Module II: Best Practices in Regenerative Medicine

MMI Stem 1
MMI Stem 2

“This activity is jointly provided by Global Education Group and Metabolic Medical Institute.”

Target Audience

The educational design of this activity addresses the needs of Internal Medicine, Cardiology, Oncologists, Orthopedics, Sports Medicine, Nurse Practitioners, Physician Assistants involved in the treatment of patients using stem cells.

Statement of Need/Program Overview

This module aims to improve the safe use of stem cell therapy, regenerative medicine as a revolutionary approach to restore, rejuvenate, and regenerate cells, tissue, or organs that are diseased or injured.

Educational Objectives

After completing this activity, the participant should be better able to:

  • Develop expert understanding of the harvesting methods employed for autologous bone marrow, adipose, and peripheral blood stem cell procedures
  • Discuss the risks, benefits, applications, and current legalities surrounding cell cryopreservation and cell banking
  • Review the concepts and implementation of Good Tissue Practices (GTP) and Good Manufacturing Practices (cGMP) as it relates to the field of regenerative and translational medicine
  • Investigate guidelines surrounding Institutional Review Board (IRB) approved clinical studies and their importance in the field of regenerative and translational medicine
  • Analyze current state, US governmental and worldwide agency position on human cells, tissues, and cellular and tissue-based products
  • Review the ethical considerations surrounding cellular therapy

Physician Accreditation Statement

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Global Education Group (Global) and Metabolic Medical Institute. Global is accredited by the ACCME to provide continuing medical education for physicians.

* This CME/CE activity complies with all requirements of the federal Physician Payment Sunshine Act. If a reportable event is associated with this activity, the accredited provider managing the program will provide the appropriate physician data to the Open Payments database.

Physician Credit Designation

Global Education Group designates this live activity for a maximum of 26.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Disclosure of Conflicts of Interest

Global Education Group (Global) requires instructors, planners, managers and other individuals and their spouse/life partner who are in a position to control the content of this activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly vetted by Global for fair balance, scientific objectivity of studies mentioned in the materials or used as the basis for content, and appropriateness of patient care recommendations.

Americans with Disabilities Act

Event staff will be glad to assist you with any special needs (ie, physical, dietary, etc). Please contact ______Laura D’Onofrio____ prior to the live event at (561) 997-0112.

For information about the accreditation of this program, please contact Global at 303-395-1782 or inquire@globaleducationgroup.com.

Module II: Session Schedule

Thursday May 19, 2016

7:30-8:00 am

Introduction to Best Practices in Regenerative Medicine

Sharon McQuillan, MD

8:00-9:30 am

Bone Marrow Harvesting Methods with Video Demonstration

Sharon McQuillan, MD

9:30-9:45 am

BREAK

 

9:45-10:45 am

Bone Marrow-Derived Stem Cell Isolation Methods

Marcela Salgado, MD

10:45-11:45 am

Peripheral Blood Harvesting and Cell Isolation Methods

Anasua Kusari, PhD

11:45-1:15 pm

LUNCH

 

1:15-3:15 pm

Adipose Tissue Harvesting Methods with Video Demonstration

Sharon McQuillan, MD

3:15-3:30 pm

BREAK

 

3:30-5:00 pm

Adipose Derived Stem Cell Isolation Methods

Marcela Salgado, MD

5:00-5:45 pm

Importance of Cell Product Standardization

Rafael Gonzalez, PhD

5:45-6:30 pm

Cell Validation Methods and Interpretation

Rafael Gonzalez, PhD

Friday May 20, 2016

7:30-8:30 am

Biology & Harvesting of Platelet Rich Plasma & Platelet Rich Fibrin Matrix

Luis Rodriguez-Menocal, PhD

8:30-9:00 am

Role of Exosomes & Microvesicles in Regenerative Medicine

Marcela Salgado, MD

9:00-10:00 am

Autologous Adult Cell Cryopreservation & Banking Techniques

Rafael Gonzalez, PhD

10:00-10:15 am

BREAK

 

10:15-11:15 am

Cell Banking Regulations and Requirements

H. Thomas Temple, MD

11:15-12:15 pm

Overview of FDA Regulation for Significant Risk Clinical Trials

Kevin MacDonald

12:15-1:45 pm

LUNCH

 

1:45-2:30 pm

Current Good Tissue Practices (GTP) and their Application in Your Practice

Marisol Castro-Paiz

2:30-3:15 pm

Role of Good Manufacturing Practices (cGMP) in Regenerative Medicine

Marisol Castro-Paiz

3:15-3:30 pm

BREAK

 

3:30-4:30 pm

Implementing Good Clinical Practices (GCP) in a Medical Office Setting

Yvette Jivanjee, MS

4:30-5:30 pm

Importance of Good Laboratory Practices (GLP) in Regenerative Medicine

Nelson Piludu, MT

5:30-6:30pm

Live Case Study Evaluations in HCT/Ps, cGMP, GLP, GCP

Faculty Panel

Saturday May 21, 2016

7:30-8:30 am

Current FDA Position Regarding HCT/P’s, Stem Cells, etc.

Sharon McQuillan, MD

8:30-9:30 am

FDA Case Reports Regarding HCT/P’s

Faculty Panel

9:30-9:45 am

BREAK

 

9:45-10:45 am

Regulatory Affairs in Regenerative Medicine: World View

Sharon McQuillan, MD

10:45-11:45 am

Medical Tourism: Issues, Implications, Insight

Sharon McQuillan, MD

11:45-1:15 pm

LUNCH

 

1:15-2:15 pm

Introduction to Cell Culturing and Expansion

Raphael Gonzalez, PhD

2:15-3:15 pm

Tissue Engineering Overview

Aymee Perez, PhD

3:15-3:30 pm

BREAK

 

3:30-4:30 pm

Use of Biomaterials in Regenerative Medicine

Aymee Perez, PhD

4:30-5:30 pm

Role of Clinical Research and IRB Studies in Regenerative Medicine

Yvette Jivanjee, MS

5:30-6:00 pm

Gearing Up for Clinical Research in a Medical Office Setting: Road Map for Success

Nelson Piludu, MT Marcela Salgado, MD

Marisol Castro-Paiz, PhD

Marisol Castro-Paiz, PhD

An accomplished and highly skilled scientist dedicated to the research and development of pharmaceuticals and medical products from early discovery through regulatory and clinical development. Extensive experience managing pre-clinical and clinical research and development projects in biological sciences, immunology, ophthalmology, study design, assay development, biomarker analysis, and scientific writing. In multidisciplinary product development and research project teams, utilizes scientific knowledge and technical expertise to design experiments, address complex questions, and interpret results in the broader context of the project. Demonstrates attention to detail and strong written and verbal communication skills in effectively managing collaborations and relationships with clinical investigators and CROs, developing and writing study protocols, and preparing high quality reports and publications. Proven contributor and leader, motivated by continually learning, applying knowledge and experience to new challenges, and ensuring the continued success of an organization.

Rafael Gonzalez, Ph.D and associates

Rafael Gonzalez, Ph.D

Dr. Gonzalez serves as Vice President of Research & Development at DaVinci Biosciences and is responsible for the development of clinical stem cell applications for several disease/trauma states. Dr. Gonzalez has been Member of Advisory Board at BioStem Technologies, Inc. since October 2014. Dr. Gonzalez has expertise in degenerative disorders involving the spinal cord and has extensive experience in stem cell culture and biology from human embryonic, pre-natal and adult sources. Prior to joining DaVinci Biosciences, Dr. Gonzalez served as a Research Scientist at PrimeGen Biotech where he was responsible for the design and execution of experiments involving adult (bone marrow, menstrual blood, adipose) and pre-natal stem cells (neural, bone marrow, liver, gonadal) for potential clinical application. Dr. Gonzalez was also responsible for developing PrimeGen's pre-clinical stem cell/spinal cord injury model. Dr. Gonzalez developed his thesis at the Reeve-Irvine Research Center, University of California, Irvine, under the advisory of Dr. Hans Keirstead, entitled: "The Role of the Chemokine CXCL10 in Secondary Degeneration Following Spinal Cord Injury". Pre-clinical studies conducted during this time lead by Dr. Gonzalez were aimed at reducing secondary degenerative effects. The studies conducted by Dr. Gonzalez and Dr. Keirstead precipitated the start-up of Ability Biomedical, a company that developed anti-IP10 antibody, an antibody which can be used to treat several degenerative disorders such as multiple sclerosis, rheumatoid arthritis, and SCI. Ability Biomedical was purchased by Medarex in 2007 which was purchased by Bristol-Myers Squibb that sponsors a phase II clinical trial using anti-IP10 antibody (MDX-1100). He also was involved with preclinical studies in the development of the use of human embryonic stem cells into spinal cord injury. Dr. Gonzalez has several scientific publications in the field of stem cells, spinal cord injury and the immune system. Dr. Gonzalez received his BS in Biological Science and his Ph.D. in Anatomy and Neurobiology from the University of California, Irvine, CA.

Yvette Jivanjee, MS

Yvette Jivanjee, MS

A Clinical Research Professional with 17 years of experience within the Academic and Biomedical industries. Yvette has led clinical and quality teams to achieve site compliance by providing training and education on SOPs, GCP, documentation practices, ICF process, AE/SAE reporting & CAPA implementation & effectiveness, while maintaining a professional relationship with the Sponsor, PI and research study teams.

Yvette has formerly held Quality Assurance/Regulatory Affairs Manager positions within the biomedical industry at BioTissue, Inc. and TissueTech, Inc. and is currently a Senior Clinical Research Monitor at the University of Miami School of Medicine.

Therapeutic Areas: Oncology, Stem Cell Research, Medical Device, Regenerative Biologic Therapy, Kidney & Pancreatic Islet Cell Transplantation, Ophthalmology, Dermatology & Cutaneous Surgery, Spinal Cord Injury and Hepatology.

Manufacturing Experience: Development of 510 (k) Class II Medical Device, Cosmetics & Human Cell Tissue Products.

Anasua Kusari, PhD

Anasua Kusari, PhD

Dr. Anasua Kusari is a scientist and Molecular Biology Core Manager at DaVinci Biosciences. She has decades of expertise in cell signaling and protein-protein interactions in mammalian cells. For last several years she has been working with stem cells. Currently, Dr. Kusari is working on developing a better understanding of the differentiation of cartilage from bone marrow stromal cells at the molecular level. She has many publications of her work in peer reviewed journals.

Kevin MacDonald

Kevin MacDonald

Kevin has more than 25 years of experience and a successful track record with achieving regulatory market clearances/approvals in the United States and abroad.

 His main area of expertise is as a regulatory, clinical, and quality consultant working with small medical device startup companies. He has held Vice President positions at NeoTract, Concentric Medical and RA/CA/QA positions with Fox Hollow Technologies, Heartport, Cordis, Boston Scientific Corporation, and CR Bard.

Sharon McQuillan, MD

Sharon McQuillan, MD

Dr. McQuillan is a board certified physician who specializes in aesthetic, anti-aging, and regenerative medicine.  She founded The Ageless Aesthetic Institute-a level 4 ACCME accredited aesthetic training program for medical professionals in order to standardize and elevate the practice of aesthetic medicine.  Dr. McQuillan has educated thousands of medical professionals in the art and science of aesthetic and anti-aging treatments for over a decade.  Dr. McQuillan lectures internationally on aesthetic and regenerative medicine for many organizations and is the medical director of The Aesthetic Fellowship, hosted by the American Academy of Anti-Aging Medicine.   The Fellowship is a six-part didactic plus hands-on clinical experience medical education program in aesthetic procedures, offering certification via written and case study examination for its attendees.

Dr. McQuillan has been featured in Dermatology Times, Vogue, Medical Spa Report, Medesthetic, Miami Herald, Aesthetic Guide and on Telemundo and Good Morning America.

Dr. McQuillan owns and operates the Ageless Institute in Aventura, FL offering anti-aging, aesthetic, regenerative, and weight loss treatments.  In 2009, Dr. McQuillan forms the Ageless Regenerative Institute in conjunction with a team of experts in stem cell therapies.  This expert team has has developed an approved method and protocol for the harvesting and isolation of adipose-derived stem cells for autologous transplantation.

Nelson Piludu, LMT

Nelson Piludu, LMT

Nelson R Piludu Nelson R Piludu is a Medical Technologist by training and has over 10 years experience in the Clinical Research industry. He studied Medicine in Universidad Nacional Autónoma de Nicaragua, León and obtained a degree from Miami Dade in Medical Technology. He has worked and specialized in the field of Flow Cytometry for such institutions as University of Miami School of Medicine, Transplant , the Johns Hopkins School of Public Health and the Johns Hopkins Hospital performing Flow Cytometry analysis, validation, cell sorting in the pediatric and adult myelodysplasias arenas. Since 2006 he has been a Clinical Research Associate working in the development and conduct of Clinical Trials, phases I to IV for pharmaceutical companies such as Pfizer, Takeda, MGI and others. His experience in therapeutics areas include oncology, neurology, regenerative medicine, endocrine and metabolic, biological and device studies. Currently Mr. Piludu holds a position as a Senior Clinical Research Monitor for the University of Miami School of Medicine.  

Marcela Salgado, MD

Marcela Salgado MD, a Medical Research administrator with extensive and proven expertise in Clinical & Translational Research and Pathology.  Received her Medical Doctor degree from the El Bosque University at Bogota, Colombia following her internship with focus in Dermatology and Pathology.  Her post doctoral training initiated working as a Post Doctoral fellow at the Department of Dermatology of El Bosque University and lately with the interest of clinical research and pathology developed since her first approach with Tropical Diseases and retrospective studies from her country working with a group of expert researchers to facilitate case managing and surveillance of terrible diseases like Hemorrhagic Dengue. Dr Salgado developed great interest in teaching and education during her years working as an Assistant Professor at South Colombian University.  Her development in Clinical Research continues at the University of Miami-Miller School of Medicine working initially a a Clinical Research fellow as her first approach to Stem Cell Therapies and subsequently as an Assistant Scientist and Sr Clinical Research Coordinator at the Interdisciplinary Stem Cell Institute and the department of Dermatology and Cutaneous Surgery conducting several research studies Preclinical (Translational) and FDA approved Phase I/II Clinical Research Trials with Stem Cell therapies and Regenerative Medicine awarded by the National Institutes of Health (NIH) and The Department of Defense (DOD) for the past 6 years.  Her evolution in Translational as well as Clinical research contributed to multiple scientific papers, abstracts, and Two University of Miami research patents involving Human Mesenchymal Stem Cells and multiple grants submissions.  She is an active member of the Society of Clinical Research Associates (SOCRA) and the Association of Clinical Research Professionals (ACRP) since 2009 to develop her continuous research education following the most current FDA Clinical Trials requirements, regulations and compliance, promoting Good Clinical Practice policies. 

Educationally Partnered With

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