Perelman School of Medicine at the University of Pennsylvania

Business of Regenerative Medicine 2018

banner image


Full PDF of Program HERE



Monday July 16, 2018 Smilow Center for Translational Research Atrium


4:30 p.m.


Registration Opens


5:00 p.m.

Opening Address:


Facilitating the Development of innovation Regenerative medicine products

Peter Marks, MD, PhD

Director, Center for Biologics

Evaluation and Research

U.S. Food and Drug Administration


Rubenstein Auditorium, Smilow Center for Translational Research


6:00 –

8:00 p.m.


Welcome Address and Cocktail Reception


Tours of the Novartis Center for Advanced Cellular

Therapies at University of Pennsylvania



Bruce Levine, PhD

Barbara and Edward Netter Professor in Cancer Gene Therapy


Ken Zaret,PhD

Joseph Leidy Professor, Cell and Developmental Biology



Tuesday July 17, 2018 Rubenstein Auditorium


8:00 –

8:30 a.m.


Registration Open | Continental Breakfast



Smilow Atrium


8:30  –

8:40 a.m.





Jonathan Epstein, M.D.
Executive Vice Dean and Chief Scientific Officer
 Perelman School of Medicine at the University of Pennsylvania


Bruce Levine, PhD

Barbara and Edward Netter Professor in Cancer Gene Therapy


Ken Zaret, PhD

Director, Institute for Regenerative Medicine



8:40 a.m.


State of the Industry



Reni Benjamin, PhD

Managing Director Equity Research Biotechnology, Raymond James


Session I:  Development Success Stories and New Challenges                               Session Chair: Reni Benjamin, PhD


9:10 a.m.


“From academic innovation to global patient access: reimagining medicine with Kymriah ”



Pascal Touchon

Senior Vice President, Global Head Cell & Gene Therapy, Novartis



9:45 a.m.


“Turning Genes into Medicines: Gene Therapy Comes of Age”


Kathy High, MD

President, Head of R&D, Spark Therapeutics



10:20 – 10:40 am Coffee Break, Smilow Atrium


Session II:  Immune Cell Therapies — The Next Generation                                   Session Chair: Bruce Levine, PhD


10:40 a.m.


“Neoantigen discovery and application to clinical trials”




Gerald P. Linette, MD, PhD

Medical Director, Sean Parker Institute of Cancer Immunotherapy, University of Pennsylvania



11:00 a.m.


“Immune Cell Therapies: Where to Now? Novel cell engineering approaches to treat myeloid neoplasms.”



Saar Gill, MD PhD

Assistant Professor in Medicine

University of Pennsylvania


Session III: Spotlight on Regenerative Medicine in Diabetes                                 Session Chair: Ken Zaret, PhD


11:20 a.m.


“Development of a Cell Therapy/Combination Product for Diabetes”



Mark Zimmerman, PhD

Vice President, ViaCyte

Session IV: Regenerative Medicine Lightning Talks                                           Session Chair: Ken Zaret, PhD

11:45 a.m.

  • Rumela Chakrabarti "Identification of mammary stem cell niche: therapeutic implications in breast cancer"
  • Wei Tong "Expanding stem cells to treat blood disorders"
  • Yuanquan Song “New therapeutic targets for treating neural injury and neurodegenerative diseases”
  • Jamie Shuda “IRM Outreach: Inspiring future scientists and engaging the community”


IRM Young Investigators



12:00 – 1:00 p.m. LUNCH – Smilow Atrium



1:00 p.m.                  Regenerative Medicine Economics Impact                                    David Smith/ Morrie Ruffin

                                                                                                                                      ARM Foundation for Cell and Gene Medicine


Session V: Translating Regenerative Medicine                                                        Session Chair: Ken Zaret, PhD


1:15 p.m.


“Guiding stem cells to build muscles” 



Faye Mourkioti, PhD

Assistant Professor, Orthopedic Surgery and Cell Development

Co-Director, IRM Musculoskeletal Program University of Pennsylvania



1:35 p.m.


“Aiming for Skintastic!”




Sarah E. Millar, PhD

Albert Kligman Professor and Vice Chair for Basic Research



1:55 p.m.


“Application of 3D brain organoids in regenerative medicine and drug testing”




Hongjun Song, PhD

Professor of Neuroscience

University of Pennsylvania



2:15 p.m.


"Adipose-Derived Cell-Based Therapeutics: From Cells to Secretome"



Keith March, MD, PhD

Professor of Medicine

Director, Center for Regenerative Medicine
University of Florida



2:45 p.m. Coffee Break


Session VII: Regulatory, Ethical and Public Policy Issues in Cell and Tissue Therapies 

Session Chair: Brock Reeve, MBA


3:05 p.m.


“Ethical Challenges in First-in-Human and Phase I Clinical Trials”



Jonathan Kimmelman, PhD

Associate Professor, STREAM Research Group

Director, Biomedical Ethics Unit

McGill University



3:20 p.m.


“Efficient Drug Development for Regenerative Medicine”




Wilson Bryan, MD

Director, Office of Tissues and Advanced Therapies

Center for Biologics Evaluation and Research

Food and Drug Administration


3:35 p.m.


“Reconciling Profitability, Speed-To-Market, Reimbursement and Compliance for RegenMed Products"




Scott P. Bruder, MD, PhD

Founder and CEO

Bruder Consulting and Venture Group, LLC



3:50 p.m.



“Ethical and Policy Considerations For an Era of Unproven Cell Therapies”



Aaron D. Levine, PhD

Associate Professor & Director of Graduate Studies

School of Public Policy | Georgia Tech



4:05 p.m.


Session VII Panel Discussion



Session VIII: Novel Applications of MSC and Placental Derived stem cells           

Session Chair: Arnold Caplan, PhD


4:35 p.m.



“Mesenchymal Stem/Stromal Cell Therapies”


Jan A. Nolta, PhD

Professor, Director, Stem Cell Program and Institute for Regenerative Cures | University of California Davis

Scientific Director, UC Davis GMP Facility




5:00 p.m.



"Placental Platform Technology : Novel Source of Immune, Stem and Progenitor Cells for Immunotherapy"



Robert J. Hariri, MD, PhD

Founder, Chairman and CEO of Celularity



Day 1 Sessions adjourned


6:30 p.m.


 Seated Dinner

  • Kevin B. Mahoney,  Executive Vice President and Chief Administrative Officer, Penn Medicine - Creating “Cellicon Valley”
  • Patient Clinical Trial Experiences and Advocacy in the New Era of Cell Therapy and Regenerative Medicine

Jordan Medical Education Center Atrium







Wednesday July 18, 2018 Rubenstein Auditorium

8:00 a.m.


Smilow Atrium


Session IX:  The intersection of Engineering and Biology in the creation of Novel Therapies 

Session Chair: Robert Guldberg, PhD


8:30 a.m.


“Microengineered physiological biomimicry: human organs-on-chips”


Dan Huh, PhD

Wilf Family Term Assistant Professor, Bioengineering, University of Pennsylvania



8:55 a.m.


“Engineering Materials for Cell Transplantation”



Andrés J. García, PhD

Rae S. and Frank H. Neely Chair and Regents’ Professor

Georgia Institute of Technology



9:20 a.m.


“Tools for Accelerated Medical Innovation”



Jeffrey Karp, PhD

Professor of Medicine

Brigham and Women’s Hospital, Harvard Medical School



 9:45 – 10:05 a.m. BREAK

Session X: Operation of a cell manufacturing facility Technology transfer to advance development 

Session Chair: Bruce Levine, PhD


10:05 a.m.


“Academic Perspective on Cell and Gene Therapy Development and Manufacturing”




David DiGiusto, PhD 

Executive Director - Stem Cells and Cellular Therapeutics Operations

Founding Director – Stanford Laboratory for Cell and Gene Medicine



10:30 a.m.



“Academic to Industry Bridges for Cell Therapies:

From Proof of Concept to Commercialization”



Bruce Levine, PhD

Founding Director, Clinical Cell and Vaccine Production Facility


Session XI: The role of academic industry government consortia and professional societies in advancing the field                                                                                                                                     Session Chair: Michael May, PhD


10:55 a.m.


"CMaT – A 10 year vision for academic-industry-government partnership to enable transformative advances in cell manufacturing"


Krishnendu Roy, PhD

Robert A. Milton Chair, Georgia Institute of Technology

Director, NSF Engineering Research Center (ERC) for Cell Manufacturing Technologies (CMaT)



11:15 a.m.


“Scaling Commercialization through Public-Private Partnerships and Strategic Investment in Infrastructure and Expertise”



Michael H. May, PhD

President & CEO




11:35 a.m.


“The Role of ISCT in Fostering the development of cell and gene therapy products for the benefit of patients.”



Miguel Forte, MD PhD

CEO, Zelluna Immunotherapy

Chief Commercialization Officer,

International Society for Cell and Gene Therapy



11:55 a.m.


“BioFabUSA: Challenges and opportunities in manufacturing engineered tissues”




Tom Bollenbach, PhD

Scientist, DEKA Research and Development Corp., and

Chief Technology Officer at the

Advanced Regenerative Manufacturing Institute



12:15 p.m. LUNCH


Session XII: Intellectual property and Licensing: Turning science into business into public benefit

Session Chair: John Swartley, MBA, PhD


1:10 p.m.


“Strategic Use of Intellectual Property in Commercialization of Regenerative Medicine”



Ainslie Little, PhD

Director, Intellectual Property

BlueRock Therapeutics



1:35 p.m.


“Who Owns CRISPR?:  The Patent Fight Over The Next Big Thing”



Daniel M. Scolnick, PhD, JD

Partner, Registered patent attorney, Pepper Hamilton LLP.


1:55 p.m. BREAK

Session XIII: Entrepreneurial Science Commercialization: Start Up, Move Forward, Cross the finish line

Session Chair:  Steven Nichberger, MD


2:15 p.m.



“Translating Gene and Cell Therapies into Viable Commercial Products”



Usman “Oz” Azam, MD

President & CEO

Tmunity Theraputics, LLC.



2:35 p.m.


“Transforming SOC via Single Dose Gene Therapy”


Geoff MacKay

President and CEO of AVROBIO, Inc.



2:55 p.m.


“Next-Generation Gene Editing for off-the-Shelf Gene Cell Therapies”



Rachel Haurwitz, PhD

President and CEO, Caribou Biosciences


Session XIV: Closing Panel

Session Chair:  Janet Lambert, CEO ARM


3:15 p.m.


Panel and Audience discussion on the state and future of the business of regenerative medicine




4:00 p.m.



Close of Symposium