Advanced Therapy Medicinal Products (ATMP) in South & Central America.

When:  Nov 29, 2022 from 12:00 to 13:30 (ET)

Advanced Therapy Medicinal Products (ATMP) in South & Central America. Is regulation part of the problem or the solution?

Presented by the ISCT South & Central America Legal & Regulatory Affairs Committee (SCA LRA)

November 29, 2022
09:00 PT | 12:00 ET | 14:00 CLT/BRT

Note the LIVE event is Open Access however the recording will only be made available to ISCT Members.  


Webinar Description:

Advanced medical therapies and cell therapies are in worldwide expansion. However, deployment in some South & Central American locations often times encounter legal voids or a wrong ethical balance for the protection of research subjects versus the benefits of participation. We will succinctly address the components of present day regulatory guidelines in the US, Japan and Europe in contrast with the emerging efforts in Latin America. In a final expert panel we will discuss steps towards harmonization that might foster multicentric international clinical trials and how LATAM regulatory panels can contribute to such coordination.

Key Learning Objectives:

  • Provide an overview of the scope of current cell therapies
  • Discuss a schema for the main components of the regulatory framework for ATMPs in the US, Japan and Europe, indicative of time-served pathways
  • Cover the more recent 2018 requirements established by the Brazilian Health Surveillance Agency for ATMP clinical trials
  • Discuss steps that could contribute to the establishment of harmonized guidelines, enabling the development of research and clinical trials of ATMPs in the South and Central American region.

Chaired By: 


Fernando E. Figueroa, MD, FACP
Professor of Medicine
Universidad de los Andes School of Medicine
Santiago, Chile


Dr. Figueroa is the Head of the Division of Rheumatology and Program Director for Translational Research in Cell Therapy at Universidad de los Andes. He is a former Dean of the School of Medicine and founder of “Cells for Cells”, a “spin-off” from his home University. His expertise is focused mainly on Translational research in Osteoarthritis and Connective Tissue Diseases and he has authored numerous papers within the field of Mesenchymal Stromal Cell Biology and Regenerative Medicine. He is the Co-Chair of the ISCT South and Central America Legal and Regulatory Affairs Committee (SCA LRA).



Bruce Levine, PhD
Barbara and Edward Netter Professor in Cancer Gene Therapy
Founding Director, Clinical Cell and Vaccine Production Facility
University of Pennsylvania Perelman School of Medicine
United States

Dr. Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, is the Founding Director of the Clinical Cell and Vaccine Production Facility (CVPF) in the Department of Pathology and Laboratory Medicine and the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania. He received a B.A. (Biology) from Penn and a Ph.D. in Immunology and Infectious Diseases from Johns Hopkins. First-in-human adoptive immunotherapy trials include the first use of a lentiviral vector, the first infusions of gene edited cells, and the first use of lentivirally-modified cells to treat cancer. Dr. Levine is co-inventor of the first FDA approved gene therapy (Kymriah), chimeric antigen receptor T cells for leukemia and lymphoma, licensed to Novartis. Dr. Levine is co-inventor on 29 issued US patents and co-author of >200 manuscripts and book chapters with a Google Scholar citation h-index of 97. He is a Co-Founder of Tmunity Therapeutics, and of Capstan Therapeutics both spinouts of the University of Pennsylvania. Dr. Levine is a recipient of the William Osler Patient Oriented Research Award, the Wallace H. Coulter Award for Healthcare Innovation, the National Marrow Donor Program/Be The Match ONE Forum 2020 Dennis Confer Innovate Award, serves as President of the International Society for Cell and Gene Therapy, and serves on the Board of Directors of the Alliance for Regenerative Medicine. He has written for Scientific American and Wired and has been interviewed by the NY Times, Wall Street Journal, Washington Post, NPR, Time Magazine, National Geographic, Bloomberg, Forbes, BBC, and other international media outlets.



Christopher Bravery, PhD
Consulting Regulatory Scientist
United Kingdom


Christopher founded Consulting on Advanced Biologicals Ltd at the end of 2009 in order to support those developing ATMP and other novel biological medicines. Advbiols focuses on the application of regulatory science to preclinical and quality, along with European regulatory strategy. In addition to providing consulting services, Christopher also runs workshops on various topics.  Christopher has a PhD in xenotransplantation immunology and spent 8 years in biotech (Imutran Ltd, A Novartis Pharma AG Co. and Intercytex) before joining the MHRA as a quality (CMC) assessor (biologicals and biotechnology unit). During this time Christopher was involved with National implementation of the new Advanced Therapies Regulation and also involved through his participation in the CHMP’s cell products working party (CPWP) in implementation at the EMA level including drafting guidelines. 


Renata Miranda Parca, MSc
Health Regulation Specialist
Blood, Tissues, Cells and Organs Office - GSTCO


Renata Parca, biologist, Msc in animal biology, health regulation specialist at Anvisa, working in regulation of blood, tissues, cells and ATMP since 2005.

Antonio Carlos Campos de Carvalho, MD, PhD
Professor of Physiology and Biophysics
Federal University Of Rio De Janeiro


Antonio holds an MD./PhD from the Federal University of Rio de Janeiro, where he is currently Professor of Physiology and Biophysics. He has a special interest in cardiovascular science. For the last 22 years Antonio have been focusing his research interest on stem cells and cell therapies for cardiac diseases. In this field he has been conducting basic, translational and clinical research, which puts him in a privileged position to critically evaluate the need of research from bench to bedside and from the bedside back to bench. In Brazil Antonio coordinates the Brazilian Cell Therapy Network, an initiative of the Ministry of Health to speed translational research in this important area of the health sciences, and the National Institute for Science and Technology in Regenerative Medicine, whose mission is to provide advanced therapy medicinal products for the treatment of chronic/degenerative and infectious diseases.

Andrea Basagoitia, (CL)RPh, PhD (Panelist)

Senior Regulatory Advisory for Medical Devices and Digital Therapeutics
Chief Behavioural Officer, Snabb SpA
President of the Regulatory Committee, Pro Salud Chile A.G.


Dr. Basagoitia is a Pharmacist and has a Ph.D in Exact Science. She works as a HEOR and VBHC Senior Advisor and as a Senior Regulatory Advisor for Medical Devices and Digital Therapeutics. As a CBO at Snabb SpA. She is a Member of the HL7Chile Board and also the President of the Regulatory Committee at Pro Salud Chile A. G. She is a former Health Economics & Market Access Manager MD&D Southern Cone for Johnson & Johnson Medical Companies (2017-2019).  She was also the Chief of Studies and HTA for the Scientific Affairs Division at the Public Health National Institute. ISP. CHILE (2013-2017), Chair of the Research Advisory Council of the Chilean Institute of Public Health (2014-2017), Full Member of the National Commission of HTA since (Nov. 2013 - April 2017), Member of the National Commission of Medical Devices (2015 - 2017), and Mmber of VBHC Center Europe, ISPOR “International Society for Pharmacoeconomics and Outcomes Research” and RAPS "Regulatory Affairs Professional Society”. 




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