Perelman School of Medicine at the University of Pennsylvania

Business of Regenerative Medicine 2018

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Program

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.

 

Welcome

 

 

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.

7:15pm

 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.

 Breakfast

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

CCRM

 

 

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