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BioFabUSA 2018 Fall Summit


  • Technology Center Auditorium 400 Commercial St Manchester, NH 03101 US (map)

ARMI | BioFabUSA will be hosting the Fall Summit on Wednesday September 19th and Thursday September 20th, 2018.


Accelerating the Commercialization of Engineered Organs and Tissues

Many relevant lessons for accelerating the commercialization of engineered tissues and organs have been learned by industry pioneers and we have much to learn from the pioneers of other transformative industries.  BioFabrication industry leaders as well as special guests will discuss the type of strategies that exist to transition from research to clinical trial to commercial market to patient populations.  In order to ensure that this nascent industry has the talent to grow and thrive, the summit will also have a focus on needed workforce development outcomes and strategies.

The 2018 Fall Summit will run on Wednesday September 19 and Thursday September 20 at the Technology Center Auditorium in Manchester NH.

AGENDA

Wednesday September 19

7:30 – 8:40  Registration Check-in, Networking Breakfast

8:40 – 8:45  Day One Opening

8:45 – 9:15  Opening Speaker:  Dean Kamen, Executive Director, ARMI

9:15 – 9:45  Keynote Speaker:  Dr. Sandeep Patel, Open Innovation Manager, US Department of Health and Human Services - KidneyX Project

9:45 – 10:30  Session One: Visions to an Engineered Organ

  • Dr. Murray Sheldon, Associate Director of Technology and Innovation, CDRH/FDA - KHI Renal Replacement Therapy Roadmap

  • Panel Discussion: What should be the role of prizes and roadmaps in defining the final product goals and path?

    • Moderator: Dr. Becky Robinson-Zeigler, Deputy Chief Regulatory Officer, ARMI

    • Panelist: Dr. Tom Bollenbach, Chief Technology Officer, ARMI

    • Panelist: Dr. Sandeep Patel, Open Innovation Manager, US Department of Health and Human Services

    • Panelist: Dr. Murray Sheldon, Associate Director of Technology and Innovation, FDA

10:30 – 11:00  Networking Break

11:00 – 12:15  Session Two: Federal Government & Non-Federal Collaborations and Partnerships

  • Dr. Tom Bollenbach, Chief Technology Officer, ARMI - BioFabUSA Vision and Realization Update – Making the Technical Roadmap Real!

  • Dr. Amy Patterson, Chief Scientific Officer and Director of Scientific Research Programs, Policy and Strategic Initiatives, IOD/NHLBI/NIH - NIH 21st Century Cures Funding for Regenerative Medicine

  • Dr. Peter Marks, Director, CBER/FDA - FDA’s work Facilitating the Development of Regenerative Medicine Products

  • Dr. Sheng Lin-Gibson, Acting Chief of Biosystems & Biomaterials Division, NIST

  • Panel Discussion: How do I work with the Government to advance the development of engineered tissues and organs?

    • Moderator: Dr. Richard McFarland, Chief Regulatory Officer, ARMI

    • Panelist: Dr. Tom Bollenbach, Chief Technology Officer, ARMI

    • Panelist: Dr. Amy Patterson, Chief Scientific Officer and Director of Scientific Research Programs, Policy and Strategic Initiatives, IOD/NHLBI/NIH

    • Panelist: Dr. Peter Marks, Director, CBER/FDA

    • Panelist: Dr. Sheng Lin-Gibson, Acting Chief of Biosystems & Biomaterials Division, NIST

12:15 -1:35  Lunch Break

1:35 – 2:55  Session Three: Education and Workforce Development – The Road to the Roadmap and Beyond

  • Mike Decelle, Dean, UNH Manchester & Chief Workforce Officer, ARMI and Dr. Mary Stewart, Director of Education and Workforce

  • Panel Presentation and Discussion: Current Industry-Academic Efforts Toward Making the EWD Roadmap Real

    • Panelist: Stephen Kennedy, Histogenics - High School Internship Program

    • Panelist: Patrick Thayer, Bioink Officer, CELLINK - BioHackNH

    • Panelist: Dr. Kyle MacLea, Assistant Professor of Biological Sciences and Biotechnology, UNH Manchester - Online Intro to Biotech Manufacturing

    • Panelist: Dr. David Brafman, Assistant Professor, School of Biological and Health Systems Engineering, Director, ASU Stem Cell Training and Research (STaR) Program, Arizona State University - Towards Comprehensive Online Certificate and Degree Programs in Regenerative Medicine and Biomanufacturing

2:55 – 3:25  Networking Break

3:25 – 4:45  Session Four: Current Standards Landscape for Regenerative Medicine and the Map to the Future Standards Developments

  • Dr. Richard McFarland, Secretary, Standards Coordinating Body - Review of the 2018 Landscape Portrait

  • Maria Palombini, Director, Emerging Communities & Opportunities Development, Global Business Strategy & Intelligence, IEEE Standards Association

  • Christine Reilley, Business Development Director, Healthcare, ASME - Bioprocessing Equipment Standard and Certification: Use and Applications

  • Dr. Liisa Kuhn, Associate Professor & Associate Head of the Department of Biomedical Engineering in the School of Dental Medicine, University of Connecticut Health Center - Standardization Strategies to Advance the Biofabrication Industry

  • Panel Discussion

    • Moderator: Kendra Chappell, Director, Nexight Group

    • Panelist: Dr. Richard McFarland, Secretary, Standards Coordinating Body

    • Panelist: Maria Palombini, Director, Emerging Communities & Opportunities Development, Global Business Strategy & Intelligence, IEEE Standards Association

    • Panelist: Christine Reilley, Business Development Director, Healthcare, ASME

    • Panelist: Dr. Liisa Kuhn, Associate Professor & Associate Head of the Department of Biomedical Engineering in the School of Dental Medicine, University of Connecticut Health Center

4:45  Day One Close

5:00 – 8:00: BioFab & Brews at the Currier Museum of Art

Thursday September 20

7:30 – 7:45  Doors Open for Member Breakfast (attendance limited to members of ARMI | BioFabUSA only)

7:45 – 8:45  Member Breakfast and Institute Update

8:45 – 9:15  Doors Open for General Attendees

9:15 – 9:20  Day Two Opening

9:20 – 9:50  Keynote  Speaker:  Dr. Paul Lewis, Professor of Political Economy, King's College London - Training the Future Workforce for an Emerging Industry: The Case of Technician Skills and Training in Advanced Therapies

9:50 – 10:50  Session One:  Centralized or Decentralized Manufacturing – That is the Question!

  • Maureen Bennett, Partner, Jones Day - CGMP Overview-Issues for Centralized/Decentralized Manufacturing

  • Stephen Kennedy, Executive Vice President and Chief Operating Officer, Histogenics - Centralized Manufacturing is the Answer

  • Dr. Jay Hoying, Chief Scientist, Advanced Solutions Life Sciences - Decentralized Manufacturing is the Answer

  • Debate

    • Moderator: Maureen Bennett, Partner, Jones Day

    • Panelist: Stephen Kennedy, Executive Vice President and Chief Operating Officer, Histogenics

    • Panelist: Jay Hoying, Chief Scientist, Advanced Solutions Life Sciences

10:50 – 11:20 Networking Break

11:20 – 11:50  Session Two:  RMAT, What’s in a Name?  Understanding the Regulatory and Reimbursement Implications for Development of Engineered Tissue and Organs

  • Dr. Becky Robinson-Zeigler, Deputy Chief Regulatory Officer, ARMI - Overview of RMAT

  • Dr. Luke Burnett, Chief Science Officer, Keratin Biosciences Inc. - Biologically Active Scaffolds as RMAT Products

11:50 -12:50  Lunch Break

12:50 – 2:00  Session Two, Part Two: RMAT, What’s in a Name?  Understanding the Regulatory and Reimbursement Implications for Development of Engineered Tissue and Organs

  • Lucy Hodder, Director of Health Law and Policy, Professor of Law, UNH - General Overview of Reimbursement in the US

  • Dr. Wendy Dean, Senior Vice President, Program Operations, Henry M. Jackson Foundation for the Advancement of Military Medicine - Reimbursement Lessons Learned: Vascularized Composite Allotransplantation

  • Robin Bostic, DVP Global Health Economics and Reimbursement, Abbott

  • Panel Discussion

    • Moderator: Dr. Becky Robinson-Zeigler, Deputy Chief Regulatory Officer, ARMI

    • Panelist: Dr. Luke Burnett, Chief Science Officer, Keratin Biosciences Inc.

    • Panelist: Lucy Hodder, Director of Health Law and Policy, Professor of Law, UNH

    • Panelist: Dr. Wendy Dean, Senior Vice President, Program Operations, Henry M. Jackson Foundation for the Advancement of Military Medicine

    • Panelist: Robin Bostic, DVP Global Health Economics and Reimbursement, Abbott

2:00 – 3:00  Session Three: Global Efforts to Commercialize

  • Dr. Michael May, CEO, Centre for Commercialization of Regenerative Medicine

  • Dr. Patrick Ginty, Head of Regulatory Affairs, Cell and Gene Therapy Catapult - The Regulatory Framework for Developing Tissue Engineered Products – An EU Perspective

  • Dr. Christoph Feest, Innovation Facilitator & Head of Science Management, Berlin-Brandenburg Centre for Regenerative Therapies - EU-phoria: Academia’s Drive for Cell and Gene Therapy

  • Panel Discussion

    • Panelist: Dr. Michael May, CEO, Centre for Commercialization of Regenerative Medicine

    • Panelist: Dr. Patrick Ginty, Head of Regulatory Affairs, Cell and Gene Therapy Catapult

    • Panelist: Dr. Christoph Feest, Innovation Facilitator & Head of Science Management, Berlin-Brandenburg Centre for Regenerative Therapies

3:00  Summit Close


If you are attending the Fall Summit and need overnight accommodations, a room block has been set aside at the Manchester Downtown Hotel.  To make reservations please call 603-625-1000 and ask for the ARMI | BioFabUSA rate or visit https://ARMI0918