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Conference Agenda

Monday, November 6

7:00 AMRegistration
8:30 AM – 9:30

Welcome, Kahu Protocol Blessing, Conference Overview

Bryan Avery, Conference Chair, Welcome Remarks & Conference Overview

Ricardo Custodio, M.D., MPH, Opening Welcome

“Keeping the Faith and Aloha”

As an uncertain future looms above us, we must believe in our expertise, experience and each other. Our lives are defined by how we deal with the bad stuff.

9:30 AM – 10:30 AMConcurrent Sessions I
 1. The Role of Nitric Oxide in Regenerative Medicine
 Nathan S. Bryan, PhD, Baylor College of Medicine
Nathan S. Bryan, PhD, Baylor College of Medicine, Houston, Texas
Nitric oxide (NO) is a cell signaling molecule that is involved in regulation of blood flow and vascular integrity, one of the most important signaling molecules in our body. Loss of NO function is one of the earliest indicators or markers of disease. Most recently, NO is known to be responsible for the mobilization and differentiation of resident stem cells to repair dysfunctional cells and tissue. Understanding the status of NO production and restoration in patients may improve stem cell therapy and help facilitate regeneration of function within organ systems.

2. Avoiding Risk: Understanding the Legal Requirements for the Advertising, Promotion and Offering of Stem Cell Therapy in a Clinical Setting.

 Karl Nobert, Recellerate Inc.
  Stem Cells intended for use in humans are regulated under the U.S. Food and Drug Administration’s regulations governing human cells, tissues, cellular and tissue based products (HCT/Ps). Depending upon such use and their functional impact within the body however, they may also be subject to FDA’s drug, biologic or medical devices rules. This presentation will provide an overview of FDA’s legal authority and regulation governing stem cells products, the criteria that the FDA uses to determine a product’s regulatory status, and offer strategies for mitigating the potential risks associated with the marketing and selling a stem cell product in the U.S. Relying on recent FDA warning letters and court cases, the presenter will identify specific regulatory risks relevant to cellular products and therapies; and discuss methods for controlling such risks

3. Innovations & Breakthroughs in Regenerative Medicine Cell Therapy in Orthopaedics and Neurology

 Himanshu Bansal, Anupam Hospital
  There continues to be extraordinary anticipation that stem cells will advance the current therapeutic regimen for orthopaedic and neurological diseases. Presentation of the current status of using adult stem cells to treat in non-unions, osteoarthritis of knee, traumatic brain and spinal cord injury, ALS, autism and cerebral palsy for which current therapies are limited., including the basic cell types and potential mechanisms of action, and the initiation of clinical trials.
10:30 AM – 11:00 AMExhibits & Networking Break
11:00 AM – 12:00 PMPlenary Session: Attacking Inflammation – Regenerative Approaches to Chronic Diseases
 Bradley Wilcox, MD, MSC, FACP, University of Hawaii John A. Burns School of Medicine
 Jon Ruckle, MD, Pacific Pharma Group, LLC
 Timothy J. King, PhD, Hawaii Biotech, Inc.
 Gilbert M. Rishton, PhD, Cognition Therapeutics
 Chronic inflammation has long been associated with increased risk of cardiovascular disease (CVD) and decreased longevity. The recent publication by Ridker et al. of the 10,000+ subject, double-blinded, randomized, placebo trial (CANTOS) revealed the critical importance of chronic inflammation in CVD and underscores the need for safe and economical anti-inflammatory treatments. The combination of safe, anti-inflammatory action (decreased CRP, IL-6, and NF-B) in addition to FOXO3 induction, may position ASTX as a potential adjunct anti-inflammatory therapy to current lipid modifying agents aimed at decreasing CVD risk and positively influencing individual healthspan.
12:00 PM – 1:30 PMLunch, Sponsored by Hawaii Technology Development Corporation Hawaii, Sultan Ventures and American Savings Bank
 PITCH Session
 Local companies and entrepreneurs will present their ideas to investors during a lunch session at the Pacific Regenerative Medicine Conference 2017. As a startup, every opportunity you get to showcase your brand to a targeted audience of potential investors, partners and customers is invaluable. The focus of these sessions are to facilitate conversations between startups, entrepreneurs and investors and to showcase Hawaii’s up and come talent. We understand the importance of getting to know a company before making a decision to invest in them and we hope to bridge that gap in this session.
1:30 PM – 2:30 PMConcurrent Sessions 2
 1. Amnion Tissues in Orthopedic Regenerative Medicine-Merging of Radiological and Clinical Perspectives on IROM
**VIDEO Teleconference**
 David Harshfeld Jr., MD, MS, International Cellular Medicine Society
 Degenerative disc disease is the most common source of back pain and lumbar discectomy is the most common surgical intervention to treat this condition. However, residual back pain and recurrent herniation’s can be high. This Level 1 study is the first one to evaluate the benefits of placental tissue in conjunction with discectomy and is clear evidence that the benefits that have been observed in other orthopedic procedures can be brought to patients undergoing spinal surgery.
 2. Clinical Application of SVF Cells for Peripheral Vascular and Chronic Renal Insufficiency
 Michael H. Carstens, MD, FACS, Saint Louis University
  Patients with non-reconstructable peripheral vascular disease (PVD), secondary to arteriosclerosis (AS) and/or diabetes mellitus (DM), treated with local injection of non-expanded autologous, adipose-derived stromal vascular fraction (SVF) cells for the purposes of enhancing neovascularization and chronic wound healing. This series highlights the utility of non-expanded adipose-derived heterogeneous (SVF) cell population processed at the point-of-care, to treat patients with end-stage PVD as an alternative to palliation or amputation.
Mesoamerican nephropathy (MeN) is a form of chronic kidney disease of unknown etiology that is endemic to rural inhabitants of the Pacific coast of Central America, where agricultural manual labor is the predominant form of employment. This series suggests a potential role for non-expanded adipose-derived heterogeneous SVF cells processed at the point-of-care, to treat patients with MeN in the hopes of augmenting perfusion, reducing ischemia and fibrosis and thereby forestalling further progression of the disease.

3. Panel: Ethics and Legalities for Regenerative Medicine


Kalani Brady,M.D.
Karl Nobert, Recellerate Inc.

James Pietsch, University of Hawaii, Elder Law Program


As is common in new science, familiar and longstanding questions appear in the fresh context of regenerative medicine research and renew old debates. This panel discusses some of the novel technologies within regenerative medicine. The panel will examine the range of ethical issues raised by each novel regenerative medicine technology, including but not limited to: the ethics of research design; issues to consider in first-in-humans regenerative medicine research; and informed consent and the therapeutic misconception.

2:30 PM – 3:00 PMExhibits Open
3:00 PM – 4:00 PMKeynote: Regenerative Medicine in Hawaii’s Health Landscape
 Josh Green, MD, Kohala Hospital; Senator, Hawaii State Legislature
 As both a full-time local physician and long serving state senator, Dr. Josh Green will describe the landscape of healthcare in Hawaii and speculate on possible additions to the healthcare community going forward that would help people in the region and nationally.
4:00 PM – 6:00 PM

Pau Hana Reception hosted by the Regenerative Medicine Association of Hawaii (off-site location)

Tuesday, November 7

7:00 AMRegistration
8:30 AM – 9:30 AMMedical Tourism Panel: What Medical Tourism Means to a Local Economy
 Moderator: Morgan Pile, CES, GBDS, Advanced Medical Pricing Solutions
 Sherry Menor-McNamara, Hawaii Chamber of Commerce, Panel Chair
 Ira Zunin, MD, MPH, Manakai O Malama Integrative Health Care Group and Rehabilitiation Center
 Dwight Lin, MD, Regenerative Medicine & Rehabilitation of Honolulu
 Kim Kuulei Birnie, Papa O Lokahi
 Mark J. Ritchie, Department of Business Economic Development and Tourism, State of Hawaii
 David G Watamull, Cardax, Inc.
 Bob Mangat, Medical Practice Growth Expert
  L. Richard Fried, Cronin, Fried, Sekiya, Kekina & Fairbanks
 Medical tourism involves patients intentionally leaving their home country/state/province to access non-emergency health care services abroad. Growth in the popularity of this practice has resulted in a significant amount of attention being given to it from researchers, policy-makers, and the media. The progress of the Medical Tourism phenomenon has had enormous impact not just for the patient alone but it has also influenced economic, social, environmental, business and medical sectors. Hospitals in any region always provide some amount of basic service to the local population. But these therapies remain stagnant for years without any attempts at amendment or modernization. Enter medical tourists to avail some frequent treatment, and the entire scenario transforms. The same clinic with barely any essentials now has state-of-the-art medical equipment, advanced diagnostic facilities, customer helpdesks offering international toll free calling, a fully equipped ICU, and advanced surgical amenities etc. Such is the effect of healthcare tourism on a regions therapeutics industry. Morgan Pile, renowned consultant, along with our distinguished panelists, puts light on both the positive and negative impacts of medical tourism which are more than obvious.

 9:30 AM – 10:30 AM

 Plenary: How To Build, Grow & Scale Regenerative Medicine In Your Practice
 Bob Mangat is one of the most sought after medical marketing and practice growth experts in the world. He has spoken at medical conferences nationwide to discuss practice growth, traffic and conversion strategies. He is a #1 Amazon Best Selling Author, speaker, serial entrepreneur, proud husband and father with over 15 years of hands-on experience architecting ADVANCED business growth systems
10:30 AM – 11:00 AMExhibits & Networking Break
11:00 AM – 12:00 PMConcurrent Sessions 3
 1. 3D BioPrinting An Improved Biofabrication Process to Enhance Cell Survival and Distribution in Bioprinted Scaffolds for Cartilage Regeneration
 MSc. Jose Manuel Baena, BRECA Health Care and REGEMAT 3D, University of Granada, Spain
 Tissue regeneration (TR) is currently one of the most challenging biotechnology unsolved problems. Tissue engineering (TE) is a multidisciplinary science that aims at solving the problems of TR. New advances in stem cell (SC) research for the regeneration of tissue injuries have opened a new promising research field. Learn of the development of a enhanced printing processes named Injection Volume Filling (IVF) to increase the viability and survival of the cells when working with high temperature thermoplastics without the limitation of the geometry and the viability of the printing process using chondrocytes for cartilage regeneration.

2. Understanding the Techniques Used to Repair Damaged Collagen Within the Framework of Functional Physical Medicine Clinic

Kevin Davison, ND, Maui Regenerative Medicine
  The four key components to optimize your outcome for joint and soft tissue injury: RIT (regenerative injection techniques), nutraceutical aids to joint and ligament repair, removing the obstacles to collagen repair and the role of core centric regenerative exercise to maximize joint, ligament and tendon repair. As with most soft tissue injuries there are various components that are often overlooked that can make the difference in more rapid and long lasting recovery.
 3. The Evolving Socio-Economic Impact of Regenerative Medicine
 Ira Zunin, MD, MPH, Manakai O Malama Integrative Health Care Group and Rehabilitiation Center
 Josh Green, MD, Kohala Hospital; Senator, Hawaii State Legislature
 Regenerative Medicine is positioned at the cutting edge of the twenty-first century´s health systems. Its main purpose is the development of new therapeutic solutions for malfunctioning organs and tissues in our increasingly older population, and to fight the continuous rise of health costs, especially in the treatment of chronic illnesses. Recent estimates point out that the USA can save over $250 billion dollars per year with the adoption of Regenerative Medicine treatments for chronic illnesses like neurodegenerative disease (Parkinson’s, injury of the spinal marrow, cardiovascular diseases, neurovascular accidents, and diabetes.) Our Panel will discuss these issues and more…
12:00 PM – 1:30 PMNetworking Lunch
1:30 PM – 2:30 PMConcurrent Sessions 4

1. 3D BioPrinting WORKSHOP – Advance in Cartilage Recognition and Other Tissue Applications

 Jose Manueal Baena, BRECA Health Care and REGEMAT 3D, University of Granada
  The 3D BioPrinting of tissues and organs represents a major breakthrough in regenerative medicine and tissue engineering. Cartilage and bone regeneration provides an alternative in the treatment of diseases such as degenerative osteoarthritis, injuries of articular cartilage, osteonecrosis and bone fractures, among others. Stem cell based therapies for cartilage regeneration have been successful in animal studies in vivo however, tissue engineering techniques in humans are still in the early stages of development. More evidence based studies are needed, and any identified benefits must be supported with scientific results. We have developed a modular workstation with 3D printing technologies with enhanced printing processes to increase the viability and survival of the cells when working with high temperature thermoplastics. This system allows researchers to print 3D multicomponent parts; with a scaffolds structure, hydrogels with cells and fibers, to produce parts in vitro to regenerate living tissues.

2. Autologous Stem Cells for Beta Cell Regeneration and Treatment of Type 1 Diabetes


Adeeb Al-Zoubi, Stem Cells Arabia

  This cutting edge work could potentially cure diabetes by transplanting a patient’s own stem cells into the pancreas and modulating the immune system to keep insulin-producing cells alive. This double edge approach uses specific populations of stem cells that are taken from the patient’s own blood. Those cells are prepared using special procedures involving magnetic purification especially developed for diabetic patients. Once prepared the cells are implanted into the pancreas, where they then produce insulin. A further component of the procedure is that the patient’s disease-fighting T cells are modulated with the goal of stopping an immune attack on insulin-producing beta cells. The application for such technology potentially offers a treatment, or even a cure for type 1 diabetes. And, unlike islet cell transplantation, whereby insulin-producing beta cells from a cadaver pancreas are transplanted into a person’s liver to produce insulin is minimally invasive.
 3. Hawaiian Modalities: Connecting Today’s Millennials with Hawaii’s Medical and Technical Future
 Manning S. Taite III, NALU Studies
 Non-traditional studies will bridge the future to career opportunities within the scientific communities, using cross-disciplines of STEM teaching to reveal the students’ untapped potential, exposing them to unlimited possibilities in academic and post-secondary success. Understand how careers in botany, computer sciences, oceanography, engineering, art and other disciplines are all related in the medical industry. 
2:30 PM – 3:00 PMExhibits Open
3:00 PM – 4:00 PMConcurrent Session 5
 1. Autologous Dermal Fibroblasts for the Correction of Age-Related Skin Changes (SPRS Therapy®)
VIDEO teleconference
 Vadim L. Zorin, PJSC Human Stem Cells Institute, Moscow, Russia
 Currently in the practice of aesthetic medicine there is a large range of methods applied, such as PRP therapy, peels, fractional photothermolysis, radio wave therapy, dermabrasion, etc. – with the main purpose to stimulate the functional activity of fibroblasts. A new method related to regenerative medicine – the use of cultured fibroblasts derived from the patient’s own skin to correct the age-related changes. The specifics of this technology is that it allows to replenish the population of resident fibroblasts, diminished with ages, with young and functionally active cells, grown in a special laboratory environment, that in turn allows for the unique biological mechanisms to effectively correct age-related skin defects. One of the innovative methods to correct the age-related skin changes is the use of cultured fibroblasts derived from the patient’s own skin. The technology called SPRS therapy® (Service for Personal Regeneration of Skin) has been officially approved in 2011 in Russia (developed by the public biotech company Human Stem Cells Institute (HSCI), Moscow).

2. Regulatory Panel on Regenerative Medicine

Ira Zunin, MD, MPH, Manakai O Malama Integrative Health Care Group and Rehabilitiation Center

Karl Nobert, Recellerate Inc.

This panel discussion, featuring experts from the regulatory, medical field and FDA, will focus on the challenges faced by scientists/physicians in navigating Regenerative Medicine. It aims to assess current public and scientific understanding of the processes involved, and will discuss our expert’s predictions for how regulation may evolve in the future.

We hope this discussion will be an insightful resource bringing together the latest knowledge and providing the current perspectives on Regenerative Medicine development, regulation and commercialization, and stimulating discussion about the future directions of this field.

What will you learn? (a) How the regulation of Regenerative Medicine could affect this field’s development; (b) The current regulatory landscape of Regenerative Medicine; (c) the future evolution of Regenerative Medicine therapies to adapt to new technology; (d) How regulators weigh pateint safety vs. treatment availability. Who may this interest? (a) Graduate students, researchers and practitioners working in the multidisciplinary field of Translational or Regenerative Medicine development; (b) Individuals with an interest in areas of Regenerative Medicine therapies; (c) Regenerative medicine investors; (d) Regulators / decision – makers / policy-makers in this field


3. Introducing Regenerative Healthcare to Employers, Self-Insured Companies and Government Agencies by eliminating waste, fraud and abuse.


Lucia Fields, Future Health Alliance


Paying for healthcare in America has reached a crisis point. Regenerative medicine one of the great answers but adoption has been slow. This session discusses the lessons we have learned from other industries regarding the use of technology, data and applied learning to find critical dollars in healthcare spend that will fund the push for regenerative care. We will discuss specific ways we can find savings by eliminating waste, fraud and abuse and introduce Regenerative Medicine and Regenerative Therapies as effective long term answers for injury, disease management and health and welfare for major employers and government agencies who are struggling for better answers for their employees.

 Panelist TBA
4:00 PM – 5:00 PMPau Hana Reception
5:00 PM – 7:30 PMLuau Dinner and Award Ceremony