
Dr. Howard L. Golub, MD, Ph.D was appointed Executive Vice President/Chief Science Officer in june, 2023. For over 10 years, Dr. Golub was a principal at Care-Safe LLC (a clinical research consulting company whose corporate clients included biotech/drug/medical device companies.)
He also currently serves as one of the Clinical Leads for an N.I.H. program designed to develop and accelerate accurate COVID-19 testing programs and bring them to market. From 2014 to 2016, he was Vice President of Research and Development at Walgreens Co. and developed an innovative program that utilized Walgreen’s massive customer database to power clinical trial patient recruitment. Previously, he was a founder and CEO of CareStat LLC, a 150 person CRO in the Boston Area, which was sold in 2008.
Earlier, Dr. Golub served as a serial entrepreneur, where he was one of the founders, and participated as CEO for 3 healthcare companies, two of which were successfully sold. In addition, from 2003 to 2013 he held an adjunct professorship at the Harvard-M.I.T. joint M.S., M.B.A. program and taught a course entitled “Clinical Development for Private Enterprise.”
Dr. Golub received his Ph.D. in biomedical engineering and an M.D. from that same Harvard Medical School-M.I.T. joint program.
Jackie Domenech
VP of Operations
Jackie Domenech manages operations, accounting, and financial reporting for Organicell. Ms. Domenech has over 15 years of operations and accounting management experience with companies in healthcare, media, and technology. Prior to joining Organicell, Ms. Domenech was the Controller of Equisolve, an award-winning digital agency tailored to enhance investor relations. During her tenure, she led a successful transition from an outsourced accounting provider to creating an internal accounting division.
She also served as Controller for various startups including MedicFP & MDLIVE. Most notable is MDLIVE, a telehealth company acquired by Cigna for $2 billion dollars in 2021. She is passionate about the art of entrepreneurship and has volunteered for an organization in South Florida that focuses on disrupting the market by assisting amateur entrepreneurs with developing proof of concepts and product development. Ms. Domenech received her BA in Accounting from the University of South Florida and plans to attain her CPA licensure in 2024.
Jill Swartz
Chief Product Officer
Jill Swartz is a seasoned executive with nearly two decades of executive leadership experience with highly successful healthcare businesses – specifically in the concierge medicine arena. Prior to joining Organicell, in 2015, Jill founded both PRP Science and Specialty Med Training. These ventures provided comprehensive turn-key solutions for healthcare providers in the regenerative medicine field.
Previously, Jill co-founded BodyLogicMD, the nation’s largest medical franchise of anti-aging physicians. In her 10-year tenure with the organization, as the Senior Vice President of Sales and Marketing, Jill played a pivotal role in successfully transforming over 50 physician practices.
Recognized as a thought leader and influencer, Jill’s expertise extends beyond her corporate endeavors. She serves as a distinguished speaker for The Jim Moran Institute for Global Entrepreneurship College and is actively involved at the Adams Center for Entrepreneurship at Florida Atlantic University in Boca Raton, FL. By sharing her knowledge and experiences, she inspires aspiring entrepreneurs and contributes to the growth of the business community.
Jill’s remarkable career trajectory, marked by her exceptional leadership, strategic acumen, and deep industry insights, positions her as a visionary executive capable of driving transformative success in the functional, integrative, and regenerative medicine arena.
Ian T. Bothwell
From 2003 through November 2015, Mr. Bothwell served in various executive positions for Central Energy GP LLC, the general partner of Central Energy Partners LP, a publicly traded master limited partnership.
From July 2007 through November 2015, Mr. Bothwell served as President and a director of Regional Enterprises, Inc. Since April 2007, Mr. Bothwell has served as the President and controlling member of Rover Technologies, LLC, a company formed to provide management solutions to the public transportation industry. Since 2015, Mr. Bothwell has also served as the President and controlling member of CountOnMe Inc., a company that provides software solutions for the educational industry. Mr. Bothwell received his Bachelor of Science in Business Administration from Boston University in 1984.
Julian Milberg
Julian Milberg’s background and training are in the field of engineering, specifically Biomedical Engineering. His skill and expertise in highly evolved
equipment have proven to be a major asset to the industry. He has worked with the Leica Confocal and a Leica TCS SP8 Stimulated Emission Depletion (STED) imaging modality and has instructed engineering students on the proper use and maintenance of a scanning electron microscope. His current work with Organicell in the field of Nanotechnology, specifically with the
Nano Sight NS 300 is helping the industry in looking into the field of virus and vaccine development, gene therapy, and drug delivery systems. In addition to his instructional experience, Mr. Milberg has published technical articles concerning cancer treatment.
HIS ADVANCED TRAINING INCLUDES:
Analysis of Amniotic Fluid
Scanning Electron Microscopy
Robotics
Computer Systems
Testing of Biomedical Equipment
EDUCATION
Mr. Milberg graduated from The University of Miami, School of Engineering after obtaining a BS in Biomedical Engineering and then his Master’s Degree in the field.
BOARD AFFILIATIONS AND CERTIFICATIONS
Microsoft Office Suite Certified
CITI Animal Care and Use
Practical Radiologic Technologist
Basics of Extracellular Vesicles
Fluent in German and Conversant in Spanish
Cassie Bennett, Ph.D.
Dr. Cassie Bennett holds her doctorate in biomedical engineering. She focuses in research, development, and project management within biomedical environments. Her accomplished work has led her to author and co-author numerous peer-reviewed papers, as well as several poster conference presentations. Dr. Bennett received her doctorate from The University of Miami, during which time she worked as a research assistant and lab manager until her graduation. After graduating, she joined the Organicell team to oversee quality control, the development of standard operating procedures, and quality assurance at the biomedical level.
ADVANCED TRAINING INCLUDES:
Biomedical Engineering
Gene Expression
Immunochemistry
Tissue & Blood Processing
Cell Work
Lab Management
Research
Scientific Publication
Medical & Technical Writing
EDUCATION
Dr. Bennett received her Bachelor of Science in Biological Engineering from Mississippi State University in 2016. In 2021, she graduated with her doctorate in Biomedical Engineering from The University of Miami.
BOARD AFFILIATIONS AND CERTIFICATIONS
Society Of Neuroscience | Member
American Medical Writers Association | Member
Six Sigma | Green Belt Certified
Zanub Abdullah
Zanub is a Cell Processing Specialist at Organicell Regenerative Medicine and brings close to four years of professional experience in medical, manufacturing, quality assurance, regulatory and service environments. She is proficient in FDA rules, regulations, and current good manufacturing practices (cGMP) for research and clinical manufacturing.
RESPONSIBILITIES:
Process extracellular vesicles and perinatal-derived nanoparticles to create therapies for patients following strict FDA guidelines.
Write and revise Standard Operation Procedures (SOPs).
Responsible for laboratory maintenance, reagent receipt and inspection, data entry and analysis, stocking of supplies, and day to day functions of the laboratory.
Responsible for placing all laboratory orders and returns.
Process, store, and release therapies for clincal trails and emergency INDs.
Ivan Santos
Ivan Santos is the Biologics Manufacturing and Operations Manager at Organicell. Experienced in regenerative medicine, Ivan has a strong ability to translate design requirements into actionable plans. He brings valuable experience in biotechnology and neuroscience research, and is a key contributor to the development of novel therapeutics at Organicell.
Ivan is immensely adept with biologic quantification techniques such as ELISA assays, bradford analysis, flow cytometry, nanosight technology, and is skilled in biologic processing such as exosome isolation, and cell culturing and expansion.
He also has extensive experience with MATLAB/Simulink, Wolfram Mathematics, and Python, contributing qualitative analysis programing to biologic research and manufacturing.
SKILLS INCLUDE:
ELISA/Bradford/Flow Cytometry/Nano sight
MSCs Cell Culture/Exosomes Isolation
Quality Assurance/Validation
Extensive experience in MATLAB/Simulink, Wolfram Matematica, Python
Michael A. Bellio, Ph.D.
As the Laboratory Director at Organicell Regenerative Medicine, I have lead the research, development, and manufacturing of novel biological medicine for the treatment of pulmonary, cardiovascular, and orthopedic degenerative disease. Our teams mission is to advance biological medicine to offer safe and effective solutions to treat diseases. I received comprehensive training manufacturing, characterizing, and culturing primary stem cells and cell derived nanoparticles and exosomes for research, pre-clinical, and clinical regenerative medicine application at the University of Miami’s Interdisciplinary Stem Cell Institute (ISCI). This experience includes the translation of molecular biology techniques including, flow cytometry analysis, protein and RNA analysis, and fluorescence microscopy to the completion of research development and processing validation tasks required in an expanding cGMP production facility. My past research has focused on the develop of in vitro culture systems that modulate physiological levels of oxygen to better isolate and expand potent cell products for use in translational and clinical projects. More recently, I have developed a methodology for the large-scale manufacturing of exosome products from bioreactors for use in translational and pre-clinical research and presented the results at the 2019 International Society of Cell Therapy meeting as a young professional abstract awardee.
EDUCATION/TRAINING:
Sacred Heart University
B.S. – Biology
University of Miami- Miller School of Medicine
Ph.D. – Molecular and Cellular Pharmacology
University of Miami- Interdisciplinary Stem Cell Institute
Post-Doc – Clinical Cell Manufacturing
Howard L. Golub, MD, Ph.D
Executive Vice President
Chief Science Officer
Dr. Howard L. Golub, MD, Ph.D was appointed Executive Vice President/Chief Science Officer in june, 2023. For over 10 years, Dr. Golub was a principal at Care-Safe LLC (a clinical research consulting company whose corporate clients included biotech/drug/medical device companies.)
He also currently serves as one of the Clinical Leads for an N.I.H. program designed to develop and accelerate accurate COVID-19 testing programs and bring them to market. From 2014 to 2016, he was Vice President of Research and Development at Walgreens Co. and developed an innovative program that utilized Walgreen’s massive customer database to power clinical trial patient recruitment. Previously, he was a founder and CEO of CareStat LLC, a 150 person CRO in the Boston Area, which was sold in 2008.
Earlier, Dr. Golub served as a serial entrepreneur, where he was one of the founders, and participated as CEO for 3 healthcare companies, two of which were successfully sold. In addition, from 2003 to 2013 he held an adjunct professorship at the Harvard-M.I.T. joint M.S., M.B.A. program and taught a course entitled “Clinical Development for Private Enterprise.”
Dr. Golub received his Ph.D. in biomedical engineering and an M.D. from that same Harvard Medical School-M.I.T. joint program.
George Shapiro, M.D., F.A.C.C.
Dr. Shapiro has been a practicing physician for 30 years, specializing in Internal Medicine, Cardiovascular Disease and Age Management Medicine. His career in medicine began in 1988 when he graduated from New York Medical College. An internship and residency then followed at Albert Einstein College of Medicine, after which Dr. Shapiro completed a fellowship at Columbia University College of Physicians and Surgeons in 1994, focusing on Cardiovascular Disease Management, including Congestive Heart Failure and Heart Transplantation.
Dr. Shapiro was the recipient of the 10th Annual Alan P. Mintz, M.D. Award, for Clinical Excellence in Age Management Medicine, as he has become known nationwide as an expert in age management medicine, and leads one of the most prominent age management practices in the country as president of Cenegenics New York City.
Always challenged by the need for innovative medicine, Dr. Shapiro has patented medical devices as well as explored and innovated new medical protocols. He has long been known as one of New York’s foremost cardiologists, specializing in regenerative medicine and improving longevity, including the genomics of cardiovascular disease and congestive heart failure.
Dr. Shapiro is active in 13 medical societies, has been a speaker for the Age Management Medicine Group (AMMG) group for many years, and is a long-standing member of the AMMG Conference Planning Committee. Dr. Shapiro was named 2016-2020 Top Doctor in New York City.
