Sign Up for Alerts to be informed when the 2016 World Stem Cell Summit agenda is available

In the meantime please view the 2015 World Stem Cell Summit Agenda below:

Wednesday, December 9, 2015

1:00p - 6:00p  -Terrace Foyer

Wednesday, December 9

Early Registration

Pick up of registration materials for Speakers, Exhibitors and Poster Presenters.

1:00p - 5:00p  -Grand Hall West & East / Prefunction

Wednesday, December 9

Exhibitor and Poster Set-Up

6:30p - 8:30p  -

Wednesday, December 9

Leadership & Speaker Reception – By Invitation Only — International Ballroom North

INVITATION ONLY LEADERSHIP AND SPEAKER RECEPTION – LOCATED IN THE INTERNATIONAL BALLROOM NORTH.

Thursday, December 10, 2015

7:30a - 10:00a  -Grand Hall West & East / Prefunction

Thursday, December 10

Exhibitor / Poster Final Set-Up

8:00 - 8:30a  -Regency Ballroom

Welcome Overview

Thursday, December 10

Opening Remarks

Moderator

 Bernard F. Siegel, JD, Genetics Policy Institute

Speakers

 Julie G. Allickson, PhD, Wake Forest Institute for Regenerative Medicine

 Linda Myers, ASCP, MT, SBB, CQA (ASQ), BioBridge Global

 Norio Nakatsuji, DSc, Institute for Integrated Cell-Material Science (iCeMS), Kyoto University

 Robert M. Nerem, PhD, Georgia Tech

 Andre Terzic, MD, PhD, Center for Regenerative Medicine, Mayo Clinic

 Michael Yaffe, PhD, New York Stem Cell Foundation

8:30a - 9:30a  -Regency Ballroom

Panel Discussion

TRANSLATION AND CLINICAL TRIALS

Thursday, December 10

FDA Oversight in Regenerative Medicine: What are the Options to Accelerating Translation?

Moderator

 Julie G. Allickson, PhD, Wake Forest Institute for Regenerative Medicine

Speaker

 Robert Califf, MD, U.S. Food and Drug Administration (FDA)

 Celia M. Witten, MD, PhD, U.S. Food and Drug Administration (FDA)

9:30a - 10:30a  -Regency Ballroom

Concurrent Session

DISCOVERY

Thursday, December 10

Stem Cells Translational Medicine Alpha Clinic Panel – Standing on the Precipice

The stem cell field keeps advancing rapidly, with biological discoveries and knowledge expanding  daily. However, the clinical pace has been slower, mostly due to the unique nature of human trials with biologics, the expenses involved, and long term follow up needed. The field is now truly standing at the precipice, where either it continues to move upward in its progress, or drops into an abyss of unsolvable challenges. Alpha Med Press, a leading publisher in the field with two major high impact journals dedicated to disseminating sound basic and translational regenerative medicine science (Stem Cells, and Stem Cells Translational Medicine), is sponsoring a panel of experts that will cover this timely topic. Participants include Drs. Mahendra Rao, Jan Nolta, Joanne Kurtzberg, and Anthony Atala. The expert panel will cover relevant scientific and clinical advances, current challenges, and opportunities for the future. The panel promises to present a lively discussion, with active audience participation.

Moderator

 Anthony Atala, MD, Wake Forest Institute for Regenerative Medicine

Speakers

 Joanne Kurtzberg, MD, Duke University Medical Center

 Jan A. Nolta, PhD, UC Davis

 Mahendra Rao, MD, PhD, Q Therapeutics & NYSCF

9:30a - 10:30a  -Grand Hall East A-B

Concurrent Session

REGMED CAPITAL CONFERENCE (RMCC)

Thursday, December 10

Introduction to “Living” Drugs and the Curative Industries

Moderator

 Gregory A. Bonfiglio, Proteus Venture Partners

Speakers

 Jane C. Andrews, PhD, Frost & Sullivan

 Chris Mason, MBBS, PhD, FRCS, University College London

9:30a - 10:30a  -Hanover C-D

Concurrent Session

INNOVATION SHOWCASE

Thursday, December 10

How Advanced Blood & Tissue Banks are Engendering Growth in Regenerative Medicine (supported by BioBridge Global)

This session will focus on some of the ways advanced blood and tissue banks are helping in the translation of biomedical advances into clinically useful tools.  From access to biological materials to manufacturing capabilities to regulatory compliance expertise, specific examples will be given as to how research institutions and commercial organizations are benefitting from the creative solutions blood and tissue banks are providing, and how the blood and tissue  banks are benefitting in return.

Moderator

 Sean Thompson, MS, MBA, CLP, GenCure

Speakers

 C. Geoffrey Davis, PhD, Angiocrine Bioscience, Inc.

 Jed B. Gorlin, MD, Innovative Blood Resources

 Robert J. Tressler, PhD, MS, San Diego Blood Bank

9:30a - 10:30a  -Grand Hall East C-D

Concurrent Session

TRANSLATION AND CLINICAL TRIALS

Thursday, December 10

Restoring Vision – Discoveries and Clinical Trials

This session will provide an overview of current efforts to apply stem cells toward the treatment of retinal degenerative disease using stem cell derived retinal pigment epithelium. Participants will address a number of key areas. I) strategies for the functional validation of stem cell derived retinal pigment epithelia (RPE), ii) design and planning for an IND to test autologous iPS cell derived RPE in patients with geographic atrophy due to age-related macular degeneration, and iii) use of tissue derived stem cells and the level of differentiation required prior to transplantation for effective therapy.

Moderator

 Alan D. Marmorstein, PhD, Mayo Clinic

Speaker

 Kapil Bharti, PhD, National Institutes of Health (NIH)

 Sheldon S. Miller, PhD, National Institutes of Health (NIH)

 Jeffrey H. Stern, PhD, MD, Neural Stem Cell Institute

9:30a - 10:30a  -Hanover G-F

Concurrent Session

REGENERATIVE SERVICES AND APPLICATIONS

Thursday, December 10

Sports Medicine 1: The Use of Stem Cells in Sports Medicine–The “Here and Now”

Moderator

 Shane A. Shapiro, MD, Mayo Clinic College of Medicine

Speaker

 Ron Courson, ATC, PT, NREMT-I, CSCS

 Malcolm Mitchell, University of Georgia

 Steven E. Sampson, DO, The Orthohealing Center

9:30a - 10:30a  -Hanover E

Concurrent Session

HOT TOPICS & FUTURE TRENDS

Thursday, December 10

Road Maps for Reimbursement for Cell Therapies

Moderator

 Michael P. Levinson, MD, JD, Hogan Lovells

Speaker

 Deborah Dean, MiMedx

 Amnon Pelz, Taburit, Cord Blood - Stem Cell Solutions

 Elizabeth Powers, IMS Consulting Group

9:30a - 10:30a  -Hanover A-B

Track Keynote

ETHICS, LAW & SOCIETY (ELSI)

Thursday, December 10

Bioethics and the Future of Medicine — First Lessons from Beings 2015

Moderator

 Paul Root Wolpe, PhD, Emory University

10:30a - 11:00a  -Grand Hall West & East / Prefunction

Break

Thursday, December 10

Morning Break

Morning Break – Visit our Exhibitors and Poster Area

11:00a - 12:30p  -Regency Ballroom

Concurrent Session

DISCOVERY

Thursday, December 10

Pluripotency and Differentiation

Moderator

 Gary D. Smith, PhD, HCLD, University of Michigan

Speaker

 Karl Tryggvason, MD, PhD, Karolinska Institutet, Duke-NUS

 Ravi Kane, PhD, Georgia Institute of Technology

 Thomas P. Zwaka, MD, PhD, Icahn School of Medicine at Mount Sinai

11:00a - 12:30p  -Grand Hall East A-B

Concurrent Session

REGMED CAPITAL CONFERENCE (RMCC)

Thursday, December 10

What Investors Need to Know Before Investing in Life Science Start-Ups

Moderator

 Connie Koch Harrell, Keiretsu Forum Southern California

Speakers

 Arnold Caplan, PhD, Case Western University

 Edward A. Tenthoff, Piper Jaffray & Co.

11:00a - 12:30p  -Hanover C-D

Concurrent Session

INNOVATION SHOWCASE

Thursday, December 10

Roundtable Discussion — Core Laboratory Manager’s Best Practices

Moderator

 Ian McNiece, PhD, MD Anderson Cancer Center

Speakers

 Daniel Paull, PhD, NYSCF

 Zachary Resch, PhD, Mayo Clinic

 Henry J. Walker, Mayo Clinic

11:00a - 12:30p  -Grand Hall East C-D

Concurrent Session

TRANSLATION AND CLINICAL TRIALS

Thursday, December 10

Leading Nations: Development Strategies for Regenerative Medicine

This panel of global leaders in the Regenerative Medicine field from China, the UK, Israel, Canada, and Switzerland will share their insights on the strategies that have been most successful for advancing the field to date, and on the strategies that are most promising for 2016 and beyond.  

Moderator

 Michael N. Druckman, Hogan Lovells

Speakers

 Yijia Li, PhD, Yunnan Shunxi Stem Cell and Regenerative Medicine Research Center

 Michael H. May, PhD, Centre for Commercialization of Regenerative Medicine (CCRM)

 Chris Mason, MBBS, PhD, FRCS, University College London

 Avi Treves, PhD, Sheba Medical Center

 Alain Vertes, PhD, NxR Biotechnologies

11:00a - 12:30p  -Hanover G-F

Concurrent Session

REGENERATIVE SERVICES AND APPLICATIONS

Thursday, December 10

Currently Approved Adipose Tissue Cellular Therapies

The American Society of Plastic Surgeons has always been active in clinical research and at the forefront of restorative and regenerative medicine. It was a Joseph Murray, a Plastic Surgeon who ushered in the era of organ transplantation when he performed the first successful kidney transplant in 1954 and later won a Nobel Prize for it. In the late 90’s it was Dr. Adam Katz at the University of Pittsburgh who first identified that AdiposeTissue is the most abundant source of Adult Mesenchymal Stem Cells in the human body.

This finding gave enormous impetus to the field of Adipose Tissue grafting resulting in major advances, such as healing the previously incurable condition of Radiation Induced Fibrosis (RIF). Notwithstanding, recent regulatory concerns have arisen that threaten the availability of Fat Grafting as a readily available regenerative tool. This is of particular concern for women who suffer from RIF as a result of breast cancer therapy.

Moderator

 Ricardo Luis Rodriguez, MD, Cosmeticsurg

Speakers

 Michael W. Neumeister, MD, FRCSC, FACS, Southern Illinois University School of Medicine

 Richard A. D'Amico, MD, FACS, Plastic Surgery and Skin Care Center

 J. Peter Rubin, MD, University of Pittsburgh

11:00a - 12:30p  -Hanover E

Concurrent Session

HOT TOPICS & FUTURE TRENDS

Thursday, December 10

Tissues to Organs 1

These two sessions cover challenges, priorities, and progress in tissue and organ bioengineering. Some of the challenges that will be considered include mapping, cell manufacturing & sourcing, immunosuppression, integration, and vascularization. The priorities for advancing organ bioengineering will focus on 4 parallel pathways: (1) layer-by-layer building of organs and tissues, (2) Recellularization strategies, (3) Cellular Repair or Regeneration, and (4) Xenotransplantation. After addressing these challenges and presenting priorities for advancing organ bioengineering we will consider advances academia is making in this exciting area. Topics include laryngeal transplantation, building a heart, and case studies for bioengineering organs such as the bladder.

The second session will start off with current clinical approaches being used to provide some relief to organ shortage. We will then consider various perspectives from industry as they advance different technologies. Some of these technologies will include: (1) 3D printing organs layer-by-layer and (2) Challenges to develop off the shelf extracellular matrix tissue products. We will end with considering lessons learned from tissue engineering and how this shapes the vision for the future of tissue and organ bioengineering.

Moderator

 Joshua Hunsberger, PhD, Wake Forest Institute for Regenerative Medicine

Speakers

 David G. Lott, MD, Mayo Clinic

 Shay Soker, PhD, Wake Forest Institute for Regenerative Medicine

 Doris A. Taylor, PhD, FAHA, FACC, Texas Heart Institute at St. Luke's Episcopal Hospital

11:00a - 12:30p  -Hanover A-B

Concurrent Session

ETHICS, LAW & SOCIETY (ELSI)

Thursday, December 10

Should We Ban or Regulate Potentially Curative Technologies that Modify the Human Germline?

Moderator

 Marie A.. Vodicka, PhD, Hogan Lovells

Speakers

 Aubrey de Grey, PhD, SENS Foundation

 Paul Knoepfler, PhD, UC Davis

 Aaron D. Levine,PhD, Georgia Tech

12:30p - 2:00p  -

Conversation with Experts

Thursday, December 10

Conversation with Experts – Lunch Roundtables

Boxed Lunch Pick-Up outside of the Grand Hall West

2:00p - 2:30p  -Regency Ballroom

Plenary Keynote

Thursday, December 10

Changing Medicine in the 21st Century

Presenter

 Andre Terzic, MD, PhD, Mayo Clinic

2:30p - 3:30p  -Regency Ballroom

Concurrent Session

DISCOVERY

Thursday, December 10

Curing Cancer – Spotlight on New Technologies and Potential Breakthrough Discoveries including CAR-T & CAR-NK

Moderator

 William K. Decker, PhD, Baylor College of Medicine

Speakers

 Karen S. Aboody, MD, City of Hope National Medical Center & Beckman Research Institute

 Evren Alici, MD, PhD, Karolinska Institutet

 Massimo Dominici, MD, International Society of Cellular Therapies (ISCT)

2:30p - 3:30p  -Grand Hall East A-B

Concurrent Session

REGMED CAPITAL CONFERENCE (RMCC)

Thursday, December 10

RegMed Company Presentations to Investors – Sessions 1-4

Moderator

 Connnie Koch Harrell, Keiretsu Forum Southern California, LLA

Speakers

 Michael McCullough, MD, RegenMed Systems

 Keith Murphy, Organovo

 Brian A. Pollok, PhD, Propagenix, Inc.

 Jeffrey H. Stern, PhD, MD, Neural Stem Cell Institute

2:30p - 3:30p  -Hanover C-D

Concurrent Session

INNOVATION SHOWCASE

Thursday, December 10

The Power of Gene Editing — Implications for the Future of Medicine

As industry and academic researchers move forward in their quest to enhance their understanding of human development and diseases, discover novel therapeutic compounds and develop improved tests for toxicity, so does the demand to move toward a more relevant source of research materials. This panel will discuss new developments in gene editing and that anticipates gene editing in combination with human cells that will have significant positive impact on advancements in relevant models and stem cell based assays.

Moderator

 Steven L. Stice, PhD, Regenerative Bioscience Center

 Colin Edward Bishop, PhD, Wake Forest Institute for Regenerative Medicine

 Jan A. Nolta, PhD, UC Davis

 Thomas P. Zwaka, MD, PhD, Icahn School of Medicine at Mount Sinai

2:30p - 3:30p  -Grand Hall East C-D

Concurrent Session

TRANSLATION AND CLINICAL TRIALS

Thursday, December 10

Pre-Clinical Trials Using Large Animals & Non-Human Primates

Moderator

 Marcel M. Daadi, PhD, Southwest National Primate Research Center

Speakers

 Anthony W.S. Chan, DVM, PhD, Emory University School of Medicine

 Franklin D. West, PhD, University of Georgia

2:30p - 3:30p  -Hanover G-F

Concurrent Session

REGENERATIVE SERVICES AND APPLICATIONS

Thursday, December 10

A Clinician’s Guide to Fat Grafts

Speaker

 Camillo Ricordi, MD, University of Miami Diabetes Research Institute

 Ricardo Luis Rodriguez, MD, Cosmeticsurg

2:30p - 3:30p  -Hanover E

Concurrent Session

HOT TOPICS & FUTURE TRENDS

Thursday, December 10

The Science of Microgravity — Stem Cells on the International Space Station (Supported by CASIS)

Moderator

 Clifford Folmes, PhD, Mayo Clinic

Speakers

 Mary Kearns-Jonker, PhD, Loma Linda University School of Medicine

 Chunhui Xu, PhD, Emory University School of Medicine

 Abba C. Zubair MD, PhD, Mayo Clinic Florida

2:30p - 3:30p  -Hanover A-B

Concurrent Session

ETHICS, LAW & SOCIETY (ELSI)

Thursday, December 10

Stem Cell Research Oversight: Ethical Guidelines and Best Practices for IRB’s, SCRO’s and ESCRO’s – Part 1

Speakers

 Melinda Abelman, MSc, CIP, Partners HealthCare System

 Amy Wilkerson, The Rockefeller University

3:00p - 5:00p  -The Learning Center

SPECIAL EVENT

Thursday, December 10

Patient Advocate-Scientist Partnerships: The Key to Funding Research and Clinical Trials (supported by the Americans for Cures Foundation)

 Mary Bass, Americans for Cures Foundation

 David Bluestone, ClearPath Strategies

 Robert Klein, Americans for Cures Foundation

 Don C. Reed, Americans for Cures Foundation

 Jason Stewart, 50+1 Strategies, Americans for Cures Foundation

3:30p - 4:00p  -Grand Hall West & East / Prefunction

Break

Thursday, December 10

Afternoon Break – Exhibits & Posters Open

4:00p - 5:00p  -Hanover C-D

Concurrent Session

INNOVATION SHOWCASE

Thursday, December 10

Tissues to Organs 2

These two sessions cover challenges, priorities, and progress in tissue and organ bioengineering. Some of the challenges that will be considered include mapping, cell manufacturing & sourcing, immunosuppression, integration, and vascularization. The priorities for advancing organ bioengineering will focus on 4 parallel pathways: (1) layer-by-layer building of organs and tissues, (2) Recellularization strategies, (3) Cellular Repair or Regeneration, and (4) Xenotransplantation. After addressing these challenges and presenting priorities for advancing organ bioengineering we will consider advances academia is making in this exciting area. Topics include laryngeal transplantation, building a heart, and case studies for bioengineering organs such as the bladder.

The second session will start off with current clinical approaches being used to provide some relief to organ shortage. We will then consider various perspectives from industry as they advance different technologies. Some of these technologies will include: (1) 3D printing organs layer-by-layer and (2) Challenges to develop off the shelf extracellular matrix tissue products. We will end with considering lessons learned from tissue engineering and how this shapes the vision for the future of tissue and organ bioengineering.

 

Moderator

 Jason Wertheim, MD, PhD, Northwestern University

Speakers

 Shannon L.M. Dahl, PhD, Humacyte

 Keith Murphy, Organovo

 Gail K. Naughton, PhD, Histogen, Inc.

4:00p - 5:00p  -Grand Hall East C-D

Concurrent Session

TRANSLATION AND CLINICAL TRIALS

Thursday, December 10

DEEP INSIGHTS INTO MESEMCHYMAL SC’S (SIGNALING-STROMAL STEM CELLS)

Moderator

 Arnold I. Caplan, PhD, Case University

Speaker

 Atta Behfar, MD, PhD, Mayo Clinic

 Xiao-Dong Chen, MD, PhD, StemBioSys, Inc.

4:00p - 5:00p  -Hanover G-F

Concurrent Session

REGENERATIVE SERVICES AND APPLICATIONS

Thursday, December 10

Regenerative Medicine in the Operating Room

Moderator

 Anthony Atala, MD, Wake Forest Institute for Regenerative Medicine

Speakers

 Nicholas Boulis, MD, Emory University School of Medicine

 C. Randal Mills, PhD, California Institute for Regenerative Medicine (CIRM)

 H. Thomas Temple, MD, Nova Southeastern University

4:00p - 5:00p  -Hanover A-B

Concurrent Session

ETHICS, LAW & SOCIETY (ELSI)

Thursday, December 10

Stem Cell Research Oversight: Ethical Guidelines and Best Practices for IRB’s, SCRO’s and ESCRO’s – Part 2

Speakers

 Melinda Abelman, MSc, CIP, Partners HealthCare System

 Amy Wilkerson, The Rockefeller University

5:00p - 6:30p  -Grand Hall West & East / Prefunction

Exhibits / Posters Reception

Thursday, December 10

Exhibitor Networking Reception & Poster Viewing with Presenters Present

6:30p - 7:30p  -Terrance Foyer / Regency Foyer

Stem Cell Action Awards

Thursday, December 10

Stem Cell Action Awards – RECEPTION

7:30p - 9:30p  -Regency Ballroom

Stem Cell Action Awards

Thursday, December 10

Stem Cell Action Awards & Dinner

MEET THE 2015 STEM CELL ACTION AWARD HONOREES

Robert M. NeremLeadership Award: Robert M. Nerem, PhD – Bob has a long and distinguished career in engineering for medicine. A giant in the field of cellular and tissue engineering, Bob began at Georgia Tech in 1987 as a Professor and Parker H. Petit Distinguished Chair for Engineering in Medicine. He is the founder of the Georgia Tech/Emory Center for the Engineering of Living Tissues which has evolved into the Center for Regenerative Engineering and Medicine (REM), a joint collaboration between Emory University, Georgia Tech and The University of Georgia, with a mission to fundamentally transform the treatment of human diseases and injuries through the development and translation of new technologies that enhance the body’s ability to heal itself. The integration of engineering technologies, biological discoveries, and clinical expertise and infrastructure will establish Georgia as a national leader in regenerative clinical therapies.

ann-murphyEducation Award: Ann Murphy, PhD – Ann co-founded AlphaMed Press in 1983 and launched STEM CELLS, the first journal devoted entirely to the subject. With offices in Durham, NC, San Francisco, CA, and Belfast, NI, Ann publishes and is the managing editor of two other international peer-reviewed journals with globally recognized editorial boards dedicated to advancing research and education in their focused disciplines: The Oncologist and STEM CELLS Translational Medicine (the official journal partner of the Regenerative Medicine Foundation). In 2000, Ann co-founded the Society for Translational Oncology to fill the gap between discovery of new cancer treatments and their global translation into oncology practice. The Oncologist is its official journal.  

Tory WilliamsAdvocacy Award: Tory Williams & the Alabama Institute of Medicine – Born and raised in the small town of Millry, Alabama, Tory Williams is a proud mother or 4. She co-founded with Roman Reed the nonprofit Alabama Institute of Medicine (AIM). She played a leadership role in the passage of the TJ Atchison Spinal Cord Injury Act, also known as “TJ’s Law” which provided over $800,000 in funding for spinal cord injury in Alabama. Even while battling polycystic kidney disease (PKD), Tory found time and strength to author a compelling book, Inevitable Collision- The Inspiring Story That Brought Stem Cell Research to Conservative America.  

Jeanne LoringAdvocacy Award: Jeanne Loring, PhD – Jeanne is Professor and founding Director of the Center for Regenerative Medicine at The Scripps Research Institute. She is a bold and outspoken advocate, educator and gifted scientist. Her research team studies genomics and epigenomics of hESCs and iPSCs. As part of the “Frozen Zoo” project her lab generated the first reprogrammed cells from endangered species. Her translational projects include stem cell applications for Parkinson’s disease, multiple sclerosis, autism, Alzheimer disease, and addiction. Under her guidance, her lab is creating collections of cell lines for disease modeling and ethnicity-associated drug toxicity studies. Jeanne is also involved in the societal issues associated with stem cell research, including the ethics of stem cell generation and clinical use, the legal implications of stem cell patents, and educating the public about the dangers of unregulated stem cell treatments. She has served on the ethics boards of Merck KGaA and the Bill and Melinda Gates Foundation and is a long-standing member of the GPI Science Advisory Board.  

Cure CPInspiration Award: CURE CP – Cerebral palsy (CP) is a broad term used to describe a group of chronic “palsies” — disorders that impair control of movement due to damage to the developing brain. CP is one of the most common causes of chronic childhood disability, affecting 1 in 323 children (second only to autism). Cure CP, a nonprofit organization, undertakes and supports initiatives at leading, American research institutions developing therapeutic methodologies for the treatment of CP. Through passionate, grassroots advocacy and fundraising, Cure CP undertakes and supports forward-thinking research, including current, ongoing clinical trials at Duke University School of Medicine and UTHealth. Founded by two Atlanta-based families with children affected by CP, Cure CP and its dedicated volunteers seek a better life and future for children and adults with cerebral palsy.  

Speakers

Friday, December 11, 2015

7:15a - 7:00p  -Terrace Foyer

Registration

Friday, December 11

Registration

7:15a - 8:15a  -Grand Hall West & East / Prefunction

Breakfast

Friday, December 11

Networking Breakfast with Exhibits Open

7:55a - 8:00a  -Regency Ballroom

Welcome Overview

Friday, December 11

Opening Remarks

Presenter

 Bernard Siegel, JD, Genetics Policy Institute

8:00a - 8:30a  -Regency Ballroom

Plenary Keynote

Friday, December 11

Cell-based therapeutics as a broad spectrum, new generation biological therapy

Presenter

 Joshua M. Hare, MD, FACC, FAHA, University of Miami Miller School of Medicine

8:30a - 9:00a  -Regency Ballroom

Plenary Keynote

Friday, December 11

RECENT ADVANCES IN TISSUE ENGINEERING IN JAPAN

New regulation has just accelerated clinical application of regenerative medicine in Japan.  “Heart Sheet”, which is transplanted on to ischemic heart received conditional and time limited approval.  Furthermore, several tissue engineering projects have also started for future organ fabrication.

Presenter

 Professor Tatsuya Shimizu, Japanese Society for Regenerative Medicine, Tokyo Women's Medical University

9:00a - 10:00a  -Regency Ballroom

Concurrent Session

DISCOVERY

Friday, December 11

Perinatal Sources of Tissue and Cells: Cord Blood, Amnion, Cord Tissue

Moderator

 Kyle J. Cetrulo, Auxocell Laboraties, Inc.

Speaker

 Thomas J. Koob, PhD, MiMedx

 John E. Wagner, MD, University of Minnesota

9:00a - 10:00a  -Grand Hall East A-B

Concurrent Session

REGMED CAPITAL CONFERENCE (RMCC)

Friday, December 11

RegMed Company Presentations to Investors – Sessions 5-8

Moderator

 Robert Margolin, MBS, MBA, Cognate Bioservices, Inc.

 Adam Gridley, Histogenics Corporation

 Bob Hutchens, StemBioSys, Inc.

 James McGorry, MBA, HART

 Michael H. May, PhD, Centre for Commercialization of Regenerative Medicine (CCRM)

9:00a - 10:00a  -Hanover C-D

Concurrent Session

INNOVATION SHOWCASE

Friday, December 11

Cell Culture – Assessing Defined Media and Xenogenic-free Culture

Moderator

 Michael Yaffe, PhD, Vice President, Special Projects The New York Stem Cell Foundation

Speakers

 Ohad Karnieli, PhD, MBA, Pluristem and Karnieli Ltd.

 Karl Tryggvason, MD, PhD, Karolinska Institutet, Duke-NUS

 Claudia Zylberberg, PhD, Akron Biotechnology, LLC

9:00a - 10:00a  -Grand Hall East C-D

Concurrent Session

TRANSLATION AND CLINICAL TRIALS

Friday, December 11

CHALLENGING BIOETHICS ISSUES AND PUBLIC POLICY – HOW TO EFFECTIVELY ADVOCATE AND INTEGRATE

Stem cell science and technology continues to progress, with a corresponding need for crosslinks to patient advocacy, ethics, and regulatory science. This panel will explore the status of these links through the eyes of panel members representing each of these disciplines.

Moderator

 Don Gibbons, CIRM

Speakers

 Aaron D. Levine,PhD, Georgia Tech

 Jeanne F. Loring, PhD, The Scripps Research Institute

 Beth Roxland, JD, M.Bioethics, Johnson & Johnson, Inc.

9:00a - 10:00a  -Hanover G-F

Concurrent Session

REGENERATIVE SERVICES AND APPLICATIONS

Friday, December 11

Regenerative Medicine Applications in Orthopedics

This session will summarize emerging concepts in regenerative therapies for musculoskeletal applications, including the use of stem cells for a variety of orthopedic injury types. The role of regenerative medicine in challenging injury environments, such as limb trauma, and the utility of large animal models in translation of regenerative therapies for orthpedic injuries will also be discussed.

Moderator

 Johnna Temenoff, PhD, Georgia Institute of Technology

Speaker

 John F. Peroni, DVM, MS, Dip ACVS, University of Georgia

 William L. Murphy, PhD, University of Wisconsin

 Nick J. Willett, PhD, Emory University

9:00a - 10:00a  -Hanover E

Concurrent Session

HOT TOPICS & FUTURE TRENDS

Friday, December 11

Advances in Cardiovascular Research and Major Clinical Trials

Moderator

 Timothy J. Kamp, MD, PhD, University of Wisconsin School of Medicine

Speakers

 Karl-Henrik Grinnemo, MD, Karolinska Institutet

 Joshua M. Hare, MD, FACC

9:00a - 10:00a  -Hanover A-B

Concurrent Session

ETHICS, LAW & SOCIETY (ELSI)

Friday, December 11

The Wild World of Retractions — Inaccuracies, Mistakes & Misconduct

We will engage the audience in a discussion of the wide range of reasons for and consequences of scientific retractions. We will discuss the causes of the increase in retractions, and how retractions can and should be useful to the community.  The roles  of post-publication review and institutional responsibility will also be highlighted. Lastly, the issues encountered during  the National Academies of Science Committee on Responsible Science rewriting of the 1992 book, “Responsible Science”, will serve to educate ourselves on why progress in our ability to monitor and police scientific misconduct has been hampered.  

Moderator

 Graham Parker, PhD, Wayne State University School of Medicine

Speakers

 Ivan Oransky, MD, MedPage Today, Retraction Watch

 Paul Root Wolpe, PhD, Emory Center for Ethics

10:00a - 10:30a  -Grand Hall West & East / Prefunction

Break

Friday, December 11

Morning Break with Exhibits Open

10:30a - 12:00p  -Regency Ballroom

Concurrent Session

DISCOVERY

Friday, December 11

Stem Cell Science on the Frontier — Infertility and Mitochondrial Disease

Moderator

 Gary D. Smith, PhD, HCLD, University of Michigan

Speakers

 Shanta Dhar, University of Georgia

 Outi Hovatta, MD, PhD, Karolinska Institutet

 Daniel Paull, PhD, NYSCF

10:30a - 12:00p  -Grand Hall East A-B

Concurrent Session

REGMED CAPITAL CONFERENCE (RMCC)

Friday, December 11

RegMed Company Presentations to Investors Sessions 9-14

Moderator

 Scott B. Livingston, Livingston Securities LLC

 Caleb B. Bell, III, PhD, Bell Biosystems, Inc.

 Eric Clopper, Foregen

 Gail K. Naughton, PhD, Histogen, Inc.

 Jon A. Rowley, PhD, Rooster Bio

 Diping Zhang, PhD, Shenzhen Cell Bio-tech Co., Ltd.

10:30a - 12:00p  -Hanover C-D

Concurrent Session

INNOVATION SHOWCASE

Friday, December 11

Breakthroughs in Regenerative Engineering & Bioprocessing

This session will highlight recent scientific breakthroughs in Regenerative Engineering & Bioprocessing and the implications of associated FDA requirements.   The potential impact of emerging technologies in areas such as stem cell engineering, biomanufacturing and micro RNAs on regenerative therapies will be a focus of the panel discussion.

Moderator

 Robert E. Guldberg, PhD, Georgia Institute of Technology

Speakers

 Peter C. Johnson, MD, Scintellix, LLC

 Elizabeth G. Loboa, PhD, University of Missouri, Columbia

 Todd C. McDevitt, PhD, Gladstone Institute of Cardiovascular Disease

 Ian McNiece, PhD, MD Anderson Cancer Center

 Mary Pat Moyer, PhD, INCELL Corporation

10:30a - 12:00p  -Grand Hall East C-D

Concurrent Session

TRANSLATION AND CLINICAL TRIALS

Friday, December 11

Global Regulatory Affairs: What can we Learn from Other Countries to Accelerate the Safe Development of Regenerative Medicine?

Moderator

 Julie G. Allickson, PhD, Wake Forest Institute for Regenerative Medicine

Speakers

 Fabiana Arzuaga, PhD
Advisory Commission on Cellular Therapies and Regenerative Medicine
Ministry of Science, Technology and Productive Innovation
Argentina

 C. Randal Mills, PhD, California Institute for Regenerative Medicine (CIRM)

 Takumi Miura, PhD, National Institute of Health Sciences (Japan)

 Alain Vertes, PhD, NxR Biotechnologies

10:30a - 12:00p  -Hanover G-F

Concurrent Session

REGENERATIVE SERVICES AND APPLICATIONS

Friday, December 11

Regenerative Medicine for Healing Wounded Warriors – From Funding Research to the Clinical “Here and Now”

Moderator

 Anthony Atala, MD, Wake Forest Institute for Regenerative Medicine

Speakers

 J. Peter Rubin, MD, University of Pittsburgh

 Anthony J. Windebank, MD, Mayo Clinic

10:30a - 12:00p  -Hanover E

Concurrent Session

HOT TOPICS & FUTURE TRENDS

Friday, December 11

Stem Cell & Regenerative Medicine Institutes — Forging Essential Internal and External Collaborations – A Roundtable Discussion

The panel will seek to define the complex nature of the many collaborative (and sometimes bumpy) relationships that research scientists have with the various stakeholders in the stem cell space.  We will be examining collaboration on many fronts, including scientists with (1) other scientists (both local, domestic and international); (2) patients; (3) industry; (4) disease foundations; (5) non-dilutive funding agencies; (6) dilutive capital providers (investors); (7) oversight bodies (including political officials); (8) regulatory agencies; (9) payors and any other stakeholder groups that might come up in discussion.

Moderator

 Jonathan Thomas, PhD, JD, CIRM

Speakers

 Dan Gincel, PhD, MD Stem Cell Research Fund

 Thomas A. Gonwa, MD, FASN, FACP, Mayo Clinic College of Medicine

10:30a - 12:00p  -Hanover A-B

Concurrent Session

ETHICS, LAW & SOCIETY (ELSI)

Friday, December 11

Mandatory Patent Law Update for Companies, Investors and Tech Transfer Offices

 Tina McKeonToday’s Stem Cell Company – Practical Intellectual Property Tips”
Today it is harder to acquire but easier to challenge an issued patent covering stem cell technology than it was a few years ago.  Given the changes and uncertainties in today’s intellectual property law, we will discuss how you can best protect your intellectual property, address the concerns of investors, and position your company relative to competitors.  For example, we will address whether trade secret protection is a reasonable alternative to patent protection and the importance of aligning your intellectual property and commercial goals.  We will also discuss monitoring and influencing the intellectual property position of your competitors.  As an overarching theme, we will suggest having reasonable, well-informed expectations and interactions with the patent office, investors, and competitors.”

Patrick Kelleher –Stem cell patents – a European Perspective” :  Patrick will give an overview of the new European Unitary Patent and European Unified Patent Court in which a single granted patent will soon be available covering the entire EU.  He will also look at the new approach being adopted by the European Patent Office in examination of patent applications covering stem cell related inventions.

Robert Sullivan—“ Is your granted patent vulnerable to being invalidated in the USPTO? Inter-Partes Review Proceedings at the U.S. Patent & Trademark Office-the new approach to attacking granted US patents “.  A brief review of IPR proceedings; how they work, the pros and cons of using the IPR to challenge an issued patent; and how to defend your patent if challenged.

Peter Ludwig—Eligibility for Patenting – A Hot Button issue for US Life Science Inventors-What Gets in  the Door at the USPTO today- The new framework for patent eligibility of all natural products, natural phenomena and laws of nature. An exploration of what is eligible for patenting in the USPTO today.

 

Moderator

 S. Peter Ludwig, Principle, Fish & Richardson P.C.

Speakers

 Patrick Kelleher, Bird & Bird

 Tina W. McKeon, PhD, Kilpatrick Townsend

 Robert C. Sullivan, Jr., Fish & Richardson P.C.

12:00p - 1:30p  -Grand Hall East

Lunch

Friday, December 11

Lunch

Pre-paid Box Lunch Pick Up in Grand Hall East

12:10p - 1:30p  -Regency Ballroom

Symposia

Friday, December 11

Japan Symposium: Open Innovation for Large Scale and Cost Effective Cell Production Systems using Human ES/iPS Cell Lines

This symposium will show you our recent progress of a Japanese government-funded project, “Project Focused on Developing Key Evaluation Technology: Manufacturing Technology for Industrialization in the Field of Regenerative Medicine,” supported by Japan Agency for Medical Research and Development (AMED) from 2014 to 2018. Four academia groups and 11 companies are collaborating as an open innovation project. Four speakers from our AMED project and another from Ajinomoto Co. will present their latest progresses.

Moderator

 Takashi Asada, PhD, Kyoto University

Speakers

 Kouichi Hasegawa, PhD, Kyoto University

 Hideaki Kagawa, FUJIFILM Corporation

 Koji Kuchiishi, Cyfuse Biomedical K.K.

 Chang Jessica Lizong, PhD, Ajinomoto Co., Inc.

 Norio Nakatsuji, DSc, Institute for Integrated Cell-Material Science (iCeMS), Kyoto University

12:10p - 1:30p  -Grand Hall East C-D

Symposia

Friday, December 11

National Institutes of Health – Funding & Resources for Early Stage Regenerative Medicine & Life Sciences Companies

The National Institutes of Health (NIH) is the nation’s medical research agency that supports scientifi­c studies that turn discovery into health. The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs (http://sbir.nih.gov) are one of the largest sources of early-stage capital for innovative small companies in the United States. This year, NIH’s SBIR and STTR programs will invest over $780M into early-stage life science companies focused on advancing technologies toward the clinic. Learn how to access NIH funding and resources to accelerate the transition from lab to market, and specific opportunities at the National Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Biomedical Imaging and Bioengineering (NIBIB), and National Cancer Institute (NCI).

Moderator

 Jennifer C. Shieh, PhD, National Heart Lung Blood Institute

Speakers

 Rebecca Roof, PhD, NINDS / NIH

 Todd Merchak, National Institute of Biomedical Imaging and Bioengineering

 Ming Zhao, PhD, National Cancer Institute

12:30p - 3:30p  -Dunwoody

PRIVATE EVENT

Friday, December 11

CASIS Workshop – PRIVATE EVENT

Private Event for CASIS – Located in Dunwoody Room, Level 3

Americans die each day while waiting for transplants because of the shortage of donated organs. The Us. Department of Health and Human Services estimates that each day, an average of 79 people receive organ transplants.  However, an average of 22 people die each day waiting for transplants because of the shortage of donated organs.  And the gap continues to widen. Right now, there are more than enough people waiting for an organ to fill a large football stadium twice over.1 Globally the numbers may vary, but regardless of geography, the number of transplants far outpaces the number of available organs. Advances in stem cell biology, development of micro-physiologic systems (organs-on-chips), and 3D bioprinting are helping to accelerate drug discovery and bring the possibility of bioengineering whole organs for transplantation closer to reality.

1:30p - 2:30p  -Regency Ballroom

Concurrent Session

DISCOVERY

Friday, December 11

Cord Blood – Discovery and Clinical Advances (sponsored by Cord Blood Association)

Topical Focus of this Session:

  • Using Cord Blood and Cord Tissue in Regenerative Medicine
  • Cord Blood Monocytes as a Sources of Cell Therapty Products for Treatment of Brain Injuries
  • Game Changers: Using Cord Blood to Help the Brain

Moderator

 Joanne Kurtzberg MD, Carolinas Cord Blood Bank at Duke

Speakers

 Andrew Balber, PhD, Duke University Translational Medical Institute

1:30p - 2:30p  -Grand Hall East A-B

Concurrent Session

REGMED CAPITAL CONFERENCE (RMCC)

Friday, December 11

RegMed Company Presentations to Investors – Sessions 15-18

Moderator

 Jeffrey S. Cohen, Ladenburg Thalmann & Co. Inc.

 R. Lee Buckler BEd, LLB, RepliCel Life Sciences, Inc.

 Wade Lange, NeuroFx

 Rebecca Marshall, CellectCell, Inc.

 Tracy Worthington Stice, ArunA Biomedical, Inc.

1:30p - 2:30p  -Hanover C-D

Concurrent Session

INNOVATION SHOWCASE

Friday, December 11

Cryopreservation – First Step to Success in Research & Translation (supported by Panasonic)

Topics include: (1) Physiological Oxygen new data, speaking of how to grow cells  (2) Now that good cells are being grown, how to maintain a clean environment, discussing the Panasonic Cell Processing Work Station and its market equivalents and (3) How to store all these good cells, made in a GMP environment in a proper cryogenic state using mechanical freezers (or LN2 tanks) and having the ability to monitor and log the data of that environment on a real time basis. A story of a good pathway from the start of cell growth through cryogenic storage.

Moderator

 Deepak Mistry, Panasonic Healthcare Corporation of America

Speakers

 Kartoosh Heydari, MD, Stanford School of Medicine

 Ram Bedi, PhD, MBA, University of Washington

1:30p - 2:30p  -Grand Hall East C-D

Concurrent Session

TRANSLATION AND CLINICAL TRIALS

Friday, December 11

A Cellular Therapy Case Study Organized by The International Society for Cellular Therapeutics (ISCT)

Here ISCT experts are dissecting the different challenges that may affect the development of therapeutic approaches based on MSC towards clinical application, as cell therapy case study. 

Speakers will be addressing issues such as cell expansion, characterization, potency assay developments, pre-clinical in vivo evidences and how to translate those outcomes into robust MSC-based therapeutics. 

Attention will be additionally given to MSC reagents, processing and scale up during their GMPification phases and how to combine the clinical scale production with the desired biological properties  that emerged during early pre-clinical investigations.

Moderator

 Massimo Dominici, MD, International Society for Cellular Therapeutics

Speakers

 Claudia Zylberberg, PhD, Akron Biotechnology, LLC

1:30p - 2:30p  -Hanover G-F

Concurrent Session

REGENERATIVE SERVICES AND APPLICATIONS

Friday, December 11

Stem Cell Therapies Using Adipose Tissue — From Fat Grafts to 3-D Cultures (supported by iFATS)

Adipose tissue was considered an unreliable and unpredictable material for tissue reconstruction until very recently. With the development of standardized techniques for harvesting, processing and delivering fat grafts pioneered by Sidney Coleman MD, the indications and uses for these grafts quickly spread. Initially thought of as “structural” grafts, their regenerative impact was evident to practitioners. This finding was buttressed by the discovery that adipose tissue is an abundant source of mesenchymal stem cells, capable of delivering therapeutic doses of MSC’s in a single operative session (Zuk et al 2001). Current advances in Fat Grafting technology have focused on delivering the full regenerative potential of adipose derived MSC’s within the constraints of FDA regulatory standards. Fat grafting is a Regenerative Technnology already in use clinically  for many conditions including reversal of radiation damage, degenerative joint disease, and many other conditions. We are just beginning to understand how to harvest the full potential of Fat Grafting.

Moderator

 Ricardo Luis Rodriguez, MD, Cosmeticsurg

Speakers

 Annie Bowles, Tulane University

 William W. Cimino, PhD, The GID Group, Inc.

 Camillo Ricordi, MD, University of Miami Diabetes Research Institute

1:30p - 2:30p  -Hanover E

Concurrent Session

HOT TOPICS & FUTURE TRENDS

Friday, December 11

Evolution and De-extinction – The Frozen Zoo and Cloning the Mammoth

Moderator

 Jeanne F. Loring, PhD, The Scripps Research Institute

Speaker

 Franklin D. West, PhD, University of Georgia

2:30p - 3:30p  -Regency Ballroom

Concurrent Session

DISCOVERY

Friday, December 11

Amniotic Tissue and Cells – New Potential for Healing

This session will provide an overview of the potential for amniotic tissue and cells to promote healing for various clinical applications, including wound repair and post-traumatic arthritis. In addition to new basic science data, translational issues such as FDA regulation will be discussed.

Moderator

 Robert E. Guldberg, PhD, Georgia Institute of Technology

Speaker

 Donald Fetterolf, MD, FACS, MiMedx

 Shabnam M. Namin, PhD, MBA, UMTB Biomedical, Inc.

2:30p - 3:30p  -Grand Hall East A-B

Concurrent Session

REGMED CAPITAL CONFERENCE (RMCC)

Friday, December 11

Analysis, Banking & Investment Roundtable

Moderator

 Jeffrey S. Cohen, Ladenburg Thalmann & Co. Inc.

Speakers

 Reni Benjamin, PhD, Raymond James & Associates, Inc.

 Steve Brozak, MBA, WBB Securities

 Henry McCusker, RegMedinvestors

2:30p - 3:30p  -Hanover C-D

Concurrent Session

INNOVATION SHOWCASE

Friday, December 11

Challenges in Bio-Manufacturing of Therapeutic Cells: An Industry Perspective

Moderator

 Krishnendu Roy, PhD, Georgia Institute of Technology

Speakers

 Jon A. Rowley, PhD, Rooster Bio

 Eytan Abraham, PhD, Lonza Walkersville, Inc.

 Philip G. Vanek, PhD, GM Cell Therapy Technologies

 Wen Bo Wang, PhD, Cellular Dynamics International

2:30p - 3:30p  -Grand Hall East C-D

Concurrent Session

TRANSLATION AND CLINICAL TRIALS

Friday, December 11

Spinal Cord Injury and Neurological Disorders – Clinical Pathways

Moderator

 Evan Snyder, PhD Sanford Burnham Prebys Medical Discovery Institute,

Speaker

 Anthony J. Windebank, MD, Mayo Clinic

 Xianmin Zeng, PhD, Buck Institute on Aging

2:30p - 3:30p  -Hanover G-F

Concurrent Session

REGENERATIVE SERVICES AND APPLICATIONS

Friday, December 11

Plastic Surgeon Clinical Update in a Shifting Regulatory Landscape

The modern era of Adipose Tissue Regenerative Therapy was ushered in by the standardization of safe and effective methods for harvesting, processing, and injecting adipose tissue (Fat Grafting) pioneered by Sydney Coleman MD. Clinicians have widely adopted Fat Grafting and it is now a major component of any modern Plastic Surgery practice. More importantly, it is rapidly spreading to other specialties such as Dermatology, Otolaryngology/Head and Neck surgery, and Orthopedics as clinicians grasp the regenerative potential of Fat Grafting. Nonetheless, the shifting regulatory landscape may call into question the role of Adipose tissue as a readily available clinical tool. Specific questions to be addressed are: Is Adipose Tissue solely a “STRUCTURAL” tissue, or does it have endocrine, metabolic, and regenerative functions? Is the female breast solely a lactating organ or does it serve a role in sexual and personal identity? Should the regulatory framework of Medical Therapy reflect commonly accepted scientific facts?

Moderator

 Ricardo Luis Rodriguez, MD, Cosmeticsurg

Speakers

 Michael N. Druckman, Hogan Lovells US LLP

 J. Peter Rubin, MD, University of Pittsburgh

 Karen B. Vaniver, MD, FACS, Lourdes Health Network

2:30p - 3:30p  -Hanover E

Concurrent Session

HOT TOPICS & FUTURE TRENDS

Friday, December 11

Patients & Doctors — Your Questions Answered About Safe Stem Cell Therapies and Enrolling in Clinical Trials

Moderator

 Paul Knoepfler, PhD, UC Davis School of Medicine

Speakers

 Steven A. Davis, MD, StemBioSys, Inc.

2:30p - 3:30p  -Hanover A-B

Concurrent Session

ETHICS, LAW & SOCIETY (ELSI)

Friday, December 11

Engaging Student Involvement in the Field of Stem Cells & Regenerative Medicine

As the stem cell research and regenerative medicine field advances, career opportunities are exponentially increasing. It is important that we creating an industry adequately training the next generation of talent, for all career paths and with a humanitarian perspective of the science. Historically, students have had a powerful voice in the pro-cures movement and have demonstrated the ability to be effective community educators and advocates. This session will host expert panelist from nationally recognized organizations seeking to address special topics on attracting students to the field, career development, advocacy, and resources for supporting student involvement in stem cell research and regenerative medicine. Additionally, a special audience participation component will take place seeking to provide unique value for session attendees.

Moderator

 Marion J. Riggs, PhD, Harvard Medical School

Speakers

 Laurel Barchas, MA, Student Society for Stem Cell Research

 Mary Bass, Americans for Cures Foundation

 Antara Rao, University of California, Berkeley

 Joan Schanck, MPA, Wake Forest Institute for Regenerative Medicine

3:30p - 4:00p  -Terrace Foyer

Break

Friday, December 11

Afternoon Break – Exhibits Open

4:00p - 5:00p  -Regency Ballroom

Concurrent Session

DISCOVERY

Friday, December 11

Tackling Pediatric Neurological Disorders, Autism & Brain Damage Using Cell Therapies

Moderator

 Joanne Kurtzberg MD, Carolinas Cord Blood Bank at Duke

 Davis George, Duke University

 Evan Y. Snyder, MD, PhD, FAAP, Sanford Burnham Prebys Medical Discovery Institute

4:00p - 5:00p  -Grand Hall East A-B

Track Keynote

REGMED CAPITAL CONFERENCE (RMCC)

Friday, December 11

Venture Philanthropy: How to create an ecosystem of innovation and a culture of servant leadership to bridge the gap between innovation and access, and to improve patient care

Bill Gates recently said the two greatest problems in global health are the lack of investment in innovation and the lack of access to the solutions that innovation creates. For Ross, this became very personal when he broke his neck in August of 2007 and realized the gap between innovative research and actual solution in the marketplace. The American Medical Association has indicated that it takes 17 years for best practice to become common practice in the healthcare system. Ross is committed to giving patients access to the latest technologies treatments in spinal cord and neurological injuries and other diseases, injuries and illnesses that affect the patient population.Using the healthcare ecosystem in Georgia as a working model to implement solutions that can be replicated nationally/globally, Ross created HINRI to bridge the “implementation gap” between innovation and access to improve patient care. Taking business principles from venture capital to aid other nonprofits with raising capital, establishing strategic partnerships, building advisory/governing boards, introducing technology and servant leaders so that they are more effective at saving lives, saving money and having a more sustainable impact, HINRI seeks to address health challenges around the world by identifying, partnering and collaborating with leading innovators, philanthropists, entrepreneurs, nonprofits and policymakers to accelerate the implementation of key solutions to bridge the gap between innovation and access and improve patient care.

Speaker

 Ross Mason, The Healthcare Insititute for National Renewal and Innovation (HINRI)

4:00p - 5:00p  -Hanover C-D

Concurrent Session

INNOVATION SHOWCASE

Friday, December 11

Therapeutic Cell Manufacturing: The Role of Industry – Academia – Government Partnership

Moderator

 Krishnendu Roy, PhD, Georgia Institute of Technology

Speakers

 Sheng Lin-Gibson, PhD, National Institute for Standards and Technology (NIST)

 Michael H. May, PhD, Centre for Commercialization of Regenerative Medicine (CCRM)

4:00p - 5:00p  -Grand Hall East C-D

Concurrent Session

TRANSLATION AND CLINICAL TRIALS

Friday, December 11

Advances in Gene Therapies

Moderator

 Richard Jove, PhD, Nova Southeastern University

Speakers

 H. Trent Spencer, PhD, Emory University School of Medicine

 Evren Alici, MD, PhD, Karolinska Institutet

 William K. Decker, PhD, Baylor College of Medicine

4:00p - 5:00p  -Hanover G-F

Track Keynote

REGENERATIVE SERVICES AND APPLICATIONS

Friday, December 11

Training Physicians for Regenerative Medicine Practice

Moderator

 Kristin Comello, US Stem Cell (Bioheart)

4:00p - 5:00p  -Hanover E

Concurrent Session

HOT TOPICS & FUTURE TRENDS

Friday, December 11

Regenerative Medicine Platform Resources

Moderator

 Thomas A. Gonwa,MD, FASC, FACP, Mayo Clinic College of Medicine

Speakers

 Julie G. Allickson, PhD, Wake Forest Institute for Regenerative Medicine

 Don L. Gibbons, California Institute for Regenerative Medicine

5:00p - 7:00p  -Grand Hall West & East / Prefunction

Exhibits / Posters Reception

Friday, December 11

Exhibitor Networking Reception & Poster Viewing with Presenters Present

7:30p - 10:30p  -

SPECIAL EVENT

Friday, December 11

Come see the future and choose your fate (sponsored by fluidigm) — White Oak Kitchen & Cocktails

Ever wondered what you could accomplish if you could see the future? Were those long hours differentiating and reprogramming cells spent in vain?  Is that grant funding coming in to further my research?  Wonder no more and come have all your questions answered by the skilled team of Fluidigm fortune tellers and soothsayers at the White Oak Kitchen & Cocktails. 270 Peachtree St. NW, Atlanta GA

Join your colleagues for:

Appetizers
Drinks
Bourbon tastings
Palm reading
Tarot card reading
A chance to learn how to choose your cell fate with Callisto®

Register to attend today.  Space is limited.

 

Saturday, December 12, 2015

8:00a - 1:00p  -Terrace Foyer

Registration

Saturday, December 12

Registration

8:00a - 9:00a  -Grand Hall West & East / Prefunction

Breakfast

Saturday, December 12

Networking Breakfast – Exhibits Open

8:30a - 9:00a  -Regency Ballroom

Saturday, December 12

Poster Winners Announcement & Special Presentation

2015 World Stem Cell Summit Poster Winners.
Special Presentation: Stem Cells Translational Medicine Young Investigator Awards:  Kamil Kranc, MD, PhD, University of Edinburgh and Dustin R. Wakeman, PhD, Rush University Medical Center

Presenter

 Julie G. Allickson, PhD, Wake Forest School of Medicine

 Jan A. Nolta, PhD, UC Davis

9:00a - 9:20a  -Regency Ballroom

Plenary Keynote

Saturday, December 12

Team Training – Inspiring Scientists and Advocates into Action

The fields of stem cells, immunotherapy, gene therapy and regenerative medicine are poised to change the face of healthcare. Immunotherapy is giving terminal cancer patients a second chance at life, gene therapy can cure rare diseases, and living stem cells are beginning to be prescribed for certain indications. This changes the fields of medicine, nursing, and pharmacy, since the new generations of healthcare students will need to learn how to handle drugs that are not pills or liquids in a vial, but rather are living biological medicines. At UC Davis we are committed to training the science and healthcare work force of the future, and to continuing to improve and deliver these novel cutting edge therapies that can offer cures rather than palliative remedies, for patients who currently have limited options.

 Social media allows closer interaction between scientists, patients and patient advocates, MDs, foundations, funding agencies, industry partners, and students at all levels, including interested members of the public. The common passion to treat a specific disease or disorder unites these interesting multifaceted teams, and each member brings a unique perspective to the group. It is important for members of these broad and committed groups to remember to always seek evidence-based solutions for developing novel treatments that have the best chance of impacting the disorder that they hope to cure. Publication of peer-reviewed “Proof-of-Concept” data in reputable journals with relatively high impact factor should accompany claims of efficacy. World Stem Cell Summit brings together interested people from all backgrounds to discuss important advances in the field of regenerative medicine in an exciting open forum venue.

Presenter

 Jan A. Nolta, PhD, UC Davis

9:20a - 10:00a  -Regency Ballroom

Plenary Keynote

Saturday, December 12

Regenerative Medicine Industry Update in Japan

Presenter

 Kunihiko Suzuki, FIRM - Forum for Innovative Regenerative Medicine

9:00a - 10:00a  -Grand Hall East A-B

Workshop

Saturday, December 12

Dare to be Great! Turning Your Lab research into a Thriving Commercial Enterprise

Moderator

 Connie Koch Harrell, Kerietsu Forum Southern California LLA

 Sy Griffey, StemBioSys, Inc.

 Chris Mason, MBBS, PhD, FRCS, University College London

10:00a - 11:00a  -Regency Ballroom

Concurrent Session

DISCOVERY

Saturday, December 12

Immunotherapy Revolution – Breakthrough Discoveries

Moderator

 Richard Jove, PhD, Nova Southeastern University

Speakers

 Raphael Gorodetsky, PhD, Hadassah Medical Center

 Edmund K. 'Ned' Waller, MD, PhD, Emory University School of Medicine

10:00a - 11:00a  -Grand Hall East A-B

Concurrent Session

REGMED CAPITAL CONFERENCE (RMCC)

Saturday, December 12

The Business of Selling Cells & Regenerative Products

Speaker

 Kaz Hirao, Cellular Dynamics International Inc.

 Asutosh T. Yagnik, Aura Capital Partners

 Bob Hutchens, StemBioSys, Inc.

10:00a - 11:00a  -Hanover C-D

Concurrent Session

INNOVATION SHOWCASE

Saturday, December 12

Logistics, Systems and Infrastructure to Support Commercial Scale Autologous Immunotherapy Manufacturing

Presenter

 Robert E. Margolin, MBS, MBA, Cognate BioServices, Inc.

10:00a - 11:00a  -Grand Hall East C-D

Concurrent Session

TRANSLATION AND CLINICAL TRIALS

Saturday, December 12

Diabetes – Research and Clinical Trial Update

Moderator

 Camillo Ricordi, MD, Diabetes Research Institute Foundation

Speaker

 Karl Tryggvason, MD, PhD, Karolinska Institutet, Duke-NUS

 Alan Colman, PhD, Harvard Department of Stem Cells and Renergative Biology

 Federico Pereyra-Bonnet, BSc, PhD, The Italian Hospital of Buenos Aires

10:00a - 11:00a  -Hanover E

Concurrent Session

HOT TOPICS & FUTURE TRENDS

Saturday, December 12

Accelerating Cures: The Critical Role of Patient Advocates

Moderator

 Kevin McCormack, CIRM

Speakers

 Don C. Reed, Americans for Cures Foundation

 Frances D. Saldaña, HD Care

 Tory Williams, AIM

11:00a - 11:30a  -Grand Hall West & East / Prefunction

Break

Saturday, December 12

Morning Break – Exhibits Open

11:30a - 12:30p  -Regency Ballroom

Track Keynote

DISCOVERY

Saturday, December 12

Emerging Trends in the Regenerative Medicine Industry – Hot Topic & Future Trends

Presenter

 Michael D. West, PhD, BioTime, Inc.

11:30p - 12:30p  -Grand Hall East A-B

Concurrent Session

REGMED CAPITAL CONFERENCE (RMCC)

Saturday, December 12

RegMed Company Presentations to Investors – Sessions 23-26

Moderator

 Steven A. Davis MD, StemBioSys, Inc.

Speakers

 Ram Mandalam, PhD, Cellerant Therapeutics

 Howard Leonhardt, BioLeonhardt Myo-Stim

 Takuya Yokokawa, FujiFilm Corporation

 Joshua M. Hare, MD, FACC

11:30a - 12:30p  -Hanover C-D

Concurrent Session

INNOVATION SHOWCASE

Saturday, December 12

Progress in Disease Modeling

This panel will discuss the advantages and disadvantages associated with generating in vitro disease specific models and more importantly how these cells can be used as assay platforms. The Next Generation Genetic Association Studies program derive over 1500 iPSC lines as surrogates for clinical disease phenotypes (including surrogates for diabetes, cardio-pulmonary disorders, sickle cell anemia, etc.), and are now using them to study how naturally occurring human genetic variation influences molecular phenotypes in cell based models of disease.   Additionally, a large bank of disease-affected human embryonic stem cell lines are being generated along with a robust and efficient differentiation process for skeletal muscle and are being used in small molecule drug screening. Finally, patient specific and gene edited lines developed for neuroprotective assays, including dopaminergic neurons for Parkinson’s disease as well as other neurodegenerative disorders will be discussed.

Moderator

 Steven L. Stice, PhD, Regenerative Bioscience Center

Speaker

 Tenneille Ludwig, PhD, WiCell

 Dr. Uli Schmidt, Genea Biocells US Inc.

 Xianmin Zeng, PhD, Buck Institute on Aging

11:30p - 12:30p  -Grand Hall East C-D

Concurrent Session

TRANSLATION AND CLINICAL TRIALS

Saturday, December 12

Regenerative Medicine: A New Era of Discovery and Innovation – Liebert Editors

Moderator

 John Sterling, Genetic Engineering & Biotechnology News (GEN)

Speakers

 Aubrey de Grey, PhD, SENS Foundation

 Peter C. Johnson, MD, Scintellix, LLC

 Jeanne F. Loring, PhD, The Scripps Research Institute

 Graham Parker, PhD, Wayne State University School of Medicine

12:30p - 2:00p  -Grand Hall East

Lunch

Saturday, December 12

Lunch

12:40p - 2:00p  -Hanover C-D

Symposia

Saturday, December 12

Novel Collaborations in Stem Cell Research (supported by BioBridge Global)

This panel will highlight new means of accessing biological materials and resources for stem cell research that are the result of novel institutional collaboration models.  Discussion will include donor access, quality control of starting materials and characterization of finished product.           

 Becky Cap, BioBridge Global

 Scott Jones, PhD, QualTex Laboratories

 Charles Mooney, Oklahoma Blood Institute

 Linda Myers, ASCP, MT, SBB, CQA (ASQ), BioBridge Global

 Robert J. Tressler, PhD, MS, San Diego Blood Bank

12:40p - 2:00p  -Grand Hall East A-B

Workshop

Saturday, December 12

Understanding the Risks and Rewards in Investing in the RegMed Sector

Speakers

 Steve Brozak, MBA, WBB Securities

 Henry McCusker, RegMedinvestors

12:40p - 2:00p  -Grand Hall East C-D

Symposia

Saturday, December 12

Humankind 2.0 – Curing the Diseases of Aging and Extending the Human Lifespan

Historically, efforts to postpone the ill-health of old age have focused on either the symptoms of that ill-health (essentially attempting to cure them as one cures an infection) or else the metabolic processes that create the lifelong accumulating damage underlying eventual physiological decline (essentially attempting to extrapolate from the differences between species in the rate of aging). Now, however, it is increasingly recognised that regenerative medicine has far greater therapeutic potential for the elderly than either of these approaches, because it can genuinely turn back the clock of aging. In this session we will discuss a selection of recent advances that are contributing to the realisation of true medical rejuvenation.

Moderator

 Aubrey de Grey, PhD, SENS Foundation

Speaker

 John P. Cooke, MD, PhD, Houston Methodist Research Institute

 Xianmin Zeng, PhD, Buck Institute on Aging

 Michael D. West, PhD, BioTime, Inc.

2:00p - 3:00p  -Regency Ballroom

Concurrent Session

DISCOVERY

Saturday, December 12

Stem Cell Transplant

Speaker

 Lakshmanan Krishnamurti, MD, Children's Healthcare of Atlanta

 Edmund K. 'Ned' Waller, MD, PhD, Emory University School of Medicine

2:00p - 3:00p  -Hanover C-D

Concurrent Session

INNOVATION SHOWCASE

Saturday, December 12

Regenerative Engineering and Bio-Materials

Moderator

 Saverio La Francesca, Executive Vice President and Chief Medical Officer... Is a cardiothoracic surgeon with extensive clinical experience committed to the clinical translation of transformative medical research. Saverio has a unique combination of experience that features over 25 years of academic clinical surgical practice and innovative research, with a foundation in the cardiovascular, thoracic transplantation, cardiac assist device and regenerative medicine fields. He joins the company from the Dept. of Cardiovascular Surgery and Transplantation at the DeBakey Heart and Vascular Center at the Houston Methodist Hospital, where he developed the current surgical and perfusion techniques for thoracic organ procurement and preservation and where he was also the Director of the Exvivo lung perfusion laboratory. Previously he was an attending surgeon at the Department of Cardiopulmonary Transplantation at the Texas Heart Institute in Houston, Texas. Saverio still holds an appointment as Associate Professor of Surgery at the University of Rome "La Sapienza” in Rome, Italy. He received his M.D. in medicine and surgery in 1985 at the University of Palermo. Saverio did his Residency in Cardiovascular Surgery in the Dept. of Cardiovascular Surgery at the University of Rome "La Sapienza". He then completed his post-doctoral training with fellowships at the Texas Heart Institute under the supervision of pioneer surgeon Denton Cooley. He was also a Clinical/ Research fellow at McGill University in Montréal, Québec, Canada and at the Baylor College of Medicine in Houston. Saverio holds UNOS certifications as heart transplant surgeon and lung transplant surgeon. He is also certified as surgeon for the use of the HeartMate and the Jarvik 2000 left ventricular assist devices.

Speakers

 Samuel P. Franklin, MS, DVM, PhD, University of Georgia

 Timothy Ganey, PhD, Atlanta Medical Center

2:00p - 3:00p  -Grand Hall East C-D

Concurrent Session

TRANSLATION AND CLINICAL TRIALS

Saturday, December 12

2015 Clinical and Business Overview + Exciting Clinical Readouts for 2016

Moderator

 Robert Margolin, MBS, MBA, Cognate Bioservices, Inc.

2:00p - 3:00p  -Grand Hall East A-B

Concurrent Session

HOT TOPICS & FUTURE TRENDS

Saturday, December 12

Radiation! Surviving Standard Medical Treatments, Space Travel and in Post-Apocalyptic Scenarios

“Surviving Total Body Irradiation Exposures: A Radiation Oncologist’s Perspective”

Abstract

Given the current social and political uncertainty across the world, defense indicators point towards a potential nuclear disaster as part of terrorist activity in the future. Previous nuclear disasters have resulted from nuclear accidents like the Chernobyl accident, defense related activities such as the Hiroshima & Nagasaki Atomic bomb, and medical uses. Radiation is currently used as part of routine medical treatments, especially for those patients undergoing total body irradiation. The focus of the talk will be on uses of total body irradiation as part the standard medical treatments for a wide variety of leukemia’s. We will discuss the expected acute and late side effects and how to manage many of these these side effects. We will also focus on the recent developments in radiation countermeasures including the development of small molecules and stem cell based therapies which can potentially serve as future radioprotectors and radiation mitigators;   Further developments are needed in order to move some of these compounds into clinical practice, but early preclinical results appear to be promising.

Moderator

 Ram Mandalam, PhD, Cellerant Therapeutics

Speakers

 Raphael Gorodetsky, PhD, Hadassah Medical Center

 Mohammad K. Khan, MD, PhD, DABR, Emory University School of Medicine

2:00p - 3:00p  -Hanover A-B

Track Keynote

ETHICS, LAW & SOCIETY (ELSI)

Saturday, December 12

Human Organs and Tissues for Use in Regenerative Medicine and Stem Cell Research

Presenter

 Jeremy J. Brown, MD, IIAM

3:00p - 4:00p  -Regency Ballroom

Concurrent Session

DISCOVERY

Saturday, December 12

The Best of the Best: Poster and Young Investigator Oral Presentations

Oral Presentations by WSCS 2015 Poster Winners and the SC and SCTM Young Investigator Award Winners

 Kamil Kranc, MD, PhD, University of Edinburgh - Young Investigator Award Winner

 Dustin R. Wakeman, PhD, Rush University Medical Center - Young Investigator Award Winner

3:00p - 4:00p  -Grand Hall East C-D

Track Keynote

TRANSLATION AND CLINICAL TRIALS

Saturday, December 12

The Mesenchymal Stromal Cell Paradigm and How Failed Industrial Clinical Trials Inform Rational Development of Cellular Pharmaceuticals

The use of cryopreserved allogeneic mesenchymal stromal cells (MSCs) for treatment of an array of immune and tissue injury disorders has become medical practice in many jurisdictions.  The enthusiasm for their use builds upon compelling phase II clinical trial data published by European collaborative groups in the past few years. Notwithstanding, a large multicenter phase III clinical trials conducted in the USA examining the use of industrial MSC products for GvHD, colitis and stroke fail to meet their primary clinical endpoints of effectiveness when compared to placebo.  It is worthwhile taking pause and reflecting upon the apparent discrepancy between encouraging animal pre-clinical data, the European academic experience and Industry-sponsored studies.  This presentation will focus on articulating plausible failure analysis focusing on the potential variables affecting MSCs, potential remedies and the lessons learned informing the cellular pharmaceutical field at large.

Presenter

 Jacques Galipeau, MD, FRCS (C), Emory University School of Medicine

4:00p - 4:15p  -Regency Foyer

Break

Saturday, December 12

Afternoon Break

4:15p - 5:30p  -Regency Ballroom

Plenary Keynote

Saturday, December 12

Advocacy Keynote & Town Hall Meeting

Moderator

 Bernard F. Siegel, JD, Genetics Policy Institute

5:30p - 6:30p  -Regency Foyer

Saturday, December 12

Closing Reception