2022 Conference Speakers November 3, 2022

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

Upcoming Virtual Conferences

Close-up of a smiling man with light brown hair, wearing glasses and a blue suit outdoors.

Kyle Cetrulo

President of the Perinatal Stem Cell Society Welcome ​

  • Kyle Cetrulo
    President and Founder, Perinatal Stem Cell Society
    Co-Founder and CEO, Auxocell Laboratories, Inc.

    ​Conference Presentation Topic: Clinical Trials with Perinatal Cells

    Kyle Cetrulo has been interested in Perinatal Stem Cells and non-profit organizations since 1998.  As the former Director of the International Cord Blood Society (ICBS), Mr. Cetrulo organized the 5th and 6th International Congresses for the ICBS in 2002 and 2004, which had representatives from 23 countries participate in the meetings.

    In 2008, Mr. Cetrulo co-founded Auxocell Laboratories, Inc. (Auxocell).  Auxocell achieved profitability in three years under his leadership and Mr. Cetrulo currently remains in the position of Chief Executive Officer at Auxocell.  Editor of two editions of Perinatal Stem Cells (Wiley Press, 2010 and 2013) and 2006 guest editor of the Stem Cell Reviews journal special edition focused on Perinatal Stem Cells, Mr. Cetrulo developed relationships with the world’s preeminent stem cell researchers working in the perinatal stem cell field.

    In 2013, Mr. Cetrulo along with his co-founders, decided to form the non-profit International Perinatal Stem Cell Society, Inc., in order to provide a platform for collaboration and the dissemination of knowledge and information about perinatal stem cells.

A man wearing glasses and a white medical coat, standing in front of a blue background with a computer monitor.

Camillo Ricordi, MD

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

  • 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.

A man with dark hair and a beard wearing a light blue dress shirt, posing against a neutral background.

Duncan Ross, PhD

Exosome Characterization and Regulatory Considerations​

  • Duncan Ross, Ph.D.
    Founder of Kimera Labs, Inc.

    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.

A woman with long dark hair in a white medical coat, smiling, in a professional portrait.

Maria Ines "Mari" Mitrani, MD

Clinical Update of a Human Amniotic Fluid Derived Extracellular Vesicle Biologic

  • 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.

Professional man in a suit and glasses smiling in an office setting

Marcus Kaiser

Marcus Kaiser advises clients in the pharmaceutical

    • 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.

A man with gray hair and glasses wearing a dark suit, white shirt, and purple tie, speaking or gesturing in a formal setting.

Peter Marks, MD, PhD

How FDA Regulates Perinatal Stem Cell and Tissue Products​.

  • 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: ​How FDA Regulates Perinatal Stem Cell and Tissue Products

A smiling middle-aged man with gray hair, glasses, wearing a black suit, white shirt, and a yellow tie.

Bernie Siegel

The Future of Regenerative Medicine

  • Bernie Siegel
    Executive Director of the Regenerative Medicine Foundation and the Founder & Chair World Stem Cell Summit.

    Conference Presentation Topic:  The Future of Regenerative Medicine

    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.

A man in a suit smiling in an indoor setting

Bert Lao

Bert Lao is a senior associate in the Pharmaceutical and Biotechnology

    • 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.

A woman with shoulder-length brown hair, smiling, wearing a white top, outdoors with greenery in the background.

Beth E. Roxland

Beth E. Roxland, J.D., M.Bioethics, is an Attorney and Bioethicist with multifaceted experience

    • 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.

Headshot of a man in a suit and tie smiling, with glasses and short hair, in front of a modern office building

Mike Druckman

Perinatal Stem Cell and Tissue Products Regulation

  • Mike Druckman
    Chairs the Hogan Lovell’s Cell, Tissue, and Gene Therapies Working Group

    Conference Presentation Topic: Perinatal Stem Cell and Tissue Products Regulation

    Mike Druckman leverages his prior experience at the FDA in the Office of the Chief Counsel and what he has learned since then while extricating companies from regulatory problems to anticipate and prevent life science clients from getting into trouble in the first place.

    Mike chairs the Hogan Lovell’s Cell, Tissue, and Gene Therapies Working Group, a cross-disciplinary team that advises companies in this emerging space on the evolving regulatory and business challenges they face. Mike and the team work closely with companies developing stem cells, cord blood, placental tissues, gene therapies, proteins, and other cellular and tissue products to help people with serious health problems.  Mike also advises companies with a full range of regulatory challenges involved in investigating new drugs, biologics, and combination products, obtaining FDA approval for those products, and in promoting, selling, and distributing them.