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Tissue Engineering and Therapeutics Workshop

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Tissue Engineering and Therapeutics Workshop

Back to ARM Events

Tissue Engineering and Therapeutics Workshop

The Alliance for Regenerative Medicine held a 1-day workshop on Tissue Engineering and Therapeutics on September 6, 2023, in the Rockville, MD area. This workshop highlighted scientific advances, CMC and regulatory insights, and funding perspectives.

About This Workshop

Tissue engineering seeks to restore, maintain, improve, or replace damaged tissues and organs through the combination of scaffolds, cells, and/or biologically active molecules. Artificial skin and cartilage are examples of engineered tissues that have been approved by the FDA. Eight tissue engineered products have been approved in the U.S. to date, with a steady pipeline of clinical-stage products advancing towards regulatory decisions. For tissue engineered products, CMC (chemistry, manufacturing, and controls) activities during development and scaling of manufacturing present unique challenges to developers due to the complexity of these products that often feature scaffolds in addition to a cell-based products.

This workshop will provide an update on the state of this rapidly advancing field, starting with an overview of the newest scientific advances in a “science slam” format, followed by in-depth panel discussions on current CMC challenges focusing on manufacturing as well as delivery, dosing, and potency. The workshop will then venture into funding and partnering perspectives and explore market opportunities. The day will conclude with a session on regulatory perspectives and provide an opportunity to address common hurdles and pave the way for future avenues.


Wednesday, September 6

8:00 – 8:45am: Registration and Breakfast
8:45 – 9:00am: Welcome Remarks

Mike Lehmicke, Vice President, Scientific and Industry Affairs, Alliance for Regenerative Medicine (ARM)

9:00 – 10:45am: SCIENCE BRIEFINGS: Tissue Engineering – Science and Application Development (15 minute presentations)

Bioengineering Transplantable Organs to Address the Transplant Need- Jeff Ross, CEO, Miromatrix
Adaptive Biologic Therapeutics for Cardiovascular Disease- Jordan Lancaster, CEO, Avery Therapeutics
Bioprinted Tissue Therapeutics to Transform How We Treat Disease- Eric Roos, Chief Business Development Officer, Aspect Biosystems
3D-Bioprinted Vascularized Eye Tissue for Disease Modeling and Cell Therapy- Kapil Bharti, Director, Intramural Research Program, National Eye Institute, NIH
EpiBone: Pioneering Regenerative Medicine for Musculoskeletal Repair- Nina Tandon, CEO, EpiBone
Bioprinting engineered tissues to restore healthy function- Caralynn Collens, CEO, Dimension Inx

10:45 – 11:00am: Morning Break
11:00am – 12:00pm: PANEL DISCUSSION: CMC Perspectives – Scaling of Manufacturing

Jane Lebkowski, President of Research and Development, Regenerative Patch Technologies (Moderator)
Luis Alvarez, CEO, Theradaptive
Richard McFarland, Chief Regulatory Officer, ARMI
Harold Ott, CEO, Iviva Medical
Matt Panning, Director of Manufacturing, Humacyte

12:00 – 1:00pm: Lunch Break
1:00 – 2:00pm: PANEL DISCUSSION: CMC Perspectives – Delivery, Stability, Potency

Geoff Hamilton, Co-Founder and CEO, Stemson Therapeutics (Moderator)
Tom Lowery, Chief Technology Officer, Satellite Bio
Blair McNeill, Executive Vice President CMC and Manufacturing, Enzyvant
Kim Raineri, Chief Technology Officer, Aspen Neuroscience
Tina Rausch, Senior Director of Quality, Miromatrix Inc.
Carl Simon, Biologist, NIST

2:00 – 2:45pm: PANEL DISCUSSION: Funding, Partnering Perspectives and Market Opportunities

Brock Reeve, CEO and Co-Founder, Eos BioInnovation (Moderator)
Justin Briggs, Biologist and Partner, Prime Movers Lab
Rima Chakrabarti, Partner, KdT Ventures
Ruchika Nijhara, Executive Director, Maryland Stem Cell Research Fund
Rahul Thakar, Program Director, National Heart, Lung, and Blood Institute

2:45 – 3:00pm: Afternoon Break
3:00 – 3:30pm: PRESENTATION: Regulatory Considerations for Cell-Based Tissue Engineered and Regenerative Medicine Products

Laura Ricles, Chief of Tissue Engineering Branch 1, FDA

3:30 – 4:30pm: PANEL DISCUSSION: Regulatory Perspectives

Deborah Hursh, Principal, Hursh Cell Therapy Consulting, LLC (Moderator)
Don Fink, Master Practice Expert, Regulatory at Dark Horse Consulting Group
Heather Lombardi, Director of the Office of Cellular Therapy and Human Tissue CMC, FDA
Mason Macenski, VP of Clinical and Regulatory Affairs, Miromatrix
Laura Ricles, Chief of Tissue Engineering Branch 1, FDA
Debra Webster, Vice President Regulatory Affairs, Aditum Bio

4:30 – 4:45pm: Concluding Remarks

Mike Lehmicke, Vice President, Scientific and Industry Affairs, Alliance for Regenerative Medicine (ARM)

September 6, 2023
9:00am - 4:45pm ET

The Bethesda North Marriott
Hotel & Conference Center

5701 Marinelli Rd.
Rockville, MD 20852


Please contact Natalie Fekete at