Why Should You Attend:
Stem cells have ability to differentiate into numerous cells upon various stimulations. This has led to their wide utilization across several therapeutic areas of medicine, including high risk diseases. Of course, significant scientific breakthroughs in the use of stem cells to prevent, diagnose, and treat numerous diseases has caused numerous start-up companies to form. Despite, such promise, the FDA has yet to approve stem cell therapies for a wide range of diseases, except cord blood-derived hematopoietic progenitor cells for certain indications.
This session will provide an historical context for the use of stem cells in medicine, where the field has been and where it is going. FDA's regulations and policies updates for regenerative medicine including stem cell treatments, tissue engineering and gene therapies will be reviewed as well as updates on policies regarding regenerative combination products and devices. It will also provide the few examples of FDA approved use of stem cells in medicine and what is needed for the field to progress and practical solutions for staying compliant and avoid FDA warning letters during audit.
Areas Covered in the Webinar:
Provide an overview for preclinical and clinical development phase for HCT/Ps
Discuss fundamentals of HCT/Ps development and regulatory requirements
Provide an overview for FDA’s regulatory approvals process for HCT/Ps
Discuss FDA guidance documents and most recent policies updates for regenerative medicine and stem cell technologies
Applicable good manufacturing and good laboratory practices
Product labeling, marketing and advertising
Discuss post-licensure requirements
Stem cells have ability to differentiate into numerous cells upon various stimulations. This has led to their wide utilization across several therapeutic areas of medicine, including high risk diseases. Of course, significant scientific breakthroughs in the use of stem cells to prevent, diagnose, and treat numerous diseases has caused numerous start-up companies to form. Despite, such promise, the FDA has yet to approve stem cell therapies for a wide range of diseases, except cord blood-derived hematopoietic progenitor cells for certain indications.
This session will provide an historical context for the use of stem cells in medicine, where the field has been and where it is going. FDA's regulations and policies updates for regenerative medicine including stem cell treatments, tissue engineering and gene therapies will be reviewed as well as updates on policies regarding regenerative combination products and devices. It will also provide the few examples of FDA approved use of stem cells in medicine and what is needed for the field to progress and practical solutions for staying compliant and avoid FDA warning letters during audit.
Areas Covered in the Webinar:
Provide an overview for preclinical and clinical development phase for HCT/Ps
Discuss fundamentals of HCT/Ps development and regulatory requirements
Provide an overview for FDA’s regulatory approvals process for HCT/Ps
Discuss FDA guidance documents and most recent policies updates for regenerative medicine and stem cell technologies
Applicable good manufacturing and good laboratory practices
Product labeling, marketing and advertising
Discuss post-licensure requirements
Agenda
- Provide an overview for preclinical and clinical development phase for HCT/Ps
- Discuss fundamentals of HCT/Ps development and regulatory requirements
- Provide an overview for FDA’s regulatory approvals process for HCT/Ps
- Discuss FDA guidance documents and most recent policies updates for regenerative medicine and stem cell technologies
- Applicable good manufacturing and good laboratory practices
- Product labeling, marketing and advertising
- Discuss post-licensure requirements
Speakers
Marina Malikova, Ph.D., MSci, MA, CCRA, RAC - Executive Director, Surgical Translational Research: Operations and Compliance.Dr. Malikova has over 20 years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.
Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.
In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and macro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.
Dr. Malikova has 10 years of teaching experience as an Instructor for Clinical and Biomedical Sciences Program, Metropolitan College. She has developed and taught several courses such as: Design and Conduct of Clinical Trials, Drug Development, Introductory Pharmacology, Clinical Trials Management at Boston University, School of Medicine.
She also served as an Instructor of the Good Clinical Practices (GCPs) course for the Master of Science Program in Clinical Investigation, Division of Graduate Medical Sciences, Boston University, School of Medicine since Summer, 2012.
Dr. Malikova is a member of Association for Clinical Research Professionals (ACRP), Drug Information Association (DIA), Regulatory Association Professionals Society (RAPS) and European Society of Radiology (ESR). Currently, she is serving as an Editor for SAGE publishing group and National Institute of Health (NIH) reviewer for grants and clinical trial proposals.
