​2022 Conference Speakers

The Perinatal Stem Cell Society is hosting:
Industry Workshop to present a RoadMap to FDA for the future of Biologics.
Westin Beach Resort in Fort Lauderdale, Florida
​November 3, 2022

Click on images to read full bios

​Kyle Cetrulo
President of the Perinatal Stem Cell Society Welcome ​

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Camillo Ricordi, M.D. 
Professor of Surgery, Director of the Diabetes Research Institute and Cell Transplant Center at the University of Miami, Florida. Research interests include diabetes cure-focused research, cellula therapies, immune tolerance, regenerative and healthspan medicine. Ricordi is well-known for inventing the technology that made it possible to isolate large numbers of pancreatic islets and for performing the first series of successful clinical islet allotransplants that reversed diabetes. 

​Conference Presentation Topic: Perinatal Stem Cell to Defeat the Pandemics of the 21st Century: Viral, Autoimmune and Degenerative Diseases Associated to Unhealthy Aging

In 2020 he led the international team that successfully completed the first FDA approved controlled trial to treat severe cases of COVID-19 with Umbilical Cord Mesenchymal Stem Cells infusions that was subsequently authorized by the FDA to move to Phase 3. He recently launched an initiative Fit4Healthspan.org to promote resistance to disease progression following  viral infections, with strategies that are now also studied to prevent or halt progression of autoimmune diseases and age related chronic degenerative conditions, to prolong healthy lifespan.
 
Ricordi has received numerous honors and awards, was Knighted by the President of the Republic of Italy and was inducted into the Association of American Physicians (AAP) and into the National Academy of Inventors for contributing outstanding inventions that have made a tangible impact on quality of life, economic development, and welfare of society. He also served on Supreme Council of Health (Consiglio Superiore di Sanita’) of the Ministry of Health of Italy, and was founding president of The Cure Alliance.

Ricordi contributed over 1,175 publications, that received over 50,000 citations, has 112 H-index and 27 patents awarded.

Camillo Ricordi, MD
Perinatal Stem Cell to Defeat the Pandemics of the 21st Century: Viral, Autoimmune and Degenerative Diseases Associated to Unhealthy Aging

Bernie Siegel
As the Executive Director of the Regenerative Medicine Foundation and the Founder & Chair
World Stem Cell Summit, Bernie Siegel has a unique perspective on the direction that the Perinatal stem cell field is headed.

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Peter Marks, MD, PhD
Director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. The center is responsible for assuring the safety and effectiveness of biological products, including vaccines, allergenic products, blood and blood products, and cellular, tissue, and gene therapies.


Conference Presentation Topic: ​TBA

Peter Marks, MD, PhD
Director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration

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Duncan Ross Ph.D

​Conference Presentation Topic: Exosome Characterization and Regulatory Considerations

Dr. Duncan Ross is an expert in stem cell culture and has developed and patented proprietary methods of stem cell manipulation and licensing using growth factors and nucleic acids. A native of Miami Beach, Florida, Dr. Ross earned a Bachelor of Science in Microbiology and Immunology and a Ph.D. in Immunology/Biochemistry from the University of Miami in Coral Gables, Florida, where his research focused on mechanisms of suppression of graft vs. host disease in minor antigen mismatched allogeneic hematopoietic stem cell transplantation.
 
As founder of Kimera® Labs, Inc., Dr. Ross’s work is focused on controlling disease with immunological molecular approaches, in particular, exosome isolation from perinatal cells and amniotic fluid. As a pioneer in the development of cell-free exosome products, Dr. Ross’s research has been and continues to be employed by many physicians and clinics in a variety of regenerative medicine protocols. 

Dr. Ross has been featured in various peer reviewed publications including “Blood” and “Biology of Blood and Marrow Transplantation”, in which he discussed the use of various cell types to suppress immunological diseases, and currently has a patent pending for wound healing exosomes.

Dr. Ross is also the founding board member of the federal nonprofit research organization, The Kimera® Society, which has developed a number of clinical partners in the US and abroad by serving as an educational conduit for clinics.

Duncan Ross PhD
Exosome Characterization and Regulatory Considerations​

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Barbara Krutchkoff, PhD FAARM
Executive Director, Institute of Regenerative and Cellular Medicine
CEO of A3Cell/Consultancy
Visiting Lecturer, Universite Paris Descartes
Director of Cell and Gene Applications USAuthentic Trading

Conference Presentation Topic:  Role of the IRB in Cell Therapy

Barbara Krutchkoff, PhD is a consultant for physicians and biomedical start-up companies in regenerative and cellular medicine. She is Executive Director of the Institute of Regenerative and Cellular Medicine, and Chair of the IRCM IRB, which provides support for translational research and validation of regenerative therapies. Her A3Cell/Exponential Resources consultancy helps venture funds, biotech entrepreneurs, and clinics vet the latest technology, strategize develop market strategies, navigate the regulatory pathway, as well as design and manage clinical studies. Barbara has worked tirelessly throughout her 25+ year career to engage with university and industry leaders and help to bring regenerative medicine safely to patients. As Chief of Scientific Affairs for Lipogems US, Barbara successfully gained FDA approvals, funding, and national distribution for an international start-up with a novel medical device wishing to enter the US market. She co- founded LSMRI, which facilitates translational research, and has developed a portfolio of innovative biologics and highly personalized therapeutic protocols. She currently serves on advisory boards of a variety of companies and organizations, including KLOTHO Therapeutics, RareCells, Personalized Stem Cells, and the Academy of Innovative Cancer Strategies. Her diverse educational background includes physics and computer science at the University of Florida, biomedical engineering graduate studies at Virginia Tech, Doctoral programs in behavioral phycology and integrative medicine, Stem Cell Fellowships at A4M and UCLA where she spent two years in the lab working with Bruno Peault focused on the basic science and mechanism of action of MSCs. Barbara is a board-certified Diplomat and Fellow of the AABRM (American Academy and Board of Regenerative Medicine). Barbara presents at various scientific conferences within the US and internationally and is currently involved in developing a platform for medical AR/VR training.  She is an adjunct lecturer at the Universite Paris Descartes.  Barbara, via IRCM, has helped to design and oversee over 400 clinical studies. She is on the IRCM/Regenerative Outcomes committee for the NIH outcomes registry and currently engaged in an initiative to employ blockchain to revolutionize clinic trial data collection and bioinformatics.

Ian White, PhD 
Purified amniotic fluid used in clinical research and clinical trials​

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Dr. Maria Ines "Mari" Mitrani.
Chief Science Officer and co-founder of Organicell Regenerative Medicine. For the past 14 years

Conference Presentation Topic:  Clinical Update of a Human Amniotic Fluid Derived Extracellular Vesicle Biologic

Dr. Mitrani has led Organicell in developing innovative treatments to various health conditions. She was most recently recognized as one of the ‘Top 100 Healthcare Leaders’ by IFAH for her work spearheading COVID-19 therapeutics. Over the past few years, Dr. Mitrani has built a team of forward-thinking scientists and researchers and has received several FDA approvals to conduct clinical trials; these include COVID-19 acute and Long Hauler sequelae, Chronic Obstructive Pulmonary Disease, and Knee Osteoarthritis.
 
Dr. Mitrani started her work in her native country, Ecuador, where she co-founded the American Cellular & Anti-Aging Center in Quito, one of the first Autologous Stem Cell centers in South America and was instrumental in opening additional stem cell clinics in Guatemala, Trinidad & Tobago, and Jamaica. Her background in international aid to underprivileged and underserved people granted her the Humanitarian Award by the Ecuadorian Congress in 2016.

​Maria Ines "Mari" Mitrani, MD
Clinical Update of a Human Amniotic Fluid Derived Extracellular Vesicle Biologic
 

Bert Lao

Marcus Kaiser

Mike Druckman

Beth Roxland

Mike Druckman, Beth Roxland, Bert  Lao and Marcus Kaiser 
Legal and ethical challenges to getting innovative cell and tissue therapies to patients sooner

• Bert Lao is a senior associate in the Pharmaceutical and Biotechnology practice at Hogan Lovells, and provides guidance to clients on a broad array of topics as they navigate one of the most heavily regulated industries in the United States.
• Marcus Kaiser advises clients in the pharmaceutical, medical devices and biotech industry on all kinds of commercial and regulatory aspects from a German and European perspective. He is a German qualified lawyer and located in Berlin, Germany. Marcus's work focuses on regulatory advice on pharmaceutical and medical device law, contract drafting for different stakeholders in the life sciences sector, advertising matters as well as HCP compliance.
• Mike Druckman is a partner in the Pharmaceutical and Biotechnology practice at Hogan Lovells, and formerly served in FDA’s Office of the Chief Counsel.  He advises clients developing regenerative medicine therapies and biologics on a wide range of FDA regulatory issues.  He also co-chairs the firm’s Global Cell, Tissue, and Gene Therapy Team, which is over 140 members strong, spanning 5 continents and a wide range of disciplines, including intellectual property, corporate, litigation, all manners of regulation, and even cybersecurity, real estate, and environmental.
• Beth E. Roxland, J.D., M.Bioethics, is an Attorney and Bioethicist with multifaceted experience across Industry, Government, Law, and Academia. She is the Founder of Roxland Consultants, Ltd., where she serves as an independent advisor to biotechnology and life-science entities, academic medical centers, law firms, and professional and patient associations, providing strategic support and guidance on complex regulatory, ethical, operational and communications challenges. In this role, Beth has successfully assisted clients navigating policy issues involving Expanded Access, Compassionate Use and Right-to-Try Laws.